New & Improved!

Establish a Robust Drug Shortages Program
January 2012 - Vol. 9 No. 1 - Page #6

In recent years, the increased number and persistence of drug shortages has become one of the most serious, potentially life-threatening issues in health-system pharmacy practice. Today, the incidence of drug shortages has risen to critical levels, having more than tripled since 2005.1 Clearly, there is no easy fix for this widespread problem. Shortages adversely affect drug therapy, compromise or delay treatment, and can even result in failure to properly treat disease and the consequent progression of disease. The adjustments to treatment regimens that are necessary as a result of shortages, such as drug substitutions, can and have led to medication errors and adverse patient events. As of December 2011, there have been over 250 documented shortages this year—the highest number ever recorded (see Figures 1 and 2).

Click here to view a larger version of these Figures.

Perhaps the most frustrating aspect of these shortages is that the vast majority of them may very well be avoidable, but until fundamental changes to our processes and systems around manufacturing are made in the US, shortages are a reality. With so many existing shortages—and new ones occurring daily—facilities with well-developed programs and active committees to address this issue are at a distinct advantage. At Massachusetts General Hospital in Boston, the primary goal of our drug shortages program is to mitigate the impact of these events on patient care (our current P&P is available at www.pppmag.com/PandP). To this end, we focus on managing the practical, day-to-day implications by evaluating and implementing best practices to allow patients to continue receiving the medications they need.

Critical Drug Shortage Escalation Process
Our facility’s medication management committee monitors shortages on a daily basis. When a shortage is identified, pharmacy leadership is consulted to gather the necessary information to guide downstream decision-making. If there is a shortage of a drug that is limited to a specific dosage form, but other suitable dosage forms are available that can provide an adequate level of therapy, the shortage investigation will likely not progress beyond pharmacy leadership. However, if the shortage affects all strengths of a particular drug and there is no drug felt to be an easy substitution, the shortage may be deemed critical and the investigation will escalate to a wider audience that includes key thought leaders, physicians, nurses, and possibly other specialists in the institution—such as respiratory therapists, who may be directly affected by the shortage—to quantify and evaluate the potential impact on workflow and patient care.

If the shortage is deemed critical, we create a contingency plan for the affected medication. For example, if a shortage appears for a drug of which we have 75 vials in-house, and we use an average of 25 vials per week in general circulation and it is not expected to be available for 6 weeks, a contingency plan will be developed. The plan may be designed to allocate supply with the intent to ride out the shortage; alternatively, the plan may target what to do on the third week when the supply will be exhausted. Such contingency plans should include any necessary mitigation strategies for managing across multiple disciplines as well as an allocation and/or substitution plan for the critical drug. In some cases, an automatic substitution plan is instituted; in other situations, protocols are developed to guide allocation of the drug to the most critical departments and patients. In both of these scenarios, staff is educated on any required changes in workflow.

For example, as a result of the recent IV labetalol shortage we decided to allocate this medication to patients with intracranial hemorrhage, even though there are several alternative agents that could have been used that were in good supply. In this case, labetalol was our first-line agent for acutely managing blood pressure in the setting of intracranial hemorrhage. The staff in these areas were comfortable using labetalol as a first-line agent and it appeared in our templates and guidelines for managing intracranial hemorrhage as our drug of choice for acute blood pressure control. After discussing the shortage with our colleagues in cardiology, anesthesia, and in the ED, we discovered that for the other indications IV labetalol might be used (eg, hypertensive emergencies) the staff were very comfortable using the available alternatives. Thus, we opted to allocate our limited supply of labetalol to intracranial hemorrhage so our staff would not need to deviate significantly from the standard they were already accustomed to.

Centralize Stock
Mass General maintains medication supplies in the central pharmacy, but also stocks many of those same medications on patient care units, in the ORs, and in other key areas for streamlined medication distribution. While this decentralized stocking is important for timely distribution, it can also make it more difficult to implement and manage a mitigation strategy that involves allocation. Therefore, an additional technique to manage shortages is to pull back that critical stock from outlying locations and centralize the entire supply in the pharmacy. This allows us to gauge the exact volume of medication we have in-house, narrow any necessary allocation to one distribution point, and determine the most prudent and focused distribution plan.

As with other processes that require a custom—and often counterintuitive—workflow solution, physically centralizing shorted medication stock is a challenging process. As a large facility, we use hundreds of ADCs to store and dispense medications and with multiple OR suites and other medication stocking locations, simply finding and returning every dose of a specific drug, especially one that has become a valuable commodity, is a difficult process. Not surprisingly, for drugs that are stocked ubiquitously throughout the institution, centralizing or redistributing supply can pull technicians and pharmacists away from normal responsibilities for several hours a day, potentially creating a domino effect that results in more workload and supply issues for the department. 

Making Difficult Choices
When there is a critical need for a life-sustaining medication but no straightforward substitution is available, often the solution lies in finding a combination of drugs that when taken concomitantly, elicit the same—or as similar as possible—effect as the drug on shortage. In these situations, it is critical that pharmacy decision-makers work closely with physician and nursing leadership both to educate staff and make the necessary downstream adjustments in prescribing and distribution systems to reflect these changes.

