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OMR Full 63.pdf 1 4/14/2011 2:29:49 PM
Committee Chairs
Agreement
(OMA-Ministry of Health and
Long-Term Care)
Agreement Board Co-ordinating
Committee
Dr. M. Toth
Forms Committee
Dr. A. Studniberg
Joint Committee on the Schedule
of Benefits
Dr. P. Conlon
Medical Audit Oversight Committee
Dr. D. Hellyer
Medical Services Payment Committee
Dr. L. Colman
Physician LHIN Tripartite Committee
Dr. T. Nicholas
Physician Services Committee
Dr. M. Toth
Workplace Safety & Insurance Board
Steering Committee
Dr. J. Tracey
Governance
Board Governance Committee
(Board Co-ordinating Committee)
Dr. M. Toth
Annual Meeting Planning Committee
Dr. M. MacLeod
Audit Committee
Dr. R. Mann
Awards Committee
Dr. J. Willett
Board Planning Committee
Dr. D. Weir
Budget Committee
Dr. V. Tandan
Committee on Committees
Dr. R. Mann
Council Committee on Structure & Bylaws
Dr. J. Willett
Nominations Committee
Dr. M. MacLeod
Staffing Committee
Dr. V. Walley
Health Policy
Health Policy
(Board Co-ordinating Committee)
Dr. S. Chris
eHealth Working Group
Dr. S. Chris
Hospital Issues Committee
Dr. V. Tanden
Member Services
Member Services
(Board Co-ordinating Committee)
Dr. V. Walley
Physician Health Program Advisory Panel
Dr. D. Puddester
Public & Political Advocacy
Communications Advisory Committee
(Board Co-ordinating Committee)
Dr. D. Weir
Outreach to Women Physicians Committee
Dr. R. Forman
Executive, Board, Council, Committee Chairs
Executive Committee
President
Dr. M.S. Kennedy, Thunder Bay
President Elect
Dr. D. Weir, Toronto
Past President
Dr. M. MacLeod, London
Chair of the Board
Dr. S. Wooder, Stoney Creek
Honorary Treasurer
Dr. V. Tandan, Hamilton
Secretary
Dr. M. Toth, Aylmer
Board of Directors
District
1 Dr. D.J. Hellyer, Windsor
2 Dr. M. MacLeod, London
Dr. M. Toth, Aylmer
3 Dr. C. Cressey, Palmerston
4 Dr. V. Tandan, Hamilton
Dr. R. Tytus, Hamilton
5 Dr. S. Whatley, Mount Albert
Dr. J. Tracey, Brampton
6 Dr. J. Ludwig, Peterborough
7 Dr. A. Steacie, Brockville
8 Dr. G. Beck, Ottawa
Dr. A. Kapur, Ottawa
9 Dr. P. Bonin, Sudbury
10 Dr. M.S. Kennedy, Thunder Bay
11 Dr. S. Chris, North York
Dr. L. Colman, Etobicoke
Dr. C. Jyu, Scarborough
Dr. C. Pinto, Etobicoke
Dr. A. Studniberg, Scarborough
Elected by Council
Dr. A. Donohue, Ottawa
Dr. W. Tanner, Toronto
Dr. V. Walley, Peterborough
Dr. D. Weir, Toronto
Dr. S. Wooder, Stoney Creek
Academic Representative
Dr. R.K. Edwards, Kingston
CouncilChair
Dr. A. Hudak, Orillia
Vice-Chair
Dr. E. Barker, Wiarton
Mar12_executive_committee_p1.indd 1 12-03-05 10:14 AM
INDICATIONS AND CLINICAL USEZOSTAVAX® is indicated for the prevention of herpes zoster (shingles) in individuals50 years of age or older.
SELECTED IMPORTANT SAFETY INFORMATIONZOSTAVAX® is not a treatment for zoster or postherpetic neuralgia (PHN). If anindividual develops herpes zoster despite vaccination, active current standard ofcare treatment for herpes zoster should be considered. Vaccination with ZOSTAVAX®may not result in protection of all vaccine recipients. ZOSTAVAX® is contraindicatedin patients with a history of hypersensitivity to any component of the vaccine,including gelatin; a history of anaphylactic/anaphylactoid reaction to neomycin;primary and acquired immunodeficiency states due to conditions such as: acuteand chronic leukemias; lymphoma; other conditions affecting the bone marrowor lymphatic system; immunosuppression due to HIV/AIDS, cellular immunedeficiencies; immunosuppressive therapy (including high-dose corticosteroids);active untreated tuberculosis; pregnancy. In clinical trials, ZOSTAVAX® has beenevaluated for general safety in more than 32,000 adults 50 years of age or older.ZOSTAVAX® was generally well tolerated. Vaccine-related injection-site andsystemic adverse experiences reported at an incidence ≥1% are shown below.The overall incidence of vaccine-related injection-site adverse experiences wassignificantly greater for subjects vaccinated with ZOSTAVAX® versus subjects whoreceived placebo (48% for ZOSTAVAX® and 17% for placebo among recipientsaged≥60 (Shingles Prevention Study [SPS]) and 63.9% for ZOSTAVAX® and 14.4%for placebo among recipients aged 50-59) (ZOSTAVAX® Efficacy and Safety Trial[ZEST]). Vaccine-related injection-site and systemic adverse experiences reported in≥1%of adults who received ZOSTAVAX® (N=3,345) or placebo (N=3,271) (0-42DaysPostvaccination) in the Adverse Event Monitoring Substudy of the SPS were:erythema† (35.6%, 6.9%), pain/tenderness† (34.3%, 8.6%), swelling† (26.1%,4.5%), hematoma (1.6%, 1.4%), pruritus (7.1%, 1.0%), warmth (1.7%, 0.3%),headache (1.4%, 0.9%). Most of these adverse experiences were reported asmild inintensity. The remainder of subjects in the SPS received routine safetymonitoring, butwere not provided report cards. The types of events reported in these patients weregenerally similar to the SPS subgroup of patients in the Adverse Event MonitoringSubstudy. Vaccine-related injection-site and systemic adverse experiencesreported in ≥1% of adults who received ZOSTAVAX® (N=11,094) or placebo(N=11,116) (1-42 Days Postvaccination) in the ZEST were: pain† (53.9%, 9.0%),erythema† (48.1%, 4.3%), swelling† (40.4%, 2.8%), pruritus (11.3%, 0.7%),warmth (3.7%, 0.2%), hematoma (1.6%, 1.6%), induration (1.1%, 0.0%),headache (9.4%, 8.2%), pain in extremity (1.3%, 0.8%).
THE FIRST AND ONLY VACCINE INDICATEDTO HELP PREVENT HERPES ZOSTER
IN INDIVIDUALS 50 YEARS OF AGE OR OLDER
* ZOSTAVAX® is not indicated to reduce the morbidity and complications associated with herpes zoster.† Designates a solicited adverse experience. Injection-site adverse experiences were solicited only from Days 0-4 postvaccination in SPSand from Days 1-5 postvaccination in ZEST.
Please visit our website at:www.merck.ca
VACC-1008558-0000-E-CDN-AUG-12
A DISEASE THAT MAY CAUSEBURNING, STABBING,SEARING PAIN2*
® Registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. Used under license.© 2011 Merck Canada Inc., a subsidiary of Merck & Co., Inc. All rights reserved.
Approximately 95% of Canadian adults have hadchickenpox and are therefore at risk for herpes zoster1
And there is no way to predictwho will develop herpes zoster3
ZST-076 SP Ad OntMedRev:Layout 1 8/8/11 3:16 PM Page 1
7 Editorial: Response to the Drummond Report Too many of Drummond’s recommendations are distanced from the realities of
frontline patient care, and do not adequately acknowledge the significant vari-
ables that impact the provision of services in various disciplines, care settings,
and geographic areas of the province. The potential impacts on public health
and the social determinants of health are not well articulated. And, the related
costing — both immediate and long term — is absent or vague.
10 132nd OMA Annual General and Council Meeting:
calendar of events, registration information
16 General surgery in Ontario: volume and mix changes
over time An analysis by the OMA Economics Department shows that while Ontario’s
wait time strategy (WTS) initiative in general has been successful in reducing
wait times for patients receiving a select group of services, it has done so at
the cost of hindered access to patients needing non-WTS services, and work
opportunities for physicians providing those services.
20 OMA programs and workshops strengthen physician
leadership roles in Ontario Member feedback regarding the many leadership initiatives offered by the
OMA continues to be very positive. The Physician Leadership Development
Program is now accepting applications for its third cohort, which will begin in
September 2012. Details are posted online — the deadline to apply is May 5.
22 Medical societies partner with Physician Health
Program to present “mindfulness” seminar Markham Stouffville and York County medical societies recently joined forces
with the OMA Physician Health Program to provide local physicians with an
opportunity to partake in a unique event entitled “Mindfulness in Medicine.”
28 Interpretive Bulletin: pre-dental/pre-operative
assessments, fee code Z110 The Education and Prevention Committee has prepared a review of 2011
changes to the Schedule of Benefits regarding pre-dental/pre-operative
assessments, and fee code Z110 (extensive debridement of an onychogry-
photic nail involving the removal of multiple laminae).
33 The promising value of an MBA for the Canadian MD As the Canadian health-care system evolves, the fundamental skills taught
through a Master of Business Administration program — such as change
management, leadership, learning to work in a team, and financial literacy —
are likely to increase in value to physicians.
March 2012
Volume 79 Number 3
www.oma.org
March 2012 Volume 79 Number 3
www.oma.org
PM
4114
4507
Dedicated to Doctors. Committed to Patients.
OMA Annual General Meeting132nd OMA AGM/Council Meeting May 3-6 in
Toronto: calendar of events, registration
EditorialResponse to the Drummond Report
Electronic Medical RecordsHow to select an EMR that best meets your
practice needs
Physician LeadershipPhysician Leadership Development Program now
accepting third cohort applications — May 5 deadline
General Surgery in OntarioVolume and mix changes over time
Interpretive BulletinSchedule of Benefits changes to pre-dental/
pre-operative assessments, fee code Z110
Successfully managing your career in medicine
Publications Mail
Agreement # 41144507
Undeliverables, please return to:
Ontario Medical Review
150 Bloor St. West, Suite 900
Toronto, Ontario M5S 3C1
FEATURES
March 20123ONTARIO MEDICAL REVIEW
44 Successfully
managing your career
in medicine
Generally speaking, physicians
graduate from medical school in
their mid-to-late 20s, and retire
in their mid-to-late 60s. Thus,
a medical career tends to span
at least 40 years. What sustains
and excites us at the start of our
professional journey may not be
enough to fulfil us during other
phases of our career. Dr. Mamta
Gautam, a pioneer in the area
of physician health and keynote
speaker at the upcoming 13th
Annual Women’s Health Care
Seminar, provides strategies and
knowledge to help physicians
assess and reshape their goals
to ensure they maintain a high
level of satisfaction throughout
their professional and personal
lives.
Mar12_table_contents_p3_p5.indd 1 12-03-09 4:22 PM
Bell comes to your aid with a variety of telecommunication solutions.
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Name: MB-M-011612_pub_Bell_OMA_8_125x10_875_20110808.pdf Size: 8.125x10.875 Date: Aug 8, 2011Color:CMYK
Bell can provide you with simple solutionsat rates exclusive to OMA members.
For more information dial 1 855 662-2355
24 Electronic Medical Records: selecting an EMR that
meets your practice needs OntarioMD has prepared a step-by-step guide to selecting the right electronic
medical record system for your practice, including tips on arranging vendor
demonstrations, co-ordinating site visits with existing users of various systems,
conducting vendor reference checks, and negotiating a contract.
26 Ask the EMR Expert: maintaining patient engagement
when using a computer during consultation There are a number of approaches to the placement and organization of office
furniture that can help physicians maintain a positive dialogue and rapport
with patients when using an EMR/computer during the consultation.
46 OMA Insurance Update: will power — the importance
of estate planning The right insurance and investment strategies are two important parts of sound
financial planning. The third part — your will — is an essential component of
an effective estate plan, providing for an orderly transfer of your assets to your
chosen beneficiaries, and the opportunity to choose the executor of your estate.
COLUMNS
March 20125ONTARIO MEDICAL REVIEW
Editor
Jeff Henry
Managing Editor
Elizabeth Petruccelli
Associate Editor
Matthew Radford
Advertising/Circulation Co-ordinator
Kim Secord
Production Co-ordinator
Angelica Santacroce
Classifieds Co-ordinator
Vita Ferrante
Art Direction
Artful Dodger Communications Inc.
Publisher’s Notes
Published 11 times yearly by the
Ontario Medical Association
150 Bloor St. West
Suite 900
Toronto, Ontario
M5S 3C1
Tel. 416.599.2580 or
Toll-free: 1.800.268.7215
Fax: 416.340.2232
Email: omr@oma.org
OMA website: www.oma.org
ISSN 0030 302X
Any opinions expressed in articles and
claims made in advertisements are
the opinions of the authors/advertisers
and do not imply endorsement by the
Ontario Medical Association.
The Ontario Medical Review welcomes
readers’ views. Letters to the editor
should be addressed to Ontario Medical
Review, 150 Bloor St. West, Suite
900, Toronto, Ontario M5S 3C1; fax
416.340.2232; email: jeff.henry@oma.
org. Note: letters may be edited for
space and clarity. Please include name,
address and daytime phone number.
(Additional “Publisher’s Notes” appear
on page 63)
March 2012
Volume 79 Number 3
www.oma.org
CAPSULE NEWS
9 13th Annual Women’s Health Care Seminar to be held May 3 in Toronto
13 Education and Prevention Committee presents complimentary
accredited medical billing seminar, May 4 in Toronto
32 Update re opioid prescribing and dispensing
37 Members invited to provide input on OMA policy priorities
41 Ontario Medical Student Bursary Fund 8th Annual Fundraising Golf
Tournament: June 15, Angus Glen Golf Club
48 OMA 2012 Corporate Hotel Directory: preferred rates for members
DEPARTMENTS
1 OMA Executive, Board, Council,
Committee Chairs
6 OMA Section Chairs
38 Health Policy Report
40 Board of Directors Report:
February 8-9, 2012
43 In Memoriam
58 Classifieds
64 Medectoon/Advertisers’ Index
Mar12_table_contents_p3_p5.indd 2 12-03-09 4:22 PM
Addiction Medicine Dr. R. Cooper
Allergy and Clinical Immunology
Dr. B. Wong
Anesthesiology Dr. J. Watson
Cardiac Surgery Dr. F. Rubens
Cardiology Dr. W. Hughes
Chronic Pain Physicians Dr. H. Jacobs
Clinical Hypnosis Dr. M. Dales
Clinical Teachers Dr. R. Edwards
College and University Student Health
Dr. D. Grant
Community Health Centre & Aboriginal
Health Access Centre Physicians
Dr. I. Tamari
Complementary and Integrative Medicine
Dr. C. Appleyard (Acting Chair)
Critical Care Medicine Dr. M. Warner
Dermatology Dr. S. Gupta
Diagnostic Imaging Dr. M. Prieditis
Emergency Medicine Dr. M. Haluk
Endocrinology and Metabolism
Dr. J. Shaban
French-Speaking Physicians Dr. T. Dufour
Gastroenterology Dr. D. Baron
General and Family Practice Dr. J. Lusis
Genetics Dr. L. Velsher
Geriatrics and Long-Term Care Dr. A. Baker
GP Psychotherapy Dr. M. Paré
Group Practice Dr. G. Maley
Hematology and Medical Oncology
Dr. P. Kuruvilla
Hospitalist Medicine Dr. L. Bustani
HSO Physicians Dr. J. Craig
Hyperbaric Medicine Dr. A.W. Evans
Independent Physicians Dr. J. Szmuilowicz
Infectious Diseases Dr. N. Rau
Internal Medicine Dr. M. Wilson
Interns and Residents Dr. M. Dufour
Laboratory Medicine Dr. C.M. McLachlin
Medical Students
Ms. S. Kenny, Ms. M. Olszewski
Nephrology Dr. C. Edwards
Neurology Dr. E. Klimek
Neuroradiology Dr. S. Symons
Neurosurgery Dr. F. Gentili
Nuclear Medicine Dr. C. Marriott
Obstetrics and Gynecology Dr. B. Mundle
Occupational and Environmental Medicine
Dr. M. Cividino
Ophthalmology Dr. N. Nijhawan
Orthopedic Surgery Dr. D. MacKinlay
Otolaryngology - Head and Neck Surgery
Dr. O. Smith
Palliative Medicine Dr. D. Cargill
Pediatrics Dr. H. Yamashiro
Physical Medicine and Rehabilitation
Dr. D. Berbrayer
Plastic Surgery Dr. B. Vanbrenk
Psychiatric Hospitals, Schools
Dr. S. Allain
Psychiatry Dr. D. Brownstone
Public Health Physicians Dr. H. Shapiro
Radiation Oncology Dr. D. D'Souza
Reproductive Biology Dr. C. Librach
Respiratory Disease Dr. H. Ramsdale
Rheumatology Dr. P. Baer
Rural Practice Dr. S. Cooper
Sleep Disorders Dr. A. Soicher
Sport and Exercise Medicine
Dr. T. Jevremovic
Surgery, General Dr. A. Maciver
Surgical Assistants Dr. D. Esser
Thoracic Surgery Dr. R. Zeldin
Urology Dr. F. Papanikolaou
Vascular Surgery Dr. A. Dueck
Section Chairs
March 20126ONTARIO MEDICAL REVIEW
Mar12_section_chairs_p6.indd 1 12-03-05 10:42 AM
EDITORIAL
ONTARIO MEDICAL REVIEW March 20127
THE RECENT RELEASE OF THE REPORT OF THE COMMISSION ON THE REFORM OF ONTARIO’S PUBLIC
SERVICES, CHAIRED BY ECONOMIST DON DRUMMOND, PROMPTED A TREMENDOUS VOLUME OF MEDIA
COVERAGE AND PUBLIC COMMENTARY, MUCH OF IT FOCUSED ON HEALTH CARE.
The OMA issued an initial response,
which we communicated to members
via the President’s Update, and our
internal analysis of the Drummond file
is continuing as this issue of the OMR
goes to press.
Our policy, economics and legal
departments, and other program areas
within the Association, are doing a
thorough review of the Commission’s
research and recommendations. We
will notify members once that work is
concluded.
The Commission’s emphasis on
patient-centred care and improved
efficiency, quality and integration are
already significant components of the
health-care system that we have been
engaged in for a number of years.
Of course, we support the call to
more actively promote healthy lifestyles
and preventive care among Ontarians.
Though we cannot overlook the gibe
that “doctors address diet and exercise
issues before reaching for the prescrip-
tion pad when dealing with...cardio-
vascular disease and late-onset Type 2
diabetes.” This is an insult to physicians
and discredits the report and its authors.
The OMA shares the commitment
to advance team-based care and inter-
professional collaboration, and more
reliance on information technology in
doctors’ offices. Unfortunately, the re-
port is void of any discussion regarding
the inherent related costs to the system.
And, we firmly believe that a move
toward more specialized treatment cen-
tres outside of hospital, and enhanced
home care and community-based
services are in the best interests of
patients, providers, and government.
In its focus on physicians, the Com-
mission urges government to “aggres-
sively negotiate with the Ontario Medical
Association for the next agreement.”
The Commission makes the glib
(and inaccurate) assertion that Ontario
doctors are the highest paid in Canada,
therefore “it is reasonable to set a goal
of allowing no increase in total compen-
sation.”
The Commission further proposes
that negotiations “must go well beyond
compensation. They must also address
the integration of physicians into the
rest of the health-care system and the
objective of working towards the best
possible health quality regime.” We can
safely predict that integration and qual-
ity will be priorities for doctors and gov-
ernment.
Drummond uses the terms “total
compensation” and “total compensa-
tion envelope” in assigning the govern-
ment’s negotiations goal for doctors.
Nowhere are the terms defined, but this
does warrant some attention.
The population of Ontario contin-
ues to grow and age. The number of
complex patients is increasing. And the
College of Physicians and Surgeons of
Ontario has certified an unprecedented
number of new physicians in the effort
to keep pace with the medical require-
ments of the citizens of this province.
At the same time, the Ministry of
Health and Long-Term Care recently
announced its ambitious Action Plan
for Health Care, which sets out a broad
range of new initiatives.
If there is no increase in total com-
pensation — as Drummond advises
— how will government address the
Response to Drummond
Mar12_editorial_pp7-8_v5.indd 1 12-03-09 4:25 PM
ONTARIO MEDICAL REVIEW
growing public need for medical ser-
vices associated with demographic
trends?
And how will we sustain the tremen-
dous improvements in patient access
to care and system innovation that we
have worked so hard to achieve?
Is Drummond suggesting that gov-
ernment ration or cut certain services to
patients in order to fund new or alterna-
tive areas of health investment? This
scenario is plainly unacceptable.
The health-care segment of this
report reflects a basic cut and paste
of the Commission’s discussions with
individuals, organizations, corporations
and government.
The report lacks the evidence to
support many of its recommendations.
There is no costing associated with
suggestions to expand certain health
services, and it lacks an implementation
schedule that takes into consideration
impacts on patient care.
Overall, too many of Drummond’s
recommendations are distanced from
the realities of frontline patient care,
and do not adequately acknowledge
the significant variables that impact the
provision of services in various disci-
plines, care settings, and geographic
areas of the province.
Also, the potential impacts of the
Commission’s recommendations on
public health and the social determi-
nants of health are not well articulated.
While the report offers 105 recom-
mendations on health care alone, it
rings hollow in terms of presenting
any new ideas or innovative thinking to
guide the system forward.
And, as noted earlier, the related
costing — both immediate and long
term — is absent or vague.
Also, the tone of the Commission’s
Report toward physicians is dismissive
and abrupt, and frankly not helpful in
encouraging a constructive dialogue.
The physicians of Ontario have
worked exceptionally hard and excep-
tionally well throughout the past decade
to improve public access to care and to
address many long-standing targeted
problems in the health-care system.
We have achieved this progress
working together in partnership with the
Ministry of Health and Long-Term Care
and other health-care stakeholders and
organizations.
The Drummond Report chooses to
ignore or diminish a lot of these accom-
plishments, much like the Auditor
General’s recent Annual Report.
Instead, doctors are painted as barriers
to progress and innovation, wedded to
the status quo.
Not only is this untrue, but it is unfair
and inappropriate, and a disservice to
the medical profession in Ontario.
It has taken years to improve the
province of Ontario’s reputation as a
preferred place to practise medicine.
We have worked very hard to address
the physician shortage, to attach
patients to family doctors, and bolster
our medical training programs.
We’ve developed very unique and
innovative means to address both local
and systemic problems, to incent pro-
viders, encourage collaboration, and
transform the delivery of care.
The evidence is found in our master
agreements, varied payment mecha-
nisms, and tailored programs and
services designed by physicians and
government to enhance the provision
of care to patients throughout this prov-
ince.
Yet, rather than acknowledge the
leadership role of Ontario doctors in
affecting real positive change in the
health-care system, the Drummond
Report espouses that physicians
should be dealt with arbitrarily, if at all.
The report advocates that the prov-
ince of Ontario is the leader among
al l provinces in health care. The
Commission cites the need to invest
in medical innovation and to imple-
ment more incentives in health care
to advance change and efficiency. Of
course, these are all laudable objec-
tives.
Unfortunately, the numerous contra-
dictions and narrow focus throughout
the report serve to undermine its many
positive recommendations.
As I stated recently to the media:
Now is not the time to put the brakes on
progress. Nor can we afford to back-
slide based on ill-informed assump-
tions.
The OMA is determined to work
with government and others to main-
tain the positive course that we have
set in health care, to tackle current chal-
lenges, and forge a better system for
patients and providers in the future.
Dr. Stewart Kennedy
OMA President
EDITORIAL
8 March 2012
Do you have an OMA-related question and
don’t know who to contact?
Send the Response Centre an email at
info@oma.org or call 1.800.268.7215 and
press 0.
Mar12_editorial_pp7-8_v5.indd 2 12-03-09 4:25 PM
ONTARIO M EDICAL ASSOC IAT ION
The 13th annual Women’s Health Care Seminar
is complimentary to OMA members, and has
been accredited in previous years for CME
credits. To register, visit www.oma.org/AGM, or
contact Jennifer Csamer at 1.800.268.7215, ext.
3461, or via email (jennifer.csamer@oma.org).
Featuring Dr. Mamta Gautam on Understanding Physician Health
Current Challenges in Mental Health
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ONTARIO MEDICAL REVIEW
132nd OMA Annual General and Council MeetingCalendar of Events
Thursday, May 3 – Sunday, May 6, 2012
Toronto Marriott Downtown Eaton Centre Hotel, Toronto, Ontario
Pre-registration is required for all meetings. You may register online at: www.oma.org/AGM
March 201210
WOMEN’S HEALTH CARE SEMINAR:
CURRENT CHALLENGES IN MENTAL HEALTH
– THURSDAY, MAY 3
The OMA Outreach to Women Physicians Committee
presents the 13th Annual Women’s Health Care Seminar,
“Current Challenges in Mental Health.” This year features a
keynote address by Dr. Mamta Gautam on Understanding
Physician Health (see page 9 for more details).
EDUCATION AND PREVENTION COMMITTEE
BILLING SESSIONS – FRIDAY, MAY 4
The Education and Prevention Committee (EPC), in con-
junction with the OMA, will host educational billing sessions
on Friday, May 4, from 0900 – 1200 and 1400 – 1700. The
morning session, beginning at 0900, will focus on recent
changes to the Schedule of Benefits (and what they mean
to you). This session is intended for all physicians, regard-
less of specialty or experience. At 1000, the Ministry of
Transportation will address obligations and requirements
under the Highway Traffic Act for mandatory reporting of
a medical condition. The final topic, at 1045 – 1200, is
intended primarily for physicians practising in the specialty
of internal medicine (including internal medicine sub-special-
ties). Billing cases/scenarios will be discussed.
The afternoon session, from 1400 – 1700, will be dedi-
cated to FHO/FHG Primary Care Billing. This session is
intended only for physicians participating in either a FHO
or FHG billing model. Topics include Q codes, after-hours
obligations, preventive care bonuses, and more (please
refer to page 13 for the registration form, or register online
at www.oma.org/AGM).
0900 – 1630
13th Annual Women’s
Health Care Seminar:
Current Challenges in
Mental Health (see p. 9
for more details)
Throughout the Day
and Evening
Section Annual Meetings
(see p. 12 for more
details)
0730 – 1700
Annual Meeting and
Council Registration (see
p. 11 for more details)
0730 – 1700
Annual Meeting and
Council Registration
(see p. 11 for more details)
Morning and Evening
Section Annual Meetings
Educational Sessions
and Training
(see p. 12 for more details)
1200 – 1400
Adam Linton Memorial
Feature Luncheon
(see p. 11 for more details)
1400 – 1700
Council Policy Discussion
0730 – 1700
Council Registration
(see p. 11 for more details)
0900 – 1700
Annual Meeting of Council
(see p. 11 for more details)
1230 – 1330
Council Luncheon
1830 – 2400
Awards Presentations,
Presidential Installation,
Gala Dinner/Dance
(see p. 11 for more details)
0730 – 1200
Council Registration
(see p. 11 for more details)
0900 – 1700
Annual Meeting of Council
(see p. 11 for more details)
1230 – 1330
Council Luncheon
SUMMARY OF EVENTS
Thursday,May 3
Friday,May 4
Saturday,May 5
Sunday,May 6
Mar12_AGM_calender_events_pp10-12.indd 1 12-03-05 3:45 PM
ONTARIO MEDICAL REVIEW
SOCIAL MEDIA TRAINING – FRIDAY, MAY 4
The Social Media Training 101 workshop will offer you a
hands-on approach to understanding social media and set-
ting up your own personal social media presence. The social
media universe may seem complicated and confusing, but
this introductory course will allow you to understand the
basics of operating such social media networks. You will
be able to sign up for these social networks in a detailed
step-by-step walk-through, understand some of the com-
mon social media language, and connect with users from
across the web. Questions about setup, privacy settings,
and benefits of having an online presence will be answered
at this workshop.
ADAM LINTON MEMORIAL FEATURE LUNCHEON
– FRIDAY, MAY 4
The 20th Annual Adam Linton Memorial Feature luncheon
and lecture will be presented on Friday, May 4, from 1200
– 1400, as part of the Annual General Meeting. The lecture
honours the memory and accomplishments of Dr. Adam
Linton, OMA President from June 1991 to January 1992.
Dr. Linton was a nationally renowned educator who spent
much of his time working to improve Ontario’s health-care
system. The lecture will be presented by Andrew Coyne,
writer for The National Post, and the former national editor of
Maclean’s — one of Canadian journalism’s most prestigious
and influential positions. An original member of The National
Post, where he held the position of national affairs columnist,
Mr. Coyne has established himself over the last two decades
as one of this country’s most thoughtful, passionate and
articulate commentators on political and economic issues.
There is no charge for this event, thanks to a generous
contribution from the Canadian Medical Association and its
subsidiary, MD Management.
