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Pharmacovigilance

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Pharmacovigilance

Pharmacovigilance

Pharmacovigilance is the process and science of monitoring the safety of medicines and taking action to reduce the risks and increase the benefits of medicines. The practice of monitoring the effects of medical drugs after they have been licensed for use, especially in order to identify and evaluate previously unreported adverse reactions. After the approval for marketing authorization the Post Marketing surveillance is undertaken to investigate the adverse effects, toxic effects of the particular drug product. It is the IV step of stage of the clinical Trail. 

The three main types of post-marketing Pharmacovigilance are:

  1.  Drug safety surveillance.
  2. Drug abuse and adverse effects monitoring.
  3. Safety monitoring of new products.

There the set of Guideline for the pharmacovigilance called as Good Pharmacovigilance Practices. The different Countries have different.

EU-Eudravigliance

In the Pharmaceutical  industry, ensuring the safety of drugs is crucial. EudraVigilance, a centralized European database that gathers and tracks reports of suspected adverse drug reactions, is one of the main instruments in this effort.

Role of Eudravigilance

A crucial part of the pharmacovigilance system in the European Union (EU) and European Economic Area (EEA) is EudraVigilance, which was created by the European Medicines Agency (EMA). Its main goal is to make it easier to identify and assess adverse drug responses that are marketed in these areas as soon as possible. The safety profile of pharmaceuticals may be continuously monitored throughout their lives thanks to this technology.

  • Reporting Adverse Reactions: Patients, medical practitioners, and pharmaceutical corporations notify EudraVigilance of any suspected adverse reactions. These reports include information about the patient, the medication in question, and any possible adverse reactions.
  • Data Gathering and Analysis: EudraVigilance compiles the submitted information and carries out in-depth analysis to find any possible safety issues related to particular drugs. This includes signal detection algorithms, statistical techniques, and periodic safety update reports (PSURs) that are filed by pharmaceutical companies.
  • Risk Assessment and Communication : EudraVigilance works with pharmaceutical companies and regulatory bodies to evaluate the risk-benefit ratio of the pharmaceuticals in question after detecting possible concerns. Healthcare professionals and patients are informed about any emergent safety risks through the implementation of communication tactics, such as product information updates and safety alerts.

Advantages Of Eudravigilance

  • Early Safety Signal Detection: EudraVigilance helps identify possible safety issues with medications early by gathering and evaluating adverse reaction information from a variety of sources.
  • Increased Patient Safety: By allowing patients and healthcare providers to make educated decisions about pharmaceutical usage, timely detection and discussion of safety risks improves patient safety.
  • Enhanced Pharmacovigilance processes: By offering insightful information on the safety profiles of pharmaceuticals, EudraVigilance helps to continuous enhance pharmacovigilance processes.

US- Office of Pharmacovigilance & Epidemiology

The Office of Pharmacovigilance & Epidemiology (OPE) is a critical component within pharmaceutical companies, regulatory agencies, and healthcare organizations. Its primary focus is on monitoring the safety and effectiveness of medications and vaccines throughout their lifecycle in US.

Role of Office Of Pharmacovigliance and Epidmeology

  • Drug Safety Monitoring: Following approval, OPE is in charge of keeping an eye on the safety profiles of pharmaceuticals and immunizations. This entails gathering, evaluating, and analyzing adverse event reports from patients, clinical trials, and healthcare providers.
  • Risk Assessment: OPE thoroughly assesses any possible safety issues pertaining to medications and vaccinations. It evaluates the advantages and disadvantages of pharmaceutical use to assist with well-informed decision-making by examining adverse event data and carrying out epidemiological research.
  • Signal Detection: To find possible safety signals or new concerns related to drugs, OPE uses advanced data mining and signal detection algorithms. These indicators call for additional research and could result in safety announcements or legal action.
  • Post-Marketing Surveillance: OPE is in charge of post-marketing surveillance initiatives to keep an eye on the efficacy and safety of medications and vaccines in the real world. This covers risk management plans (RMPs), post-authorization safety studies (PASS), and pharmacovigilance studies.
  • Epidemiological Research: OPE carries out epidemiological research to comprehend medicine use, adverse drug reactions (ADRs), and disease patterns and drivers. This study helps guide regulatory decision-making and offers insightful information on drug safety.
  • Regulatory Compliance: OPE guarantees adherence to pharmacovigilance rules and directives issued by regulatory bodies, including the European Medicines Agency (EMA) in Europe and the Food and Drug Administration (FDA) in the United States. This covers adhering to pharmacovigilance regulations, timely reporting of adverse occurrences, and submission of safety reports.
  • Risk Management Techniques: OPE creates and puts into practice risk management techniques to lessen hazards connected to prescription drugs. These tactics could consist of post-marketing research, label modifications, restricted distribution plans, and more safety monitoring.

