Sympto - Introduction to pharmacovigilance
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This document provides an introduction to pharmacovigilance (PV). It defines PV as the science and practice of monitoring the effects of pharmaceutical products after they have been approved for market use. The key aspects of PV that are summarized include collecting, detecting, analyzing and preventing adverse drug reactions. PV aims to generate knowledge about drug safety profiles in order to improve treatments and protect public health. It works through a system of clinical trials, post-marketing surveillance, adverse reaction reporting and regulatory oversight.
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Sympto - Introduction to pharmacovigilance
- 1. Introduction to pharmacovigilance A crash course on the basics of drug safety monitoring
- 2. The importance of PV
- 3. ® Slideshare 3/37 The importance of PV PV processes ADRs Reporting ADRs PV regulations Risks Control The importance of PV The discovery of new substances for treating disease is key to advancing global healthcare and quality of life. But it is equally important to constantly expand and build our knowledge on the substances we already use. That’s why we need pharmacovigilance. And experts that can advance the field. • • • The importance of pharmacovigilance
- 4. ® Slideshare 4/37 The importance of PV PV processes ADRs Reporting ADRs PV regulations Risks Control The importance of PV Collecting Detecting Analyzing Monitoring Preventing adverse effects from pharmaceutical products • • • • • Pharmacovigilance (PV) is the science and practice of:
- 5. ® Slideshare 5/37 The importance of PV PV processes ADRs Reporting ADRs PV regulations Risks Control The importance of PV To monitor all emerging information related to a medicinal product or substance. To analyze and report all relevant findings to regulatory authorities. • • The purpose of PV
- 6. ® Slideshare 6/37 The importance of PV PV processes ADRs Reporting ADRs PV regulations Risks Control The importance of PV • • • The purpose of PV Generate new insight that will expand our knowledge on the substance’s effects. Use that knowledge to improve treatments and healthcare. Protect the public and prevent risks.
- 7. PV processes
- 8. ® Slideshare 8/37 The importance of PV PV processes ADRs Reporting ADRs PV regulations Risks Control PV processes • • • How does PV work? A pharmaceutical company becomes a marketing authorization holder (MAH) when their product is approved for the market. Each MAH has to set up a PV system and appoint a qualified person responsible for safety monitoring. They report to their designated competent authority.
- 9. ® Slideshare 9/37 The importance of PV PV processes ADRs Reporting ADRs PV regulations Risks Control PV processes • • • Clinical trials Clinical trials are conducted before marketing authorisation. They analyze the safety and efficacy under controlled conditions. The population using the substance is limited and carefully selected.
- 10. ® Slideshare 10/37 The importance of PV PV processes ADRs Reporting ADRs PV regulations Risks Control PV processes • • • Post-marketing surveillance After a medicine is authorized for use, it reaches a larger population. The information about the medicine’s safety profile increases both in number and importance. Through safety monitoring we gain insight on risks and benefits, and communicate them to the public.
- 11. ® Slideshare 11/37 The importance of PV PV processes ADRs Reporting ADRs PV regulations Risks Control PV processes • • • Pharmacovigilance system Governments establish their national pharmacovigilance system to conduct PV in their country. EMA coordinates the EU pharmacovigilance system. Every MAH is required to maintain a master file that describes their pharmacovigilance system (PSMF). • • • Pharmacovigilance system Governments establish their national pharmacovigilance system to conduct PV in their country. EMA coordinates the EU pharmacovigilance system. Every MAH is required to maintain a master file that describes their pharmacovigilance system (PSMF).
- 12. ADRs
- 13. ® Slideshare 13/37 The importance of PV PV processes ADRs Reporting ADRs PV regulations Risks Control ADRs • • • Adverse drug reaction ADR = adverse drug reaction. ADR is a term for any injury that occurs during the use of a substance or medicinal product. An ADR is the same as an adverse effect or a side-effect.
- 14. ® Slideshare 14/37 The importance of PV PV processes ADRs Reporting ADRs PV regulations Risks Control ADRs • • Adverse event An adverse event is not the same as an adverse reaction, adverse effect or a side-effect. An adverse event is a term for any injury that occurs during the use of a substance or medicinal product, without an established cause.
- 15. ® Slideshare 15/37 The importance of PV PV processes ADRs Reporting ADRs PV regulations Risks Control ADRs • • • Establishing ADRs When determining if a medicinal product has provoked an ADR, we assess causality. There has to be a reasonable possibility that the ADR was caused by the medicinal product. Every spontaneous report by consumers is considered a suspected ADR.
- 16. ® Slideshare 16/37 The importance of PV PV processes ADRs Reporting ADRs PV regulations Risks Control ADRs • • Detecting ADRs PV officers monitor and report suspected ADRs. Competent authorities analyze suspected ADRs, then act on them if necessary.
