Procurement is only one of several elements of the drug management cycle, but can be the function that takes up much of the time of pharmacists in small countries.
The Drug Management Cycle
The supply and management of drugs is a continuous process that is illustrated below:
Selection of drugs |
Selection of drugs for procurement by the public sector should be based on the national essential drugs list. The methodology for selection of essential drugs can be found in The Use of Essential drugs, WHO Technical Report Series No. 895, Geneva 2000 (4). |
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Quantification of drug needs |
To avoid wastage through over-stocking or stock-outs of pharmaceuticals, a reliable system of quantification of drug needs is required. Estimating Drug Requirements, A Practical Manual, WHO/DAP/88.2 (5) is a useful guide for quantification of needs. |
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Procurement |
Procurement is being done through various methods such as tenders, competitive negotiations or direct procurement. The aim is to provide quality drugs at the lowest possible cost when needed. |
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Storage/distribution |
Correct storage of drugs to avoid deterioration and waste is essential, as is a proper stock inventory control system that can be computerized. Drugs should be available when needed. A system that enables coordination between drug needs and supply will ensure adequate distribution of drugs from the central source to the health facilities. |
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Use |
In addition to being available in the required quantities when needed, drugs have to be used rationally. If not, drugs can be useless and even harmful. In addition to serious health consequences, irrational drug use leads to waste, thus increasing the cost of running a drug supply system. The adoption of the essential drugs concept, use of standard treatment guidelines, monitoring of drug use and interventions for improvements are all important tools that should be actively used. |
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Monitoring and improving the Drug Management Cycle |
The Drug Management Cycle is a continuous process that needs to be monitored with the aim of improving all its elements. |
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Quality assurance in the Drug Management Cycle |
In each of the above-mentioned steps of the cycle, quality assurance measures should be included. The following issues should be addressed:
• Selection of well documented quality products from reliable manufacturers.
• Certificate of Analysis of delivered products.
• Use of the WHO certification scheme,
• Quality assessment of drugs upon receipt.
• Inspection of shipments.
• Laboratory testing.
• Appropriate storage and transport
• Appropriate dispensing and use
• Monitoring of product quality/reporting system
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The pharmaceutical staff usually performs a variety of tasks in smaller countries while bigger countries require several departments to handle the following duties:
• Selection of drugs
• Management of the essential drugs programme
• Estimation of drug needs
• Procurement
• Distribution and storage
• Rational use of drugs
• Drug control
The extent to which these duties are carried out may vary according to the capacity of the handling agency.
Most small countries generally base their drug requirements on past consumption as data on drug utilization and morbidity are usually lacking. Procurement is carried out through a tender system that is either restricted or open. Ideally, before marketing approval is granted in a country, pharmaceutical products undergo initial evaluation for safety, efficacy and quality by the national drug regulatory authority (DRA) through a drug registration process which is described together with the functions of the DRA in the publication entitled Marketing Authorization of Pharmaceutical Products with Special Reference to Multisource (Generic) Products. A Manual for a Drug Regulatory Authority. Regulatory Support Series No. 5, World Health Organization, Geneva, 1999 (6).
In small countries whereby the DRA lacks the capability to evaluate pharmaceutical products, one department may carry out both drug control and procurement. Ideally, such functions should be separated.
For pharmaceutical products with proper drug registrations and marketing approvals, the procurement agency concentrates mainly on the commercial aspects of procurement. However, it must ensure that such products have complied with quality standards.
In countries that have no drug registration system, quality assurance measures must be built into the procurement process to ensure safety, efficacy and quality of pharmaceutical products. In addition, a system for monitoring and maintaining product quality throughout the product’s shelf life is important.
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