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Drug Shortages: A Pharmacy Informatics Perspective


April 2011 - Vol. 8 No. 4 - Page #26

Managing drug shortages is daunting because the impact of one drug shortage on any health system has several detrimental downstream implications. These implications affect our patients, multiple departments, a myriad of health care professionals, various information systems, and other health information technology (HIT) that support the medication use process. In the event of a drug shortage, practitioners that understand the clinical application and associated workflows of HIT, as well as have the skills necessary to implement change in these sophisticated and interoperable systems, are crucial, thereby emphasizing the importance of pharmacy informatics specialists.

The definitive informatics pharmacist is one that understands the complex relationship between HIT, clinical workflows, operational processes, and drug policy. Informatics pharmacists are typically the most adept at navigating the continuum of medication-use practices among stakeholders, systems, and accompanying workflows. As such, they are the best equipped at handling any changes that may be required. In the context of drug shortages, it is essential to include an informatics pharmacist as soon as possible to enable modifications to what are often a multitude of systems. To appreciate such a need, it is clearly important to understand the role of the informatics pharmacist.

The Value of Informatics
A core responsibility and practical application of pharmacy informatics in any health care setting revolves around the construction, maintenance, and governance of the medication-use process. The influx and importance of computerized and robotic systems is not lost on any level of modern pharmacy, from major health systems to rural community hospitals. We now have electronic medical records (EMRs) to facilitate the storing of patient information, clinical decision support systems to assist providers in medication ordering, and e-prescribing and computerized provider order entry (CPOE) systems, which eliminate the need for paper orders or prescriptions in most cases. Medication carousels, packagers, and automated dispensing cabinets (ADCs) assist in medication dispensing; tools to assist nursing staff in medication administration (and the documentation of administration), such as intelligent infusion pumps, bar code medication administration (BCMA), and electronic medication administration records (eMAR), are becoming ubiquitous. Technology now surrounds us at every step, and these sometimes disparate information systems must be able to adequately share information with one another in order to achieve a fully interoperable state.

Consider the circumstance when the pharmacy receives a new NDC but fails to validate its bar code in the pharmacy information system. If that product is physically dispensed, a nurse will attempt to scan the bar code but the BCMA system will not recognize it, leading to frustration and possible workarounds; circumventing the necessary safety checks causes the entire process to lose fidelity. Multiply this one example by all the potential discrepancies among information systems at any given point in time, and the complexity and coordination of deploying technological solutions (whether they are upgrades, fixes, or temporary bridges, as with drug shortages) for the medication-use process becomes apparent.

Thus, we are presented with the need for informatics pharmacists that understand this process from beginning to end. With a clearer understanding of the role of the informatics pharmacist, we can now better understand and work through recent examples of drug shortages to derive lessons learned and potential strategies for success when handling drug shortages in the future.

Informatics Solutions to Shortages: Case Examples
The series of propofol shortages that began in the fall of 2009 affected virtually all health systems. Propofol is in constant demand at Oregon Health & Science University (OHSU) because of its widespread use in procedural sedation, as well as sedation for ventilated patients. Among the reasons for the shortages was the discovery that products from two of the three propofol manufacturers for the US market were found to contain microbial contamination and particulate matter. These two manufacturers therefore halted production, leaving only one manufacturer to provide supply for the entire US.

As soon as we learned about this shortage, members of our management team—consisting of our clinical manager, supply chain manager, operations manager, and informatics manager—immediately convened to discuss a solution strategy. Our first course of action was to determine how much stock we had on hand and evaluate our propofol utilization data. We found we had approximately one week’s worth of the drug onsite, giving us time to formulate and invoke a departmental plan, starting with the operations manager’s centralizing the propofol stock to exert more control over the inventory. While one week does not seem like a long period, when dealing with drug shortages, this is actually fairly ample. From an informatics perspective, we evaluated all of the potential points in our EMR where providers could potentially order propofol and evaluated our tools to provide clinical decision support. We knew we had to provide alerts at various points of ordering to notify providers of the shortage and to encourage them to consider clinically appropriate alternatives. By manipulating our decision support tools, we were able to provide the alternatives of lorazepam, midazolam, and dexmedetomidine. As part of our discussion to determine the most appropriate clinical alternatives, we considered the use of fospropofol, but quickly decided fospropofol should continue to be restricted for patients undergoing GI procedures only, since much of the preliminary efficacy data on fospropofol was for GI indications. From a pharmacokinetic perspective, fospropofol behaves a bit differently than propofol, as it is a prodrug that is able to exist in an aqueous environment. The propofol shortages began over a year and a half ago and we are still experiencing supply issues, though the overall pharmacy solution strategy we developed at OHSU has helped mitigate the detrimental effects.

