Transcript Carole Piriou

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
79
Kenya
313
Madagascar
73
Malawi
21
Uganda
57
Zambia
79
Promotional material analysis
WHO Ethical Criteria compliance:
Promotion to health professionals Promotion to the general public
•
•
•
•
•
•
•
•
•
•
•
Name of active ingredient
• Name of active ingredient
Brand name
• Brand name
Content of active ingredient
• Major approved indications
Name of other ingredients known • Major precautions,
to cause problems
contraindications, warnings
Approved indications
• Name and address of
manufacturer
Dosage form or regimen
+ No use of the word safe without
Side effects, adverse drug
qualifications
reactions
Precautions, contraindications,
warnings
Interactions
British National Formulary 56th edition
Name and address of
(September 2008) used as a reference to
manufacturer
determine adherence to the technicallyReference to literature as
based criteria
appropriate
%
Advertisement in medical journals:
Results
100
90
80
70
60
50
40
30
20
10
0
Compliance with WHO Ethical Criteria
brand name
generic name
approved
indication
< 70% generic name
< 60% approved indication
< 33% safety related information
precautions contra
side effects and indications
interactions
warnings
ADRs
None of the advertisements studied
meet all the criteria assessed
V
Advertisement to the public: Results
100
90
80
70
Promotion of approved therapeutic
uses
%
60
50
40
30
20
10
0
Kenya
Zambia
Malawi
Madagascar
Uganda
Less than half of the materials
promote only approved indications
 Extension of the indications
Advertisement for an antibiotic,
Kenya, 2008
 Promotion of unlicensed indications
V
Advertisement to the public: Results
100
90
80
Major precautions, contra
indications, warnings
70
%
60
50
40
30
20
10
0
Advertisement for an
antispasmodic, Zambia,
2008
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
Regulation on
print
advertisement
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