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Semelhante a Relationship Between Pharmacovigilance And Patient Safety[1]
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Relationship Between Pharmacovigilance And Patient Safety[1]
- 1. Pharmacovigilance, Patient safety and Current Challenges around Safety Reporting Dr. Siddarth S Chachad
- 2. Treatment may be worse than the disease
- 4. Vioxx safety data manipulated In Sep 2004, Merck publicly announced its voluntary withdrawal of the drug vioxx a 2.5 billion $ seller from the market worldwide. The drug company was found to have suppressed and manipulated certain critical data that misled the regulatory body — U.S.FDA. Journal of the American Medical Association confirms that the Merck was well aware of its dangers even before it withdrew the drug in 2004
- 9. Thus, in order to have complete assessment of the drug product in real life setting, safety reporting in post-authorisation era or pharmacovigilance is equally important as addressing safety during clinical trials.
- 12. Different Points of View
Notas do Editor
- ….n from this arises the need for establishing the relationship between patient safety and pharmacovigilance
- Safety research methods such as case analysis, review of medical info, active surveillance……
- Ever since product patent regime has been implemented in India in 2005, there is need for every Indian Pharma company to get into research and development. The companies, which were once truly generic, have not got into novel drug deliveries, biosimilars and even NCEs for that matter… Besides IT sector As per the business analysts, the current business….. ……..This apprehension stems from the fact that only a fraction of about 500,000 doctors are trained in ICH-GCP, which could mean inaccurate safety profiling. …… whereas it is the inadequate documentation of safety which could raise doubt in minds of the regulators.
- One can understand submitting related unexpected cases on expedited basis to the regulatory authorities however to comply local authority guidelines, sponsor ends up submitting unrelated cases to DCGI office, such as fracture radius in case of asthma medication study.
- This works fine in case of single centre studies, however in multicentric studies….
- Therefore in such cases, modalities for reporting these adverse reactions must be clearly defined in the protocol. This needs to be addressed clearly in schedule Y.
- No validated test for causal relationship No unique or consistent clinical pattern for a given study drug Re-challenge assessment presents an ethical concern
- code events….. n this creates confusion while doing the final safety data analysis. reactions...Here the problem is that MedDRA is available on subscription basis so the availability of the latest version is limited. Plus there are limitations with respect to this coding as well such as translation problems. E.g. Angina refers to chest pain in English but means sore throat in French
- … .so same ICSR submitted in post-authorisation era to EMEA on expedited basis in electronic format will have to be sent separately to local competent authorities by MA holder. … The National Pharmacovigilance Programme is sponsored by WHO and is based on the recommendations made in the WHO document titled " Safety Monitoring of Medicinal Products - Guidelines for Setting Up and Running a Pharmacovigilance Centre ". PMDA – Pharmaceutical & Medical Devices Agency Due to these differences in reporting systems, diligent compliance becomes difficult for the MA holders. Thus, international harmonisation “in true sense” is essential.