To follow-on with our previous posting, we provide another important update regarding Supply Chain Matters ongoing commentaries addressing significant supply breakdowns of critical life-saving drugs within pharmaceutical and drug supply chains. When legitimate essential drugs become scarce, unscrupulous activities unfortunately take advantage.

During these past few weeks, regulatory agencies have been alerting doctors and healthcare providers that in the light of severe shortages of hundreds of drugs, there are now clear signs that unauthorized or counterfeit versions of these drugs are infiltrating global supply chains. The U.S. FDA recently alerted to the appearance of “non-FDA approved injectable cancer medications.”  These include non-authorized versions of Faslodex, Hercetin, Neupogen and Rituxan.

The most visible headlines among traditional business media regarding the appearance of counterfeit versions involve the drug Avastin, prescribed to treat brain, colon, lung and kidney cancers.  Last week Swiss drug maker Roche, and its Genetech unit, the global producers of Avastin, indicated that counterfeit versions of its top-selling cancer drug, ones without any active ingredient, were being circulated in the U.S. Patients receiving this counterfeit version would thus not received required therapy. The FDA has further alerted 19 U.S. medical centers about purchases made from suspect distributors.

What is ever more concerning to supply chain management teams is the global based chain of custody now involved in these suspect drugs, adding many more points of vulnerability.  As shortages of life-saving drugs become more acute, healthcare providers are  turning to secondary channels in hopes of securing essential supply, sometimes not knowing the reliability product sourcing of such smaller wholesalers. In the specific case of Avastin, the counterfeit version flowed through wholesalers in Switzerland, Denmark and the United Kingdom before entry into the U.S.  According to an article published in the Financial Times, the Medicines and Healthcare products Regulatory Agency (MHRA) in the U.K. is further investigating whether the source of the counterfeit drug originated from a supplier in Egypt. It was also reported that some of these wholesalers never saw nor physically inspected the drug.  In essence, the existence of a counterfeit gets passed unnoticed all along the chain until it reaches the healthcare provider pharmacy. In its reporting, the Wall Street Journal included a graphic which indicates the multiple alternative wholesaler paths that were reported for distribution of the suspect Avastin.

Since there are currently no clear signs of improvement in overcoming critical shortages of life-saving injectable drugs, the emergence of increased distribution of unapproved or counterfeit drugs will only increase.

If there were ever a time for increased ‘track and trace’ or serial number control processes to assure legitimacy of supplies, it is clearly now.  While the industry has been generally dragging its feet on these initiatives, limiting such efforts to conform to specific U.S. state or national mandate schedules, current alarming events will only force legislative regulators to mandate increased controls for authentication., or possibly accelerate implementation timetables.  The problem is global in scope, meaning that tracking processes and standards must accommodate global supply chain distribution channels.

There is little question that pharmaceutical and drug supply chains have fallen down in insuring adequate and reliable supply of life-saving injectable drugs. Obviously, there are many ongoing problems to resolve, not the least of which is too much single sourcing and lack of adequate supplier monitoring of quality and consistency.  One big problem invariably leads to others, and now, an alarming trend for increased appearance of non-conforming or counterfeit versions leads to yet another problem, insuring authenticity and reliability of supply.

The bottom line, in our view, is that all members of pharmaceutical and drug supply chains, industry and regulators, need to bring serious attention and resources to bear on processes related to sourcing, supply planning, supplier monitoring and product authenticity.

We encourage comments from readers within the industry dealing with these problems.

Bob Ferrari

©2012, The Ferrari Consulting and Research Group LLC and the Supply Chain Matters blog.  All rights reserved.

We provide a brief but important update regarding Supply Chain Matters ongoing commentaries addressing significant supply breakdowns of critical life-saving drugs within pharmaceutical and drug supply chains.

Yesterday the U.S. Food and Drug Administration (FDA) approved two additional suppliers for two life-saving cancer drugs that have experienced short supply because of the unplanned shutdown of contract producer Ben Venue Laboratories, a division of Germany based Boehringer Ingelheim GmBH.

To respond to the critical shortage of ovarian cancer treatment drug Doxil, distributed by Johnson and Johnson, the FDA has approved temporary importation of the replacement drug Lipodox as an alternative to Doxil.  The FDA has authorized a limited arrangement specific to Mumbai India based Sun Pharm. Global FZE and its authorized distributor, Caraco Pharmaceutical Laboratories Ltd., based in Detroit. In its press release, the FDA reinforces that temporary importation of unapproved foreign drugs is considered in rare cases when there is a shortage of an approved drug that is critical to patients and the shortage cannot be resolved in a timely fashion with FDA-approved drugs.

Another drug that is in critical short supply in the U.S. drug supply chain is the drug methotrexate, prescribed to treat many forms of cancer and chronic disease. Their have been recent media reports indicating that only two weeks of supply of the drug remained to fulfill patient demand. The FDA has additionally approved a preservative-free generic equivalent manufactured by Illinois based APP Pharmaceuticals, a division of Fresenius Kabi AG based in Germany. Drug maker Hospira additionally expedited release of additional 31,000 vials of methotrexate, described as the equivalent of one month’s demand for this drug. The FDA is also working with other drug producers to free-up additional supplies.

The FDA also issued additional guidance to drug manufacturers regarding more detailed requirements for both mandatory and voluntary notifications to the FDA regarding future drug shortages or potential drug shortages.

Supply Chain Matters applauds these latest actions coming from both the FDA and the industry.  The fact remains however that the potential for stockouts of any critical life-saving drug remains unacceptable, and the industry continues to find itself in a situation of too much sourcing risk, without contingency plans for augmenting supply.  We also strongly suspect that the new FDA directives regarding notification of short supply will only increase the visibility to other drugs in short supply, adding more embarrassment, patient and healthcare provider mistrust concerning the U.S. drug supply chain.  We fear that this will only add to the growing problem of counterfeit and grey market supplies of critical drugs.  We hope that we are proven wrong.

Bob Ferrari