Transcript Drug Promotion & EDM Strategy 2004 - WHO archives

WHO Medicines Strategy
Priorities: 2004-2007
Dr Guitelle Baghdadi
Essential Drugs and Medicines Policy
World Health Organization
August 2004
WHO Medicines 2004 – 2007: 4 objectives,
7 components and 44 expected outcomes
OBJECTIVES
 Policy

Access
COMPONENTS
1. Implementation and monitoring of medicines policies
2. Traditional medicine and CAM
3.
4.
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Quality and safety
Rational use
Fair financing and affordability
Medicines supply systems
6.
Norms and standards
Regulations and QA systems
7.
RU by health professionals and consumers
5.
Medicines Strategy 2004 – 2007: development process
of 1 year with three main phases
 Phase
I: internal update with 5 working groups
 WHO
staff: HQ, Regional offices and country offices
 5 areas: policy, TRM/CAM, access, quality & safety, and RUM
 Means: telephone conferences and emails
 Phase
II: external review
 Sent
to full range of partners (259): Member States, WHO collaborating
centres, WHO expert committees, UN family, NGOs, etc.
 71replies received
 Phase
III: finalization
 Telephone
conferences with Member States
 Videoconference between WHO/HQ and Regional Offices
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WHO Medicines Strategy 2004-2007: 5 priorities
Objectives: policy, access, quality & safety, rational use
1. National medicines policies that focus on human rights, need
for innovation, health-oriented approach to trade agreements,
stronger ethical dimension
2. Access to traditional medicine by protecting knowledge and
access, expanding evidence base, ensuring safety, informing
consumers
3. Access to essential medicines, with emphasis on HIV medicines
for 3-by-5, medicines for malaria, tuberculosis, childhood illness,
reproductive health
4. Safer medicines through expanded safety monitoring and
continued strengthening of quality assurance
5. Rational use through continuing education, initiatives linked to
health insurance
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Ethical Criteria for Promotion of
Medicines
Dr Guitelle Baghdadi
Essential Drugs and Medicines Policy
World Health Organization
August 2004
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WHO definition of promotion
"all informational and persuasive
activities by manufacturers and
distributors, the effect of which is to
induce the prescription, supply,
purchase and/or use of medicinal drugs"
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Overview
1. Promotion of medicines: current challenges
2. WHO ethical criteria for drug promotion
3. Some countries practices…
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Overview
1. Promotion of medicines: current challenges
2. WHO ethical criteria for drug promotion
3. Some countries practices…
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Examples of promotional tools and target audiences
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Prescribers
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Pharmacies
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Consumers
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Sales Representatives
Education events
Journal advertisements
Gifts
Samples
Enter patients in clinical trials against payment
Physicians or opinion leaders paid as speakers
Discounts
Gifts
Educational events
Monitoring of prescriptions
Direct to consumer advertising (DTCA)
Medicalisation or "illness promotion"
Support to patient-help organizations
"Imbalance between commercially produced and
independent drug information"
(1)
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Large amount spent around the world for drug promotion:
US$ 13 – 15 billion (2000) (1)
 Australia:
US$ 1.3 – 2 billions per year (2)
 Italy:
US$ 1.1 billion (1998) (1)
 Low-income countries: 20 – 30% of sales revenue (1)
 US:
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Growth spending on DTCA for prescription drugs
 US:
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US$ 55 million (1991) to US $ 2.4 billion (2001) (3)
Others figures (US):
 currently
80,000 sales reps (1)
 314,000 physician events in 2003 (sponsored industry) (1)
 free samples: $ 11 billion (retail value) or $ 2-3 billion (prod. cost)
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Only 50% countries have drug information centres (1999) (1)
(1) WHO Medicines Strategy 2004 – 2007
(2) www.healthyskepticism.org
(3) HAI, DTCA prescription drugs, the European Commission's proposal for legislative change, December 2001
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Increasing evidence that promotion techniques
influence physicians' prescribing
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Medical journals ads: information content generally poor (1)
 Headlines
can be misleading (32%)
 Lead to improper prescribing if no additional information (44%)
 Little or no educational value (57%)
 Often minimize risks and harmful effects (50% to 60%)
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Advertisement material: only 6% material supported by scientific
evidence (2)
 15%
of brochures did not contain any citations
 22% citations listed could not be found
 63% info correctly referenced but articles did not reflect results
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Sponsored medical conferences
 Attendance
associated with increased prescribing of sponsored product (3)
(1) Wilkes M. Pharmaceutical Advertisements in Leading Medical journals: Experts' Assessment. Ann Intern Med. 1992;116:912-9
(2) Tuffs A. Only 6% of drug advertising material is supported by evidence [news]. BMJ 2004; 328: 485
(3) Wazana A. Physicians and the pharmaceutical industry. JAMA 2000; 283:373-380
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Sales representatives too often only source of
