Developing a Standard Process for Managing Drug Shortages


October 2012 - Vol. 9 No. 10 - Page #2

Effectively planning for and managing drug shortages remains a challenge due to the fact that each shortage is different in size, scope, and significance. One shortage may involve a rarely used medication at a given facility, require minimal changes in workflow, and be resolved quickly, whereas another may involve a highly utilized drug, thereby require numerous and extensive workflow changes, and last several months. Regardless of how varied these drug shortages may seem, instituting a drug shortages process to standardize the action steps that must be taken when a medication goes on shortage will ensure a consistent response mechanism and ultimately, improve patient access to medications. 

Yale-New Haven Hospital, Saint Raphael Campus, is a 511-bed academic teaching facility affiliated with the Yale School of Medicine. The pharmacy, which operates 24/7, provides decentralized clinical services and utilizes technologies such as computerized prescriber order entry (CPOE) and automated dispensing units. As with most hospitals in recent years, the depth and breadth of drug shortages have created roadblocks to ensuring that patients receive necessary medications in a timely manner. In response to the continued emergence of drug shortages, the Saint Raphael Campus developed a standardized drug shortage management plan, including a hospital-wide communication process and computerized alerts, to enable the pharmacy to properly manage all shortages in a consistent manner. 

The State of Nationwide Shortages
Reasons for drug shortages can be multifactorial, including manufacturing issues affecting the safety and quality of finished products, and more than half of drug shortages have involved generics.1 As reported in February of this year, 195 potential drug shortages were prevented in 2011, 114 of these since President Obama’s executive order on October 31, 2011, as a result of early notification. There has also been a six-fold increase in the number of voluntary reports from manufacturers of anticipated drug shortages.1 Clearly, action is being taken to prevent future shortages, to better prepare facilities for the onset of shortages, and to improve access to medications. However, fully realizing the effects of these changes has been slow, and as most clinicians will attest, drug shortages remain a constant concern. 

Drug Shortages Strategy 
Standardize and Delineate the Process
Our campus’ drug shortages management strategy focuses on the creation and implementation of a standardized process, from identification of a potential drug shortage to development and communication of the action plans. To develop this strategy, we first engaged individuals from various disciplines, including nurses, prescribers, quality improvement personnel, pharmacists, technicians, information technology (IT) specialists, administrators, and members of the pharmacy and therapeutics (P&T) committee and patient safety steering committee. Representatives provided feedback into defining what a drug shortage was for the institution and what the required processes would be for more effective communication of the shortage and associated action plans throughout the organization. Nursing leadership and prescriber leadership were key champions in supporting this new process, as well as disseminating the frequent communications. Our IT specialists created alerts for use within the CPOE system as an important mechanism to alert prescribers at the time of medication order entry. A core drug shortages pharmacy management team was then formed to meet regularly regarding the impact of new shortages and attendant action plans. 

At our facility, we decided to focus our efforts on drug shortages impacting the hospital supply while maintaining a surveillance of national trends. Drug shortages are categorized into three types: no remaining drug supply in the hospital, a limited supply in the hospital requiring immediate action, and drug supply availability concerns but no immediate action required. In the latter case, a watchful waiting or careful monitoring approach is employed. Each drug shortages team member’s duties, even those that could be deemed fairly insignificant, are spelled out within our processes to ensure a seamless, effective response to the shortage. For example, the steps include not only information on how to request alerts within the CPOE system, but also suggested email communication subject headings and the locations of the satellite pharmacies where the communications also must be posted. Ensuring that details such as these are delineated allows us to address and communicate changes as needed within the hospital, including times when we may need to cross-cover other core drug shortages management team members’ functions. (see Figure 1). 

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Identify Drug Shortages
Identifying drug shortages is an obvious first goal. With drug shortages involving potentially all segments of the supply chain—for example, raw material vendors, pharmaceutical manufacturers, suppliers, and federal regulators—identifying a shortage may involve various steps.2,3 These steps may include regular surveillance of Web sites, such as those from the Food and Drug Administration (FDA) and the American Society of Health-System Pharmacists (managed by the University of Utah Drug Information Service); direct communication with manufacturers, group purchasing organizations, and distributors; and use of subscription services that provide product alerts. Despite these efforts, at times the only sign of an impending drug shortage may be when an expected drug order is not received when anticipated, orders are partially filled, or certain strengths or formulations become more difficult to obtain. Hence, our drug purchaser is central to our drug shortages management process. The purchaser identifies and tracks drug shortages for the team, sets the agenda for our weekly drug shortages meeting, and then communicates this information to the drug shortages management team. 

