Drug Shortage Communication Planning

2016 - 4 August- Clinical Controversies Highlighted at the 45th Critical Care Congress
Ryan Hakimi, DO, MS; Maresa Glass, PharmD, BCPS; Suprat Saely Wilson, PharmD, BCPS
Read about drug shortage communication planning.


 

Medication shortages have become a regular part of the practice of medicine, affecting medical providers, pharmacists, nurses and, most importantly, patients.(1) What was once an infrequent occurrence linked primarily to unanticipated needs has transformed into a daily occurrence linked to a variety of causes, including manufacturing difficulties, active pharmaceutical ingredient shortages, and regulatory concerns, amongst others.(1) Communication of medication shortages and supply status in a timely fashion remains a challenge.

In most healthcare organizations, the pharmacy department is the first to become aware of a medication supply shortage or potential shortage. Disseminating information on these shortages poses a significant challenge because there are a lot of uncertainties associated with shortages.

Consider the following situation: A supplier informs the pharmacy that there is a shortage of sodium bicarbonate, with an expected resolution in two weeks. The current on-hand hospital supply is expected to last two-and-a-half weeks. Pharmacy leaders now must make a decision as to whether and when this information should be communicated to practitioners; the supply status may change daily. While real-time notification is ideal, the sodium bicarbonate may become available before supply diminishes completely, making notification to providers unnecessary. However, if new supply is not available as soon as expected, then the delay in communication is harmful.

Frequently, there is not even an expected release date associated with a product shortage. In these cases, the pharmacy must make a management plan that includes alternative therapeutic options and conservation of current supplies. Decisions should be made in conjunction with the prescribers in the field to ensure that the remaining supply is best utilized. This management plan then needs to be communicated.

One of the challenges of communicating medication shortage information includes identification of who should receive the notification. Identifying stakeholders is key in the medication shortage management plan and associated communication. The obvious key stakeholders are clinical practitioners, particularly prescribers. Targeted stakeholders should also include pharmacy staff and bedside nurses. Other ancillary stakeholders may include information technology personnel and affected patients.

Dissemination of the information presents another challenge. E-mail is an easy and effective form of communication that can provide real-time notification to a large number of users. Unfortunately, notifications of shortage status may be buried in a large number of e-mails and consequently missed. Practitioners may not be able to check e-mails in a timely manner while involved in direct patient care activities. Communication between pharmacy leadership and the unit-specific medical and nursing directors during meetings such as a daily huddle can also be effective. This method of communication targets the individual stakeholders and allows staff the opportunity to ask questions. However, communication in the setting of a meeting may be insufficient because the individuals in attendance may not be able to provide the information to other colleagues who would also benefit from the knowledge.

Other platforms of communication include posting general medication shortage information on a hospital intranet or similar site that can be accessed by all staff. Having a central repository for all shortage updates is helpful to the staff but may not be easily accessible when making prescribing decisions. Using alerts upon ordering in the computer order entry system is an effective way to get real-time notification about a shortage to the prescribers. This method targets the right stakeholder at the time at which they need the information. Collaboration between pharmacy and information technology specialists allows the electronic medication records to be edited on an as-needed basis. Similarly, such systems can provide information regarding substitutions, whether in the route of administration, formulation, component drugs or medications with similar mechanisms of action. In addition, these systems may have the ability to send electronic messages to the provider when a patient who has been taking a particular medication will need to be switched to a different product due to a shortage.

This method of communication from within the electronic health record is not without problems. Generally there is a time lag to implementation, so the alert may not represent the most up-to-date information as the shortage status can change daily. Once the shortage resolves, these alerts, if not removed promptly, can result in confusion and alert fatigue. Phone calls or pages by pharmacy to providers upon order entry of an affected medication continue to be another effective method of real-time communication, but can be a burdensome and time-consuming process to the involved parties.

Electronic communication tools are now a primary method for communication of drug shortages and the associated management plan. Institutions continue to be challenged by the task of communicating this information to the appropriate target audience in a timely fashion. Using multiple methods of communication is paramount in order to ensure that medication shortage information is received.

References:

1. U.S. Food and Drug Administration. Executive Summary: A Review of FDA’s Approach to Medical Product Shortages. Silver Spring, MD: U.S. Food and Drug Administration; November 3, 2011. http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/ucm277744.htm. Accessed May 26, 2016.