Case Study Report Pharmacovigilance

The conclusions of Loke and colleagues (1) are based on the erroneous
assumption that the only way to determine causality of a case report of an
adverse drug reaction (ADR) is by performing a controlled follow-up study.
They ignore pharmaceutical and regulatory authority databases and decision
-making which play a significant role in further evaluation.

Case reports act to direct attention to a possible ‘new’ ADR (or a
known ADR in a specific risk group). This serves to stimulate
practitioners to be alert for this in their patients and to report
suspected cases to regulatory authorities and pharmaceutical companies.
The information from these reports, together with possible reanalysis of
clinical trial data held by the companies and the regulators, will often
form the basis of the causality assessment, and potential change of
product labelling with or without new risk-benefit analysis and possible
withdrawal of the drug from the market. Such a system is very effective at
early identification of ADRs.(2,3)

It is therefore both expected and comforting that Loke et al. found
more changes to product labelling than there were validation studies for
case reports. Investigation of the basis for safety-related product
labelling changes by regulatory authorities would probably arrive at
sharply different conclusions about the value of case reports in
pharmacovigilance than the present study.


1. Yoon Kong Loke, Deirdre Price, Sheena Derry, and Jeffrey K
Aronson. Case reports of suspected adverse drug reactions—systematic
literature survey of follow-up. BMJ 2006; 332: 335-339

2. Stricker BH, Psaty BM. Detection, verification, and quantification of
adverse drug reactions. BMJ 2004;329: 44-7.

3. Vandenbroucke JP. In defense of case reports and case series. Ann
Intern Med 2001;134: 330-4.

Competing interests:
None declared

Individual Case Study Report (ICSR) is an adverse event report for an individual patient and is source of data in pharmacovigilance.
The main focus of ICSRs (individual case safety reports) are reports from healthcare providers and patients in member countries of the WHO Programme. A WHO global individual case safety report database (VigiBase) is maintained and developed on behalf of the WHO by the UMC.

ISO ICSR standard

The European Medicines Agency (EMA) has published a guide to support the implementation of a new international standard for the safety monitoring of medicines in the European Union (EU). The so-called ISO ICSR standard improves the reporting of suspected side effects of medicines in Individual Case Safety Reports (ICSRs). The use of the new international standard will take effect on 1 July 2016. EMA is herewith closing the circle between ICSR and XEVMPD by using the ISO IDMP´s controlled vocabularies. It requires the use of the new ISO IDMP standards when they become available for use in the EU.

MPID – Medicinal Product Identifier

The interesting part for closing the circle between XEVMPD and ISCR is the so called MPID – Medicinal Product Identifier – also part of IDMP standard ISO 11615 identifying the product with ist entire liefe cycle (development, authorisation, post-Marketing and renewal or withdrawal from the market. Further it is stated that ‘until such a time as the ISO IDMP standards are implemented worldwide the support for free text will be required.
However, when the circle will be closed, then the aim of IDMP to increase the patients´safety will be reached.

ICSR Format

ISO ICSR aims at establishing the same format for the reports on individual cases of suspected side effects in patients due to a medicine across the world. It also is expected to include better information on medicines that might be associated with an adverse drug reaction and on the therapeutic uses of those medicines. In addition, the standard also strengthens personal data protection in the records of ICSRs collected by pharmaceutical companies and regulatory authorities.

This will improve the quality of data collected, and increase the ability to search and analyse them. Regulatory authorities will be able to detect and address safety issues with medicines more quickly, and therefore better protect patients.

EMA´s ICSR Implementation Guide

The new guide developed jointly by EMA and the Heads of Medicines Agencies (HMA) will be of interest to pharmaceutical companies and medicines regulatory authorities in EU Member States and will support them to prepare for the use of the standard. The guide specifically defines the electronic transmission process of ICSRs, the format and content of the ICSR, the business rules for report validation as well as classification and data quality principles. It will also assist software providers and IT developers as pharmacovigilance databases are being developed.


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