E-DRUG: Returned medicines and drug donations (7)
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As founding director of the Partnership for Quality Medical Donations, I
agree with Kirsten Myhr that the good returned medicines might do is
outweighed by the harm, real or potential.
The concern many express about unused drugs going to waste while patients
in need go without is understandable, and in some locales, admirable
efforts have been organized to meet unmet needs responsibly. The best
solution, however, requires systemic change rather then patching.
For eight years, the WHO Guidelines on Drug Donations have proscribed
donation of returned medicines. During that time, PQMD-member drug
donations conforming to the Guidelines have multiplied perhaps six-fold,
suggesting no need to weaken them.
Lastly, in contemplating what standards to apply for drugs for the
indigent, the rules protecting the rest of us should apply. In the US,
I know, dispensing a returned medication is a violation of Federal law.
Regards,
Jim
James B. Russo
146 Koenig Rd.
Bernville, PA 19506
USA
610 488 9060
484 269 7490 (m)
jbrusso@aol.com
E-DRUG: Returned medicines and drug donations (8)
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Jim,
It is not very clear for me whether you in principle support sending
unused returned medicines as donations, but accept the guidelines as
they are. Or whether you support the US legislation which forbids
reusing medicines.
Donations take many forms:
- bits and pieces collected from pharmacies as returned medicines and
consisting of many different medicines in quantities from almost 0 pills
to a few hundred. Most industrialised countries will not allow returned
medicines to be resold or donated to citizens. Why should there be
another standard for developing countries? From international generic
suppliers essential medicines can be purchased very cheap. Why not buy
there after finding out what the recipient is in need of? We can afford
that. E.g. you can buy 150 000 hydrochlorothiazide tablets for around
150 USD. That can treat hypertension in 400 people for one year!
- donations from NGOs, e.g. national Red Cross societies, of medicines
purchased in their own countries and sometimes consisting of
non-essential and even banned medicines and with unreadable labels
because they are in a national language.
- donations from pharmaceutical companies of nearly outdated medicines
and even medicines which showed in clinical trials to have such a bad
risk/benefit profile that they never got registered in rich countries.
Or companies donate non-essential medicines for which there is no need.
I have documented donations in several countries and been fed up seeing
box after box of Tylenol in all sorts of fashions. Tylenol contains
paracetamol + different sorts of cough and cold substances which now FDA
is warning against (pseudoephedrine, ephedrine etc.). If you manage to
find the list of ingredients on the box you will find a substance called
acetaminophen. This is the US name for paracetamol and known by hardly
anyone outside the US. This is just one example, there are plenty. A
substance such as ephedrine is in some countries on a restricted list
and supply of such unauthorised donations can cause meny problems.
- donations come to countries which have a viable pharmaceutical
industry and no need. Sometimes this causes problem for the local
country. E.g. Why do Lilly donate insulin to countries with own
production of insulin if it were not to introduce its own product?
- donations to special programmes to eradicate tropical diseases.
In the US, instead of having a good healthcare coverage, doctors of
patients who cannot afford the medicines, can apply for company
donations. It is then up to a pharmaceutical company to accept or reject
and to decide for how long the patient can be treated. Novartis tried to
introduce the same in India instead of reducing the price of their
cancer medicine, Glivec (imatinib) or allow copies. I think this is a
system most of us will not want to see in our own countries or spread
around the world. In the e-drug archive, there is a message from me on
that: http://www.essentialdrugs.org/edrug/archive/199812/msg00041.php
If there were no unused, returned medicines, this discussion would not
take place. Also high-income countries should be concerned that so many
medicines are not used and take measures to improve prescribing.
Kirsten
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 (10)
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Kirsten,
Thank you for your excellent comments.
Another thought regarding donations: how can media be used better?
For example, when disasters occur anywhere in the world today, one often
hears television announcers make appeal for not only food and water, but
also medicines which no doubt leads to misdirected donations of all kinds.
What should announcers say instead - if anything? Should a general
policy/phrasing (apart from the content in WHO's Guide to Drug Donations)
be agreed upon?
Margaretha Helling-Borda
former Director WHO Action Programme on Essential Drugs)
E-mail: m.helling-borda@bluewin.ch