Stockholms läns läkemedelskommitté - Janusinfo · The clinical pharmacologist provided support...

Stockholms läns läkemedelskommitté

Day 2, Wednesday September 12 Study visits

Hold on to this

International organizing group

Lars L Gustafsson, Stockholm

Dr Richard Laing, WHO Geneva,

Eva Andersén Karlsson, Stockholm

Dr Brian Godman, Stockholm/Liverpool

Dr Öyvind Melien, Oslo

Dr Sabine Vogler, Vienna

Organizing group, Stockholm Eva Andersén Karlsson, Chairperson DTC, Stockholm, associate

professor

Johan Bratt, associate professor

Carl-Gustaf Elinder, professor

Lars L Gustafsson, professor

Rickard Malmström, associate professor

Malena Jirlow, communication officer

Kristina Johansson, pharmacist

Paula Nordahl, executive secretary

Anna-Lena Forssén, executive secretary

Magnus Edlund, graphic designer

Welcome to Stockholm!

The Stockholm Model Including the ”Wise List”

Associate professor Eva Andersén Karlsson

Chairperson, Drug and Therapeutics Committee

(DTC), Stockholm County Council

Objectives

Efficient and safe treatment for patients

Making sure every patient receives the drug/s

that she/he needs – neither too much, nor too

little

Prescribers

Internal

Patients

External

County Council Board SLL administration/Support for Evidence-Based Medicine Stockholm DTC Information physicians/pharmacists Politicians Health care information officers Pharmacy stakeholders

Primary care Hospitals Private practitioners Students/KI Heads of Departments

Nat´l Board of Health and Welfare Ministry of Health Medical Products Agency Dental and Pharmaceutical Benefits Agency Sw Council on Health Technology Assessment Sw Assn of Local Authorities and Regions Sw Assn of the Pharmaceutical Industry Pharmaceutical companies Pharmacy stakeholders Patient organisations Sw. Med.Assn./sections Other county councils

Population Patient organisations

Stakeholders in the pharmaceutical field

Mass media

It all happens here!

Drug and Therapeutics Committee in Stockholm County Council

Rumiana Zlatewa Specialistläkare CityHeart Hjärtspecialistmottagning

Produktion

21 Expert Panels

Spesam

KUST Val- beredn

Evidence-based Medicine

QRC

Karolinska Institutet

HSF

Med fort- bildning

Metodrådet

Försäkringsmed kommitté

Pat.säkerhets- kommittén

Central strål- skyddskommitté

Central gaskommitté Vårdhygien

Stockholms län

Smittskydd Stockholm

Strama Stockholm

Sakkunnig- kansli

Med program- arbete

Dept. Support

Omv- råd

28 Specialist Boards

Produktion

SLK- kansli

Stockholm Drug and Therapeutics

Committe DTC

Stockholm Medical Board

SMR

Drug and Therapeutics Committee

Qualified analysis of

medicines –

recommendations

Wise List

New Medicines

Prescribing data

feedback to

prescribers and head

physicians

Identify poor

prescribing

– Medical Education

– Follow-up

The Key Role of Experts and Opinion Leaders Expert Panels:

21 Expert Panels covering all major diseases

Leaders in academic medicine and clinical drug research

(Karolinska Institutet)

