Guidelines For Donations of Medicines and Health Care Equipment in Nigeria
Guidelines For Donations of Medicines and Health Care Equipment in Nigeria
Guidelines For Donations of Medicines and Health Care Equipment in Nigeria
BY
April, 2007
FOREWORD
I am delighted to write the foreword to these Guidelines for Donations of Medicines and Healthcare
Equipment in Nigeria.
The publication of the guidelines is in line with Governments drive to ensure good quality
healthcare for the Nigerian people. The National Drug Policy, which is a component of the Health
Sector Reform Programme of Government, provides for the development of guidelines for
medicines and healthcare equipment donations. The aim is to coordinate the current haphazard
donation of medicines and healthcare equipment to Nigeria. I am, therefore, pleased that this
aspect of the Reform Programme has been accomplished, after due consultations with the relevant
stakeholders.
The donation of medicines and healthcare equipment would, henceforth, enjoy a certain measure
of control as the guidelines clarify issues relating to donations and facilitate the involvement of all
actors in the donation process. The guidelines would ensure that any donations made would be
relevant to the emergency situation in question and also ensure that the medicines and equipment
donated would be safe and of good quality. We shall always welcome the kind gesture of donors
who have always extended a helping hand to us in times of emergency.
In conclusion, I would like to appreciate the commitment of the National Medicine and Healthcare
Equipment Donation Guidelines Committee. I commend also the inputs of the various stakeholders
to this document. The technical and financial support of the World Health Organisation is highly
appreciated.
I hereby enjoin all who will be involved in the implementation of these guidelines at the different
levels of government and agencies (Federal, State, LGAs, wharfs, airports, etc.) to adopt positive
attitudes that will facilitate all aspects of implementation. Government shall endeavour to provide
the enabling environment for the effective implementation of the guidelines.
The contributions of the following Ministries & agencies are gratefully acknowledged:
Abia State Ministry of Health
Centre for Disease Control
Delta State Ministry of Health
Department for International Development (of the British Government)
Federal Ministry of Science & Technology
GHAIN/ Family Health International
Health & Human Services Department, Federal Capital Territory
Nasarawa State Ministry of Health
National Action Committee on AIDs
National Agency for Food, Drug Administration and Control
National Emergency Management Agency
National Primary Healthcare Development Agency
Niger State Ministry of Health
Partnership for Transforming Health Systems (PATHS)
Pharmaceutical Manufacturing Group of the Manufacturers Association of Nigeria
Pharmaceutical Society of Nigeria
Pharmacists Council of Nigeria
Planned Parenthood Federation of Nigeria
University of Nigeria Teaching Hospital, Enugu
CORE PRINCIPLES12
1. INITIATION AND SOURCING OF MEDICINES AND EQUIPMENT DONATION. 13
1.1 Initiation of Donations. 13
1.2 Sourcing of Donations. 14
2. SPECIFIC REQUIREMENTS FOR MEDICINE DONATION..14
2.1 Approval for Use14
2.2 Presentation and Formulation..15
2.3 Quality Assurance and Shelf Life..15
2.4 Packaging and Labelling.17
3. SPECIFIC REQUIREMENTS FOR EQUIPMENT DONATION..19
General Quality and Safety..19
Obsolete Equipment..19
Appropriate Technology20
Installation and Operational Instruction..20
Maintenance...20
Used and Refurbished Equipment..20
Packaging and Shipping21
Customs Clearance...21
Installation and Commissioning...21
3.10 Evaluation and Feedback.21
Unfortunately, experience has shown that not all drug donations are beneficial as some donated drugs have
often not been relevant to the emergency situation for which they were donated (i.e., for the disease pattern
or level of care needed). Some donated drugs have caused more harm than good. They may sometimes be
unknown to local health professionals and patients and may not comply with the policies and standards of
the disaster region.
In light of this, the World Health Organisation (WHO) has developed General Guidelines for drug donation to
be adapted by member countries, in line with their drug policies. Consequently, the Federal Ministry of
Health, in collaboration with WHO, set out to develop Guidelines for Donations of Medicines and Healthcare
Equipment in Nigeria. This document is the outcome of the initiative.
