Pharmacovigilance in Drug Development

 Pharmacovigilance (PV) is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug related problem. It collects, records, codes adverse drug reactions analyses and assesses the reports, promotes the safe use of drugs, creates appropriate structures and means of communication needed to perform its tasks.The aims of PV are to improve patient care and safety, improve public health and safety, contribute to the assessment of benefit, harm, effectiveness and risk of medicines, promote education and clinical training, promote effective communication to public and promote rational and safe use of medicines.

The process of drug discovery and development is a long-term, competitive, expensive and complicated process. Bringing the drugs from the bench to the market, that is, from screening and identification of the drug as a compound to its introduction to the market, takes several years of efforts. The complete process of presenting a drug to the patients involves four stages-

1. Drug discovery
2. Drug development
3. Regulatory review and approval
4. Marketing

Pharmacovigilance is the pharmacological science which deals with drug safety including accumulation, detection, assessment, monitoring, and prevention of adverse effects of the drugs.
It is a process focusing on detection of unidentified safety issues, identification of risk factors, quantifying risks and preventing patients from being adversely affected unnecessarily.

Pharmacovigilance plays a critical role at various stages of drug discovery and development process
for example, in clinical research, pharmacovigilance requires submission of the reports on adverse events during clinical trials to regulatory authorities within a specified time frame, notification of such events to all investigators and ethics committees, and a safety review by independent Drug Safety Monitoring Boards (DSMB). Annual reports, a summary and analysis of all the serious adverse events, new safety findings from animal studies, and evaluations of benefit and risk are also required.

Pharmacovigilance also plays a significant role when the drug is commercialized. Reporting the safety reviews is mandatory for companies in a marketing phase. These safety reviews include
-Risk Management Plan (RMP)
-Periodic Benefit Risk Evaluation Report (PBRER)
-The Development Safety Update Report (DSUR)
-Periodic Safety Updates Report (PSUR)
-Phase 4 studies (post-marketing surveillance)

Pharmacovigilance plays a very critical role in drug discovery and development process. It will require comprehensive documentation and severe monitoring at every phase of drug development including pharmacovigilance inspection and audit, risk management, and reporting of ADR medicinal drugs, periodic safety update report, and post-authorization safety studies, additional monitoring, and safety communication.

Author- Sirisha Boidapu, Pharmacist, PV Professional