Doing it right: the rigorous approach to medical literature monitoring for drug safety

Correctly identifying adverse events from medical literature is one of the key tasks in pharmacovigilance (PV). It’s also one of the most complex. The sheer volume of information available is overwhelming: so much so that even in the most precisely constructed searches, only five percent of references retrieved will be relevant. Then there’s the issue of duplicate articles, which on average, account for around one-third of references retrieved in medical literature monitoring. It’s no surprise that issues around finding adverse events are the #1 minor finding in recent audit reviews by the UK Medicines and Healthcare products Regulatory Agency (MHRA).

Medical literature monitoring has an additional layer of complexity, added by the processes and software used to carry out the task more efficiently. Here, regulations demand high levels of rigour and quality management, with both people and technology required to operate to detailed and demanding standards. And from search strategies to deduplication algorithms, everything has to be up to date and fit for regulatory inspection at any time.

PV failings have serious consequences that extend all the way up to billion-dollar lawsuits and the withdrawal of drugs from the market. Pharmaceutical companies face a dilemma. What’s more painful, the fines for non-compliance or the cost of doing it right?

Today, there’s a body of best practice and technology that can significantly reduce the pain of medical literature monitoring in PV, making this dilemma unnecessary.

From best practices to algorithms, software to sources, we set out best practice for how medical literature monitoring can be done right – without the cost, time and effort that is such a daunting prospect for many pharmaceutical companies.