OPE works closely with a wide range of stakeholders, including as university researchers, pharmaceutical firms, patients, healthcare providers, and regulatory bodies. This partnership improves pharmacovigilance procedures, encourages transparency, and makes it easier to share safety information.

Japan - Post Marketing Safety Measures

From Company and medical experts, they gather safety data on adverse drug responses, infections brought on by using medications and medical devices, and adverse events brought on by using medical devices. The data is kept in a database for future scientific research and analysis. 

The investigation’s findings are submitted to the MHLW, which then takes administrative measures to guarantee the safe use of medications and medical equipment, among other things. They create and apply novel approaches and strategies for post-marketing safety operations, such as the sentinel medical institution network and data mining method, to improve prompt problem-solving and precise safety actions. It therefore makes it possible for us to anticipate and avoid safety issues.

Risk Mangement Plan

Measuring adequate risk management strategies for pharmaceuticals is crucial for ensuring their safety at every stage of their lifecycle, from development to regulatory review and post-marketing care. An RMP is a document that demonstrates how medications are consistently risk-managed from the point of development to the point of post-marketing. To reduce drug risks, RMP calls for regular reviews of drug hazards or adjustments based on the development of pharmacovigilance and post-marketing surveillance programs. It is anticipated that the publication of RMPs and the dissemination of risk management knowledge among medical practitioners will guarantee additional improvements to post-marketing safety measures.

Australia- The Australian Adverse Drug Reactions Reporting System

In this system, you can report a case of a suspected adverse reaction in association with a medicine (including complementary, OTC or prescription) or a vaccine. The Therapeutic Goods Act 1989 (the Act) provides post-market safety monitoring for therapeutic goods, and the information in this report is gathered to support that monitoring. Every report is evaluated and added to the Australian Adverse Drug Reactions System (the ADRS) maintained by the Therapeutic Goods Administration (TGA). In this report, the TGA gathers personal data in order to:

  1. Evaluate the Act-mandated safety of medications and vaccinations. ( In case more information is needed, get in touch with the adverse event reporter.)
  1. Speak with representatives of companies that provide pharmaceuticals to address adverse incidents that have been documented.
  2. Verify that company haven’t gotten the same adverse event information more than once.

Canda- Canada Vigilance Program

Health Canada’s post-market monitoring program, known as the Canada Vigilance Program, gathers and evaluates information of possible negative responses to pharmaceuticals sold in Canada. Health Canada can monitor the safety profile of health products after they are launched through post-market surveillance, ensuring that the benefits of the goods continue to outweigh the risks.

Since 1965, the Canada Vigilance Program has gathered reports of possible adverse responses. Health professionals and consumers voluntarily report adverse reactions to Health Canada directly or through Market Authorization Holders. Prescription and over-the-counter drugs; natural health products; biologics (which include vaccines, biotechnology products, fractionated blood products, human blood and blood components, as well as human cells, tissues, and organs); radiopharmaceuticals; and disinfectants and sanitizers with disinfectant claims are among the health products marketed in Canada that are gathered by the program. The Canada Vigilance Online Database provides access to the data gathered by the program. Seven Canada Vigilance Regional Offices serve as a regional point of contact for consumers and health professionals and support the Canada Vigilance Program. The regional offices gather reports, which are then sent to the Canada Vigilance National Office for additional examination.

 

U.K-MHRA

The UK’s Pharmacovigilance program is still under the purview of the MHRA. Regarding Great Britain and Northern Ireland, there are certain distinct regulations for products that are sold in the UK. England, Wales, and Scotland make up Great Britain. As stated in this guidance, EU pharmacovigilance standards will continue to apply in addition to UK regulations for products that are authorized for sale or supply in Northern Ireland.

Role of Eudravigliance

In accordance with UK regulations, as a Marketing Authorization Holder (MAH) for medications that have national authorization in the country, you will have to provide pharmacovigilance data to the MHRA. This data must include:

  • Individual Case Safety Reports (ICSRs) from the UK and outside.
  • PSURs, or periodic safety update reports.
  • Plans for Risk Management (RMPs)
  • The protocols for Post-Authorization Safety Studies (PASS) and the final study reports.

OMC medical will Provide specialised pharmacovigilance consulting experts provide insightful guidance to navigate the intricacies of safety regulations and optimise product profiles.

 

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