E-DRUG: expired drug donations?

e-drug
1

E-drug: expired drug donations?
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Dear E-druggers,

We found an article called 'a study of the stability of some comercial solid dosage
forms beyond their expiration dates' by Stark et al in May 3 Pharmaceutical Journal (UK)
(vol 258) p. 637-640. Captopril, theophylline, fluclox and cefoxitin were
tested. The conclusion was more or less that because these drugs were OK
several years after expiry , it was 'responsible' to send expired drugs to
developing countries. We responded as follows. It would be good if
others could also - especially victims in the 'developing' countries.

To:editor@pharmj.org.uk
From:bev@mbcmr.unimelb.edu.au (Beverley Snell)
Subject:Stark et al May 3

SIR, - Mr Stark and colleagues in their article on drug product
stability (PJ, May 3, 1997) conclude that 'soon-to-expire medicines
could responsibly be donated to countries in need'.

This recommendation contravenes guidelines for pharmaceutical donations
which have been prepared and tested by the WHO and other international
agencies. It is unacceptable for several reasons:

* It is a double standard - if the drugs are of acceptable
quality, why are they not used in the donor community?

* Sending the waste of one country to another country is not
acceptable. Disposal of waste in developing countries where it is much
more difficult than in industrialised countries, is the subject of
increasing concern.

* Where National policies on donated drugs have been formulated in
developing countries, the expressed request is that all donated drugs
should have a remaining shelf-life of at least one year after the
arrival in the recipient country. Transportation of donated drugs can
take several months with drugs stored in extreme conditions and
distribution from the centre to periphery within country can take many
more months, again under extreme conditions.

* Information gained from testing 4 preparations in laboratory
conditions cannot be extrapolated to apply to other drugs.

* Increasingly, developing countries are establishing their own
National Standard Drug Lists which are lists of essential drugs
calculated to address the real needs of their own populations. In this
way the best use is made of available funds and cost-effective
procurement of a reliable supply of good quality essential drugs for the
population's needs from reliable agencies is possible. In addition,
inappropriate drugs offered by donation are excluded.

* Encouragement to donate drugs beyond expiry date to developing
countries undermines National Drug Policies and Essential Drugs Programs
which are aimed at education and promotion of rational use of essential
drugs.

Jonathan Dartnell
Beverley Snell

Advisory Working Party, Australian guidelines for drug donations to
developing countries. Australian Pharmaceutical Advisory Council.

Jonathan Dartnell
(M/ship No. R 5277)
Research Pharmacist
Dept of Clinical Pharmacology and Therapeutics
Royal Melbourne Hospital
P O 3050 Vic. Australia

Beverley Snell
Public Health Pharmacist
International Health Unit
Macfarlane Burnet Centre for Medical Research
P O Box 254 Fairfield Vic. Australia.

Wilbert Bannenberg, SADAP Coordinator
Hallmark 938, P/Bag X 828, Pretoria 0001, South Africa
Tel work +27-12-3120374/5 Fax +27-12-3244525 Cellphone +27-82-5756249
Email 73377.3055@compuserve.com or bannew@hltrsa.pwv.gov.za
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