Drug Rationing in American Medicine
Rationing of care is often one of the most concerning issues in the U.S. health care system. Pharmaceutical shortages are occurring on an increasingly regular basis across the United States. For health professionals and their patients, this rise in shortages for crucial medications that reduce symptoms, manage pain, and prevent further complications is concerning.
Broad Spectrum of Shortages
Specialized drugs, such as drugs used in chemotherapy, are not the only ones experiencing shortages on a regular basis. Many commonly used compounds are also in short supply, which means that patients could encounter a shortage or substitution in their care at any time. The American Society of Health-System Pharmacists lists more than 150 drugs that are currently in short supply. Here is just a sample of scarce pharmaceuticals:
• Digoxin injections, used to treat a heart rhythm disorder
• Acellular whooping cough vaccine
• Fursemide injections, used to treat fluid retention in people with heart, liver, and kidney diseases and disorders
• Heparin premixed bags, used to prevent blood clots
• Polio vaccine
• Yellow Fever vaccine
Shortages in Supply and Access
Manufacturers are required to notify the FDA six months in advance only if they plan to stop production of a medically necessary drug, and only if they are the only source of the compound. They are also required to notify the FDA of drug quality problems, but there’s no penalty for a failure to notify.
Many shortages are also caused by supply chain or business-related issues, which fall outside of the requirements to notify. The process of manufacturing certain vaccines and antibiotics is so complex that advance notice of supply chain problems or other difficulties is not always possible.
In addition to supply shortages, some patients are facing limited access to life-saving drugs because of the prohibitive cost. In these cases, insurers determine which patient populations receive expensive drugs—typically only for extremely advanced cases where the patient’s life is in immediate danger. Patients have filed class-action lawsuits against insurers who have been rationing coverage to hepatitis C drugs like Sovaldi and Harvoni, citing that insurers promise to cover “medically necessary” services. Their attorneys argue that this denial of treatment until the case is critical is illegal.
The Ethics of Drug Rationing
When drugs aren’t available, medical professionals have to make hard decisions when creating a care plan for their patients. Those who are most likely to develop complications are first to receive drugs that are in short supply. Other patients, who would have otherwise received these drugs, may have to first show signs of developing medical problems before getting treatment.
Medical outcomes are less reliable thanks to this practice. Panels of professional ethicists, physicians, administrators, and patient representatives routinely meet to discuss who gets the precious medications and who does not.
Choices are often made on the basis of age, weight, and severity of illness. Allowing an illness to worsen before starting treatment runs counter to the Hippocratic Oath. This decision can be particularly painful for pediatric professionals, who must carefully weigh the needs of one young patient over another.
Until a more effective way of monitoring potential drug shortages is implemented, it is likely that more patients will not have access to critical medications. And while the insurers and patients battle out the definition of “medically necessary,” the cases in which patients are denied access to medical care will continue to grow.