COUNCIL ORIENTATION SESSION – FRIDAY, MAY 4
The Chair and Vice Chair of Council will be holding a Council
orientation session for Delegates. The session will focus on
providing participants with:
a) Information on your role as Council Delegates;
b) Information on the process for developing and submitting
motions to Council.
The session will be held on Friday evening, May 4, from
1730 – 1830.
ANNUAL MEETING OF COUNCIL
– SATURDAY, MAY 5 AND SUNDAY, MAY 6
Council is the governing body of the Ontario Medical
Association. The power to vote and put forward resolutions
is limited to Council Delegates, elected by the members of
each OMA Territorial Division, District and Section. However,
any OMA member who registers is entitled to attend the
meeting as an observer.
AWARDS PRESENTATIONS, PRESIDENTIAL
INSTALLATION AND GALA DINNER/DANCE
– SATURDAY, MAY 5
This year’s event will take place at The Carlu, 444 Yonge
Street (at College), 7th floor.
OMA members are invited to join in celebrating the many
contributions and accomplishments of our medical col-
leagues. The evening commences at 1830 with the awards
presentations and presidential installation. A brief reception
will follow at approximately 1930, and dinner will be held at
approximately 2000. A dance will take place after dinner,
featuring the music of the band “Blush.”
The gala dinner is presented, in part, by a generous con-
tribution from the Canadian Medical Association and its
subsidiary, MD Management.
March 201211
FEATURED EVENTS
REGISTRATION
Please register online for all meetings, including Council,
via the following link: www.oma.org/AGM. You may also
register for Council by contacting Suzi Mijango, Membership
Operations, at 416.599.2580 or 1.800.268.7215, ext. 2975,
or email: Suzi.Mijango@oma.org.
HOTEL RESERVATIONS
Rooms have been reserved at the Toronto Marriott
Downtown Eaton Centre Hotel at the rate of $199 for either
single or double occupancy. You may telephone the hotel
directly at 416.597.9200 or 1.800.905.0667. When reserv-
ing, please indicate that you are attending the meetings of
the Ontario Medical Association to ensure you receive the
preferred rate. The deadline for reservations is April 2, 2012.
After this date, reservations will be accepted on a space-
available basis only.
NOVEMBER 2012 COUNCIL MEETING AND
2013 ANNUAL MEETING
The 2012 Fall Council Meeting will be held on Saturday,
November 24 and Sunday, November 25 in Toronto at the
Toronto Marriott Downtown Eaton Centre Hotel. The 133rd
OMA Annual General and Council Meeting will be held in
Hamilton at the Hamilton Convention Centre from Thursday,
May 2 to Sunday, May 5.
GENERAL INFORMATION
Mar12_AGM_calender_events_pp10-12.indd 2 12-03-05 3:45 PM
ONTARIO MEDICAL REVIEW March 201212
Pre-registration is required for all meetings (you may register online at: www.oma.org/AGM). This schedule is preliminary
and may be amended. Your Section flyer outlining agenda items will be distributed in the coming weeks.
SECTION PROGRAM LISTING (alphabetical)
CHRONIC PAIN
Friday, May 4
& Scientific Session
0830 – 1200
CLINICAL HYPNOSIS
Thursday, May 3
1830 – 1900
1900 – 2100
CME: Mindful Treatment
of Sexual Dysfunction:
Dr. Frank Sommers
GENERAL AND FAMILY
PRACTICE
Friday, May 4
1700 – 1830
1830 – 2100
A COLLABORATIVE
OMA SESSION —
MENTAL ILLNESS/
MENTAL HEALTH
The OMA Section on GP
Psychotherapy, in association
with the OMA Sections on
Ontario Psychiatric Hospitals
and Hospital Schools,
Complementary & Integrative
Medicine, Interns and Residents,
Occupational & Environmental
Medicine and Psychiatry
Thursday, May 3
1800 – 2100
Friday, May 4
(continued)
0900 – 1100
Section on GP
Psychotherapy
1100 – 1200
HOSPITALIST MEDICINE
Friday, May 4
0800 – 1000
1000 – 1200
HSO PHYSICIANS
Friday, May 4
& Dinner
1830 – 2030
INTERNAL MEDICINE
Friday, May 4
1900 – 2000
LABORATORY MEDICINE
Friday, May 4
900 – 1200
NEPHROLOGY
Friday, May 4
& Dinner
1830 – 2100
NEUROLOGY
Friday, May 4
1730 – 1200
ONTARIO PSYCHIATRIC
HOSPITALS & HOSPITAL
SCHOOLS & OPDPS
Friday, May 4
1100 – 1200
OPHTHALMOLOGY
Friday, May 4
(Executive Members Only)
1500 – 1700
and Dinner
1800 – 2030
PHYSICAL MEDICINE AND
REHABILITATION
Friday, May 4
0800 – 1100
- 0800 – 0900
Ultrasound-Guided
Intervention in Musculoskeletal
Pain Management:
Dr. Philip Peng
- 0900 – 1000
Assessment and
Management of Those
with Persistent
Symptoms Post
Concussion:
Dr. Mark Bayley
- 1000 – 1100
Approach to Myopathy in
Clinical Practice:
Dr. Mark Tarnopolsky
- 1100 – 1200
Annual General Meeting
and Discussion of Billing
Pearls or Pitfalls
Mar12_AGM_calender_events_pp10-12.indd 3 12-03-05 3:45 PM
Education and Prevention Committee
Complimentary Accredited Medical Billing Seminar
Friday, May 4, 2012
Toronto Marriott Downtown Eaton Centre Hotel
9:00 a.m. - 10:00 a.m. 1) Ministry of Health Presentation: Summary of Schedule Changes 2011
Intended for all physicians regardless of specialty or experience. There may be limited time
for questions related to the items covered in the presentation; however, questions will be
addressed after the presentation and pending available time.
10:00 a.m. - 10:45 a.m. 2) Ministry of Transportation (MTO) Presentation: Mandatory Reporting of Medical
Condition to MTO (fee code K035)
Intended for all physicians regardless of specialty or experience. Staff from MTO will ad-
dress obligations and requirements under the Highway Traffic Act for mandatory reporting
of a medical condition. EPC members will also be on hand to discuss the OHIP payment
requirements for eligibility of payment for K035 (form fee for the mandatory reporting).
10:45 a.m. - 12:00 p.m. 3) Ministry of Health Presentation: Internal Medicine Billing for
Assessments/consultations for Hospital In-patients
Intended primarily for physicians practising in the specialty of Internal Medicine (including
Internal Medicine sub-specialties). Billing cases/scenarios will be discussed. This session
may be of interest to other specialists working in hospitals however it will only address
internal medicine specialty services.
The EPC would request that any advance questions/scenarios from Internal Medicine specialists treat-
ing hospital in-patients be faxed in advance to the number below. Only scenarios provided in advance
will be addressed in this session. The ministry will make every effort to accommodate all requests in
the allotted time.
12:00 p.m. - 2:00 p.m. Adam Linton Lunch
2:00 p.m. - 5:00 p.m. 4) FHO & FHG Primary Care Billing
Intended for physicians that are practicing in a FHO or FHG primary care model. Topics
include new codes to the schedule of benefits, clarification of existing Q codes, after hours
care, and more. A question and answer period will be available for specific issues not
covered during the presentation.
NOTE: The seminar is open only to physicians and all events are available on a first-come, first-served basis.
To register, please log on to www.oma.org/AGM by April 27, 2012.
For questions please contact Practice Advisory Services at practiceadvisory@oma.org.
Name (surname first)
Address
City Postal Code
Phone
Fax
Specialty
Please register me for:
Session 1: Schedule Changes
Session 2: Ministry of Transportation
Session 3: Internal Medicine
Adam Linton Lunch (note you must register to attend
the lunch)
Session 4: Primary Care Billing
If submitting a question/scenario for discussion during
session 3, please fax your question to 416.340.2244.
All questions will be forwarded to the EPC anonymously.
The Education and Prevention Committee (EPC) is a joint
committee of the Ontario Medical Association and the
Ministry of Health and Long-Term Care.
CouncilBillingSeminarOMRadV2.indd 1 12-02-27 2:00 PM
See prescribing summary on page
®
DOV.05.11.AdOMR.indd 1 6/14/11 11:00:24 AM
ONTARIO MEDICAL REVIEW 15
DID YOU KNOW?50% to 80%
of psoriasis patients have
SCALP INVOLVEMENT
et al J Eur Acad
Dermatol Venerol
See prescribing summary on page
12
In need of medical-legal
advice?OMA Legal Services can provide advice to members on
the following issues relating to practice:
Inquiries should be directed to OMA Legal Services:
Jim Simpson
Tel. 416.340.2940 or 1.800.268.7215, ext. 2940
Email: jim.simpson@oma.org
Robert Lee
Tel. 416.340.2934 or 1.800.268.7215, ext. 2934
Email: robert.lee@oma.org
Adam Farber
Tel. 416.340.2894 or 1.800.268.7215, ext. 2894
Email: adam.farber@oma.org
Jennifer Gold
Tel. 416.340.2889 or 1.800.268.7215, ext. 2889
Email: jennifer.gold@oma.org
Mar12_XAMIOL_1/3P+legal_filler_pxx.indd 1 12-03-05 3:51 PM
FEATURE
ONTARIO MEDICAL REVIEW
Also, despite this growth in the hospital
sector, many hospital-based physicians
(particularly those in surgical specialties)
have reported constraints in their abil-
ity to provide patient access to needed
services. These constraints include
hospital OR closures during certain
times of the year, reduced OR availabil-
ity, and an increasing trend toward last-
minute surgery cancellations.
The purpose of this paper is to exam-
ine if Ontario general surgeons, and their
patients, have experienced constrained
access to hospital resources, despite
the large expenditure increases on hos-
pitals by the provincial government.
Recently, there has been anecdotal
evidence that new surgeons have been
having difficulty finding work, and estab-
lished surgeons have been restricted
in their ability to perform surgery due
to constraints and cost-cutting mea-
sures implemented by hospitals (i.e.,
lack of OR time, nursing resources,
beds, etc.). If such restrictions are wide-
spread, they have an adverse effect on
patient access to care and wait times.
A recent national physician sur-
vey by the Fraser Institute indicates
that the most frequently cited reason
for increasing wait times has been the
“availability of OR time.”1
These views have been expressed
most recently by Ontario surgeons dur-
ing the OMA negotiations consultation
process. The surgeons cited that lack
of OR time, cancelled surgeries, etc.,
were impacting their patient access
to timely care, and that WTS services
were given priority by hospitals at the
expense of other needed services.
However, system-wide data that sub-
stantiate these claims has not been
available, and it was felt that it would
be difficult to obtain this data from hos-
pitals.
In an attempt to gather system-wide
data from administrative records, we
conducted an analysis to see if such
patterns can be discerned. If these
hospital behaviours/constraints are as
prevalent as our discussions seem to
suggest, they should be discernible in
the data. In particular, we focused on
an analysis of the number of surgeries
per general surgeons and surgery as
a share of total activity over time, and
compared all surgeries to WTS-related
surgeries. The study methodology and
results are presented below.
Summary of Results
Results of the analysis indicate that
there has been a statistically significant
decline in the number of surgeries per
doctor and in the share of surgeries in
the physician’s total practice.
The results also indicate that the
decline in the overall number of sur-
geries comes predominantly from the
decline in the non-wait time strategy-
related surgeries.
Specifically, the decline is statistically
significant only for the non-wait time
surgeries (p-value < 0.05), but not for
March 201216
General surgery in Ontario:
volume and mix changes over timepatient access to WTS services maintained at
the expense of non-WTS services
by Boris Kralj, PhD, OMA Economics Department
Jasmin Kantarevic, PhD, OMA Economics Department
OVER THE PAST DECADE, ONTARIO GOVERNMENT SPENDING ON HOSPITALS HAS DOUBLED. IN THE LATE
1990s, THESE EXPENDITURES AMOUNTED TO ABOUT $8 BILLION. TODAY, THEY APPROACH $18 BILLION.
SOME OF THIS GROWTH IS DUE TO A GROWING AND AGING POPULATION, AND MAJOR INITIATIVES SUCH AS
THE WAIT TIME STRATEGY (WTS). YET, WHILE HOSPITAL EXPENDITURES HAVE INCREASED, THE ACTUAL NUMBER
OF BEDS, HOSPITALIZATIONS AND SURGICAL DISCHARGES HAS DECLINED (SEE FIGURES OPPOSITE).
Mar12_general_surgery_pp16-19.indd 1 12-03-07 2:42 PM
ONTARIO MEDICAL REVIEW
General Surgery in Ontario
17 March 2012
the wait time surgeries (p-value > 0.1).
Between fiscal 2005/06 and 2009/10,
the number of surgeries performed per
general surgeon declined by about 9%,
or about 28 surgeries. Similarly, sur-
gery as a share of total surgeon activity
declined by about 11%.
These results support the hypoth-
esis that surgeons are facing hospital
restrictions and that these restrictions
mostly apply to non-WTS services and
patients.
Study Methodology
The sample includes all physicians in
the OHIP Specialty 03 (General Surgery)
with any claims from fiscal 2005/06
through 2009/10. For each physician,
the number of surgeries is calculated as
the number of all A-suffix services with
M, N, R, or S prefixes. These surgeries
are further divided into surgeries that
are on the wait time strategy list and
surgeries that are not on the wait time
list. The main categories of the wait time
surgeries include cancer, cardiac, and
knee and hip surgeries.
We use the multivariate regression
framework to test for statistically sig-
nificant differences in the number of
surgeries over time. We report both
unadjusted estimates as well as esti-
mates adjusted for the confounding
effects of physician age, gender, and
geographic location of practice (Local
Health Integration Network).
We adjust for age using eight age
intervals because there is a well-known
inverted U-shape relationship between
age and phys ic ian product iv i ty .
Similarly, we adjust for gender because
of well-documented differences in pro-
ductivity between male and female phy-
sicians.
Lastly, we control for potential
regional variation by including a full set
of 14 LHIN indicators.
Study Results
The summary statistics are presented
in Table 1 and Figures 3 and 4 (see pp.
18-19). For the sample of all general
surgeons, the average number of sur-
geries per physician decreased from
298 in fiscal 2005/06 to 271 in fiscal
2009/10 (about a 9% decline). This
declining trend is also evident for the
share of surgeries in the physician’s
total practice (a decline of 11%).
Furthermore, the decline is more
pronounced for the non-wait time sur-
geries (-12%) than for the wait-time sur-
geries (-5%).
Lastly, this declining trend is even
stronger when we limit our analysis to
the sample of general surgeons who
are present in each year over the sam-
ple period — a panel (a 12% decline
over the sample period).
These summary statistics do not
adjust for the known influence of age,
gender, and regional variation on the
physician practice profiles. In Table 2,
we present the results from the multi-
variate regression that adjusts for these
6,000
7,000
8,000
9,000
10,000
11,000
12,000
13,000
14,000
15,000
16,000
17,000
18,000
1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011
Source: OMA Economics, CIHI
Figure 1:
Ontario Government Spending on Hospitals
1998-2011 ($ millions)
850,000
900,000
950,000
1,000,000
1,050,000
1,100,000
1,150,000
1,200,000
Source: OMA Economics, CIHI
1995
-199
6
2009
-201
0
1996
-199
7
1997
-199
8
1998
-199
9
1999
-200
0
2000
-200
1
2001
-200
2
2002
-200
3
2003
-200
4
2004
-200
5
2005
-200
6
2006
-200
7
2007
-200
8
2008
-200
9
Figure 2:
Ontario Inpatient Hospitalizations
Mar12_general_surgery_pp16-19.indd 2 12-03-07 2:42 PM
ONTARIO MEDICAL REVIEW
General Surgery in Ontario
18 March 2012
Panel of Same General Surgeons (2)
All Surgeries
(3)
All Surgeries/
Total Services
(4)
Non-WTS
Surgeries
(5,7)
WTS
Surgeries
(6,7,8)
362 6.4% 210 152
345 5.8% 200 145
330 5.5% 190 140
325 5.4% 182 143
318 5.3% 177 141
-12% -17% -16% -7%
All General Surgeons (1)
Fiscal Year All Surgeries
(3)
All Surgeries/
Total Services
(4)
Non-WTS
Surgeries
(5,7)
WTS
Surgeries
(6,7,8)
2005 298 6.1% 178 120
2006 292 5.6% 173 119
2007 280 5.4% 165 115
2008 271 5.3% 155 116
2009 271 5.4% 156 115
2009 vs.
2005-9% -11% -12% -5%
Notes
1) All physicians in OHIP Specialty 03 (General Surgery) with any FFS claims.
2) All physicians in OHIP Speciality 03 (General Surgery) with any FFS claims in each year 2005/06 to 2009/10.
3) Surgeries are defined as all A-suffix services with M, N, R, or S prefix.
4) Surgeries as defined in (3) as a percentage of total professional services.
5) Surgeries as defined in (3) for fee codes that are not on the list of wait time codes.
6) Surgeries as defined in (3) for fee codes that are on the list of wait time codes.
7) Full list of wait time fee codes is available upon request.
Table 1: Average Number of Surgeries per Physician, by Type of Surgery (Wait Time vs. Other), Fiscal 2000/01-2009/10,
OHIP Specialty 03 (General Surgery)
Table 2: Average Number of Surgeries per Physician, by Type of Surgery (Wait Time vs. Other), Fiscal 2005/06 vs. 2009/10
All General Surgeons (1) Panel of Same General Surgeons (2)
Estimated Difference p-value (8) Estimated Difference p-value (8)
All Surgeries (3)
Unadjusted
Adj. for Age (9)
Adj. for Age, Gender, Location (9,10)
-27.1
-30.9
-28.6
0.03
0.01
0.01
-43.5
-40.2
-40.3
0.01
0.00
0.00
Ratio of All Surgeries/All Services (4)
Unadjusted
Adj. for Age
Adj. for Age, Gender, Location
-0.7%
-0.7%
-0.8%
0.02
0.01
0.00
-1.1%
-1.2%
-1.2%
0.00
0.00
0.00
Surgeries for Wait Time Fee Codes (6,7)
Unadjusted
Adj. for Age
Adj. for Age, Gender, Location
-5.7
-7.4
-7.1
0.31
0.13
0.14
-10.8
-6.9
-8.2
0.15
0.28
0.20
Surgeries for Non-Wait Time Fee Codes (5,7)
Unadjusted
Adj. for Age
Adj. for Age, Gender, Location
-21.4
-23.5
-21.5
0.03
0.01
0.02
-32.7
-33.3
-32.1
0.01
0.00
0.00
Notes
1) All physicians in OHIP Specialty 03 (General Surgery) with any FFS claims.
2) All physicians in OHIP Speciality 03 (General Surgery) with any FFS claims in each year 2005/06 to 2009/10.
3) Surgeries are defined as all A-suffix services with M, N, R, or S prefix.
4) Surgeries as defined in (3) as a percentage of total professional services.
5) Surgeries as defined in (3) for fee codes that are not on the list of wait time codes.
6) Surgeries as defined in (3) for fee codes that are on the list of wait time codes.
7) Full list of wait time fee codes is available upon request.
8) p-value associated with a test that the difference between 2009/10 and 2005/06 is not statistically significant.
9) Differences are adjusted for eight five-age intervals in a regression framework.
10) Location is defined as the LHIN of physician practice. The regression includes 14 such indicators.
Mar12_general_surgery_pp16-19.indd 3 12-03-07 2:42 PM
OntariO Medical review
General Surgery in Ontario
19 March 2012
factors. These results indicate that the decline in the number of surgeries and the share of surgeries in the physician’s total practice is statistically significant, even when controlling for age, gen-der and location of practice (p-value < 0.05). These results hold for both the sample of all general surgeons and the sub-sample of general surgeons who were present in each year between 2005/6 and 2009/10.
The results also indicate that the decline in the overall number of sur-geries comes predominantly from the decline in the non-wait time surgeries. Specifically, the decline is statistically significant only for the non-wait time surgeries (p-value < 0.05), but not for the wait time surgeries (p-value > 0.1).
Concluding RemarksThis analysis indicates that there is a reduction in the number of surgeries per physician between 2005/06 and 2009/10. This result holds for the num-ber of surgeries, as well as the share of surgeries in physician total practice.
Moreover, the result holds even after adjusting for the confounding factors of age, gender, and location of practice.
Lastly, the reduction is statistically significant only for the non-wait time sur-geries, but not for the wait time surger-ies. WTS surgeries have not declined, but other surgeries have declined sig-nificantly.
While the WTS initiative in general has been successful in reducing wait times for patients receiving a select group of services, it has done so at a cost of hindered access to patients needing non-WTS services and work opportunities for physicians providing those services.
Reference
1. http://www.fraserinstitute.org/uploadedFiles/
fraser-ca/Content/research-news/research/
publications/why-we-wait.pdf
Dr. Kral j is Execut ive Director, OMA Department of Economics and OMA Chief Economist. Dr. Kantarevic is Senior Director, OMA Department of Economics.
0
50
100
150
200
300
250
350
2000
132
195
131
195
127
187
122
186
120
181
120
178
119
173
115
165
116
155
115
156
2001 2002
Non-Wait Time Codes Wait Time Codes
2003 2004 2005 2006 2007 2008 2009
Figure 3: Average Surgeries per Physician, Fiscal 2000/01 to 2009/10
OHIP Specialty 03 (General Surgery)
7.2% 7.1% 6.8% 6.8% 7.0%
6.1% 5.6%
5.4% 5.3% 5.4%
0.0%
1.0%
2.0%
3.0%
4.0%
5.0%
6.0%
7.0%
8.0%
9.0%
10.0%
2000 2001 2002 2003 2004 2005 2006 2007 2008 2009
Figure 4: Average Share of Surgeries per Physician, Fiscal 2000/01 to 2009/10
OHIP Specialty 03 (General Surgery)
Mar12_general_surgery_pp16-19.indd 4 12-03-27 10:59 AM
FEATURE
ONTARIO MEDICAL REVIEW
Launched two years ago in col-
laboration with the Canadian Medical
Association, the immensely success-
ful Physician Leadership Development
Program (PLDP) saw its first group of
participants graduate in June 2011.
The PLDP is currently running its sec-
ond session, with participants due to
graduate this June.
With the first cohort of graduates now
successfully applying their learning to
practice, and the second cohort more
than half-way through the program, the
response from all PLDP participants to
date has been extremely positive.
Applications for the program’s third
cohort, set to begin in September 2012,
are now being accepted. Interested
physicians can find up-to-date infor-
mation and application packages on
the PLDP website, or by contacting the
program by phone or email (see contact
information at the end of this article).
Physicians from across Ontario,
in any specialty, and at any stage in
their career, are encouraged to apply.
Applicants should be currently involved
in an institutional, community-based, or
professional leadership role, and have
the desire to reflect deeply on their own
leadership and how it both inhibits and
enhances the transformation of the
health-care system.
Also, the OMA will be hosting its
first ever Medical Student Leadership
Summit on March 31. This project was
initiated by the student leaders of the
Ontario Medical Student Association
(OMSA), a Section of the OMA, who
requested leadership training as a
supplementary learning experience
to complement their current medical
school curriculum.
The event wil l be faci l i tated by
Brenda Zimmerman, a professor of
strategic management and an expert
in complexity science and manage-
ment in health care. Speakers and
guests will include OMA CEO Ron
Sapsford; Dr. Joshua Tepper, vice-
president, education, Sunnybrook
Health Sciences Centre; former OMA
President Dr. Suzanne Strasberg; Dr.
Shital Gandhi, medical director, clini-
cal teaching unit, Mount Sinai Hospital;
Dr. Andrew Brown, founder of Altitude
Mentoring; and Mark Bowden, creator
of TruthPlane, and renowned body lan-
guage expert.
The day will be an interactive learning
experience that focuses on allowing par-
ticipants to better understand their own
learning styles, and apply the knowledge
gained to their own leadership roles.
The OMA is at the forefront of leader-
ship development for physicians, and
is working to make leadership educa-
tion more widely available to interested
members. While future initiatives are
at the very early stage of investigation
to determine their feasibility, the OMA
is pleased to discuss any of its current
member programs by email or phone.
Reminder: application materials for
cohort 3 of the Physician Leadership
Deve lopment Program are now
posted. The deadline for applica-
tions is May 5, 2012. For more infor-
mation, please visit the Physician
Leadership Development Program
website at www.oma.org/pld, or con-
tact 1.800.268.7215, ext. 2239, or
416.340.2239, or email Physician.
Leadership@oma.org.
March 201220
Physician Leadership Development
OMA programs and workshops strengthen
physician leadership roles in Ontario:new programs being considered to reach more members
by Octavia Davidson
Chris Cartwright
OMA Member Services
POSITIVE MEMBER FEEDBACK REGARDING THE MANY LEADERSHIP PROGRAMS AND WORKSHOPS HOSTED
BY THE OMA IN RECENT YEARS — INCLUDING THE PHYSICIAN LEADERSHIP DEVELOPMENT MASTER’S
CERTIFICATE PROGRAM, LEADERSHIP TRAINING FOR MEDICAL STUDENTS, AND SEVERAL REGIONAL LEADER-
SHIP INITIATIVES — HAS ENCOURAGED THE OMA TO WORK TOWARD DEVELOPING ADDITIONAL PROGRAMS TO
REACH MORE MEMBERS, AND TO FURTHER STRENGTHEN PHYSICIAN LEADERSHIP IN ONTARIO.
REV_Mar12_physician_leadership_p20.indd 1 12-03-09 12:12 PM
The OMA Physician Health Program is a
confidential service for physicians, residents,
medical students and their family members.
Our caring, helpful, health-care professionals
assistance to those who may be
problems ranging from stress,
or family issues, through to
psychiatric illness.
Confidential Toll-Free Line 1.800.851.6606
php.oma.org
BECAUSE EVERY MOMENT COUNTS
Good Health Matters
FEATURE
ONTARIO MEDICAL REVIEW
Joining forces with its neighbouring
territorial division — the York Central
Medical Society — a co-hosted meet-
ing was held on January 24, 2012. The
focus of the event, determined in part-
nership with the PHP, was “Mindfulness
in Medicine.”
In an ever-changing, fast-paced
medical environment, physicians need
to refocus themselves from time to time
in the context of their professional and
personal lives.
As OMA District 5 Director Dr. Shawn
Whatley explained, “Physicians tend to
be quite conservative. The mindfulness
presentation was geared to provide a
safe environment to learn about some-
thing a little different, that seems to
show promise for some patients” — as
well as physicians.
PHP presenters Ted Bober and Ann
Davidson noted, “The essence of the
Mindfulness in Medicine workshop is
to introduce physicians to evidence-
based mindfulness practices.”
These workshops provide an oppor-
tunity to enhance physician health and
well-being, as well as improve attention
and situational awareness. Participants
also learn how to communicate and
act skillfully during a difficult clinical
encounter, and how to lead with greater
openness and flexibility, rather than in a
manner that may compromise patient
care and team functionality.
Mindfulness is not simply the prac-
tice of meditation, although this is one
potential component. True mindfulness
is also being present in everything that
one does throughout the day.
For physicians working in a fast-
paced environment, such as the emer-
gency department, operating room,
or busy family practice office, it is
important to always be present in the
moment and not be distracted by extra-
neous stimuli.
Many physicians at the meeting
expressed interested in receiving tips
for their patients who may benefit from
a calming, centering approach to life.
Dr. Scott Kapoor, an emergency
physician in Markham, appreciated
the helpful tips, which can be of use to
physicians and patients alike. “After
this meeting, I use the STEPP method
all the time — Stop, Take a breath,
Expand your awareness, Pause,
Proceed,” said Dr. Kapoor.
Dr. Brigitte Monrose, a family physi-
cian in Markham, appreciated that the
workshop provided her with “new infor-
mation as to what is available through
the OMA. I enjoyed the meeting and
the enlightening topic of mindfulness. In
this stressful type of work, there is defi-
nite benefit to be able to calm the mind
and focus on the moment.”
All participants benefited in some
way from the workshop. Many were
impressed by the focus on literature
and evidence that underlies the prac-
tice of mindfulness, and some partici-
pants were inspired to seek advanced
information on the topic.
To find out about events in your area,
engage with your local physician col-
leagues, or obtain more information on
OMA Regional Engagement Services,
please contact info@oma.org, or call
1.800.268.7215.
March 201222
Spotlight on Local Leadership
“Mindfulness in Medicine”Markham Stouffville,York Central medical societies
partner with OMA Physician Health Program
by OMA Regional Engagement Services
IN EARLY 2011, THE MARKHAM STOUFFVILLE MEDICAL SOCIETY EXECUTIVE SURVEYED ITS MEMBERSHIP TO
DETERMINE INTERESTS FOR FUTURE MEETINGS. WITH A NEW LEADER IN PLACE, AND A DESIRE TO ENGAGE
MORE MEMBERS, THE EXECUTIVE POLLED OVER 400 DOCTORS TO GATHER FEEDBACK ON A VARIETY OF
POTENTIAL TOPICS. CONTINUING A TREND SEEN IN OTHER AREAS OF THE PROVINCE, A WORKSHOP FROM THE
OMA PHYSICIAN HEALTH PROGRAM (PHP) WAS IDENTIFIED AS A PREFERRED OPTION.