For example, physicians use templates to process patients throughout various transitions of care, such as from the ED, to the ICU, and into a general care unit. These templates, by design, reflect only those drug choices that are on formulary. In situations where we must mix and match drugs to obtain a desired effect, templates and systems must be updated to reflect the changes. When complex strategies are implemented, we map out what changes must be made to each step of the drug delivery system, as well as the optimal timing of each change. For example, when implementing our plan for the recent midazolam shortage we needed to make sure that our supply in the ADCs was reallocated, CPOE was updated, and staff was educated to reflect the restriction to procedural use and/or pediatric use while ensuring the timing of the changes did not negatively impact patients actively receiving midazolam.

Be Prepared for Shortages
While clearly it is not possible to forecast every medication that will go into shortage, pharmacy leaders should be prepared to mitigate the harm shortages can cause by having set protocols in place and moving quickly through those protocols. As shortages have become a relatively constant reality for hospitals, there is no excuse to remain unprepared. When a shortage is first identified, hospitals and pharmacy practitioners must react immediately and decisively. Have a plan in place to enable contact with the wholesaler to determine how much stock they have and how much of that stock you can secure. For medications deemed critical, purchasing enough to last for a minimum of a few days, weeks, or months, can preempt short-term availability outages. Any extra stock that can be acquired when a shortage is announced buys the hospital time to create and institute a full-scale contingency plan in the event of a long-lasting shortage.

Of course, it can be difficult to secure drugs that are on short supply, so a priority should be placed on developing your institution’s mitigation strategy. In some cases, reacting quickly and implementing an allocation program may preserve enough to ride out the shortage in those areas deemed critical. Your hospital also should clearly delineate in advance who its primary and secondary (if applicable) wholesalers are. Care should be taken to avoid using gray market wholesalers who can mark up the price of a drug much higher than the original cost. Hospitals also should avoid wholesalers that are unable to provide the product’s history or pedigree, as the integrity of the product must be guaranteed.

Dissemination of Data to Patients
When a shortage occurs, the resolution often focuses on clear and open communication of drug shortage information between departments and among staff; consequently, patients are often left outside of this information loop. While most pharmacy leaders recognize the urgency of instituting a timely and effective in-house shortages communication plan, fewer approach patient education with the same assertiveness. Pharmacy professionals may hope to spare patients the worry we ourselves experience when a lifesaving drug is in short supply. However, patients expect honest, up-front information regarding the availability of their prescribed medications and deserve to know if their therapy regimen will be affected or altered.

The creation of a more transparent communication process surrounding drug shortages would ensure that physicians, pharmacists, and patients are on the same page regarding the availability of medications. Although the media has been reporting on the dire nature of recent shortages, few patients expect that a potentially life-saving drug will be unavailable when they enter the hospital. Accordingly, physicians and pharmacy often bear the brunt of patients’ frustration when drug shortages cause disruptions in their treatment plans, especially if the patient has not been openly informed.

At Mass General, we provide a great deal of ambulatory oncology care and are careful to give timely information regarding the availability of chemotherapy drug regimens to this highly educated patient population. However, in the future we hope to further improve information access by using an online system that can provide health care providers up-to-the-minute information on shortages that can be used to educate and plan by both the medical community and the public. Such a system would shed clear light on the drug shortages problem and enable patients to gain a realistic understanding of the nature and scope of shortages that may affect them.

An Opportunity to Reflect on Practice
Among the many negatives presented by shortages, including caregiver and patient frustration, the potential risk to patient safety, and the misuse of resources, shortages also may introduce a unique opportunity to reflect on your current practice. For example, when confronting the IV phosphorus shortages we discovered that we did not need five different sizes/strengths of sodium phosphate each for central and peripheral IV access, nor did we need to offer potassium phosphate as an option for our adult patients. When the IV magnesium shortage occured, we also quickly discovered that we did not need to include magnesium sulfate in most of our cardiac admission templates in the CPOE system. In both situations, we maintained the changes we made to our systems as a result of the shortage, even after the shortage was over. By eliminating the potential for inappropriate magnesium orders and streamlining our sodium phosphate options, we were able to make a small contribution to our ongoing efforts to reduce practice variation and improve efficiency.

While drug shortages have become an increasingly unfortunate hindrance to pharmacy practice in recent years, addressing them immediately, deliberately, and comprehensively will minimize their impact on patient care. Making the commitment to increase the depth and breadth of patient education will ensure additional transparency among physicians, pharmacists, and the community, while assuring patients that their treatment team is committed to providing the best possible level of care.

Reference
1. http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/ucm277744.htm


Paul Arpino, PharmD, BCPS, is an associate chief for the department of pharmacy, instructor of medicine at Harvard Medical School, and chair of the
Formulary and Approval Committee at Massachusetts General Hospital.

 

 

 

 

 

 

 

 


 

 

Tips for Weathering Drug Shortages

 Use ASHP guidelines to create a drug shortages communication plan that denotes proper staffing levels.1 Develop a written policy that delineates who is responsible for providing information to staff and who will make adjustments to automation systems and pharmacy databases in the event of product switches. One team member should be tracking shortages on a daily basis and communicating this information to the rest of the team.

