Basic terminologies used in Pharmacovigilance
Introduction
Pharmacovigilance is the science and activities related to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problems. Here are some basic terminologies used in pharmacovigilance:
1. Adverse Drug Reaction (ADR): Any harmful and unintended response to a medicinal product occurring at doses used for the diagnosis, treatment, or prevention of diseases or symptoms. ADRs can range from mild side effects to severe and life-threatening reactions.
2. Serious Adverse Event (SAE): An adverse event that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity, or causes a congenital anomaly or birth defect.
3. Suspected Adverse Reaction: A reaction that is reported after the administration of a drug but where a causal relationship between the drug and the reaction is not yet established.
4. Pharmacovigilance System: The system put in place by pharmaceutical companies, regulatory authorities, and other stakeholders to monitor the safety of medicinal products and manage adverse events.
5. Signal: Information that arises from one or multiple sources, such as clinical trials, spontaneous reports, or epidemiological studies, suggesting a potential causal relationship between an intervention (e.g., drug) and an adverse event.
6. Risk-Benefit Assessment: An evaluation of the risks associated with a drug versus its potential benefits to determine if its use should be continued, modified, or discontinued.
7. Signal Detection: The process of identifying potential safety issues or signals from pharmacovigilance data.
8. Adverse Event Reporting: The process of collecting and submitting reports of adverse events associated with the use of medicinal products to the relevant regulatory authorities.
9. Spontaneous Reporting: The voluntary reporting of suspected adverse reactions by healthcare professionals, patients, or consumers to regulatory authorities.
10. Aggregate Safety Report: A comprehensive report that provides an overview of the safety profile of a medicinal product, including data from clinical trials and post-marketing surveillance.
11. Pharmacoepidemiology: The study of the use and effects of drugs in large populations to determine their safety and effectiveness.
12. Periodic Safety Update Report (PSUR): A periodic report submitted by marketing authorization holders to regulatory authorities, summarizing the safety data of a medicinal product.
13. Risk Management Plan (RMP): A plan developed by pharmaceutical companies to identify, characterize, and minimize the risks associated with a medicinal product.
14. Post-Marketing Surveillance: The ongoing monitoring of the safety of a drug after it has been approved and made available in the market.
15. Benefit-Risk Ratio: The comparison between the positive therapeutic effects of a drug (benefits) and its potential adverse effects (risks) to determine the overall safety and usefulness of the drug.
These are some of the fundamental terms used in pharmacovigilance. The field of pharmacovigilance is continually evolving, and new terms may be introduced as science advances.
