A Guide to Pharmaceutical Recalls

A Guide to Pharmaceutical Recalls

Posted: by Stericycle on Jan 31, 2019

Most people take it for granted that when we consume a prescribed or purchased medicine that it meets the most stringent of safety standards.

While this is the case the vast majority of the time, with many pharmaceutical products going through years of testing before being put to market, the fast-paced changes and developments of new technologies mean that when it comes to regulation, we’re increasingly wading into the unknown. And with the unknown comes a heightened risk.

In Europe, The European Medicines Agency (EMA) coordinates the assessment of reports of product quality defects of centrally authorised medicines, and decides on the recall strategy. In the UK, the Medicines & Healthcare products Regulatory Agency (MHRA) works closely with the EMA.

Thankfully, large-scale recalls of pharmaceutical products are rare. However, last year the contamination of a popular blood-pressure medicine became a global problem. Found in medicines designed to control blood pressure, what was a US issue quickly escalated, with global batches at risk of contamination from N-nitrosodimethylamine (NDMA), a carcinogen used by scientists to induce cancer in lab rats and which can be toxic for the liver.

During the first two weeks in January, only one recall notice was issued in the UK, by Actavis Group PTC EHF, which discovered a risk of contamination in some of its batches with N‑nitrosodiethylamine (NDEA) – a carcinogenic and constituent of tobacco smoke. Stockists have been advised to quarantine all remaining stock and organise a recall with suppliers.

Looking at the above, both cases stemmed from a risk of contamination from a known carcinogen – which can go on to cause cancer. Although extensive tests are carried out pre-regulation, relatively few drugs have undergone significant long-term post-marketing surveillance for adverse effects, including elevated cancer risk.

With many adults and children taking medications regularly, more research must be carried out so manufacturers can understand the long-term impacts.

As well as the contamination risks presented by harmful and toxic substances, as the supply chain continues to diversify, ‘fake’ medicines are becoming more readily available – with poor manufacturing techniques resulting in quality, purity and potency risks. It’s a market that’s difficult to regulate, with consumers advised not to purchase anything without having complete authority of its origins.

All suppliers of pharmaceutical products will have policies in place, with medical professionals trained on recall processes should the need arise. Many manufacturers will also have a hotline number to contact for more information.