the Bulletin - nspharmacists.ca · the Bulletin 9 Governing the ... macy practice and NSCP...

14
Nova Scotia College of Pharmacists Like pharmacists, the NSCP itself must continu- ally evolve to meet its regulatory obligations in an every-changing healthcare envi- ronment. The NSCP‘s primary pur- pose is to govern the practice of pharmacy in the interest of Nova Scotians. Through the Pharmacy Act, the government gives the NSCP the authority and the re- sponsibility of self-regulation. In exchange for this privilege, the NSCP is expected to develop and enforce standards that are designed to protect the public by ensuring pharmacy services are provided in a competent and ethical manner. In recent years, the privilege of self- regulation has been under scrutiny globally. There is growing concern that self-regulation, in some in- stances, may not be rigorous enough to truly protect the public. In some countries, regulatory bod- ies face the serious risk of losing the right to self-regulate. In response to this concern, self- regulation around the world is undergoing sig- nificant transformations. Regulatory authorities are taking steps to ensure that they are respon- sive and accountable to the public. The NSCP Council has also taken steps over the past year to ensure the quality of its regulatory poli- cies and practices. In the spring, the NSCP Council participated in a gov- ernance session to more clearly define its governance responsi- bilities and to ensure the NSCP continues to meet its legislated obligations to protect the pub- lic. As a result, a new model for governance was approved by the Council, which included the formation of Council govern- ance committees and policies to promote transparency and ac- countability. The Council, along with invited stakeholders including the Dal- housie University Health Law Institute, also participated in a comprehensive strategic plan- ning session in the spring of 2009 to not only agree upon strategic goals for the next three years, but also clarify the NSCP‘s core business. The Council re-affirmed the core business of the NSCP to be: registration/licensure quality assurance practice standards professional accountability Message from the Registrar the Bulletin December 2009 Governing the practice of pharmacy in Nova Scotia in the interest of the health and well being of the public In recent years, the privilege of self-regulation has been under scrutiny globally. In some countries, regulatory bodies are losing the right to self- regulate. This Bulletin is forwarded to every licensed pharmacist and certified dispenser in Nova Scotia. Decisions of the Nova Scotia College of Pharma- cists regarding matters such as regulations, drug schedules, pharmacy practice, etc., are published in this Bulletin. The Nova Scotia College of Pharmacists therefore assumes that all pharmacists/certified dispensers are aware of these matters. Message from Registrar 1-2 Annual Report 2 New Staff NSCP 3 New Location Notice 3 Congratulations Dal Grads 2009 3 Correction Notice 3 Council Membership 4 Welcome New Council Members 5 MACP Signed 5 Online Special Interest Groups 6-7 Warning/Advisories 8 Drug Schedule Changes 9 Natural Health Products 9 New Policies Coming 10-11 Faxed Prescriptions 12 Prescription Transfers 12 Emailed Prescriptions 12 Potential Drug Diversion EffortsBeware 13 Medication Errors & Apology Act 13 Ethics in the Spotlight 14 Holiday Hours 14 Inside this issue: Self-regulation concerns, strategic planning, and fees…

Transcript of the Bulletin - nspharmacists.ca · the Bulletin 9 Governing the ... macy practice and NSCP...

Page 1: the Bulletin - nspharmacists.ca · the Bulletin 9 Governing the ... macy practice and NSCP governance 4. Effective and relevant legislation, ... In 2010, further restructuring will

Nova Scotia

College of Pharmacists

Like pharmacists, the NSCP itself must continu-

ally evolve to meet its regulatory obligations in

an every-changing healthcare envi-

ronment. The NSCP‘s primary pur-

pose is to govern the practice of

pharmacy in the interest of Nova

Scotians. Through the Pharmacy

Act, the government gives the

NSCP the authority and the re-

sponsibility of self-regulation. In

exchange for this privilege, the

NSCP is expected to develop and

enforce standards that are designed

to protect the public by ensuring

pharmacy services are provided in

a competent and ethical manner.

In recent years, the privilege of self-

regulation has been under scrutiny

globally. There is growing concern

that self-regulation, in some in-

stances, may not be rigorous

enough to truly protect the public.

In some countries, regulatory bod-

ies face the serious risk of losing

the right to self-regulate.

In response to this concern, self-

regulation around the world is undergoing sig-

nificant transformations. Regulatory authorities

are taking steps to ensure that they are respon-

sive and accountable to the public. The NSCP

Council has also taken steps over the past year

to ensure the quality of its regulatory poli-

cies and practices. In the spring, the NSCP

Council participated in a gov-

ernance session to more clearly

define its governance responsi-

bilities and to ensure the NSCP

continues to meet its legislated

obligations to protect the pub-

lic. As a result, a new model for

governance was approved by

the Council, which included the

formation of Council govern-

ance committees and policies to

promote transparency and ac-

countability.

The Council, along with invited

stakeholders including the Dal-

housie University Health Law

Institute, also participated in a

comprehensive strategic plan-

ning session in the spring of

2009 to not only agree upon

strategic goals for the next

three years, but also clarify the

NSCP‘s core business. The

Council re-affirmed the core

business of the NSCP to be:

registration/licensure

quality assurance

practice standards

professional accountability

Message from the Registrar

the Bulletin December 2009

Governing the practice of pharmacy in Nova Scotia in the interest of the health and well being of the public

In recent years,

the privilege of

self-regulation

has been under

scrutiny globally.

