Will Continued Drug Shortages Increase the Risk for Medical Malpractice?

lots of pills, medical malpracticeAlternative therapies to accommodate shortages of vital medications in hospitals puts the health of patients at risk, opening the door for medical malpractice lawsuits. Medical malpractice lawyers work on behalf of patients who suffer injuries because of inadequate care, including when injuries are related to forgoing or switching medications.

Hospitals Are Struggling with Prolonged Drug Shortages

Drug shortages have been increasing in frequency of the past decade. A hospital pharmacy may be unaware that a shortage exists until it is too late and spread throughout the industry. When shortages occur, drug manufacturers may be able to increase production by utilizing outsourcing facilities. However, this normally takes five to six weeks. Outsourcing production cannot happen until a product appears on the FDA’s medication shortage list. It is common for providers to run out of their supply before a company begins outsourcing production.

Often doctors are forced to make decisions regarding medications on the fly, and while they are at a patient’s bedside. Instead, a plan should be in place to consider the patient’s prognosis, curability, and the necessity of the drug for positive patient outcome. Such decision-making requires the need for transparency and an appeal process for patients.

When a drug shortage occurs, health providers often seek substitutes. However, the process of securing replacement drugs can be expensive and time-consuming. When they are available, already over-burdened manpower is needed to make sure the medication is stocked in all systems, including patients’ electronic medical records, automated dispensing cabinets, and pump libraries. Changes in formularies also lead to more mistakes when administering unfamiliar medications.

Why Are Common Medications and Supplies in Short Supply?

Drug manufacturers sometimes discontinue a common drug without notice. This can happen when a drug is no longer profitable, there are questions over its safety, or the FDA as ordered that production be stopped. Natural disasters like Hurricane Maria destroyed drug and medical supply manufacturing facilities in Puerto Rico, which led to a severe shortage of IV saline bags.

How Are Patients Affected?

When critical drugs are in short supply, hospitals are forced to make difficult decisions. Patients, including seriously ill children with cancer, may not be able to get the medications they need. Substitutions or rationing of drug supplies may happen while doctors must choose to prioritize which patients will receive the medication while others have their treatments delayed.

Hospitals have resorted to deviating from regular care methods in dealing with drug and supply shortages. This results in risks to patients. If a hospital has limited supplies of IV saline bags, they may reserve this treatment for patients who are severely dehydrated only. Patients who are mildly or moderately dehydrated might be treated with oral hydration therapy. This method would not work for critically ill or severely dehydrated patients. Another alternative that hospitals have tried is giving patients saline solution through IV injections. However, this is time-consuming and must be performed by nurses whose schedules are already pushed to the limit.

In cases where shortages of sterile generic injectables for chemotherapies occurred, oncologists in some hospitals had to be creative with how the drugs were dispensed. For example, where only a partial amount of a drug would be needed for a child, it would be normal to throw away the remainder. However, the oncologists would resort to bringing in a group of children who were on that same drug, whether it was time for a treatment or not, to make the best use of the drug. For some patients, this meant coming in two weeks earlier or not getting the drug at all, which delays treatment and further puts the health of the patient at risk.

Shortages of other drugs like nitroglycerin or the chemotherapy drug bleomycin forced hospitals and doctors to reserve their limited supplies for the sickest patients. Prioritizing the care of one patient over another and delaying treatment is a slippery slope that can result in questions surrounding ethics and medical malpractice.

What Do Hospitals Need to Do?

With no end in sight to continuing drug shortages, hospitals and health care systems must implement strategies to deal with the challenges facing patient care. In 2018, the American Society of Health-System Pharmacists released recommendations for dealing with drug shortages.

  • Hospitals and health care systems should create drug shortage teams who are responsible for making decisions regarding shortages in drug and product supplies
  • Formal processes should be developed for approving alternative therapies in response to shortages
  • Performing operational assessments to determine the impact of new drug shortages
  • Creating protocols to communicate with patients and family members who will be affected by a drug shortage

These recommendations are to help health providers quickly respond when shortages occur and take steps to mitigate the impact on patients and their care.