Mar12_regional_engagement_p22.indd 1 12-03-07 2:54 PM
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EasternCaribbeanNYE_AdOMR_v4.indd 1 12-01-30 4:09 PM
FEATURE
ONTARIO MEDICAL REVIEW
During the Prepare stage, you estab-
lished your EMR system requirements.
You did this by specifying your vision
and goals, and by completing an on-
site readiness assessment and work-
flow analysis. Now, during the Select
stage, you make use of this work. You
compare the capability of the various
EMR systems against those system
requirements. You make your selec-
tion, and sign a contract with the cho-
sen vendor.
To simplify the process, OntarioMD
has done much of the background
research. OntarioMD has assembled
a list of vendors and tested their prod-
ucts to ensure that they meet spe-
cific functionality. The government of
Ontario, through eHealth Ontario and
OntarioMD, provides financial support
for the purchase of these funding-eligi-
ble EMR offerings.
To assist in the selection process,
Ontar ioMD has created a simple
“EMR Solution Selection Guide and
Workbook.” This guide helps your
selection team compare different
EMR offerings against a specific set of
functions. With it, you should be able
to identify the two or three systems
that come closest to meeting your
needs.
The Selection Team
The project leader and project team
members from the Prepare stage now
turn their attention to assessing and
selecting the EMR product. The team
membership can remain as originally
constituted, or be altered if additional
skills are required. In any case, the
members must be intimately familiar
with the work that has already gone
into the project. Furthermore, the team
must possess the business judgment
to decide what features are nice-to-
have versus must-haves, and the con-
sequences of those decisions.
The Selection Process
Your Practice Advisor will help you
develop your specific selection pro-
cess. A selection process typically
includes vendor demonstrations, site
visits with existing users of the vari-
ous systems, and vendor reference
checks.
Negotiating the contract with the
supplier involves specifying the equip-
ment, defining the scope of work (who
does what, and by when) and setting
out the training support. Many prac-
tices have their lawyer review the con-
tract before they sign it.
Types of EMR Service Models
One of the first decisions to be made
is the type of EMR service delivery
model. There are two types: the local
solution model, and the application
service provider (ASP) model. In gen-
eral, the former is less expensive, but
requires more on-site technology skills
for ongoing maintenance. The oppo-
site is true for the ASP model.
With the local solution, you own
and manage the computer server. The
server is physically located in a secure
spot in your facility, with the physicians
and staff accessing the data from their
offices and workstations. You are
March 201224
Electronic Medical Records
Managing change in the medical practice: Part 3 — “Select” an EMR that meets your needs
by OntarioMD
SUCCESSFULLY IMPLEMENTING AN ELECTRONIC MEDICAL RECORD SYSTEM CAN BE A DAUNTING TASK.
TO HELP GUIDE PHYSICIANS AND STAFF THROUGH THE PROCESS, ONTARIOMD HAS PREPARED A SERIES
OF ARTICLES THAT DRAW ON THE PRINCIPLES OF CHANGE MANAGEMENT. LAST MONTH, WE EXAMINED HOW
TO PREPARE. BELOW WE EXPLORE STAGE TWO — HOW TO SELECT AN EMR.
Mar12_EMR_feature_pp24-25.indd 1 12-03-06 4:26 PM
ONTARIO MEDICAL REVIEW
responsible for the maintenance of the
server, backups, software updates,
disaster recovery and data security.
Some practices perform these activi-
ties internally. Others have an outside
contractor do it.
With the ASP model, the server and
all the software resides at the secure
eHealth Ontario data centre. You own
the data, but not the server or the soft-
ware. Everything outside of your facility
is managed for you on a fee-for-ser-
vice basis. eHealth Ontario looks after
software and data security, disaster
recovery, updates, etc.
Vendor Demonstrations
For the systems that you want to
investigate, your Practice Advisor will
arrange vendor demonstrations and
prepare you with questions to ask.
These demonstrations allow you to see
how well the EMR products would fulfil
your practice needs. Be ready to ask
as many questions as you see fit. The
more information you have, the better
you will be able to make an informed
choice.
Visit Existing Users and Check
Vendor References
The vendors and your Pract ice
Advisor can refer you to existing users
whose practices are similar to your
own. You can learn much by visit-
ing them and talking to them about
their experience. Ask them about their
likes and dislikes regarding the prod-
uct and vendor support. In addition,
inquire about the terms and costs in
their vendor contracts. Have them
identify what they were, and were not,
able to negotiate.
Negotiate the Contract
In acquiring your EMR system, you are
not technically buying the software.
You don’t own it. Instead, you are
licensing the rights to use it. Vendors
typically start with a standard agree-
ment and then allow some flexibility
in the terms and conditions. Review
all aspects of the agreement. If any
part of it is unclear, ask for additional
wording to clarify the meaning. Be
guided by what you learned on your
site visits.
Finally, consider having your lawyer
review the final agreement before sign-
ing it. The purpose of the legal review
is not necessarily to comment on the
specific business deal, rather, it is to
ensure that you understand each par-
ty’s rights and obligations under the
agreement.
Scope of Work Document
The Scope of Work document is an
addendum to the contract. It contains
a list of the many tasks that must be
completed during the EMR imple-
mentation, and sets out who will be
responsible for doing what, and by
when — whether it is you, the vendor,
or any third parties.
Training Requirements
The better the training, the smoother
and faster your start-up wi l l be.
Consequently, training is a very impor-
tant aspect of the contract that you
sign with the vendor. OntarioMD has
created a “Training Requirements
Guide” to help you address the intri-
cacies of specifying the amount, type
and schedule of vendor-supplied train-
ing support.
From an implementation perspec-
tive, all staff members need to receive
some level of training, and the more
that they receive the better. Minimizing
initial training may save you some
money at the start, but there is a good
chance you will pay for it later on with
the cost of resolving post-implementa-
tion difficulties.
Recap of “Select” Stage
At the end of the Select stage, you
wil l have a signed contract with a
vendor for your EMR system. At this
point, you can take a bit of a breather
as the vendor gets everything ready
for the “implement” stage. In next
month’s article, we will delve into what
is involved in that stage of the change
management process.
More Information
To learn more about EMR adoption,
contact OntarioMD at 1.866.744.8668,
or email support@ontariomd.com. All
guides and tools referenced in this arti-
cle are available online at: www.ontario
md.ca.
Electronic Medical Records
25 March 2012
Mar12_EMR_feature_pp24-25.indd 2 12-03-06 4:26 PM
FEATURE
ONTARIO MEDICAL REVIEW
There are a number of strategies you
can use to help maintain a positive
dialogue and rapport with your patient
when using an EMR/computer dur-
ing the consultation. These strategies
involve both the layout of the physi-
cal space, and your communication
approach.
A variety of factors impact examining
room organization and furniture place-
ment:
the desk and chairs are arranged.
-
ments where placement is not at the
sole discretion of the physician.
There is no single best solution or
layout that will work for all physicians
across the diversity of practice situa-
tions. Each arrangement has its advan-
tages and disadvantages.
However, a layout that provides
both patient and physician access to
the computer screen while maintaining
sight of each other — a triangle con-
sisting of patient/physician/computer
screen at each corner — can aid in
communication and rapport.
Any number of potential office con-
figurations can achieve this objective,
as illustrated in Figure 1 and Figure 2
below.
In some examination rooms the
computer screen wil l be between
the patient and practitioner in order
to keep the practitioner’s body facing
the patient to maintain eye contact.
Having a swivelling screen will help
share EMR information and educa-
tional materials with the patient in this
configuration (see Figure 3).
Regardless of your office layout,
maintaining an open posture while
using the computer is important. It
is quite easy to be physically drawn
toward the computer screen/keyboard,
and hunched over the desk when typ-
ing or reading, which can contribute to
patients feeling isolated and ignored.
An open posture will not only help your
patients feel more connected, but will
help you avoid potential back problems.
Developing and maintaining rapport
with patients is essential for a success-
ful physician/patient relationship; by
attending to spatial relationships, and
adjusting communication techniques,
you can seamlessly integrate the EMR
into your consultation process to build
and strengthen patient interactions.
Next month’s column will delve fur-
ther into the specifics of rapport build-
ing communication techniques with
your EMR.
To submit queries to “Ask the EMR Expert”
please email communications@ontariomd.
com.
March 201226
Electronic Medical Records
“Ask the EMR Expert”maintaining patient engagement when
using an EMR during consultation
by Anne DuVall, MD
T
Figure 3Figure 1
EMR
PtMD
EMR
Pt
MD
EMR
MD
Pt
Figure 2
Mar12_EMR_ask_expert_pp26.indd 1 12-03-06 11:37 AM
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March 2012ONTARIO MEDICAL REVIEW
INTRODUCTION
What is the Education and Prevention Committee (EPC)?
The Ministry of Health and Long-Term Care and the Ontario Medical Association (OMA) have jointly established the
Education and Prevention Committee (EPC). The EPC’s primary goal is to educate physicians about submitting OHIP
claims that accurately reflect the services provided and that are in compliance with the law.
What is an Interpretive Bulletin?
Interpretive Bulletins are prepared jointly by the Ministry and the OMA to provide general advice and guidance to physi-
cians on specific billing matters. They are provided for education and information purposes only and express the Ministry’s
and OMA’s understanding of the law at the time of publication. The information provided in this Bulletin is based on the
September 1, 2011, Schedule of Benefits — Physician Services (Schedule). While the OMA and Ministry make every
effort to ensure that this Bulletin is accurate, the Health Insurance Act (HIA) and Regulations are the only authority in this
regard and should be referred to by physicians. Changes in the statutes, regulations or case law may affect the accuracy
or currency of the information provided in this Bulletin. In the event of a discrepancy between this Bulletin and the HIA or
its Regulations and/or Schedule under the regulations, the text of the HIA, Regulations and/or Schedule prevail.
EPC Bulletins are available on the OMA website (http://www.oma.org/Resources/Pages/EPCbulletins.aspx). The Schedule
is available on the Ministry website (http://www.health.gov.on.ca/english/providers/program/ohip/sob/sob_mn.html).
Education and Prevention Committee Interpretive Bulletin - Volume 10, No. 3
Schedule Changes to Pre-Dental/Pre-Operative
Assessments, and Fee Code Z110
28
PurposeThe purpose of this Interpretive Bulletin is to provide physi-
cians with information on specific changes to the Schedule,
which came into effect in 2011.
While there were several changes to the Schedule in 2011,
this Bulletin focuses on revisions specific to:
-
photic nail involving the removal of multiple laminae).
Pre-Dental/Pre-Operative AssessmentsNew fee codes for pre-dental/pre-operative assessments
rendered by specialists (A904, C904 and W904) were
added to the Schedule, effective July 1, 2011. In addition,
amendments were made to the pre-dental/pre-operative
general assessment (A903, C903 and W903).
A pre-dental/pre-operative assessment, listed on page A3
of the Schedule, is described as the service “required to
provide history and physical exam information to the peri-
operative team that will be assessing suitability for surgery
and anaesthesia.”
There are separate listings for the pre-dental/pre-operative
assessment, depending on the level of assessment ren-
dered and the specialty of the physician. The location of the
patient determines the appropriate prefix:
(non-emergency long-term care inpatient) — when a
Mar12_EPC_bulletin_pp28-30.indd 1 12-03-05 1:57 PM
March 2012ONTARIO MEDICAL REVIEW
Education and Prevention Committee Interpretive Bulletin - Volume 10, No. 3
29
full general assessment is rendered by the primary care
physician in the specialty of general/family practice, pedi-
physician in any other specialty.
Payment RequirementsA/C/W903 require that a full medically necessary general
assessment be rendered, the elements of which include a
full history, family medical history, an examination of all body
parts and systems, and other requirements listed on page
GP18.
A/C/W904 require, at a minimum, that a medically neces-
sary partial assessment be rendered, which includes a his-
tory of the presenting complaint and the necessary physical
examination (see page GP20).
These services are not eligible for payment for filling out a
hospital’s pre-operative form, unless the payment require-
ments of the service have been met (i.e., these are not form
fees).
Limits and maximums:
patient per physician over a 12-month period (they also
constitute “general assessments” for the purpose of cal-
culating the general assessments limits stated on page
GP18).
Note: When a claim for a pre-dental/pre-operative assess-
ment for an individual patient is payable by OHIP, and that
patient is subsequently admitted to hospital for elective
surgery within 30 days of the pre-dental/pre-operative
assessment, the admission general assessment (C003)
or a general re-assessment (C004) is not eligible for pay-
ment.
The patient’s medical record must document the findings
of the assessment, and meet the payment requirements
for the level of assessment rendered. The assessment
must also be personally rendered by a physician and can-
not be delegated to a non-physician for OHIP payment
purposes.
ExamplesExample 1
Dr. W is a family physician. On October 3, 2011, she
performed a pre-operative assessment prior to cataract
extraction from Mrs. F’s left eye.
Is Dr. W eligible for payment of A903?
Yes, provided the payment requirements are met (includ-
ing a complete general assessment) and the maximums
for general assessments (including A003) for the 12-month
period have not been reached. If a complete general
assessment is not medically necessary or not performed, a
minor or intermediate assessment should be claimed based
upon their specific payment requirements.
Example 2
Dr. T, an anesthesiologist, evaluates 78-year-old Mr. B prior
to Ministry of Health and Long-Term Care pre-approved
day surgery to extract Mr. B’s remaining teeth. Is Dr. T
eligible for payment of A904 for this service?
If the purpose of Dr. T’s evaluation is only to provide the
peri-operative team with patient history and physical exami-
nation, the evaluation is not on the same day as surgery,
and the evaluation is not performed as the pre-anesthetic
evaluation that is included in the anesthetic service (see
GP70), then A, C or W904 may be eligible for payment,
provided the requirements of the pre-dental assessment
are met.
A/C/W903 A/C/W904
Assessment
required
General
Assessment
Partial assessment at a
minimum
Eligible
specialties
General/Family
Practice (00),
Emergency
Medicine (12), or
Pediatrics (26)
All specialties other than
00, 12 or 26
Limits Maximum of two
per patient per
physician per
12-month period
Not eligible on day of
surgery
Regarding a patient and his or her surgery:
assessment is eligible for payment (i.e., one
a pre-dental/pre-operative assessment.
Mar12_EPC_bulletin_pp28-30.indd 2 12-03-05 1:57 PM
April 2011ONTARIO MEDICAL REVIEW
Education and Prevention Committee Interpretive Bulletin - Volume 9, No. 2
March 2012ONTARIO MEDICAL REVIEW
Education and Prevention Committee Interpretive Bulletin - Volume 10, No. 3
30
If Dr. T is the physician who administers the anesthesia for
Mr. B, and the evaluation is performed on the same day as
surgery, A904 is not eligible for payment based on the pay-
ment rules for A904.
Example 3
Dr. H, a family physician, assesses Mrs. G. on admission for
an elective hysterectomy. Is Dr. H eligible for payment of a
pre-operative general assessment?
Provided that a pre-operative general assessment has not
been performed by Dr. H in the last 30 days, he is eligible for
payment of A/C903. However, if Dr. H or any other physi-
cian has performed a pre-operative assessment in the last
30 days, that service constitutes the admission assess-
ment, and an additional admission assessment (e.g., C003
or C004) is not eligible for payment.
Example 4
Dr. S, a surgeon, renders a consultation to a patient and
recommends surgery at the visit. The information required
for the peri-operative team (which includes Dr. S as sur-
geon) is gathered and documented during the assessment/
consultation, thereby satisfying the hospital’s requirements
for pre-operative paperwork. Is A904 payable in addition to
the consultation?
No, A904 is not payable on the same day as a consultation
as, in general, only one assessment is eligible for payment
to a physician on the same day. In the example above,
because the information required to fill out a pre-operative
form was obtained during the consultation, a separate
service is not payable as A904 is not simply a form fee.
Z110 – Extensive Debridement of an Onychogry-photic Nail, Involving Removal of Multiple LaminaeEffective September 1, 2011, the Schedule was amended to
personally by the physician in order to be eligible for payment
of the listed fee. If the service is not rendered personally by
the physician (e.g., delegated to a non-physician) it remains
insured for the patient (which means that the patient cannot
be charged), and payable at zero to the physician.
may be eligible for payment to a physician who personally
removes multiple layers of the onychogryphotic nail. As with
all insured services, the patient’s medical record must doc-
for payment for trimming or clipping of nails. The provision
of medically or therapeutically necessary general foot care
services that are not separately listed in the Schedule are
specific elements of the assessment. See page M19 of the
Your feedback is welcomed and appreciated!The Education and Prevention Committee welcomes your feedback on the Bulletins in order to help ensure that these are
effective educational tools. If you have comments or questions on this Bulletin, or suggestions for future Bulletin topics, etc.,
please submit them in writing (referencing this Bulletin) to:
Physician Services Committee Secretariat
150 Bloor Street West , 9th Floor
Toronto, Ontario M5S 3C1
Fax: 416.340.2961
Email: Secretariat@pscs.ca
Dr. Laura Anweiler, Co-Chair (Acting)
Dr. Larry Patrick, Co-Chair
Education and Prevention Committee
The PSC Secretariat will anonymously forward all EPC Interpretive Bulletin comments, questions or suggestions to the
Co-Chairs of the EPC for review and consideration.
For specific inquiries on Schedule interpretation, please submit your questions IN WRITING to:Health Services Branch
Physician Schedule Inquiries
370 Select Drive
P.O. Box 168
Kingston, Ontario K7M 8T4
Mar12_EPC_bulletin_pp28-30.indd 3 12-03-05 1:57 PM
Take Advantage of the OMA’s affinity program.
OMA Advantages provides OMA members with special offers and
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Please visit our website to learn more about this exclusive program.
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ONTARIO MEDICAL REVIEW
The OMA, Col lege of Physic ians
and Surgeons of Ontario, Ontario
Pharmacists’ Association, and Ontario
College of Pharmacists have developed
the following message to share with our
respective members:
After a fatality apparently resulting
from a change in prescription from
OxyContin to another opioid analgesic,
physicians and pharmacists are being
advised to work closely in determining
the appropriate dosage for medications
prescribed to replace the discontinued
OxyContin.
Over the next several weeks and
months, physicians and pharmacists
will be facing situations that may require
either a direct shift in prescribing and
dispensing from OxyContin to the new,
tamper-resistant OxyNEO or a more
complex conversion from OxyContin to
another opioid alternative. In the latter
scenario, both physicians and pharma-
cists must be aware of the challenges
associated with such conversions, say
the regulatory bodies and associations
of both professions.
The College of Pharmacists and
the Ontario Pharmacists’ Association
are encouraging their members to
contact the prescribing physician for
clarification of dose changes where
possibly unintentional dose escalation
is noted. The College of Physicians
and Surgeons of Ontario and the
Ontario Medical Association are urg-
ing physicians to be receptive to this
contact and work closely with phar-
macists in determining the equi-
analgesic dose of alternative opioid
therapies for chronic non-cancer pain
management.
Conversion charts are available to
help health practitioners determine the
equi-analgesic dose of alternative opi-
oid therapies for chronic non-cancer
pain management. These charts and
other important and useful practice
tools can be found on the Michael G.
DeGroote National Pain Centre website
(http://nationalpaincentre.mcmaster.
ca/).
Physicians may have a number of
questions about the Ministry of Health
and Long-Term Care’s removal of
OxyContin from the Ontario Drug
Benefit Formulary/Comparative Drug
Index and its replacement, OxyNEO.
Answers to frequently asked questions
are available at: http://www.health.
gov.on.ca/english/providers/program/
drugs/opdp_eo/notices/exec_office_
odb_20120217.pdf.
This information was distributed to members
via President’s Update on March 7, 2012.
32 March 2012
Opioid Prescribing and Dispensing:
Physicians and Pharmacists Urged to Work Together
Are you thinking of starting or adding to your family?
Take advantage of the Pregnancy and Parental Leave Benefit Program (PPLBP) which allows you to take paid time away from your practice. Part of the wonder of parenting is experiencing the changes your child goes through during his or her first few months at home. Don’t miss out on these precious milestones — apply for the PPLBP.
To find out more information about this program, including eligibility requirements, please visit https://www.oma.org/Benefits/Pages/PPLBP.aspx or call 1.800.268.7215, ext. 2896 or 416.340.2896.
Learn and grow together.
Mar12_opiod_prrescribing_p32.indd 1 12-03-07 4:56 PM
FEATURE
ONTARIO MEDICAL REVIEW
Since this statement restricts profiting
from the delivery of health care, what
would motivate a physician to pursue
formal business training, and how
would he or she utilize such training in
the Canadian health-care system?
If the recent and rapid growth in
the number of MD/MBA2 programs
being offered in the United States is
any indication, there appears to be an
increase in the number of physicians
interested in acquiring an MBA.3
One may say that this trend exists
because of the privatized nature of the
U.S. health-care system; however, two
MD/MBA programs are now being
offered at Canadian universities.3
Numerous complementary skills
to the practice of medicine may be
acquired through an MBA program.
Parekh and Singh found that,
according to physicians, the five most
applicable skills to their career learned
by completing an MBA “were related
to evaluating systems operations and
implementing improvements, learning
how to be a more effective leader,
comprehending financial principles,
working within a team setting, and
negotiating effectively.”4
Despite the many skills that a phy-
sician may obtain by completing for-
mal management training, it does not
come without its share of sacrifices.
Sohn and Germain state that pursuing
an MBA is costly from a time and finan-
cial perspective.5 The authors also cite
a sentiment that a physician’s time
may be better served pursuing educa-
tion to enhance his or her clinical skills
and expertise.5
Some scholars even note that
among their colleagues, a stigma
exists for MD/MBAs with respect to
putting profit ahead of patient care.6,7,8
This presumes that management
education is all about making a profit,
even though many MBA programs
offer specialization in management of
not-for-profit and health-care organi-
zations.
The skills that may be gained by a
physician completing an MBA hold the
potential to improve patient care and
drive positive change in the Canadian
health-care system.
As a result of the gap in Canadian
data and the abundant benefits that
may result from an increase in MD/
MBAs, the purpose of this article is
to understand the rationale as to why
Canadian physicians would pursue an
MBA, what skills they learn by com-
pleting this degree, and how MD/
MBAs are applying their skills in the
Canadian health-care system.
This article also seeks to under-
stand from a dual-degree holder’s
perspective what MBA skills they feel
should be incorporated into under-
graduate medical education, and
whether or not Canadian physician
MBAs are stigmatized (as appears
evident in the U.S.) as a result of their
education.
March 201233
The promising value of an MBA
for the Canadian MDby Matthew Solomon, BSc., MBA
THE CANADA HEALTH ACT REQUIRES THAT “THE HEALTH CARE INSURANCE PLAN OF A PROVINCE MUST BE
ADMINISTERED AND OPERATED ON A NON-PROFIT BASIS BY A PUBLIC AUTHORITY APPOINTED OR DESIGNATED
BY THE GOVERNMENT OF THE PROVINCE.”1
Given the changing landscape of clinical medicine
toward a team-based approach, MBA skills are
becoming increasingly applicable to health care.
Mar12_MBA_canadian_md_pp33-36.indd 1 12-03-07 4:19 PM
ONTARIO MEDICAL REVIEW
Methodology
After a comprehensive l i terature
review, personal interviews were con-
ducted with 10 physicians (nine prac-
tising in Canada and one in the U.S.),
in person or via telephone. All nine
Canadian physicians had acquired
both an MD and an MBA, and the
American physician was in the process
of acquiring an MBA. Each interviewee
was provided with directed questions
in advance. Numerous follow-up ques-
tions were posed based on the con-
versations that emerged.
Results of Research and Discussion
An MBA is a generalist degree, and the
skills taught may be applied to a broad
range of careers. Therefore, it comes
as no surprise that each physician who
pursued an MBA had a unique ratio-
nale for doing so. Each interviewee
indicated that he or she was applying
(or planning to apply) his or her learned
skills in his or her own way. The 10
participants were utilizing their MBA
skills in health-care administration,
health-care consulting, clinical practice,
teaching, entrepreneurial pursuits, and
in their personal lives.
Canadian subjects revealed a great
degree of consistency in terms of the
skills learned by completing an MBA.
The skills most cited were (in no par-
ticular order):
These skills are consistent with
scholarly texts written on this topic,
and reflect an appreciation for both the
soft skills and hard skills that may be
learned by completing an MBA.
To date, a strong emphasis on man-
agement training has not been incor-
porated into medical school education.
Interviewees were asked to comment
on what skills they felt should be inte-
grated into medical school curriculum.
Participants indicated that given the
changing landscape of clinical medi-
cine toward a team-based approach,
MBA skills are becoming increasingly
applicable to health care.
All interviewees felt at least some
of the management skills that they
attained through their MBA should be
incorporated into undergraduate med-
ical education or residency training to
a greater extent than they have been
previously. This was particularly true
for the soft skills, namely learning how
to work well in a team-based environ-
ment and change management.
In many ways, this information
builds upon the work of Healey, et. al.,
who indicated that since the medical
school curriculum does not include
leadership training, physicians are
often unprepared for the task when
they attain leadership roles.9
Moreover, Desai, et. al. state that
“it is commonly (incorrectly) assumed
that a physician successful in clinical
practice could easily transfer to the
duties of managing (or leading) a surgi-
cal suite, a hospital, or any other large
organization; however, leadership and
management, like medicine, require
specific talents, study and experi-
ence.”10
There is a fundamental difference in
the way in which managers behave.10
Physicians are used to one-to-one
interactions with their patients and are
typically autonomous, while managers
frequently interact using a team-based
approach, and value collaboration.10
There is an increasing need to
include leadership training for al l
physicians. Physicians and health-
care managers need to learn to work
together to ensure that Canadian
patients are receiving the highest qual-
ity care. A more comprehensive under-
standing of management principles
among physicians may be useful to
bring about this change.
Team-based learning was cited by
eight of the 10 study participants as
a valuable skill obtained in their MBA
and/or a skill they feel should be incor-
porated into all medical school curri-
cula.
Forty per cent (40%) of the inter-
viewees also cited a need for some
basic business training for all medical
students to help them effectively
manage and run a practice.
An MBA would not be required for
medical students to acquire these
basic skills, but they are important
given the structure of health care in
Canada.
In essence, each physician or group
practice is itself a small business,
MBA for the Canadian MD
34 March 2012
Mar12_MBA_canadian_md_pp33-36.indd 2 12-03-07 4:19 PM
ONTARIO MEDICAL REVIEW
and in order to provide patients with
the best possible health care, each
practice must be operating efficiently
and effectively.
The most significant data gleaned
from this study was the stark contrast
between Canadian MD/MBAs’ per-
spective of a stigma, and that cited
by U.S.-based research. The subjects
in this study revealed very little, if any,
stigma for a Canadian physician hold-
ing an MBA.
Only one interviewee indicated that
he felt that other physicians negatively
view the fact that he holds an MD and
an MBA. Specifically, he said: “Those
credentials (MD/MBA) have a certain
commercialization slant to it. So, in
some ways, I would say people view
me as someone who is trying to profit
more than another person with a
similar degree.”
In contrast, another interviewee
said, “Colleagues really embrace (the
MBA).” He continued by explaining that
physicians “Build credibility among…
peers by being a good doctor (and) if
your colleagues respect you as a phy-
sician, then it’s what else can you offer
and how can there be synergy.”
The remaining Canadian inter-
viewees indicated that an MBA did not
draw any negative judgment from their
physician colleagues.
Conclusions
As the Canadian health-care system
evolves, the fundamental skills taught
through MBA programs are likely to
increase in value to physicians.
There are many soft skills offered
by an MBA that have the potential to
directly improve patient care through
an individual’s understanding of peo-
ple and team dynamics.
As the Canadian health-care sys-
tem struggles with sustainability con-
cerns, the problem-solving approach
and business savvy that MD/MBAs
possess, paired with their medical
knowledge, may be of significant value
going forward.
An MBA is not the only way that
a physician may learn relevant man-
agement skills. Management training
may be acquired by completing other
graduate programs, such as an MPH
(Master of Public Health), MHA (Master
of Health Administration or Master
of Healthcare Administration) or MS
(Master of Science).
Also, these skills can be acquired
less formally through continuing medi-
cal education courses or through work
experience.
However, according to Lyons, the
aforementioned degrees “are not seen
as equivalent to the MBA.”11 Moreover,
acquiring the skills informally may not
provide the same level of rigor that
would come from the completion of a
graduate level degree.
But, an MBA is not right for all phy-
sicians given the tremendous time
and cost required to complete such
a program. As a result, the best com-
promise may lie in incorporating some
management training into all medical
school curricula.
Key Takeaways
1. The MBA ski l ls most c i ted by
interv iewees to be valuable to
health care in Canada are change
management, leadership, learning
to work in a team, and financial
literacy.
2. The apparent stigmatization of MD/
MBAs by colleagues in the U.S. is
seemingly absent among Canadian
MD/MBAs.
3. With the changing landscape in the
Canadian health-care system, the
skills that MD/MBAs provide are
becoming increasingly relevant.
MD/MBAs should be valued and
respected for the skills they can
offer to improve health care in
Canada.
