E-DRUG: FIP-statement on drug donations

[Wemos <Wemos@tip.nl>]

E-DRUG: FIP-statement on drug donations
---------------------------------------

Dear E-druggers,

The FIP (International Pharmaceutical Federation) adopted
a statement of principle on guidelines for drug donations 
at its world congress held in September at Vancouver, Canada.

In the statement, it is explicitly stated that pharmacists 
should be involved, either directly or by advising others, 
in the arrangements for donations of medicines. The text also 
states that returned drugs should not be donated. The statement 
mainly follows the guidelines for drug donations as published 
by the WHO in 1996. 

The concept of essential drugs is however not mentioned in 
the text of the statement. 'Essential drugs' are vital in the understanding of the guidelines for drug donations. Also the 
statement is not quite clear about the one-year shelf-life 
requirement as described in guideline number 6 of the 
guidelines for drug donations. 

I am reproducing the FIP statement below. Other e-druggers 
interested commenting on it, please contact me at Wemos by 
email at wemos@tip.nl.

Thank you and best regards from Amsterdam,

Mark Raijmakers
Program Coordinator
Wemos Foundation
________________________________________________________
The Wemos Foundation is a Dutch non-profit organisation 
that addresses international health issues through policy 
advocacy and education activities. 
          Wemos Foundation
(ADR)     P.O. Box 1693
          1000 BR Amsterdam
          The Netherlands
(TEL)     +31-20-420.22.22
(FAX)     +31-20-620.50.94
(EMA)     wemos@tip.nl (NEW address since April 1, 1997)
(WWW)     http://www.antenna.nl/wemos (under construction)
________________________________________________________
Here's the FIP-statement on drug donations:

--------------------------------------------------------------
GOOD PRACTICE IN DONATIONS OF MEDICINES

This statement was adopted by the Council of the 
International Pharmaceutical Federation (FIP) at its 
Council meeting in Vancouver on 5th September 1997.

Preface:
This statement is intended for pharmacists and others 
to use in donor countries (countries from which donated 
medicines are obtained). More extensive advice for those 
working in recipient countries (countries where donated 
medicines are to be used) can be found in a WHO document
entitled Guidelines for Drug Donations (WHO/DAP/96.2) 
issued in May 1996.

Introduction:
(1) This statement aims to improve the quality of medicine
donations, not to hinder them. It is intended to serve as 
a basis for national guidelines, to be reviewed, adapted 
and implemented by national pharmaceutical associations in 
giving advice to pharmacists, agencies involved in the 
donation of medicines and government departments. There are 
many different scenarios for the donation of medicines. They
may take place in acute emergencies or as part of development 
aid in non-emergency situations. There are many basic rules 
for an appropriate donation that apply to all scenarios.
Medicines are an essential element in international 
humanitarian relief efforts.

(2) There are many examples of donations of medicines that 
cause problems instead of being helpful.

Examples of such problems include:
(a) Donated medicines are often not relevant for the 
emergency situation,
(b) Many donated medicines arrive unsorted and labelled in a 
language which is not easily understood,
(c) The quality of the donated medicines does not always 
comply with standards in the donor country,
(d) Medicines may be donated in the wrong quantities,
(e) The common but mistaken belief is that, in an acute 
emergency, any type of medicine is better than none at all,
(f) A  general lack of communication between the donor and 
the recipient may lead to many unnecessary donations. This is unfortunate because in disaster situations and war zones 
inappropriate donations of medicines create an extra workload 
in sorting, storage and distribution and can easily overstretch 
the capacity of scarce human resources and transport facilities.
(g) Donating unused medicines returned to a pharmacy for safe disposal, or free samples given to health professionals are 
examples of double standards because in most countries their use 
would not be permitted due to concerns about quality. For this 
reason this type of donation is forbidden in an increasing number 
of countries and is generally discouraged.

(3) This Statement gives guidance because:
(a) Donors intend well, but often do not realise the possible
inconveniences and unwanted consequences at the receiving end.
(b) Donor and recipient may not communicate effectively.
(c) Medicine needs may vary between countries and from situation 
to situation.
(d) The donation of medicines must be based on a sound analysis 
of the needs, and their selection and distribution must fit 
within existing health policies and administrative systems.
(e) Unsolicited and unnecessary donations of medicines are 
wasteful and should not occur.
(f) The quality requirements for medicines are different from 
other donated items, such as food and clothing. Medicines can 
be harmful if misused, they need to be identified easily 
through labels and written information, they may expire, and 
they may have to be destroyed in a professional way.

Taking into account this introduction and these definitions, it
is the policy of FIP that:

Pharmacists should be involved, either directly or by advising 
others, in the arrangements for donations of medicines and 
should seek to ensure that the following four principles are 
complied with:

1. Donated medicines should benefit the recipient to the 
maximum extent possible. This implies that all donations should 
be based on an expressed need and that unsolicited medicine 
donations are to be discouraged.
2. A donation of medicines should only take place with full 
respect for the wishes and authority of the recipient, and be supportive of existing government health policies and 
administrative arrangements.
3. 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.
4. There should be effective communication between the donor and 
the recipient. Donations should never be sent unannounced

In order to comply with these principles the following 
additional guidance is given:
(a) All donated medicines, or their generic equivalents, should 
be approved for use in the recipient country.
(b) The presentation, strength and formulation of donated 
medicines should, as much as possible, be similar to those 
commonly used in the recipient country.
(c) All donated medicines should be obtained from a reliable 
source and comply with quality standards in both donor and 
recipient country. As a minimum standard all medicines should be manufactured in accordance with Good Manufacturing Practice. This should be confirmed by use of the WHO Certification Scheme on the Quality of Pharmaceutical Products moving in International 
Commerce.
(d) No medicines should be donated that have been issued to 
patients and then returned to a pharmacy or elsewhere, or were 
given to health professionals as free samples.
(e) All donated medicines should have an appropriate shelf life.
Normally a shelf life should be at least one year from the time 
of arrival in the recipient country. Where a shorter shelf life 
is appropriate then the donor is responsible for ensuring that 
the health professional at the receiving end is aware of the 
shelf life, the remaining shelf life allows for the proper 
administration of the medicine and that the date of arrival is communicated to the recipient well in advance.
(f) All medicines should be labelled in a language that is 
understood by health professionals in the recipient country. The 
label on each individual container must include the generic name (whenever possible the international non-proprietary name - INN -
 or the national non-proprietary name), batch number, dosage form, strength, name of manufacture, quantity in the container, storage conditions and expiry.
(g) As much as possible, donated medicines should be presented in larger quantity units and hospital packs that can be easily subdivided.
(h) All donated medicines should be packed in accordance with
international shipping regulations, and be accompanied by a 
detailed packing list which specifies the contents of each 
numbered carton. The packing list should contain the same 
information as the label on each individual container 
(see f. above). The weight per carton should not exceed 50 
kilograms. Medicines should not be mixed with other supplies
in the same carton.
(i) Recipients should be informed of all donations of medicines 
that are being considered or prepared and of progress when 
actually in transit.
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