In: Nursing
What are the major benefits of being able to share information in individual case safety reports (ICSRs) and view reports submitted in other countries?
ANSWER
Individual Case Safety Report (ICSR) captures information needed to support reporting of adverse events, product problems and consumer complaints associated with the use of FDA regulated products.
All adverse events of the medicines and products occurring in a post-marketing situation and qualifying for your national ICSR database should be shared with the other members of the WHO Programme, both serious and non-serious cases.
VigiBase is mainly a database for spontaneous ICSRs on registered medicinal products. However, UMC also accepts cases from clinical trials and literature; the type of report should be specified in the ICSR.
ICSRs on medication errors, counterfeit/substandard medicines and therapeutic failure should also be submitted. ICSRs on ordinary allopathic medicines, traditional medicines (herbals), as well as biological medicines, including vaccines, should be shared.
Medicines in combination with medical devices should also be sent. ICSRs on veterinary medicines, cosmetic/hygiene products or medical devices are not within the scope of the WHO Programme and should not be shared in VigiBase.