Study Limitations
There are limitations to this study:
not completely capture the range of
opinion of Canadian MD/MBAs.
by networking rather than random
selection. This resulted in 70% of the
interviewees being physicians who
currently practise medicine in an
urban/suburban academic hospital,
and their opinions may not be gener-
alized to a larger population.
any research of this nature, there
is an inherent subject bias. The
interviewees have each invested a
MBA for the Canadian MD
35 March 2012
Mar12_MBA_canadian_md_pp33-36.indd 3 12-03-07 4:19 PM
ONTARIO MEDICAL REVIEW
tremendous amount of time, effort
and money into their MBA, and they
have a vested interest in describing
all of the benefits that they obtained
by completing this education.
representative number of male and
female interviewees. Although one
female was included in the study, the
data may have a gender bias.
Editor’s Note: an excerpt of this study
appeared in the fall 2011 issue of the
Canadian Society of Physician Executives
newslet ter (Vol . 13, No. 3) . The fu l l
study may be obtained from the author:
msolomon09@schulich.yorku.ca
Matthew Solomon recently graduated from
the MBA program at the Schulich School
of Business with a specialization in Health
Industry Management and Organizational
Studies. He is working to gain entrance into
medical school in hopes of acquiring the
credentials to become a physician leader in
the Canadian health-care system.
References
1. Canada. Department of Justice. Canada
Hea l t h Ac t , R .S .C . , 1985 , c . C-6 .
[Internet]. Ottawa, ON: Department of
Justice [updated 2012 Feb 7] ; [about 16
screens]. Available from: http://laws-lois.
justice.gc.ca/eng/acts/C-6/FullText.html.
Accessed: 2012 Feb 29.
2. Please note that in this article MD/MBA is
used to refer to both combined MD/MBA
programs as well as acquiring an MD and
an MBA separately.
3. Butcher L. The rapid growth of MD/MBA
programs: are they worth it. Physician
Exec. 2011 Jan-Feb;37(1):22-6.
4. Parekh SG, Singh B. An MBA: the utility
and effect on physicians’ careers. J Bone
Joint Surg Am. 2007 Feb;89(2):442-7.
5. Sohn N, Germa in M. Does an MBA
enhance a physician’s ability to manage
a medical practice? Med Econ. 2011 Jan
25;88(2):38, 40-1.
6. Desai AM, Trillo RA Jr, Macario A. Should
I get a Master of Business Administration?
The anesthesiologist with education train-
ing: training options and professional
opportunities. Curr Opin Anaesthesiol.
2009 Apr;22(2):191-8.
7. Sherrill WW. The traitor complex. MD/MBA
students struggle with medicine vs. man-
agement dilemma. Physician Exec. 2005
Jan-Feb;31(1):48-9.
8. Duda J. The management of medicine:
will you need an MBA to practice? The
New Physician. 2011 Mar-Apr; 60(2):13-
14. [Internet]; [updated 2011 Apr 26] ;
[about 4 screens]. Available from: http://
www.amsa .o rg /AMSA/Homepage/
Publications/TheNewPhysician/2011/0311
AcademicTactics.aspx. Accessed: 2012
Feb 29.
9. Healey BJ. Marchese M, Kile J. Physician
executive education. Academy of Health
Care Management Journal 2009; 5(1-2).
10. Desai AM, Trillo RA Jr, Macario A. Should
I get a Master of Business Administration?
The anesthesiologist with education train-
ing: training options and professional
opportunities. Curr Opin Anaesthesiol.
2009 Apr;22(2):191-8.
11. Lyons MF. The MBA mystique. Physician
Exec. 1996 Nov;22(11):39-41.
MBA for the Canadian MD
36 March 2012
Mar12_MBA_canadian_md_pp33-36.indd 4 12-03-07 4:19 PM
The mandate of the Health Policy Committee is to develop
and maintain a policy agenda for the Ontario Medical
Association, subject to Board approval and direction, and
to facilitate the development and approval of policies that
are required to support that agenda and the OMA strategic
plan. It is the Board vehicle for ensuring effective director
oversight of the OMA’s health policy work. Member input
and involvement will be sought in policy development.
In pursuing member input and involvement in policy devel-
opment, the Health Policy Committee of the OMA is pre-
paring a list of members interested in participating in the
development of important health policy issues as they arise.
Physicians who have completed the annual registration will
be contacted on an as-needed basis to review and com-
ment upon policy documents relevant to the topics the phy-
sician has selected. In addition, members may be asked to
participate in member fora or time-limited working groups.
Areas of Health Policy Committee Focus
The OMA’s health policy work is both proactive and respon-
sive to external forces. There are certain practice domains
where the OMA maintains a watching brief, including hospi-
tals, long-term care, primary care, mental health, and public
health. In addition, we are active in terms of interprofessional
care and expanding scopes of practice for various health
professions. We monitor and respond to the regulatory envi-
ronment, including CPSO policy, legislation, and the work
of the Health Professions Regulatory Advisory Commission
(HPRAC). We are engaged in issues relating to drugs and
pharmacotherapy and the increasing influence of e-health
upon physician practice.
We intend to focus heavily in the next three years upon the
quality agenda and how it translates into practice.
In addition to our ongoing work, the OMA undertakes
specific short-term projects. In 2011, these included
regionalization, models of delivery for specialty care, and
community-based care (home care).
Time Commitments
Most review and comment work will take one or two hours.
Physician fora and working groups will generally involve half-
day meetings. There is no obligation to respond at any time.
Compensation
Members are paid at the hourly rate for their review/
comments and in accordance with the existing policy on
member honoraria for meetings.
To Register
Complete the form below and fax to Patricia Graham at
416.340.2238, or visit the OMA website (http://www.oma.
org/Member/Resources/Documents/HPInput.html). To
obtain a copy of the form by email or surface mail, contact
Patricia Graham via email (patricia.graham@oma.org), or
phone 416.599.2580, ext. 3434. Register to be contacted
to provide input on heath policy as needed:
First Name: ______________________________________
Last Name: ______________________________________
OMA Membership #: ______________________________
Email: ___________________________________________
Check topics that you are interested
in being contacted about:
Hospital Issues
Long-Term Care
Primary Care
Mental Health
Public Health
Interprofessional Care and Scopes of Practice
CPSO Policies
Drugs and Pharmacotherapy
eHealth
Quality
Regionalization
Models of Delivery for Specialty Care
Community-Based Care
System Issues
Value for Money
Areas of expertise and/or experience relevant to the above:
__________________________________________________
__________________________________________________
__________________________________________________
37 March 2012ONTARIO MEDICAL REVIEW
Members Invited to Provide Input on OMA Policy
Mar12_Health_Policy_1P_b/w_p37.indd 1 12-03-07 4:14 PM
ONTARIO MEDICAL REVIEW
Change in Funding Status of Oxycodone Controlled-Release TabletAs reported to members in a recent
OMA President’s Update, effective
March 1, 2012, Purdue Pharma dis-
continued the production of Oxy Contin
in Canada, and replaced it with another
oxycodone controlled-release drug,
OxyNEO.
A s a r e s u l t , O x y C o n t i n w a s
removed from the Ontario Drug Benefit
Formulary/Comparative Drug Index,
effective February 29, 2012.
OxyNeo will only be funded through
the Exceptional Access Program and
through the Facil itated Access to
Palliative Care Drugs mechanism.
The reimbursement mechanism,
and the doses of OxyNEO available,
depend on the patient’s condition.
Special provisions have been made
for Ontario Drug Benefit recipients
who submitted a claim for OxyContin
between September 1, 2011, and
February 28, 2012.
Please note that OxyContin and
OxyNEO prescriptions are not inter-
changeable. Therefore, patients cur-
rently receiving OxyContin will require a
new prescription.
Regrettably, the OMA was not pro-
vided the opportunity for advance con-
sultation on this change. However, the
Association is now working with the
Ministry of Health and Long-Term Care
to address physician concerns.
Details regarding the criteria for
funding, the available reimbursement
mechanisms, and the provisions made
for current OxyContin recipients, are
posted on the Ministry website at:
http://www.health.gov.on.ca/english/
providers/program/drugs/opdp_eo/
notices/exec_office_odb_20120217.
OMA Staff Contact: Jessica Katul, ext. 2859
Family Health Team (FHT) Issues CommitteeCurrently, more than 2,000 family phy-
sicians and 2.7 million patients are
attached to Family Health Teams in
Ontario.
To help address the issues physi-
cians face while practising as part of
a FHT, the OMA Board of Directors
approved the establishment of the
Family Health Team Issues Committee.
This Committee will proactively
identify, analyze, and make recom-
mendations on key FHT issues that
directly or indirectly impact both physi-
cians and patients, including, but not
limited to: actual or potential policy
or practice issues; governance and
accountability requirements; strategies
for improving relationships between
physicians and interdisciplinary health
professionals; and priorities and initia-
tives of the Ontario government and its
agencies.
The FHT Issues Committee mem-
bers are:
To correspond with the FHT Issues
Committee, please contact Peter
Brown, senior policy analyst, OMA
Health Policy Department, by email at
peter.brown@oma.org, or by phone
416.340.2989.
OMA Staff Contact: Peter Brown, ext. 2989
March 201238
Change in Funding Status of Oxycodone Controlled-Release Tablet
Family Health Team Issues Committee
by OMA Health Policy Department
HEALTH POLICY REPORTA summary of current health legislation and policy developments
OMR Ads Hit Home!
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ONTARIO MEDICAL REVIEW 39 March 2012
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Health Policy
-
Economic
Appointments
OntarioMD Board of Directors
March 201240
OMA Board of Directors Meeting
February 8-9, 2012
BOARD REPORTSummary of resolutions
Mar12_board_resolutions_p40.indd 1 12-03-06 11:19 AM
Ontario Medical Student Bursary Fund 8th Annual Fundraising Golf Tournament
Friday, June 15, 2012 — 7:45 a.m. Shotgun Start
Angus Glen Golf Club, host site of the 2002 & 2007 Canadian Open
$400 per ticket / $1,600 per foursome. Price includes: 18 holes of golf with cart, breakfast, lunch, and participation in
golf contests with great prizes!! Partial tax receipts will be issued to those who pay directly to OMSBF.
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All proceeds fund student bursaries from OMSBF. Reserve now — last year’s tournament sold out early!Register by March 31, 2012 and your name will be entered in a contest for a free foursome at the 2013 OMSBF Golf Tournament!
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ONTARIO MEDICAL REVIEW 42 March 2012
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Bergeron, Joseph Aurele O.
Sudbury
Laval University, 1955
January 2012 at age 89
Duffin, Donald Forester
Sault Ste. Marie
University of Western Ontario, 1950
November 2011 at age 88
Elek-Baan, Susanna
Toronto
Franz Joseph University of Kolozsvar,
1952
November 2011 at age 85
Fabris, Gilbert
Bolton
University of Calgary, 1988
December 2011 at age 55
Fishell, Eve Kelton
Toronto
University of Toronto, 1955
November 2011 at age 80
Gingrich, Ronald Gordon
Bright
University of Western Ontario, 1967
January 2012 at age 69
Sellors, John William
MacTier
McMaster University, 1972
December 2011 at age 65
Sewell, Ian MacIntosh
Thunder Bay
University of Toronto, 1950
November 2011 at age 86
Ziolkowski, Rosemary “Rose” Jean
Trenton
English Conjoint Board, 1946
December 2011 at age 91
March 201243ONTARIO MEDICAL REVIEW
IN MEMORIAMThe OMA would like to express condolences to the families and friends of the following members.
The OMA publishes brief notices about deceased members as a service to their colleagues. Information concerning these members should
be sent to carlene.nash@oma.org. If you know a colleague or a relative of a deceased member who has practice-related questions and
needs advice, or would like an information package on winding down a practice, please have them contact Practice Management and
Advisory Services at 1.800.268.7215, or email practiceadvisory@oma.org.
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ONTARIO MEDICAL REVIEW March 201244
Successfully managing your career in medicineby Mamta Gautam, MD
PRACTICE MANAGEMENT
Most of us looked ahead to becoming a doctor, but likely gave little thought to
what would come after that. Generally speaking, physicians graduate from
medical school in their mid-to-late 20s, and retire in their mid-to-late 60s. Thus, we
have at least a 40-year career in medicine. What excites and sustains us at the start
may not be enough to fulfil us at other phases of our career.
Luckily, there are strategies and knowl-
edge that we can harness to manage
our career in medicine and continue to
enjoy it, including:
1. Realizing we have choices: The
key to career satisfaction is to pro-
actively shape your own career
path. Think about this consciously.
Some of us may choose to con-
tinue to do the same thing through-
out our entire career, while others
may choose to have varying areas
of interest and focus at different
times. There is no right answer.
What is important is that we see it
as a choice that we can make at
any point in the process.
2. Three normal stages of a career
— energy/excitement, reality, leg-
acy: We start off with energy and
excitement, then reality sets in and
we can feel tired and discouraged.
We then redefine and set more
accessible goals, so we can leave a
legacy. We will all go through these
three stages. This is normal and
natural, so expect and embrace
this process.
3. The seven-year rule: One can only
do something and truly enjoy it for
about seven years at a time. Thus,
we can plan to regularly reassess
what we are doing, and modify it in
some minor or major way to con-
tinue to enjoy it further.
4. Consider why: Identify why you may
want to make a change. Define
what you like and do not like about
what you are now doing. State your
needs, interests, and values. Once
you can recognize these factors,
you can better ensure that your new
choice is what you are looking for.
5. The three-step rule for change:
There are generally three steps in
making a change in your medical
career — modify, change within
medicine, and change outside of
medicine. Just because you are
no longer feeling fulfilled does not
mean that you have to throw it all
away. Many people successfully
modify part of what they are cur-
rently doing, or how they do it, and
the situation improves. Sometimes,
it may require a change of focus
within medicine, either a new clini-
cal focus, or adding new roles in
medical education, research,
writing, politics or administration.
Finally, some of us make choices
that will take us out of medicine
entirely.
6. Consider what: Start to explore the
new area of focus you have identi-
fied. Talk to colleagues and men-
tors, and network with people in
the field. Browse related websites,
attend conferences, and/or volun-
teer on related committees.
7. The 80%-20% overlap: If possible,
do not plan to make a complete
change all at once. Plan to have the
next step overlap this one by 80%.
Start with modifying 20% of what
you are currently doing to include
your new area of focus; maintain
80% as is for now. This will allow
Mar12_practice_management_pp44-45.indd 1 12-03-02 3:40 PM
ONTARIO MEDICAL REVIEW
you to assess and adjust as neces-
sary, and confirm your choice.
8. Consider when: Making a change
in career in midlife is not easy. We
need to consider many factors,
such as finances, family needs, or
willingness to relocate. Set a real-
istic timeline, as it usually takes
two to three years to make a major
change.
9. More educat ion : Review and
update your CV. Education and
qualifications are important, but
you already possess a great deal
of both, and more is not necessarily
better. Consider what you want to
do first, and then work backwards
to see if you will need to build on
your current knowledge and skills
to achieve your goals.
10. Expect to grieve and manage loss:
Even if you want and choose it,
there is still a loss associated with
change. Anticipate this, and the
associated feelings of denial, pro-
test, anger, sadness, and accep-
tance, both within yourself, as well
as the people around you who will
be impacted by the change.
Using a positive, proactive approach,
you must plan to continuously assess
and reshape your career goals. You
can actively mould your career paths,
and ensure that you develop personally
and professionally, and remain satisfied
throughout your entire career.
(Note: for further information on this
topic, please refer to Dr. Gautam’s
website at www.peakmd.ca.)
Dr. Mamta Gautam is a psychiatrist in
Ottawa, and a pioneer in the area of physi-
cian health. She is a keynote speaker at the
upcoming 13th Annual Women’s Health
Care Seminar (see p. 9 for details).
The Practice Management column is pro-
v ided by the OMA Member Serv ices
Department. Do you have a topic or ques-
tion you would like to see appear in the
Ontario Medical Review? Please let the
Practice Advisory Service team know at
416.340.2911 or 1.800.268.7215, ext. 2911,
or email: practiceadvisory@oma.org.
45 March 2012
PRACTICE MANAGEMENT
PMAS provides OMA members with:Practice management seminars
CyberMed online learning
Billing inquiries and advocacy
Practice management resources and toolkits
General inquiries on managing your practice
Contact us: web: www.oma.org | phone: 1.800.268.7215
email: practiceadvisory@oma.org
OMA Practice Management and Advisory Services (PMAS) can help you manage your practice.
g | phone: 1.800.268.7215
isory@oma.org
Mar12_practice_management_pp44-45.indd 2 12-03-08 12:43 PM
ONTARIO MEDICAL REVIEW March 201246
Will power: the importance of estate planningby OMA Insurance Services
OMA INSURANCE UPDATE
“All three parts line up to form your
overall plan,” says Judy Wood, a senior
insurance advisor with OMA Insurance.
A will provides for an orderly transfer
of your assets to your chosen beneficia-
ries, and the opportunity to choose the
executor of your estate.
Are you aware of what happens
if you die without a valid will? This is
what is known as dying “intestate.” In
such cases, Ontario law stipulates how
your estate is distributed, and it often
goes to family or other living relatives.
Although there are rules in place, issues
can occur, including:
your wishes. Having the court settle
your estate can lead to a possible
undesired division, to unintended
consequences (such as the govern-
ment looking after your children’s or
grandchildren’s inheritance until they
are 18), or to family feuds.
money or property (from real estate
to possessions) to more distant rela-
tives, friends, or charity.
-
trator of your estate, and no one will
have the authority to act on behalf
of your estate until that time. This
could mean a significant delay for
your beneficiaries to receive the pro-
ceeds. As a result, your estate might
pay more in additional legal costs
and taxes. The best way to defer
tax upon death is to leave everything
to your spouse, but this cannot be
done if you die intestate.
-
ianship of minor children, based on
what he or she sees as being in the
child’s best interest (which may be
contrary to your desires).
For more information, visit the online
resources listed at the end of this article.
Lacking a valid will can also cause
lengthy problems. For instance, Jimi
Hendrix, Pablo Picasso, and Howard
Hughes all died intestate. Their siz-
able estates took many years to
settle, and were eventually divided
up among multiple claimants simply
because they did not have a will.
While having a will is a priority, it
doesn’t end your estate planning. “With
significant life changes, you want to
review your will,” says Ms. Wood.
Changes, such as marriage, divorce,
remarriage, a common-law relation-
ship, children, stepchildren, grandchil-
dren, the status of dependents, and
retirement, can all affect your will.
It is easy to let such updates fall
through the cracks, especially when
work and life are so busy. However, it
is important to talk to your tax lawyer
or accountant to ensure that your will
is current.
Keep your accountant, financial con-
sultant and insurance advisor informed
to ensure that you have adequate
Where there’s a will there’s a way” to protect your estate. The right insurance
and investment strategies are two important parts of sound financial planning.
The third part — your will — is essential for developing an effective estate plan.
“
Nobody likes to think about their death, but
knowing your estate will be settled as you wish, in
an efficient manner, provides peace of mind.
Mar12_insurance_update_pp46-47.indd 1 12-03-05 2:01 PM
ONTARIO MEDICAL REVIEW
insurance working in concert with your
estate, and that the financial well-being
of your loved ones is secure.
When writing or updating your will,
you may want to consider two addi-
tional needs:
attorney prepared while writing or
updating a will. A power of attorney
for property means appointing some-
one to manage your financial affairs if
you cannot do so. With a power of
attorney for personal care, you can
also appoint someone to make deci-
sions on your behalf regarding your
personal care and consent to treat-
ment if you are unable to do so.
will,” which most physicians are very
familiar with. A living will is a docu-
ment that expresses your desires
and directives around medical treat-
ment should you be in a terminal
state. Not all family members may
agree on life-support decisions; a liv-
ing will removes that doubt, helping
to keep harmony in the family during
a difficult time.
“Nobody likes to think about their
death, but knowing that your estate will
be settled as you wish, and in the most
efficient way possible, provides peace
of mind,” says Ms. Wood.
For assistance in finding the right
insurance solutions to suit your needs,
please contact OMA Insurance at
1.800.758.1641, or emai l in fo@
omainsurance.com to schedule an
appointment with one of our non-com-
missioned OMA Insurance Advisors.
Additional information is available on
the OMA Insurance website at: www.
omainsurance.com.
Online resources
1. “When someone dies with or without a
will,” Government of Ontario, http://www.
ontario.ca/en/life_events/death/004689.
html.
2. “How an estate is distributed,” Ministry of
the Attorney General, http://www.attorney
heirclaim.asp.
47 March 2012
OMA INSURANCE UPDATE
Exciting improvements are coming
to your OPIP program – the first
enhancement is scheduled for
April 1, 2012, with more to
follow in 2013.
For details visit:
www.omainsurance.com
Funded Health
Benefits For Ontario’s
Practicing Physicians
OMA Priority Insurance Program
Mar12_insurance_update_pp46-47.indd 2 12-03-05 2:01 PM
Feature Name
1ONTARIO MEDICAL REVIEW 48 March 2012
The 2012 OMA Corporate Hote l
Directory is onl ine year-round in
the “OMA Advantages (Aff in i ty &
Discounts)” area of the OMA WebLink
site (www.oma.org).
To ensure you receive the rate
quoted in the directory, please state
that you are an OMA member at the
time of booking a reservation.
Note that the rates quoted are not
always the lowest available rate at
the time of booking. Many hotels will
offer special rates at certain times of
the week or year. Please inquire when
making your reservation to ensure you
receive the lowest possible rate.
Also note that most rates quoted
in the directory are subject to avail-
ability, thus you may be offered the
“best available rate” if the hotel has
sold out of the type of room for which
the OMA has contracted. Rates are
quoted for standard accommodation,
unless otherwise noted.
To ensure a late arrival guarantee, a
credit card number must be given at the
time of booking a reservation.
All rates listed in the directory are
effective from January 1, 2012 to
December 31, 2012, unless otherwise
noted, and are subject to applicable
taxes.
Please note, you may be asked
to present corporate identification at
the time of check-in, so remember
to carry your OMA membership card
with you.
For further information on pre-
ferred hotel room rates for OMA
members, please contact OMA Con-
ference Planning at 416.599.2580;
1.800.268.7215 or jennifer.csamer@
oma.org.
ONTARIO MEDICAL REVIEW
OMA Conference
Planning has negotiated
an extensive listing of
preferred 2012 rates for
OMA members at hotels
located throughout
Ontario.
2012 OMA
CORPORATE
HOTEL DIRECTORY
Mar12_corporate_hotel_directory_pp48-49.indd 1 12-03-02 4:02 PM
ONTARIO MEDICAL REVIEWONTARIO MEDICAL REVIEW 49
BARRIE
Holiday Inn
BELLEVILLE
Ramada Hotel, Resort & Conference Centre
Travelodge Hotel Belleville
BRANTFORD
Best Western Brant Park Inn
BURLINGTON
Homewood Suites by Hilton
CAMBRIDGE
Homewood Suites by Hilton
Cambridge-Waterloo
COLLINGWOOD
Tyrolean Village Resorts at
Blue Mountain
CORNWALL
Best Western Parkway Inn &
Conference Centre
GANANOQUE
Colonial Resort & Spa
GRIMSBY
Casablanca Winery Inn
GUELPH
Delta Guelph
HAMILTON
Sheraton Hamilton Hotel
KINGSTON
Ambassador Conference Resort
Courtyard Marriott Kingston
Days Inn Kingston
Four Points Hotel & Suites by
Sheraton Kingston
Holiday Inn Express & Suites Kingston
Holiday Inn Kingston-Waterfront
Radisson Hotel Kingston Harbourfront
KITCHENER-WATERLOO
Best Western St. Jacobs Country Inn
Delta Kitchener-Waterloo
Destination Inn & Suites
Hampton Inn & Suites by Hilton
Holiday Inn Kitchener-Waterloo Hotel
& Conference Centre
Radisson Hotel Kitchener Waterloo
LONDON
Delta London Armouries
Hilton London
Homewood Suites by Hilton
StationPark All Suite Hotel
MISSISSAUGA
Delta Meadowvale-Mississauga
Delta Toronto Airport West
Four Points by Sheraton Toronto
Mississauga
Hilton Garden Inn Toronto Airport
Hilton Garden Inn Mississauga/
Toronto Airport
Homewood Suites by Hilton
Toronto-Mississauga
MUSKOKA & AREA
Delta Grandview – Huntsville
Delta Rocky Crest – Muskoka
Delta Sherwood – Port Carling
NIAGARA FALLS
Crowne Plaza
DoubleTree Fallsview Resort &
Spa by Hilton
Hilton Fallsview Niagara Falls
Marriott Gateway
Sheraton on the Falls
NIAGARA-ON-THE-LAKE
Hilton Garden Inn Niagara-on-the-Lake
Pillar and Post
Prince of Wales
Queen’s Landing
White Oaks Resort
OAKVILLE
Hilton Garden Inn Toronto/Oakville
Homewood Suites by Hilton
Toronto-Oakville
OTTAWA
Albert at Bay Suite Hotel
Best Western Victoria Park Suites
Brookstreet Resort
Delta Ottawa Hotel and Suites
Fairmont Chateau Laurier
Holiday Inn Hotel & Suites
Ottawa Downtown
Lord Elgin Hotel
Novotel Ottawa
Sheraton Ottawa
Westin Ottawa
PETERBOROUGH
Holiday Inn Peterborough Waterfront
SARNIA
Holiday Inn Sarnia/Point Edward
SAULT STE. MARIE
Delta Sault Ste. Marie Waterfront Hotel
and Conference Centre
SUDBURY
Holiday Inn
Homewood Suites by Hilton
THUNDER BAY
Valhalla Inn Thunder Bay
TORONTO (GTA)
Cosmopolitan Toronto
Courtyard by Marriott Downtown Toronto
Delta Chelsea-Downtown Toronto
Delta Markham
Delta Toronto East
Doubletree by Hilton Toronto Airport
Fairmont Royal York
Four Points by Sheraton Toronto Airport
Four Seasons (closing in March)
Hampton Inn by Hilton Toronto Airport
Corporate Centre
Hilton Garden Inn Toronto/Ajax
Hilton Garden Inn Toronto/City Centre
Hilton Garden Inn Toronto/Downtown
Hilton Garden Inn Toronto/Vaughan
Hilton Suites Toronto/Markham
Conference Centre & Spa
Hilton Toronto
Homewood Suites by Hilton Toronto
Airport Corporate Centre
Hyatt Regency Toronto on King
InterContinental Toronto Centre
InterContinental Toronto Yorkville
Le Meridien King Edward
Metropolitan Hotel
Minto Suite Hotel
Novotel Toronto Centre
Pantages Hotel
Park Hyatt Toronto
Renaissance Toronto Hotel Downtown
Sheraton Centre Toronto
Sheraton Gateway Hotel
Sheraton Toronto Airport Hotel &
Conference Centre
The Old Mill Inn
The Sutton Place
Toronto Marriott Downtown Eaton Centre
Westin Harbour Castle
WINDSOR
Caesars Windsor
Hilton Windsor
March 2012ONTARIO MEDICAL REVIEW
Mar12_corporate_hotel_directory_pp48-49.indd 2 12-03-02 4:02 PM
ONTARIO MEDICAL REVIEW March 201250
Modified Release Tablets 375 mg enteric-coated naproxen/20 mg immediate release esomeprazole & 500 mg enteric-coated naproxen/20 mg immediate release esomeprazole
Prescribing Summary
Patient Selection Criteria
THERAPEUTIC CLASSIFICATION: NSAID and H+, K+-ATPase inhibitor INDICATIONS AND CLINICAL USE: Adults: VIMOVO (naproxen/esomeprazole) is indicated for the treatment of the signs and symptoms of osteoarthritis (OA), rheumatoid arthritis (RA) and ankylosing spondylitis (AS) and to decrease the risk of developing gastric ulcers in patients at risk for developing NSAID-associated gastric ulcers. VIMOVO is not recommended for initial treatment of acute pain because the absorption of naproxen is delayed (as with other modified release formulations of naproxen). For patients with an increased risk of developing cardiovascular (CV) and/or gastrointestinal (GI) adverse events, other management strategies that do NOT include the use of NSAIDs should be considered first (see CONTRAINDICATIONS and WARNINGS AND PRECAUTIONS). Use of VIMOVO should be limited to the lowest effective dose for the shortest possible duration of treatment in order to minimize the potential risk for cardiovascular or gastrointestinal adverse events (see CONTRAINDICATIONS and WARNINGS AND PRECAUTIONS). VIMOVO, as a NSAID, does NOT treat clinical disease or prevent its progression. VIMOVO, as a NSAID, only relieves symptoms and decreases inflammation for as long as the patient continues to take it. Geriatrics (>65 years of age): Evidence from naproxen clinical studies and postmarket experience suggest that use in the geriatric population is associated with differences in safety (see WARNINGS AND PRECAUTIONS; Special Populations and Product Monograph, CLINICAL TRIALS). Pediatrics (<18 years of age): VIMOVO should not be used in children or adolescents under 18 years of age. The safety and efficacy of VIMOVO in this population has not been established.CONTRAINDICATIONS: VIMOVO is contraindicated in: the peri-operative setting of coronary artery bypass graft surgery (CABG) (although VIMOVO has NOT been studied in this patient population, a selective COX-2 inhibitor NSAID studied in such a setting has led to an increased incidence of cardiovascular/thromboembolic events, deep surgical infections and sternal wound complications); the third trimester of pregnancy, because of risk of premature closure of the ductus arteriosus and prolonged parturition; women who are breastfeeding, because of the potential for serious adverse reactions in nursing infants; patients with severe uncontrolled heart failure; patients with known hypersensitivity to naproxen, esomeprazole, substituted benzimadazoles or to any of the components/excipients (see DOSAGE FORMS, COMPOSITION AND PACKAGING); patients with history of asthma, urticaria, or allergic-type reactions after taking ASA or other NSAIDs (i.e. complete or partial syndrome of ASA-intolerance–rhinosinusitis, urticaria/angioedema, nasal polyps, asthma) (fatal anaphylactoid reactions have occurred in such individuals. Individuals with the above medical problems are at risk of a severe reaction even if they have taken NSAIDs in the past without any adverse reaction. The potential for cross-reactivity between different NSAIDs must be kept in mind [see WARNINGS AND PRECAUTIONS; Hypersensitivity Reactions, Anaphylactoid Reactions]); patients with active gastric/duodenal/peptic ulcer, active GI bleeding; patients with cerebrovascular bleeding or other bleeding disorders; patients with inflammatory bowel disease; patients with severe liver impairment or active liver disease; patients with severe renal impairment (creatinine clearance <30 mL/min or 0.5 mL/sec) or deteriorating renal disease (individuals with lesser degrees of renal impairment are at risk of deterioration of their renal function when prescribed NSAIDs and must be monitored) (see WARNINGS AND PRECAUTIONS; Renal); patients with known hyperkalemia (see WARNINGS AND PRECAUTIONS; Renal, Fluid and Electrolyte Balance) and children and adolescents less than 18 years of age.
