E-DRUG: Returned medicines and drug donations
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Dear Colleagues,
I am carrying out research on behalf of the Royal Pharmaceutical
Society of Great Britain on medicines that have been returned to
pharmacies and whether these should be used in international drug
donations.
Currently the WHO Guidelines for Drug Donantions (revised 1999) state
that 'no drugs should be donated that have been issued to patients
and then returned to a pharmacy or elsewhere'.
I am looking for research evidence that either supports or
contradicts that WHO position and I am hoping members of this list
may be aware of work that has looked at this subject. I would be
grateful for any opinions or resources on this issue.
This issue was recently the subject of the article: 'Returned
Medicines: waste or a wasted opportunity?' By. Mackridge AJ and
Marriott JF and published in the Journal of Public Health in 2007.
Abstract: http://jpubhealth.oxfordjournals.org/cgi/content/abstract/
29/3/258
Many thanks,
Colin Meek
colin@ardessie.com
Consultant to Royal Pharmaceutical Society of Great Britain.
Professional Ethics, Practice and Quality Improvement Directorate.
[Whereas I applaud efforts to take a fresh look at any established concept, I really wonder whether we should continue to investigate the usefulness of sending second hand and near-expiry medicines to poorer countries. After some 20 years of work by a variety of individuals and groups to explain the undesirability of drug donations, and a clear consensus by most international players, the subject continues to surface at almost predictable moments. If there is a desire to help the poorer countries to meet their essential medicines needs, wouldn't it be better to just help them to procure it from the international not-for-profit sources? HH, E-drug moderator]
E-DRUG: Returned medicines and drug donations (2)
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There is ample evidence that returned medicines are absolutely
inappropriate for donating to developing countries. The International
Guidelines on Drug Donations and countries own national versions of the
guidelines all support this stand.
After the tsunami that hit particularly Aceh and Sri Lanka, further
detailed documentation and graphic descriptions of the chaos caused by
inappropriate donations, re-emphasised the need for promulgation of the
guidelines to control inappropriate donations.
New pharmaceutical legilsation in Fiji enshrines the policy for all
pharmaceuitcals donations (emergency and non-emergency) in law and
provides for penalties for donors who cotravene the policy.
The Sri Lanka and Aceh reports on inappropriate donations
are available here:
*Beverley Snell*
*Senior Fellow*
*Centre for International Health*
*Macfarlane Burnet Institute for Medical Research & Public Health *
*GPO Box 2284, Melbourne 3001 Australia*
*http://www.burnet.internationalhealth.edu.au***
*Telephone 613 9282 2115 / 9282 2275*
*Fax 61 3 9282 2144 or 9282 2100*
*Time zone: 10 hours ahead of GMT.*
*email <bev@burnet.edu.au>*
*Site: Alfred Medical Research & Education Precinct (AMREP),*
*85 Commercial Road, Prahran 3004*
E-DRUG: Returned medicines and drug donations (3)
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Dear E-druggers,
Whilst I know of no research that has been done on this subject, I know from
conversaions with members of the Drug Regulatory Authorities in some of the
recipient countries how dangerous these donations can be, since they are
often brought into the country without the normal QA/QC checks being carried
out. Also, this contravenes the GDP requirements for treatment of
non-defective returns, which can only be re-used if they are properly
assessed and the history of their previous use and storage is known.
E-DRUG: Returned medicines and drug donations (14)
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Does the fact that the Royal Pharmaceutical Society of Great Britain is
carrying out reseach on returned medicines to be used in INTERNATIONAL (my
emphasis) drug donations say somehting about double standards???. Why not
for reuse in GB? I am disappointed that, today, RPSGB can actually think of
doing this.
Eva Ombaka
Coordinator,
Ecumenical Pharmaceutical Network,
P. O. Box 73860-00200,
Nairobi, Kenya.
Tel: 254-20-4444832/ 4445020
Fax: 254-20-4441090
Email: eombaka@epnetwork.org
Website: www.epnetwork.org
E-DRUG: Returned medicines and drug donations (15)
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Like other members of e-drug, I too am startled and concerned that the
RPSGB has chosen to revisit this issue. It would be helpful to know from
Colin Meek what has given rise to this.
As a long-time member of the Society, I was happy that, after previous
debates over several years, the Society included in its "Medicines,
Ethics and Practice" publication a statement that pharmacists should not
be involved in recycling medicines. However, I can't now see this
statement in the current web-based publication at: http://www.rpsgb.org/informationresources/downloadsocietypublications/#g
This may be because the Society has thought that the UK Hazardous Waste
Regulations introduced in 2005 were restrictive enough to have wiped out
the business of recycling. But the fact that Colin Meek has been asked
to work on the issue suggests that the issue is still live in the UK.
Pharmacists are still however, obliged to "Be satisfied as to the
integrity and quality of products to be supplied to patients" (Ethics
Code 1.6)
The Inter-Agency Guidelines for Drug Donations are pretty clear and well
argued. However, I know of various organizations that focus more on
supplying unwanted medicines to keep individuals' treatment going (for
example with ARV treatment) or to support small clinics in rural areas.
The Guidelines don't say anything about this kind of support and maybe
some new guidance is needed to set out what is ethical and safe in this
area?
Carolyn Green
Senior Advisor: Training
Global Fund Support Team
International HIV/AIDS Alliance, Brighton, BN1 3XF, UK
E-mail: cgreen@aidsalliance.org