ICSRs: Definition, Features and Pharmacovigilance Services’ Roles (Part Two)
Individual Case Safety Reports (ICSRs) are vital drug safety documents required by EU pharmacovigilance law for each and every medicine or medicinal product a Marketing Authorisation would apply to. In the first part of our overview of we discussed their definition and key formatting required by regulators. There was also a brief mention of the roles external pharmacovigilance services often undertake for small to medium pharmaceutical companies in relation to ICSRs. In the second and final part, we will examine the type of key content the regulators require, and again touch upon services often used by small to medium sized Marketing Authorisation Holders.
In particular, Volume 9a of The Rules Governing Medicinal Products in the European Union [1] makes reference to compliance with ICH E2A by ensuring the ICSR contains a “case narrative”, meaning a comprehensive and complete medical description of the case. This should include [2]:
- Patient characteristics
- Diagnosis
- Therapy Details
- Medical History
- Narrative of Clinical events
- Known adverse reactions alongside the relevant outcome
- Results of laboratory tests along with the normal ranges
- “any other information that refutes or confirms an adverse reaction” [2]
As well as inclusion of component items, the report must follow the formatting guidelines as a matter of obligation rather than the regulators preference. Volume 9a is quite clear that this may require some of the information stipulated to be repeated [2]. The format must also apply when new information is added for follow-up reporting, which should be clearly delineated from the original case narrative. Except to describe results of standard tests, abbreviations are to be avoided [2].
Pharmaceutical companies clearly have complex legal obligations in this area of drug safety monitoring. Many choose to outsource the compilation of ICSRs to external pharmacovigilance services providers for this very reason. Whilst there is a provision for times when information is not available in some circumstances, incorrectly submitted ICSRs are to be avoided at all costs. Many external providers offer a ‘complete’ service, processing the necessary data into the final format for compliant electronic submission. This can be of particular value to small to medium sized companies where it may sometimes be the case that not all available staff have current training and experience in the exacting requirements for both ICSR format and content.
References:
- Volume 9A of The Rules Governing Medicinal Products in the European Union – Guidelines on Pharmacovigilance for Medicinal Products for Human Use. 2011. Part III, p.159-171 [ONLINE] Available at: http://ec.europa.eu/health/files/eudralex/vol-9/pdf/vol9a_09-2008_en.pdf. [Accessed 22 January 2011].
- Volume 9A of The Rules Governing Medicinal Products in the European Union – Guidelines on Pharmacovigilance for Medicinal Products for Human Use. 2011. Part III, Article 5.1, p. 164. [ONLINE] Available at: http://ec.europa.eu/health/files/eudralex/vol-9/pdf/vol9a_09-2008_en.pdf. [Accessed 22 January 2011].
