Individual case safety reports reportability

E2B(R3) Clinical Safety Data Management Data Elements for Transmission of Individual Case Safety Reports... 

This working party considers safety-related issues at the request of the CPMP and national authorities, resulting in the harmonization of the summary of produet eharae-teristics and package leaflets of marketed products. Regular videoeonferenees are held with the U.S. Food and Drug Administration (FDA) to discuss issues of mutual interest. A pilot project has been started for the electronic transmission of individual case safety reports with a restricted number of participants from national authorities and marketing authorization holders. 

ICH E2B(M) Clinical Safety Data Management data elements for transmission of individual case safety reports. 

CPMP Joint Pharmacovigilance Plan for the Implementation of the ICH E2B Ml and M2 Requirements Related to the Electronic Transmission of Individual Case Safety Reports in the Community. 

Specification (M2)], ICH/287/95 [Guidance on Clinical Safety Data Management Data Elements for Transmission of Individual Case Safety Reports (E2B)], ICH/288/95 [Guidance on Clinical Safety Data Management Periodic Safety Update Reports for Marketed Drugs (E2C)], and ICH/377/95 [Clinical Safety Data Management Definitions and Standards for Expedited Reporting (E2A)]. 

Note for Guidance on the Electronic Data Interchange (EDI) of Individual Case Safety Reports (ICSRS) and Medicinal Product Reports (MPRS) in Pharmacovigilance during the Pre-and Post-Authorisation Phase in the EEA (EMEA/115735/2004) (Eudra Vigilance TIG adopted September 2004)... 

Postmarketing Expedited and Periodic Individual Case Safety Reports. This allows for voluntary electronic submission of all postmarketing individual case safety reports, whether expedited or periodic, in electronic format in place of paper. 

AERS. A pilot program for electronic submission of individual case safety reports is now being conducted with pharmaceutical manufacturers with approved products. The format follows the International Conference on Harmonization (ICH) standards. For more information on the ICH, please contact Timothy Mahoney at mahoneyt cder.fda.gov. 

For more information on the proposed electronic submission of individual case safety reports, see 63 FR 59746, Advanced Notice of Proposed Rule-making for Electronic Reporting of Postmarketing Adverse Drug Reactions, published on November 5,1998. 

International Conference on Harmonization Guideline on Data Elements for Transmission of Individual Case Safety Reports. This document s efforts focus on quality control/quality assurance endeavors to ensure accuracy and to promote validation in the handling of case safety reports for both preapproval and postapproval periods. It covers both adverse drug reaction and adverse event reports. 

Figure 34.4 Flowcharts for reportability assessment (a) assessment of expedited reportability (Europe) investigational medicinal products (IMPs) (b) assessment of reportability of individual case safety reports (ICSRs) in Europe post-marketing...

Transmission of Individual Case Safety Reports in the Community. 

Over the past few years, the relative emphasis of pharmacovigilance activities has shifted (Figure 6.1). In the past, most pharmacovigilance departments at biopharmaceutical companies focused on the handling of individual adverse event reports (called individual case safety reports [ICSRs]) with less attention paid to systematic analysis and review of aggregate adverse... 

Tengstrand M, Star K, van Puijenbroek EP, Hill R. Alopecia in association with lamotrigine use an analysis of individual case safety reports in a global database. Drug Saf 2010 33(8) 653-8. 

The number on the outside of the case is required to be numeric or alphanumeric, not the name of the patient. Patient names are not permitted to be publicly disclosed in the context of a MedWatch report according to 21 CFR 21.63(f). The initial report is the first reported information received by the company about an individual s adverse drug experience. There must be a prompt attempt to obtain follow-up information about each initial report. The attempt(s) are made according to the company s written procedures. If the written safety procedures are not followed, the safety reports are not appropriately submitted, or the safety records are not appropriately kept, FDA has the authority under Section 80 of Part 315 to withdraw the market NDA. The follow-up report is the format for submitting additional information about an experience. Each case regards only one individual unless the experience is both temporally and clinically unrelated to a second event experienced by the same person taking the same drug product. 

An industry association that collects process safety metrics allows its members to compare their performance to that of other members. In some cases the reported data does not allow for identification of Individual members performance, so the comparisons can only be made to the association s reported norms. In other cases, more detailed information may be reported. In either case, this information can be valuable for validating a company s objectives and improvement efforts to ensure the company does not lag behind industry performance. 

As the number of adverse event case reports increases, the relative reliance on different types of data and analytic techniques changes. When there are a relatively small number of cases, pharmacovigilance professionals can review the data, focusing on clinical characteristics of individual cases. Statistical and epidemiological methods become essential and more useful as large amounts of data are accumulated. However, irrespective of the size of the safety databases, clinical judgment and assessment remains important. 

Many causality algorithms and categorisation systems have been proposed but none has gained universal acceptance, and the value of assessing this for each individual report of a suspected ADR now seems to be doubtful. It is certainly much more efficient to reserve such assessment for a series of cases which might represent a new and/or important safety issue. Systematic assessment of causality in individual cases occurring in clinical trials is intrinsically a weaker approach to assessing causality than comparison of numerical cormts. 

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