Post market surveillance
Distribution and supply of medical products
The medical products manufacturing process is heavily regulated to ensure that products are safe and effective. Equally important is the distribution and supply processes to ensure that consumers are dispensed medical products that remain high-quality and safe. Licensed and regulated distributors, wholesalers, and retailers have the responsibility of complying with proper storage and distribution practices and should be subject to routine inspections by the appropriate national regulatory authorities. Regulatory policies, procedures, and sanctions should be published, applied proportionately, and consistently to those knowingly engaged in the trade-in SF medical products. Distributors and retailers should be able to clearly show regulatory authorities where they purchased or sourced the medical products they are supplying. Distributors, wholesalers, and retailers should remain vigilant for substandard and falsified (SF) medical products and report suspicions to the National Regulatory Authority.
Pharmacovigilance (PV) is the science and activities related to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problem. Prompt reporting of adverse reactions leads to quicker identification of SF medical products. According to the WHO Guidelines on the Conduct of Surveys of the Quality of Medicines, 10% of all SF medical products reported to the Global Surveillance and Monitoring System are associated with causing a toxic reaction in patients. The toxic response ranges in severity from a rash on the skin to hospitalizations and fatalities. Nevertheless, the other 90% of SF medical products reported that do not cause a toxic reaction in the patient, still fail to treat the disease or condition for which they are intended. These cases are challenging to identify and can lead to severe consequences for patients who believe they are treating their condition when they are not. Improving pharmacovigilance reporting by healthcare professionals and patients as well as increasing awareness on the importance of reporting any unusual lack of efficacy of a medical product are critical components in identifying SF medical products.
Some countries have put in place patient reporting systems, telephone hotlines, and web-based reporting systems to improve identification of substandard and falsified medical products. Some of the most serious cases reported to WHO by National Regulatory authorities originated from patients, nurses, and pharmacists.
Regular sampling and surveying of both regulated and unregulated supply chains is another method to identify SF medical products. Different methodologies are used to sample the market ranging from random sampling to targeted sampling of particular products and outlets. Surveying is an important tool in assessing access to quality, safe, and efficient medical products.