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SADC/HM/2/2006/6.7a

SADC GUIDELINES FOR DRUG DONATIONS

INTRODUCTION

These Guidelines aim to improve the quality of drugdonations. There are many different scenarios for drugdonations. They may take place in acute emergencies or aspart of development aid in non-emergency situations. Theymay be corporate donations (direct or through privatevoluntary organizations), aid by governments, or donations

aimed directly at single health facilities. Although there arelegitimate differences between these scenarios, there aremany basic rules for an appropriate donation that apply toall. The Guidelines aim to describe this common core ofGood Donation Practice.

1. Before a donation is sent to a SADC membersstate, the recipient should be contacted by thepotential donor (or vice versa) in order to

establish the need for such medicines at thattime.This provision stresses the point that it is the primeresponsibility of the recipients to specify their needs. Itis intended to prevent unsolicited donations, anddonations which arrive unannounced and unwanted. Italso empowers the recipients to refuse unwanted gifts.

2. Donations must consist only of medicines ofknown good quality that are included in the list ofessential drugs supplied by the SADC memberstate, or in the absence of such a list are on theWHO Model List of Essential Drugs.It is expected that donors would comply with NationalDrug Policies and essential drug programmes and henceaim at the implementation of their components, such as

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the provision of medicines which are considered to benecessary in the treatment of diseases afflicting mostpeople in a SADC member state.

3. All donated medicines must be registered in thecountries of origin, and manufactured inconformity with the guidelines on GoodManufacturing Practices (GMP) and certifiedaccording to the WHO Certification Scheme On theQuality of Pharmaceutical Products Moving inInternational Commerce.

This provision prevents double standards: drugs ofunacceptable quality in the donor country should not bedonated to other countries. Donated drugs should beauthorized for sale in the country of origin, andmanufactured in accordance with international standardsof Good Manufacturing Practice (GMP). This also guardsagainst fake or substandard products.

4. No drugs should be donated that have been

issued to patients and then returned to apharmacy or elsewhere, or were given to healthprofessionals as free samples.Patients return unused drugs to a pharmacy to ensuretheir safe disposal; the same applies to drug samplesthat have been received by health workers. In mostcountries it is not allowed to issue such drugs to otherpatients, because their quality cannot be guaranteed.For this reason returned drugs should not be donated

either. In addition to quality issues, returned drugs arevery difficult to manage at the receiving end because ofbroken packages and the small quantities involved.

5. All drugs should be labelled in at least one officiallanguage of the recipient members state; the label

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on each individual container should at leastcontain the International Non-proprietary Name(INN) or generic name, batch number, dosageform, strength, name of manufacturer, quantity in

the container, storage conditions and expiry date.All donated drugs, including those under brand name,should be labelled also with their INN or the officialgeneric name. The INNs are internationally known andunderstood in any country where Roman script is used.Most training programmes are based on the use ofgeneric names. Receiving drugs under different andoften unknown brand names and without the INN isconfusing for health workers and can even be dangerousfor patients. In the case of injections, the route of

administration should be indicated.

6. After arrival in the recipient member state alldonated drugs should have a remaining shelf-lifeof at least one year. An exception may be madefor direct donations to specific health facilities,provided that: the responsible professional at thereceiving end acknowledges that (s)he is aware ofthe shelf-life; and that the quantity and remaining

shelf-life allow for proper administration prior toexpiration. In all cases it is important that thedate of arrival and the expiry dates of the drugsbe communicated to the recipient well in advance.

This is because there may be a logistic problem indistribution, which may cause the medicines to reach thepatient after expiry. Very often the regular drugdistribution system has limited possibilities forimmediate distribution. Regular distribution throughdifferent storage levels (e.g. central store, provincial

store, district hospital) may take six to nine months. It isimportant that the recipient official responsible foracceptance of the donation is fully aware of thequantities of drugs being donated, as overstocking maylead to wastage.

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7. If medicine is sent to the same place orprogramme regularly, it is highly appreciated ifthe strength and dosage of such medicine couldremain constant.

The reason for this is that health workers at differentlevels of the health care system have been trained touse medicines in relation to a particular dosage andstrength, and treatment schedules have been developedaccordingly. Also, health workers with insufficienttraining in making necessary calculations to modifyschedules may end up giving wrong dosages.

8. As much as possible, donated drugs should be

presented in larger quantity units and hospitalpacks.These are less bulky, and therefore easier and cheaperto handle.

9. Costs of international and local transport,warehousing, port clearance and appropriatestorage and handling should be paid by the donoragency, unless specifically agreed otherwise withthe recipient in advance.This provision prevents the recipient from being forcedto spend effort and money on the clearance andtransport of unannounced consignments of unwanteditems, and also enables the recipient to review the list ofdonated items at an early stage.