Thoughts on the Pew Prescription Project analysis of the U.S. drug supply

 

Plenty of opportunity for counterfeiters to inject unsafe drugs into the US pharmaceutical supply chain.

Firstly, I’d like to categorically state that this blog doesn’t do politics.  It is strictly concerned with promoting awareness of patient safety issues and to provide safety related best practice recommendations to professional and lay stakeholders.  Now that disclaimer is out of the way, I’d like you to cast your mind back to 2007 when 149 patients in the US died after receiving tainted Heparin originating from a Chinese manufacturing facility.  The cause was the addition of a cheap additive, Chondroitin Sulfate, which was also linked to the deaths of patients in Australia, Canada, China, Denmark, France, Germany, Italy, Japan, the Netherlands and New Zealand.

Last year, the Pew Charitable Trusts Prescription Project, which based on its project overview, does do politics, released its report “After Heparin: Protecting Consumers from the risks of Substandard and Counterfeit drugs”.  It was a good report in that it provided an indepth analysis of the current state of the U.S. pharmaceutical supply chain. However, some of its findings could be interpreted as being politically motivated in nature.  This is unfortunate since the topic at hand is an extremely important one.

An analysis of the Key findings of the Pew Prescription Projects analysis can be found in a powerpoint presentationhere.  An alarming finding of the groups research is that over a quarter of US adults surveyed knew nothing at all about drugs being made with “cheap or toxic ingredients”.  Another 37% knew very little about such things while only 3% stated they knew a great deal about the issue.  On the bright side most respondents felt the government should do more to prevent the contamination of both US and foreign manufactured drugs indicating that many see value in maintaining a safe drug supply.

The majority of respondents rightly had concerns about the safety of drugs manufactured in China and India, although it should be noted that counterfeit drugs originate in many countries including the US.   At the risk of appearing to take a position on the subject, which I am not, the Pew Charitable Trust points out that between 2001 and 2008, the number of drug products made outside of the U.S. doubled.  In and of itself this should not necessarily raise alarm bells, but the FDA does not routinely inspect foreign manufacturing facilities today and it appears funding to do so in the future will not be a priority given the massive budget concerns that exist today.  While the Pew graphic in the following link is somewhat inflammatory, it does point to the fact that there is room to improve patient safety by ensuring the medications we consume are manufactured according to Good Manufacturing Practices.  It also points out that there are currently few effective controls around preventing counterfeit or unsafe drugs from entering the drug supply.

One of the reports more promising recommendations is the proposal that all components of the supply chain should implement electronic tracking systems to ensure the patency of every medication in the system.   “Track and Trace” relies on each drug package bearing a “serialized national drug code” embedded in an electronically readable tag as well as a robust secure database that houses transaction information for each drug package in the supply chain.  This would certainly impact a critical hole in the U.S. pharmaceutical supply chain which the Pew Prescription Project overlooked.  Namely, aggressive spot market sellers of drugs in short supply.  These are companies that speculate that a particular drug will be in short supply and purchase as many doses of the product they possibly can, storing it and then aggressively marketing it directly to to hospital and retail pharmacies at prices that can be many times the average wholesale price (AWP) of the drug.  Implementation of “Track and Trace” would help hospitals verify conclusively that the drugs purchased from them, which in the past have included Factor VII and Factor VIII as well as vaccines in critically low supply, are in fact the genuine article and therefore safe.  JH RPh


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