E-DRUG:Hazardous drugs in developing countries
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BMJ No 7122 Volume 315
Editorial Saturday 13 December 1997
Hazardous drugs in developing countries
The market may be healthier than the people
The international pharmaceutical market shows substantial regional
differences in availability and promotion of drugs.(1) This variation
depends on affluence, health requirements, capacity for local
manufacture, and the restrictions which countries may impose to
control dangerous or inappropriate use of drugs.(2,3) Because of
their limited industrial base, most developing countries import most
of their drugs, and transnational corporations are adept at
exploiting variations in such markets.(1) Commercial interests may
conflict with public health needs in developing countries,(4-6)
particularly when people are poisoned due to inadequate restriction
of pharmaceutical use, misleading advertising or labelling, or
frankly bogus products.
Promotion of unsafe drugs in the developing world has long attracted
criticism, particularly when products have been banned or restricted
in the country of manufacture.(3)(5) Pharmaceutical adverts,
labelling, and package inserts in developing countries often show
the twin problems of exaggerated indications and minimised adverse
effects.(1)(5,6) Drug exports from the United States to developing
countries were reviewed independently in 1993 and found to have
"severe labelling deficiencies," in many cases posing life
threatening risks.(7) Locally produced drugs have labelling problems
which may exceed even those of imports.(5)
A further problem arises from unscrupulous entrepreneurs whose bogus
merchandise mimics acceptable drugs. Whether manufactured locally or
imported from the West, such counterfeit drugs can be dangerous,(8)
particularly when contaminated. Unethical promotion and
counterfeiting are compounded by several factors: inconsistent import,
export, and quality controls(3); the dominance of private pharmacies
and self medication(9); direct advertising to pharmacies and
consumers(5,6); and the fact that promotional material may be the main
information available to prescribers.(1)(3)
Promotion of expensive brand names increases apparent choice but can
also hobble developing countries' efforts to meet pharmaceutical
needs by bulk purchase or manufacture of essential generics.(1)(3)(6)
Ironically, "humanitarian" drug donations may serve donor companies
(through brand awareness and tax incentives) more than recipient
countries, which commonly suffer disposal costs (or toxic
consequences) from inappropriate or poorly labeled drugs.(10)
The health impacts of inappropriate pharmaceutical exports have
included multiple fatal poisoning,(3)(11,12) the spread of antibiotic
resistant infections,(3)(13) and a host of problems arising from the
mismanagement of diarrhoea in children.(4)(14) Women and children
appear particularly susceptible to the health problems associated
with the unrestricted use of particular pharmaceuticals.(3)(11,12)
Inappropriate promotion of some products (such as stimulants to treat
"lethargy" in children) is also lamentable, as it diverts attention
and resources away from fundamental public health needs.(1)(13)
Control of hazardous drugs is an international imperative. Threats to
public health posed by inconsistent control of various chemical
hazards have prompted the United Nations to publicise existing
regulations, ostensibly to encourage international consensus.(2) A
compendium of restricted pharmaceutical, agricultural, industrial,
and domestic products has been systematically updated since 1982.(2)
Analysis of the pharmaceutical section indicates that a country's
capacity to restrict dangerous drugs depends heavily on its wealth,
as illustrated by the strong correlation of restrictions with per
capita gross national product (r =0.65, n=162, P<0.001). This dismal
picture may underestimate the true extent of the disparity, since
poor countries with notable restrictions (including Bangladesh,
Ethiopia) lack administrative machinery to police these.(3)(13)
The gravity of the situation has prompted resolutions from the World
Health Organisation, the United Nations, and other corporations
against inappropriate export and promotion of drugs. But whether such
non-binding agreements help is debatable,(3 )5 and an enforceable
code is lacking. Despite evidence of progress since the 1970s, some
transnationals continue to promote irresponsibly, exploit frail
national restrictions on imports, and behave in other unethical ways,
for example offering doctors "commissions" for prescribing.(1)(6)
Inappropriate pharmaceutical promotion has also been challenged by
non-governmental organisations. For example, lobbies such as Health
Action International(3) and the Medical Lobby for Appropriate
Marketing(1) monitor and publicise improper marketing and use of
drugs. These lobbies also encourage governments and industry to invest
in the development and appropriate use of antibiotics, contraceptives,
and other (generally unprofitable) essentials for developing
countries.(13)
With pharmaceuticals as with other technologies, unrestricted market
forcesdo not always work in favour of public health, particularly in
countries with the most urgent needs. While sustainable economic
development will be necessary finally to relieve the excess burden of
illness in poor countries,(13) steps can be taken now to use available
resources more appropriately. Rational use of cost-effective
pharmaceuticals is an achievable priority, and enforceable agreements
are required to control promotion of inessential and hazardous
agents.(1)(3) The medical community has a role to play in this effort,
as it can influence both industry and government policy. Whatever
their political leanings, doctors inevitably have a stake both in the
control of hazardous technology and in the appropriate use of
medicines.
David B Menkes Senior lecturer
Dunedin School of Medicine,
University of Otago,
PO Box 913,
Dunedin,
New Zealand
email: david.menkes@stonebow.otago.ac.nz
References
1 Lexchin J. Deception by design. Pharmaceutical promotion in the
Third World. Penang: Consumers International, 1996.
2 United Nations Department for Policy Coordination and Sustainable
Development. Consolidated list of products whose consumption and/or
sale have been banned, withdrawn, severely restricted or not approved
by governments. 5th ed. New York: United Nations, 1994.
3 Kanji N, Hardon A, Harnmeijer J W, Mamdani M, Walt G. Drugs policy
in developing countries. London: Zed Books, 1992.
4 Cash R. Inappropriate treatment for dysentery. BMJ 1996;313:181-2.
5 Silverman M, Lydecker M, Lee P R. Bad medicine: the prescription
drug industry in the Third World. Stanford: Stanford University Press,
1992.
6 Chetley A. Problem drugs. London: Zed Books, 1995.
7 Drug labelling. WHO Drug Information 1993;7:43-4.
8 Fake drugs: a scourge on the system. WHO Drug Information 1995;9:
127-9.
9 Cederlof C, Tomson G. Private pharmacies and the health sector
reform in developing countries. J Soc Admin Pharmacy 1995;12:101-12.
10 Hogerzeil H V, Couper M R, Gray R. Guidelines for drug donations.
BMJ 1997;314:737-40.
11 Hanif M, Mobarak M, Ronan A. Fatal renal failure caused by
diethylene glycol in paracetamol elixir: the Bangladesh epidemic. BMJ
1995;311:88-91.
12 English M, Marsh V, Amukoye E, Lowe B, Murphy S, Marsh K. Chronic
salicylate poisoning and severe malaria. Lancet 1996;347:1736-7.
13 World Health Organisation. World Health Report 1996. Geneva:
United Nations, 1996.
14 Costello A M, Bhutta T I. Antidiarrhoeal drugs for acute diarrhoea
in children: none work, and many may be dangerous. BMJ 1992;304:1-2.
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