Do J&J, Pfizer even know where the wood pallets came from?
In a report on recent drug recalls, one risk analyst suggests they don’t. Aggressive cost-cutting in both in manufacturing operations and in the supply chain may be contributing to the quality problems that have led to a wave of product recalls in the drug supply recently, a Reuters report suggests this week.
Seeking out the cheapest materials, both those that go in the drugs and those involved in their manufacture and transport (like the wood pallets treated with chemicals that seeped into recalled bottles of Johnson & Johnson products and Pfizer’s Lipitor), has not only made he supply chain more complex, but diluted the control—and even awareness—drug makers have over their supply chains.
We thought this insight from the article was especially illuminating:
“Things that were off the table in the past are now on the table,” said Jim Lawton, president of Dun & Bradstreet Supply Management Solutions, which tracks and monitors supply chain risks for clients.
“As a result you’ve got all these supply chains now that are fragmented across all sorts of companies and they’re all geographically dispersed,” Lawton said.
“My guess is they (J&J and Pfizer) don’t even know who the pallet manufacturer is, and yet they’re on the hook at the end of the day for whether or not consumers think they can buy Tylenol and if it’s going to be a safe product to ingest.”
The FDA’s Hamburg agreed that supply chains are getting much more complex.
“There are many, many more players involved as a drug moves through the distribution process and at every point along the way is a point where there needs to be attention or problems may occur,” she said.And many countries don’t come close to having the same quality control standards as a drugmakers’ home turf.
“I work with a company that had outsourced something to China and the manufacturer in China had turned around and outsourced a key portion of that to sub-Saharan Africa, and yet my customer is saying, ‘I didn’t even know we had suppliers in Africa.’ And they are just exposed,” Lawton said.
Learn more about securing the drug supply chain at the Pew Prescription Project.
–Kate Petersen, PostScript blogger
November 13th, 2010 at 6:16 am
More fundamentally than not knowing where the wood pallets came from, is knowing even whether wood pallets were implicated. While TBA has been associated with wood pallets (it is banned in much of the world including North America, Europe and Australia)that is not to say that wood pallets were the source of the TBA. Take for example the wording of this recent Pfizer release, quoted at http://www.packagingrevolution.net:
“Earlier this year,” Pfizer states, “a “musty” or “moldy” smell recently reported in bottles of another pharmaceutical company’s products turned out to be caused by 2,4,6 tribromoanisole, or TBA. It results from a chemical change that occurs to another compound, 2, 4, 6 tribromophenol, or TBP, commonly found in wood preservatives, paint, insulating materials and other items. Humid conditions, as in tropical regions, promote mold that can cause TBP to turn into TBA. Plastic bottles can pick up traces of TBA if they are stored in areas where TBP or TBA exist, or on wooden pallets (portable platforms for transport or storage of goods) that are treated with TBP.”
Supply chains are indeed complex, and product contact involves many more variables than wood pallets, which tend to make a convenient scapegoat.
November 18th, 2010 at 5:30 pm
McNeil/JNJ actually did find the “smoking pallet” and confirmed the presence of TBA from pallet samples (they have not provided the data). The pallet was received from their bottle manufacturer in PR. The source lumber for the pallet was from Central or South America where it is believed the TBP was applied. So in this instance the pallet is the logical root cause. Depomed purchased bottles from the same supplier. Pfizer purchased bottles from another supplier in PR. But to your statement that the pallets are a convenient scapegoat is accurate as the further recalls of products by Pfizer and McNeil/JNJ prove. If the pallets were the problem, drug manufacturers should be able to trace the bottle lots that were contaminated and pull back all the product affected. I think what we are seeing in these additional recalls is the effect of secondary contamination in the supply chain. TBA contaminating materials other than pallets (packaging materials, shipping containers, product)most likely have left the island and have contaminated the shipping, storage and distribution channels ex-PR. And who is to say this has not been the case all along but only recently it has been detected and spotlighted by the FDA. The aggressiveness of TBA in spreading to other materials and surfaces in the supply chain is concerning in that once it is absorbed you can’t get it out, and it is detectable by the consumer at ppb levels. In addition there are no acceptable limits determined. There is no tox data for TBA and the FDA considers contaminated product to be adulterated and should be recalled. Pallets will not be exonerated but will probably be joined by many other suspects as time goes by. Implementing a program to only use certified heat treated pallets is just the start of actions necessary to correct and prevent this contamination in the supply chain.
March 26th, 2011 at 3:37 pm
[...] Do J&J, Pfizer even know where the wood pallets came from TBA contaminating materials other than pallets (packaging materials, shipping containers, product)most likely have left the island and have contaminated the shipping, storage and distribution channels ex-PR. … Do J&J, Pfizer even know where the wood pallets came from [...]