Opinion: Still not getting it right

Published: 15-Jan-2015

The future for pharma development is bright, but there are still too many potentially dangerous recalls in the manufacturing sector

As we enter a new year, there is much to look forward to: more biologics and biosimilars produced more effectively and less expensively; a potential breakthrough antibiotic; and the slightly more distant prospect of stem cell therapies making a real impact.

But it’s not all good news. The turn of the year was marked by a series of product recalls that pose varying degrees of risk to patients.

In the latest in a series of incidents, Valeant Pharmaceuticals is recalling one lot of Virazole, an inhaled medication that can be used to treat hospitalised infants, because of suspected microbial contamination.

Hospira’s quality issues continue, with a recall of 10 lots of the cancer drug mitoxantrone manufactured at a plant in Australia criticised by the FDA in a warning letter last year.

Meanwhile US-based Wallcur’s IV training products have somehow ended up in the US healthcare supply chain and have been used on patients with ‘serious adverse results’. The company and the FDA are still trying to find out how this could happen.

And Baxter, which last year reported adverse reactions in dialysis patients who had received a peritoneal product later found to have mould in it, has now had to recall two batches of saline injections because particles of glass had broken off the vial adapter and ended up in the product.

Ironically, track and trace rules for pharmaceutical manufacturers, wholesalers and logistics companies came into force in the US on 1 January 2015, requiring them to be able to provide full documentation of lots of prescription drug products along the entire chain of custody. But the day before the rules were due to come into effect, the FDA decided to delay enforcing the new rules until 1 May, apparently because some companies reported ‘unforeseen complications’ that could disrupt shipments and prevent access to medicines for some patients.

It looks like a case of two steps forward and one step back where patient safety is concerned.

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