Develop an Action Plan
The clinical team member evaluates potential alternative medications working with relevant department contacts for that particular drug shortage (eg, anesthesia, labor and delivery, etc). The operations team member evaluates the  logistical steps required for the shortage and, working in concert with the clinical team member/pharmacist, implements and coordinates the action plan. The medication safety coordinator works to identify any potential medication safety concerns, incorporating steps to avoid or mitigate these within the team’s action plan. 

It is important to note that eschewing gray market purchasing is critical to ensuring a safe medication supply. The dangers of buying drugs outside of tightly regulated pharmaceutical distribution channels are well known—they may be counterfeit, stolen, diverted, mishandled, and/or adulterated—and must be avoided. Be sure to only purchase medications from an established supply source with a guaranteed origin and authenticity. 

Communicate Management Strategies
Using a set template for email communication to delineate shortage information continues to be one of our primary methods of drug shortages education. Nursing leadership and prescriber leadership disseminate these email communications within the organization. Key contacts for the medical and surgical residency training programs, as well as physician assistants, are members of the prescriber leadership group. Pharmacy and IT specialists also receive these communications, which provide the relative start date of the hospital drug shortage; target audience; areas of the hospital anticipated to be affected; the specific drug on shortage; reported reason(s) for the shortage, if available; the anticipated shortage duration, if available; drug alternatives and recommendations; and operational/distribution changes, if any are required. We also created an internal use-only section within our communications as a reminder for how to reverse steps taken when a shortage has been resolved. For example, including these details can help us remember to turn off a CPOE alert and to change a product selection or distribution process (see Sample Drug Shortage Communication at www.pppmag.com/shortagecommunication). 

Within operating room (OR) areas, the OR pharmacy staff post drug shortages communications specific to these areas on each of the anesthesia automated dispensing units. 

Results
Standardizing our drug shortages management process and effectively communicating these shortages plans throughout the hospital has brought about several meaningful results. Feedback from staff has been extremely positive, and we have received fewer complaints on the shortages process as a result. We also have been able to react more quickly, using a multidisciplinary approach, due to the heightened awareness of drug shortages overall. For example, during a recent propofol shortage, we were able to collaborate with anesthesiologists, intensivists, nurses, and IT specialists to implement changes the same day in order to further limit use and thereby preserve the drug for priority patients. 

Each shortage is an opportunity to learn and apply these lessons to improve management of new shortages. These lessons are both global in nature, such as engaging other disciplines right from the start with each shortage, as well as shortage-specific, for example, deciding to pull back all supply of affected formulation versus using up existing supply in order to avoid potential confusion. In addition, we have fast-tracked P&T formulary reviews of alternatives to shortage drugs, as needed. 

Within the first year of implementing the systematic process changes in April 2010, 71 hospital-wide email communications were sent, representing 38 different drugs. These communications involved 25 resolved drug shortages and 13 current shortages. Since that first year, we have sent many more shortages, updates, and resolution communications. 

Shortages of essential medications have become a daily reality in hospitals nationwide. Until the situation improves, pharmacy must continue to work closely with all affected disciplines to institute an effective, carefully planned management strategy for drug shortages.

References

  1. Hamburg, MA. Challenges and Opportunities for the Generic Drug Industry. The FDA Web site. February 23, 2012. http://www.fda.gov/NewsEvents/Speeches/ucm294978.htm Accessed August 7, 2012.
  2. American Society of Health-System Pharmacists. ASHP guidelines on managing drug product shortages in hospitals and health systems. Am J Health-Syst Pharm. 2009;66:1399-1406. www.ashp.org/DocLibrary/BestPractices/ProcureGdlShortages.aspx. Accessed September 10, 2012.
  3. Institute for Safe Medication Practices Web site. Weathering the storm: Managing the drug shortage crisis. ISMP Medication Safety Alert! October 7, 2010 issue. http://www.ismp.org/Newsletters/acutecare/articles/20101007.aspAccessed September 10, 2012. 

Teresa Seo, PharmD, BCPS, FASHP, is the assistant director of clinical services with Cardinal Health Pharmacy Solutions at Yale-New Haven Hospital, Saint Raphael Campus, in New Haven, Connecticut. She obtained her bachelors in pharmacy at the University of Toledo and her PharmD at the Ohio State University. Teresa completed an ASHP-accredited specialty residency in adult internal medicine at the Medical University of South Carolina. She serves as the PGY1 pharmacy residency program director and as a preceptor for both residents and students. 

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