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Safety first

Posted 23/02/2012 by sevans

Apart from patent expiries, Big Pharma is reeling under a couple of other issues that essentially revolve around the safety of its products. And those issues involve safety both in terms of the industry’s own manufacturing processes and operations and also the potential backlash of counterfeit and adulterated products produced and distributed by criminal organisations.

It was significant that last week on the very morning of a panel discussion at the Informex show in New Orleans, US, that was billed to look risks to the pharmaceutical supply chain, there was a headline in the Wall Street Journal concerning the discovery of counterfeit drugs in the US. 

The news story proves that the global pharmaceutical supply chain is under threat from counterfeiting, product adulteration and sub-standard manufacturing, with the consequent risk to consumer safety and confidence. And this impact on consumers will also have an economic impact on the industry.

As one panel member expressed it, criminal minds quickly latch onto the opportunity that high value goods offer – until recently the US pharmaceutical sector was losing millions of dollars as a result of thefts from trucks. Thankfully, this problem has been addressed and electronic goods now represent a better opportunity and now account for the largest proportion of high value product thefts.

Counterfeiting and product adulteration is now the key issue, as once again, the high value of drugs offers a major opportunity for criminal gain. 

To address this supply chain issue, the RX-360 initiative has been an international development that now involves most of the world’s Big Pharma companies and more recently an increasing number of smaller companies including contract manufacturers. The initiative began after the incident concerning counterfeit heparin supplied to Baxter Laboratories, which resulted in a number of patient deaths. This incident and the resulting initiative have been a major influence on increased transparency and information sharing between most of the top 20 pharmaceutical majors.

So progress is being made, but the issue of product safety and manufacturing standards among the legitimate pharmaceutical producers is becoming serious. A number of recent inspections by the US Food & Drug Administration have thrown up manufacturing problems not just in emerging markets but also in manufacturing sites owned by Big Pharma companies located in Europe and the US, something that many might consider a contradiction in terms – after all, hasn’t Big Pharma led the way in pushing up manufacturing standards and product safety?

As many might also add, however, familiarity breeds contempt, but is there another issue here? Have the cutbacks in staffing and investment that have resulted from the world’s economic troubles had an effect, or is it that we have become too reliant on automatic safety systems, computer control and the elimination of human intervention?

The March issue of C&I will look at error management in processes and how potential mistakes can be tackled and avoided. Some might say that human error is unavoidable but that is no reason not to look at all the ways its effect can be minimised.

Neil Eisberg - Editor

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  • Anonymous said:
    13/03/2012 10:02

    Thanks John for your comment. I took your ruvsey and look forward to seeing the results. The issue of privacy online is bigger than just for health care, although privacy is especially important in this area.

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