The Impact of Drug Shortages on the US Health System

Although drug shortages are now widely recognized as a global issue, this was not always the case. Between 1996 and 2002, there was a total of 224 drug shortages as tracked by the University of Utah Drug Information Service. But in 2015 alone, ASHP reported 207 drug shortages. So it is important to understand the implications of drug shortages; why they occur; and how to alleviate them.

Drug shortages have many implications to the patient and the healthcare system. First and foremost, patients suffer the brunt of drug shortages when they occur. In one common scenario, a patient comes to the pharmacy to pick up his medication, only to find out that it is out of stock due to a drug shortage. The patient must choose whether to purchase a costly alternative medication or try to wait it out, without the benefit of his doctor's advice. Drug shortages also have a large impact on the healthcare profession, especially in the in-patient setting. In one example, a nurse might administer an unfamiliar alternative drug - let's say, IV hydromorphone - but at the intended dose of morphine. This could be lethal! Or when limited supplies of a life-saving drug exist, clinicians are forced to make difficult ethical decisions: what patients get it? And no matter what decision they make, they are at an increased risk of litigation by patients who believe they received improper care due to the drug shortage.

On the health system level, institutions also face ethical dilemmas with respect to drug shortages. What if an out-of-stock drug is available through the gray market? Knowing a drug’s pedigree with 100% certainty is nearly impossible, which raises questions about its safety, authenticity, or efficacy. But what if a local compounding pharmacy could manufacture the drug on demand? However, the 2012 meningitis outbreaks due to improper handling at the New England Compounding Center show the risks of using compounding pharmacies. So it is important for every health system to formulate its own regulations to deal with these issues BEFORE a drug shortage occurs.

So how do drug shortages occur? The most common reasons for shortages are: manufacturing difficulties, regulatory issues, and product discontinuation for any reason. Manufacturing difficulties arise from lack of raw materials, equipment breakdown, or even loss of personnel. Additionally, drug shortages may occur when manufacturers halt production due to regulatory issues, particularly due to not following cGMPs (current Good Manufacturing Practices). Although cGMPs are not mandated by law, pharmaceutical companies recognize that compliance is necessary for products to enter and remain on the market per the FDA. So, sometimes manufacturers preemptively recall products to avoid even the risk of FDA legal action. Product discontinuations also lead to drug shortages. It is important to note that manufacturers do not discontinue drugs only when they are unprofitable – even revenue-generating drugs may be discontinued. If production capacity is filled to the max, the company will analyze its product line up to determine which products are the lowest performers. By cutting those products, the company can focus on manufacturing its best performers and thus improve revenues.

Unfortunately the FDA cannot force a manufacturer to produce a product. Additionally, manufacturers are not required to report discontinuation plans unless they are the “sole manufacturer of a drug that is life supporting; life-sustaining; or intended for use in the prevention of a debilitating disease or condition”. The problem is that this is a very narrow range of drugs.

It will take the collaboration of the health system, FDA, and manufacturer in order to prevent or mitigate drug shortages. Health systems should implement a set of universal guidelines before drug shortages occur, and notify the FDA as soon as a drug shortage is detected. Although the FDA has limited authority over manufacturing companies, it can take certain steps to mitigate existing shortages. For example, it can incentivize other pharmaceutical companies to increase production of the product. Finally, manufacturing companies must also take responsibility for drug shortages. Although firms are not required to report discontinuation plans to the FDA, I believe that they should still be held morally accountable for reporting such plans to the public. If manufacturing companies were held to a higher moral standard, patients could only benefit.