Here’s a thing. It is your personal responsibility to spot potential risks in drug safety. If you don’t see them before they become a danger to the patient and a regulator can prove you had the information to mitigate them, you are liable to face the following: closure of your business unit, a prosecution case that could lead to a jail sentence and personal responsibility for the serious illness or death of a patient. Well, Happy New Year, and welcome to the worlds of our stressed Heads of Pharmacovigilance.
But panic not, for Nostrapharmus brings excellent news for the New Year. There is now a tried and tested Risk Management framework that enables you to spot, record and mitigate drug safety risks before they take place, in a structured way. It’s already producing great results in Pharma Manufacturing. And early adopters are trialling it in their UK Drug Safety units now, with a view to rolling it out across the globe.
The new approach merges proven methodologies such as Failure Mode Effect Analysis (FMEA) with best practice risk management in five easy steps. The first is identifying the risk – tracking information gleaned from sources such as questionnaires, audit reports, meetings and conference calls. Step 2 is Analysis – what system/process/component is affected by the risk. Impact – how big is the risk if it happened? Could it harm the patient, the business, or both? Each risk is assessed and scored as to its scale of impact. Calculate the likelihood of it happening by the scale of impact 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 and monitor your actions. Monitor the risks continuously as work takes place – is there a chance the risk could return? Take it through a risk cycle until you are sure it is completely mitigated.
How do you know where the risks might spring from? Well, without a crystal ball do the sensible thing: work with safety process experts who know the industry, who have worked on Risk Management with others, who can bring the lessons learnt and the expertise to your own team.
To read the article in full, please click on the pdf link below:
About Pharma Magazine
Aimed at the international pharmaceutical and bio-pharmaceutical community, Pharma magazine covers every aspect of manufacturing from R&D to finished product. With a worldwide circulation of more than 40,000 individuals, it is the first truly global magazine for the pharma industry, bringing together the disciplines of discovery and development, the drug manufacturing process and the resultant business and management issues. For further information visit the Pharma website at www.pharma-mag.com