In some

countries,

regulatory bodies

are losing the

right to self-

regulate.

This Bulletin is forwarded to every licensed pharmacist and certified dispenser in Nova Scotia. Decisions of the Nova Scotia College of Pharma-

cists regarding matters such as regulations, drug schedules, pharmacy practice, etc., are published in this Bulletin. The Nova Scotia College of

Pharmacists therefore assumes that all pharmacists/certified dispensers are aware of these matters.

Message from Registrar 1-2

Annual Report 2

New Staff NSCP 3

New Location Notice 3

Congratulations Dal

Grads 2009

3

Correction Notice 3

Council Membership 4

Welcome New Council

Members

5

MACP Signed 5

Online Special Interest

Groups

6-7

Warning/Advisories 8

Drug Schedule Changes 9

Natural Health Products 9

New Policies Coming 10-11

Faxed Prescriptions 12

Prescription Transfers 12

Emailed Prescriptions 12

Potential Drug Diversion

Efforts—Beware

13

Medication Errors &

Apology Act

13

Ethics in the Spotlight 14

Holiday Hours 14

Inside this issue:

Self-regulation concerns, strategic planning, and fees…

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practice issues. There will also be an individual who

will work directly with the QA / Competency As-

sessment consultant in the development of the en-

hanced QA process and who will assume responsibil-

ity for this area once the program has been finalized.

The NSCP Council acknowledges that its rigorous

strategic plan and the resulting staff restructuring

comes with significant fee increases for its regis-

trants. The resulting pharmacist fee of $725, while

significantly higher than previous years‘ fees in Nova

Scotia, is consistent with fees across the country,

including our closest neighbor NB, where the annual

pharmacist fee is $880. The Council also recognizes,

however, that it must provide a regulatory frame-

work that is responsive to an evolving healthcare

environment, to consumer expectations, and to a

significantly expanded scope of practice for pharma-

cists. The NSCP understands that its‘ regulation of

the profession needs to reflect this new environment

and that its regulatory structures and processes need

to address the challenges that will arise while ensur-

ing competence, performance and safety as the pro-

fession evolves. The reputation of the profession and

the health and safety of the public depends upon the

effectiveness of the NSCP‘s regulation of the practice

of pharmacy.

The Council also approved a comprehensive strategic

plan with 10 strategic goals to be completed over the

next three years:

1. Optimal scope of practice for pharmacists;

2. Regulation of Pharmacy Technicians;

3. Quality Assurance programs for pharmacists, phar-

macy practice and NSCP governance

4. Effective and relevant legislation, regulations, stan-

dards, policies and codes;

5. Robust professional accountability system;

6. Efficient use of technology;

7. Optimal collaboration

8. Effective communication

9. Optimal input into/impact upon e-Health initiatives;

10. Maintenance of current core and administrative activi-

ties in a sustainable fashion.

Following the approval of the strategic plan, an expert

consultant helped to develop a comprehensive opera-

tional plan consistent with the NSCP‘s core business and

strategic goals. Council accepted the recommendation

that a significant restructuring of the current administra-

tion, including the addition of staff, was needed in order

to continue to satisfy the NSCP‘s regulatory obligations

under the Act, to ensure the successful fulfillment of the

strategic goals, and particularly in order to appropriately

dedicate resources to the changes in regulation as the

result of the expanded scope of practice for pharmacists

and the regulation of pharmacy technicians.

In response, a 0.6 FTE devoted exclusively to Professional

Accountability (complaints and discipline) was hired (see

page 3). In 2010, further restructuring will include a staff

member whose primary responsibility will be pharmacy

Message continued...

Page 2 the Bulletin

Annual Report—it IS a good read!

Included with this Bulletin is the Nova Scotia College of Pharmacists An-nual Report 2008-2009. All are encouraged to

read the report as it is a comprehensive source of information on the activities and undertakings of the College this

past year and as we look to the future.

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After many years of ―rooming in‖ with our friends at the Pharmacy

Association of Nova Scotia, we moved into our new home in Sentry

Place in early October. Our new address is 1559 Brunswick

Street, Suite 200 (next door to Cambridge Suites).

PANS successfully sold the Dresden Row condo and have moved

their offices to Dartmouth Crossing – Suite 225, 170 Cromarty

Drive (above Backyard Veranda). We wish them the best of luck in

their new home.

The New Face of Complaints and Discipline

Have you seen our new place?

the Bulletin February 2009

Chalmers Hospital. Her community experience includes

thirteen years as pharmacy owner of St. Andrews

Pharmacy Ltd. and six years as pharmacy owner of St.

Stephen Prescription Centre Ltd. Prior to joining the

NSCP staff, Cindy was working at Pharmasea Community

Pharmacy in Hatchet Lake, NS.

Cindy has a strong interest in pharmacy legislation and its

application to pharmacy practice and professional ac-

countability, and has served on the NSCP‘s Investigation

Committee and Hearing Committee.

