E-DRUG: The Health Planner's Dilemma: Putting Products or Patients at Risk?
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The US Government recently announced that there were over 40 million doses of the H1N1 vaccine worth an estimated $260 million which had expired and would be incinerated. It is expected that an additional 30 million doses will expire soon and also will be destroyed. The article describing the disposal is posted at:
http://www.washingtonpost.com/wp-dyn/content/article/2010/07/01/AR2010070101006.html
The amount to be destroyed will be approximately 40% of the production of the vaccine which remained unused primarily because the demand never took off, for several reasons:
1. Tests of the vaccine soon showed only one dose was enough to protect most people.
READ that to mean a change in treatment regimen
2. Much of the vaccine was not ready until late 2009, after the largest wave of swine flu illnesses passed.
READ that the tender was not in good synchronization with the illness.
3. Swine flu turned out not to be as deadly as was first feared. About 12,000 deaths have been attributed to it -or roughly a third of the estimated annual deaths from seasonal flu.
READ that the disease was not as virulent as originally estimated.
Those same reasons occur in all health planning efforts.
However all knowledgeable health planners and over 50% of the American public would prefer to over estimate the need and destroy excess product than to place our population at risk of not being treated. These same sorts of product risks plague all health planners:
- How do you plan for a change in treatment regimens when treatment is underway?
- How do you synchronize an expected disease outbreak 18 months in advance? and
- How do you estimate the virulence of an unknown disease or multiple health risks in a patient population?
Our best forecasts and supply plans are doomed to be incomplete because there are too many unknowns in the equation.
The demand complexity for pharmaceuticals is further compounded because the supply chain actually begins with starting materials for the synthesis of the Active Pharmaceutical Ingredient that can be used to produce the finished pharmaceutical product (FPP). This part of the supply chain could add a year or more to the staging of the FPP production; this entire process could exceed several years which could affect product availability at the time of the annual tender issuance.
The answer is that there is no perfect solution and the decision has to be made as to which risk to favor. For sure in the US the vote is to have enough product to reduce the people risk which always means some product will exceed the expiry date before use and have to be destroyed.
Unfortunately many health managers do not wish to acknowledge this inherent and unavoidable situation and retain their expired products invisible in their inventories until a disaster strikes somewhere in the world. The expired inventory then can be repackaged as an 'altruistic gift' to those who have suffered through the disaster so it can be taken off their inventories without having to admit to having purchased or, in the case of a manufacturer, produced excess product.
Many companies see donating expired drugs as a great way to help out, generate some positive publicity, and take a tax write-off by donating goods they would not be able to sell. However, although that may be great for the company, it is not great for the health professionals that receive crates of expired drugs that they cannot use but must store or dispose of. This rule allows for expired drugs to be sent only if the health facility is well aware of the status and still believe that the donated drugs will be more beneficial than harmful given their current circumstance.
We all need to accept that we are not perfect and make errors but let's try to keep those errors on the side of too much and not too little to treat the patients. This also means we should be prepared to 'bite the bullet' or accept the pain of having to clear our supply chains of unusable materials and destroy or recycle them in an environmentally acceptable manner.
Thomas Layloff, Ph.D.
Senior Quality Assurance Advisor
Supply Chain Management System
1616 N. Fort Myer Drive, 12th Floor
Arlington, VA 22209-3100
Email tlayloff@pfscm.org