At the University of Utah, a large number of staff are involved in updating databases and adding drugs to the formulary to properly manage the downstream challenges that arise during shortages. Evaluate the FTEs required to make updates quickly and efficiently when a shortage develops. For example, if your facility must make adjustments to the smart pump library and update 100 smart pumps for each product substitution, determine the time and staff required to complete these updates to minimize the shortage’s effect on the facility’s workflow.
Pharmacies often look to place orders directly with the manufacturer during a shortage. Ensure that you have the right staff to establish direct accounts and place these orders. Placing direct orders can be time consuming, so consider batching the calls by manufacturer.


Recognize the multifactorial nature of shortages. While manufacturing problems, supply and demand issues, suppliers discontinuing production, and lack of raw materials all contribute to drug shortages, in 55% of shortages manufacturers decline to provide a reason. FDA states that most shortages are caused by manufacturing problems; uncovering reasons for these problems is vital to developing solutions. While the decreasing profitability of producing certain drugs is problematic, it is clearly not the only, or even the principle, determination exacerbating shortages. Data from the recent IMS Institute for Healthcare Informatics report show that approximately half of drugs in short supply have just one or two suppliers and two-thirds of drugs in short supply have three or fewer suppliers.2 As the problem has multiple causes, multiple solutions will be necessary to delineate answers.


Educate your team regularly. Subscribe to the ASHP Drug Shortages Resource Center’s RSS feed, which is updated daily by the University of Utah’s Drug Information Service, to keep abreast of the first signs of shortages. The ASHP Web site includes drugs that are on shortage, the reasons for the shortage (if known), the projected length of the shortage, and alternative agents to use (when available). Encourage your team to report shortages via this Web site as well. The University of Utah’s team investigates these reports and based on information provided from the manufacturer, posts information to the ASHP Drug Shortages Resource Center as quickly as possible.


Increase resiliency in a fragile supply chain. While stockpiling drugs clearly creates artificial shortages and worsens existing shortages, a careful evaluation of any holes in your supply chain may uncover areas that could be strengthened. For example, some facilities will not order chemotherapy until the patient enters the hospital for the procedure. Increasing par levels slightly may improve the availability of chemotherapy. If every member of the supply chain—facilities, wholesalers, and manufacturers—are using just-in-time inventory, this weakens its resiliency and worsens the effect of shortages. Carefully balance the possibility of waste with the likelihood of a shortage. While tightening inventory is typically a sound financial practice, it may exacerbate problems during a shortage.


Utilize compounding but proceed with caution. Increasing in-house and outsourced compounding can be advantageous during shortages, but practice caution. The risks associated with improperly compounded products are well known and potentially deadly. Work closely with your compounding suppliers. Determine whether they follow <797> regulations and if they test for sterility, stability, and pyrogens. Request written documentation from all suppliers and do not buy product from a supplier that cannot provide these credentials.


Support new legislation. Proposed legislation, the Preserving Access to Life-Saving Medications Act,3 introduced by Senators Amy Klobuchar (D-MN) and Bob Casey (D-PA), would give the FDA the ability to require early notification from pharmaceutical companies when an event arises that may result in a shortage, including a lack of a raw materials, a decline in production capabilities, or business decisions such as mergers, withdrawals, or changes in output. This notification would be confidential and allow the FDA to work to prevent drug shortages, something the agency has an excellent track record of doing: in 2011, the FDA prevented more than 100 shortages. The legislation also would require the FDA to provide up-to-date public notification of shortages along with the steps being taken to address these shortages.


Collect data to substantiate switches. There is danger involved when replacing a drug rife with clinical data to support its use with a drug that has insufficient data or with a combination of drugs. Thoroughly investigate the literature and collect data on drug dosing variations, safety, and efficacy prior to switching products.

References

  1. Fox ER, Birt A, James KB, Kokko H, Salverson S, Soflin DL. ASHP guidelines for managing drug product shortages in hospitals and health systems. Am J Health-Syst Pharm. 2009;66:1399-1406.
  2. IMS Institute for Healthcare Informatics Web site. Drug Shortages: A closer look at products, suppliers and volume volatility. http://www.imshealth.com/portal/site/ims/menuitem.edb2b81823f67dab41d84b903208c22a/?vgnextoid=a6fbcc0f68f73310VgnVCM100000ed152ca2RCRD. Accessed December 15, 2011.
  3. Preserving Access to Life-Saving Medications Act of 2011. http://www.govtrack.us/congress/billtext.xpd?bill=h112-2245 Accessed December 13, 2011.
  4. The White House Web site. Executive Order 13588–Reducing Prescription Drug Shortages. http://www.whitehouse.gov/the-press-office/2011/10/31/executive-order-reducing-prescription-drug-shortages. Accessed December 14, 2011.

Erin R. Fox, PharmD, is the manager of the drug information service at University of Utah Health Care (UUHC). She received her PharmD at the University of Utah and completed a specialized residency in drug information at UUHC.

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