The Nova Scotia College of Pharmacists wel-comes

Cindy Ingersoll to the new position of Manager of

Professional Accountability. Cindy‘s key

responsibilities in this role are to direct and manage the

professional accountabil-ity processes of the College,

including com-plaints, investigations and hearings.

Cindy received her pharmacy degree from Dalhousie Uni-

versity in 1985. Upon graduation she practiced for several

years in the hospital setting, serving as Director of Phar-

macy at Charlotte County Hospital, and as Assistant Di-

rector/ Interim Director of Pharmacy at Dr. Everett

WE ARE

HERE!

Congratulations

As the year draws to a close, the NSCP would like to extend congratulations to the 2009 Dalhou-sie College of

Pharmacy Graduates for a successful first year of practice and a wish for many per-sonal and professional successes in

the future. It is indeed an optimistic time for the profession and we are confident that your practice will aptly be

guided to always serve in the best interest of the public.

Correction Notice

Our apologies to KINBURN PHARMACY. In our last issue of the Bulletin, we incorrectly listed the location of this

pharmacy at Lunenburg. The correct location is Mahone Bay.

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Ever Wonder who sits at the Boardroom Table?

Page 4 the Bulletin

The NSCP congratulates Chelsea Caldwell and Mary Abriel-Sangster who were successful in the Council elections and

look forward to an exciting and productive year working together. The NSCP gratefully acknowledges the service and

contributions of our departing Council members, Sujay Khiroya and Anne Marentette, whose knowledge and wis-

dom has helped guide the successful course of the NSCP over the last number of years.

Presenting

the

NSCP

Council

for

2010

Trevor

Simmons

PRESIDENT

Zone 1 Rep (Hospital)

Tom

Mahaffey

PAST PRESIDENT

Public Rep

Deb

Barnhill

Zone 3 Rep

Janelle

Gray

Zone 4 Rep

Frank

Burgoyne

Public Rep

Craig

Connelly

VICE-PRESIDENT

Zone 1 Rep

Sarah

Murphy-Boutilier

Zone 2 Rep

Rita

Caldwell

College of

Pharmacy Rep

Cathy

Comeau

Pharmacy

Technician

Observer

Mary

Abriel-Sangster

Zone 1 Rep

Chelsea

Caldwell

Zone 1 Rep

NB: Position of SECRETARY-TREASURER to filled

NEW! NEW!

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Chelsea Caldwell—Zone 1

Chelsea has worked with Lawtons since graduation from

Dal in 2004 and cur-rently manages the Duffus Street

loca-tion (since 2008). She is also is a third year skills lab

tutor and a preceptor for the Practical Experience

Program at Dal.

Chelsea is interested in the expanding role of the pharma-

cist and has successfully completed the Immunization

Training Program through Dal CPE.

Mary Abriel-Sangster—Zone 1

Mary, also a 2004 Dal grad, started her career in phar-

macy in Ottawa where she was a manager for Loblaws

DRUGStore Pharmacy. She was on the Ottawa Carle-

ton Pharmacists‘ Association Executive and served as

the membership coordinator. In 2007, she moved back

to Halifax and continued her employment with DRUG-

Store Pharmacy in Bayers Lake where she still works as

a staff pharmacist.

A closer look at our two new Council members...

Let’s begin by defining some of the “lingo”:

MACP = Mobility Agreement for Canadian Pharmacists

MRA = Mutual Recognition Agreement [for Pharmacists in

Canada]

AIT = Agreement on Internal Trade

NAPRA = National Association of Regulatory Authorities

Next some background:

The AIT (Chapter 7) was revised and came into effect early

this year. This is an intergovernmental trade agreement

with Canada‘s First Ministers to reduce and eliminate, to the

extent possible, barriers to the free movement of persons,

goods, services, and investment within Canada and to estab-

lish an open, efficient, and stable domestic market.

Significance?

This is particularly significant to those workers in Canada

who work in regulated occupations or trades. It means

qualifications of workers from one part of the country are

to be recognized and accommodated in other parts of Can-

ada, and differences in occupational standards are to be rec-

onciled as much as possible. The goal is to see people li-

censed and registered based primarily on their competency

to do the job, not on where they come from.

Response to the new AIT

The Nova Scotia College of Pharmacists is proud to be

a signatory to the new Mobility Agreement for Canadian

Pharmacists (MACP). The National Association of

Pharmacy Regulatory Authorities (NAPRA) led the

adoption of this significant

document by all Canada‘s

pharmacy regulatory

authorities. The MACP, which

was signed during a special

celebration on Sunday,

November 1, 2009 in

Montréal, replaces the Mutual

Recognition Agreement for

Pharmacists in Canada. It

captures commonly held

principles and requirements to

allow the movement of

pharmacists across Canada

without imposing unreasonable

or discriminatory

requirements – is a significant

document for pharmacists.

A copy of the agreement can

be accessed from the NAPRA

website: www.napra.ca/

Content_Files/Files/Mobilty_

Agreement_EN_May2009_

final_ samplecopy.pdf

Page 5

MACP replaces MRA:

What does that mean?

