E-DRUG: Returned medicines and drug donations (5)
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I researched the problem of unsolicited drug donations in emergencies
on the example of post-tsunami Sri Lanka. I think you might be
interested in some of the findings and conclusions.
Please have a look on:
http://jha.ac/2007/09/26/drug-donations-in-emergencies-the-sri-lankan-post-tsunami-experience/
Best regards
Rafal Hechmann
e-mail: rafalhechmann@gmail.com
E-DRUG: Returned medicines and drug donations (6)
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I agree with the moderator that this topic should have been buried long
time ago, but unfortunately, some people still donate used and returned
medicines and companies and pharmacies donate overstocked non-essential
medicines with short shelflives. Often these medicines are not even
familiar to the recipient country. Amongst the donors you find the
French government, unless they changed recently. The NGO PSF
(Pharmaciens sans Frontieres) was started in France and collected used
medicines from pharmacies. They soon found out that this was not a good
idea, but years later it has still not been possible to convince the
French government.
Your best source of information is to search the E-drug archives using
donation as search string. I think almost everything that has happened
is documented in messages to E-drug.
Ms Kirsten Myhr, MScPharm, MPH
RELIS Drug Info and Pharmacovigilance Centre
Ulleval University Hospital
0407 OSLO, Norway
Tel: +47 23 01 64 11 Fax: +47 23 01 64 10
myhr@online.no
E-DRUG: Returned medicines and drug donations (12)
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[Great to hear that the French government has changed its position, Ghisleine! HH, E-drug moderator]
Dear Colleagues,
We have been fighting for many years against the donations of medicines that
have been returned to pharmacies, also called "unused drugs". At the
beginning of last year, finally, the French Senate approved a law to forbid
their use. Unfortunately, this new law will come into force only on December
2008.
Since medicines are potentially dangerous products, all countries have
strict regulations regarding the manufacturing, marketing, quality control,
storage, sale, prescribing, dispensing and destruction of such products.
However, as part of humanitarian assistance, donors think that they are not
required to comply with the pharmaceutical legislation of the recipient
country and ignore the WHO Guidelines for Drug Donations.
Non compliance with the Guidelines for Drug Donations and with the national
drug policy of recipient countries have resulted in an anarchic situation in
many southern countries where a huge illicit market has developed to the
detriment of public health.
Examples are related in the WHO guidelines for drug donations revised in
1999. More recently 2004 tsunami affected countries had to face the same
problem and we have to admit that, almost 10 years after the first
publication of the Guidelines for Drug Donations, the quality of
humanitarian aid with respect to drug donations has not improved.
It has instead deteriorated with an increase in the number and diversity of
donors, many of them dumping unused drugs collected in their country when
the WHO guidelines recommend the use of WHO-type emergency kits designed to
meet needs during the first weeks after a disaster. Each kit contains
essential drugs under International Non proprietary Name for a population of
10,000 persons for 3 months. In post-emergency situations, coordination
committees in the field and the Ministry of Health will help to find out
what medicines are normally used by health professionals in the country and
who their suppliers are in order not to import medicines unknown to doctors,
nurses and patients.
As for development aid, countries have, since the early 90s, put in place
supply and distribution channels for drugs included in a National Essential
Medicines List defined by the Ministry of Health, which also develops
treatment protocols based on this list. All orders are consolidated at the
national level in order to take advantage of economies of scale. As part of
development assistance to help countries to be self-sufficient, medicines
must be sourced through theses official channels.
Additional WHO guidelines for drug donations as part of development state
that due regard must be given to pharmaceutical legislations:
"Special care should therefore be taken that the donated drugs respond to an
expressed need, comply with the national drug policy, and are in accordance
with national treatment guidelines in the recipient country.
Administratively, the drugs should be treated as if they were procured. This
means that they should be registered or authorized for use in the country
through the same procedure that is used for government tenders.
They should be entered into the inventory, distributed through the existing
distribution channels and be subject to the same quality assurance
procedures."
Risks and dangers of inappropriate drug donations are many:
- They are unsuitable, often misappropriated for resale on the black market,
an obstacle to the implementation of national health policies.
- They frequently fail to meet the needs of local pathologies.
- They were not designed for adverse weather conditions (heat, humidity...).
- Their prestige as "medicines from industrialized countries" means they are
coveted and can be sold for high prices on the black market.
- The same active substance is often presented in different aspects (tablets
or capsules of varying sizes and colours) which mean that it is difficult to
ensure they are used properly.
- They can be distributed by unqualified staff without respecting the
correct dosage, which can lead to irrational consumption.
- Instructions written in the language of the country of origin are not
always understood by the patricians and the patients in the countries that
use them.
- As far as unused medicines are concerned, quality and traceability, or the
ability to track manufacturing batches from the factory to the user-patient,
cannot be ensured since there is a break in the pharmaceutical chain when
the drugs are first delivered to the patient in the rich donor country.
- Their remaining shelf life is often fairly short, they arrive in countries
where conditions are far from ideal for fast efficient distribution and many
expire before they reach those intended to benefit from them.
- In development countries, they threaten and inhibit the implementation of
health policies based on a national list of generic essential medicines and
national treatment protocols.
- Their management and destruction are very expensive for the recipient
countries.
We need to respect the right of these countries to develop and the right of
their populations to quality-assured essential medicines.
Rich countries won't be rich forever and we won't be able to help them
forever. They need to develop sustainable essential medicines procurement
and distribution channels. That is what we help them to do.
Ghislaine Soulier
Pharmaciens Sans Frontières Comité International
9 rue André Darbon
33300 Bordeaux - France
gsoulier@psfci.org