Safety Information
WARNINGS AND PRECAUTIONS:
Serious Warnings and PrecautionsRisk of Cardiovascular (CV) Adverse Events: Ischemic Heart Disease, Cerebrovascular Disease, Congestive Heart Failure (NYHA II-IV) (See WARNINGS AND PRECAUTIONS; Cardiovascular). Naproxen is a non-steroidal anti-inflammatory drug (NSAID). Use of some NSAIDs is associated with an increased incidence of cardiovascular adverse events (such as myocardial infarction, stroke or thrombotic events) which can be fatal. The risk may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk.
Caution should be exercised in prescribing NSAIDs such as naproxen, which is a component of VIMOVO (naproxen/esomeprazole), to any patient with ischemic heart disease (including but NOT limited to acute myocardial infarction, history of myocardial infarction and/or angina), cerebrovascular disease (including but NOT limited to stroke, cerebrovascular accident, transient ischemic attacks and/or amaurosis fugax) and/or congestive heart failure (NYHA II-IV). Use of NSAIDs such as naproxen, which is a component of VIMOVO, can promote sodium retention in a dose-dependent manner, through a renal mechanism, which can result in increased blood pressure and/or exacerbation of congestive heart failure (see also WARNINGS AND PRECAUTIONS; Renal, Fluid and Electrolyte Balance). Randomized clinical trials with VIMOVO have not been designed to detect differences in cardiovascular events in a chronic setting. Therefore, caution should be exercised when prescribing VIMOVO. Risk of Gastrointestinal (GI) Adverse Events (see WARNINGS AND PRECAUTIONS, Gastrointestinal and Product Monograph, CLINICAL TRIALS) Use of NSAIDs such as naproxen, which is a component of VIMOVO, is associated with an increased incidence of gastrointestinal adverse events (such as peptic/duodenal ulceration, perforation, obstruction and gastrointestinal bleeding).
General: Frail or debilitated patients may tolerate side effects less well and therefore special care should be taken in treating this population. To minimize the potential risk for an adverse event, the lowest effective dose should be used for the shortest possible duration. As with other NSAIDs, caution should be used in the treatment of elderly patients who are more likely to be suffering from impaired renal, hepatic or cardiac function. For high-risk patients, alternate therapies that do not involve NSAIDs should be considered. VIMOVO, which contains naproxen, is NOT recommended for use with other NSAIDs, with the exception of low-dose ASA for cardiovascular prophylaxis, because of the absence of any evidence demonstrating synergistic benefits and the potential for additive adverse reactions (see DRUG INTERACTIONS; Drug/Drug Interactions, Acetylsalicylic acid (ASA) or other NSAIDs). VIMOVO should not be used concomitantly with other naproxen containing drugs since they all circulate in plasma as the naproxen anion. Concomitant administration with atazanavir or nelfinavir is not recommended (see DRUG INTERACTIONS). In the presence of any alarm symptom (e.g., significant unintentional weight loss, recurrent vomiting, dysphagia, hematemesis or melena), and/or when gastric ulcer is suspected or present, malignancy should be excluded, as treatment may alleviate symptoms and delay diagnosis.Special Populations: Pregnant Women: VIMOVO is CONTRAINDICATED for use during the third trimester of pregnancy because of risk of premature closure of the ductus arteriosus and the potential to prolong parturition (see TOXICOLOGY). Caution should be exercised in prescribing VIMOVO during the first and second trimesters of pregnancy. Inhibition of prostaglandin synthesis may adversely affect pregnancy and/or the embryofetal development. Data from epidemiological studies suggest an increased risk of miscarriage and of cardiac malformation after use of a prostaglandin synthesis inhibitor in early pregnancy. In animals, administration of a prostaglandin synthesis inhibitor has been shown to result in increased pre- and post-implantation loss and embryo-fetal lethality. In addition, increased incidences of various malformations, including cardiovascular, have been reported in animals given a prostaglandin synthesis inhibitor during the organogenetic period. VIMOVO, which contains naproxen, is not recommended in labour and delivery because naproxen-containing products, through their prostaglandin synthesis inhibitory effect, may adversely affect fetal circulation and inhibit uterine contractions, thus increasing the risk of uterine hemorrhage. Nursing Women: See CONTRAINDICATIONS. Pediatrics (<18 years of age): See CONTRAINDICATIONS. Geriatrics: Patients older than 65 years and frail or debilitated patients are more susceptible to a variety of adverse reactions from NSAIDs. The incidence of these adverse reactions increases with dose and duration of treatment. In addition, these patients are less tolerant to ulceration and bleeding. Most reports of fatal GI events are in this population. Older patients are also at risk of lower esophageal injury including ulceration and bleeding. For such patients, consideration should be given to a starting dose lower than the one usually recommended, with individual adjustment when necessary and under close supervision. Of the total number of patients who received VIMOVO (n=1157) in clinical trials, 387 were ≥65 years of age, of which 85 patients were 75 years and over. No meaningful differences in efficacy (reduction in gastric ulcer rates or pain relief) or safety were observed between these subjects and younger subjects. Elderly patients in the VIMOVO group compared with the naproxen group (n=426) were consistently observed to have significantly lower gastric ulcer rates, 1.5% vs 28.5% in patients ≥65 years of age (p<0.001), and 0% vs 19.2% in patients ≥75 years of age (p=0.019). VIMOVO non-inferiority to celecoxib for pain relief was maintained in elderly patients >65 years of age, generally considered to be at greater risk of GI side effects. The incidence of adverse events was generally consistent between age populations (see WARNINGS AND PRECAUTIONS; Gastrointestinal and Product Monograph, CLINICAL TRIALS).
Mar12_VIMOVO_3.5P_PI_pp50-53.indd 1 12-03-02 3:35 PM
ONTARIO MEDICAL REVIEW March 201251
ADVERSE REACTIONS: Adverse Drug Reaction Overview: Since VIMOVO contains both naproxen and esomeprazole, the same pattern of undesirable effects reported for these individual substances may occur. The most common adverse reactions seen with naproxen are gastrointestinal, of which peptic ulcer, with or without bleeding, is the most severe. Fatalities have occurred particularly in the elderly. Other common adverse reactions include dyspepsia, stomach pain, nausea and vomiting. Common reactions seen with esomeprazole in clinical trials include headache, diarrhea, flatulence, abdominal pain, nausea, vomiting and dizziness, which are thought to be causally related. The most commonly reported adverse reactions with VIMOVO are erosive gastritis, dyspepsia and gastritis. No new safety findings were identified during VIMOVO treatment compared to the established safety profile for the individual substances. To report a serious or unexpected reaction to this drug, you may notify Health Canada by toll-free telephone: 866-234-2345 or toll-free fax: 866-678-6789.
Administration
Dosing considerations: VIMOVO must be swallowed whole with water, and not split, chewed or crushed. VIMOVO should be taken at least 30 minutes before meals. VIMOVO does not allow for administration of lower daily doses of naproxen or esomeprazole. If a lower daily dose of either naproxen (i.e. ≤750 mg/day) or immediate-release (IR) esomeprazole (i.e. ≤40mg/day) is more appropriate, alternate therapy should be considered. Since VIMOVO is a combination product, carefully consider the implications of any dosing schedule on both components. Recommended dose and dose adjustment: For osteoarthritis/rheumatoid arthritis/anklyosing spondylitis, the recommended daily dosage of VIMOVO is 375/20 mg (naproxen/esomeprazole) twice daily or 500/20 mg (naproxen/esomeprazole) twice daily. Dosing Considerations in Special Populations: Geriatrics: See WARNINGS AND PRECAUTIONS; Special populations. Pediatrics (<18 years): VIMOVO is not recommended for use in pediatric patients (see CONTRAINDICATIONS).Dosage Forms and Packaging: VIMOVO contains an enteric-coated (EC) naproxen core and immediate-release (IR) esomeprazole film coat. The formulation is designed to release the active ingredients in a sequential fashion: esomeprazole is rapidly released in the stomach followed by the delayed release of naproxen in the small intestine. VIMOVO (naproxen/esomeprazole) 375/20 mg tablets are yellow, oval film coated tablets printed “375/20” in black ink on one side; 500/20 mg tablets are yellow, oval film coated tablets printed “500/20” in black ink on one side. VIMOVO tablets contain the following non-medicinal ingredients: carnauba wax, croscarmellose sodium, glycerol monostearate, hypromellose, iron oxide black, iron oxide yellow, macrogols, magnesium stearate, methacrylic acid-ethyl acrylate copolymer (1:1) dispersion, methyl parahydroxybenzoate, polydextrose, polysorbate, povidone, propylene glycol, propyl parahydroxybenzoate, silica colloidal anhydrous, titanium dioxide and triethyl citrate. VIMOVO 375/20 mg or 500/20 mg tablets are supplied in HDPE bottles of 60 tablets.SUPPLEMENTAL PRODUCT INFORMATIONWARNINGS AND PRECAUTIONS: Carcinogenesis and mutagenesis: There is no evidence from animal data that either naproxen or esomeprazole are carcinogenic or mutagenic. In the long-term repeat-dose/carcinogenicity studies with omeprazole, gastric enterochromaffin-like (ECL) cell carcinoids were noted in the rat, but not the mouse or dog. It has been demonstrated that this is a result of an indirect mode of action, rather than being a direct effect of omeprazole on the ECL-cells; prolonged acid suppression leads to prolonged hypergastrinemia, provoking ECL cell hyperplasia, which eventually progresses into ECL cell carcinoids (see Product Monograph, TOXICOLOGY). Treatment with esomeprazole for up to 1 year in more than 800 patients has not resulted in any significant pathological changes in the gastric oxyntic endocrine cells. Short-term treatment and long-term treatment with the racemate, omeprazole, capsules in a limited number of patients for up to 11 years have not resulted in any significant pathological changes in gastric oxyntic endocrine cells. Cardiovascular: Naproxen is a non-
steroidal anti-inflammatory drug (NSAID). Use of some NSAIDs is associated with an increased incidence of
cardiovascular adverse events (such as myocardial infarction, stroke or thrombotic events) which can be fatal.
The risk may increase with the duration of use. Patients with cardiovascular disease or risk factors for
cardiovascular disease may be at greater risk. Caution should be exercised in prescribing VIMOVO, which
contains naproxen, to patients with risk factors for cardiovascular disease, cerebrovascular disease or renal
disease, such as any of the following (NOT an exhaustive list): Hypertension, dyslipidemia/hyperlipidemia,
diabetes mellitus, congestive heart failure (NYHA I), coronary artery disease (atherosclerosis), peripheral
arterial disease, smoking, creatine clearance <60 mL/min or 1 mL/sec. Use of NSAIDs such as naproxen, which is a component of VIMOVO, can lead to new hypertension or can worsen pre-existing hypertension, either of which may increase the risk of cardiovascular events as described above. Thus blood pressure should be monitored regularly. Consideration should be given to discontinuing VIMOVO, should hypertension either develop or worsen with its use. Use of NSAIDs such as naproxen, which is a component of VIMOVO, can induce fluid retention and edema, and may exacerbate congestive heart failure, through a renally-mediated mechanism (see WARNINGS AND PRECAUTIONS; Renal, Fluid and Electrolyte Balance). For patients with a high risk of developing an adverse CV event, other management strategies that do NOT include the use of NSAIDs should be considered first. To minimize the potential risk for an adverse CV event, the lowest effective dose should be used for the shortest possible duration. Endocrine and Metabolism: Corticosteroids: VIMOVO is NOT a substitute for corticosteroids. It does NOT treat corticosteroid insufficiency. Abrupt discontinuation of corticosteroids may lead to exacerbation of corticosteroid-responsive illness. Patients on prolonged corticosteroid therapy should have their therapy tapered slowly if a decision is made to discontinue corticosteroids (see DRUG INTERACTIONS; Drug-Drug Interactions, Glucocorticoids). Gastrointestinal: Serious GI toxicity (sometimes fatal), such as ulceration, inflammation, perforation, obstruction and gastrointestinal bleeding, can occur at any time, with or without warning symptoms, in patients treated with NSAIDs, such as naproxen, which is a component of VIMOVO. While VIMOVO has been shown to significantly decrease the occurrence of gastric ulcers compared to EC-naproxen alone, ulceration and associated complications can still occur. Minor upper GI problems, such as dyspepsia, commonly occur at any time. Health care providers should remain alert for ulceration and bleeding in patients treated with VIMOVO, even in the absence of previous GI tract symptoms. Most spontaneous reports of fatal GI events are in elderly or debilitated patients and therefore special care should be taken in treating this population. To minimize the potential risk for an adverse GI event, the lowest effective dose should be used for the shortest possible duration. For high risk patients, alternate therapies that do not involve NSAIDs should be considered (see WARNINGS AND PRECAUTIONS; Special Populations, Geriatrics). Patients should be informed about the signs and/or symptoms of serious GI toxicity and instructed to discontinue using VIMOVO and seek emergency medical attention if they experience any such symptoms. The utility of periodic laboratory has NOT been demonstrated, nor has it been adequately assessed. Most patients who develop a serious upper GI adverse event on NSAID therapy have no symptoms. Upper GI ulcers, gross bleeding or perforation, caused by NSAIDs, appear to occur in approximately 1% of patients treated for 3-6 months, and in about 2-4% of patients treated for one year. These trends continue, thus increasing the likelihood of developing a serious GI event at some time during the course of therapy. Even short-term therapy has its risks. Caution should be taken if prescribing VIMOVO to patients with a history of ulcer disease or gastrointestinal bleeding. If GI bleeding or ulceration occurs, VIMOVO should be discontinued immediately and appropriate treatment sought. Other risk factors for GI ulceration and bleeding include the following:
Helicobacter pylori infection, increased age, prolonged use of NSAID therapy, excess alcohol intake, smoking, poor general health status or concomitant therapy with any of the following: Anti-coagulants (e.g. warfarin); anti-platelet agents (e.g. ASA, clopidogrel); oral corticosteroids (e.g. prednisone); Selective Serotonin Reuptake Inhibitors (SSRIs) (e.g. citalopram, fluoxetine, paroxetine, sertraline). In studies comprising patients who were older than 50 years of age and/or had a prior history of peptic ulcer, VIMOVO was shown to significantly lower gastric ulcer rates compared to EC-naproxen, regardless of concomitant therapy with low-dose ASA (see Product Monograph, CLINICAL TRIALS). Gastrointestinal symptomatic response to therapy with VIMOVO does not preclude the presence of gastric malignancy. Genitourinary: Some NSAIDs are associated with persistent urinary symptoms (bladder pain, dysuria, urinary frequency), hematuria or cystitis. The onset of these symptoms may occur at any time after the initiation of therapy with a NSAID. Should urinary symptoms occur, in the absence of an alternate explanation, treatment with VIMOVO should be stopped to ascertain if symptoms disappear. This should be done before urological investigations or treatments are carried out. Hematologic: NSAIDs inhibiting prostaglandin biosynthesis interfere with platelet function to varying degrees; patients who may be adversely affected by such an action, such as those on anti-coagulants or suffering from hemophilia or platelet disorders should be carefully observed when VIMOVO is administered. Anti-coagulants: Numerous studies have shown that the concomitant use of NSAIDs and anti-coagulants increases the risk of bleeding. Concurrent therapy of VIMOVO, which contains the NSAID naproxen, with warfarin requires close monitoring of the international normalized ratio (INR). Even with therapeutic INR monitoring, increased bleeding may occur. Anti-platelet Effects: NSAIDs inhibit platelet aggregation and have been shown to prolong bleeding time in some patients. Unlike acetylsalicylic acid (ASA), their effect on platelet function is quantitatively less, or of shorter duration, and is reversible. NSAIDs have no proven efficacy as anti-platelet agents and should NOT be used as a substitute for ASA or other anti-platelet agents for prophylaxis of cardiovascular thromboembolic diseases. Anti-platelet therapies (e.g. ASA) should NOT be discontinued (see DRUG INTERACTIONS; Drug-Drug Interactions, Acetylsalicylic Acid (ASA) or other NSAIDs). Blood dyscrasias: Blood dyscrasias (such as neutropenia, leukopenia, thrombocytopenia, aplastic anemia and agranulocytosis) associated with the use of NSAIDs are rare, but could occur with severe consequences. Anemia is sometimes seen in patients receiving NSAIDs. This may be due to fluid retention, GI blood loss, or an incompletely described effect upon erythropoiesis. Patients on long-term treatment with NSAIDs, should have their hemoglobin or hematocrit checked if they exhibit any signs or symptoms of anemia or blood loss. Hepatic/Biliary/Pancreatic: With NSAIDs, borderline elevations of one or more liver enzyme tests (AST, ALT, alkaline phosphatase) may occur in up to 15% of patients. These abnormalities may progress, may remain essentially unchanged, or may be transient with continued therapy. Chronic alcoholic liver disease and probably other forms of cirrhosis reduce the total plasma concentration of naproxen, but the plasma concentration of unbound naproxen is increased. The implication of this finding for naproxen dosing is unknown, but caution is advised when high doses are required. It is prudent to use the lowest effective dose. A patient with symptoms and/or signs suggesting liver dysfunction, or in whom an abnormal liver function test has occurred, should be evaluated for evidence of the development of a more severe hepatic reaction while on therapy with this drug. Severe hepatic reactions including jaundice and cases of fatal hepatitis, liver necrosis and hepatic failure, some of them with fatal outcomes, have been reported with NSAIDs. Although such reactions are rare, if abnormal liver tests persist or worsen, if clinical signs and symptoms consistent with liver disease develop (e.g. jaundice), or if systemic manifestations occur (e.g. eosinophilia, associated with rash, etc.), this drug should be discontinued. If there is a need to prescribe this drug in the presence of impaired liver function, it must be done under strict observation. Hypersensitivity Reactions: Anaphylactoid Reactions: As with NSAIDs in general, anaphylactoid reactions have occurred in patients without known prior exposure to naproxen, a component of VIMOVO. In post-marketing experience, rare cases of anaphylactic/anaphylactoid reactions and angioedema have been reported in patients receiving naproxen. VIMOVO, which contains naproxen, should NOT be given to patients with the ASA-triad. This symptom complex typically occurs in asthmatic patients who experience rhinitis with or without nasal polyps, or who exhibit severe, potentially fatal bronchospasm after taking ASA or other NSAIDs (see CONTRAINDICATIONS). ASA-Intolerance: VIMOVO, which contains naproxen, should NOT be given to patients with complete or partial syndrome of ASA-intolerance (rhinosinusitis, urticaria/angioedema, nasal polyps, asthma) in whom asthma, anaphylaxis, urticaria/angioedema, rhinitis or other allergic manifestations are precipitated by ASA or other NSAIDs. Fatal anaphylactoid reactions have occurred in such individuals. As well, individuals with the above medical problems are at risk of a severe reaction even if they have taken NSAIDs in the past without any adverse reaction (see CONTRAINDICATIONS). Cross-sensitivity: Patients sensitive to one NSAID may be sensitive to any of the other NSAIDs as well. Serious skin reactions: See WARNINGS AND PRECAUTIONS; Skin. Immune: See WARNINGS AND PRECAUTIONS; Infection, Aseptic Meningitis. Infection: Naproxen, a component of VIMOVO, as with other NSAIDs, may mask signs and symptoms of an underlying infectious disease. Aseptic Meningitis: Rarely, with some NSAIDs, the symptoms of aseptic meningitis (stiff neck, severe headaches, nausea and vomiting, fever or clouding of consciousness) have been observed. Patients with autoimmune disorders (systemic lupus erythematosus, mixed connective tissue diseases, etc.) seem to be pre-disposed. Therefore, in such patients, the health care provider must be vigilant to the development of this complication. Pseudomembranous colitis: Pseudomembranous colitis has been reported with nearly all antibacterial agents, including clarithromycin and amoxicillin, and may range in severity from mild to life threatening. Therefore, it is important to consider this diagnosis in patients who present with diarrhea subsequent to the administration of antibacterial agents. Treatment with antibacterial agents alters the normal flora of the colon and may permit overgrowth of Clostridia. Studies indicate that a toxin produced by Clostridium difficile is a primary cause of “antibiotic-associated colitis”. After the diagnosis of pseudomembranous colitis has been established, therapeutic measures should be initiated. Mild cases of pseudomembranous colitis usually respond to discontinuation of the drug alone. In moderate to severe cases, consideration should be given to management with fluids and electrolytes, protein supplementation, and treatment with an antibacterial drug clinically effective against C. diff colitis. Decreased gastric acidity due to any means, including any proton pump inhibitors, increases gastric counts of bacteria normally present in the gastrointestinal tract. Treatment with proton pump inhibitors may lead to a slightly increased risk of gastrointestinal infections such as Salmonella, Campylobacter and possibly C. diff. Neurologic: Some patients may experience drowsiness, dizziness, blurred vision, vertigo, tinnitus, hearing loss, insomnia or depression with the use of NSAIDs, such as naproxen, a component of VIMOVO. If patients experience such adverse reaction(s), they should exercise caution in carrying out activities that require alertness. Ophthalmologic: Blurred and/or diminished vision has been reported with the use of NSAIDs. If such symptoms develop, VIMOVO, which contains naproxen, should be discontinued and an ophthalmologic examination performed. Ophthalmologic examination should be carried out at periodic intervals in any patient receiving VIMOVO for an extended period of time. Peri-Operative Considerations: See CONTRAINDICATIONS; Coronary Artery Bypass Graft Surgery. Psychiatric: See WARNINGS AND PRECAUTIONS; Neurologic. Renal: Long term administration of NSAIDs to animals has resulted in renal papillary necrosis and other abnormal renal pathology. In humans, there have been reports of acute interstitial nephritis, hematuria, low grade proteinuria and occasionally nephrotic syndrome. Renal insufficiency due to NSAID use is seen in patients with pre-renal conditions leading to reduction in renal blood flow or blood volume. Under these circumstances, renal prostaglandins help maintain renal perfusion and glomerular filtration rate (GFR). In these patients, administration of a NSAID may cause a reduction in prostaglandin synthesis leading to impaired renal function. Patients at greatest risk of this reaction are those with pre-existing renal insufficiency (GFR <60 mL/min or 1 mL/s), dehydrated patients, patients on salt restricted diets, those with congestive heart failure, cirrhosis, liver dysfunction, taking angiotensin-converting enzyme inhibitors, angiotensin-II receptor blockers, cyclosporin, diuretics, and those who are elderly. Serious or life-threatening renal failure has been reported in patients with normal or impaired renal function after short term therapy with NSAIDs. Even patients at risk who demonstrate the ability to tolerate a NSAID under stable conditions may decompensate during periods of added stress (e.g. dehydration due to gastroenteritis). Discontinuation of NSAIDs is usually followed by recovery to the pre-treatment state. Caution should be used when initiating treatment with NSAIDs, such as naproxen, a component of VIMOVO, in patients with considerable dehydration. Such patients should be rehydrated prior to initiation of therapy. Caution is also recommended in patients with pre-existing kidney disease. Advanced Renal Disease: See CONTRAINDICATIONS. Fluid and Electrolyte Balance: Use of NSAIDs such as naproxen, a component of VIMOVO, can promote sodium retention in a dose-dependent manner, which can lead to fluid retention and edema, and consequences of increased blood pressure and exacerbation of congestive heart failure. Thus, caution should be exercised in prescribing VIMOVO in patients with a history of congestive heart failure, compromised cardiac function, hypertension, increased age or other conditions predisposing to fluid retention (see WARNINGS AND PRECAUTIONS; Cardiovascular). Use of NSAIDs such as naproxen, a component of VIMOVO, can increase the risk of hyperkalemia, especially in patients with diabetes mellitus, renal failure, increased age, or those receiving concomitant therapy with adrenergic blockers, angiotensin-converting enzyme inhibitors, angiotensin-II receptor antagonists, cyclosporin, or some diuretics. Electrolytes should be monitored periodically (see CONTRAINDICATIONS). Respiratory: ASA-induced asthma is an uncommon but very important indication of ASA and NSAID sensitivity. It occurs more frequently in patients with asthma who have nasal polyps. Sexual Function/Reproduction: The use of naproxen as with any drug known to inhibit cyclooxygenase/prostaglandin synthesis, may impair fertility and is not recommended in women attempting to conceive. Therefore, in women who have difficulties conceiving, or who are undergoing investigation of infertility, withdrawal of VIMOVO, which contains naproxen, should be considered. Skin: In rare cases, serious skin reactions such as Stevens-Johnson syndrome, toxic epidermal necrolysis, exfoliative dermatitis and erythema multiforme have been associated with the use of some NSAIDs. Because the rate of these reactions is low, they have usually been noted during post-marketing surveillance in patients taking other medications also associated with the potential development of these serious skin reactions. Thus, causality is NOT clear. These reactions are potentially life threatening but may be reversible if the causative agent is discontinued and appropriate treatment instituted. Patients should be advised that if they experience a skin rash they should discontinue their NSAID and contact their physician for assessment and advice, including which additional therapies to discontinue.SPECIAL POPULATIONS:Hepatic Insufficiency: VIMOVO is not recommended for use in patients with severe hepatic impairment due to increased risk of NSAID associated bleeding and/or renal failure (see CONTRAINDICATIONS and WARNINGS AND PRECAUTIONS; Hepatic/Biliary/Pancreatic). In patients with mild to moderate hepatic impairment VIMOVO should be used with caution and hepatic function closely monitored. Renal Insufficiency: VIMOVO is not recommended for use in patients with severe renal impairment or deteriorating renal disease (see
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CONTRAINDICATIONS and WARNINGS AND PRECAUTIONS; Renal). In patients with mild to moderate renal impairment VIMOVO should be used with caution and renal function closely monitored. Poor Metabolizers: The CYP 2C19 and CYP 3A4 isozymes are responsible for metabolism of esomeprazole. The CYP 2C19 isozyme, which is involved in the metabolism of all available proton pump inhibitors, exhibits polymorphism. Some 3% of Caucasians and 15-20% of Asians lack CYP 2C19 and are termed “poor metabolizers”. At EC-esomeprazole steady state (40 mg for 5 days), the ratio of AUC in poor metabolizers to AUC in the rest of the population is approximately 2. Dosage adjustment of VIMOVO based on CYP 2C19 status is not necessary (see DOSAGE AND ADMINISTRATION and Product Monograph ACTION AND CLINICAL PHARMACOLOGY; Pharmacokinetics, Special Populations).MONITORING AND LABORATORY TESTS:Patients on long-term treatment with VIMOVO should have their blood pressure monitored regularly and an ophthalmic examination should be carried out at periodic intervals (see WARNINGS AND PRECAUTIONS; Cardiovascular and Ophthalmic). Hemoglobin, hematocrit, red blood cells (RBCs), white blood cells (WBCs), and platelets should be checked in patients on long-term treatment with VIMOVO. Additionally, concurrent therapy with warfarin requires close monitoring of the international normalized ratio (INR) (see WARNINGS AND PRECAUTIONS; Hematology). Serum transaminase and bilirubin should be monitored regularly during VIMOVO therapy (see WARNINGS AND PRECAUTIONS; Hepatic, Biliary, Pancreatic). Serum creatinine, creatine clearance and serum urea should be checked in patients during VIMOVO therapy. Electrolytes including serum potassium should be monitored periodically (see WARNINGS AND PRECAUTIONS; Renal). Monitoring of plasma lithium concentration is recommended when stopping or starting VIMOVO therapy.ADVERSE REACTIONS:Since VIMOVO contains both naproxen and esomeprazole, the same pattern of undesirable effects reported for these individual substances may occur. The most common adverse reactions seen with naproxen are gastrointestinal, of which peptic ulcer, with or without bleeding, is the most severe. Fatalities have occurred particularly in the elderly. Other common adverse reactions include dyspepsia, stomach pain, nausea and vomiting. Common reactions seen with esomeprazole in clinical trials include headache, diarrhea, flatulence, abdominal pain, nausea, vomiting and dizziness, which are thought to be causally related. The most commonly reported adverse reactions with VIMOVO are erosive gastritis, dyspepsia and gastritis. No new safety findings were identified during VIMOVO treatment compared to the established safety profile for the individual substances.Clinical Trial Adverse Drug Reactions: Because clinical trials are conducted under very specific conditions the adverse reaction rates observed in the clinical trials may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug. Adverse drug reaction information from clinical trials is useful for identifying drug-related adverse events and for approximating rates. Adverse event data is provided from controlled studies using VIMOVO, involving 2317 patients ranging in duration from 3-12 months. Patients received either 500/20 mg of VIMOVO twice daily (n=1157), 500 mg of enteric-coated (EC) naproxen twice daily (n=426), 200 mg of celecoxib once daily (n=488), or placebo (n=246). All adverse reactions, regardless of causality, occurring in ≥2% of patients from two 6-month randomized, double-blind, parallel-group controlled clinical studies (Study 301 and 302) conducted in patients at risk of developing NSAID-associated ulcers compared to EC-naproxen are presented in the below table.Table 1: Adverse Reactions, regardless of causality, occurring ≥2% in arthritisa patients at risk of NSAID-induced ulcers from Studies 301 and 302 (pooled, 6 months duration)
Preferred term (sorted by SOC) Percentage of Subjects With Adverse Events
VIMOVO (500/20 mg) BID(n=428)
EC-naproxen 500 mg BID(n=426)
Gastrointestinal disorders
Gastritis Erosive 19.4 38.0
Dyspepsia 18.0 26.8
Gastritis 17.1 14.1
Diarrhea 6.1 5.2
Gastric Ulcer 5.6 23.7
Abdominal Pain Upper 5.6 8.7
Nausea 5.1 4.9
Hiatus Hernia 4.2 5.9
Abdominal Distension 3.7 3.8
Flatulence 3.7 3.1
Esophagitis 3.5 7.5
Constipation 2.6 2.8
Abdominal pain 2.3 1.6
Erosive Duodenitis 2.1 11.7
Abdominal pain lower 2.1 2.6
Duodenitis 1.4 7.3
Gastritis hemorrhagic 1.2 2.1
Gastroesophageal reflux disease 0.9 3.5
Duodenal ulcer 0.7 5.4
Erosive esophagitis 0.5 5.6
Infections and infestations
Upper respiratory tract infection 4.9 3.8
Bronchitis 2.3 1.9
Urinary tract infection 2.3 1.4
Sinusitis 1.9 2.1
Nasopharyngitis 0.9 2.3
Musculoskeletal and connective tissue disorders
Arthralgia 1.2 2.3
Nervous system disorders
Headache 2.6 1.4
Dysgeusia 2.1 1.4
Respiratory, thoracic, and mediastinal disorders
Cough 2.3 2.6
a Studies also included 23% patients with chronic musculoskeletal conditions requiring ongoing NSAID therapy
Patients taking VIMOVO had significantly fewer pre-specified NSAID-associated upper GI adverse events (including duodenal ulcers) (53.3%) compared to patients taking EC-naproxen alone (70.4%). As well, patients taking VIMOVO had significantly less discontinuations due to adverse reactions compared to patients taking EC-naproxen alone (7.9% vs. 12.5% respectively). The most common reasons for discontinuations due to adverse events in the VIMOVO treatment group were upper abdominal pain (1.2%, n=5), duodenal ulcer (0.7%, n=3) and erosive gastritis (0.7%, n=3). Among patients receiving naproxen alone, the most common reasons for discontinuations due to adverse events were duodenal ulcer 5.4% (n=23), dyspepsia 2.8% (n=12) and upper abdominal pain 1.2% (n=5). The proportion of patients discontinuing treatment due to pre-specified NSAID-associated upper gastrointestinal adverse events (including duodenal ulcers) in patients treated with VIMOVO was 4.0% compared to 12.0% for patients taking EC-naproxen (p<0.001).Adverse reaction data for VIMOVO, regardless of causality, occurring in ≥2 % of patients, and greater than placebo from two 3-month randomized double-blind, placebo-controlled clinical studies conducted in patients with osteoarthritis of the knee are presented below.
