Course objectives
The aim of this course is to provide trainees with:
- an awareness of the importance of examining suspect pharmaceuticals in order to facilitate the inspector's decision whether or not to act
- sufficient knowledge and skills to examine counterfeit pharmaceuticals
- an understanding of the difference between counterfeit and substandard drugs
- knowledge of the value and limitations of techniques for rapid examination, and the ability to make rational decisions about their use
- the ability to justify legal action in the context of detection and prosecution.
Types of training
Theory and practice involving examination of drugs.
Educational background of trainees and trainers
Previous or formal training of trainees is not absolutely required for the examination of drugs, but former training would be advantageous. Preferably, trainees should meet the following criteria, according to country requirements:
- knowledge of and competence in selected laboratory techniques, such as using a weighing balance and volumetric measurements, and the ability to perceive differences in colours
- reading and writing skills to facilitate adequate record-keeping
- an understanding of the need and the willingness to work as a team and to share information.
The trainer should be experienced and have full knowledge of general and official analytical methods. Furthermore, he or she should be able to conduct and design, when necessary, the training programme. Other characteristics include:
- an appreciation of the role of chemical testing in the legal system for combating counterfeit products
- an understanding of the difference between counterfeit and substandard drugs
- knowledge of the latest statistics on the prevalence of counterfeit pharmaceuticals in the country, if possible
- knowledge of relevant quality standards
- knowledge of characteristics of various dosage forms
- thorough overall knowledge of the subjects to be taught.
Course programme items
The following items should be included in the course; the actual content of each item will depend on the prior experience of the trainees (see Box 4).
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Box 4
Course programme items for examiners
- overview of relevant legislation
- national drug regulatory systems, inspection and quality control
- drug distribution systems
- illegal distribution channels
- types of counterfeit pharmaceuticals encountered
- general characteristics of various dosage forms, such as active ingredient to excipient ratio in tablets, capsules, ampoules, powder for injection, ointments, creams, etc.
- sampling methods
- reference substances and working standards: importance and maintenance
- reference data in books or electronic form (e.g. Internet)
- security aspects
- record-keeping, the importance of properly documented laboratory work including description of samples
- preparation of official reports
- relations with WHO
- examination techniques (see below)
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After demonstration of the techniques to be used, trainees should practice with an adequate number of known dosage forms, preferably including capsules, tablets, injectable preparations and ointments. Trainees will then test unknown samples, report on their work and draw conclusions as to whether the samples are counterfeit or require additional analysis. The results will be compared with previously determined data and will be discussed in the group.
In the course, the trainee will be taught to perform various examinations including:
- examination of labelling features, packaging materials and packaging of various drug forms
- measurement of various physical properties of the product
- thin-layer chromatography
- other specifically selected examination procedures.
Duration of course
Duration of the course depends on the local situation. A typical course would take about 10 days, consisting of:
- introduction (1-2 days)
- theory (1-2 days)
- practical work in the laboratory and field, if necessary on various dosage forms (4 days)
- preparation of a summary and reporting (2 days).
Reiterative training
Refresher courses should be regularly organized and attended. Country demand would determine the frequency of these courses.
Assessment
Continuous assessment will be conducted during the programme.
Certificate
An appropriate certificate should be issued on satisfactory completion of all parts of the programme.
Evaluation of the programme
Evaluation is an important component of any such activity, particularly since the occurrence and nature of counterfeiting differ from country to country. This may result in changes in the activities of inspectors. Therefore, a refresher course could be of a different nature if so indicated by evaluation.
Document kit
Trainees should be supplied with a document kit which should include references (26)-(28) and (32).
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