“What we achieved

is outstanding.

With the signing of

the agreement by

all of Canada’s

pharmacy regula-

tory authorities, it

recognizes the high

degree of common-

ality in our profes-

sion and provides

enhanced mobility

for our pharma-

cists,” said Dianne

Donnan,

NAPRA President.

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Ever find yourself wondering what someone else would do

in your situation? What about wishing you had some

more effective tools to aid in your practice? And then

there is just wanting to talk things through with someone

else….

The good news is that you are not alone...but you probably

already knew that! The great news is that help is but a

click away.

There are many online interest groups available to practic-

ing pharmacists (and some are free!) to assist them in

their practice. Have a look at some of the options listed

below and see if you might want to answer this Want Ad!

Page 6 the Bulletin

Primary Care Pharmacy Specialty Network

(PSN)

The Primary Care Pharmacy Specialty Network is a

group of pharmacists across Canada with a common in-

terest in patient care in primary health care and family

practice. This may include pharmacists integrated into a

family medicine practice or pharmacists who are devel-

oping or providing services to individuals in a community

-based setting. This PSN is jointly sponsored by CSHP

and CPhA. The primary focus is to promote and opti-

mize the role of the pharmacist in the primary health

care setting. Objectives include:

To promote sharing of practice-based resources

and tools

To develop, support and maintain networking op-

portunities for Canadian pharmacists with an in-

terest in primary care practice, education and/or

research

To design and disseminate education and/or train-

ing initiatives for members

To advocate for the role and practice develop-

ment of the pharmacist in family practice and pri-

mary care settings

To provide an opportunity for mentorship of new

pharmacists in the practice setting.

If you have practice or research questions, your peers are

willing to give you the benefit of their experience and ex-

pertise.

To join, go to www.pharmacists.ca/primarycare. It is free

to members of CPhA and CSHP. Check out the website:

www.psnextranet.pharmacists.ca

Canadian Pharmacy Practice Research Group

CPPRG

CPPRG now has a Google Group ―CPhA-CPPRG‖ to fa-

cilitate communications among Canadian pharmacy prac-

tice researchers. As a member of this group, you will have

access to:

Archived issues of the Translator and Live Links

Funding opportunities

Description of current pharmacy practice research

(PPR) projects in Canada

Powerful search engine to find relevant PPR posted

on this Group

Chance to connect with other pharmacy practice

researchers

And much more!

If you are interested in joining this group, please contact

[email protected] to receive your invitation and

more information. Membership is free and open to any-

one interested in pharmacy practice research.

WANTED

Enthusiastic pharmacist wanting to

meet like-minded individuals who en-

joy strolling through online chat

rooms, discussion boards, and clinical

practice guidelines. Must be open-

minded and willing to engage in a

meaningful sharing relationship with

colleagues. Must be between 20-100

years old.

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Governing the practice of pharmacy in Nova Scotia in the interest of the health and well being of the public Page 7

Canadian Action Network for the Advance-

ment, Dissemination, and Adoption of Prac-

tice-Informed Tobacco Treatment

As pharmacists, you are one of the most accessible

groups of health care professionals around. Giving advice

about smoking cessation on-site, where Nicotine Re-

placement Therapy (NRT) like nicotine gum or patches

can be purchased, means you can have quite an impact on

smokers‘ cessation efforts.

With National Non-Smoking Week around the corner

(January 17-23), CAN-ADAPTT is set to serve as your

source of clinical information on smoking cessation. CAN

-ADAPTT offers tools to prepare you to initiate a con-

versation with smokers and to help them find effective

ways to kick the habit.

CAN-ADAPTT is the Canadian Action Network for the

Advancement, Dissemination and Adoption of Practice-

Informed Tobacco Treatment (www.can-adaptt.net), a

project initiated by Ontario‘s Centre for Addiction and

Mental Health (CAMH). It‘s a practice-based research

network facilitating knowledge exchange among health-

care professionals and researchers in the area of smoking

cessation.

Get Involved!

Join the CAN-ADAPTT network and be part of the lar-

ger healthcare community seeking evidence-based prac-

tices that will help tobacco users to stop using. As a

member, you can:

Use the discussion board to connect/collaborate with

other pharmacists and healthcare professionals in Can-

ada;

Exchange knowledge about better smoking cessation

practices that you can implement; and

Post questions, receive feedback, disseminate infor-

mation and resources.

Access up-to-date, evidence-based clinical practice

guidelines for tobacco control; and

Contribute to the development of the first Canadian

Clinical Practice Guidelines for Tobacco Control.

Get links to smoking cessation/tobacco control re-

sources including websites, projects, literature reviews,

and articles.

Access Seed grant opportunities for practitioner-

researcher teams to address gaps in research and exist-

ing tobacco control guidelines.

Membership is free, and is open to pharmacists and

other healthcare professionals interested in contributing

to practice-based approaches to tobacco cessation.

What’s Next?

One of CAN-ADAPTT‘s main objectives is to develop

and promote the adoption of national clinical practice

guidelines (CPG‘s) for pharmacists and other health

practitioners. The dissemination and adoption of CPG‘s

will complement smoking cessation initiatives that phar-

macists already provide and will help to establish smok-

ing cessation as a standard of care in pharmacies in

Nova Scotia and across the country. CPG‘s can help

pharmacists provide the most up-to-date, evidence-

based care and interventions to help their clients quit

smoking.

