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Introduction
These Guidelines for
drug donations have been developed by the World Health Organization (WHO) in cooperation with the major international agencies active in humanitarian relief.
The
first version was issued in May 1996 and represented the consensus of WHO, Churches' Action for Health of the World Council of Churches, the International
Committee of the Red Cross, the International Federation of Red Cross and Red Crescent Societies, Médecins Sans Frontières, the Office of the United Nations
High Commissioner for Refugees, OXFAM and the United Nations Children's Fund. In 1999 the number of co-sponsors expanded to include Caritas Internationalis,
the International Pharmaceutical Federation, Pharmaciens Sans Frontières, UNAIDS, the United Nations Development Programme, the United Nations Population Fund
and the World Bank.
The
Guidelines aim to improve the quality of drug donations, not to hinder them. They are not an international regulation, but are intended to serve as a basis for
national or institutional guidelines, to be reviewed, adapted and implemented by governments and organizations dealing with drug donations.
The
original Guidelines were based on several rounds of consultation and comments by over 100 humanitarian organizations and individual experts. In 1996 WHO was
requested by the World Health Assembly, in resolution WHA49.14, to review the experiences with the guidelines after one year. In autumn 1997 WHO's Action
Programme on Essential Drugs therefore initiated a global review of first-year experiences. The results of the review are presented in the forthcoming document
First-year experiences with the interagency guidelines for drug donations. The evaluation formed the basis for the changes in the text. In general, experiences
with the Guidelines were very positive. But there were complaints that the authorities in some recipient countries strictly adhered to the Guidelines, without
regard for the exceptions specifically included, and as a result useful donations were lost. For example, problems were reported with Guideline 6:
"donated drugs should have a remaining shelf-life of 12 months upon arrival in the recipient country". However, the problems arose from
misunderstanding of or failure to refer to the stated exceptions to that guideline, rather than from the text of Guideline 6 itself. In this revised edition
Guideline 6 has been modified. It now allows for direct donations of drugs with a remaining shelf-life of less than one year to specific health facilities,
provided assurance can be given that the drugs can be used prior to expiration.
There
are many different scenarios for drug donations. They may take place in acute emergencies or as part of development aid in non-emergency situations. They may
be corporate donations (direct or through private voluntary organizations), aid by governments, or donations aimed directly at single health facilities. And
although there are legitimate differences between these scenarios, there are many basic rules for an appropriate donation that apply to all. The Guidelines aim
to describe this common core of "Good Donation Practice".
This
document starts with a discussion on the need for guidelines, followed by a presentation of the four core principles for drug donations. The guidelines for
drug donations are presented in Chapter IV. When necessary for specific situations, possible exceptions to the general guidelines are indicated. Chapter V
gives some suggestions on other ways that donors may help, and Chapter VI contains practical advice on how to implement a policy on drug donations.
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These
Guidelines are not international regulations; they are intended to serve as a basis for national or institutional guidelines, to be
reviewed, adapted and implemented by governments and organizations dealing with drug donations.
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I - The need for guidelines
In the face of disaster and suffering there is a natural human impulse to reach out and help those in need. Medicines are an essential element in alleviating suffering, and international humanitarian relief efforts can greatly benefit from donations of
appropriate drugs.
Unfortunately, there are also many examples of drug donations which cause
problems instead of being helpful. A sizeable disaster does not always lead to an objective assessment of emergency medical needs based on epidemiological data
and past experience. Very often an emotional appeal for massive medical assistance
is issued without guidance on what are the priority needs. Numerous examples of inappropriate drug donations have been reported (see Annex). The main problems
can be summarized as follows:
- Donated drugs are often not relevant for the emergency situation, for the
disease pattern or for the level of care that is available. They are often unknown by local health professionals and patients, and may not comply with
locally agreed drug policies and standard treatment guidelines; they may even be dangerous.
- Many donated drugs arrive unsorted and labelled in a language which is not easily understood. Some donated drugs come under trade names which are
not registered for use in the recipient country, and without an International Nonproprietary Name (INN, or generic name) on the label.
- The quality of the drugs does not always comply with standards in the donor country. For example, donated drugs may have expired before they reach the
patient, or they may be drugs or free samples returned to pharmacies by patients or health professionals.
- The donor agency sometimes ignores local administrative procedures for receiving and distributing medical supplies. The distribution plan of the donor
agencies may conflict with the wishes of national authorities.
- Donated drugs may have a high declared value, e.g. the market value in the donor country rather than the world market price. In such cases import taxes
and overheads for storage and distribution may be unnecessarily high, and the (inflated) value of the donation may be deducted from the government drug
budget.
- Drugs may be donated in the wrong quantities, and some stocks may have to be destroyed. This is wasteful and creates problems of disposal at the
receiving end.