Table 2: Adverse Reactions, regardless of causality, occurring ≥2% in patients with osteoarthritis of the knee from Studies 307 and 309 (3 months duration)
Preferred term (sorted by SOC) Percentage of Subjects With Adverse Events
VIMOVO (500/20 mg) BID(n=490)
Celecoxib 200 mg QD(n=488)
Placebo(n=246)
Gastrointestinal disorders
Dyspepsia 8.4 10.7 12.2
Diarrhea 5.5 2.9 3.7
Abdominal Pain Upper 4.1 4.3 3.3
Constipation 3.5 2.0 1.2
Nausea 3.5 3.1 3.7
Nervous system disorders
Dizziness 3.1 0.8 2.0
Headache 2.7 3.7 5.3
General disorders and administration site conditions
Peripheral edema 3.1 1.2 1.2
Musculoskeletal and connective tissue disorders
Arthralgia 1.4 2.9 1.6
Back pain 1.2 2.9 2.0
Respiratory, thoracic and mediastinal disorders
Cough 1.4 0.6 2.8
Infections and infestations
Sinusitis 1.0 1.2 2.4
Similar percentages of subjects receiving either VIMOVO or celecoxib withdrew from these studies due to treatment emergent adverse events (6.9% and 7.8% respectively). There were no adverse reactions in which more than 1% of subjects withdrew from any treatment group. The long-term safety of VIMOVO was evaluated in an open label clinical trial of 239 patients, of which 135 patients received 500/20 mg of VIMOVO for 12 months. There were no differences in frequency or types of adverse reactions seen in the long-term safety study compared to shorter-term treatment in the randomized controlled studies above. In the pooled data from all VIMOVO clinical trials in patients (n=2317), there were 4 reports of atrial fibrillation/flutter. All 4 events occurred in patients assigned to VIMOVO but all were assessed as unrelated or unlikely to be related to study drug.Other Adverse Events: Post-Market Adverse Drug Reactions: Because post-marketing events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or clearly establish a causal relationship to the product. The following post-marketing adverse events have been reported with NSAIDS including naproxen and naproxen sodium, taken alone. Gastrointestinal: Peptic ulcers, perforation, or GI bleeding, sometimes fatal, particularly in the elderly. Heartburn, nausea, esophagitis, vomiting, diarrhea, flatulence, constipation, dyspepsia, abdominal pain, nonpeptic gastrointestinal ulceration, melena, hematemesis, stomatitis, ulcerative stomatitis, exacerbation of ulcerative colitis and Crohn’s disease, pancreatitis, gastritis. Infections: Aseptic meningitis. Blood and Lymphatic System Disorders: Agranulocytosis, aplastic anemia, eosinophilia, hemolytic anemia, leucopenia, thrombocytopenia. Immune System Disorders: Anaphylactoid reactions. Metabolic and Nutrition Disorders: Hyperkalemia. Psychiatric Disorders: depression, dream abnormalities, insomnia. Nervous System Disorders: Dizziness, drowsiness, headache, lightheadedness, retrobulbar optic neuritis convulsions, cognitive dysfunction, inability to concentrate. Eye Disorders: Visual disturbances, corneal opacity, papillitis, papilledema. Ear and Labyrinth Disorders: Hearing impairment, hearing disturbances, tinnitus, vertigo. Cardiac Disorders: Palpitations, cardiac failure has been reported in association with NSAID treatment, congestive heart failure. Vascular Disorders: Hypertension, vasculitis. Respiratory, Thoracic and Mediastinal Disorders: Dyspnea, pulmonary edema, asthma, eosinophilic pneumonitis. Hepatobiliary Disorders: Hepatitis (some cases of hepatitis have been fatal), jaundice. Skin and Subcutaneous Tissue Disorders: ecchymoses, itching (pruritus), purpura, skin eruptions, sweating, alopecia, epidermal necrolysis, very rarely toxic epidermal necrolysis, erythema multiforme, bullous reactions, including Stevens-Johnson syndrome, erythema nodosum, fixed drug eruption, lichen planus, pustular reaction, skin rashes, SLE, urticaria, photosensitivity reactions, including rare cases resembling porphyria cutanea tarda (“pseudoporphyria”) or epidermolysis bullosa and angioneurotic edema. If skin fragility, blistering or other symptoms suggestive of pseudoporphyria occur, treatment should be discontinued and the patient monitored. Musculoskeletal and Connective Tissue Disorders: myalgia, muscle weakness. Renal and Urinary Disorders: hematuria, interstitial nephritis, nephrotic syndrome, renal disease, renal failure, renal papillary necrosis. Reproductive System and Breast Disorders: Female infertility. General Disorders and Administration Site Conditions: Edema, thirst, pyrexia (chills and fever), malaise. Investigations: Abnormal liver function tests, raised serum creatinine. From esomeprazole post-marketing experience there have been uncommon reports (<1%) of peripheral edema, insomnia, paresthesia, somnolence, vertigo and increased liver enzymes. There have also been rare reports (<0.1%) of blurred vision, hypersensitivity reactions (e.g. angioedema, anaphylactic reaction/shock), myalgia, leukopenia, thrombocytopenia, depression, alopecia, hepatitis with or without jaundice, hyponatremia, agitation, confusion, taste disturbance, bronchospasm, stomatitis, GI candidiasis, rash, dermatitis, photosensitivity, arthralgia, malaise, and hyperhidrosis. Very rarely (<0.01%) agranulocytosis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, pancytopenia, aggression, hallucination, hepatic failure, hepatic encephalopathy, interstitial nephritis, muscular weakness, gynecomastia, and hypomagnesaemia have been reported.DRUG INTERACTIONS:Drug-Drug Interactions: Overview: Studies conducted with VIMOVO have shown no interactions between its two components, naproxen and esomeprazole. Interaction studies have not been conducted with VIMOVO and other drugs. Interactions for VIMOVO would be expected to reflect those of the monocomponents, taken separately, which are detailed below. NSAID related drug-drug interactions: Acetylsalicylic acid (ASA) or other NSAIDs: The use of VIMOVO in addition to an NSAID, including over-the-counter ones (such as ASA and ibuprofen) for analgesic and/or anti-inflammatory effects is NOT recommended because of the absence of any evidence demonstrating synergistic benefits and the potential for additive adverse reactions. The exception is the use of low-dose ASA for cardiovascular protection, when another NSAID containing product, such as VIMOVO is being used for its analgesic/anti-inflammatory effect, keeping in mind that combination NSAID therapy is associated with additive adverse reactions. However, in clinical trials, patients taking VIMOVO in combination with low-dose ASA did not have an increased occurrence of gastric ulcers compared to patients taking VIMOVO alone. Ulcer complications such as bleeding, perforation and obstruction were not studied in VIMOVO trials. Some NSAIDs (e.g. ibuprofen) may interfere with the anti-platelet effects of low-dose ASA, possibly by competing with ASA for access to the active site of cyclooxygenase-1. Albumin Bound Drugs: The naproxen anion may displace from their binding sites other drugs which are also albumin-bound and may lead to drug interactions. For example, in patients receiving bishydroxycoumarin or warfarin, the addition of VIMOVO, which contains naproxen, could prolong the prothrombin time. These patients should, therefore, be under careful observation. Similarly, patients receiving VIMOVO and a hydantoin, sulfonamide or sulfonylurea should be observed for adjustment of dose if required. Antacids: The rate of absorption of naproxen is altered by concomitant administration of antacids but is not adversely influenced by the presence of food. Anti-coagulants: See WARNINGS AND PRECAUTIONS; Hematologic, Anti-coagulants. Anti-hypertensives: NSAIDs may diminish the anti-hypertensive effect of Angiotensin Converting Enzyme (ACE) inhibitors. Combinations of ACE inhibitors, angiotensin-II antagonists, or diuretics with NSAIDs might have an increased risk for acute renal failure and hyperkalemia. Blood pressure and renal function (including electrolytes) should be monitored more closely in this situation, as occasionally there can be a substantial increase in blood pressure. Naproxen and other NSAIDs can reduce the antihypertensive effect of propranolol and other beta blockers as well as other antihypertensive agents. Anti-platelet Agents (including ASA): There is an increased risk of bleeding, via inhibition of platelet function, when anti-platelet agents are combined with NSAIDs, such as naproxen, a component of VIMOVO (see WARNINGS AND PRECAUTIONS; Hematologic, Anti-platelet Effects). Cyclosporin: Inhibition of renal prostaglandin activity by NSAIDs may increase the plasma concentration of cyclosporine and/or the risk of cyclosporine induced nephrotoxicity. Patients should be carefully monitored during concurrent use. Cholestyramine: Concomitant administration of cholestyramine can delay the absorption of naproxen, but does not affect its extent. Digoxin: Concomitant administration of an NSAID with digoxin can result in an increase in digoxin concentrations which may result in digitalis toxicity. Increased monitoring and dosage adjustments of digitalis glycosides may be necessary during and following concurrent NSAID therapy. Diuretics: Clinical studies as well as post-marketing observations have shown that NSAIDs can reduce the effect of diuretics. Glucocorticoids: Some studies have shown that the concomitant use of NSAIDs and oral glucocorticoids increases the risk of GI adverse events such as ulceration and bleeding. This is especially the case in older (>65 years of age) individuals. Lithium: Monitoring of plasma lithium concentrations is advised when stopping or starting a NSAID, as increased lithium concentrations can occur. Methotrexate: Caution is advised in the concomitant administration of naproxen and methotrexate since naproxen and other NSAIDs have been reported to reduce the tubular secretion of methotrexate in an animal model, thereby possibly enhancing its toxicity. Probenecid:
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Probenecid given concurrently increases naproxen anion plasma levels and extends its plasma half-life significantly. Caution is advised when probenecid is administered concurrently. Selective Serotonin Reuptake Inhibitors (SSRIs): Concomitant administration of NSAIDs and SSRIs may increase the risk of gastrointestinal ulceration and bleeding (see WARNINGS AND PRECAUTIONS; Gastrointestinal). Tacrolimus: As with all NSAIDs caution is advised when tacrolimus is co-administered because of the increased risk of nephrotoxicity. Esomeprazole related drug-drug interactions: Esomeprazole magnesium is metabolized by the cytochrome P-450 system (CYP), mainly in the liver, through CYP 2C19 and CYP 3A4. There are no clinically significant interactions between esomeprazole and diazepam, phenytoin, quinidine or cisapride (cisapride not marketed in Canada). Drugs known to inhibit CYP 2C19 or CYP 3A4 or both (such as clarythromycin and voriconazole) may lead to increased esomeprazole serum levels by decreasing the rate of esomeprazole’s metabolism. Drugs known to induce CYP 2C19 or CYP 3A4 or both (such as rifampin and St. John’s Wort) may lead to decreased esomeprazole serum levels by increasing the esomeprazole metabolism (see DRUG-HERB INTERACTIONS). Diazepam: Concomitant administration of EC-esomeprazole (30 mg once daily for 5 days) resulted in a 45% decrease in the clearance of diazepam in healthy male volunteers. Studies in females have not been conducted. Increased levels of diazepam were seen some 12 hours after dosing and later when the plasma levels of diazepam were below its therapeutic range. Therefore, this interaction is unlikely to be of clinical significance. Warfarin: Concomitant administration of 40 mg EC-esomeprazole (once daily for 3 weeks) to male and female patients on stable anticoagulation therapy with warfarin, resulted in a 13% increase in trough plasma levels of R-warfarin (the less potent enantiomer) while that of S-warfarin was unchanged. Coagulation times were stable throughout the entire study period. No clinically significant interaction was observed. However, from post marketed use, cases of elevated international normalized ratio (INR) of clinical significance have been reported during concomitant treatment with warfarin. Close monitoring is recommended when initiating and ending treatment with warfarin or other coumarin derivatives (refer to approved Product Monograph for warfarin or relevant coumarin derivative). Cilostazol (not marketed in Canada): Omeprazole as well as esomeprazole act as inhibitors of CYP 2C19. Omeprazole, given in doses of 40 mg to healthy subjects in a cross-over study, increased C
max and AUC for cilostazol by 18% and 26% respectively, and one of its active metabolites,
3,4-dihydrocilostazol, by 29% and 69% respectively. Phenytoin: Concomitant administration of 40 mg EC-esomeprazole (once daily for 2 weeks) to male and female epileptic patients stabilized on phenytoin, resulted in a 13% increase in trough plasma levels of phenytoin. This minor interaction is unlikely to be of clinical relevance as dose reduction was not required in any patient nor was the profile and frequency of adverse events affected. Results from a range of interaction studies with EC-esomeprazole versus other drugs indicate that daily doses of 40 mg EC-esomeprazole, given for 5 to 21 days in male and/or female subjects, has no clinically relevant interactions with CYP 1A2 (caffeine), CYP 2C9 (S-warfarin), and CYP 3A (quinidine, estradiol and cisapride [cisapride not marketed in Canada]). Antiretroviral Drugs: Omeprazole, the racemate of esomeprazole, like other acid-reducing agents, has been reported to interact with some antiretroviral drugs. The clinical importance and the mechanisms behind these interactions are not always known. A change in gastric pH may change the absorption of the antiretroviral drug. Other possible interaction mechanisms are via CYP 2C19. Reports indicate that omeprazole has a significant impact on atazanavir exposure, decreasing AUC, C
max and C
min. This interaction is only partially overcome by
the addition of ritonavir to the atazanavir treatment regimen. Similarly, decreased serum levels of nelfinavir have also been reported when given together with omeprazole. Concomitant administration of omeprazole with atazanavir and nelfinavir is not recommended. For other antiretroviral drugs, such as saquinavir, increased serum levels have been reported. There are also some antiretroviral drugs where unchanged serum levels have been reported when given with omeprazole. Due to the similar pharmacodynamic effects and pharmacokinetic properties of omeprazole and esomeprazole, concomitant administration of EC-esomeprazole and antiretroviral drugs such as atazanavir and nelfinavir is not recommended (see WARNINGS AND PRECAUTIONS). Voriconazole: Concomitant administration of EC-esomeprazole with a combined inhibitor of CYP 2C19 and CYP 3A4 may result in more than double the levels of esomeprazole exposure. As with all drugs that reduce gastric acidity, changes in plasma levels of other drugs whose absorption is pH dependent (e.g. ketoconazole or itraconazole) must be taken into account when they are co-administered with esomeprazole. Digoxin: The absorption of digoxin can increase during treatment with esomeprazole and other drugs that reduce gastric acidity. Concomitant treatment with omeprazole (20 mg daily) and digoxin in ten healthy subjects increased the bioavailability of digoxin by an average of 10% (up to 30% in two out of ten subjects). Other interactions: As demonstrated with other PPIs, prolonged use may impair the absorption of protein-bound Vitamin B
12 and may contribute to the development of Vitamin B
12 deficiency. Drug-Food Interactions: Concomitant
administration of food can delay the absorption of the naproxen component of VIMOVO, but does not affect its extent of absorption. Concomitant administration of food however, does not delay the absorption of the esomeprazole component of VIMOVO, but significantly reduces its extent of absorption (see DOSAGE AND ADMINISTRATION; Dosing Considerations and Product Monograph ACTIONS AND
CLINICAL PHARMACOLOGY; Pharmacokinetics, Absorption, Food Effect). Drug-Herb Interactions: Use of St. John’s Wort may lead to decreased esomeprazole serum levels by increasing the esomeprazole metabolism (see DRUG INTERACTIONS, Esomeprazole related Drug-Drug Interactions). Drug-Laboratory Interactions: During treatment with antisecretory drugs, chromogranin A (CgA) increases due to decreased gastric acidity. The increased CgA level may interfere with investigations for neuroendocrine tumours. To avoid this interference esomeprazole treatment should be temporarily stopped five days before CgA measurements. (See also WARNINGS AND PRECAUTIONS; Special Populations, Monitoring and Laboratory Tests). Drug-Lifestyle Interactions: There are no specific studies about effects on the ability to drive vehicles and to use machinery. It should be taken into account that some of the adverse effects (e.g. dizziness) reported following the use of VIMOVO may reduce the ability to react. Patients who experience visual disturbances or other central nervous system disturbances should refrain from these activities. Concurrent use of alcohol with an NSAID may increase the risk of gastrointestinal side effects, including ulceration and hemorrhage.DOSAGE AND ADMINISTRATION:Missed Dose: The missed dose should be taken as soon as remembered, and then the regular dosing schedule should be continued. Two doses of VIMOVO should not be taken at the same time. Special Populations: Hepatic Insufficiency: VIMOVO is not recommended for use in patients with severe hepatic impairment (see CONTRAINDICATIONS, WARNINGS AND PRECAUTIONS; Hepatic/Biliary/Pancreatic and WARNINGS AND PRECAUTIONS; Special Populations). Renal Insufficiency: VIMOVO is not recommended for use in patients with severe renal impairment or deteriorating renal disease (see CONTRAINDICATIONS, WARNINGS AND PRECAUTIONS; Renal and WARNINGS AND PRECAUTIONS; Special Populations). Poor Metabolizers: Dosage adjustment based on CYP 2C19 status is not necessary (see WARNINGS AND PRECAUTIONS; Special Populations and Product Monograph ACTION AND CLINICAL PHARMACOLOGY; Pharmacokinetics, Special Populations).OVERDOSAGE:
For management of suspected drug overdose, contact your regional Poison Control Centre.
There is no clinical data on overdosage with VIMOVO. Any effects of an overdose with VIMOVO would be expected to reflect those of the monocomponents of naproxen and esomeprazole, taken separately. Naproxen: Significant overdosage may be characterized by drowsiness, dizziness, disorientation, heartburn, indigestion, epigastric pain, abdominal discomfort, nausea, vomiting, transient alterations in liver function, hypoprothrombinemia, renal dysfunction, metabolic acidosis and apnea. A few patients have experienced convulsions, but it is not clear whether or not these were naproxen related. Gastrointestinal bleeding may occur. Hypertension, acute renal failure, respiratory depression and coma may occur after the ingestion of NSAIDs but are rare. Anaphylactoid reactions have been repeated with therapeutic ingestion of NSAIDs, and may occur following an overdose. Patients should be managed by symptomatic and supportive care following NSAIDs overdose. There are no specific antidotes. Prevention of further absorption (e.g. activated charcoal) may be indicated in patients seen within 4 hours of ingestion with symptoms or following a large overdose. Forced diuresis, alkalinization of urine, hemodialysis, or hemoperfusion may not be useful due to high protein binding. Esomeprazole: Limited information is available on the effects of higher doses in man, and specific recommendations for treatment cannot be given. Experience from a patient who deliberately ingested an overdose of EC-esomeprazole (280 mg), demonstrated symptoms that were transient, and included weakness, loose stools and nausea. Single doses of 80 mg EC-esomeprazole have been shown to be uneventful. No specific antidote is known. Esomeprazole is extensively protein-bound and is therefore not readily dialyzable. Treatment should be symptomatic and general supportive measures should be utilized.Product Monograph is available upon request from AstraZeneca Canada Inc.Revision date: January 13, 2011.
VIMOVO® and the AstraZeneca logo are registered trademarks of the AstraZeneca group of companies. © AstraZeneca 2011
AstraZeneca Canada Inc.1004 Middlegate Road, Mississauga, Ontario L4Y 1M4
www.astrazeneca.ca T 1-800-668-6000 F 1-800-250-1909VIM105E
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Prescribing Summary
THERAPEUTIC CLASSIFICATION Live, attenuated virus varicella-zoster vaccine
INDICATIONS AND CLINICAL USE ZOSTAVAX® is indicated for the prevention of herpes zoster (shingles).
ZOSTAVAX® is indicated for immunization of individuals 50 years of age or older.
SPECIAL POPULATIONSFor use in special populations, see Supplemental Product Information, WARNINGS AND PRECAUTIONS, Special Populations.
CONTRAINDICATIONSHistory of hypersensitivity to any component of the vaccine, including gelatin. History of anaphylactic/anaphylactoid reaction to neomycin (each dose of reconstituted vaccine contains trace quantities of neomycin). Neomycin allergy generally manifests as a contact dermatitis. However, a history of contact dermatitis due to neomycin is not a contraindication to receiving live virus vaccines.
Primary and acquired immunodeficiency states due to conditions such as: acute and chronic leukemias; lymphoma; other conditions affecting the bone marrow or lymphatic system; immunosuppression due to HIV/AIDS; cellular immune deficiencies. Immunosuppressive therapy (including high-dose corticosteroids); however, ZOSTAVAX® is not contraindicated for use in individuals who are receiving topical/inhaled corticosteroids or low-dose systemic corticosteroids or in patients who are receiving corticosteroids as replacement therapy, e.g., for adrenal insufficiency.
Active untreated tuberculosis.
Pregnancy (see WARNINGS AND PRECAUTIONS - Pregnant Women in the Supplemental Product Information).
WARNINGS AND PRECAUTIONS GeneralThe health care provider should question the patient about reactions to a previous dose of any varicella-zoster virus (VZV)-containing vaccines (see CONTRAINDICATIONS).
As with any vaccine, adequate treatment provisions, including epinephrine injection (1:1000), should be available for immediate use should an anaphylactic/anaphylactoid reaction occur. Deferral of vaccination should be considered in the presence of fever >38.5°C (>101.3°F). ZOSTAVAX® does not protect all individuals against the development of Herpes Zoster or its sequelae. See ACTION AND CLINICAL PHARMACOLOGY and CLINICAL TRIALS in the product monograph.
The duration of protection beyond 4 years after vaccination with ZOSTAVAX® is unknown. The need for revaccination has not been defined.
ZOSTAVAX® has not been studied in individuals who have previously experienced an episode of herpes zoster.
Transmission In clinical trials with ZOSTAVAX®, transmission of the vaccine virus has not been reported. However, post-marketing experience with varicella vaccines suggests that transmission of vaccine virus may occur rarely between vaccinees who develop a varicella-like rash and susceptible contacts. Transmission of vaccine virus from varicella vaccine recipients who do not develop a varicella-like rash has also been reported and is therefore a theoretical risk for vaccination with ZOSTAVAX®. The risk of transmitting the attenuated vaccine virus to a susceptible individual should be weighted against the
risk of developing natural herpes zoster and potentially transmitting wild-type VZV to a susceptible contact.
ADVERSE REACTIONS Adverse Drug Reaction Overview In clinical trials, ZOSTAVAX® has been evaluated for general safety in more than 32,000 adults 50 years of age or older. ZOSTAVAX® was generally well tolerated.
ZOSTAVAX® Efficacy and Safety Trial (ZEST) in Subjects 50 to 59 Years of Age
In the ZEST study, subjects received a single dose of either ZOSTAVAX® (n=11,184) or placebo (n=11,212) and were monitored for general safety throughout the study. During the study, a vaccine-related serious adverse experience was reported for 1 subject vaccinated with ZOSTAVAX® (anaphylactic reaction).
All subjects received a vaccination report card (VRC) to record adverse events occurring from Days 1 to 42 postvaccination in addition to undergoing routine safety monitoring throughout the study.
Vaccine-related injection-site and systemic adverse experiences reported at an incidence of ≥1% are shown in Table 1. The overall incidence of vaccine-related injection-site adverse experiences was significantly greater for subjects vaccinated with ZOSTAVAX® versus subjects who received placebo (63.9% for ZOSTAVAX® and 14.4% for placebo).
Table 1: Vaccine-Related Injection-Site and Systemic Adverse Experiences Reported in ≥1% of Adults Who Received
ZOSTAVAX® or Placebo (1-42 Days Postvaccination) in the ZOSTAVAX® Efficacy and Safety Trial
ZOSTAVAX® Placebo (N = 11,094) (N = 11,116) Adverse Experience % %
Injection-Site Pain† 53.9 9.0 Erythema† 48.1 4.3 Swelling† 40.4 2.8 Pruritus 11.3 0.7 Warmth 3.7 0.2 Hematoma 1.6 1.6 Induration 1.1 0.0
Systemic Headache 9.4 8.2 Pain in extremity 1.3 0.8
† Designates a solicited adverse experience. Injection-site adverse experiences were solicited only from Days 1-5 postvaccination.
Within the 42-day postvaccination period in the ZEST, noninjection-site zoster-like rashes were reported by 30 subjects (15 for ZOSTAVAX® and 15 for placebo). Of 21 specimens that were adequate for Polymerase Chain Reaction (PCR) testing, wild-type VZV was detected in 10 (3 for ZOSTAVAX®, 7 for placebo) of these specimens. The Oka/Merck strain of VZV was not detected from any of these specimens.
Within the same 42-day postvaccination reporting period in the ZEST, varicella-like rashes were reported by 115 subjects (64 for ZOSTAVAX® and 51 for placebo). Of 21 specimens that were available and adequate for PCR testing, VZV was detected in one of these specimens from the group of subjects who received ZOSTAVAX®; however, the virus strain (wild type or Oka/Merck strain) could not be determined.
