Once again we are facing national shortage of key drugs, including anesthetics, painkillers, antibiotics, and cancer treatments. We have written several times about previous drug shortages, all resulting in little to no beneficial long-term action.
The American Society of Health-System Pharmacists maintains a list of drug shortages, which is currently 150 drugs and therapeutics long. The 150 drugs are at inadequate supply levels for a multitude of reasons, ranging from manufacturing problems to federal safety crackdowns to drug makers abandoning low-profit drugs. While the shortages have long been public knowledge, what hasn't been in the public eye as much is the rationing that results from the shortages.
Why Does This Continue to Happen?
While there are a multitude of reasons behind the continuing saga of drug shortages, one such reason is that many drugs are made by only one manufacturer, so production or safety problems at just one plant can have huge ramifications. For any other company to begin making comparable drugs and getting them approved by regulators requires a magic equation of manufacturing capabilities and economic incentives.
Other reasons may include product quality concerns, difficulty in acquiring component parts or active pharmaceutical ingredients (API), increases in demand, and shipping delays, among many other things. Another reason is in the US there are Medicare Price Controls on generic injectable drugs under Medicare Part B.
Choices as to who receives the drugs that are in short supply have been made in different ways at different institutions, sometimes resulting in contradictory conclusions, murky ethical reasoning, and even medially questionable practices.
While some institutions have formal committees that include ethicists and patient representatives, other institutions rely on individual physicians, pharmacists, or even drug company executives, to decide which patient will receive the necessary drug.
The decisions made by hospitals, individual providers, and pharmacists have real consequences to the individuals who are not considered "better qualified" for the drug. For some shortages, the effects of rationing are immediate, such as increased pain or nausea, when the drugs that are typically used to control symptoms are withheld, or patients who have to undergo invasive surgery to control cancer when anti-tumor medicines are delayed.
Studies have associated alternative treatments during drug shortages like this with higher rates of medication errors, side effects, disease progression, and deaths. While many physicians say that many of the changes they make seem to do no harm, they acknowledge that no one is really tracking outcomes in patients who get a drug versus those who get a substitute or delayed treatment.
A study published last year in Anesthesia and Analgesia, a medical journal, surveyed patients at the Mayo Clinics in Arizona, Florida, and Canada about their preferences when it comes to drug shortages. The study found that most patients wanted to know about a drug shortage that might affect their care during elective surgery, even if there was only a minor difference in potential side effects. Many said they would even delay surgery, if they knew of a drug shortage that would affect them.
When the study was published, the journal published an accompanying editorial that urged healthcare professionals to disclose any drug shortages, and their implications. The editorial stated, "[p]atients want to know and they should know. There is no ethical ambiguity."
Surveys performed in 2012 and 2013 showed that 83% of healthcare professionals who regularly prescribed cancer drugs reported being unable to provide the preferred chemotherapy agent at least once during the previous six months. Being unable to provide the preferred chemotherapy agent led to forced "difficult decisions about which patients to exclude."
Dr. Peter Adamson, the Chair of the Children's Oncology Group, has assigned his organization to set priorities, saying, "[w]e've been forced into what we think is a highly unethical corner." The priority effort is being led by Dr. Yoram Unguru, a Baltimore oncologist, who recommends that the drugs be rationed based on the ability to save lives or years of life, including how curable the child's cancer is and the importance of the drug in improving chances.
The FDA has previously asked for comment on how to improve the continuing drug shortages, and Congress has previously taken a stab at fixing things their way. Neither approach has gotten anywhere, nor have any new ideas been populated by either branch of government.
We once again argue that we believe one of the reasons these drug shortage problems continue to happen is because the market does not sufficiently reward quality. Buyers – including hospitals and clinics – tend to consider generic products as perfect substitutes, giving manufacturers little room for differentiations. The FDA has previously acknowledged this, in a report written in part by Janet Woodcock, MD, the director of the Center for Drug Evaluation and Research at the Food and Drug Administration. In that report, Woodcock and other FDA officials argued that "the fundamental problem with injectable shortages is insufficient market reward for quality (including reliability of production) stemming from the buyers' inability to observe it." Such a situation gives manufacturers strong incentives to minimize quality system investments, especially when faced with other pressures, such as new production opportunities, aging facilities, and the economic downturn that has not fully rebounded. Until new incentives exist for manufacturers to improve quality, it is unlikely that drug makers will adequately address quality issues.