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