Shingles Prevention Study (SPS) in Subjects 60 Years of Age and Older
In the largest of these trials, the Shingles Prevention Study (SPS), 38,546 subjects received a single dose of either ZOSTAVAX® (n=19,270) or placebo (n=19,276) and were monitored for safety throughout the study. During the study, vaccine-related serious adverse experiences were reported for 2 subjects vaccinated with ZOSTAVAX® (asthma exacerbation and polymyalgia rheumatica) and 3 subjects who received placebo (Goodpasture’s syndrome, anaphylactic reaction, and polymyalgia rheumatica).
In the Adverse Event Monitoring Substudy, a subgroup of individuals from the SPS (n=3,345 received ZOSTAVAX® and n=3,271 received placebo) were provided vaccination report cards to record adverse events occurring from Days 0 to 42 postvaccination in addition to undergoing routine safety monitoring throughout the study.
Patient Selection Criteria
Safety Information
Table 2: Number of Subjects with ≥1 Serious Adverse Events (0-42 Days Postvaccination) in the Shingles Prevention Study
ZOSTAVAX® Placebo n/N n/N Relative Risk Cohort % % (95% CI)
Overall Study Cohort
All ages 255/18671 254/18717 1.01 1.4% 1.4% (0.85, 1.20)
60-69 years old 113/10100 101/10095 1.12 1.1% 1.0% (0.86, 1.46)
≥70 years old 142/8571 153/8622 0.93 1.7% 1.8% (0.74, 1.17)
AE Monitoring Substudy Cohort
All ages 64/3326 41/3249 1.53 1.9% 1.3% (1.04, 2.25)
60-69 years old 22/1726 18/1709 1.21 1.3% 1.1% (0.66, 2.23)
≥70 years old 42/1600 23/1540 1.76 2.6% 1.5% (1.07, 2.89)
N=number of subjects in cohort with safety follow-upn=number of subjects reporting an SAE 0-42 Days postvaccination
The incidence of death was similar in the groups receiving ZOSTAVAX® or placebo during the Days 0-42 postvaccination period: 14 deaths occurred in the group of subjects who received ZOSTAVAX® and 16 deaths occurred in the group of subjects who received placebo. The most common reported cause of death was cardiovascular disease (10 in the group of subjects who received ZOSTAVAX®, 8 in the group of subjects who received placebo). The overall incidence of death occurring at any time during the study was similar between vaccination groups: 793 deaths (4.1%) occurred in subjects who received ZOSTAVAX® and 795 deaths (4.1%) in subjects who received placebo.
Vaccine-related injection-site and systemic adverse experiences reported at an incidence ≥1% are shown in Table 3. Most of these adverse experiences were reported as mild in intensity. The overall incidence of vaccine-related injection-site adverse experiences was significantly greater for subjects vaccinated with ZOSTAVAX® versus subjects who received placebo (48% for ZOSTAVAX® and 17% for placebo).
Table 3: Vaccine-Related Injection-Site and Systemic Adverse Experiences Reported in ≥1% of Adults Who Received ZOSTAVAX® or Placebo (0-42 Days
Postvaccination) in the Adverse Events Monitoring Substudy of the Shingles Prevention Study
ZOSTAVAX® Placebo (N = 3345) (N = 3271)Adverse Experience % %
Injection Site Erythema† 35.6 6.9 Pain/tenderness† 34.3 8.6 Swelling† 26.1 4.5 Hematoma 1.6 1.4 Pruritus 7.1 1.0 Warmth 1.7 0.3
Systemic Headache 1.4 0.9
† Designates a solicited adverse experience. Injection-site adverse experiences were solicited only from Days 0-4 postvaccination.
The remainder of subjects in the SPS received routine safety monitoring, but were not provided report cards. The types of events reported in these patients were generally similar to the subgroup of patients in the Adverse Event Monitoring Substudy. Within the 42-day postvaccination reporting period in the SPS, the number of reported noninjection-site zoster-like rashes among all subjects was small (17 for ZOSTAVAX®, 36 for placebo; p=0.009). Of these 53 zoster-like rashes, 41 had specimens that were available and adequate for PCR testing. Wild-type VZV was detected in 25 (5 for ZOSTAVAX®, 20 for placebo) of these specimens. The Oka/Merck strain of VZV was not detected from any of these specimens.
The number (n=59) of reported varicella-like rashes was also small. Of these varicella-like rashes, 10 had specimens that were available and adequate for PCR testing. VZV was not detected in any of these specimens. The results of virus testing in subjects with varicella-like and zoster-like rashes should be interpreted with caution due to the number of samples that were not available for testing.
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The numbers of subjects with elevated temperature (≥38.3°C [≥101.0°F]) within 7 days postvaccination were similar in the ZOSTAVAX® and the placebo vaccination groups [6 (0.2%) vs. 8 (0.3%), respectively].
Other StudiesIn other clinical trials conducted prior to the completion of the SPS, the reported rates of noninjection-site zoster-like and varicella-like rashes within 42 days postvaccination were also low in both zoster vaccine recipients and placebo recipients. Of the 17 reported noninjection-site zoster-like and varicella-like rashes, 10 specimens were available and adequate for PCR testing. The Oka/Merck strain was identified by PCR analysis from the lesion specimens of only two subjects who reported varicella-like rashes (onset on Day 8 and 17).
To address concerns for individuals with an unknown history of vaccination with ZOSTAVAX®, the safety and tolerability of a second dose of ZOSTAVAX® was evaluated. In a placebo-controlled, double-blind study, 98 adults 60 years of age or older received a second dose of ZOSTAVAX® 42 days following the initial dose; the vaccine was generally well tolerated. The frequency of vaccine-related adverse experiences after the second dose of ZOSTAVAX® was generally similar to that seen with the first dose.
Post-Marketing Adverse Drug ReactionsThe following additional adverse reactions have been identified during post-marketing use of ZOSTAVAX®. Because these reactions are reported voluntarily from a population of uncertain size, it is generally not possible to reliably estimate their frequency or establish a causal relationship to the vaccine.
Skin and subcutaneous tissue disorders: rash.Musculoskeletal and connective tissue disorders: arthralgia; myalgia.General disorders and administration site conditions: injection-site rash; injection-site urticaria; pyrexia; injection-site lymphadenopathy.Immune system disorders: hypersensitivity reactions including anaphylactic reactions.
To report a suspected adverse reaction, please contact Merck Canada Inc. by:Toll-free telephone: 1-800-567-2594Toll-free fax: 1-877-428-8675By regular mail: Merck Canada Inc., P.O. Box 1005, Pointe-Claire – Dorval, QC H9R 4P8
DRUG INTERACTIONS
OverviewZOSTAVAX® must not be mixed with any other medicinal product in the same syringe. Other medicinal products must be given as separate injections and at different body sites.
Concurrent administration of ZOSTAVAX® and antiviral medications known to be effective against VZV has not been evaluated.
Use with Other VaccinesZOSTAVAX® and PNEUMOVAX® 23 (pneumococcal vaccine, polyvalent, MSD Std.) should not be given concomitantly because concomitant use resulted in reduced immunogenicity of ZOSTAVAX® (see CLINICAL TRIALS in the product monograph).
DOSAGE AND ADMINISTRATION(see Product Monograph for complete information) Recommended Dose and Dosage Adjustment
FOR SUBCUTANEOUS ADMINISTRATION.
Do not inject intravascularly.
Individuals should receive a single dose consisting of the entire content of the vial (approximately 0.65 mL).
ZOSTAVAX® is not a treatment for zoster or postherpetic neuraligia (PHN). If an individual develops herpes zoster despite vaccination, active current standard of care treatment for herpes zoster should be considered.
At present, the duration of protection after vaccination with ZOSTAVAX® is unknown. In the Shingles Prevention
Study (SPS), protection was demonstrated through 4 years of follow-up. The need for revaccination has not yet been defined.
Reconstitute immediately upon removal from the freezer.
To reconstitute the vaccine, use only the diluent supplied, since it is free of preservatives or other antiviral substances which might inactivate the vaccine virus.
Vial of diluent:To reconstitute the vaccine, first withdraw the entire contents of the diluent vial into a syringe.
To avoid excessive foaming, slowly inject all of the diluent in the syringe into the vial of lyophilized vaccine and gently agitate to mix thoroughly. Withdraw the entire contents into a syringe, and using a new needle, inject the total volume of reconstituted vaccine subcutaneously, preferably into the upper arm - deltoid region.
IT IS RECOMMENDED THAT THE VACCINE BE ADMINISTERED IMMEDIATELY AFTER RECON-STITUTION, TO MINIMIZE LOSS OF POTENCY. DISCARD RECONSTITUTED VACCINE IF IT IS NOT USED WITHIN 30 MINUTES.
Do not freeze reconstituted vaccine.
CAUTION: A sterile syringe free of preservatives, antiseptics, and detergents should be used for each injection and/or reconstitution of ZOSTAVAX® because these substances may inactivate the vaccine virus.
It is important to use a separate sterile needle and syringe for each patient to prevent transfer of infectious agents from one individual to another.
Needles should be disposed of properly.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. ZOSTAVAX® when reconstituted is a semi-hazy to translucent, off white to pale yellow liquid.
OVERDOSAGEThere are no data with regard to overdose.
For management of a suspected drug overdose, contact your regional Poison Control Center.
STORAGE AND STABILITYStorageZOSTAVAX® SHOULD BE STORED FROZEN at an average temperature of -15°C or colder until it is reconstituted for injection (see DOSAGE AND ADMINISTRATION). Any freezer, including frost-free, that has a separate sealed freezer door and reliably maintains an average temperature of -15°C or colder is acceptable for storing ZOSTAVAX®. The diluent should be stored separately at room temperature (20 to 25°C) or in the refrigerator (2 to 8°C). Do not store the diluent in a freezer.
Before reconstitution, protect from light.
DISCARD IF RECONSTITUTED VACCINE IS NOT USED WITHIN 30 MINUTES.
DO NOT FREEZE THE RECONSTITUTED VACCINE.
References:
1. National Advisory Committee on Immunization. Update on varicella. CCDR 2004;30(ACS-1):1-28.
2. Oxman MN. Clinical manifestations of herpes zoster. In: Arvin AM, Gershon AA, editors. Varicella-zoster virus virology and clinical management. Cambridge Press 2000:246-75.
3. Data on file, Merck Canada Inc.: Product Monograph. ZOSTAVAX®, 2011.
Supplemental Product InformationWARNINGS AND PRECAUTIONS
Special Populations
Geriatric: The mean age of subjects enrolled in the largest (N=38,546) clinical study of ZOSTAVAX® was 69 years (range 59-99 years). Of the 19,270 subjects who received ZOSTAVAX®, 10,378 were 60-69 years of age, 7,629 were 70-79 years of age, and 1,263 were 80 years of age or older. ZOSTAVAX® was demonstrated to be generally safe and effective in this population.
Pregnant Women: There are no studies in pregnant women. It is also not known whether ZOSTAVAX® can cause foetal harm when administered to a pregnant woman or can affect reproduction capacity. However naturally-occurring varicella-zoster virus infection is known to sometimes cause foetal harm. Therefore, ZOSTAVAX® should not be administered to pregnant women; furthermore, pregnancy should be avoided for three months following vaccination (see CONTRAINDICATIONS).
Nursing Women: It is not known whether VZV is secreted in human milk. Therefore, because some viruses are secreted in human milk, caution should be exercised if ZOSTAVAX® is administered to a nursing woman.
Pediatrics: ZOSTAVAX® is not recommended for use in this age group.
HIV-AIDS Patients: The safety and efficacy of ZOSTAVAX® have not been established in adults who are known to be infected with HIV with or without evidence of immunosuppression (see CONTRAINDICATIONS).
Immunocompromised Subjects: Data are not available regarding the use of ZOSTAVAX® in immunocompromised subjects (see CONTRAINDICATIONS).
® Registered trademarks Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. Used under license.
11-05_139888
VACC-1008558-0000-E-CDN-AUG-12
PRODUCT MONOGRAPH AVAILABLE ATwww.merck.caOR UPON REQUEST AT 1-800-567-2594
Administration
MERCK CANADA INC.P.O. BOX 1005, POINTE-CLAIREDORVAL, QUEBEC H9R 4P8
www.merck.ca
Study References
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THERAPEUTIC CLASSIFICATIONTopical Antipsoriatic Agent Vitamin D Analogue/Corticosteroid
INDICATIONS AND CLINICAL USEDovobet® ointment is indicated for the topical treatment of psoriasis vulgaris for up to 4 weeks. Dovobet® should not be used on the face.
CONTRAINDICATIONSKnown hypersensitivity to any of the ingredients of Dovobet® ointment; not for ophthalmic use; treatment of viral, fungal or bacterial skin infections, tuberculosis of the skin, syphilitic skin infections, chicken pox, eruptions following vaccinations, and in viral diseases such as herpes simplex, varicella and vaccinia.
WARNINGS AND PRECAUTIONSGeneralIf Dovobet® is used in excess of the maximum recommended weekly amount of 100 g, it is important to monitor the serum calcium levels at regular intervals due to the risk of hypercalcaemia secondary to excessive absorption of calcipotriol. If the serum calcium level becomes elevated, therapy should be discontinued and the serum calcium level monitored until it returns to normal.
SkinDovobet® should not be used on the face since this may give rise to itching and erythema of the facial skin. Patients should be instructed to wash their hands after each application of Dovobet® in order to avoid inadvertent transfer to the face. Should facial dermatitis develop in spite of these precautions, Dovobet® therapy should be discontinued.Prolonged use of corticosteroid-containing preparations may produce striae or atrophy of the skin or subcutaneous tissues. Therefore, it is recommended that corticosteroid treatment be interrupted periodically, and that one area of the body be treated at a time. Topical corticosteroids should be used with caution on lesions of the face, groin and axillae as these areas are more prone to atrophic changes than other areas of the body. If skin atrophy occurs, discontinue treatment. There may be a risk of rebound psoriasis when discontinuing corticosteroids after prolonged periods of use.
CarcinogenesisCalcipotriol when used in combination with ultraviolet radiation (UVR) may enhance the known skin carcinogenic effect of UVR. (See TOXICOLOGY, Carcinogenicity, in the Product Monograph).
Endocrine and MetabolismApplication on large areas of damaged skin, under occlusive dressings, or in skin folds should be avoided since it increases systemic absorption of corticosteroids and the risk of adverse effects such as adrenal suppression with the potential for glucocorticosteroid insufficiency after withdrawal of treatment. Manifestations of Cushing’s syndrome, hyperglycaemia and glucosuria can also be produced in some patients by systemic absorption of topical corticosteroids. Occlusive dressings should not be applied if body temperature is elevated. All of the adverse effects associated with systemic use of corticosteroids, including adrenal suppression, may also occur following topical administration of corticosteroid-containing products such as Dovobet®, especially in children.
SPECIAL POPULATIONSPregnant Women: The safety of calcipotriol and/or topical corticosteroids for use during pregnancy has not been established. The use of Dovobet® is not recommended in pregnant women.
Nursing Women: The safety of calcipotriol and/or topical corticosteroids for use in nursing women has not been established. The use of Dovobet® is not recommended in nursing women. Pediatrics (<18 years of age): There is no clinical trial experience with the use of Dovobet® in children. Children may demonstrate greater susceptibility to systemic steroid-related adverse effects due to a larger skin surface area to body weight ratio as compared to adults.
MONITORING AND LABORATORY TESTSTreatment with Dovobet® in the recommended amounts does not generally result in changes in laboratory values. In patients at risk for hypercalcaemia it is recommended that baseline serum calcium levels be obtained before starting treatment with subsequent monitoring of serum calcium levels at suitable intervals.
ADVERSE REACTIONSIn clinical trials, the most common adverse reaction associated with Dovobet® was pruritus. Pruritus was usually mild and no patients were withdrawn from treatment. Calcipotriol is associated with local reactions such as transient lesional and perilesional irritation. Topical corticosteroids can cause the same spectrum of adverse effects associated with systemic steroid administration, including adrenal suppression. Adverse effects associated with topical corticosteroids are generally local and include: dryness, itching, burning, local irritation, striae, atrophy of the skin or subcutaneous tissues, telangiectasia, hypertrichosis, folliculitis, skin hypopigmentation, allergic contact dermatitis, maceration of the skin, miliaria, or secondary infection. If applied to the face, acne rosacea or perioral dermatitis can occur. In addition, there are reports of the development of pustular psoriasis from chronic plaque psoriasis following reduction or discontinuation of potent topical corticosteroid products.Rare cases of hypersensitivity reaction have been reported.To report an adverse reaction please notify Health Canada at 1-866-234-2345 or LEO Pharma Inc. at 1-800-263-4218.
DRUG INTERACTIONSThere is no experience of concomitant therapy with other antipsoriatic drugs.
Dosing ConsiderationsDovobet® is FOR TOPICAL USE ONLY. Not for ophthalmic use. There is no clinical trial experience with the use of Dovobet® in children.
Recommended Dose and Dosage AdjustmentDovobet® should be applied topically to the affected areas once daily for up to 4 weeks. After satisfactory improvement has occurred, the drug can be discontinued. If recurrence takes place after discontinuation, treatment may be reinstituted.
The maximum recommended adult dose of Dovobet® ointment is 100 g per week.
SUPPLEMENTAL PRODUCT INFORMATION
SUPPLEMENTAL SAFETY INFORMATION
Missed DoseIf a dose is missed, the patient should apply Dovobet® as soon as he/she remembers and then continue on as usual.
OverdosageDue to the calcipotriol component of Dovobet® (calcipotriol and betamethasone dipropionate), excessive administration (i.e. more than the recommended weekly amount of 100 g) may cause elevated serum calcium, which rapidly subsides when treatment is discontinued. In such cases, it is recommended to monitor serum calcium levels once weekly until they return to normal. Excessive or prolonged use of topical corticoster-oids can suppress pituitary-adrenal function, resulting in secondary adrenal insufficiency and manifestations of hypercorticoidism, including Cushing’s disease. Recovery is usually prompt and complete upon steroid discontinuation. In cases of chronic toxicity, slow withdrawal of corticosteroids is recommended.
For further information, please contact Medical Information at LEO Pharma Inc. 1-800-263-4218. ® Registered trademark of LEO Pharma A/S used under license and distributed by LEO Pharma Inc., Thornhill, ON.
Patient Selection Criteria
Prescribing Summary
Safety Information
Administration
LEO Pharma Inc. Thornhill, Ontario L3T 7W8 www.leo-pharma.com/canada
Mar12_DOVOBOET_1P_PI_p56.indd 1 12-03-02 3:36 PM
ONTARIO MEDICAL REVIEW March 201257
THERAPEUTIC CLASSIFICATIONTopical Antisporiatic Agent Vitamin D Analogue/Corticosteroid.
INDICATIONS AND CLINICAL USEXamiol® (calcipotriol and betamethasone dipropionate) gel is indicated for the topical treatment of moderate to severe scalp psoriasis for up to 4 weeks.
CONTRAINDICATIONSKnown hypersensitivity to Xamiol® (calcipotriol and betamethasone dipropionate) or any ingredient; ophthalmic use; patient with known disorders of calcium metabolism; viral lesions of the skin; fungal or bacterial skin infections; parasitic infections; skin manifestations in relation to tuberculosis or syphilis; perioral dermatitis, atrophic skin; striae atrophicae; fragility of skin veins; ichthyosis; vulgaris and rosacea acne; rosacea; ulcers and wounds; guttate, erythrodermic, exfoliative and pustular psoriasis; severe renal insufficiency or severe hepatic disorders.
WARNINGS AND PRECAUTIONSGeneralDue to the content of calcipotriol, hypercalcaemia may occur if the maximum weekly dose (100 g) is exceeded. Serum calcium is quickly normalized when treatment is discontinued. The risk of hypercalcaemia is minimal at recommended dosing.
CarcinogenesisCalcipotriol when used in combination with ultraviolet radiation (UVR) may enhance the known skin carcinogenic effect of UVR.
Endocrine and MetabolismXamiol® contains a potent group III steroid and concurrent treatment with other steroids on the scalp must be avoided. Application on large areas of broken skin or under occlusive dressings should be avoided since it increases systemic absorption of corticosteroids; adverse effects such as adrenocortical suppression with the potential for glucocorticosteroid insufficiency after withdrawal of treatment; manifestations of Cushing’s syndrome, and affects on the metabolic control of diabetes mellitus can also be produced in some patients by systemic absorption of topical corticosteroids.
SkinFacial skin is very sensitive to corticosteroids and Xamiol® is not indicated for use in this area. The patients must wash their hands after each application to avoid accidental transfer to the face, mouth and eyes. If facial dermatitis or corticosteroid related adverse effects develop, Xamiol® should be discontinued. There may be a risk of generalised pustular psoriasis or of rebound psoriasis when discontinuing corticosteroids after prolonged periods of use. Patients who apply Xamiol® to exposed skin (e.g. a bald scalp) should avoid both natural and artificial sunlight.
SPECIAL POPULATIONSPregnant Women: The safety of calcipotriol and/or topical corticosteroids for use during pregnancy has not been established. The use of Xamiol® is not recommended in pregnant women.Nursing Women: The safety of calcipotriol and/or topical corticosteroids for use in nursing women has not been established. The use of Xamiol® is not recommended in nursing women. Pediatrics (<18 years of age): There is no clinical trial experience with the use of Xamiol® in children, use is therefore not recommended. Children may demonstrate greater susceptibility to systemic steroid related adverse effects due to a larger skin surface area to body weight ratio as compared to adults.
MONITORING AND LABORATORY TESTSIn patients at risk of hypercalcaemia, it is recommended that baseline serum
calcium levels be obtained before starting treatment and subsequent monitoring of serum calcium levels at suitable intervals. (see OVERDOSAGE)
ADVERSE REACTIONSApproximately 8% of patients treated with Xamiol® experienced an adverse reaction. Based on data from clinical trials, the most common adverse reaction is pruritus. The following adverse reactions led to discontinuation of the treatment with Xamiol® in 0.1-0.2% of patients: pruritus, skin pain or irritation, dermatitis, eye irritation, rash, burning sensation, face oedema, folliculitis and dry skin. Other adverse reactions were observed for the individual drug substances calcipotriol and betamethasone dipropionate. Systemic effects due to topical use of corticosteroids in adults occur infrequently but can be severe. To report an adverse reaction please notify Health Canada at 1-866-234-2345 or LEO Pharma Inc. at 1-800-263-4218.
DRUG INTERACTIONSThere is no experience of concomitant therapy with other anti psoriatic drugs.
Dosing ConsiderationsXamiol® (calcipotriol and betamethasone dipropionate) is not recommended for use in patients below the age of 18 years. Xamiol® is FOR TOPICAL USE ONLY and not for ophthalmic use.Xamiol® should be applied to affected areas of the scalp once daily for up to 4 weeks. After satisfactory improvement has occurred, the drug can be discontinued. If recurrence takes place after discontinuation, treatment may be reinstituted. The maximum daily dose including other calcipotriol-containing products on the body should not exceed 15 g and the maximum weekly dose should not exceed 100 g. If a dose is missed, the patient should apply Xamiol® when remembered, but only once a day and then continue on as usual.
SUPPLEMENTAL PRODUCT INFORMATIONADVERSE REACTIONSTwo pivotal and 4 supporting controlled clinical studies were conducted in scalp psoriasis. The incidence of patients with at least one ADR was lowest in the Xamiol® gel group.
Table 1. Adverse Drug Reactions Occurring in 1% of Patients for the Pivotal Scalp Studies: safety analysis set
Detailed and/or summarized report
Xamiol® gel (n=1093)
Betamethasone gel
(n=1104)
Calcipotriol gel (n=548)
Gel vehicle (n=135)
Primary System Organ Class1
Preferred Term1
Number of
Patients%
Number of
Patients%
Number of
Patients%
Number of
Patients%
Nervous system disorders
Headache 6 0.5 11 1.0 1 0.2 1 0.7
Burning sensation 2 0.2 6 0.5 10 1.8 0 0.0
Skin and subcutaneous tissue disorders
Pruritus 25 2.3 18 1.6 45 8.2 7 5.2 Skin irritation 5 0.5 5 0.5 15 2.7 3 2.2
Alopecia 4 0.4 6 0.5 3 0.5 2 1.5
Erythema 4 0.4 4 0.4 16 2.9 1 0.7 Dry skin 1 0.1 3 0.3 6 1.1 0 0.0
General disorders and administration site conditions
Pain 1 0.1 0 0.0 3 0.5 3 2.21Coded according to MedDRA version 6.1
OVERDOSAGE:Use of Xamiol® (calcipotriol and betamethasone dipropionate) above the recommended dose may cause elevated serum calcium which should rapidly subside when treatment is discontinued. In such cases, it is recommended to monitor serum calcium levels once weekly until they return to normal. Excessive prolonged use of topical corticosteroids may suppress the pituitary-adrenal functions, resulting in secondary adrenal insufficiency which is usually reversible. If this occurs, symptomatic treatment is indicated. In cases of chronic toxicity, treatment with Xamiol® must be discontinued gradually.
® Registered trademark of LEO Pharma A/S used under license by LEO Pharma Inc., Thornhill, ON.
Full Product Monograph available on request by contacting LEO Pharma Inc. at 1-800-263-4218.
50 mcg/g calcipotriol (as monohydrate) and 0.5 mg/g betamethasone (as dipropionate) gel
Prescribing Summary
Patient Selection Criteria
Safety Information
Administration
LEO Pharma Inc. Thornhill, Ontario L3T 7W8 www.leo-pharma.com/canada
Mar12_XAMIOL_1P_PI_p57.indd 1 12-03-02 3:36 PM
ONTARIO MEDICAL REVIEW
OFFICE SPACE AVAILABLE
Bayview and Elgin Mills: New medical space available with Shoppers Drug Mart within property. Leasehold improve-ments and rent subsidy available.Contact: LorraineTel. 905.882.2320
Beautiful workplace setting in the heart of Thornhill: Lots of natural light and latest equipment, EMR in every room. Passionate, well-trained staff of nurses, medical assistants, students and administrators are ready to serve you and make your transition smooth and stress-free. We are interested in friendly physicians who are dedicated to delivering excellent patient care. Oppor-tunity for family doctor, pediatrician or OB/GYN entry into our lucrative practice with competitive split. Tel. 416.670.7393Email: diseramedical@gmail.com
Boxgrove Medical Centre — now open: Four-storey, 60,000 sq. ft. medical building located at the 9th Line and Highway 407. Prime medical space available for lease. X-ray, lab, rehab and urgent care on-site. Contact: HowardTel. 416.357.7509
Brampton — looking for general prac-titioner for busy family practice/walk-in clinic. Retiring physicians/IMG welcome. Supervision available. Excellent split.Tel. 647.278.5358Email: sbfamilycare@gmail.com
Mississauga — excellent medical office for family physicians: Fully furnished, recently renovated suites with private underground free parking. Units have 3-6 spacious exam rooms, private reception and common patient waiting area. Great location inside a medical centre, close to Credit Valley & Trillium hospitals in a dense residential and commercial area near Square One. Lab services and pharmacy on-site. Low rent and relocation incentives. Tel. 416.587.9430
Oakville professional medical building: Steps to Oakville Trafalgar Memorial. 2,671 sq. ft. can divide 1,298/1,373 sq. ft. Improvements available to suit needs. All floors serviced by elevator. Private doctor parking. Free patient parking. Highway access, public transportation. Contact: Nat Assenza, Real Estate Sales Rep, Royal LePage Your Community RealtyTel. 905.832.6656Email: nassenza@trebnet.com
Opportunity for general practitioner or specialist (F/T, P/T) in a new modern dental/medical multispecialty practice located in central Mississauga. Contact: Elaine Tel. 905.270.5112Email: info@smiledesigning.ca
Ottawa — medical office space for lease: Three months free rent, near Hunt Club and Merivale. Newly built medical centre, space already set up and avai lable for immediate occu-pancy, ground floor, beautiful working environment, 2,200 sq. ft. (can be divided 900/1,300 sq. ft.).Contact: Dominic Dostie, Real Estate Broker, CBRE Ltd.Tel. 613.751.2874Email: dominic.dostie@cbre.com
PAR-Med Realty Ltd.: Specializing in medical office building leasing, property management, and building sales. We have over 70 medical office buildings in our portfolio throughout Ontario. For leasing inquiries:Contact: Brad StoneburghTel. 416.364.5959, ext. 403Email: bstoneburgh@par-med.comWebsite: www.par-med.com
58 March 2012
Classifieds
Following are the classified
advertising deadline dates
for the next six issues.
I S S U E D E A D L I N E
May 2012 April 10
June 2012 May 10
July/August 2012 June 15
September 2012 August 10
October 2012 September 10
November 12 October 10
GENERAL INFORMATION
Advertisements are accepted by mail, email or
fax. Copy deadline, notice of cancellation and/
or changes to existing advertisements must
be submitted in writing no later than the 10th
of the month prior to the month of publica-
tion. A proof copy of your classified ad will be
faxed to your attention for approval prior to
publication.
Payment: Payment is accepted by VISA, Mas-
tercard or American Express. Please provide
credit card information by phone only to Vita
Ferrante 416.340.2263 or 1.800.268.7215,
ext. 2263, at time of booking.
