The Council for International Organizations of Medical Sciences (CIOMS) announces the publication of Practical approaches to risk minimisation for medicinal products: Report of CIOMS Working Group IX. Medical science continues to bridge new frontiers with an ever-widening array of medicinal products to treat illnesses and health conditions. No medicine is devoid of risk, however, and for that reason, it becomes paramount to appropriately manage all kinds of risks, from the very minor ones to those with serious adverse effects, with the objective being a positive balance of benefits to risks. Risk management of medicines is a wide and rapidly evolving concept and practice, following a medicine throughout its lifecycle, from first administration in humans through clinical studies and then marketing in the patient population at large.
Previous reports from CIOMS I – VIII provided practical guidance in some essential components of risk management such as terminology and reporting of adverse drug reactions, management of safety information from clinical trials, and safety signal detection. Beyond the detection, identification, and characterisation of risk, “risk minimisation” is used as an umbrella term for the prevention or mitigation of an undesirable outcome. Risk management always includes tools for “routine risk minimisation” such as product information, the format depending on the jurisdiction, to inform the patient and the prescriber, all of which serve to prevent or mitigate adverse effects. Until this current CIOMS IX document, limited guidance has been available on how to determine which risks need “additional risk minimisation,” select the appropriate tools, apply and implement such tools globally and locally, and measure if they are effective and valuable. Included in the report is a CIOMS framework for the evaluation of effectiveness of risk minimisation, a discussion of future trends and developments, an annex specifically addressing vaccines, and examples from real life.
ISBN 978 92 9036 084 4
Citation of document: Practical approaches to risk minimisation for medicinal products: Report of CIOMS Working Group IX. Geneva, Switzerland: Council for International Organizations of Medical Sciences (CIOMS), 2014. *Please observe that due to order requests, the definition for the unlimited copy options concerns a country-level license and that the price for global-level usage has been established as of 23 September 2014.
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