A series of meetings were held with the different stakeholders which included the following:
1. National Emergency Management Agency,
2. National Agency for Food, Drug Administration and Control,
3. Pharmacists Council of Nigeria,
4. Pharmaceutical Society of Nigeria,
5. National Primary Healthcare Development Agency,
6. Pharmaceutical Manufacturing Group of the Manufacturers Association of Nigeria,
7. Federal Ministry of Science & Technology,
8. University of Nigeria Teaching Hospital, Enugu,
9. Department For International Development,
10. Partnership for Transforming Health Systems,
11. Planned Parenthood Federation of Nigeria,
12. National Action Committee on AIDs,
13. Health & Human Services Department, Federal Capital Territory,
14. GHAIN/ Family Health International,
15. Centre for Disease Control,
16. Niger State Ministry of Health, and
17. Abia State Ministry of Health.
3. THE RECIPIENT
Application to FMOH for approval of drugs being solicited from external donors
Application to NAFDAC for clearance of the FMOH approval
Bearing the cost of destruction of any sub-standard drugs received
Informing FMOH of unsolicited drug donations
4. THE DONOR
Informing recipients of drugs being considered for donation
After initial consultations, a draft which had been developed from the WHO General Guidelines was
circulated to all 36 States of the Federation for their inputs. Responses were received from five
States (including the F.C.T.) as follows:
i. Niger State Ministry of Health,
ii. Abia State Ministry of Health,
iii. Delta State Ministry of Health,
iv. Nasarawa State Ministry of Health, and
v. Health and Human services Dept. of the Federal Capital Territory.
Nasarawa State, Delta State and the F.C.T endorsed the draft as presented, while Niger and Abia
States made useful comments, some of which have been incorporated into the final draft.
Unfortunately, the donations do not always achieve their intended objectives. Some have caused
more problems than they set out to solve. An emotional appeal may be issued without a proper
assessment of the needs and priorities. Health care equipment may end up lying idle because the
technology and human resources required for their operation are not available locally. The
equipment may require huge maintenance costs beyond the capability of the recipient. Donated
equipment may be removed from service in the hospitals of an industrialised country and donated
to developing countries. Such equipment may never work. Where they work, lack of trained
operators, support facilities and spare parts may turn such donations into a liability for the
recipients.
The commonly encountered problems with medicines and medical equipment donations
may be summarised as follows:
Donated medicines are often not relevant for the emergency situation, the disease condition or
the level of trained human resources available to administer health care. They may be
unknown to local health professionals, and not in line with the countrys drug policies and
treatment guidelines;
Donated medicines may arrive unsorted and there may be problems with adequate storage
and distribution. These may waste valuable human and financial resources;
Many donated medicines may be labelled in a language that is not understood in the recipient
country. They may also be labelled with trade names, which are not registered for use in
Nigeria and carry no generic name;
The quality of donated medicines does not always comply with standards in the donor country.
Donated medicines may have expired before reaching the recipient country, or they may be
free samples returned by health professionals;
These problems arise owing to several factors. A critical factor is the general lack of
communication between donor and recipient. Another important factor is the belief that in a disaster
situation, any type of donation is better than none at all. With wrong donations, the total handling
cost may be higher than the total value of donated items. Excess medicines and equipment, when
stockpiled in the system will encourage pilferage and black market sales. Health care needs and
required professional competences vary amongst various levels in the country. Consequently, it is
imperative that aid interventions in the form of medicines and health care equipment be linked to
the technology, expertise and expressed need within the Nigerian health care delivery system.
Core Principles
The following Guidelines for the donation of medicines and health care equipment are based on
four core principles as follows:
The donation should benefit the recipient. Donations should, therefore, be based on
expressed need. Unsolicited donations of medicines, medical equipment and devices are
to be discouraged and donations must not be sent unannounced;
A donation should be made with full respect for the wishes and authority of the recipient,
and should be supportive of existing government health policies and administrative
arrangements;
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; and
SCOPE
The Guidelines shall be applicable to all donations of medicines and health care equipment within
Nigeria and shall include donations emanating from internal as well as external donors.