There are several underlying reasons for these problems. Probably the most
important factor is the common but mistaken belief that in an acute emergency any
type of drug is better than none at all. Another important factor is a general lack of
communication between the donor and the recipient, leading to many unnecessary donations. This is unfortunate because in disaster situations and war zones
inappropriate drug donations create an extra workload in sorting, storage and
distribution and can easily overstretch the capacity of precious human resources and
scarce transport volume. Often, the total handling costs (duties, storage, transport)
are higher than the value of the drugs. Stockpiling of unused drugs can encourage pilfering and black market sales.
Donating returned drugs (unused drugs returned to a pharmacy for safe disposal, or
free samples given to health professionals) is an example of double standards because in most countries their use would not be permitted due to quality control
regulations. Apart from quality aspects, such donations also frustrate management
efforts to administer drug stocks in a rational way. Prescribers are confronted with
many different drugs and brands in ever changing dosages; patients on long-term treatment suffer because the same drug may not be available the next time. For
these reasons this type of donation is forbidden in an increasing number of countries and is generally discouraged.
In the early 1980s the first guidelines for drug donations were developed by
international humanitarian organizations, such as the International Committee of the Red Cross (ICRC) and the Christian Medical Commission (CMC) of the World
Council of Churches, later called Churches' Action for Health. In 1990 the WHO Action Programme on Essential Drugs, in close collaboration with the major
international emergency aid agencies, issued a first set of WHO guidelines for donors (1) later refined by the WHO Expert Committee on the Use of Essential
Drugs.(2) In 1994 the WHO office in Zagreb issued specific guidelines for humanitarian assistance to former Yugoslavia.(3)
In view of the existence of these different drug donation guidelines the need was felt
for one comprehensive set of guidelines that would be endorsed and used by all
major international agencies active in emergency relief. For this reason a first draft
was prepared by the WHO Action Programme on Essential Drugs and further refined
in close collaboration with the division of Drug Management and Policies and the division of Emergency and Humanitarian Action, major international relief
organizations and a large number of international experts. The final text represents
the consensus between the World Health Organization, UNICEF, the Office of the
United Nations High Commissioner for Refugees, the International Committee of the
Red Cross, the International Federation of Red Cross and Red Crescent Societies, Churches' Action for Health of the World Council of Churches, Médecins sans
Frontières and OXFAM. In the process comments by over 100 humanitarian organizations and individual experts were taken into consideration.
The examples of inappropriate donations quoted above constitute ample reasons to
develop international guidelines for drug donations. In summary, guidelines are needed because:
- Donors intend well, but often do not realize the possible inconveniences and
unwanted consequences at the receiving end.
- Donor and recipient do not communicate on equal terms. Recipients may need support in specifying how they want to be helped.
- Drugs do not arrive in a vacuum. Drug needs may vary between countries and from situation to situation. Drug donations must be based on a sound
analysis of the needs, and their selection and distribution must fit within existing drug policies and administrative systems. Unsolicited and
unnecessary drug donations are wasteful and should not occur.
- The quality requirements of drugs are different from other donated items, such as food and clothing. Drugs 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.
II - Core Principles
The twelve articles of the Guidelines for Drug Donations are based on four core
principles. The first and paramount principle is that a drug donation should benefit the
recipient to the maximum extent possible. This implies that all donations should be based on an expressed need and that unsolicited drug donations are to be
discouraged. The second principle is that a donation should be given with full respect
for the wishes and authority of the recipient, and be supportive of existing government
health policies and administrative arrangements. The third principle is that 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. The fourth principle is that
there should be effective communication between the donor and the recipient: donations should be based on an expressed need and should not be sent unannounced.
Core principles of a donation
- Maximum benefit to the recipient
- Respect for wishes and authority of the recipient
- No double standards in quality
- Effective communication between donor and recipient
III - Guidelines for drug donations
Selection of drugs
1. All drug donations should be based on an expressed need and be relevant
to the disease pattern in the recipient country. Drugs should not be sent without prior consent by the recipient.
Justification and explanation
This provision stresses the point that it is the prime responsibility of the recipients to specify their needs. It is intended to prevent unsolicited donations, and donations which arrive unannounced and unwanted. It also empowers the recipients to refuse unwanted gifts.
Possible exceptions
In acute emergencies the need for prior consent by the recipient may be waived, provided the drugs are amongst those from the WHO Model List of Essential Drugs(4) that are included in the UN list of emergency relief items recommended for use in acute emergencies.(5)
2. 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.
Justification and explanation
This provision is intended to ensure that drug donations comply with national drug policies and essential drugs programmes. It aims at maximizing
the positive impact of the donation, and prevents the donation of drugs which are unnecessary and/or unknown in the recipient country.