Representatives from major specialist clinics, Primary Health

Care Centres, together with clinical pharmacologists and

pharmacists

In some cases, nurses are also members of the Expert Panel

The clinical pharmacologist provided support in drug evaluation

principles

2010-04-13

8

Stockholm DTC – 21 Expert Advisory Panels General medicine

Analgetics/rheumatological diseases

Anaesthetics, fluid therapy/nutrition

Endocrinological /metabolic diseases

Gastroenterological diseases

Geriatric diseases

Cardio-vascular diseases

Skin diseases

Infectious diseases

Pulmonary and allergic diseases

Medical kidney diseases

Neurological diseases

Obstetrics and gynaechology

Oncological and hematological

diseases

Plasma products and certain

antithrombotic drugs

Psychiatric diseases

Radiological drugs

Orphan drugs

Urology

Vaccinations

Eye diseases

Expert Advisory Panels Play Very Important Role

Some 180 medical experts have reviewed over

800 drugs – evaluating the scientific literature,

the clinical experience and pharmaceutical

appropriateness of various preparations, as

basis for decisions

Continuous real-world intelligence gathered

within specialised areas, following EMA,

pharma industry

2012-09-13

Medicinskt Kunskapscentrum

10

South/South-West 32 units

Anna Zucco Christer Norman

South-East 41 units

Sten Ronge Per Hedman

City 26 units

Kristina Aggefors

North-West 38 units

Laila Bucht Sjöström Sara Hallander

North-East 32 units

Teresa Alton Borgelin Eva Wikström

Johnsson

Division areas of responsibility Information pharmacists and physicians

West 26 units

Marie Bergfeldt

Södertälje 12 units

Johan Eklund

Evidence of Successful Education

Must correspond to needs of

receivers

Best conducted in small groups

with interactive methodology

Followed up using a variety of

methods


Continued Medical Education

Drug information as part of the treatment

panorama for a certain disease

Information cannot stand by itself

Knowledge about diseases is a prerequisite for

high-quality treatment

Knowledge about diseases is a prerequisite for

selecting the right drug

Continued Medical Education and Communication Between Peers

Update medicine and

drugs at

Södersjukhuset

Hospital


Kloka Listan Forum 2012

Academic detailing in a PHC

Continuing Medical Education 2012 – some examples

Implementing the Wise List – Summary

Kloka Listan Forum

Evening seminars

Update about medicines at hospitals

Academic detailing at Primary Health

Care Centres and workplaces

– Information physicians and pharmacists

– Interactive continuous medical education and follow-up of drug use

The Drug Bulletin ”Evidens”

www.janusinfo.se – independent, up-to-date guidelines, drug news and more

New drugs – flow chart within the County Council through February 2013

Horizon scanning – unbiased, expert evaluation – supported by groups of experts and passed in DTC (a recurrent item at DTC meetings)

Communication plan

Continuing Medical Education according to scientific, well-tried methods

Target group-approproate communication (e.g. cardiologists, pediatricians, oncologists, family doctors)

Tools, e.g. Take Care

Follow-up, evaluation

Ongoing challenges High cost of incorrect/irrational drug utilization

Regional and socio-economic differences

Changed premises for selling drugs

Lack of knowledge regarding environmental impact of drugs

Drugs poorly integrated with/evaluated against other forms

of therapy

Increasing number of drugs approved for sale are biological

drugs – effects of generic reform will decrease

There is a potential to develop the price-setting model

further

Too-slow uptake of new drugs?

Success Factors Drug Therapeutic Committee, DTC Expert advisory groups Wise List Knowledge-based support enabling wise,

evidence-based presribing Drug statistics stimulating physicians to

follow-up their own prescribing Credible, independent continuing medical

education, CME Operative support via Division Support for

Evidence-Based Medicine

Stockholm Drug Therapeutics Committee

The way in which the DTC by way of

expert-driven, efficient tendering and

attractive knowledge-based management

enables evidence-based and cost-

effective drug utilization in Stockholm

County Council


2007-12-17

Läkemedelscentrum

24

Thank You!

New Instruction for DTC in Stockholm County Council – HSN decision 20.12.2011


Kloka Listan - the Wise Drug list

Issued by the regional


Focus on the rational choice of drugs

for common diseases in outpatient care

Drugs selected by 21 expert panels

with GPs, specialists, pharmacists

& clinical pharmacologists

Information campaigns towards

prescribers (and patients/the public)

Website www.janusinfo.se

Wise Drug Use and Prescribing

Pedagogical recommendations – Wise List/Wise Advice/Wise guidelines

Communication strategy – well-considered – adapted to target groups

Computerised decision support –Take care…

Networking – the whole of Stockholm Interactive pedagocial model Follow-up


Wise Drug Utilization

Requires long-term strategies with a patient focus, committed collaborators, experts and management in every county council/region and national concordance

Requires evidence-based recommendations for old and new drugs valid regardless of type of management according to national/international recommendations from independent DTCs with a central, independent role in knowledge-based management in every region/county council

Wise Drug Utilization

Becomes problematic without national and successively international collaboration and standardization between health care regions, particularly expert evaluations, management of e-health services, introduction of new, expensive drugs and financing

Requires systematic introduction and follow-up of new drugs and consistency/integrity in contacts with pharma industry and other stakeholders

Requires economic management and incentives based on medical usefulness/safety, professional involvement and responsibilty, expert recommendations and follow-up

Introduction of new drugs

Discussion: Need of horizontal prioritization A holistic apprach

DTC is planning a seminar on drugs and priorities with some concrete examples September 2012 Target groups: politicians, civil servations,

experts, DTC reference group, physicians with interest in pharmaceuticals


Introduction of new expensive therapies! Strict guidelines and follow-up protocols for

expensive drugs (per patient) or in total – new principles and biological drugs

For patient groups that have been studied Need for CME and quality follow-up Need for complementary natural studies

including randomized dito Health economic evaluations



Independent drug expert organization with network • Regional DTC with expert panels with shared values and policy for declaring and managing potential conflicts of interest – in particular with the pharmaceutical industry. The policy is known, communicated and followed. This policy is fundamental for the DTC system and for trust in its experts [28]. • General practitioners, hospital-based specialists, clinical pharmacologists and pharmacists from major health care providers in the region are members of the regional DTC. They participate in selection of drugs in the ‘Wise List’. • Training of members of the DTC in the principles of critical drug evaluation by clinical pharmacologists. This helps to maintain high quality of drug selection principles across expert groups.

