Pharmacovigilance for quality investigation of marketed medicines
Dr Md Anawar Hossain
Summary
Drug is an essential material people have to buy and take it frequently in their life whenever they become sick. It is an important part of life. Drug quality and safety is a prime issue, because it is related to safety of the human life. Any deterioration in drug quality may cause the adverse effects to human body and eventually may cause death. Therefore, continuous monitoring and investigation of marketed medicines is a high priority issue in the pharmaceutical and healthcare sectors. Pharmacovigilance plays a momentous role in drug quality investigation.
Deterioration in quality of marketed medicines may originate from the different processes and issues of drug manufacturing and distribution to the markets. Pharmacovigilance is a part of pharmaceutical and healthcare sciences which can survey, monitor and assess any quality-related adverse effects reported by the drug consumers. Accordingly, it can suggest some preventive strategies to rectify the defects in the manufacturing and distribution processes, and thus reduce the risk of deterioration in drug quality (Sardella et al., 2021). Pharmacovigilance follows some rigorous processes or steps to perform this job, which includes collection, detection, assessment, monitoring, and prevention of adverse reactions with pharmaceutical products.
In the first decade when a new drug is marketed after getting authorisation from the drug authority, drug safety is surveyed and monitored. Therefore, the information related to adverse reactions of medicines is gathered and assessed to identify any safety issues from its use. This information can be collected and assessed by the drug authority and drug sponsors which will help the manufacturer to modify the quality control, manufacturing and distribution processes.
Some medicines are already on the market for long time. Therefore, their safety information is already well-known to the authority and manufacturers. However, any safety risk can be generated anytime if the manufacturers do not follow the adequate quality control, appropriate manufacturing processes and distribution systems. As for example, the older medicines, such as generic drugs, can also generate new risks due to the result of inadequate control of their quality process, manufacturing and distribution systems (Sardella et al., 2021). Therefore, the manufacturers should follow the complete integrated manufacturing process for quality control, manufacturing process and distribution systems.
Pharmacovigilance can check the following processes to ensure the product safety and efficacy:
- The manufacturers are following the standard processes, and procedures and quality defects are detected during the manufacturing, proper distribution systems and use of medicinal products,
- Pharmacovigilance can assess (1) product quality complaints; (2) out-of-trend stability studies; (3) cross-contaminations; (4) regulatory actions against manufacturers following inspections; (5) temperature excursions outside the labelling storage conditions during distribution; (6) counterfeit/falsified products detected in the supply channel.
- Pharmacovigilance data can identify manufacturing, distribution or counterfeiting issues.
- Voluntary reporting systems can be running which can help to identify sub-standard/spurious/falsely labelled/falsified/counterfeit medical products.
How are drug safety hazards created?
- Drug safety hazards have been identified from product quality defects.
- Product contamination has been detected from raw materials.
- Pharmacovigilance has identified drug safety hazards from manufacturing issues.
Source: Sardella M, Belcher G, Lungu C, Ignoni T, Camisa M, Stenver D I, Porcelli P, D’Antuono M, Castiglione N G, Adams A, Furlan G, Grisoni I et al., 2021. Monitoring the manufacturing and quality of medicines: a fundamental task of pharmacovigilance. Therapeutic Advances in Drug Safety, Vol. 12: 1–17.