Rates: $50 for first 4 lines (minimum), each line
approximately 35 characters; $5 per line there-
after; $5 for each line of contact information.
Spot colour billed at $20 per issue.
Send advertisements to:
Vita Ferrante
Ontario Medical Association
150 Bloor Street West
Suite 900
Toronto, Ontario M5S 3C1
Tel. 1.800.268.7215, ext. 2263 or
416.340.2263
Fax: 416.340.2232
Email: vita.ferrante@oma.org
The Ontario Medical Review is required to com-
ply with the provisions of the Ontario Human
Rights Code 1990 in its editorial and advertis-
ing policies, and assumes no responsibility or
endorses any claims or representation offered
or expressed by advertisers.
Added Value
Classified ads are posted online and acces-
sible to OMA members and the general public:
https://www.oma.org/Pages/OMR.aspxA Classified Advertisement Insertion Order
Form is posted online: www.oma.org/
Resources/Documents/AdOrder.pdf
Mar12_classifieds_p58.indd 1 12-03-05 3:14 PM
ONTARIO MEDICAL REVIEW
Pickering medical building — two suites available of 835 sq. ft. and 1,186 sq. ft. Price starts at $2,196 all inclusive. Available now. Central and busy. Contact: Donald Lesley, BrokerRE/MAX First Realty Ltd., BrokerageTel. 416.798.7288Email: DonLesley@rogers.com
Psychiatrist to share office suite: Spacious office, shared waiting room. Yonge and St. Clair, Toronto. Contact: Dr. Joseph Feldmann Tel. 416.961.2282Email: jfeldmann@sympatico.ca
Psychotherapy offices available — full time & part time: Furnished. Full-time office manager on-site 8 am-5 pm. Evening hours available. Internet and telephone included.Contact: Dr. Kasra KhorasaniTel. 416.627.4590Email: kasra.khorasani@utoronto.ca
Scarborough — space available in a medical building: Located at Eglinton and McCowan. Ideal for family physi-cians. Fully renovated and ready to move in with physiotherapy clinic and spa on property. Pharmacy to come. Available 500-2,000 sq. ft. Ample free parking. TTC & GO Train within walking distance. Dense residential area. Basic rent and no TMI.Email: ad.medical4@gmail.com
Special rent for qualified tenants: Furnished, turnkey medical off ice opportunity in Toronto. Up to eight exam rooms available. Tel. 416.564.7585Email: youannas@rogers.com
Start your practice in Markham! New medical clinic in retail plaza with T&T supermarket, Hwy. 7 & Kennedy Rd. Next to upscale downtown Markham. Ground floor, 1,500 sq. ft., experienced staff.Contact: Dr. Shawn SeitTel. 416.617.2883
Steeles/York University: Golden opportunity for a new medical centre. X-ray, laboratory, walk-in clinic, 5,150 sq. ft. corner unit in a busy plaza with ample parking, TTC service, fronting on Steeles. Reasonable rent. Contact: Dan Tel. 416.629.7799
We have an opening for family phy-sician/clinical investigator with Con-solidated Clinical Research of Canada, Mississauga, Ontario. Looking for an MD interested in opening a new family practice and also conducting clinical trials. Medical office available shortly. Setting up the conduct of clinical trials in diabetes and pain management. Cl in ical research co-ordinator and required systems provided. All interested individuals, please contact us.Contact: George E. Markus, M.Sc.President, Consolidated ClinicalResearch of CanadaTel. 416.873.1836 (cell)Email: ccrc@rogers.com
59 March 2012
Classifieds
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Mar12_classifieds_p58.indd 2 12-03-05 3:14 PM
ONTARIO MEDICAL REVIEW
Yonge/Lawrence medical office with parking at TTC. See website for photos.Tel. 416.357.8530Website: http://viewitbiz.ca/2916
LOCUM TENENS
Two full-time locums needed in May and in July to cover for maternity leaves. Instant full practice in the big FHG, congenial colleagues, extremely busy, fully EMR. Full time available after the locum.Contact: Dr. Thomas VanTel. 647.227.5088Email: thomvan@rogers.com
REAL ESTATE
Collingwood, 43 acre estate on Blue Mountain: Four-bedroom chalet-style house, pond, Silver Creek with spawn-ing trout, 18 stall barn, arena. Permit for second residence pending. Spec-tacular view of Georgian Bay. Use as is or build your dream home. Tel. 416.520.9274
Disney/Orlando real estate, former Ontario resident. Contact: Kathy JaworskiExit Realty Cozy HomesEmail: kat-florida@live.com
Realty engineer: Over 20 years help-ing the medical community engineer their real estate portfolios. Investment, office leasing/sales or residential.Contact: Itamar Teich, B.Eng., MBAReal Estate Sales RepresentativeRe/Max Realtron Realty Inc., BrokerageTel. 905.764.6000, Cell: 416.823.8735Email: teichitamar8@gmail.com
POSITIONS WANTED
Family physician looking to either share office, to take over existing practice, or replace retiring physician in Toronto (North York or Scarbor-ough).Email: familyphysician@hotmail.ca
Two qualified and licensed physi-cians are looking for work opportu-nities in methadone clinics. Willing to travel from northern GTA up to Sudbury.Email: methdoctors@hotmail.com
POSITIONS VACANT
70:30 split or better: South Ottawa. Family medicine or specialists. Flexible schedule, full EMR, excellent nursing and resident support, full time, part time or locum, and opportunity of joining FHO. Enjoy life, earn a phenomenal wage, get home for a hot meal and stop fretting about stuff! Let us do all the administrative work. Contact: FaizaTel. 613.692.5433Email: khc@doctor.com
$200/hour: GP required immediately at Mississauga outpatient clinic. Hours: 8 a.m. to 11 p.m. seven days a week.Contact: AngelaTel. 905.272.5200
$250 per hour minimum: Pediatrician, internist, surgeon, subspecialist in busy outpatient clinic in Mississauga.Contact: Dr. SteinTel. 416.464.0238
Brampton, Ontario: F/T, P/T family physicians & specialists required for a very busy family practice/walk-in clinic.Very modern and computerized exam rooms, paperless, attractive split, guar-anteed number of patients per hour and guaranteed income available.Contact: WilliamTel. 647.627.4170Email: Chinguacousy-medical@hotmail.com
Brampton, Ontario: Full-time/part-time family physicians and GP psy -cho thera pist required for busy family pract ice/walk- in cl in ic. Attract ive modern office. Option to join FHG. High fee-for-service split or flat monthly rate. Best EMR.Tel. 416.949.3830Fax: 647.340.2586Email: bramptonfamilyhealth@gmail.com
Busy walk-in clinic in Brampton looking for doctors (F/T, P/T). All office expenses covered. Experienced and competent staff. Excellent split offered. Great hours. Contact: medicalclinicbrampton@hotmail.com
C-era (Cardiometabolic Evaluation and Risk Assessment) in Calgary is seeking a F/T general internist, endocrinologist or cardiologist (pref-erably with echo training) to join our team. We offer an exceptional lifestyle, excellent remuneration, opportunity for clinical stimulations and continued growth and engagement as part of a multidisciplinary team.Contact: Dr. A. Nanji, Medical DirectorTel. 403.209.1115Fax: 403.541.0073Email: careers@c-era.comWebsite: www.c-era.com
Clinics in St. Catharines require the following: 1) Retired physician required who is registered with the College of Physicians and Surgeons of Ontario (CPSO) to work in a St. Catharines clinic three to five hours per day pro-viding supervision of nurses in a low- stress environment. The hourly pay is $80. 2) Physician registered with the CPSO required to join existing walk-in clinic which pays 80 per cent split in St. Catharines. Close proximity to lab and X-ray facilities. 3) Physician regis-tered with the CPSO to join a group that is opening a walk-in clinic, 80 per cent split in Niagara area. 4) Family physician or specialist registered with the CPSO to share space in a medical building in St. Catharines. Lots of free parking, each room has its own sink, shared waiting room, eight private offices, newly renovated, located near hospital. Please email interest and resumé.Email: comprehensivehealthclinic@hotmail.com
Davisville/Yonge — busy family/walk-in clinic seek part-time/full-time MD, FHG. Very convenient location.Contact: Dr. Liang Tel. 647.776.8433Email: healthindavisville@gmail.com
Dermatologist and psychiatr ist required for a group of 14 GPs with a huge population base. Extremely busy, EMR and PACS, great income low overhead. Contact: Dr. Thomas Van Tel. 647.227.5088Email: thomvan@rogers.com
60 March 2012
Classifieds
Mar12_classifieds_p58.indd 3 12-03-05 3:14 PM
ONTARIO MEDICAL REVIEW
Downsview, Ontar io: Paper less computerized new clinic in a medical building with pharmacy, lab and X-ray. No set-up cost. Part time or full time. Move existing practice or bui ld up from walk-in clinic. Support staff for EKGs, PFTs, venipuncture for income supplement. Contact: Mr. SamuelTel. 647.400.0401
Downtown, Toronto — physician required at mental health cl inic specializing in integrated assessment and treatment of ADHD individuals and families across the lifespan. Staff at present includes professionals in medicine, health education, psychol-ogy, and counseling. Part time, full time and locum hours available.Contact: LaurenTel. 416.901.3077Email: lkouba@springboardclinic.com
Downtown Toronto — Yonge and College new medical office: Close to many hospitals. High traffic, high vis-ibility. New, fully equipped medical office in busiest part of Yonge St., 13 exam rooms, plus three offices. EMR or paper, P/T, F/T, one of many GPs. Move ex-isting practice or build up from walk-in clinic. Very attractive split or flat rent.Contact: DavidTel. 416.895.4745Email: enerhealth@on.aibn.com
Endocrine clinic at Yonge and Eglinton: Available to share with another endo-crinologist or internist. It is a newly set-up specialty clinic, located at a busy and diversified area in Toronto with nearby medical support facilities. It has indoor parking, across from Eglinton subway.Contact: ViVienTel. 416.481.7720Email: edc.toronto@gmail.com
Exceptional practice opportunity available in an attractive mid-western Ontario city – university city, good schools, parks and recreational facili-ties. Immediate possession of well-established family practice (FHO billing format) progressing to FHT format. Excellent income, very low overhead, unique and attractive practice loca-tion, wonderful staff with opportunity for diversification into non-OHIP billing opportunities. Email: jemy.ventresca@wellserve.on.ca
Family and walk-in doctor: Locum/part time/full time. Instant full practice. Extremely busy! Congenial colleagues and low overhead. EMR, FHG, partner-ship option, >700K billing for a five-day work week. Contact: Thomas VanTel. 647.227.5088Email: thomvan@rogers.com
Family and walk-in physicians needed in Thornhill, Ontario: Great patient population. Eight fully equipped modern and spacious exam rooms. Specialists & new grads welcome. No financial investment. Flexible hours. IMG super-vision available.Tel. 416.305.4269 or 416.823.4750Email: hanyhjm@yahoo.ca
Full-time or part-time medical doctors required for a busy walk-in located in downtown Mississauga. Contact: AdelTel. 416.904.2929 or 905.897.6160 (office)
GP and specialists are needed for a very busy clinic in Mississauga.Contact: EvaTel. 647.291.1489Email: evetghobrial@hotmail.com
Internal medicine and/or subspecial-ties required immediately for outpa-tient coverage in Mississauga. FT/PT/locum. No on-call. Top take-home pay.Contact: Dr. SekelyTel. 416.464.0238
London, Ontario: Full time/part time. Anesthesiologists or any other doctors that have experience treating chronic pain. The London Pain Institute is a reputable, soon to be open, pain man-agement facility with a passion for ex-cellence. Is seeking to fill the position of anesthesiologist and chronic pain specialists for our London location. As a team member, the successful candi-date will be responsible for designing and implementing pain management protocols or performing a variety of procedures, including epidural steroid injections, facet joint blocks, para-vert-ibal blocks, trigger point injections, and other nerve blocks. We offer you: flex-ible weekday hours, stimulating work environment, the chance to join a team in making a positive difference. Com-pensation: excellent/negotiable.Fax: 416.941.7933
Email: angferrari@rogers.com orlarissa.musya@hotmail.com
Looking for family physicians (F/T, P/T) for busy family practice/walk-in medi-cal clinics in Scarborough, Markham, Keswick, Cambridge, Mississauga and Welland. Excellent split or salary. Contact: AntoniaTel. 416.949.9373 Email: antoniamdrecruits@gmail.com
Looking immediately for general practitioner (F/T, P/T), split or minimum. Guaranteed for Clarkson Medical Clinic. Located on a busy residential area in Mis-sissauga/Oakville. For details, please call.Tel. 416.219.3191
Medical Psychotherapy Clinic: Over the last eight months we have expanded our clinic twice. We must be doing something right! Physicians needed — enjoy medicine more — enjoy medicine again! If you have an interest in this im-portant clinical area. We would like you to join our busy clinic. We need fam-ily doctors, GPs, GP psychotherapists, psychiatrists, semi-retired, part time or full time. We are open weekends and weeknights. We provide comfortable offices, professional staff, excellent f inancial arrangements, professional supervision, and CME programs are available.Contact: Dr. Michael ParéWebsite: www.medicalpsychclinic.org
MedVisit Doctors Housecall Service: Greater Toronto or Ottawa. P/T or F/T. Net income $250/hour + bonus. Afternoon, evening or weekend shifts. No overnight call. Drivers available to accompany physician on calls.Contact: Dr. Tom Burko Tel. 416.631.0298 or 1.800.355.6668Email: drburko@medvisit.ca Website: www.medvisit.ca/doctors
Milton — shifts available in a very busy walk-in/family clinic.Tel. 905.864.9898Email: healthyfamilyclinic@yahoo.ca
Mississauga, ON: Shifts available in a busy well-established walk-in/family clinic. We welcome new graduates. Clinic also needs a dermatologist.Tel. 416.995.1600 Email: doctors@bell.net
61 March 2012
Classifieds
Mar12_classifieds_p58.indd 4 12-03-05 3:14 PM
ONTARIO MEDICAL REVIEW
NR medical clinic is a multidisci-plinary medical clinic looking to have onboard fully licensed family physi-cians, cardiologists, and other special-ists. The posting is for temporary to permanent positions. EMR, EKG, and support staff. Start date is April 1, 2012. Location: 1250 Castlemore Ave., Unit #1, Markham, ON L6E 0H7. Flexible hours: Monday to Friday, 9 a.m.-5 p.m., Saturday, 10 a.m.-3 p.m.Contact: Naheed RizviTel. 905.201.7770Email: nrmedicalclinic@gmail.comWebsite: www.nrmedicalclinic.com
Pain physicians — The Jacobs Pain Centre is seeking pain medicine physicians to join a dynamic team of physicians. The clinic is an interven-tional pain clinic certified by the CPSO. Training will also be offered to suitable candidates who may be interested in changing their scope of practice. For further information, please call.Contact: Dr. Howard JacobsMedical DirectorTel. 905.305.9484
OB/GYN — busy office practice: Toronto downtown. Flexible hours, locum or for sale. Three exam rooms, Ritter tables, two ultrasound machines, colposcopy, cryotherapy, LEEP. Ideal for new grads, semi-retired gynecol-ogist. Tel. 416.923.7311Fax: 416.923.1287Email: slibrach@rogers.com
Opportunity in Richmond Hil l & midtown Toronto, Ontario: Wel l-established family practice seeking physician full time or part time. Walk-in shifts also available. No financial commitments, clinics are fully EMR integrated (EMR training included). On-site lab. Above-average compen-sation package. Tel. 416.709.8876Email: mjiwan@uptownhealthcentre.com, dranu@uptownhealthcentre.com
Ottawa — central/east: Sunshine Medical Clinic is expanding and looking for physicians of all specialties. Join us. Low overhead. Best EMR.Tel. 613.695.9001 Email: contact@sunshineclinic.ca
Ottawa — family medicine: Full-time or part-time positions available in an attractive building in a beautiful new community. Free parking. Contact: Dr. AshikianTel. 613.822.0171 (9 a.m. to noon, or 1 p.m. to 3 p.m., Monday to Friday)Fax: 613.822.1838Email: drhaigashikian@gmail.com
Psychiatrists, medical psychothera-pists are needed at a busy private mental health clinic. Turnkey office. Support available as needed.Tel. 416.778.1496
Richmond Hill, Ontario: Richmond Hill After-Hours Clinic requires phy sicians for daytime shifts 9 a.m. to 5 p.m., as well as evenings and weekends. Guaranteed minimum 70:30 split. Con tact: Dr. Ian ZatzmanTel. 905.884.7711Fax: 905.553.5360Email: medz@rogers.com
Scarborough and North York Loblaws Superstores: Busy, expanded walk-in clinics/family practice located inside Loblaws seeking family physicians, pediatrician and specialists. Physi-cians required for walk-in shifts as well as opportunity to relocate an existing practice or build a new practice. Flex-ible hours and very attractive split. Tel. 647.206.0790
Scarborough, Ontario: F/T, P/T family physicians required for medical clinic serving mainly Cantonese and Manda-rin-speaking seniors. Open to public. Pharmacy on-site.Contact: Martin ChaiTel. 416.299.0555, ext. 12Email: martin.chai@ymail.com
Specialists — Brampton, Ontario: Dermatologist, pediatrician, internist, and psychiatrist required for medical centre with several GPs and large pa tient base. Attractive modern office with seven days/week reception service. Fee-for-service split or low flat monthly rate. Tel. 416.949.3830Fax: 647.340.2586Email: bramptonfamilyhealth@gmail.com
Stouffville Family Health Centre: Opening 2012. Connected to a large daycare. Ideal for pediatrician/primary care physician. North of Stouffville Road, on 10th Line. If interested now, would have choice of square footage/design. Varying attractive inducement options available. Fulfils OMA rural requirement.Contact: SarahTel. 905.479.2571
Thornhill/Brampton, ON: F/T, P/T family physicians required for family practice/walk-in clinic. New graduates welcome. Attractive modern office. Option to join FHG. Guaranteed 70:30 split.Contact: Jenny A.Tel. 905.731.5707Email: maxcare_med@yahoo.ca
Vaughan, Jane and Rutherford — new clinic in a medical building. Part time or full time GPs needed. No set-up cost, move existing practice or build up from walk-in clinic. Contact: Mr. SamuelTel. 647.400.0401
West end Ottawa — supportive group of four family physicians looking for a fifth physician to join us. New 2,500 sq. ft. clinic to be completed for November 2012. Payment structure is that of a FHO. Looking for an associate to be an equal member of the FHO. EMR based. Competitive overhead.Contact: Nisha SoniTel. 613.719.7774Email: westboromedical@hotmail.com
PRACTICES
Dawson Road Family Medical Clinic: Guelph FHT/FHO clinic accepting two GPs. Supported by NPs, nurse clini-cians, counselors, IT, EMR. Full admin. Progressive collaborative environment. Outstanding opportunity.Contact: KevinEmail: kevin.mcguirk@DRFMC.ca
Looking for family physician to take over existing full practice. Clinic has lab, four exam rooms. Existing MD closing practice due to illness. Missis-sauga, Ontario — walking distance from Square One. Free.Contact: Sharmil MithiaTel. 416.624.8318
62 March 2012
Classifieds
Mar12_classifieds_p58.indd 5 12-03-05 3:14 PM
ONTARIO MEDICAL REVIEW 63 March 2011
Classifieds
Need family physician to take over an established practice. English/Chinese speaking preferred. GTA location.Email: haclinics@gmail.com
Practice for sale — turnkey: Great GTA location. Modern, bright medical office. Close proximity to hospitals. Minutes from major highways. Easy access, ample parking.Tel. 416.888.1362
SERVICES AVAILABLE
Arya & Sher, health lawyers: Prac-tice focused on representing medical practitioners, clinics, hospitals, and health-care companies. Business and regulatory issues, including profes-sional incorporations, business reg-istrations, contracts, partnership/shareholder issues, tax and estate planning, employment, leasing, medi-cal real estate, and regulatory matters. Contact: Kashif Sher, LLB, MBATel. 416.218.8373Email: ksher@aryasher.comWebsite: www.aryasher.com
Bil l ing agent — electronic data transfer to MOHLTC for all practices, specialties and locums. Medical Billing and Secretarial Services.Contact: Edith ErdelyiTel. 416.576.6788
Experience and knowledge matter: Insurance broker specializing in disabil-ity and life insurance, financial/retirement planning and planned giving programs for sole practitioners and professional cor-porations. Dedicated to giving high-qual-ity and personalized service since 1986.Contact: James Corrigan, RHU, CLUTel. 866.235.1754, ext. 23Website: www.thelivingbenefitsgroup.com
Free record storage for closing practices: RSRS is Canada’s leading paper and digital storage provider. No prohibitive fees to patients. Physician managed since 1997.Tel. 1.888.563.3732, ext. 221 Website: www.RSRS.com
Going EMR? Need to scan your pa tient records? We can find you an affordable solution that fits your budget. For more information and many references:Contact: Sid Soil, DOCUdavit SolutionsTel. 1.888.781.9083, ext. 105Email: ssoil@docudavit.com
MedBill — for all your billing needs: Accepting new clients. All specialties. Over 20 years of billing experience. Reasonab le ra tes . Now o f fe r ing “MedBill Mobile” service.Tel. 416.906.1434Email: val@medbill.caWebsite: www.medbill.ca
Medical Billing Clerks: Getting you paid — on time, every time! Professional and efficient. Specializing in OHIP and all other types of medical claims sub-mission in all practice areas. Reasonable rates. Contact us today to get your billings underway.Contact: KamiTel: 416.888.6076Email: info@medicalbillingclerks.ca
Medical Transcription Services: Telephone dictation and digital recorder f i les. PIPEDA compliant; excel lent quality, next business day service. All specialties, patient notes, letters, reports, including medical-legal and IME reports.Tel. 416.503.4003 or 1.866.503.4003Website: www.2ascribe.com
Moving or moved to EMR? Still have lots of paper? RSRS scans your re-cords and offers full electronic access to your active patient records. It’s easier than you think. PHIPA compliant. Contact: RSRS Tel. 1.888.563.3732, ext. 221 Website: www.RSRS.com
Retiring, moving or closing your practice? Physician’s estate? DOCU-davit Medical Solu tions provides free paper or electronic patient record storage with no hidden costs. Contact: Sid Soil, DOCUdavit SolutionsTel. 1.888.781.9083, ext. 105Email: ssoil@docudavit.com
UPCOMING EVENTS
Disney Wonder Alaska Cruise: Psy-chiatry Review Course CME, July 9-16, 2012: Join us for an unforget-table experience as only Disney can provide aboard the elegant Disney Wonder cruise ship, sailing to spec-tacular Alaska. Great for adults and children alike. Companion cruises free.Tel. 647.882.1427Email: info@psychiatryreviewcourse.comWebsite: www.psychiatryreviewcourse.com
Publisher’s Notes (continued from page 5)
REPRINTING OF ARTICLES
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may not be reproduced in whole or in
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DISPLAY ADVERTISING
Current display advertising rate card,
effective January 1, 2012, available
on request.
Advertising representative:
Marg Churchill
Keith Communications Inc.
1599 Hurontario Street, Unit 301
Mississauga, Ontario L5G 4S1
Tel. 905.278.6700 / 1.800.661.5004
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Mar12_classifieds_p58.indd 6 12-03-05 3:14 PM
Advertisers’ Index
Arya & Sher Health Lawyers ................ 35
AstraZeneca .................................... OBC
Bell Canada ........................................... 4
CME at Sea ......................................... 59
Hamilton Medical Walk-In Clinic ........... 42
Klinix Software Inc .............................. IFC
Leo Pharma.................................... 14,15
Manjog Holding Inc.............................. 25
MD Physician Services
Software .............................................. 47
Merck Canada .................................... 2,6
Queen’s University .............................. 39
Record Storage and Retrieval
Services .............................................. 40
Rosen Sunshine LLP ........................... 36
Sea Courses Cruises ........................... 45
TD Bank Financial ................................ 27
TPC Financial Group Ltd ..................... 43
Torkin Manes LLP ............................... 42
Yes Medical System ............................ 34
OMA Programs and Services
OMA Advantages Partner
Discount Program .............................. 31
OMA CME Cruises .............................. 23
OMA Insurance Services ......... 39,47,IBC
OMA Legal Services ............................ 15
OMA Physician Health Program .......... 21
OMA Practice Management and
Advisory Services ........................... 13,45
OMA Pregnancy and Parental Leave
Benefit Program .................................. 32
OMA Response Centre ......................... 8
OMA Women’s Health Care
Seminar ................................................. 9
OMSBF Annual Golf Tournament ........ 41
OMR Classifieds .................................. 42
Prescribing Information
Dovobet .............................................. 56
Vimovo ...........................................50-53
Xamiol ................................................. 57
Zostavax ........................................54-55
64 March 2012ONTARIO MEDICAL REVIEW
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REV_Mar12_medectoon_p64.indd 1 12-03-09 2:15 PM
Insurance Solutions
Designed exclusively for physicians, medical students and
residents.
Portability: OMA plans move with you wherever you go
Cancellation protection: Unlike other group plans, your plan cannot be
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Premium refund: Money not used to pay claims and expenses for certain
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Non-commissioned Insurance Advisors: We provide education,
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phone: 1.800.758.1641
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InsuranceSolutions2012JanV1.indd 1 12-01-09 10:29 AM
We’re in this together
VIMOVO® and the AstraZeneca logo are registered trademarks of the AstraZeneca group of companies. © AstraZeneca 2012
11/12
VIMOVO is indicated for the treatment of the signs and symptoms of osteoarthritis (OA), rheumatoid arthritis (RA) and ankylosing spondylitis (AS) and to decrease the risk of developing gastric ulcers in patients at risk for developing NSAID-associated gastric ulcers.
VIMOVO is not recommended for initial treatment of acute pain because the absorption of naproxen is delayed (as with other modified-release formulations of naproxen).
For patients with an increased risk of developing cardiovascular (CV) and/or gastrointestinal (GI) adverse events, other management strategies that do NOT include the use of NSAIDs should be considered first. Use of VIMOVO should be limited to the lowest effective dose for the shortest possible duration of treatment in order to minimize the potential risk for cardiovascular or gastrointestinal adverse events.
VIMOVO, as an NSAID, does NOT treat clinical disease or prevent its progression.
VIMOVO, as an NSAID, only relieves symptoms and decreases inflammation for as long as the patient continues to take it.
Evidence from naproxen clinical studies and postmarket experience suggest that use in the geriatric population is associated with differences in safety.
VIMOVO is contraindicated in the peri-operative setting of coronary artery bypass graft surgery (CABG); in women in the third trimester of pregnancy or who are breastfeeding; in patients with severe uncontrolled heart failure, known hypersensitivity to naproxen, esomeprazole, substituted benzimidazoles or to any of the components/excipients; history of asthma, urticaria, or allergic-type reactions after taking ASA or other NSAIDs; active gastric/duodenal/peptic ulcer or active gastrointestinal bleeding; cerebrovascular bleeding or other bleeding disorders; inflammatory bowel disease; severe liver impairment or active liver disease; severe renal impairment or deteriorating renal disease; known hyperkalemia and in children and adolescents less than 18 years of age.
WARNING
Risk of cardiovascular (CV) adverse events: ischemic heart disease (IHD), cerebrovascular disease, congestive heart failure (HF) (NYHA II-IV) Naproxen is a non-steroidal anti-inflammatory drug (NSAID). Use of some NSAIDs is associated with an increased incidence of cardiovascular adverse events (such as myocardial infarction, stroke or thrombotic events) which can be fatal. The risk may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk.
Caution should be exercised in prescribing NSAIDs such as naproxen, which is a component of VIMOVO (naproxen/esomeprazole), to any patient with ischemic heart disease (including but NOT limited to acute myocardial infarction, history of myocardial infarction and/or angina), cerebrovascular disease (including but NOT limited to stroke, cerebrovascular accident, transient ischemic attacks and/or amaurosis fugax) and/or congestive heart failure (NYHA II-IV).
Use of NSAIDs such as naproxen, which is a component of VIMOVO, can promote sodium retention in a dose-dependent manner, through a renal mechanism, which can result in increased blood pressure and/or exacerbation of congestive heart failure.
Randomized clinical trials with VIMOVO have not been designed to detect differences in cardiovascular events in a chronic setting. Therefore, caution should be exercised when prescribing VIMOVO.
Risk of gastrointestinal (GI) adverse events Use of NSAIDs such as naproxen, which is a component of VIMOVO, is associated with an increased incidence of gastrointestinal adverse events (such as peptic/duodenal ulceration, perforation, obstruction and gastrointestinal bleeding).
The recommended daily dosage of VIMOVO is 375/20 mg or 500/20 mg (naproxen/esomeprazole) twice a day.
The most common adverse reactions seen with naproxen are gastrointestinal, of which peptic ulcer, with or without bleeding, is the most severe. Fatalities have occurred, particularly in the elderly.
The most commonly reported adverse reactions for VIMOVO were dyspepsia (11.8%), erosive gastritis (7.2%) and gastritis (6.5%).
See the Product Monograph for full contraindications, warnings, precautions, dosing and administration. Reference: VIMOVO® Product Monograph. AstraZeneca Canada Inc. January 13, 2011.
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