Pharmacovigilance planning
Introduction:
The pharmacovigilance activities are mainly used for the early post-marketing period of new drugs and their safety specifications. These all should be submitted at the time of licensed application. It is used to protect our health by identifying the risks involved in these pharmaceutical products and other medicinal products. Patient safety is the fundamental principle of the pharmacovigilance department. These pharmacovigilance departments are involved with individuals who ever work with industry, regulators, healthcare professionals, and patients. We have to draw basic planning of this. How to do it, what to do, when to do etc. all the things are to be planned in a basic way. then implement it for advanced technologies and then decide how to implement it for all these safety specifications. All the ADRs and ADEs are to be minimized by using these plans.
Pharmacovigilance:
According to the World Health Organization Pharmacovigilance means the science and activities relating to the collection detection, evaluation, monitoring, and prevention of adverse drug reactions with pharmaceutical products or any other drug-related problems.
Adverse drug reaction:
Any untoward signs and symptoms which may be possibly related to the drug.
Adverse drug event:
Any untoward medical occurrences which may or may not be related to the drug.
Safety specifications:
The common technical document (CTD) is used especially for the overview of safety benefits and risk conclusions. Sponsors should support the safety specifications with references to the safety page of the CTD or any other relevant documents. This safety specification is intended to help industry and regulators and also needs to identify the safety data collection of the pharmacovigilance plan. To identify the protection requirements that ensure the system failures that do not cause any injury or death or any environmental damage.
Risk identification = Hazard identification
Risk analysis = Hazard assessment
Risk decomposition = Hazard analysis
Risk reduction = Safety requirements specification.
Pharmacovigilance plan:
This plan gives guidance on the structure of the pharmacovigilance plan. This plan is designed should be based on safety specifications. The plan is normally developed by the sponsor and it is discussed with regulators during product development before the approval stage of a new pharmaceutical product. It should be sufficient for post-approval safety monitoring. The pharmacovigilance plan should be updated as important information on safety becomes available and milestones are reached.
Collection, follow-up, and reporting of adverse events.
Analysis of data and reporting on periodic adverse drug reactions.
Additional pharmacovigilance:
Clinical trials.
Post-authorisation safety studies.
Drug utilization studies.
Patient registries.
Physician surveys.
Prescription events.
Conclusion:
Identify the risks involved in pharmaceutical products or any other medicinal products. Report adverse drug reactions and adverse drug events are to be reported by using pharmacovigilance planning. Safety specifications are maintained throughout the process.
References:
ICH E2E guidelines, Available at: https://www.ema.europa.eu/en/ich-e2e-pharmacovigilance-planning-pvp
H wang, C wang, W Yu, S Hsu, Y Huang, from pharmacovigilance to pharmacovigilance planning – The system building for safe medication; Apr. 15, 2007. Available at: http://libir.tmu.edu.tw/bitstream/987
Student name: lakkireddy Adinarayanamma
Qualification: B. Pharmacy
Student ID: 169/0922.
Comments