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Management of Drug Shortages in the Perioperative Setting
January 2013 - Vol. 10 No. 1 - Page #12

The negative effects of critical medication and related product shortages have become well known to institutional hospital pharmacy practitioners, and managing these situations is now part of normal, everyday operations at most hospitals in the US. With reasons ranging from raw material shortages to regulatory and legislative issues,1 hospitals are forced to cope with and manage wide-ranging drug shortages that seem almost inevitable. While the frustrations caused by these events are fairly universal throughout health care, even among pharmacy operations, there are different nuances to handling shortages depending on the area of practice. 

Proper management of medications used in operating room (OR) settings is now held to increased scrutiny, yet has been aided considerably by advances in automation and software systems used to facilitate a transparent and accountable process for tracking the preparation, storage, administration, and wasting of anesthesia and surgery products. The experience of negotiating shortages in the perioperative setting is indeed a challenge to pharmacists, nurses, anesthesiologists, surgeons, and physicians alike, and the high potential for patient harm and significant cost implications associated with the sudden unavailability of essential products requires hospitals to create policies and procedures (P&Ps) to manage these situations such that patient safety is not compromised.

Duke University Hospital
Anesthesia agents—including succinylcholine, neostigmine, glycopyrrolate, remifentanil, vecuronium, and cisatracurium—are representative of medications used as standards of practice in the perioperative setting. These products also happen to be part of a growing trend in shortages affecting anesthesia agents.2 As shortages of these products became more common, the pharmacy team at Duke University Hospital (DUH) recognized that the loss of any one of these agents could have a significant impact on the safety and quality of care we provide our patients. 

A tertiary and quaternary care hospital, the 957-bed DUH in Durham, North Carolina, operates over 45 ORs comprising the major surgery suite, an endosurgery center, an ambulatory surgery center, and an eye center. Considering the level of patient volume experienced by our surgical ORs at any given time, we realized that the mounting threat of drug shortages in the perioperative setting would require practice collaboration and the implementation of P&Ps to encourage custodial utilization of agents in short supply, as well as reduce waste.



The First Sign of Trouble
In September 2009, DUH experienced a shortage of multiple neuromuscular blocking agents (NMBAs). As a result, we were unable to obtain a steady supply of vecuronium and cisatracurium, and had already exhausted our supply of atracurium, which had gone on shortage months before. Our procurement team notified pharmacy managers and key clinical pharmacists about the supply issue and requested a meeting to develop a contingency plan in case we exhausted our supply of vecuronium and cisatracurium as well. Not only would the lack of supply for these two agents be an issue, but we recognized that the removal of these two products from the market would result in hospitals across the country increasing their supply of all other available NMBAs to prevent their institutions from exhausting supply of the drug class as a whole. 

Between January 1996 and June 2002—a period of six-and-a-half years—the drug information service at the University of Utah Health Services (which supports the ASHP drug shortage program) tracked a total of 224 drug shortages. Less than ten years later, the nation began seeing similar numbers over the period of a single year: 2007 saw 129 shortages, 2009 saw 166 shortages, and 2010 saw 211 shortages, the highest number ever recorded in a single year.3 The ramifications of the NMBA shortages, in addition to other significant agents experienced at this time, emboldened our hospital to develop a structured process for managing future drug shortages. Ultimately, the hospital recognized a need to ensure transparency, address shortage issues quickly and efficiently, and communicate plans effectively. 

Defining a Collaborative Approach
Led by the chief pharmacy officer and associate chief pharmacy officer for central services, a team of key leaders from pharmacy, medical and surgical staff, nursing, the ethics committee, risk management, and DUH senior leadership developed P&Ps to guide our practice for managing drug shortages. The policy outlines the processes to follow when a drug shortage has been identified and the steps required to develop and communicate plans for proper management. 

Integral to the effective deployment of these P&Ps was the development of a multidisciplinary drug shortage response team (MDSRT) for perioperative services, consisting of area-specific clinicians including anesthesiologists, surgeons, OR nurses, certified registered nurse anesthetists, and clinical pharmacists. When a shortage has been identified, the manager of pharmacy procurement, distribution, and repackaging will contact the pharmacy representatives of the MDSRT and explain the details of the situation. Depending on how significant the shortage is deemed, plans will be made at the unit level or hospital level accordingly: 

  • Unit Level—changes will impact specific units and require focused communication efforts (eg, managing a shortage of volatile gases used in the OR)
  • Hospital Level—changes will impact multiple units and will require broad communication efforts (eg, managing a shortage of propofol)

Once the significance of an event is deemed critical, the coordinator of the Center for Medication Policy will convene a pharmacy critical shortage task force (consisting of key pharmacy leadership and clinical experts) to meet and discuss how to manage the problem internally. This team discusses alternatives and determines if a shortage can be managed within the pharmacy or if a multidisciplinary approach will be required.