Possible exceptions
An exception can be made for drugs needed in sudden outbreaks of uncommon or newly emerging diseases, since such drugs may not be
approved for use in the recipient country.
3. The presentation, strength and formulation of donated drugs should, as
much as possible, be similar to those commonly used in the recipient country.
Justification and explanation
Most staff working at different health care levels in the recipient country have been trained to use a certain formulation and dosage schedule and
cannot constantly change their treatment practices. Moreover, they often have insufficient training in performing the necessary dosage calculations
required for such changes.
Quality assurance and shelf-life
4. All donated drugs should be obtained from a reliable source and comply
with quality standards in both donor and recipient country. The WHO Certification Scheme on the Quality of Pharmaceutical Products Moving in
International Commerce(6) should be used.
Justification and explanation
This provision prevents double standards: drugs of unacceptable quality in the donor country should not be donated to other countries. Donated drugs should be authorized for sale in the country of origin, and manufactured in accordance with international standards of Good Manufacturing Practice
(GMP).
Possible exceptions
In acute emergencies the use of the WHO Certification Scheme may not be
practical. However, if it is not used, a justification should be given by the donor. When donors provide funds to purchase drugs from local producers,
those which comply with national standards should not be excluded on the sole grounds that they do not meet quality standards of the donor country.
5. No drugs 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.
Justification and explanation
Patients return unused drugs to a pharmacy to ensure their safe disposal; the same applies to drug samples that have been received by health workers. In
most countries it is not allowed to issue such drugs to other patients, because their quality cannot be guaranteed. For this reason returned drugs
should not be donated either. In addition to quality issues, returned drugs are very difficult to manage at the receiving end because of broken packages
and small quantities involved.
6. After arrival in the recipient country all donated drugs should have a
remaining shelf-life of at least one year. An exception may be made for direct donations to specific health facilities, provided that: the responsible
professional at the receiving end acknowledges that (s)he is aware of the shelf-life; and that the quantity and remaining shelf-life allow for proper
administration prior to expiration. In all cases it is important that the date of arrival and the expiry dates of the drugs be communicated to the recipient
well in advance.
Justification and explanation
In many recipient countries, and especially under emergency situations, there are logistical problems. Very often the regular drug distribution system
has limited possibilities for immediate distribution. Regular distribution through different storage levels (e.g. central store, provincial store, district
hospital) may take six to nine months. This provision especially prevents the donation of drugs just before their expiry, as in most cases such drugs would
only reach the patient after expiry. It is important that the recipient official responsible for acceptance of the donation is fully aware of the quantities of
drugs being donated, as overstocking may lead to wastage. The argument that short-dated products can be donated in the case of acute emergencies,
because they will be used rapidly, is incorrect. In emergency situations the systems for reception, storage and distribution of drugs are very often
disrupted and overloaded, and many donated drugs tend to accumulate.
Additional exception
Besides the possible exception for direct donations mentioned above, an exception should be made for drugs with a total shelf-life of less than two
years, in which case at least one-third of the shelf-life should remain.
Presentation, packing and labelling
7. All drugs should be labelled in a language that is easily understood by
health professionals in the recipient country; the label on each individual container should at least contain the International Nonproprietary Name (INN,
or generic name), batch number, dosage form, strength, name of manufacturer, quantity in the container, storage conditions and expiry date.
Justification and explanation
All donated drugs, including those under brand name, should be labelled also with their INN or the official generic name. Most training programmes are based on the use of generic names. Receiving drugs under different and often unknown brand names and without the INN is confusing for health
workers and can even be dangerous for patients. In case of injections, the route of administration should be indicated.
8. As much as possible, donated drugs should be presented in larger quantity
units and hospital packs.
Justification and explanation
Large quantity packs are cheaper, less bulky to transport and conform better with public sector supply systems in most developing countries. This
provision also prevents the donation of drugs in sample packages, which are impractical to manage. In precarious situations, the donations of paediatric
syrups and mixtures may be inappropriate because of logistical problems and their potential misuse
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9. All drug donations 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 by INN, dosage form,
quantity, batch number, expiry date, volume, weight and any special storage conditions. The weight per carton should not exceed 50 kilograms. Drugs
should not be mixed with other supplies in the same carton.
Justification and explanation
This provision is intended to facilitate the administration, storage and distribution of donations in emergency situations, as the identification and
management of unmarked boxes with mixed drugs is very time and labour intensive. This provision specifically discourages donations of small
quantities of mixed drugs. The maximum weight of 50 kg ensures that each carton can be handled without special equipment.
Information and management
10. Recipients should be informed of all drug donations that are being
considered, prepared or actually underway.
