[e-drug] drug donations - will we ever learn?

e-drug
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E-DRUG: drug donations - will we ever learn?
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[Pakistan, tsunami, albania etc; disburbing data, nicely summarized by Andy Gray, writing from a South African perspective in Druginfo. WB]

Hi all

In their 30 October 2005 newsletter the Pharmaciens Sans Frontières Comité International (PSF-CI - see www.psfci.org) reports on its assessment of medicine donations to Banda Aceh province in Indonesia after the 26 December 2004 tsunami:

* medicines were donated by 140 donors, of which 53 were national organisations and 48 were international organisations from 39 countries
* 4000 tonnes of medicine were received for a population of less than 2 million people
* medicines were labelled in more than 16 foreign languages
* nearly 60% were not on the national List of Essential Drugs
* 10% had expired before they reached Banda Aceh
* 30% were due to expire in less than 6 months or had missing expiry dates
* those medicine that were approriate were received in quantities equivalent to 6-8 years' use
* 345 tonnes (1150 cubic metres) have been identified for destruction, which will cost an estimated Euro 1.4 million (75 cubic metres of donated medicines were destroyed in February 2005)

PSF-Germany has also noted that the same problems are now being experienced in Pakistan. The same happened previously in the Albania (50% of donation lists sent to the Albanian Ministry of Health during May 1999 only mentioned trade names, many of which were unknown to local health professionals; only 56% included information on shelf-life, of which about 41% of the drugs had a remaining shelf-life of less than one year; and 18% of donations contained small packs of free samples or drugs returned to pharmacies), Bosnia (a 1997 study by Epicentre and Pharmaciens Sans Frontières estimated that 50-60% of drugs donated in Bosnia were inappropriate), Rwanda, Somalia and Honduras. The cost of destruction is high - incinerators had to be sent to Mostar in 1996 and Armenia in 1988 by Médecins Sans Frontières to dispose of unsuitable donations. Pierre Chirac noted in 1999 that the only other alternative was to ship such drugs to another country, estimating that it would cost US$2-4 million to ship 1000 metric tons of inappropriate pharmaceuticals and medical supplies from Croatia for appropriate disposal.

One of the key components of the WHO Revised Guidelines for Drug Donations (http://whqlibdoc.who.int/hq/1999/WHO_EDM_PAR_99.4.pdf) is that "All donated drugs or their generic equivalents should be approved for use in the recipient country and appear on the national list of essential drugs, or, if a national list is not available, on the WHO Model List of Essential Drugs, unless specifically requested otherwise by the recipient."

The PSF-CI report reminded me of an advertorial in the SAPJ earlier this year in which Adcock Ingram announced that it had donated quantities of Inteflora (Saccharomyces boulardii . Indicated for "Prophylaxis and treatment of the intestinal and muco-cutaneous side effects induced by antibiotic therapy: diarrhoeas - colitis - candidosis; Non-specific diarrhoeas; Colitis, enterocolitis; Prevention of diarrhoeas during continuous enteral feeding" - see http://www.adcock.co.za/) to Sri Lanka after the tsunami.

This product is not included on the Sri Lanka EDL, nor does it appear in standard WHO treatment guidelines for diarrhoea (which are based on the use of ORS, with specific indications for antimicrobials use in certain circumstances and limited use of antimotility agents). I was unable to confirm with colleagues in Sri Lanka that the donated Inteflora had in fact been isolated for destruction, but they did confirm that its use would not have been in accordance with local policies, and hence that it would have been regarded as an inappropriate donation.

The NDP deals specifically with the receipt of donated medicines, stating (as a quality assurance measure) that "that Guidelines for donated drugs, to follow WHO guidelines for drug donations. Donated drugs will
- match the health needs of the country and hence appear on the Essential Drugs List
- be compatible with overall government policy
- be of appropriate quality, efficacy and safety
- be accompanied by appropriate legal and administrative documents
- be reviewed through the MCC fast track procedure"

The same should apply to medicines donated from South African sources.

regards
Andy

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E-DRUG: Drug donations - will we ever learn? (2)
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As Andy Gray states, we have seen this time and time again. The WHO Guidelines for Drug Donations clearly identify the criteria for donating drugs for long-term programs and humanitarian emergencies. There is no distinction made for emergencies. Unacceptable donations practices will continue until the donating organizations responsible are cited for their abusive practices and compelled to pay the costs of remediation.

A Hannah
drewhannah@msn.com

[Pls remember to give affiliation. Moderator]

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E-DRUG: Drug donations - will we ever learn? (3)
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Andy Gray's comment is quite timely in view of the pressing needs of many countries of the Third World.

There is need for a concerted effort on the part of the donor countries to ensure that what is meant to be a "donation to alleviate peoples sufferings" does not turn out to be a "detonation of a disastrous bomb of
poisons and counterfeits". In the early 1990s a Teaching Hospital in Nigeria received a "donation" of methyldopa from overseas (apparently from a country that is reputed for its excellent quality, CGMP, and strict compliance with laws and regulations). The colour of the product had changed and it would not pass any official test.

