Drug Safety 2007; 30 (10): 919-990 0114-5916/07/0010-0919/$44.95/0
ABSTRACTS
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Poster Presentations P.004 The Application of a Risk Based Approach to Your Pharmacovigilance Operations C. Holmes, R. Petherick, O. Steck WCI Consulting Limited, Denmead, Hampshire, UK Background: The regulators are telling us we should be doing, we all know that we should be doing it and we know it’s a good idea, but how do you put the principles of risk management into practice? Applying a risk based approach to your operational systems and processes can sound like a daunting task. At the moment it’s not a requirement, but surely that’s only a matter of time, so it makes sense to take the plunge and start reaping the benefits that risk management can offer: • A better understanding of current safety related risks • Reduce safety related risks • Systematic and consistent approach to assessing risk • Addressing operational and process risk will have a positive impact on product risk and therefore patient safety Improves compliance and therefore reduces regulatory exposure Solution: There is now a structured Risk Management framework that is easy to implement and enables you to spot, record and mitigate drug safety risks before they occur. It’s already producing great results in Pharma Manufacturing and now Drug Safety. The new approach merges proven methodologies such as Failure Mode Effect Analysis (FMEA) with best practice risk management. The process is a unique amalgamation of the classic risk management steps and FMEA and breaks down into five key steps. The first is identifying the risk – gathering information from sources such as questionnaires, audit reports and meetings. Step 2 is Analysis – what system/ process/component is affected by the risk. Score the risk for impact – what is the extent of the consequences of the risk if it occurred? Could it harm the patient, the business, or both? Next assess and score the risk for the likelihood of it occurring. Finally if the risk does occur, what are the chances that you will detect it? Allocate the risk a detectibility rating. Calculate the scale of impact by likelihood and detection and you have your priorities, and a clear indication of where to focus your resources. The next step is a plan of mitigation actions to stop the high priority risks turning into anything more serious. This is followed by ‘Control and Report’, which enables you to track your actions and trend. Finally, monitor the risks continuously – were the mitigation actions effective and is there a chance the risk could return? Take it through a risk cycle until you are sure it is completely mitigated.