Law Governing DTCs

33


The Wise Drug List

KLOKA LISTAN

LÄKSAKStockholmsläns landsting

2010

KLOKA LISTAN

Stockholms läns läkemedelskommittéStockholms läns landsting

2012

Rational use of medicines: The challenge of interface collaboration between ambulatory and hospital

care an International perspective

Richard Laing, WHO Geneva

Stockholm Interface Course 2012 1

Where in the world is the interface between hospitals and primary care good?

• Not many places! Often in some areas in a country but often not systematic and often dependent on committed leaders

• Some country examples – Zimbabwe – Scotland – Netherlands – Stockholm


Country Examples Zimbabwe

• Since 1986 Zimbabwe has had an integrated Essential Drug List (EDLIZ) and Treatment Guidelines for hospitals and primary care with tiered levels of medicines.

LEVEL OF AVAILABILITY C drugs are those required at primary health care level and should be available at all levels of care. B drugs are found at district hospital level or secondary and higher levels of care. Some B drugs may be held at primary health care facilities on a named patient basis – for example in the management and follow up of chronic illnesses. A drugs are prescribed at provincial or central hospital levels. S drugs (specialist only) have been brought back into this edition. These are drugs that require special expertise and /or diagnostic tests before being prescribed.


MAJOR HIGHLIGHTS IN THE LATEST EDLIZ

Need for Hospital formularies and Hospital Therapeutics Ideally each hospital should create its own local drug formulary which shows which drugs are considered very useful in that setting so that you do not have to order drugs that your nurse or doctors will not prescribe or use. For instance you should not keep specialist drugs if there is no specialist to prescribe them. Hospital Drug and Therapeutics Committees should select drugs for use in their hospital using the EDLIZ.


Country Examples Scotland

Next presentation by Prof K Paterson Key elements • Formularies which apply equally in primary and

secondary care • Guidelines jointly written • Managed Clinical Networks which are cross-

specialty (physicians, surgeons, pharmacists …) • Health Technology Assessment through SMC with

primary & secondary care at the table


From http://whocc.goeg.at/Downloads/Conference2011/PraesentationenPPRIKonferenz/Day1_afternoon_Sitzungssaal_1300_Paterson.pdf

Country Examples Scotland Key elements

• 20 years working together • Clinical benefits first then financial • Culture of openness and transparency • Primary and Secondary NOT Primary vs secondary • Joined up thinking • Accepted part of medicine use by clinicians,

patients and pharma


From http://whocc.goeg.at/Downloads/Conference2011/PraesentationenPPRIKonferenz/Day1_afternoon_Sitzungssaal_1300_Paterson.pdf

Country Examples Netherlands

• Two recent PhD Theses – Ruther Stuffken Medication

changes in patients transitioning between health care settings (http://igitur- archive.library.uu.nl/dissertations/2011-1027-200508/UUindex.html

– Fatma Karapinar Transitional Pharmaceutical Care for Patients Discharged from the Hospital (http://igitur-archive.library.uu.nl/dissertations/2012-0412-200334/UUindex.html


Country Examples Stockholm

Wise List Approach

• Annual Issue of List • Focus on primary care with recent addition of

hospital wise list • 20 Expert groups involving specialists, clinical

pharmacologists, GPs and pharmacists • Information Campaigns • Monitoring using DU 90%

Stockholm Interface Course 2012 8 http://whocc.goeg.at/Downloads/Conference2011/PraesentationenPPRIKonferenz/Day1_afternoon_Sitzungssaal_1300_Malmström.pdf

Monitoring a key element of the Stockholm System

Adherence to the Wise List between different PHCs in Stockholm 2003 & 2009

PHCs: n ~160

Database on medicines use

• Database of all medicines use surveys using standard indicators in primary care in developing and transitional countries

• Studies identified from INRUD bibliography, PUBMED, WHO archives

• Data on study setting, interventions, methods and drug use extracted & entered

• All data extraction and entry checked by 2 persons

• Now > 900 studies entered • Systematic quantitative review • Evidence from analysis used for

WHA60.16 in 2007

% compliance with guidelines by WB region

0102030405060

1982-1994 1995-2000 2001-2006

Sub-Saharan Africa (n=29-48) Lat. America & Carrib (n=5-13)Middle East & C. Asia (n=4-8) East Asia & Pacific (n=7-11)South Asia (n=6-12)

12

What are countries doing to promote rational use of medicines ?

