Drug Shortages Slam Patients, Health Workers, Surveys Show
By Donald A. Donahue, Jr., DHEd, FACHE
Recent surveys by the American Hospital Association and the American Society of Health-System Pharmacists reveal an escalating shortage of vital drugs that could soon affect nearly every hospital in the nation, forcing delays or substitutions in patient care, and costing up to $216 million to manage the situation nationwide. Federal Food and Drug Administration officials say the shortages are caused by manufacturing problems, firms that simply stop making drugs, and production delays.
See: www.msnbc.msn.com/id/43718291/ns/health-health_care/
The escalating shortage of certain pharmaceuticals results from a near perfect storm of divergent issues. This seeming paradox can be explained in simple terms: relatively minor disruptions in the development, production, or distribution channels arise, none of which are catastrophic alone but that have significant impact in aggregate. Despite what would appear to be monumental sums expended, drug companies commit significant resources developing new products, the majority of which never see the light of day. For every “Viagra” blockbuster drug, there are countless failures that never reach market. When a drug is successful, it takes years to get to market. This is because of multiple factors, the most significant being the safety and efficacy requirements mandated by the FDA. Pharmaceuticals are extensively tested prior to approval, and even then adverse side effects can be detected long after regulatory approval. Pharma carries a significant exposure to liability. The public decries side effects, even as it demands faster development and distribution of new and improved medicines.
The vast majority of drugs are produced by commercial firms. As business entities, these organizations must generate reasonable return – profit – on their activities. Therefore, the production of low volume, complicated, and exotic drugs is often forgone. Extensive safety standards protect us, but can also interfere with the supply. If purity or potency is suspect, production will not proceed. Demand can also outstrip supply, as has been the case in several recent flu seasons.
Ensuring an adequate pharmaceutical supply is a public health policy issue. To guard against a significant natural or terrorist outbreak, the CDC maintains the Strategic National Stockpile (SNS). The SNS is prepositioned across the nation for use during a health emergency. It cannot and should not supplement normal supply channels, however. A balanced approach is necessary to ensure the right level of supply. For some drugs, the government has granted, as part of the production contract, immunity from liability. This typically results in vehement protests against protecting pharmaceutical companies from their responsibilities, yet an alternative to the sound business decision has not been advanced. To ensure availability of certain drugs, a middle ground must be reached. The drug supply could be expanded by allowing importation, but this would place production outside the protection of US Government agencies. This creates a public policy conundrum. While exposure to disease, illness, and injury cannot be completely avoided, this once again points to the value of prevention. Unfortunately, as a society we generally fail to prevent bad things, but rather opt to address them as they occur.