This comes at a time when the government has mandated the market authorisation holders (MHA) to set up pharmacovigilance (PV) cell in their companies in accordance to the Drugs and Cosmetics Rules, 1945 to collect, process and forward the report to the licensing authority for information on adverse drug reactions (ADRs) emerging from the use of the drug manufactured or marketed by the respective MHA in the country through a gazette notification March 8, 2016.
The guidelines will feature pertinent areas like signal detection for risk-benefit evaluation and risk management programmes. Signal management is not compulsory in the present set of guidelines. Risk benefit of the product can be measured properly through signal detection.
The drug exporting pharmaceutical companies can set up a PV system to fulfill its legal tasks in relation to pharmacovigilance, design to monitor the safety of authorised medicinal products and detect any change to their risk-benefit balance.
A pharmaceutical company can meet their pharmacovigilance obligations either by setting up in-house systems for pharmacovigilance or can enter into contractual arrangements with Contract Research Organizations (CROs) specializing in pharmacovigilance function.
Typical activities in PV department are ADR case processing and reporting (electronic or hard copy), Periodic Safety Update Report (PSUR), Periodic Benefit Risk Evaluation Report (PBRER), Periodic Adverse Drug Experience Report (PADER), product quality complaints management, medical inquiries management, safety data exchange agreement management, signal detection for risk-benefit evaluation, risk management programs(RMP), literature monitoring for ADR case reports (including local literature monitoring, EU MLM search), training of company employees on ADR reporting, global compliance monitoring, audits and inspections.
The SOPs are expected to cover all pharmacovigilance functions and should be structured comprehensively detailing the necessary steps. Since pharmacovigilance involves global operations, clearly written SOPs ensures consistency, compliance, and quality, clear assignment of roles and responsibilities, uniform performance over multiple users to avoid errors of oral communication.
The number of SOPs related to pharmacovigilance may vary from few in number to many, depending upon the length and complexity of the processes involved. SOPs ought to reflect the main requirements of the relevant legislation but should also be adapted to the technical and human infrastructure of the company.
List of SOPs for PV Dept involves procedures for collecting the adverse event reports, validating the adverse reaction reports, evaluating the cases for their seriousness, follow up of cases for missing information, expedited reporting, electronic reporting, periodic reports, signal management and risk benefit assessment and response to request for information from regulatory authorities, Interaction between safety issues and product defects, handling of urgent safety restrictions and safety variations, management and use of databases, training, internal audit of the pharmacovigilance system and archiving.
Sources of collection of adverse event reports are health care professionals, consumers, clinical trials, post marketing surveillance studies, regulatory authorities, literature publications, social media, product quality complaints, medical inquiries, pre-clinical research and business partners.
Pharm.D @ SRIPMS-CBE-TN