0 20 40 60 80 100

EML updated in last 5 years

STGs updated in last 5 years

EML for insurance reimbursement

Information centre for prescribers

DTCs in most referral hospitals

Independent CME for prescribers

Public education in last 2 years

National strategy to contain AMR

Drug use audit in last 2 years

% countries implementing policies to promote rational use

Source: TCM pharmaceutical database 2003

Conclusion

• Much more to be done • Much to learn • Will need research • Can learn from others' experiences both

positive and negative


Scottish Countrywide Collaboration to Integrate

Medicine Therapy between Primary and Hospital Care

Ken Paterson Stockholm

11 September 2012

NHS Scotland Virtually monopoly payer and provider Universal coverage from general taxation Free at point of care No co-payment - all medicines provided free Secondary care provided by state-run hospitals Primary care provided by independent doctors

…but contracted to work within system ‘rules’ Long history of ‘controlled prescribing’

Initially on good clinical grounds Now also includes cost considerations

Managing the Interface - 1

Early (1990) recognition of the problems Primary care prescribing influenced by

secondary care recommendation Differential pricing of medicines in primary

and secondary care (‘loss leaders’ in hospitals)

Clinical risks in use of too many medicines …and in switching between medicines

Huge range of medicines stocked by pharmacies in community and hospitals


Early introduction of joint working Drug & Therapeutics (D & T) Committees

involving primary and secondary care Safe, quality prescribing the initial driver Cost containment soon also a factor

…equally in primary and secondary care! Single budget for healthcare (1ary and 2ary)

Joint working then established as the norm …and transferred to other areas of activity


Formularies Communications Guidelines Managed clinical networks Horizon Scanning Health technology assessment

Impact on pricing/reimbursement

Drug & Therapeutics Committees

Multidisciplinary Joint primary and secondary care May include patient/public input Evidence-based approach

Full declarations of interest Limited role for ‘key opinion leaders’ Part of the clinical community

Formularies

All 14 Health Boards have a Formulary Some individual, others shared

All are developed jointly between primary and secondary care

All apply equally in primary and secondary care …no ‘carte blanche’ for specialists

All prescribing is monitored and Formulary adherence assessed

Some medicines limited to use on specialist advice (or even specialist prescription)

Non-Formulary Prescribing

Obviously permitted if it can be justified Individual patient treatment request possible

Would be questioned if high in primary care Prescriber would be individually targetted

Might be questioned in ‘real time’ in hospital Therapeutic substitution in some settings Case-by-case justification before medicine used Routine pharmacist monitoring of non-Formulary

medicines, especially high-cost

Communication

Formulary in paper/electronic version DTC minutes on website Regular Formulary updates

Good prescribing advice ‘Drug of choice’ initiatives

Communications are local Maintain involvement and ownership Content must follow national policy

Guidelines

Almost all guidelines are jointly written Full declarations of interest Evidence-based rather than opinion-based Interface issues usually specifically addressed

eg guidance on referral to secondary care

Guideline advice informs Formulary content …and vice versa - if the guideline

recommends a class of medicine, the Formulary will name an individual medicine

Managed Clinical Networks

Disease-specific networks Cross-specialty (physician/surgeon/pharmacist..) Across the interface - primary + secondary care

Aim to cover all aspects of management Diagnosis, investigation, monitoring …also medicines use Facilitates managed introduction of new drugs

Adherence to all aspects of MCN monitored

Horizon Scanning

Identify pipeline medicines 12-24 months before launch

Focus on key medicines High cost (to allow financial planning) Service implications (to allow redesign) Interface issues (to allow guidance/protocols)

“no surprises” the aim!

Health Technology Assessment

New medicines assessment a challenge Vital to keep Formulary up-to-date Often significant cost implications

New medicines a cost pressure in all systems

Pre-2001 - local assessments 15 assessments in Scotland - wasteful Sometimes different decisions - divisive Variable quality of decisions - open to challenge

Since 2001 - Scottish Medicines Consortium

Scottish Medicines Consortium

Consortium of existing (joint) DTCs 30-member committee

Doctors, pharmacists, patients, industry Primary and secondary care at the table

Advises on ALL new medicines Primary, secondary and tertiary care

Rapid process - 18 weeks “shape practice, not change practice”

Assesses value - not reference pricing!

SMC - 2002-2011

729 submissions considered 2002 – 29 2003 – 62 2004 – 74 2005 – 87 2006 – 130 (111) 2007 – 110 (95) 2008 – 105 (87) 2009 – 81 (73) 2010 – 102 2011 – 91

Outcome of Assessments

Accepted for Use – 35% Accepted for Restricted Use – 36% Not Recommended – 29% Perhaps more ‘No’ in recent years

0

10

20

30

40

50

60

2002 2004 2006 2008 2010

AcceptRestrictNo

%

SMC Influences

Advice informs local Formulary decisions SMC says ‘no’, cannot be in local Formulary SMC says ‘yes’, can be in local Formulary

Advice informs Guideline content Guideline cannot recommend non-approved

medicine Advice informs MCN protocols

Protocol cannot recommend non-approved medicine

Case Study - Clopidogrel

Expensive compared to aspirin Time-limited therapy appropriate 3/6 month course provided by secondary care Medicine never on primary care prescription

Savings re-invested in implantable defibs Generic clopidogrel launched - different salt

SMC facilitated pan-Scotland decision Generic clopidogrel the formulation of choice

Locus of Control/Action

Define where control/action best sited National

Horizon scanning Health technology assessment Guidelines

Local Formularies/protocols Communications Prescribing monitoring

Impact on Pricing/Reimbursement

Medicines pricing reserved to UK Local policies affect local pricing/expenditure

85% of prescribing is ‘generic’ (by rINN) 70% of dispensed medicines are generics

No ‘loss leaders’ in secondary care No point in ‘influencing’ KOLs in secondary care Value assessment promotes ‘patient access schemes’

Often simple discounts (exact amount may be secret!)