information for health professionals
 Interactions
start during medical school (2)
 80 – 95% doctors see sales reps regularly (1)
 average
4 times a month (2)
 US: 1 sales rep for 15 to 30 physicians
(3)
 Seen
as important source of info (new drugs) (3)
 10% sales reps statements are inaccurate (3)
 25% doctors recognize inaccurate statements (3)
 Impacts
 prescribing
costs
 irrational prescribing
 preference of new drugs
 decreased prescription of generics (2)
(1) Moynihan R. Who pays for the pizza? BMJ 2003; 326: 1189-1192
(2) Wazana A. Physicians and the pharmaceutical industry. JAMA 2000; 283:373-380
(3) Ziegler M. & al.. The accuracy of drug information from pharmaceutical sales representatives. JAMA 1995; 273: 1296-1298
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Gifts, trips, dinners influence prescribing habits &
power needs to be acknowledged
 Most
doctors deny gifts influence their prescribing
(1)
 Recognized
as conflict of interest and established "ceilings"
(e.g. $ 100 in US) (2)
 Small
gifts play important role (2)
 Pens,
note pads, etc. act as "reminder items" (2)
 Sole or among top reasons to see sales reps (1)
 Psychological
 Food,
aspects: indebtedness, reciprocity(2)
flattery and friendships: powerful tools of persuasion
(1) Wazana A. Physicians and the pharmaceutical industry. JAMA 2000; 283:373-380
(2) Katz D & al. All gifts large and small: toward an understanding of the ethics of pharmaceutical industry gift giving. AM J Bioethics.2003;3:39-46
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DTCA of prescription-only medicines is legal only in US
and New Zealand
DTCA
raises
concerns, despite advocacy that
 US since
1980s
it creates
better1997:
informed
patients:
 FDA decision
relax restrictions
on radio and TV
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 2003: US$ 3 billion per year
Increases
prescription costs (1)
 8.5 m. people request & receive prescription after advertisement
Misleading statements lead to irrational use and undue risks 1)
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Often
breach
regulation
(1)
 2003:
GPs launched
campaign
for ban
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 New
Zealand
 Rejected
Strains onby
physicians-patient
relation
EU health ministers
in
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parliament
2003(2)
No evidenceinofDecember
health benefits
 All
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(1)
June
2003 and EU
other countries (internet, satellite, etc.)
Promotes medicalisation of normal life (1)
(1) HAI, DTCA prescription drugs, the European Commission's proposal for legislative change, December 2001
(2) Mansfield P. & al. DTCA is more profitable if it is misleading. NZ Med J 2003; 116 (1182)
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Some DTCA examples
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Overview
1. Promotion of medicines: current challenges
2. WHO ethical criteria for drug promotion
3. Some countries practices…
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WHO ethical criteria (1988) still relevant today, more
than ever
 Objective
to promote "proper behaviour"
 Reliable,
accurate, truthful, informative, balanced,
up-to date, and in good taste
 NOT
misleading or unverifiable or omissions
 Scientific
data available in public domain
 No
financial/material benefit offered to health
professional
 Scientific
and educational activities not used for
promotional purposes
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WHO ethical criteria cover wide arrange of promotional
activities
 Advertising:
 Professionals: min. summary scientific information
 Consumers: help make rational decisions, no DTCA
 Medical
representatives
 Technical knowledge and ethical conduct
 Complete/unbiased information and no offer
of inducement
 Samples
 Modest
 Difficult
quantities for prescription drugs
to justify for non-prescription drugs
 Symposia
and scientific meetings
 Objective scientific content & independent scientists
 Sponsorship clearly stated, gifts secondary to main purpose
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Post-marketing scientific studies
 Inform health authorities and validated relevant committees
 "… not be misused as a disguised form of promotion."
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Overview
1. Promotion of medicines: current challenges
2. WHO ethical criteria for drug promotion
3. Some countries practices…
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Examples of country practices include regulation,
policy and training interventions
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Increase awareness of physicians (e.g. "no free lunch")
Independent drug information centres (professionals and
consumers)
Code of conduct (professional associations, pharmaceutical
industry)
Publicly funded continuing education of staff
Training of medical students to critically assess
pharmaceutical promotion
 successful
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experience in Indonesia with long-term impact (1)
Others…
(1) Drug advertisements: a critical lesson for Indonesian students, WHO, Essential Drugs Monitor, 1997, Issue n° 23
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Questions for discussion in your countries:
What are drug promotion data in your countries?
 Amount spent on drug promotion (vs. independent
information)?
 How many violations have been found in the last few
years? Any sanctions?
 Are students trained to analyse pharmaceutical
promotion?
 Are there codes of conduct for health professionals
and/or industry?
 Etc.
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For more information visit:
http://www.drugpromo.info/
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