E-DRUG: Article on drug donations in Scrip Magazine
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Scrip Magazine, issue september 1999, published an article on
drug donations, written by Philippa Saunders. The text of the
article, entitled "It's time to call a halt to poor drug donation
practice", is included in this e-drug posting. Readers of Scrip
Magazine are mainly pharmaceutical industry spokespersons, so
this is an important publication to raise more discussion and
awareness in these circles.
With the permission of Philippa Saunders and the courtesy of
Scrip Magazine (under fair use) the text of this article is
included. The article will also be published on the
http://www.drugdonations.org site (check the English language
domain under the button 'news'). Attention: the article is 1853
words long.
Best greetings,
Mark Raijmakers
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It's time to call a halt to poor drug donation practice
by Philippa Saunders
In recent months the World Health Organisation has said that
many gifts of unusable drugs have arrived without notice in
Albania and Macedonia. this dismaying news is not unusual.
Disaster aid provided in the wake of the Armenian earthquake;
hurricane Mitch and George in Central America; the civil wars in
Rwanda, Sierra Leone and many of the countries of the former
Soviet Union, were all characterised by the accumulation of
unusable donated drugs. Similar, widely publicised, problems
occurred after the war in Bosnia and Croatia.
Clearly the lessons of previous crises have not been learned.
Political and media pressures may explain why some governments,
aid agencies, companies and small groups continue to send
medicines inappropriately. But if the mindset is to change we
need to know more about donations, in particular where they come
from and why they are sent.
All too often drug donations do not match the country's needs,
and packs are often out of date, lack information and come in
quantities which are either too great or too small.
Unfortunately, such donations have become a feature of developing
countries' regular health services.
In the mid-1980s, working for Oxfam, I visited health
institutions and medical stores in East Africa. A Tanzanian nun
in charge of drug supply in a remote mission hospital was forced
to identify drugs from an old copy of the British National
Formulary - her only reference.
Obliged to accept
She said that she often received drugs from different countries,
with brand names she did not recognise. The labelling could be in
Spanish, Dutch, German or French. Only 10% were useful and the
rest ended up on the hospital bonfire. She felt obliged to accept
this poor quality aid because if she complained the donors might
cut off all supplies. Government recipients also accept
inappropriate medicines rather than risk diplomatic
repercussions.
Only two years ago, when I went to the Caucasus as a member of
the review team for a UK government-financed pharmaceutical aid
programme, it was clear that nothing had changed. The centralised
pharmaceutical supply system had collapsed, as had the economies
of the newly independent states of Central Asia.
However basements and spare rooms had become Aladdin's caves
of unusable drugs and medical equipment. The contents of a
decommisioned NATO hospital, for example, were stacked in the
Armenian national children's hospital. One room was full of
catheters and decaying dressings, dated 1982, serving as a
reminder that medical equipment and non-drug supplies are also
involved.
Such experiences motivated me to begin to work with
non-governmental organisation (NGO) colleagues to improve the
management of drugs in line with the WHO's essential drugs
principles.
The WHO estimates that 25-50% of the world's population is
excluded from safe access to necessary drugs. Medicines shortage
is only part of the picture. The capacity to manage drug supplies
nationally and locally is often undermined because resources to
pay for training, transport. systems development and information
are lacking.
These weaknesses are highlighted in a crises when fragile
infrastructures are loaded with uninvited and inappropriate
supplies. Common sense argues that the more fractured the system,
the more disciplined and simpler should be the response and the
greater the responsibility to respect national regulations,
systems, drug priorities and therapeutic guidelines.
Audit in Albania
This clearly doesn't always happen. In May, the WHO's European
Regional Office sent pharmacists to Albania to conduct an audit
applied to conduct an audit of donated drugs. The audit applied
to drugs received by the Albanian authorities, but not to
consignments which bypassed the system. In "normal" times
Albanian can by only about 20% of its drugs requirement for
hospital so the authorities already have procedures to process
donations. However, with the Kosovo crisis Albania was swamped by
an influx of 460,000 refugees.
The audit found serious quality problems. Donations did not
match the most urgent needs: 10% were not accompanied by any
detailed packing list, 36% consisted of small samples, 32% had
brad names that were unfamiliar to Albanian health professionals,
and 65% had no expiry date or were due toe expire less than a
year from the date of donation.
Similar pattern was found in Macedonia where donated products
included garlic capsules and nicotine inhalers, as well as
paracetamol in ten different formulations and brand names. Around
40% of products examined by the WHO were unusable.
Addressing the issue
In 1996, the WHO published its widely circulated 'Guidelines for
Drug Donations' (see box on page 8), which were based on
guidelines issued 20 Years ago by the Pharmaceutical Programme of
he World Council of Churches (WCC) to improve the quality of
medicines in mission hospital, especially in Africa.
Although the WHO consulted widely when drafting the
guidelines, a degree of friction persisted. Until the March
review meeting, for example, no donation distributor or industry
representative had been part of the core group, and in 1998 the
WHO was accused of 'blocking desperately needed drugs to the
poor', and even of being responsible for unnecessary deaths.
The main bone of contention was the requirement that drugs
should be donated if they have at least one year of shelf-life.
The argument was that well-organised agencies can ensure even
short-dated drugs are used before they expire, and the guidelines
now allow for this.