Even a small (non-)country can negotiate better value-for-money

The Scottish Experience

Built over 20 years of joint working Clinical benefits prime, then financial Needs culture of openness and transparency

…no conflicts of interest - see the big picture! 1ary + 2ary, not 1ary v 2ary!

Needs careful ‘joined-up’ thinking Mixed messages unhelpful to everyone

Now an accepted part of medicines use …by clinicians and patients (and pharma!)

Scottish Medicines Consortium

www.scottishmedicines.org.uk

Catalonian country-wide collaboration to integrate

medicine therapy between primary and hospital care

Interface Management of Pharmacotherapy Promoting Hospital-Primary Care Collaboration for

Rational Use of Medicines

Eduard Diogène

Stockholm, September 11th, 2012

Anterior Següent Institut Català de la Salut • Comissió Farmacoterapèutica www.gencat.cat/ics

Overview Financial incentives and indicators @prescribing Drug and Therapeutics Committees

2


Catalonia: 7.500.000 inhabitants

Catalan Institute of Health ● 8 hospitals

• 3.247 physicians • DTC

● 288 Primary Health Care Centres • 6.399 physicians

3


Drug Policies

PHC and hospitals

Efficiency Clnical management of new drugs Conservative prescribing: safety and quality Participation and responsibility of physicians

4



35 members: ● Physicians (PHC and H) ● Pharmacists (PHC and H) ● Clinical Pharmacologists (PHC and H)

3 Stable Working Groups

● Formulary ● Information and communication ● Pharmacovigilance

5



Formulary New drugs evaluation Information Continuous medical education Pharmacovigilance Drug and Quality Prescription Indicators monitoring

6


Drug expenditure 2011

Primary Health Care: ● 1.211,78 M € (-7,6%)

Hospitals:

● 218,46 M € (-6,9%)

7


PHC drug expenditure 2011

8

ATC 2010 (M €)

2011 (M€)

Difference (M €)(%)

N06. PSYCHOANALEPTICS 124,2 116,1

-8,1 (-6,54 %)

R03 . DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES 105,5 108,6

3,1 (3,01%)

C09. AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM 108,1 95,9

-12,1 (-11,22%)

A10. DRUGS USED IN DIABETES 79,9 87.7

7,6 (9,54%)

N05. PSYCHOLEPTICS 69,3 65,7

-3,7 (-5,29%)

C10. LIPID MODIFYING AGENTS 87,6 63,6

-23,9 (-27,38%)

N03 ANTIEPILEPTICS 51,8 53,9

2,1 (4,10%)

A02. DRUGS FOR ACID RELATED DISORDERS 52,8 46,0

-6,8 (-12,94%)

N02. ANALGESICS 44,3 43,6

-0,7 (-1,62%)

G04. UROLOGICALS 42,3 41,8

-0,5 (-1,27%)


PHC drug expenditure: january-june 2012

9


Indicator Score Indicator Score

1. Non recommended new drugs / total 15 7. Asthma drugs 8

2. Generics / Total 5 % BETA 2+ CORTICOIDS/ TOTAL

%RECOMMENDED/TOTAL ANTIASMÀTICS 3 - 1 5 3

3. Antihipertensive drugs (AHT) 10 8. Antidepressants 8

%DIURETICS/ TOTAL AHT %ARB/ (ACE + ARB)

%RECOMMENDED / TOTAL AHT

2 - 1 4 ´ 3 - 2

4 - 3

%RECOMMENDED/ TOTAL

ANTIDEPRESSANTS 8 - 4

4. Antiulcer drugs (AU) 8 9. Anxiolytics and hypnotics (ANX) 8

%RECOMMENDED/ TOTAL AU

8 - 4

%RECOMMENDED/TOTAL ANX

8 - 4

5. NSAID 8 10. Non insulin antidiabetic drugs (NIAD) 8

%RECOMMENDED/TOTAL NSAID

8 - 4

% RECOMMENDED/TOTAL NIAD 8 - 5 - 3

6. Antibiotics 8 11. Lipid lowering drugs (LL) 12

DDD ANTIBIOTICS* %PENICILINS/ANTIBIOTICS

%AMOXI/ AMOXI+AMOXI-CLAVULANATE %RECOMMENDED/ANTIBIOTICS

4 - 2 1 1

2 - 1

% RECOMMENDED/TOTAL LL 12 - 8 - 4

PHC: Incentives and prescribing indicators


Hospitals: incentives and prescribing indicators

11

Indicators (DTC) Score

Outpatient/discharged/emergency adherence to CIH Formulary: Non-recommended new medicines ARB / (ARB + ACEI) Recommended Antiulcer drugs Recommended NSAID Recommended Lipid Lowering drugs Recommended Non- insulin Antidiabetic drugs

