Managing Drug Shortages
4 minute read time
While temporary drug shortages have always plagued pharmacy managers, over the past decade their frequency and length has steadily increased.
These shortages are especially damaging to health care providers because drug availability has the potential to affect the way patients are treated. When this happens, it can open you up to litigation from patients who feel they have received improper care.
In light of these trends, the Food and Drug Administration (FDA) and other federal bodies have begun to take a more active look into how drug supplies are managed. But until new policies can be instituted, individual health care providers must find their own ways to deal with shortages.
Preparing for a Shortage
Due to their very nature, drug shortages are difficult to plan for. Often times, impeding shortages come up quickly, leaving providers scrambling to obtain the drugs their patients need. Since you cannot influence drug availability, it is important to establish a contingency plan before disaster strikes. This will allow you and your staff to take immediate action when a looming shortage appears.
The American Society of Health-System Pharmacists (ASHP) suggests a three phase contingency plan to deal with shortages:
- Assessment Phase: Once a shortage is realized, it is important to identify the potential impact it will have on your organization. Drug manufacturers and the FDA should be contacted to determine the reasons for—and expected length of—the shortage. Inventory on hand should then be reviewed. Available quantity and current usage rates should be figured against the expected length of the shortage to identify how long your organization can endure.
- Preparation Phase: The first step in this phase is to identify possible alternatives to the unavailable drug. Your organization should have a set procedure to identifies possible substitutes and approve them for use. Once alternative treatments have been decided on, any changes must be clearly and effectively communicated to all members of your staff who are involved with distributing or administering medications to patients. In cases where alternative drug options are limited, you may need to develop a patient priority plan. This plan will focus on limiting prescriptions to only those that meet predetermined qualifications.
- Contingency Phase: When all options for obtaining a drug are exhausted and there is no available substitute, there is an increased chance for an inability to properly treat patients. Your regular legal staff or council should be notified so they can advise you on the best way to proceed when there is a chance that patient care could suffer. This will most likely involve a communication plan that will inform patents when their care may be compromised due to the shortage and what they can expect going forward.
Part of your contingency plan will involve switching patients to other, more readily available drugs. However, this must be done carefully as most of the complications and deaths that result from drug shortages are not caused by a direct lack of availability, but by errors made when switching patients to new medications.
When switching a patient to a new drug there is not only concern that his or her body will not accept the new medication as a stand in for the old, but also the proper dose that will be used. A certain sized dose that safely worked for a patient could be too much or too little when the type of medication is changed.
While multiple medications may work to treat the same ailments, the required dosage and potential side effects can change dramatically. The individual human body presents a wide variable, which means there can be no generic formula for converting dosages between medications. To avoid dosage errors that could result in injury or death, patients must be closely monitored whenever a new drug is substituted into a treatment regime. All those involved in the patient’s care must be clearly notified of the change, so a new medication is not administered at an old dosage amount.
This Risk Insights is not intended to be exhaustive nor should any discussion or opinions be construed as legal advice. Readers should contact legal counsel or an insurance professional for appropriate advice. © 2021 Zywave, Inc. All rights reserved.