As more pharmacists and other healthcare professionals

become involved with CAN-ADAPTT, the network will

continue to expand, generating new research and

knowledge and addressing gaps in the current set of

CPG‘s. This new evidence will then be incorporated,

keeping the guidelines up-to-date and clinically relevant

to those in the position to help smokers change their

behaviour.

Your involvement will help ultimately increase the ca-

pacity and commitment among Canadian pharmacy pro-

fessionals and other healthcare professionals in the area

of smoking cessation.

For more information, please contact:

Katie Hunter, Regional Coordinator, CAN-ADAPTT

Centre for Addiction and Mental Health

(416) 535-8501 x 7421

[email protected]

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Pharmacists, especially Pharmacy Managers, are reminded that critical health/drug advisories, warnings and drug

recalls are posted on the NSCP website homepage: www.nspharmacists.ca and the Health Canada website:

www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/

It is the responsibility of every licensed pharmacist and certified dispenser to keep abreast of these safety

advisories and to advise their patients where appropriate.

See below for the latest safety advisories. To view the full advisory, please check either website noted above.

Health Canada Advisories, Warnings, and Recalls

October 28, 2009:

Type II Product Recall of Apo-Lithium Carbonate SR 300 mg

strength tablets

October 27, 2009:

Type I Product Recall of Propofol Injection, 1 g/100 mL and 500

mg/50 mL Due to the Presence of Particulate Matter - Hospira

Healthcare Corporation

October 26, 2009:

Potential Risk of Serious Adverse Health Consequences with

Inadvertent Administration of Cesamet (nabilone) Capsules 1

mg Instead of Trazorel (trazodone hydrochloride) Tablets 50

mg Due to Mislabelling

October 23, 2009:

Association of Rituxan® (rituximab) with Progressive Multifocal

Leukoencephalopathy (PML)

October 23, 2009:

Important Tamiflu Information for Health Professionals

October 20, 2009:

Health Canada issued important safey information on CEFTRI-

AXONE

October 20, 2009:

Potential Mislabelling of Trazorel and Cesamet Bottles

October 20, 2009:

Risk of Entrapment of Patients in Hospital Beds

October 19, 2009:

New Safety Information Regarding Intelence (etravirine) and

Severe Skin and Hypersensitivity Reactions

October 15, 2009:

Important Information About the Risk of Dosing Error for

Tamiflu (oseltamivir phosphate) Powder for Oral Suspension

(12 mg/mL)

October 15, 2009:

Recall Notice, Portex Uncuffed Pediatric-Sized Tracheal Tubes

October 14, 2009:

Health Canada is advising consumers not to use the following

foreign health products due to concerns about possible adverse

reactions:

- Bao Ling, Dynasty Worldwide Jinglida So Young Formula,

STEAM, Syntrax Fyre, Texiao Fengshi Gutong Ling, Kam Yuen

Brand Wan Ying Yang Gan Wan

October 7, 2009:

Important Safety Information Regarding the Use of Sleep Aid

Drugs and the Risk of Complex Sleep-Related Behaviours

October 1, 2009:

Important Safety Information on Hospira Devices that have

Defective AC Power Cords - Hospira Healthcare Corporation

December 9, 2009:

Thyrogen (thyrotropin alfa for injection): Caution with Prepara-

tion and Administration

December 9, 2009:

Cerezyme (imiglucerase for injection), Fabrazyme (agalsidase

beta), Myozyme (alglucosidase alfa) and Aldurazyme

(laronidase): Caution with Preparation and Administration

December 8, 2009:

Important Information about Acai Berry Products containing

Prescription Medication

December 4, 2009:

One Lot of Zaditen Tablets (for Asthma) Recalled Due to Po-

tential Health Risks

December 3, 2009:

Exjade (deferasirox) - Proposed Changes to the Canadian

Product Monograph

December 2, 2009:

Rapamune (sirolimus) - Blood Level Measurement Changes

November 26, 2009:

Heparin - Decreased Potency as a Result of New United States

Pharmacopeia (USP) Standards

November 26, 2009:

Important Information on Changes to Heparin Potency

November 25, 2009:

Foreign Particles Found In Certain Products From Genzyme

November 25, 2009:

Health Canada Warns Consumers Not to Use ―Once More‖

or Any Unauthorized Product Promoted to Enhance Male Sex-

ual Performance

November 16, 2009:

Authorization for Sale and Post-Market Activities for Arepanrix

H1N1 Vaccine

November 5, 2009:

Chaotic Beverages Recalled Due to Unacceptable Health Risks

to Children

November 4, 2009:

Consumers Warned Against Buying Fraudulent H1N1 Flu Virus

Products Online

November 3, 2009:

Association of Relenza (zanamivir) Dry Powder for Inhalation

with Fatal Outcome when Administered by Nebulization In-

stead of Inhalation

October 30, 2009:

