MEASURING UNETHICAL PHARMACEUTICAL PROMOTION:

A study of advertisements in five African countries

preliminary findings

Carole Piriou Christa Cepuch Patrick Mubangizi 20 May 2009, WHA

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)

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 : 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 Kenya Madagascar Malawi Uganda Zambia 79 313 73 21 57 79

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

Advertisement in medical journals: Results

100 90 80 70 60 50 40 30 20 10 0 brand name generic name Compliance with WHO Ethical Criteria approved indication side effects and ADRs precautions contra indications warnings interactions < 70% generic name < 60% approved indication < 33% safety related information None of the advertisements studied meet all the criteria assessed

V

Advertisement to the public: Results

100 90 80 Promotion of approved therapeutic uses 70 60 50 40 30 20 10 0 Kenya Zambia Malawi Madagascar Uganda Advertisement for an antibiotic, Kenya, 2008

Less than half

of the materials promote only approved indications  Extension of the indications  Promotion of unlicensed indications

V

Advertisement to the public: Results

Advertisement for an antispasmodic, Zambia, 2008 100 90 80 70 20 10 0 60 50 40 30 Major precautions, contra indications, warnings Kenya Zambia Malawi Madagascar In all countries studied except Madagascar,

less than 40%

of the materials mention the safety claims  In most of the cases: complete absence Uganda

V

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

Promotion in national regulations

Kenya Regulations on promotion YES Regulation on print advertisement YES Madagascar NO NO Malawi Uganda Zambia YES YES NO NO YES 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