External donors refer to governments of other countries and corporate bodies, acting directly or
through voluntary organisations, non-governmental organisations and individuals wishing to make
donations from outside Nigeria.
Internal donors refer to corporate bodies, organisations and individuals operating and /or residing
within Nigeria and wishing to make donations at any level of the health care delivery system in
Nigeria.
Donations should not be sent without the prior consent of the recipient. The recipient should
prepare the request, clearly identifying the needs and prioritising them.
The written request should be backed up by an approval from a competent authority in Nigeria.
Explanatory notes:
This provision stresses the point that it is the prime responsibility of the recipients to specify their
needs. Recipients are empowered to refuse unwanted gifts. It is also intended to prevent
unsolicited donations and those that arrive unannounced. At the end of these Guidelines are lists of
typical medicines and equipment required in emergencies. The objective of the lists is to facilitate
the process of making donations. They are intended to guide, both donors and recipients.
Explanatory note:
This provision is intended to ensure that donations comply with national drugs policies and
essential drugs programmes. The aim is to maximise the positive impact of a donation and prevent
the donation of medicines that are unnecessary and/or unknown in Nigeria.
Possible exception:
An exception can be made for medicines needed in sudden outbreaks of uncommon or newly
emerging diseases and other specific medicines requested by the recipient.
Explanatory note:
Most health workers at different health care levels in Nigeria have been trained to use certain
formulations and dosage schedules and cannot constantly change their treatment practices. They
often have insufficient training in performing the necessary dosage calculations required for sudden
changes.
2.3.1 All donated medicines should be obtained from a reliable source and comply with
quality standards in both donor country and Nigeria. The WHO Certification Scheme on the
Quality of Pharmaceutical Products Moving in International Commerce should be used.
Explanatory note
This provision prevents double standards: medicines of unacceptable quality in the donor country
should not be donated to other countries. Donated medicines should be authorised for sale in the
country of origin and manufactured in accordance with international standards of Good
Manufacturing Practice (GMP).
Possible exceptions:
2.3.2 No medicines should be donated that have been previously issued to patients and
then returned to a pharmacy or elsewhere, or were given to health professionals as free
samples.
Explanation:
Patients return unused medicines to a pharmacy to ensure their safe disposal; the same applies to
samples that have been received by health workers. In most countries, it is not allowed to issue
such medicines to other patients, because their quality cannot be guaranteed. For this reason,
returned medicines should not be donated either. In addition to quality issues, returned medicines
are very difficult to manage at the receiving end because of broken packages and the small
quantities involved.
2.3.3 All donated medicines should have at least 50% of its normal shelf-life on arrival in the
country.
Explanation:
In many recipient countries, and especially under emergency situations, there are logistical
problems. Regular distribution through different storage levels (e.g., central store, Federal, State,
and primary health care facilities) may take one to three months. This provision especially
prevents the donation of medicines just before their expiry, as in most cases such medicines would
only reach the patient after expiry. Additionally, it is important that the recipient is fully aware of the
quantities of medicines being donated, as overstocking may lead to wastage. The argument that
short-dated products can be donated in cases of acute emergency because they will be used
rapidly is incorrect. In emergency situations, the systems for the reception, storage and distribution
of medicines are very often disrupted and overloaded and many donated medicines tend to
accumulate.
Explanation:
All donated medicines, including those under brand names, should also be labelled with their INN
or the official generic names. Most training programmes are based on the use of generic names.
Receiving medicines under different and often unknown brand names and without their INN is
confusing for health workers and can even be dangerous for patients. In the case of injections, the
specific route of administration should be indicated.
2.4.2 Donated medicines should be presented in larger quantity units and hospital packs
except where impracticable.
