Drug shortages can jeopardize patient safety

american society of anesthesiologists

A guest column by the American Society of Anesthesiologists, exclusive to KevinMD.com.

When doctors don’t have access to medications that are necessary to successfully perform procedures, patient safety is at risk. Over the past several years, drug shortages have significantly impacted the health care industry, making it not only difficult for physicians to do their jobs, but for patients to receive optimal care. For some reason, though, this issue hasn’t been in the public eye.

The issue and history

Drug shortages occur for a number of reasons, including manufacturing issues, raw material shortages, product discontinuation, delays and quality problems. While the U.S. Food and Drug Administration (FDA) works closely with manufacturers to help restore drugs in short supply, it is still a common problem for many areas of medicine.

The drug shortage problem in the United States is widespread, and the most affected class of drug has been the generic injectables. These are used to treat a wide range of conditions from pain to cancer, with the greatest subset being anesthesia medications. I have watched firsthand as patient diagnoses call for a certain drug, only to find it’s unavailable.

Since 2006, drug shortages have increased four times over. A 2012 survey of American Society of Anesthesiologists (ASA®) members found that 98 percent of physician anesthesiologists had experienced shortages that year, 96 percent had been forced to use alternative drugs, 50 percent had been forced to change a procedure in some way, 7 percent had postponed cases, and 4 percent had canceled cases.

Drug shortages impact patient safety

As a physician anesthesiologist, maintaining patient safety is my goal in every procedure. A single patient’s anesthetic plan involves multiple drugs, including those that provide sedation and muscle relaxation, prevent pain, and maintain appropriate blood pressure and heart rate. We aim to keep a patient safe and comfortable before, during and after a procedure, which makes drug selection integral to our role as physician anesthesiologists.

Because selecting the right medication is so important, one of the biggest challenges we face during a shortage is the lack of first-choice medications. Many times we are forced to use alternative drugs, which can increase complications such as nausea and vomiting. Alternative drugs can also cause the length of sedation to be unnecessarily extended. Longer procedure and recovery times leave the patient dissatisfied, and in extreme cases, dangerous complications can threaten a patient’s life.

A major duty of physicians is to protect patients by exercising sound medical judgment. Physicians have to carefully consider the potential outcomes of using alternative medications. Some medications may be virtually seamless substitutes for the preferred drug. For instance, the high-blood pressure medication metoprolol can be substituted for labetalol with no adverse effects. Other substitutes, however, can make a definite difference in the outcome. Epinephrine — used to treat severe allergic reactions and rescue patients from cardiac arrest — has no substitute. Alternative drugs may be similar to epinephrine, but they could have undesired effects in the operating room.

How to manage drug shortages and maintain patient safety

So, how do we as physicians make ethical decisions when dealing with low drug supplies? Patients and physicians alike should be aware of the drug shortage problem and then work together to develop a suitable anesthesia plan.

Prior to undergoing surgery, you and your physician anesthesiologist should communicate openly about what drugs will be used during your procedure and if a shortage will affect the plan. Physicians should inform you of any drug substitutions that might significantly impact your experience. It is important to be informed and ask questions before surgery. If your anesthetic could be significantly altered due to a lack of a crucial medication, a conversation between you, your anesthesiologist and your surgeon should take place. Part of that discussion may be whether it’s prudent to delay your surgery until the appropriate medications once again become available.

Drug shortages impact patient safety, medical economics and professional ethics, and the issue isn’t expected to disappear any time soon. Drug suppliers, manufacturers, distributors, doctors, government and associations all must work together to minimize shortages and keep patient care as the top priority. As we work together to make the best of less-than-ideal situations, it’s crucial that health care professionals and patients are aware of the challenges we face with drug shortages.

Jeffrey S. Jacobs is chair, committee on ethics, American Society of Anesthesiologists.

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