Sources of Cases in Pharmacovigilance
- 3. INTRODUCTION SOURCES OF SAE REPORTS SAE reports will be received from the Unsolicited source, Solicited source, Contractual agreements and Regulatory authorities. SOURCES UNSOLICITEDSOURCE SOLICITEDSOURCE CONTRACTUAL AGGREMENTS REGULATORYAUTHORITIES
- 5. UNSOLICITEDREPORTS DEFINITION Unsolicited report is not expressly requested by a person and is produced for them without their permission. Unsolicited is something proposed to a client/customer and they did not ask for it. Unsolicited reports Spontaneous report Literature reports Internet reports Othersources
- 6. Spontaneous reports A spontaneous report is unsolicited communication by a healthcare professional or consumer to a competent authority, marketing authorization holder or other organization that describes one or more suspected adverse reactions in a patient who was given one or more medicinal products and that does not derive from a study or any organized data collection systems where adverse events reporting is actively sought.
- 7. Literature reports Each MAH is expected to regularly screen the worldwide scientific literature by accessing widely used systemic literature reviews or reference databases. Cases of ADRs from the scientific and medical literature, including relevant published abstracts from meetings and draft manuscript, might qualify for expedited reporting. A regulatory reporting form with relevant medical information should be provided for each identifiable patient. The publication references should be given as the report source.
- 8. Internet reports These reports are received from websites under their management for potential ADR case reports. Unsolicited cases from the internet should be handled as spontaneous repots. For the determination of reportablity, the same criteria should be applied for this cases. Other sources Aware of case report from non-medical sources, e.g. the lay press or other media, it should be handled as a spontaneous report. For determination of reportablity, the same criteria should be applied as for other reports.
- 9. SOLICITEDREPORTS DEFINITION Derived from organized data collection systems (which include clinical trials, post-approval named patient, other patient support and discharge management programs, surveys of patients or healthcare providers, or information gathering on efficacy or patient compliance ) Solicited reports Clinicaltrialcase DRA Pharmaceutical companies Patient support programs
- 10. Organized data collection systems SOCILITED SOURCES Post-approval programs, Surveys Registries Clinical trials
- 11. CONTRACTUAL AGREEMENTS Marketing authorization holder (MAH) Third party PHARMACOVIGILANCE AGREEMENT
- 12. The marketing of many medicines increasingly takes place through contractual agreements b/n 2/more companies. Agreements vary comparably with respect to inter-company and regulatory responsibilities. It is very important to explicit contractual agreements specify the processes for the exchange of safety information, including timelines etc. Whatever the nature of arrangement, the MAH s ultimately responsible for regulatory reporting. Therefore, every reasonable effort should be made between the contracting partners to minimize data exchange so as to promote compliance with MAH responsibilities.
- 13. REGULATORY AUTHORITY SOURCES Individual serious unexpected adverse drug reports originatingfromRAs are subjectto othersby MAH Re-submission of serious ADR cases without new information to the originating RA is not usually necessary unless otherwise specified by local regulations
- 14. Reference • https://globalpharmacovigilance.com/icsr-sources/ • https://www.slideshare.net/RamakrishnaK5/pvigilance • https://www.researchgate.net/figure/Pathways-for-communicating- spontaneous-reports-in-the-Spanish-Pharmacovigilance- System_fig1_254087121