Explanation:
Large quantity packs are cheaper, less bulky to transport and conform better with public sector
supply systems. This provision also prevents the donation of medicines in sample packages, which
are impractical to manage.
2.4.3 All medicines for donation should be packed in strong outer cartons and be
accompanied by a detailed packing list which should specify the content of each carton by
generic name, quantity and expiry date. Cartons should be numbered and the contents of
each carton listed in detail in the accompanying document. In addition, the contents of
cartons should be marked on the outside of cartons, preferably using a code system.
Explanation:
This provision is intended to facilitate the administration, storage and distribution of donations in
emergency situations. The identification and management of unmarked boxes with medicines are
time-consuming and labour-intensive. This provision specifically discourages donations of small
quantities of mixed medicines. The maximum weight of 50 kilograms ensures that each carton can
be handled without special equipment.
2.4.5 The declared value of a donated medicine should be based upon the wholesale price
of its generic equivalent in Nigeria, or if such information is not available, on the wholesale
world market prices for its generic equivalent.
Explanation:
This provision is needed solely to prevent medicine donations being valued according to the retail
price of the product in the donor country. This may lead to elevated overhead costs for import tax,
port clearance and handling. It may also result in a corresponding decrease in the public sector
budget for medicines in the recipient country.
Possible exception:
2.4.6 The costs of international and local transport, warehousing, port clearance and
appropriate storage and handling should be paid by the donor unless specifically agreed
otherwise with the recipient in advance.
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. It also enables the recipient to
review the list of donated items at an early stage.
3.5 Maintenance
Detailed maintenance requirements, such as technician training, special tools, preventive
maintenance materials and recommended maintenance schedule should be communicated to the
recipient.
Six Nigerian and foreign agencies have been identified in the effective implementation of these
Guidelines. They have been assigned respective responsibilities as follows:
6.1 The Federal Ministry of Health
The Food and Drugs Services Department of the Ministry will coordinate all donations of
medicines while the Hospital Services Department will coordinate all equipment donations
within the country.
The Food and Drug Services Department of the Ministry shall issue approvals to potential
recipients of medicines and medical equipment donations upon the successful consideration of
an application.
The Coordinating Offices for donated medicines and equipment reserve the right to reject
donations that are not in line with these laid down Guidelines.
The Ministry should maintain a management information system to keep track of all information
pertaining to donated medicines and equipment.
The relevant regulatory authority for donated medicines and equipment in the donor
country shall issue a certification of the quality of the donations and this shall be
authenticated by the Nigerian Foreign Mission in that country.
6.4 The National Agency for Food and Drug Administration and Control (NAFDAC)
All relevant documents and permits for clearance must be obtained from the Agency. Where
narcotics and psychotropic medicines are involved, authorization to import and clear such
medicines must be obtained from the Narcotics Office of the Agency.
The Agency shall provide feedback to the Federal Ministry of Health on the status of all
processed donations.
The Agency shall keep on hold, at the ports of entry, all donations that do not follow approved
procedures until all documentation is completed.
The Agency shall destroy all medicine donations that are sub-standard
The Agency shall impound unsolicited medicines that do not meet Nigerian specifications. The
donor shall be responsible for the cost of destruction, storage and other associated expenses.
Christian Medical Commission of the World Council of Churches Guidelines for donors and
recipients of pharmaceutical donations, 1990, Geneva.
WHO. Interagency Guidelines for Drug Donations, 1999. (Published on behalf of agencies by the
World Health Organization.)
WHO. The Use of Essential Drugs. Geneva: World Health Organization, 1992. (Technical Report
Series, 825.)
