Transcript Overview - HAI - Medicines Transparency Alliance

Medicines
promotion:
innovative tools to
promote rational use
Carole Piriou
Project officer
Rational use of medicines
HAI Global
01/04/2016
Medicines Transparency Alliance
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Irrational use: a global concern
Rational use of medicines requires that "patients receive
medications appropriate to their clinical needs, in doses that
meet their own individual requirements, for an adequate
period of time, and at the lowest cost to them and their
community”
“Half of medicines are prescribed, dispensed or sold
inappropriately… Half are not taken correctly by patients”
WHO
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Resistance to antibiotics, antimalarials
Waste of resources
ADRs 4-6th leading cause of death and hospitalisation (US)1
> $ 170 billion in 2002 (US)2
1Lazarou
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JAMA 1998 2Ernst & Grizzle J Am Pharm Assoc. 2001
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Promotion and irrational use
 appropriate information about medicines!
UK: independent information 0.0003 $ = 1$ Industry
promotion1
Developing countries: reliance on industry promotion
There is “an inherent conflict of interest
between the legitimate business goals of
manufacturers and the social, medical and
economic needs of providers and the public
to select and use drugs in the most rational
way” WHO
Marketing
57.7
R&D
31.5
Research based industry spending, US $ billions, 2004
1Health
committee report House of Commons 2005
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adapted from Lexchin Gagnon, Plos 2008
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The multiple aspects of
promotion
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Sales representatives, gifts and free samples
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Journal advertising
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Direct-to-consumer advertising (DTCA)
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Funding of physician ‘opinion leaders’
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Sponsored continuing medical education, symposia
and conferences
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Sponsorship of patient groups, professional
societies, guidelines development
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Publication bias
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GP in Malaysia: interactions with sales
representatives during one month
Consumers International 2007
Prescribers who rely on promotion as their main source of information
tend to prescribe less appropriately, prescribe more often and adopt
new medicines faster WHO/HAI 2005 , Wazana JAMA 2000
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Curbing unethical promotion:
some existing standards
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1988: WHO Ethical Criteria
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International industry self regulatory codes
(IFPMA)
2007: WHA 60.16 urging Member States
“to enact new, or enforce existing, legislation to
ban inaccurate, misleading or unethical promotion
of medicines, to monitor drug promotion, and to
develop and implement programmes that will
provide independent, non-promotional information
on medicines.”
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National level: less than half of the world’s countries regulate
promotion World Medicines Situation WHO 2004
No clear patterns emerge in regulatory practices Effective drug regulation, a
multicountry study. WHO 2002
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Experience from MeTA
countries
Key Informants interviewed
Uganda
Kyrgyzstan
Peru
Common challenges:
•
Lack of transparency, political will and expertise
• Lack of monitoring and enforcement
• Many forms of promotion not covered by regulation
• Influence of WHO Ethical Criteria minimal
Public health needs and the concept of the rational use of medicines are often not
considered in medicines promotion regulation
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Print advertisement
HAI Africa survey of brochures in
pharmacies
<20% of advertisements comply with
• WHO Ethical criteria
• National legislation or guidelines
• IFPMA code
• Direct to consumer advertising
of prescription drugs
• Promotion of unapproved
indications
• Absence of safety information
Little on medicines promotion
in regulation
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EFFECTS OF “CME” ON VOLUME OF
PRESCRIBING
Prescribing at
major medical
institutions
Orlowski et al. Chest 1992
Towards sustainable change
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Education
HAI/WHO manual for medicine and
pharmacy students (poster)
English – Spanish – Russian
Copies available
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Independent information
Free unbiased information on medicines
to health care professionals and
patients
BNF EMA/ US FDA ISDB
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Regulation
Policy changes to control promotion
based on evidence: HAI/MeTA
methodology
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HAI/MeTA methodology: Assessing
the impact of promotion control
Literature review
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Key informants interviews
Scope of regulation on promotion
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Guidelines/laws/codes
Is monitoring effective? Are sanctions
applied?
Monitoring and enforcement
mechanisms
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Evaluate how well regulation
functions:
Accountability and transparency
Drug regulatory authorities’
responsibilities, structure and powers
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Political and societal context
Commitment of the government,
stakeholders positions
Outcome: country profiles and cross country comparisons
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Best practices
Areas to strengthen
Evidence base upon which countries can make policy choices to
improve national policies on promotion
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Challenges
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Other factors e.g. generic substitution and dispensing fees
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Private sector
IFPMA code 2007: 4 complaints, no sanctions, no disclosure
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Governements interest. Lack of human & financial resources
 find cost effective ways e.g. pre-approval of material
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Access Rational use
Shrinking health budget: doing more with
less
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Need to involve payers (e.g. insurers)
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Way forward
Rational use and promotion control is high on global agenda
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ICIUM Alexandria
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WHO EURO/ HAI regional
workshop
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HAI/ MINSA/PAHO regional
workshop in Latin america
Multi layered approach
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Publication and dissemination
of the WHO/HAI manual
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Pilot testing and release
of the methodology
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Thank you

Carole Piriou

Email: carole@haiweb
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