2 -1 1 - 0,5

0,5 0,5

1 - 0,5 1 - 0,5

Safe use of drugs 1,5

@prescribing for outpatient/discharged/emergency 1,5

TOTAL 9

Anterior Següent Institut Català de la Salut • Comissió Farmacoterapèutica www.gencat.cat/ics 12


DTC recommendation

19

Unadequate INR control: 60%

Alergy or intollerance


Atrial fibrillation patients and dabigatran follow-up

May 2012 70.135 patients on acenocumarol

1.066 patients on dabigatran Sex: 525 women (49,25%) + 546 men (51,22%) Age: 75 ± 9,9 (range: 25-100). 628 patients (58,91%) ≥ 75

20

Dabigatran (Catalonia)

Dabigatran 110mg (RE-LY)

Dabigatran 150mg (RE-LY)

Age (years)

75 ± 9,9 71,4 ± 8,6 71,5 ± 8,8

Men 546 (51,22%) 3865/6015 (64,3%) 3840/6076 (63,2%)


Atrial fibrillation patients and dabigatran follow-up

Renal function: MDRD ≤ 30 ml/min/1,73 m2: 14 patients (1,3%)

• 30 <MDRD <60 ml/min/1,73 m2: 256 patients (24,0%) • MDRD ≥ 60 ml/min/1,73 m2: 660 patients (61,9%) • No screening of renal function during last year: 136 patients (12,8%)

Dosage:

• 150 mg/12h: 272 patients (25,5%) • 150 mg/24h: 28 patients (2,6%) • 110 mg/12h: 685 patients (64,3%) • 110 mg/24h: 45 patients (4,2%) • 110 mg/48h: 1 patient. (88 years old male, MDRD-4 > 60 ml/min/m2.

Previously on aspirin. No previous IHD • 75 mg/12h: 30 patients (2,8%) • 75 mg/24h: 5 patients

170 patients (15,9%) with ischaemic heart disease

21


Previous Treatment

OAC: 380 patients (35,6%) OAC + aspirin: 54 patients (5,1%)

Clopidogrel: 54 patients (5,1%) Clopidogrel + aspirin: 18 patients (1,7%) Aspirin: 235 patients (22,0%)

Naïve: 325 pacients (30,5%)

22


Dabigatran prescriptions

0 20 40 60 80

100 120 140 160 180 200

0

200

400

600

800

1000

1200

Nº p

atie

nts

Nº p

atie

nts

2011 2011 2012 2012

New dabigatran prescriptions Acumulated dabigatran prescriptions


Participation and responsibility of physicians

Drug and Therapeutics Committees H ● Follow-up of patients and recommendations ● Analysis of drug expenditure ● Outpatients, discharged patients and emergency ward ● Safe use of drugs ● @prescribing ● Ad-hoc small groups

● Debate

● At least 1 PHC professional (Pharmacist, clinical

pharmacologist or family doctor) 26


Population 189.091

PHC physicians 151

PHC centres 22

Hospital 1

PHC Drug and Therapeutics Committee

Terres de l’Ebre


PHC DTC Terres de l’Ebre

Coordinator: PHC physician

11 PHC physicians 1 clinical pharmacologist 1 pharmacist General manager


Education ● Electronic Drug Bulletins ● Clinical Guidelines ● Follow-up feed-back

Engineering ● Indicators of adherence to formulary

Economics ● Financial incentives

Enforcement ● DTC recommendations

29


Thank you for your attention

[email protected]


PHC drug expenditure 2011

31

Drug 2010 (M €)

2011 (M €)

Difference (%)

Salmeterol 37,7 37,1 -1,5%

Atorvastatin 45,9 24,2 -47,2%

Pregabalin 19,4 22,6 14,4%

Formoterol 19,9 21,3 6,7%

Tiotropium 17,8 19,4 8,9%

Glargine Insulin 15,3 17,7 15,8%

Omeprazol 18,6 16,7 -9,7%

Clopidogrel 27,6 14,2 -48,5%

Olanzapine 17,5 14,1 -19,1%

Risperidone 13,7 12,7 -6,8%


Results UH Germans Trias i Pujol (January - April 2012)

Indicator Result Goal Score

Non-recommended new medicines

2,73% ≤2,08% (2) ≤2,14% (1)

0

ARB / (ARB + ACEI) 52% ≤48% (1) ≤49% (0,5)

0

Recommended Antiulcer drugs 80% ≥80% (0,5) 0,5

Recommended NSAID 60% ≥56% (0,5) 0,5

Recommended Non- insulin Antidiabetic drugs 41% ≥44% (1) ≥43% (0,5)

0

Recommended Lipid Lowering drugs 34% ≥40% (1) ≥39% (0,5)

0

Safe use of drugs

3,01 / 1.000 > 2,55 ADR /1.000 inpatients (1,5)

1,5

@prescribing for outpatient/discharged/emergency*

No data ≥30% (1,5) ----

* 4th trimestre 2012


Eficiència i sostenibilitat Gestió clínica de la introducció dels nous

medicaments Prescripció prudent: segura i de qualitat Participació i corresponsabilització dels clínics


Dades de la fitxa tècnica

34

Posologia recomanada: 150 mg/12h

Ajust de dosi en situacions especials:

· Pacients entre 75-80 anys: A criteri del metge, es pot considerar una dosi de 110 mg/12h quan el risc

tromboembòlic és baix i el risc d'hemorràgia és alt.