An example of an internally managed shortage can be illustrated by the remifentanil 1 mg vial shortage experienced in early 2009. Our team established the goals of reducing the risk of harm associated with introducing a different dosage strength at the point of care and minimizing changes in practice and standards of care. Therefore, we worked with our procurement team to obtain remifentanil 2 mg vials and we compounded 1 mg syringes in house for dispensing to anesthesia. Throughout the entire planning process we were able to maintain transparency with the anesthesia team and openly communicate the action steps taken. However, there was not a need to make any changes to anesthesia’s practice at the point of care.

Effectiveness and Efficiency are Key 
The perioperative MDSRT will only convene when a shortage has been identified and a collaborative approach to managing the shortage is needed. Such identification is determined after the initial pharmacy task force has met and  the option to manage the shortage within the pharmacy is not available. Depending on the quantity and severity of a given shortage, the MDSRT will meet as frequently as once a month or up to multiple times per week. MDSRT meetings are typically reserved for significant, identified shortages that could lead to changes in current standards of care. For less significant shortages, or for those that are in the pipeline as reported through resources such as the FDA, ASHP, or via notification from peer institutions, communication is performed via email and phone calls to discuss strategies. 

Let Technology Work in Your Favor
The perioperative MDSRT considers three primary themes when developing a plan: the impact of the shortage on patient safety, cost, and workflow. With these themes in mind, we strive to develop the most ideal solutions when managing drug shortages. Since 1998, DUH has used an anesthesia information management system (AIMS) for documenting medications administered to patients in the OR platform. The AIMS has been helpful during periods of drug shortages by enabling us to run utilization reports and develop alternative plans for dispensing medication to anesthesia providers. 

For example, during a shortage of glycopyrrolate 0.2 mg/mL – 5 mL vials, we used the AIMS to identify the average dose commonly administered (∆0.5 mg per patient) and subsequently worked with anesthesia to determine a dose and volume to compound premixed syringes from commercially available 20 mL vials. We determined a 0.5 mg/2.5 mL syringe would meet the needs of our providers at the point of care, help conserve supply, and reduce waste. 

Impact of a Succinylcholine Shortage
In late July 2010, DUH began to experience a significant disruption in the supply of succinylcholine. The hospital’s use of this NMBA was significant and ranged across the entire institution. The manager of pharmacy procurement, distribution, and repackaging convened an internal, critical shortage meeting with key pharmacy leaders and clinicians to discuss the shortage and state of available supply. At the time, it was understood that market resupply was not likely to occur until mid-October and that DUH would not receive any additional supply until then. The team discussed alternative products, outsourcing options, potential impact on patient care and workflow, and concluded with a recommendation to convene a larger meeting with anesthesia and other care providers to develop a more extensive management plan.

Shortly after the internal pharmacy critical shortage task force meeting, the perioperative MDSRT convened to develop a strategic plan for managing the shortage. In this case, we identified four primary options we could potentially implement to conserve supply and manage the duration of the shortage: 

  1. Use an alternative product 
  2. Implement or eliminate restrictions 
  3. Compound premixed syringes
  4. Reduce/remove supply from the anesthesia trays

We used the AIMS to identify average doses administered to our patients in case the decision to compound premixed syringes was made. The Center for Medication Policy also conducted a literature review to identify any supporting data for extended beyond-use dating of premixed syringes prepared by pharmacy. In addition, we pulled past procurement data to determine the average quantity of vials used per day. This step was important to identify the number of days of on-hand supply. The data demonstrated we had a three-week supply remaining without any promise of a shipment coming until mid-October. Recognizing the gravity of the situation, we assessed every location succinylcholine was stored and determined if the quantity stocked could be reduced until the shortage was resolved.