Health Canada Reminds Canadians to Check Medical Device

Clocks After Switch to Standard Time

Page 8 the Bulletin

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Natural Health Products

Diphenhydramine

Diphenhydramine and its salts and preparations for

topical use in concentrations of 2% or less when sold

in containers of 300 mg or less of diphenhydramine

hydrochloride – Unscheduled (from Schedule III)

Drug Scheduling Changes Page 9

Naproxen Sodium

Naproxen sodium 220 mg tablet (when sold in products la-

beled with a recommended maximum daily dose of 440 mg,

and in package sizes of up to 6,600 mg) - Schedule III

Naproxen sodium 220 mg tablet (when sold in products la-

beled with a recommended maximum daily dose of 440 mg,

and in package sizes exceeding 6,600 mg) - Schedule II

met the natural health product (NHP) definition were given six

years to come into compliance with the NHPR. These products

were given ―transitional DINs‖, and were given until December

31, 2009 to obtain a product license under the NHPR. Licensed

natural health products can be identified by the 8-digit natural

product number (NPN, or DIN-HM for homeopathic medicines)

on the product label. When a DIN is transitioned to an NPN,

the 8-digit number remains the same, - the change occurs to the

prefix before the 8-digit number (e.g. DIN 12345678 is transi-

tioned to NPN 12345678).

All NHPs for sale in Canada require a product license from

Health Canada. The NHPR includes the requirement for pre-

market review of a product‘s safety, quality and efficacy before a

product license is issued. Health Canada reviews all product li-

cense applications and issues licenses only when the information

provided by applicants supports the high quality of the product,

the safe use of the product under the recommended conditions

of use of the product under the recommended conditions of use,

and the health claim being made for that product.

Licensed Natural Health Products Database (LNHPD)

The Licensed Natural Health Products Database (LNHPD), man-

aged by Health Canada, contains product specific information on

those natural health products that have been issued a product

license by Health Canada.

The LNHPD can be found at the following address:

http://www.hc-sc.gc.ca/dhp-mps/prodnatur/applications/licen-

prod/lnhpd-bdpsnh-eng.php

Natural health product (or NHP) is a

term used in Canada to refer to a

group of health products including:

vitamin and mineral supplements,

herbal remedies and other plant-

based products, traditional medicines (such as Traditional Chinese

Medicines and Ayurvedic [Indian]

Medicines), ho-meopathic medicines,

fatty acids, pro-biotics and some

personal care prod-ucts such as

antiperspirants, shampoos and

mouthwashes.

NHPs are regulated under the Natural

Health Products Regulations (NHPR)

and are included in the definition of a

―drug‖ under the Food and Drugs Act

(FDA). They are regulated as a subset

of ―drugs‖ with a separate regulatory framework (the NHPR).

The Food and Drug Regulations (FDR) and the NHPR provide a

comparable level of regulatory oversight. Both regulatory frame-

works have premarket review of products for safety, quality, and

efficacy. Both regulatory frameworks require that good manufac-

turing practices (GMP) be met before site/establishment licenses

are issued.

When the NHPR came into force on January 1, 2004, products

which had already received market authorization in the form of a

drug identification number (DIN) under the FDR and which now

Pharmacies are

reminded that

they should not

sell Natural

Health Products or

Homeopathic

medicines that DO

NOT have a NPN

or DIN-HM on the

label

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Coming soon...

The Standards of Practice Committee has been very busy with putting together important documents and standards that

will help direct pharmacy practice. This is a heads up on what will be showing on the horizon – you should be seeing the

completed documents early in 2010.

Certain pharmaceuticals need to be in an environment

that is strictly between a narrow range of temperatures

as established and labeled by the manufacturer. Some

products, including vaccines, must be kept between 2°C

and 8°C at all times to maintain their quality and integrity.

―Cold Chain‖ refers to the system for handling, storing,

and transporting pharmaceuticals within a safe cold tem-

perature, which is usually between 2°C and 8°C for

products labeled ―for refrigeration‖.

Discussions around ―cold chain‖ have been very preva-

lent of late given the H1N1 pandemic coupled with the

anticipated move towards pharmacists immunizing in

Nova Scotia. Over the last few months, a task force has

been busy working on a Cold Chain Policy, which along

with other information will include criteria for dispensary

Page 10 the Bulletin

The public expects that pharmacists will take reasonable

steps to protect drugs on their premises from loss, theft

or diversion. This expectation is reflected in federal and

provincial legislation including the Narcotic Control regula-

tions, the Food and Drug Regulations, and the Nova Scotia

Practice Regulations to the Pharmacy Act. This expecta-

tion extends to both the pharmacy manager and the phar-

macist while on duty.

Reconciliation is a careful and methodical process of audit-

ing the recorded versus actual purchased, dispensed, and

on-hand quantities of drugs. While they are not quickly

performed activities, they are important for identifying

problems which can subsequently be investigated and

addressed.

The Narcotic Reconciliation policy is intended to provide

pharmacy managers with an effective means to assist

them in ensuring that the narcotic and controlled drugs

in the pharmacy are secure from internal loss, theft and

diversion.