· Pacients ≥ 80 anys: 110 mg/12h

· Pacients amb un major risc d'hemorràgia: 110 mg/12h

· Insuficiència renal greu: contraindicat

· Insuficiència renal moderada i alt risc de sagnat: 110 mg/12h

· Administració concomitant amb verapamil: 110 mg/12h

· Pacients amb elevació enzims hepàtics> 2 vegades el límit superior de la normalitat: no es recomana

Pacients amb ≥ 80 anys: 406 pacients (38,2%)

Dosi de dabigatran en pacients ≥

80 anys en l’ICS:

• 110 mg/12h: 335 pacients (82,5%) • 150 mg/12h: 25 pacients (6,2%) • 75 mg/12h: 20 pacients (4,9%) • 110 mg/24h: 20 pacients (4,9%) • 150 mg/24h: 3 pacients (0,7%) • 75 mg/24h: 3 pacients (0,7%)


Seguiment prescripció dabigatran

Gràfica 1. Distribució per àmbits dels pacients a tractament amb dabigatran

0

50

100

150

200

250

300

350

Nº p

atie

nts


PHC prescriptions 2011

36

Drug 2010 2011 Difference %

Omeprazol 6.206.997 6.617.140 6,61%

Paracetamol 4.836.063 4.992.692 3,24%

Simvastatin 3.463.507 3.867.251 11,66%

Aspirin 3.175.744 3.273.449 3,08%

Ibuprofen 2.594.099 2.501.511 -3,57%

Enalapril 2.316.665 2.399.388 3,57%

Metformin 2.215.633,00 2.388.180 7,79%

Artificial tears 1.752.236,00 1.950.287 11,30%

Hidrochlorotiazide 1.804.717,00 1.812.740 0,44%

Lorazepam 1.643.617,00 1.710.475 4,07%


Participació i corresponsabilització dels clínics

Comissions Farmacoterapèutiques H ● Seguiment d’acords i pacients: adeqüació, pacients ● MHDA ● Consultes externes, altes i urgències ● Seguretat en l’ús dels medicaments ● Prescripció electrònica ● Debat

37


Acord de Gestió EAP

38

Sostenibilitat Tancament pressupostari 15%

Compliment DMA 10%

Activitat i qualitat assistencial

Estàndard Qualitat Assistencial de l’EAP (EQA) 25%

Estàndard Qualitat Prescripció Farmacèutica de l’EAP (EQPF) 15%

Seguretat ús del medicament 10%

Gestió IT 5%

Millora organitzativa

Gestió compartida demanda

Implementació e-consentiment 5%

demanda aguda lleu 5%

Pla Qualitat i Seguretat del pacient 10%


Acord Gestió Hospitals

39

Sostenibilitat

Tancament pressupostari

40%

Compliment de la DMA de MHDA 10%

Activitat i qualitat assistencial

Activitat hospitalària segons contracte programa 30%

Qualitat prescripció (Guia Farmacoterapèutica. EQPF) 10%

Millora organitzativa Autoavaluació prevista per a la re-acreditació 10%


PHC DTC Terres de l’Ebre

May 2007 Monthly meetings Analysis and debate Information Continuous education CIH Drug Policy


2010 2011 Var 2011/2010

Pacients (N) 39.294 38.805 - 0,6 %

Facturació (Milions d’€) 234,6 218,5 - 6,9 %

Facturació / pacient (€/ pacient) 6.007 5.630 - 6,3 %


Agrupació Import 2011 % Import % Import Acumulat

Antiretrovirals actius contra VIH 54,1 Milions d’€ 24,8% 24,8%

Resta de medicaments d’ús hospitalari

34,1 Milions d’€ 15,6% 40,4%

Immunosupressors selectius 27,9 Milions d’€ 12,8% 53,2%

Citostàtics 25,3 Milions d’€ 11,6% 64,8%

Esclerosi múltiple 22,6 Milions d’€ 10,3% 75,1%

Total MHDA 218,5 Milions d’€ 100% 100%

| Interface Management of Pharmacotherapy Stockholm September 11 2012

Interface management in Norway - status and initiatives at national and regional levels

Øyvind Melien MD PhD Norwegian Directorate of Health Dept. of Medical Devices and Medicinal Products


Interface management in Norway

Issues • The present situation • Improvement of interface management • Implementation of new initiatives


The present situation

Health care organization and responsibilities Status at the interface

• The Patients • The Health Care System • Funding of medicines use


The present situation

Responsibility levels in Health Care

• National level - Health Ministry with agencies

• Regional level - Regional Health Enterprises – Specialist Health

Care

• Local level - Primary Health Care


National level

Ministry of Health with agencies Norwegian Directorate of Health National therapeutic guidelines

Norwegian Knowledge Centre for Health Services Evaluations, knowledge reports and HTA body

The Norwegian Medicines Agency Regulatory authority, drug information etc.


