1. A study of advertisements in five African countries
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. Background: Promotion in Africa
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)

3. Study objectives
In five African countries Kenya, Madagascar, Malawi, Uganda, Zambia.
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
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
Number of advertisements collected
Journals 79
Kenya
313
Madagascar 73
Malawi 21
Uganda 57
Zambia

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

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

9. Advertisement to the public: Results
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

10. Promotion in national regulations
Regulations on promotion
Regulation on print advertisement
Kenya
YES
Madagascar NO
Malawi
Uganda
Zambia

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 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