The danger in such sub-standard drugs is that often times Regulatory authorities in developing countries may not even be aware of their existence hence there is no regulatory scrutiny as you have during registration when a dossier and samples must be submitted for laboratory analysis.

Country Regulatory authorities should ensure that Drug Donation comply with WHO Guidelines. This will ensure that the right quality drugs are donated, hence the desired help would be achieved. Recipients should be bold enough to ask for Certificate of Analysis and in addition, subject such donated drugs to quality analysis before use. Donors that are not willing to comply should not be entertained.

On a final note, developing countries themselves should grow up and stop enjoying this beggar's position or being the Lazarus that is always collecting the crumbs from the rich man's table. Let us sit down and devised some meaning programme to solve our own health programme.

Andy Gray has just told us what we all have known but we often refuse to address. The same goes for so called "foreign aids" which may even enslave a nation like a "foreign AIDS"!

Professor 'Fola Tayo
Dept. of Clinical Pharm. & Biopharm.,
University of Lagos,
PMB. 12003,
Lagos. Nigeria.
Tel: +234-1-813-2789.
folatayo2001@yahoo.com

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E-DRUG: Drug donations - will we ever learn?: Action?
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Hi colleagues!

Once again the unpleasant side of drug donations raises it head. Action is
needed.

The WHO interagency donations guidelines continue to be a good vehicle but
this document needs updating, possibly with the addition of criteria for
donation for humanitarian emergencies and steps to take to make donating
organization more responsible including facing the consequences of abusive
practices (as pointed out by A. Hannah).

Anyone interested in joining a small email group to brainstorm and develop
this idea further? We (EPN) would be glad to lead on this.

Cheers.
Sincerely, Eva Ombaka
Ecumenical Pharmaceutical Network
P. O. Box 73860-00200
Nairobi, Kenya
Tel: 254-20-4444832/ 4445020
Fax: 254-20-4445095/4440306
Email: epn@wananchi.com
Website: www.epnetwork.org

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E-DRUG: Drug donations - will we ever learn?: Action? (3)
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I agree with this very important call for action by Eva Ombaka I think updating the WHO guidelines should be looked at least on three levels:
1. Providing solid evidence on the harmful effects of bad drug donations i.e. economic costs of wastage, health system burden, environmental and public health hazards.
2. Further emphasis on ethical issues related to donations as an extension of the existing core principles (lack of ethical consensus by donors & recipients may be one of the major cause of inappropriate donations?).
3. Further detailed instructional components both for donors on how to adhere to guideline and for recipients on how to facilitate good donations and protect themselves from inappropriate ones. Such practical details may be useful when drawing up a national guideline based on WHO's.

However, to achieve changes in current practices of drug donations even a widely disseminated, new international guideline may not be sufficient, as
experiences of inappropriate drug donations from the last 5 years show. Active implementation efforts will be needed and these are often more difficult than publishing an international/local guideline.
Someone will need to look at systematically what are the barriers/ incentives to improving drug donations practices both on the donor and recipient sides and what effective and targeted interventions (international and local) can be used to actively implement recommendations of WHO.

A systematic identification of barriers (e.g. cultural attitudes, beliefs on value of donations, economic motivations of donors or organizational, legal, informations system barriers in recipient countries, etc.) can be the first steps to identify necessary interventions (e.g. raising public awareness, active donor education, compulsory NGO education or licensing to handle drug donations, etc.) for better implementation.

Klara Tisocki

Dr Klara Tisocki
B. Pharm., M.Sc., Ph.D.
Phone: + 965 7975493
Fax: +965 534-2807
e-mail: ktisocki@yahoo.ie, tisocki@hsc.edu.kw
Faculty of Pharmacy, Kuwait University
Kuwait
ktisocki@yahoo.ie

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E-DRUG: Drug donations - will we ever learn?: Action? (10)
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HAI Africa heartily welcomes EPN's call for action on revising the
medicines donations guidelines.

As an organization, our interest is in increasing access to medicines.
While one might assume donations would be simple and beneficial, or at
the very least not harmful, it is evident that medicines donations are
often complex to manage, and in certain circumstances may even be
dangerous.

Overall, for poor countries struggling to address the barriers to
accessing medicines for their populations, the problems and complexities
associated with medicines donations are a hindrance to their efforts in
developing sustainable health systems.

Among our chief concerns:

* When donations are found to be undesirable or inappropriate, it
is most often the receiving country left to manage the costly and
labour-intensive disposal.
* Rational medicines use, including the use of Standard Treatment
Guidelines and Essential Medicines Lists, may be abandoned in favour of
using a donated product.
* Certain medicine donations jeopardize competition from the
generic industry - since there is no avenue to compete with "free"
medicines, the generic manufacturers may abandon their products, thus
paving way for a future monopoly for the donor company's medicine.

As an organization we would, therefore, like to be involved in this
brainstorming activity.