(1999; 168 pages) [Spanish]
Counterfeit pharmaceuticals may be a serious risk to public health. It is the responsibility of governments to ensure that counterfeit pharmaceuticals are taken off the market and their sources found and eradicated. This should be a part of an overall quality control system. Clearly, expertise in drug inspection and drug examination is required. These guidelines are intended to be used to train relevant staff.
The detection and prosecution of criminals who market counterfeit pharmaceuticals have several stages. First of all, suspect products have to be traced. The drug, sampled according to an established procedure, should undergo defined physical or organoleptic examination by the drug inspector. If the results indicate that the drug formulation may be a counterfeit product, then at least some chemical tests must be repeated to confirm the necessity for further analysis. Drugs are then analysed by simple tests, including thin-layer chromatography. If these tests do not provide conclusive evidence and the drug is still considered to be a possible counterfeit, then a compendial procedure is required.
Throughout the investigation, it is assumed that a chain of custody has been established, i.e. the correct procedures were followed before the drug was received for analysis by the laboratory. This ensures that the results of these examinations are reliable and will be accepted as valid in future steps, e.g. prosecution of the supplier of the counterfeit pharmaceuticals. The final results shall be submitted to the appropriate official in the drug regulatory authority.
Section 2 describes the training necessary for inspectors. Section 3 describes training in the design and implementation of a specific programme for the screening of counterfeit pharmaceuticals. There are several common requirements for both inspection and chemical testing, and these are included as items in the training programmes for inspection and examination of counterfeit pharmaceuticals. It is assumed that the trainers are already suitably experienced to perform the required inspection, examination and training. The two-tiered approach of the training programme should include training of trainers, who in turn educate those who need to be trained in drug inspection and examination. The main focus of these guidelines, however, is the training of the trainees.
The practical issues to be considered in the organization and implementation of the programme are described in Appendix 1.
Each country must develop its own strategy, appropriate for its situation, the availability of an institutional framework, and its professional and economical resources. Ideally it should be prepared by the country's drug regulatory authority in consultation with all major parties involved in the manufacturing, importation, distribution, sale, prescribing and use of legitimate drugs.