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MEASURING UNETHICAL PHARMACEUTICAL PROMOTION: A study of advertisements in five African countries preliminary findings Carole Piriou Christa Cepuch Patrick.

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Presentation on theme: "MEASURING UNETHICAL PHARMACEUTICAL PROMOTION: A study of advertisements in five African countries preliminary findings Carole Piriou Christa Cepuch Patrick."— Presentation transcript:

1 MEASURING UNETHICAL PHARMACEUTICAL PROMOTION: A study of advertisements in five African countries preliminary findings Carole Piriou Christa Cepuch Patrick Mubangizi 20 May 2009, WHA

2 Resource-poor settings : rational use is crucial Few studies about promotion ( WHO and HAI, 2005) Need for unbiased information on medicines Industry: - Powerful presence - Significant source of information (WHO and HAI 2005) Poor compliance with existing regulation (Chirac and al., 1993, Sibanda et al, 2004) Background: Promotion in Africa

3 Study objectives In five African countries Kenya, Madagascar, Malawi, Uganda, Zambia. 1.To assess the compliance of promotional materials with the WHO Ethical Criteria on Medicinal Drug Promotion 2. To establish the status of national policies and regulations on medicines promotion

4 Sampling Journals79 Kenya313 Madagascar73 Malawi21 Uganda57 Zambia79 Number of advertisements collected Journals : Advertisement in 2008 issues of the 3 leading regional medical journals were compiled ( Pharmaceutical Journal of Kenya, East African Medical Journal, East and Central African Journal of Pharmaceutical Sciences) Brochures : Data collectors from the 5 countries trained to collect advertisements in health facilities from public, private and mission sectors from different regions within each country

5 Promotional material analysis WHO Ethical Criteria compliance: Promotion to health professionals Name of active ingredient Brand name Content of active ingredient Name of other ingredients known to cause problems Approved indications Dosage form or regimen Side effects, adverse drug reactions Precautions, contraindications, warnings Interactions Name and address of manufacturer Reference to literature as appropriate Promotion to the general public Name of active ingredient Brand name Major approved indications Major precautions, contraindications, warnings Name and address of manufacturer + No use of the word safe without qualifications British National Formulary 56th edition (September 2008) used as a reference to determine adherence to the technically- based criteria

6 None of the advertisements studied meet all the criteria assessed < 70% generic name < 60% approved indication < 33% safety related information Advertisement in medical journals: Results Compliance with WHO Ethical Criteria

7 V Advertisement to the public: Results Promotion of approved therapeutic uses Less than half of the materials promote only approved indications Extension of the indications Promotion of unlicensed indications Advertisement for an antibiotic, Kenya, 2008

8 V Major precautions, contra indications, warnings Advertisement to the public: Results In all countries studied except Madagascar, less than 40% of the materials mention the safety claims In most of the cases: complete absence Advertisement for an antispasmodic, Zambia, 2008

9 V 16% of the promotional material meet all the criteria Name of active ingredient Brand name Major approved indications Major precautions, contraindications, warnings Name and address of manufacturer Use of the word safe only if qualified Advertisement for an antibiotic, 2008 Advertisement to the public: Results

10 Promotion in national regulations Regulations on promotion Regulation on print advertisement KenyaYES MadagascarNO MalawiYESNO UgandaYES ZambiaNO

11 Conclusions and recommendations Low compliance with WHO Ethical Criteria for print advertisement WHO Criteria insufficient to tackle certain aspects of unethical pharmaceutical promotion e.g. generic substitution Some regulation exist, but poor enforcement Regulation on promotion should be strengthened (WHA 60.16 on RUM) Need to educate consumers and health professionals about pharmaceutical promotion

12 Our next steps Publish a report / do advocacy to raise awareness among consumers, regulators and health professionals about unethical medicines promotion Publish the methodology to extend the study to other countries Contribute to the drafting of model regulations for national medicines regulatory agencies and work with government and consumers to monitor their implementation

13 References (1) Drug promotion what we know, what we have yet to learn. WHO and HAI, 2005 (3) Drug marketing in French-speaking African countries. Chirac and al. Social Science and Medicine 1993 (4) Pharmaceutical manufacturers compliance with drug advertisement regulations in Zimbabwe. Sibanda et al. Am J Health-Syst Pharm 2004

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