1. ANAESTHETICS
Diazepam - injection, 5mg/mL in 2mL ampoule
Ketamine - injection, 10mg/mL in 20mL vial
50mg/mL in 10mL vial
100mg/mL in 5mL vial
Lidocaine hydrochloride - injection, 1%, 2% in vials
- cream/ointment, 2 5%
- aerosol, 10%
- gel/solution, 2 4%
- dental cartridges, 2%
3. ANTI-ALLERGICS
Chlorphenamine maleate - Tablet 4mg, Syrup 2mg/5mL
injection 10mg in 1ml ampoule
Promethazine hydrochloride - tablet 10mg, 25mg, syrup 5mg/5mL
injection 25mg in 1mL, 2mL ampoule
Adrenaline HCl/acid tartrate - injection 1mg/ml in 1ml ampoule
Hydrocortisone - injection (Sodium succinate) powder
for reconstitution, 100mg in vial
4. ANTI INFECTIVE DRUGS
Mebendazole - tablets 100mg, 500mg
suspension, 100mg/5mL
Pyrantel Pamoate - tablet 125mg, Syrup 125mg/5mL
Artemether/lumefantrine - tablet 20mg/120mg
Artesunate/amodiaquine - tablet
Chloroquine - capsule, tablets (phosphate or sulphate),
150mg base (Adult), 50mg base (Child)
5. ANTI-MIGRAINE DRUGS
Paracetamol 500mg tablets
Acetylsalicylic acid 300-500mg tablets
8. CARDIOVASCULAR DRUGS
Glyceryl trinitrate - tablet, sublingual 0.5mg
Propranolol HCl - tablet 10mg, 40mg.Injection 1mg/mLampoule
Amlodipine besylate - tablet 5mg, 10mg
Atenolol - tablet 50mg, 100mg
Captopril - Tablet 12.5mg, 25mg, 50mg
Hydralazine - tablet 25mg, 50mg
injection powder 20mg in ampoule
Methyldopa - tablets 250mg, 500mg
Nifedipine - tablet 10mg, capsule 20mg
Digoxin - tablets 0.0625mg, 0.125mg, 0.25mg
elixir 0.05mg/mL in 60ml bottle
injection 0.25mg/mLin 2ml ampoule and
0.1mg/mLin 1mL ampoule
Isoprenaline - IV injection 1mg/mL in 2mL ampoule
9. DERMATOLOGICAL DRUGS
Gentian Violet - aqueous solution 0.5%, tincture 1%
Neomycin/bacitracin - cream, ointment 5mg/500 Units in 5g, 30g tubes
dusting powder 5mg/250 Units per gram
spray 165,000 units/12,500 units
10. DIURETICS
Amiloride/hydrochlorothiazide tablet 5mg/50mg
Hydrochlorothiazide - tablets 25mg, 50mg
Frusemide - tablet 40mg; injection 10mg/mL in 2mL ampoule
14. IMMUNOLOGICALS
Antiscorpion Serum - injection 1mL in ampoule
Antisnake-bite Serum - Injection, polyvalent. 10mL, 20mL in ampoule
Tetanus Antitoxin - injection 1,500 Units in ampoule
10,000 Units; 50,000 Units in vials
Typhoid Vaccine (Vi Antigen) injection 0.5mL/syringe; 10mL/vial; 20mL/vial
Typhoid Vaccine (TAB) - injection 1.5mL/vial
Yellow fever Vaccine - injection powder; 1, 5 and 10 dose vials
19. DRESSINGS
Absorbent cotton wool
Adhesive tape
Elastic bandage
Gauze bandage
Gauze compresses
Disposable gloves
Latex gloves
Examination gloves
Mucus extractor
Sutures
1. Ambulance
2. Stretchers
3. Trolleys
4. Wash hand basins
5. Hand gloves
6. Drip stand
7. Sphygmomanometer
8. Stethoscopes
9. Surgical Instruments such as scissors, scalpel, blades, sutures, gauze, cotton wool,
disinfectants, linings, dustbins
10. Oxygen cylinders
11. Ambu bags
12. Defibrillators
13. Microscopes
14. Blood group reagents
15. Small generators
16. Life jackets
17. Needle holders
18. Artery forceps
19. Dissecting forceps: Tooth and non-tooth
20. Intubation tubes
21. Kidney dishes
22. Galli pots
23. Disposable spatula
24. Adhesive plaster
25. Dressing tray
26. Face mask
27. Investigation sample bottles
28. Rain boot
29. Helmets