Another example of a recent national drug shortage involves furosemide injection. Furosemide use is more widespread compared with propofol as it may be prescribed for patients with many different conditions. However, the impact of the shortage to our end users has been just as significant. Perhaps the most difficult part of the furosemide injection shortage is simply that no one really knows the cause of the shortage other than the discontinuation of production from one manufacturer. As with the propofol shortage, though, as soon as we were alerted, we took similar steps of evaluating all the stock we had on hand, centralizing it, and evaluating utilization data. In this case, we discovered we had only two- to three-days’ worth of the drug on hand before we would be completely depleted, so we needed to work quickly. Unfortunately, such time frames are increasingly common during shortages.

From an informatics perspective, we again evaluated all potential ordering points for furosemide injection in the EMR. We implemented a series of alerts for all orders of furosemide injection explaining the shortage and suggesting bumetanide injection as an alternative. Additionally, since the circumstances were dire, the informatics team ran a report on all of the active patient orders for furosemide injection and relied on our clinical staff to change the active patient orders to oral furosemide, if possible, or to bumetanide injection.

In our haste to implement these changes in the EMR, we overlooked the more widespread clinical impact of such a product change and quickly began to receive notifications from our pediatric pharmacists about a significant clinical issue. They relayed to us that bumetanide use in the neonate population has a higher propensity to displace bilirubin from albumin binding sites, increasing the risk for kernicterus. Due to this clinical concern, we had to reengineer our original solution to allow for the prescribing of furosemide injection for the neonate population. Due to the infrastructure of our EMR, we again had to rely on pharmacy staff to determine if there was enough physical stock on hand to satisfy standing orders for furosemide injection in the neonate population.

In reviewing the propofol and furosemide injection shortage examples, a key difference between the two is the relative amount of time from notification of the drug shortage to solution implementation. In the propofol example, we had time to evaluate the drug shortage and determine what our viable options were. In the furosemide example, since the impact was immediate, we were pressed to implement change without completing an impact investigation. This experience exposed the fact that we were not fully prepared for the worst-case scenario. In both examples, we were able to work through the majority of the issues involved in the shortage, but we did not have a formalized structure or checklist to follow to ensure a sound plan from all perspectives, allowing us to implement an appropriate solution. Structure in the form of a policy, procedure, or checklist to follow at the time a drug shortage was announced would have provided better overall guidance and would have prevented much of the rework we had to perform for the furosemide injection shortage. At OHSU, we are currently working on such a policy document with hopes of having it implemented in the near future.

At first glance, it may seem like the informatics work required to accommodate both of these drug shortages was fairly simple. However, a quick review of the medication-use process illustrates otherwise (see Figure 1). Multiple information systems required a bridge to accommodate these shortages, and our informatics team—consisting of our informatics pharmacists, systems analysts, and a trainer—either directly or indirectly performed the modification to that information system or coordinated with the stakeholder to make necessary changes. For example, we needed to modify order sets to include information about the drug shortages in the EMR. For clinical decision support, we added alerts in the system to notify providers of clinical alternatives to consider. From a CPOE perspective, we removed the orderable drug items that were in short supply when appropriate to prevent providers from ordering the medications that we no longer had in stock. We needed to coordinate the removal of these items from the ADCs in order to centralize stock. Using bumetanide as our main loop diuretic in the furosemide shortage required the build of new line items in the intelligent infusion pump library. We also had to notify the billing team to be aware that these changes were occurring and to expect variance from previous practice.



In the future, OHSU plans to implement inpatient BCMA, medication carousels, and packaging equipment. The informatics team would most likely also need to modify the information systems that govern these processes. Understanding the core responsibilities of the informatics pharmacist and working through historical examples can help pharmacists better develop a strategy to ease the burden of drug shortages.

Drug Shortage Strategies
From a project management perspective, there are essentially three phases of a drug shortage: pre-drug shortage, current drug shortage, and post-drug shortage.