Throughout the period of the shortage, DUH was able to procure allocated amounts of succinylcholine intermittently, but the sporadic shipments made for a difficult management process and we decided to take a conservative approach to reduce the risk of exhausting our supply. Therefore, over a period of 35 weeks, we implemented multiple conservation strategies as follows (see Figure 1):


Weeks 1-6 (three weeks of supply remaining at day one)
1. Use of an Alternative Product 

  • After discussion with anesthesia staff, the decision was made to utilize rocuronium as an alternative agent for rapid sequence intubation (RSI) where appropriate. For cases not requiring RSI, rocuronium and vecuronium were designated as acceptable alternative agents. If the provider was worried about an extended duration of blockade, there was guidance to reduce the dose administered and ventilate with a volatile agent (eg, isoflurane).

2. Implementation and Elimination of Restrictions 

  • Prior to the shortage, succinylcholine was typically drawn up prophylactically as a precaution if needed during the case. Once supply was determined to be critically low, we decided to eliminate all prophylactic preparation. 
  • Anesthesia policy restricts both single-dose and multi-dose vials in the OR to single-use only. During this particular shortage, the decision was made to open the restriction for this particular product to be used as a multi-dose vial as long as strict aseptic technique was employed during product preparation in the perioperative environment.

Weeks 7-10 (less than two weeks of supply remaining at day one)
1. Implementation and Elimination of Restrictions 

  • Prior to the shortage, succinylcholine was used for elective procedures throughout the hospital in which other NMBAs, agents, or techniques could have been used. The plan was made to eliminate elective use of succinylcholine.
  • Succinylcholine was restricted to emergent airway rescue where other agents were not appropriate.

2. Reduce/Remove Supply from Anesthesia Trays

  • The supply of succinylcholine was reduced to one vial in the anesthesia trays. 
  • In agreement with the vice chair of anesthesia, all dispenses of succinylcholine from the OR pharmacy satellite were limited to attending approval only or to other providers when needed for an emergency.

3. Use of Alternative Products

  • The Electroconvulsive Therapy (ECT) suite’s medications are managed by the OR pharmacy satellite. Pre-shortage, the pharmacy would dispense a drug box with ten vials of succinylcholine during treatment days; during the period of shortage, it was determined that ECT should begin using rocuronium as an alternative agent. 

Weeks 11-20  (two months of supply received and in stock)
1. Implementation and Elimination of Restrictions 

  • Restrictions were relieved for emergent use and expanded to emergency medical services, the emergency department, the intensive care units, and in ECT.

Weeks 21-35 (adequate supply received on a frequent basis)
1. Implementation and Elimination of Restrictions 

  • The restrictions for elective surgery were relieved.
  • The restrictions for single-dose use were re-implemented.
  • The restrictions for prophylactic preparation remained the same to continue the practice of conserving supply as appropriate.
  • The restrictions for attending approval for pharmacy dispensing were relieved.

2. Use of Alternative Products

  • Providers were still encouraged to use alternative therapies as appropriate to conserve supply. 

3. Reduce/Remove Supply from Anesthesia Trays

  • The process to supply only one vial in each cart remained the same.


Throughout the shortage, the MDSRT was able to reduce succinylcholine utilization from an average of 50 vials per day to seven vials per day at the most critical point of the shortage. There also was a cost savings associated with doing so, as the hospital maintained a decreased utilization after the shortage resolved. However, this does not factor in the costs associated with the time our pharmacy and anesthesia providers spent in managing the shortage.

Conclusion
While some facilities have witnessed postponements and cancellation of procedures due to drug shortages, we have managed to prolong available supply (as seen with succinylcholine) and continue most surgeries as scheduled. Although it is not easy to predict drug shortages, proper planning and a formal management system will help decrease the risk of patient harm.

References

  1. Drug Shortages Summit Summary Report. November 5, 2010. http://www.ashp.org/drugshortages/summitreport. Accessed December 28, 2012.
  2. Jensen V, Rappaport BA. The reality of drug shortages—the case of the injectable agent propofol. N Engl J Med. 2010;363(9):806-807.
  3. Kaakeh R, Sweet BV, Reilly C, et al. Impact of drug shortages on U.S. health systems. Am J Health Syst Pharm. 2011;68(19):1811-1819.

Christopher Murray, PharmD, MS, is currently the manager of perioperative pharmacy services at Duke University Hospital. He received his PharmD from Hampton University in 2008 along with a minor in leadership studies. At Duke, Christopher’s staff operates 24 hours a day, 7 days a week to provide comprehensive clinical and operational pharmacy support to over 40 operating rooms and more than 80 adult PACU and pre-op beds in the main hospital and the Duke Eye Center. His professional interests include pharmacy leadership, mentorship, and medication safety.

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