Post-marketing Surveillance and Pharmacovigilance

Introduction

Pharmacovigilance and post-marketing surveillance are essential to medication control and patient safety in the medical industry. They are essential in ensuring the efficacy and safety of pharmaceutical goods once they have been authorized and put on the market.

What Is Post-marketing Surveillance?

Post-marketing surveillance is the systematic observation and assessment of pharmaceuticals, medical equipment, and other healthcare goods after they have been widely used. Beyond the tightly controlled environment of clinical trials, it tries to discover and evaluate any potential negative effects, interactions, or other safety concerns that could emerge in real-world circumstances.

What Is Pharmacovigilance?

Pharmacovigilance is the study of, evaluation of, comprehension of, and action taken to avoid any negative effects or other drug-related issues. It entails gathering, analyzing, and interpreting information from a range of sources, including patients, healthcare professionals, government regulators, and the pharmaceutical company itself.

What Are the Different Post-marketing Surveillance Programs for Reporting Adverse Events?

CDER (Center for Drug Evaluation and Research) strives to maintain the safety and efficacy of drug items currently on the market through various reporting systems:

• This computerized information database supports the FDA Adverse Event Reporting System (FAERS). The FDA's (Food and Drug Administration) post-marketing safety surveillance program for all authorized medications and therapeutic biologic products. By offering the greatest resources for storing and analyzing safety reports, FAERS' ultimate purpose is to enhance public health. The Centre for Drug Evaluation and Research's (CDER) Office of Surveillance and Epidemiology (OSE) allocates an interdisciplinary workforce of safety assessors, epidemiologists, and other researchers to analyze the data in FAERS to find safety indicators and monitor medication safety. The FDA may enact rules to improve product safety and protect public health. For example, it may update product labeling information, send out "Dear Health Care Professional" letters, or reevaluate clearance decisions.

• MedWatch is a program that allows the general people and health professionals to voluntarily report severe adverse effects and difficulties with medical items, such as medications and medical equipment. Additionally, it ensures that the medical community is promptly informed of new safety information, increasing patient care. The adverse event reporting system (AERS) database will be updated with all the information on the on this form.

How Are Pharmacovigilance and Post-marketing Surveillance Related?

• Pharmacovigilance is the science of observing and evaluating medication quality, effectiveness, and safety through clinical trials (pre-marketing) and post-marketing surveillance.

• To identify any unanticipated adverse events or other problems that might not have been found during pre-marketing studies, post-marketing surveillance procedures often entail continued monitoring of medications currently on the market.

• Post-marketing studies often entail gathering data from healthcare professionals, including doctors, chemists, nurses, and others, who work directly with patients using certain prescriptions to evaluate the long-term safety profiles of specific pharmaceuticals.

• Post-marketing monitoring efforts also involve routine checks of patient files about prescription drugs to spot any alterations or developments that could eventually point to a problem with a drug's safety profile.

What Are the Types of Post-marketing Surveillance?

1. Reporting Adverse Events Voluntarily and Spontaneously

• Reporting at the national level.

• Scientific, literary publications.

• Reporting adverse events locally and regionally.

2. Post-marketing Studies (Either Voluntarily or as a Part of the Clinical Trial)

• Randomized clinical trial.

• Observational studies.

3. Active Monitoring and Surveillance

• Sentinel initiative is the FDA's national electronic system. It helps researchers examine the safety of pharmaceuticals, vaccines, biologics, and medical devices subject to FDA regulation.

• Drug-induced liver injury network (DILIN) is used to gather and examine instances of severe liver damage brought on by prescription medications, over-the-counter medications, and complementary and alternative therapies, including herbal items and dietary supplements.

What Are the Advantages of Post-marketing Surveillance?

Post-marketing surveillance helps to study the following:

• Unusual and uncommon responses that were not seen in clinical trials.

• Prolonged or long-term result of the drug.

• Result of the drug on high-risk patients.

• Drug interactions like drug-food and drug-drug interactions.

• The reporting frequency of known and unknown adverse events and reactions increases.

What Is the Importance of Post-marketing Surveillance?

• A surveillance system aims to characterize the drug's relative incidence rates (any adverse event or report) about its market availability, units sold, and any other data to determine the drug usage patterns or situations responsible for adverse effects. Spontaneous reports, data on usage, and quantities consumed are crucial for determining the frequency of adverse reactions or safety related to a product.

• In post-market monitoring, it is crucial to assign frontline employees with the medical skills to receive and document according to standardized operating protocols (SOP). Actions like recalls of goods, reformulations, or product withdrawals from the market may be initiated, depending on the severity of the safety concern.

• In addition to spontaneous reporting, which remains a cornerstone of pharmacovigilance in the regulatory context and is essential for signal identification, the necessity for more active surveillance is becoming more and more obvious.

• Benefit-risk analysis in post-marketing has aided in a more systematic evaluation of the advantages of the drugs now on the market.

• The accuracy of medication utilization studies can be improved by systematically linking medical and prescription records. More thorough and methodical epidemiological techniques can account for the limits of spontaneous reporting and aid in addressing crucial safety issues in post-marketing surveillance programs.

Conclusion

In conclusion, when a drug is licensed and made widely available to the public, post-marketing surveillance and pharmacovigilance are crucial in assuring its safety and efficacy. These procedures are crucial for tracking and assessing how medicines are used and finding any side effects or potential safety issues. Pharmacovigilance and post-marketing monitoring work together to provide continuing evaluations of medication quality, efficacy, and safety. They aid in identifying, assessing, and controlling the dangers connected to the use of drugs. These procedures continuously track how medicines are used, providing valuable information that helps medical professionals, regulatory bodies, and pharmaceutical firms weigh the benefits and risks of various treatments to protect patient welfare and advance public health.