MEASURING UNETHICAL PHARMACEUTICAL PROMOTION: A study of advertisements in five African countries...
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MEASURING UNETHICAL PHARMACEUTICAL PROMOTION:
A study of advertisements in five African countries
preliminary findings
Carole PiriouChrista Cepuch
Patrick Mubangizi
20 May 2009, WHA
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
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
Sampling
Journals 79
Kenya 313
Madagascar 73
Malawi 21
Uganda 57
Zambia 79
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
Promotional material analysisWHO 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
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
brand name
generic nameapproved indication
side effects and ADRs
precautions contra indications warnings interactions
0
10
20
30
40
50
60
70
80
90
100
%
Compliance with WHO Ethical Criteria
V
0
10
20
30
40
50
60
70
80
90
100
Kenya Zambia Malawi Madagascar Uganda
%
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 indicationsAdvertisement for an antibiotic, Kenya, 2008
V
0
10
20
30
40
50
60
70
80
90
100
Kenya Zambia Malawi Madagascar Uganda
%
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
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
Promotion in national regulationsRegulations on promotion
Regulation on print advertisement
Kenya YES YES
Madagascar NO NO
Malawi YES NO
Uganda YES YES
Zambia NO NO
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
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
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