The pre-drug shortage phase is the time to determine what the appropriate structure should be for handling unanticipated drug shortages. Plans should be robust enough to handle all drug shortages, whether big or small. Steps that should be taken at this time include the following:

  • Become familiar with the ASHP Web site http://www.ashp.org/shortages
    • This Web site contains information about current drug shortages, clinical alternatives to consider, and an estimated duration for the shortage, if known. ASHP gets its information from a multitude of sources, one of which includes end users who are experiencing the drug shortages first hand. The authors also do an excellent job of providing appropriate alternatives. RSS feeds are available from this Web site and are sent via email.
  • Establish appropriate lines of communication
    • Create a single point of contact who will be responsible for gathering and receiving information about drug shortages in the marketplace and communicating the drug shortages to other relevant team members. An informatics pharmacist should be among those included early on in the process. This point of contact should also consider working with their GPO or directly with wholesalers to determine if they have any forecasting mechanisms in place for drug shortages. At OHSU, this point of contact is the pharmacy supply chain manager.
  • Create a checklist of all information systems in the health care setting that contain medication data
    • This checklist should include demographic information about these information systems: name, owner, clinical stakeholders, and governance committees, if applicable. When any drug shortage develops, this will serve as a quick reference for what information needs to be coordinated and with whom. After creating this checklist, have discussions with all the stakeholders (particularly if they are external to pharmacy) on the need for accelerated change management. Changes impacting several systems may take weeks to months to accommodate, and drug shortage timelines can be as little as days or even hours.

The current drug shortage phase begins when the established point of contact hears about a drug shortage or if the staff specifically calls attention to the shortage. Steps to take during this time frame include the following:

  • Evaluate the utilization data and the quantity on hand
    • Reviewing this data will assist in determining appropriate timelines for completing work to mitigate the drug shortage.
  • Begin the communication tree
    • The primary point of contact should begin prepping all parties involved that action will be required and then begin mobilizing resources.
  • Develop, document, and approve a plan of action
    • Getting informatics, clinical, and operational agreement on the strategy is crucial for success and documenting the plan is important for posterity.
  • Run through the information system checklist
    • Determine the appropriate modifications required in each of the information systems, if applicable. Be sure to communicate with the appropriate owners and/or stakeholders of the plan of action.
  • Determine the supply of clinically appropriate alternatives
    • Now that there are suggestions for alternatives for providers at the point of ordering, ensure there is an adequate supply of these medications as well. The spike in demand for alternatives may lead to new drug shortages.
  • Modify the medication-use process
    • Completing the above recommendations will decrease the likelihood of having to reengineer any fixes, and the informatics team will feel relatively comfortable making required modifications to the information systems.

The post-drug-shortage phase is often overlooked, but it is crucial to address key issues in order to return the medication-use process to its pre-shortage state. Informatics resources need to be mobilized to facilitate these changes and the following steps should be considered:

  • Ensure the drug shortage is over or has stabilized
    • Information making certain that the shortage is over should come from the single point of contact. This phase should not begin until there is sufficient evidence suggesting the drug shortage is over and that there will be ample stock in the future.
  • Undo the action plan
    • Unfortunately, there is no “Undo” button when it comes to HIT. To perform the appropriate cleanup of information systems, the informatics team should review the documented action plan and determine the appropriate steps to return the information systems to their previous states.
  • Evaluate the financial impact
    • Drug shortages will inevitably cause variances in the drug budget. Be sure to document these variances and report this information as appropriate.

Conclusion
Developing a strategy for handling drug shortages must be based on a fundamental understanding of the many downstream implications a drug shortage creates. To best identify working strategies, take advantage of previous experience and review historical examples of drug shortages to determine lessons learned. It is only through collaboration that an appropriate action plan, which will successfully navigate the ecosystem of information technology, can be developed.


P. Neil Edillo, PharmD, BCPS, CPHIMS, currently serves as the informatics manager for the department of pharmacy services at Oregon Health & Science University. He received his doctor of pharmacy degree from the University of Michigan College of Pharmacy in 2005. Immediately after pharmacy school, Neil went on to complete a pharmacy practice residency at The Johns Hopkins Hospital in 2006. He then returned to the University of Michigan Hospitals and Health Centers to complete a pharmacy informatics and technology specialty residency in 2007.

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