Regional level

Specialist Health Service System • Organized in four Health Regions as Public Health

Enterprises • Formularies for medicines use

Within each hospital, not at regional level


Local level

Primary Health Care • National guidelines, ex. use of Antibiotics in Primary

Health Care • National recommendations for preferred prescription • Drug and Therapeutic Committees not organized

• Local formularies within certain institutions


Status at the interface

The Patients - gaps in medicines treatment National Working Group established by Health Ministry

indicated a risk for gaps in patient treatment, in particular related to transfer of patients between levels in the health care system

Reference: Report from National Working Group on Rational Medicines Use, May 2009



The Health Care System National guidelines in certain fields covering all levels Implementation and follow-up systems – a major

challenge No common Common Drug and Therapeutic

Committees or common formularies developed, covering both Specialist and Primary Health Care



Different funding systems for medicines use - Specialist health care covers medicines expenses in

the hospital sector based on funding from the government

- Local governments are responsible for medicines

expenses in local institutions

- National insurance is responsible for reimbursement of medicines expenses outside institutions


Improvement of interface management

Project for ”Summary Care Records” A project under the Directorate of Health is established

to develop Summary Care Records, intended to be accessible at all levels in the health care system, containing key information concerning the individual patients, including their medicines use.

The Summary Care Records may offer a major tool for

interface management in future patient treatment


Improvement of interface management

Lists for medicines use for the patients As part of the National Patient Safety Campaign a

project has been initiated to promote the use of medicines lists for the individual patients in order to ensure correct information at any level in Specialist or Primary Health Care.


Novel initiatives in implementation

The Coordination Reform A national reform for coordination between all levels in

the Health Care System from 2012 Based on various policy instruments using

• Legislation To facilitate cooperation between levels • Professional efforts Develop patient pathways • Organisation E.g. local medical centers • Financial incentives Co-payment for hospitalization


Systematic introduction of methods in health care Implementation from 2012 In Specialist Health Care A comprehensive system For introduction of new methods in all fields of specialist

health care combining existing functions with new


The new system will include

• Horizon scanning

• Health Technology Assessment (HTA) • Single Technology Assessment (STA)

• New medicines: The Norwegian Medicines Agency • Other methods: The Norwegian Knowledge Centre

• Full HTA • All methods: The Norwegian Knowledge Centre

• Mini HTA

• Performed within the specialist health care


The new system will include

• Processes for decision making • According to regulation for prioritization based on principles

for severity of disease, benefit from treatment and cost-effectiveness

• Implementation strategies

• National guidelines: The Norwegian Directorate of Health • Implementation in specialist health care

• Coordination, monitoring and follow-up systems

South-Eastern Norway Drug Therapy Forum Working Group

Recommendations (cont.): • Well-functioning electronic

communication systems is a must for the daily use and the updating of drug lists and guidelines.

• The work should be done in close cooperation with the national initiatives in the primary health care.

Common drug and therapy guidelines

Recommendations from a

regional working group in South-Eastern Norway

Jan Henrik Lund MD South-Eastern-Norway Regional Health Authority

Responsibility levels Norwegian Health Care

• National level

–Health Ministry with agencies

• Regional level –Regional Health Enterprises – Specialist

Health Care

• Local level –Primary Health Care

Regional level

Specialist Health Care • Four regional health authorities as public health

enterprises

• South-Eastern-Norway Regional Health Authority: – 15 hospital trusts – Population: 2,7 mill

• South-Eastern Regional Drug and Therapeutic

Committee established 2008

Coverage of medicine costs on different levels

- Hospital trusts cover medicine costs in the hospitals based on funding from the government

- Local communities cover medicine costs in local

institutions

- National insurance is responsible for reimbursement of medicine expenses outside institutions

Initiatives in the hospital sector

Drug and Therapy Committees at regional level • Common drug and therapy recommendations? • Could Norway get its ”Wise List”?

• A working group in the South-Eastern Region

formed to consider common drug list and therapy recomnmendations at regional level, including interaction with primary health care


Aim: • To describe the actual situation in the region

regarding drug and therapy recommendations • To indentify obstacles hindering the forming of a

common regional drug and therapy list • To give recommendations on how to achieve a

common regional drug and therapy list • To look on how to integrate with drug lists used

in the primary health care


Recommendations: • The work for regional, or even national,

common drug and therapy guidelines should be intensified.

• Common drug and therapy guidelines must be based on national consensus and supported by the leading medical authorities.

Stockholms läns läkemedelskommitté - Janusinfo · The clinical pharmacologist provided support...

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