Module 6

03/10/2024

Module VI- Management and reporting of adverse reactions to medicinal products

What is an adverse drug reaction (ADR)? ● A response to a medicinal product which is noxious and unintended ● A causal relationship between medicinal product and adverse event is at least a reasonable possibility ● May arise from use of the product within or outside the terms of the marketing authorisation or in additional situations e.g. off label use, overdose, abuse, misuse and medication errors or from occupational exposure ● There are many associated terms e.g. SUSAR, SAE, SAR, serious ICSR...

What is an Individual case safety report (ICSR); synonym: Adverse (drug) reaction report ● Format and content for the reporting of one or several suspected ADRs to a medicinal product that occur in a single patient at a specific point of time.

13

13

13

Some special reporting situations

• Drug exposure during pregnancy and in lactating mothers A framework for evidence of the safety of medicines in pregnancy and breastfeeding Br Med J 2021; 375: n2377 Accessed @ https://www.bmj.com/content/375/bmj.n2377/rr 1 on 08 January 2022. Dr DJ Lewis, Head QPPV PRRC, Novartis; Dr L Yates, University of KwaZulu Natal, South Africa; Prof E van Puijenbroek, PV Centre Lareb, The Netherlands; A Alexe, Policy and Liaison, QPPV PRRC Office

• Overdose with and without adverse effects

• Off-label use

• Misuse, abuse, tolerance

• Medication errors including name confusion

• Occupational exposure

• Lack of therapeutic effect

• Suspected transmission of an infectious agent via a medicine

14

14

14

7