- 17. ® Slideshare 17/37 The importance of PV PV processes ADRs Reporting ADRs PV regulations Risks Control ADRs • • Who reports ADRs? The primary source is a consumer or a healthcare professional. The person responsible for pharmacovigilance reports any suspected ADR to their local official authority.
- 18. ® Slideshare 18/37 The importance of PV PV processes ADRs Reporting ADRs PV regulations Risks Control ADRs • • Monitoring ADRs PV professionals monitor ADRs by collecting all available data, analyzing and communicating it to competent authorities. The data they use to report ADRs is derived from various sources.
- 19. ® Slideshare 19/37 The importance of PV PV processes ADRs Reporting ADRs PV regulations Risks Control ADRs • • • Coding ADRs There is a universal standardized medical coding terminology for adverse reactions. The most commonly used terminology is from the MedDRA medical dictionary. It makes identification of ADRs easier.
- 20. Reporting ADRs
- 21. ® Slideshare 21/37 The importance of PV PV processes ADRs Reporting ADRs PV regulations Risks Control Reporting ADRs • Solicited reports They report information from clinical studies, patient support and disease management programs, surveys, non-interventional studies, and other organized systems of data collection.
- 22. ® Slideshare 22/37 The importance of PV PV processes ADRs Reporting ADRs PV regulations Risks Control Reporting ADRs • • Spontaneous reports When a consumer or healthcare professional communicates an ADR to a competent authority or MAH. This information does not come from organized data collection.
- 23. ® Slideshare 23/37 The importance of PV PV processes ADRs Reporting ADRs PV regulations Risks Control Reporting ADRs • • • Literature reports They are composed of scientific and medical literature. Crucial for insights on the balance of risks and benefits. Information from literature is used for writing aggregate and potentially reporting/coding the individual case safety reports.
- 24. ® Slideshare 24/37 The importance of PV PV processes ADRs Reporting ADRs PV regulations Risks Control Reporting ADRs • • • Reports from other sources Information that originates from non-medical sources. The reporter should make an effort to follow up on the information to get the minimum requirements for an ICSR. It is handled like a spontaneous report.
- 25. ® Slideshare 25/37 The importance of PV PV processes ADRs Reporting ADRs PV regulations Risks Control Reporting ADRs • • • Internet and digital media A recent form of ADR reporting. MAHs screen the Internet and digital media to for reports of potential suspected ADRs. They should also be handled as a spontaneous report.
- 26. PV Regulations
- 27. ® Slideshare 27/37 The importance of PV PV processes ADRs Reporting ADRs PV regulations Risks Control PV regulations • • • EMA European Medicines Agency. Takes care of the EU pharmacovigilance system. One of the most advanced and detailed systems in the world.
- 28. ® Slideshare 28/37 The importance of PV PV processes ADRs Reporting ADRs PV regulations Risks Control PV regulations • • • FDA US Food and Drug Administration. Protects and promotes public health. Monitors the safety of medicinal products and substances in all member states.
- 29. ® Slideshare 29/37 The importance of PV PV processes ADRs Reporting ADRs PV regulations Risks Control PV regulations • • UMC WHO’s collaborating centre for international drug monitoring. Collects information from national pharmacovigilance centres.
- 30. Risks
- 31. ® Slideshare 31/37 The importance of PV PV processes ADRs Reporting ADRs PV regulations Risks Control Risks • • Risks and benefits The core of pharmacovigilance is to monitor and assess the relationship between the beneficial effects of a medicine and its risks. Benefits should always outweigh the risks, otherwise the product will be withdrawn.
- 32. ® Slideshare 32/37 The importance of PV PV processes ADRs Reporting ADRs PV regulations Risks Control Risks • • Risk management From the insights we gain during monitoring, we derive solutions for the risks we detected. The best way to prevent risks is to educate and inform the consumers and their healthcare professionals about them.
- 33. Control
- 34. ® Slideshare 34/37 The importance of PV PV processes ADRs Reporting ADRs PV regulations Risks ControlControl • • Quality control PV teams are required to establish a quality management system to ensure compliance. QC is a vital part of literature screening and report composition.
- 35. ® Slideshare 35/37 The importance of PV PV processes ADRs Reporting ADRs PV regulations Risks ControlControl • • • • Audits Internal or by license partners. Evaluates and examines how a pharmacovigilance system functions. Carried out by an unbiased and objective auditor. In PV, audits usually have a risk-based approach.
- 36. ® Slideshare 36/37 The importance of PV PV processes ADRs Reporting ADRs PV regulations Risks ControlControl • • • • Inspections PV inspections check if safety monitoring of a medicine meets all requirements. They ensure MAHs and the pharmaceutical industry are fulfilling their legal obligations. Carried out by local competent authorities. EU inspections are also coordinated by EMA.
- 37. Thank you for your attention. To read more about PV, visit our blog.