Narcotic Reconciliation Policy

Cold Chain Policy

refrigerators and temperature monitors. While this may

necessitate a change in equipment for some pharmacies,

owners are reminded that as pharmacists, we are required

to ensure that medications are managed in a manner that

assures the integrity of the product provided to the pa-

tient. This includes the responsibility to maintain optimal

storage conditions for drugs when they are received,

stored, in the process of being prepared for dispensing,

awaiting patient pick-up and / or delivery, and finally re-

leased to the patient.

The upcoming NSCP policy was informed largely by the

Public Health Agency of Canada Guidelines which can be

viewed at http://www.phac-aspc.gc.ca/publicat/2007/

nvshglp-ldemv/section3-eng.php.

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Page 11

Given community pharmacy‘s key role in the medication

management segment of the health care process, an effec-

tive continuous quality improvement (CQI) process for

community pharmacies that is both proactive and respon-

sive, and that enables enhancement of the safety culture of

the pharmacy as well as its practices, can be expected to

have a substantial impact on patient safety.

Recognizing the importance of continuous quality improve-

ment (CQI) in enabling pharmacies to provide optimal pa-

tient care, the 2003 Practice Regulations to the revised

Pharmacy Act includes a requirement for pharmacies in

Nova Scotia to establish and maintain a continuing, docu-

mented quality assurance program.

In consideration of the existing evidence on best practice

in the area of CQI, including the results from the

SafetyNET project, the NSCP has identified the required

components of an effective quality assurance program,

and community pharmacies in Nova Scotia will be as-

sessed for compliance with the Practice Regulations

against this standard.

Standard of Practice for Quality Assurance Programs

in Community Pharmacies

Centralized Prescription Processing Policy

The Nova Scotia College of Pharmacists defines central-

ized prescription processing (―central fill‖) as ―the proc-

essing by a central fill pharmacy of a request, from the origi-

nating pharmacy (patient contact pharmacy) to prepare a

drug order or to perform processing functions such as

packaging medication to be dispensed pursuant to a pre-

scription‖.

The NSCP can foresee where this arrangement may be

desirable in cer-tain community settings provided the

services are based upon an approved policy that would

ensure public safety and maintain the provision of optimal

care to the patient.

Position on Currency of Patient Profiles

The NSCP is of the position that a current and accurate

medica-tion profile is a critical compo-nent of medication

management and an essential component for providing

optimal patient care and supporting seamless care. Members of a patient‘s health care team expect that

pharmacy will be the primary steward of a patient‘s

medication profile.

The standards of practice for pharmacy practice require

that a pharmacist gather all relevant patient information

and assess its relevance to patient care. This includes rou-

tinely collecting and documenting information about a pa-

tient's other medications or treatments that that may af-

fect the patients medical condition or interact with their

therapy.

The Currency of Patient Profiles policy is intended to clarify

the NSCP‘s expectations of the minimum standards for

ensuring that patients‘ medication records are current,

comprehensive, and accurate.

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Faxed Prescriptions...the right way!

Page 12 the Bulletin

Faxing represents an effective and efficient means of re-

laying prescription information from prescribers to phar-

macies. Indeed, it can help streamline workflow and allow

medications to be prepared in advance of the patient‘s

arrival thereby reducing the amount of time a patient is

required to wait for their prescription. However, prac-

tice standards cannot be sacrificed for the sake of con-

venience or avoidance of dialog with the physician.

In order for a faxed prescription to be considered a legal

prescription, the necessary requirements as listed in the

―Council Policy: Facsimile Transmission of Prescriptions‖(found

on website) must be fulfilled. Pharmacists are asked to

particularly note that not only must the prescription in-

clude the prescriber’s name, address, telephone number, fax

number and signature, but also certification statements by the

prescriber that:

i) the prescription represents the original of the pre-

scription drug order,

ii) the addressee (i.e. pharmacy) is the only intended

recipient and there are no others, and

iii) the original prescription will be invalidated by

marking it in such a way that it cannot be reissued.

A Model Prescription Form (found with policy) can be dis-

tributed which may help the prescriber to successfully

meet all requirements of a faxed prescription. Prescribers

may choose to develop their own form but it MUST con-

tain ALL the elements found on the Model Form.

The Nova Scotia College of Pharmacists has been made

aware that some pharmacies are continuing to accept

inap-propriate faxed prescriptions. This not only

contravenes the requirements set out by the NSCP and

the federal gov-ernment, but upon audit, the prescription

could be considered invalid by third party insurers. Additionally this practice creates problems for those pharmacists who are following the policy. Inconsistencies

in practice are perceived by prescribers which then make

it difficult for pharmacists to enforce the requirements.

Pharmacists are reminded that the responsibility to ensure

that the policy is being followed lies both with the pharma-

cist filling the prescription and the pharmacy manager.

Pharmacy Assistants and Prescription Transfers

Pharmacists and pharmacy managers are reminded that,

by law, prescription transfers require a pharmacist‘s in-

volvement on both the sending and receiving end. Verbal

transfers must be between two pharmacists. However,

the question has arisen whether pharmacy assistants can

send or receive faxed transfers of prescriptions. The

NSCP has determined that there is nothing prohibiting

technicians from being involved in and performing the

transfer process as long as there are pharmacists on either

end overseeing the process and taking responsibility for

the accuracy of the process.