Justification and explanation
Many drug donations arrive unannounced. Detailed advance information on all drug donations is essential to enable the recipient to plan for the receipt of the donation and to coordinate the donation with other sources of supply. The information should at least include: the type and quantities of donated
drugs including their International Nonproprietary Name (INN or generic name), strength, dosage form, manufacturer and expiry date; reference to
earlier correspondence (for example, the letter of consent by the recipient); the expected date of arrival and port of entry; and the identity and contact
address of the donor.
11. In the recipient country the declared value of a drug donation should be
based upon the wholesale price of its generic equivalent in the recipient country, or, if such information is not available, on the wholesale
world-market price for its generic equivalent.
Justification and explanation
This provision is needed in the recipient country to prevent drug donations being priced according to the retail price of the product in the donor country,
which may lead to elevated overhead cost for import tax, port clearance, and handling in the recipient country. It may also result in a corresponding
decrease in the public sector drug budget in the recipient country.
Possible exception
In case of patented drugs (for which there is no generic equivalent) the wholesale price of the nearest therapeutic equivalent could be taken as a reference.
12. Costs of international and local transport, warehousing, port clearance
and appropriate storage and handling should be paid by the donor agency, unless specifically agreed otherwise with the recipient in advance.
Justification and explanation
This provision prevents the recipient from being forced to spend effort and money on the clearance and transport of unannounced consignments of
unwanted items, and also enables the recipient to review the list of donated items at an early stage.
IV - Other ways donors can help
The New Emergency Health Kit
In the acute phase of an emergency, or in the case of displacements of refugee
populations without any medical care, it is better to send a standardized kit of drugs
and medical supplies that is specifically designed for this purpose. For example, the New Emergency Health Kit,(7) which has been widely used since 1990, contains
drugs, disposable supplies and basic equipment needed for general medical care for
a population of 10,000 for three months. Its contents are based on a consensus
among the same group of major international aid agencies that also issued the drug
donation guidelines. It is permanently stocked by several major international
suppliers (for example, UNICEF and IDA) and can be available within 48 hours. It is especially relevant in the absence of specific requests.
Donations in cash
After the acute phase of the emergency is over, a donation in cash for local or
regional purchase of essential drugs is usually much more welcome than further drug
donations in kind. Such a cash contribution is very supportive to the activities of the
local government or coordinating committee, it is supportive to the local and regional
pharmaceutical industry and it may also be more cost-effective. In addition, prescribers and patients are usually more familiar with locally produced drugs.
Additional guidelines for drug donations as part of development aid
When drug donations are given between governments as humanitarian support to
longlasting complex emergencies and as regular development (commodity) aid there
is usually more time to consider specific demands from the side of the recipient. On
the other hand, there is also time to link more restrictions to the donation, e.g. to
products from manufacturers in the donor country, and to drugs registered for use in the recipient country.
It should be recognized that drugs do not arrive in an administrative vacuum. drug
donations should not create an abnormal situation which may obstruct or delay
national capacity building in selection, procurement, storage, distribution and rational
use of drugs. Special care should therefore be taken that the donated drugs respond
to an expressed need, comply with the national drug policy, and are in accordance
with national treatment guidelines in the recipient country. Administratively, the drugs
should be treated as if they were procured. This means that they should be registered or authorized for use in the country through the same procedure that is
used for government tenders. They should be entered into the inventory, distributed
through the existing distribution channels and be subject to the same quality assurance procedures. If cost-sharing procedures are operational in the recipient
country, the donated drugs should not automatically be distributed free of charge.
V - How to implement a policy on drug donations
Management of drug donations by the recipient
Define national guidelines for drug donations
It is difficult for a recipient to refuse a donation that has already arrived. Prevention is
therefore better than cure. Recipients should indicate to their prospective donors
what kind of assistance they need, and how they would like to receive it. If this
information is provided in a professional way, most donors will appreciate it and will comply.
Therefore, recipients should first formulate their own national guidelines for drug
donations, on the basis of these international guidelines. They can also be included
in the national drug policy. These national guidelines should then be officially presented and explained to the donor community. Only after they have been
presented and officially published can they be enforced.
Define administrative procedures for receiving drug donations It is not enough for the
recipient to adopt and publish the general guidelines on the selection, quality,
presentation and management of drug donations. Administrative procedures need to
be developed by the recipient to maximize the potential benefit of drug donations. As
much as possible such arrangements should be linked with existing drug supply
systems, but there are several questions which apply to donations only. Examples of such important questions, which have to be addressed in each country, are:
- Who is responsible for defining the needs, and who will prioritize them?
- Who coordinates all drug donations?
- Which documents are needed when a donation is planned; who should receive them?
- Which procedure is used when donations do not follow the guidelines?
- What are the criteria for accepting/rejecting a donation; who makes the final
decision?
- Who coordinates reception, storage and distribution of the donated drugs?
- How are donations valued and entered into the budget/expenditure records?
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