Medicines Transparency Alliance14/10/ Medicines promotion: innovative tools to promote rational use Carole Piriou Project officer Rational use of medicines HAI Global

Medicines Transparency Alliance14/10/20152 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 1 Lazarou JAMA Ernst & Grizzle J Am Pharm Assoc 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

Medicines Transparency Alliance14/10/20153 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 $ = 1$ Industry promotion 1 Developing countries: reliance on industry promotion 1 Health committee report House of Commons 2005 Research based industry spending, US $ billions, 2004

Medicines Transparency Alliance14/10/20154 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

Medicines Transparency Alliance14/10/20155 Curbing unethical promotion: some existing standards 1988: WHO Ethical Criteria International industry self regulatory codes (IFPMA) 2007: WHA 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

Medicines Transparency Alliance14/10/20156 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

Medicines Transparency Alliance14/10/20157 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

Orlowski et al. Chest 1992

Medicines Transparency Alliance14/10/20159 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 14/10/ 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 comparisons Best practices Areas to strengthen Evidence base upon which countries can make policy choices to improve national policies on promotion

Medicines Transparency Alliance14/10/ 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)

Medicines Transparency Alliance14/10/ 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

Medicines Transparency Alliance14/10/ Thank you Carole Piriou