Rising pharma recalls in UK ‘a concern’, says report

pharmafile | January 29, 2010 | News story | Manufacturing and Production drug safety, medical devices, production, recalls 

Pharmaceutical and medical device recalls more than quadrupled in the UK between 2004 and 2008, with the majority caused by problems with meeting manufacturing or performance standards, according to a new report from customer management agency Blueview Group.

The analysis, citing data from Lindsell Marketing, reveals that over the five-year period starting in 2004, product recalls and ‘Caution in Use’ alerts (for manageable issues not requiring a recall) rose from 22 to 64 in the pharmaceutical sector.

Around half (52%) of the recalls resulted from defects in the product itself, with another 10% attributed to manufacturing defects, 12% from incorrect labelling and 9% resulting from compromised sterility caused by packaging errors or poor structural integrity. A further 6% of cases were due to degradation or improper drug performance.

Blueview notes that only 5% of product recalls or safety alerts in 2007 were for counterfeit products and there were no cases involving falsified products in 2008, but warns this could “instil a false sense of security” given the increase in counterfeit seizures reported by the European Commission in 2007.

The report, which also covers other industrial sectors such as food and fast-moving consumer goods, notes that one reason for the increase is that manufacturers are sourcing “ingredients, components and packaging” from further afield, resulting in less control over their supply chain and thus a higher risk of recalls.

It also notes that an increasing volume of goods were being imported from countries outside the EU, notably China, where legislation does not always align with that of Europe.

‘The rise in recalls in the pharmaceutical sector is a worrying trend for consumers,’ said Darren Ponsford, strategy and planning director of Blueview.

“When there is a problem with medication or medical devices, people have to be able to get through to the supplier and be reassured that the company is willing and able to deal with any questions that they have,“ he said.

“The forward thinking organisation invests in contingency planning so that it can quickly deploy emergency multi-channel contact centre facilities and effectively handle situations that could potentially turn into a difficult and damaging crisis for a business.”

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