Most drugs do not deteriorate by an arbitrary date, and many
are usable for months or years after they expire. Among the
exceptions are tetracycline, which can become toxic, and
antibiotics and vitamins, which lose potency. But while it may be
reasonable for prescribers to use these stocks when nothing else
is available. there can surely be no justification for donating
drugs which have either already expired, or are about to do so.
The guidelines aim to improve the quality of drug donations,
not to hinder them. And they are intended to serve as a basis for
national or institutional guidelines, to be reviewed, adapted and
implemented by governments and organisations dealing with drug
donations. About 20 governments have integrated versions of the
WHO guidelines onto their national regulations.
One practical measure to expedite drug donations for countries
in need has been the development of emergency health kits by the
WHO. These packages (see box below) were successfully used in the
Kosovo crisis and adaptations now exist to meet the needs of
emergency mental health, surgery, chronic diseases, reproductive
health and other specialised areas.
Kits are useful where administrative capacity is limited, but
they do not meet all eventualities. For example, shortages of
anaesthetics, anticancers, tranquillisers, microbiological tests
and surgical sutures have been reported in Belgrade. There will
always be requirements which change over time or because of
unforeseen developments. Donations must match specific needs and
the capacity of personnel, be timely, in appropriate quantities
and of good quality. Goods which fail to meet these criteria will
not be used and will add to the expense of safe disposal and the
workload at the receiving en of the chain.
Stumbling blocks
Despite this progress some stumbling blocks still remain to the
promotion of effective drug donations to those in need. Recent
articles en the US press have asked if tax allowances provide an
incentive for poor quality donations. And the WHO said from the
Balkans recently: "We are very concerned that some pharmaceutical
companies are using this humanitarian crisis to get rid of
unwanted stockpiles."
Indeed, in 1990, Professors Patricia Arnold and Michael Reich
published an acedemic study describing the 'natural history' of
US donation practices. Theysaid that hundreds of millions of
dollars' worth of donated supplies, including drugs are passed to
distributors by companies for shipping to the world's poorest
cuontries every year. Tax allowances, they claimed, can encourage
companies to get rid of unsold stock nearing expiry. They omitted
to mention that donating drugs also allows companies to aviod the
costs of incineration.
Because the efficiency of the private voluntary organisation
(PVOs) that distrubute the drugs tends to be judged on the ratio
of operational activities to administrative overheads, the
emphasis is on the monetary value of goods rather than their
health impact.
Arnold and Reich argued for greater public disclosure and
accountability for PVOs and called for changes in three areas
that would improve practice. These are in public accounting
standards, tax laws, and the Us Agency for International
Development regulations.
In both Europe and the US, the collection and distribution of
donated medicines is frequently outsourced to specialised
agencies. In Europe, drug samples and medicines that have been
returned are a staple of these schemes.
Where drugs are donated all parties have a responsibility to
ensure they do not undermine the disaster response, enter the
illegal market or harm the population. It should be remembered
that donations in the Kosovo crisis came from many parts of the
world, including Asia, the Middle East, and most European
countries. Governments as well as companies and aid agencies sent
inappropriate aid.
Lessons from Kosovo
Drug issues raised by donations are more complex than is often
assumed. The failure of drug distribution systems may extend to
the period of post-emergency transition which can last many
years. If countries cannot buy the drugs they need for public
health this may turn into chronic long-term dependency on donated
drugs. The unequal relationship between donors and recipients
lies at the heart of many of the problems. Because donations are
seen as 'philanthropic' gifts, they are often not subjected to
accepted safeguards.
Another humanitarian disaster will materialise before long
and, where possible, money or the WHO emergency kits, rather than
drugs, should be sent to support existing supply networks. In the
Balkans, for example, local suppliers are struggling financially
having got caught up in a less obvious casualty of war, the
collapse of commercial structures.
Government donors, NGOs and companies should have written
policies and clear internal guidelines for staff, based on WHO
principles. Agencies handling millions of dollars of drugs, in
particular, should employ experienced pharmacists.
The who could assist countries to identify their needs early on.
These needs could be posted on the newly constructed NGO Drug
Donation website -http://www.drugdonations.org - so everyone
concerned can have ready access to the information.
Finally, we should remember that current disease control and
eradication programmes, which concentrate on polio, trachoma,
malaria, onchocerciasis, Aids and lymphatic filariasis, all have
unique and sensitive aspects which must be defined with clarity
in an atmosphere of trust. Continuing flows of poor quality
donations may well undermine such initiatives, thus affecting the
health of millions of people.
Reference
1. P. Arnold and M. Reich, "PVO pharmaceutical donations: making
the incentive fit the need". Journal of Research in
Pharmaceutical Economics, 2, 4, 1990.
[A four-year study by Dr. Micheal Reich into all US
pharmaceutical company donations shipped by two private voluntary
organisations between 1994 and 1997 was published last month. It
is reported in Scrip World Pharmaceutical News 2465, dated August
20, 1999.]
(*) Philippa Saunders is manager of the Essential Drugs Project
on behalf of Oxfam, Save the children Fund and Christian Aid. She
represented Oxfam on the expert working party that drafted the
WHO guidelines.
(c) Copyright Scrip Magazine September 1999
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