Post market surveillance
Distribution and supply of medical products
The manufacturing of medical products is a heavily regulated process to ensure that products are safe, efficacious and effective.
The distribution and supply of medical products is an equally important step in ensuring that patients and consumers are dispensed medical products which remain of good quality, are safe and efficacious.
Licensed and regulated distributors, wholesalers and retailers have responsibility to comply with good storage and distribution practices, and should be subject to periodic inspections by the appropriate national regulatory authority.
Regulatory policies, procedures and sanctions should be published and 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 from where they purchased or sourced the medical products they are supplying.
Distributors, wholesalers and retailers should remain vigilant for SF medical products and report suspicions to the National Regulatory Authority.
Pharmacovigilance
Pharmacovigilance (PV) is defined as the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem. The prompt reporting of adverse reactions can lead to the early identification of SF medical products. 10% of SF medical products reported to the Global Surveillance and Monitoring System are associated with a toxic reaction in patients. This ranges in severity from a rash on the skin through to hospitalizations and fatalities.
However 90% of SF medical products reported do not cause a toxic reaction in the patient, but do fail to treat the disease or condition for which they are intended. These cases are very difficult to identify and can lead to serious consequences for patients who believe they are treating their condition when they are not.
Increasing pharmacovigilance reporting by healthcare professionals and patients and raising awareness concerning the importance of reporting an unusual lack of efficacy of a medical product is an important component in identifying SF medical products that have reached consumers.
Reporting
Some countries have put in place patient reporting systems, telephone hotlines and web based reporting systems all of which can assist in identifying SF medical products. Some of the most serious cases reported to WHO by National Regulatory authorities have originated from patients, nurses and pharmacists.
Market Surveys
Regular sampling and surveying of both the regulated and unregulated supply chains is a way of identifying SF medical products.
Different methodologies are used to sample the market and range from random sampling through to targeted sampling of particular products and outlets.
The WHO are currently consulting on recommendations on the content of a survey protocol for surveys of the quality of medicines.
Surveying is another important tool in assessing access to quality, safe and efficacious medical products.
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