Emailed

Rx

Pharmacists are reminded that emailed prescriptions are not considered legal pre-

scriptions. Until such time that security in transmission can be assured, as will be the

case when a provincial electronic drug information system (DIS) is developed, pharma-

cists are not to accept emailed prescriptions under any circumstances.

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Medication Errors—OK to say you’re sorry

Pharmacists are reminded that a new statute, the Apol-

ogy Act, was proclaimed on October 1, 2009. The

Apology Act defines an apology as ―an expression of sym-

pathy or regret, a statement that one is sorry or any other

words or actions indicating contrition or commiseration,

whether or not the words or actions admit or imply an admis-

sion of fault in connection with the matter to which the words

or actions relate‖. Nova Scotia is the sixth province to

pass such legislation, which allows pharmacists to apolo-

gize and express remorse without having that expression

used as evidence in legal proceedings to establish fault or

liability. It is, however, important to bear in mind that

although the Apology Act states that the apology itself is

not admissible in court, it does not preclude the admis-

sion into evidence of the facts that gave rise to the inves-

tigation in the first instance. The complete Apology Act

may be viewed at:: www.gov.ns.ca/legislature/legc/

bills/60th_2nd/3rd_read/b233.htm

The Pharmacy Act legislates that the primary responsibility

of pharmacists in Nova Scotia is the provision of optimal

patient care. As such, the first duty of a pharmacist

when informed of a medication error is to care for the

patient. Pharmacists are reminded of their legal, moral,

and ethical duty to fully investigate an allegation of an er-

ror, beginning with immediate consultation with the pa-

tient‘s primary health care provider in most situations.

Subsequently, the error should be documented and man-

aged in accordance with the pharmacy‘s Continuous Qual-

ity Improvement process to identify the contributing fac-

tors to the error so that action can be taken to reduce the

likelihood of a recurrence of the event. Pharmacists are

encouraged to undertake such investigations in a caring

and transparent manner. As part of the investigative proc-

ess, pharmacists may feel conflicted between their duty to

the patient and their concern regarding potential liability.

As per an order of the Hearing Committee in March 2009, pharmacists are advised that the Nova Scotia College of

Pharmacists alleged that pharmacist Ms. Tamala Fadelle breached provi-sions of the Pharmacy Act and Regulations

made thereunder, and conducted herself in a way in which a Hearing Committee properly constituted under the

Pharmacy Act could conclude that her conduct amounted to professional misconduct.

The College and Ms. Fadelle believed that a Settlement Agreement was the proper method of resolving the matter, and

agreed to a statement of facts and disposition. Information relating to the details and resolution of the matter can be

accessed on the ―Communications‖ section of the NSCP website under ―Disciplinary Decisions‖.

In consideration of the apparent rising problem of drug

diversion, the NSCP recommends that pharmacists exer-

cise vigilance when releasing narcotics, including part-fills

and balances.

Pharmacists should ensure that the individual to whom

they release the narcotics is either the patient or pa-

tient‘s agent, an individual on record as being explicitly

authorized by the patient to act on their behalf.

If the individual is unknown to the pharmacist, it is

expected that the pharmacist take steps to confirm

with certainty the individuals‘ identity, including a re-

quest for a photo id.

Pharmacists should obtain a signature for every re-

lease of a narcotic, including part-fills and balances.

Don’t be duped!

Governing the Page 13

Disciplinary Decision: Professional Misconduct

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Happy Holidays to All

From the Council and Staffat theNova Scotia College of Pharmacists

Governing the practice of pharmacy

in Nova Scotia in the interest of the

health and well being of the public.

Value VI— Pharmacists observe the law, preserve high professional standards and uphold the

dignity and honour of the profession.

Included under this value statement is the notion that pharmacists do not practice under conditions which compromise their

freedom to exercise professional judgment or which cause a deterioration of the quality of their professional service or care. The

pharmacist is ultimately responsible for the safe and effective provision of pharmaceutical care and should take what-

ever steps are necessary to ensure this outcome. A poor practice environment is not an excuse for suboptimal prac-

tice on the part of the pharmacist.

1559 Brunswick Street, Suite 200

Halifax, NS

B3J 2G1

Phone: 902-422-8528

Fax: 902-422-0885

E-mail: [email protected]

www.nspharmacists.ca

Nova Scotia

College of

Pharmacists

Ethics under the Spotlight The Code of Ethics provides guidance to pharmacists making ethical decisions. It educates phar-macists about their

ethical duties and obligations. As the practice of pharmacy evolves, factors such as economic restraints and increased

technol-ogy challenge the ability of pharmacists to practice ethically. The Code provides pharmacists with direction

for ensuring ethical decision making.

HOLIDAY HOURSAlong with mistletoe, eggnog, and merrymaking, ‗tis also the season for Ho-Ho-Holiday hours. The NSCP office will

be closing on the regular statutory holidays December 25, 28, and Jan 1. The office will be closing at noon on Dec 24,

29, 30, and 31. Please keep this in mind if you have business to do with the College before year end. We will be

checking our voice mail during this time so as to respond to any urgent matters.