Bad Medicine2 months, 3 weeks ago
Posted on Jun 29, 2018, 9 p.m.
Worldwide counterfeit drugs are a serious problem, most prevalent in countries where drug regulation and enforcement are weak. Counterfeits as compared to the authentic drugs generally don’t have any active ingredients, have different active ingredients, or active ingredients with different strengths.
Counterfeit drugs have different concentrations or active ingredients and may have differences in quality and efficacy which may make them not safe to be used. Addition of diethylene glycol in a counterfeit drug in one case caused death of more than 500 people, most of which were children. Another case of counterfeit drugs included sale of placebo contraceptive pills that led to numerous unplanned pregnancies. Bad medicine counterfeits can have dangerous effects on health and lives of the users, and weaken confidence of the population in the healthcare industry.
Numerous factors facilitate the counterfeit industry such as lack of necessary legislature to regulate manufacturing and sale of drugs; lack of legal mandate to license and authorize drugs; lack of labs for analytical testing; distribution through unlicensed agencies; and too lenient penalties for violating drug regulations. Most times when demand for a product exceeds supply spurious drugs may arise to fulfil the demands of public users.
Thin Layer Chromatography is effective at detecting spurious drugs as it can detect substances present in the drug, content and impurities of its substances. It is common for counterfeit drugs to contain similar active ingredients but in lower quantity making techniques that only detect active ingredients not levels possibly provide false or inaccurate results.
When counterfeit drugs are more sophisticated advanced analytical techniques may be applied that are more sensitive tools to detect active ingredients such as mass spectrometry, nuclear magnetic resonance, and near infrared spectrophotometer. Infrared spectrophotometer techniques are typically easy to use, portable, and don’t require much space or sample preparation to provide results within minutes.
Careful visual inspection and comparison to original product can only be made in respect to packaging and labeling. If physical appearance of package and labeling seems different it typically indicates spurious products. Indication of counterfeit may also be indicated by tampering, different packaging, non-uniform labeling and colouring of the drug. Legitimate manufacturers are encouraged to provide accurate descriptions to WHO of physical characteristics of drugs and materials to help facilitate visual assessments.
World Health Organization provides test kits to analyze counterfeit drugs, with recommendation that proper training and knowledge should be provided for implementing these tests. Thin Layer Chromatography methods require expert personnel to conduct testing, inexperienced or unqualified personnel may lead to inaccurate results.
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