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Medicines promotion: innovative tools to promote rational use

Carole PiriouProject officerRational use of medicinesHAI Global

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Irrational use: a global concern

• 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 JAMA 1998 2Ernst & Grizzle J Am Pharm Assoc. 2001

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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Promotion and irrational use

appropriate information about medicines!

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

adapted from Lexchin Gagnon, Plos 2008

Marketing 57.7

R&D 31.5

UK: independent information 0.0003 $ = 1$ Industry promotion1

Developing countries: reliance on industry promotion

1Health committee report House of Commons 2005

Research based industry spending, US $ billions, 2004

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The multiple aspects of promotion

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

Sales representatives, gifts and free samples Journal advertising Direct-to-consumer advertising (DTCA) Funding of physician ‘opinion leaders’ Sponsored continuing medical education, symposia

and conferences Sponsorship of patient groups, professional

societies, guidelines development Publication bias GP in Malaysia: interactions with sales

representatives during one month Consumers International 2007

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Curbing unethical promotion: some existing standards

1988: WHO Ethical Criteria

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.”

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

<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

HAI Africa survey of brochures in pharmacies

EFFECTS OF “CME” ON VOLUME OF PRESCRIBING

Prescribing at major medical institutions

Orlowski et al. Chest 1992

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Towards sustainable change

Education

HAI/WHO manual for medicine and pharmacy students (poster)

English – Spanish – Russian

Copies available

Independent information

Free unbiased information on medicines to health care professionals and patients

BNF EMA/ US FDA ISDB

Regulation

Policy changes to control promotion based on evidence: HAI/MeTA methodology

Medicines Transparency Alliance

HAI/MeTA methodology: Assessing the impact of promotion control

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Literature review

Scope of regulation on promotion

Guidelines/laws/codes

Monitoring and enforcement mechanisms

Accountability and transparency

Drug regulatory authorities’ responsibilities, structure and powers

Key informants interviews

Evaluate how well regulation functions:

Is monitoring effective? Are sanctions applied?

Political and societal context

Commitment of the government, stakeholders positions

Outcome: country profiles and cross country comparisonsBest practices

Areas to strengthen

Evidence base upon which countries can make policy choices to improve national policies on promotion

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Challenges

Other factors e.g. generic substitution and dispensing fees

Private sector

IFPMA code 2007: 4 complaints, no sanctions, no disclosure

Governements interest. Lack of human & financial resources

find cost effective ways e.g. pre-approval of material

Access Rational use

Shrinking health budget: doing more with

less

Need to involve payers (e.g. insurers)

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Way forward

Rational use and promotion control is high on global agenda ICIUM Alexandria

WHO EURO/ HAI regional

workshop

HAI/ MINSA/PAHO regional

workshop in Latin america

Multi layered approach Publication and dissemination

of the WHO/HAI manual

Pilot testing and release

of the methodology

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Thank you

Carole Piriou Email: carole@haiweb