E-drug: Inappropriate drug donations: the need for reforms
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[From section 'Health and human rights', The Lancet. Copied as fair
use. HH]
The Lancet. Volume 358, Number 9281, 18 August 2001
Inappropriate drug donations: the need for reforms.
Individuals and organisations tend to respond to humanitarian
emergencies with an urgent desire to help those in need. The media
often highlight shortages of medicines, and donating medicines can
seem a tangible way to express concern and solidarity. Drug
donations do play an important part in humanitarian relief efforts,
but they are not always the most effective way to help. After an
earthquake, the first needs are usually shelter and earth-moving
equipment. In refugee settings, priorities are clean water, sanitation,
shelter, food, and vaccines. The requirement for drugs is
determined with a comprehensive assessment of health problems.
Surplus drugs from hospitals and pharmacies in donor countries are
rarely what is most needed in emergency settings. If the medical
needs of the affected population are not clearly specified, responses
from hospitals and pharmacies are unlikely to be helpful. Surplus
drugs often include free samples or drugs returned by patients or
health professionals, such as cardiovascular drugs, gastrointestinal
drugs, hormones, and anti-rheumatic remedies. Some drugs have
reached or are near their expiry date.
Antimalarials and vitamin A are commonly needed in an emergency,
but are unlikely to be among the medicines donated by western
hospitals. In 1991, Pharmaciens Sans Fronti�res found that only
20% of 4 million kg of drugs collected from 4000 pharmacies in
France for international aid programmes could be used--the rest had
to be burnt.
Guidelines for drug donations were produced by several
organisations during the 1980s in response to inappropriate
donations in emergency situations. They formed the basis for
internationally endorsed drug donation guidelines.1 The 12 articles
of these guidelines are based on a set of core principles. First, there
should be maximum benefit for the recipient. Second, there should
be respect for the wishes and authority of the recipient, and
support for existing government policies. Third, there should be no
double standards in quality--if the quality of an item is unacceptable
in the donor country, it is also unacceptable as a donation. Fourth,
there should be effective communication between the donor and
the recipient.
After arrival in the recipient country all donated drugs should have a
shelf-life of at least 1 year. Drugs may lose their active properties
after their expiry date, and distribution through different storage
levels (eg, central store to provincial store to district facilities) can
take 6-9 months. Although some drugs may continue to be safe
and effective after the expiry date, their use would not be allowed
in the donor country and so they should not be donated.
Many countries have developed a national standard drug list based
on treatment guidelines for the most common diseases, to ensure
safe and reliable treatment and optimal use of resources. The
criteria for selection of drugs are appropriateness, efficacy, safety,
and cost-effectiveness. Donations of drugs on the standard list, in
consultation with recipients, can be helpful. Donations of products
not on the list should be made only if there is a strong rationale,
and after consultation with the recipient country. At the community
level, donation of inappropriate drugs can interfere with
management of common problems and can undermine a system
based on rational prescribing from standard drug lists, treatment
protocols, and trained national health workers.
Governments can buy essential generic drugs from reputable
non-profit procuring agencies at lower prices than brand-name
drugs from large multinational companies. Furthermore, medicines
identified by international non-proprietary names make training
easier by overcoming the confusion caused by different brand
names. The use of non-proprietary names also facilitates ordering
and storage of drugs.
Despite the existence of published guidelines since the 1980s,
every emergency produces new examples of inappropriate
donations. In eastern Zaire in 1994, for example, one relief
organisation chartered an aeroplane to deliver a huge shipment of a
commercial soft drink used by athletes, in the false belief that it
could be used to treat people with cholera. In fact, this product can
be dangerous if given to infants. In addition, the product was not
only bulky and difficult to store, but caused considerable waste and
was not cost-effective when compared with standard oral
rehydration therapies used to treat diarrhoea.
There are many documented cases1,2 of relief organisations,
private companies, governments, and individuals providing culturally
unacceptable and nutritionally inadequate foods; inappropriate,
expired, poorly packaged, and even dangerous drugs; and other
useless relief supplies.
Donations by pharmaceutical companies can be used to obtain tax
deductions on unused stock or to stimulate a market for certain
products. In April, 1999, growing concern about the
appropriateness and the quality of the drugs donated to Albania
during the Kosovo refugee crisis caused the WHO to voice its
concern. Albania was assisted by a WHO consultant to develop
national guidelines for drug donations and a standardised list of
drugs.
The WHO audit of Albania during May, 1999, noted that about
50% of the donated drugs were inappropriate or useless and would
have to be destroyed. 65% of drugs were due to expire within 1
year, and 32% were identified only by brand-names that were
unfamiliar to Albanian health professionals. None of the short
shelf-life donations were requested, and aid workers reported that
they could not be distributed and used before the expiry date.
Donations need to be properly thought out before they leave the
donor. Transport to the recipient country can cost more than the
value of the drugs. Packages must be clearly labelled in a language
that can be read in the region and units of drugs, such as blister
packs, should not have been opened or used. Sometimes
consignments remain at the point of entry for months because
arrangements were not made for distribution on arrival. Storage
costs and taxes may also be demanded.
If drugs are not appropriate then the recipient has to ensure their
safe disposal, which also poses difficulties. Between 1992 and
mid-1996 in Bosnia and Herzegovina, about 17 000 tonnes of
inappropriate donations cost US$34 million to destroy. There were
neither high temperature incinerators nor specialist chemical waste
treatment centres necessary for safe drug disposal.2 An incinerator
supplied to Macedonia by the UK at the time of the Kosovo refugee
crisis did not comply with British or EU emission standards. In
response to such difficulties WHO have developed and published
guidelines for the disposal of drugs.3
In most humanitarian energencies, a financial contribution is more
appropriate than donation of medicines. Such aid allows purchase
and transport from specialist procuring agencies, at a fraction of the
cost of supplying products from another country. The frustration of
waiting for consignments of donated medicines, only to find that
most were useless, led the Eritreans to develop their own
manufacturing plant for commonly used medicines during their war
for independence. By the end of 1987, this plant was able to
prepare all intravenous fluids and 40% of the tablets and capsules
needed in Eritrea. The plant formed the basis of the national
manufacturing programme which has developed since
independence.
Inappropriate donations need to be prevented and recipients must
be able to refuse unwanted gifts. Ideally, the government of a
disaster-affected country should monitor the quality of the
assistance and ensure that inappropriate aid is rejected. Without
government controls, the lead aid agency in a relief programme
should exert its authority on monitoring the quality of donations.
Well-informed media could play a part in exposing agencies,
companies, and governments that persist in sending useless drugs
to countries facing humanitarian crises.
In the long-term, the problem of inappropriate drug donations needs
to be resolved by relief agencies through education of the public
and by maintaininng a commitment to high standards through
consultation with the media, policy makers, and the drug industry.
On a positive note, the world's newest nation, East Timor, has
already developed a national standard drug list to cover all health
facilities, and procurement policies that preclude drug donations.
Beverley Snell
International Health Unit
Macfarlane Burnet Centre for Medical Research
PO Box 254, Fairfield, Victoria 3078, Australia
1. WHO. Guidelines for drug donations. Geneva: WHO, 1999.
2. Forte G, Alderslade B. Inappropriate drug-donation practices in
Bosnia and herzegovina. N Engl J Med 1998; 338: 1473.
3. WHO. Guidelines for safe disposal of unwanted pharmaceuticals
in and after emergencies. Geneva: WHO, 1999.
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