Abstract

Drug shortages have been steadily increasing for the past 6 years. A 2011 Government Accountability Office (GAO) report presented drug shortage impact data from the University of Utah Drug Information Service. The report summarized the findings that drug shortages have increased from 64 in 1996 to 196 in 2010 and were on track to beat that figure in 2011. 1 We would much rather practice in a world with abundant medication supply, but meaningful systemic changes can be made to minimize the development of shortages.
According to the American Society of Health-System Pharmacists (ASHP), the following factors contribute to drug shortages 2 :
Raw and bulk material unavailability
Manufacturing difficulties and regulatory issues
Voluntary recalls
Change in product formulation or manufacturer
Manufacturers' production decisions and economics
Industry consolidations
Restricted drug product distribution and allocation
Inventory practices
Unexpected increases in demand and shifts in clinical practice
Nontraditional distributors
Natural disasters
The only listed contributory elements that may be within direct influence of pharmacy practice are collective inventory practices, utilization of nontraditional distributors, increases in demand, and shifts in clinical practice. All other elements seem to be external factors. Our professional societies should be good advocates for our profession and lobby for desired change in regulatory matters.
Improved Drug Supply Management Processes
Though our profession has limited influence over the development of shortages, we control how we anticipate and respond to drug supply interruptions. The need for us to refine pharmacy shortage management processes has become apparent as the incidence and severity of drug supply interruptions increase. Optimizing processes is essential for minimizing the negative impacts of shortages, and processes are best optimized through a good understanding of existing processes.
Researchers in Utah developed a safety assessment checklist to evaluate potential patient safety impacts resulting from a drug shortage. They used failure modes effects analysis to identify potential vulnerabilities in shortage management processes. The following were identified as high vulnerability processes 3 :
Formulary decisions: failure to identify safety concerns
Procurement: no staff notification of alternate product acquisition; sound-alike/look-alike issues
Storage: incomplete inclusion in pharmacy and medical information and storage systems; sound-alike/look-alike issues
Ordering: lack of prescriber familiarity of shortage or of alternative agent
Order processing: failure to identify safety concerns
Preparation: errors due to sound-alike/look-alike issues or lack of familiarity with alternate concentration
Dispensing: errors due to sound-alike/look-alike issues or lack of familiarity with alternate concentration
Administration: errors due to sound-alike/look-alike issues or lack of familiarity with alternate agent or concentration
Each of these steps presents a potential opportunity for evaluating the medication management process, which could lead to an overall process improvement that could benefit patient safety at large. For example, utilization evaluation for an agent affected by shortage may reveal inefficient processes for drug distribution. Perhaps the evaluation reveals that the drug is utilized in an inappropriate population or is administered inappropriately. It is feasible that correcting the process for the sake of shortage management could have benefits that extend beyond the duration of the shortage for the affected drug or could even extend to a larger group of related drugs or even the overall process.
Resident/Student Involvement
Shortage management planning provides an excellent opportunity to involve residents and students in all aspects of the medication management process. Involvement in procurement decisions can illustrate the importance of sound-alike/look-alike considerations and provide experience in communicating with drug manufacturers. Drug supply monitoring can teach the value of Internet-based drug shortage information portals and estimation of use patterns. Drug distribution evaluation provides an opportunity to demonstrate the function of automated dispensing cabinet technology and other inventory management strategies. Evaluations of therapeutic alternatives foster discussions about clinical considerations and safety implications. Education of pharmacy, nursing, and medical staff provides teaching opportunities in communication techniques and professional writing and introduces topics related to administration concerns. Monitoring is an important aspect of the medication management process that gives residents and students exposure to navigating complex medical records and designing effective audit tools. New practitioners can emerge from the experience with operational and clinical experience they may not otherwise encounter.
Emergency Preparedness
“Just in time” inventory practices make health systems vulnerable to drug supply interruptions. Natural disasters or severe weather events strain lean drug inventories and outages can emerge quickly. Processes to manage drug supply interruptions should be developed when there are no shortages, so they can be deployed with efficiency during times of extreme hardship.
Strategic Partnerships
The effects of drug shortages extend beyond the pharmacy to the prescribers and nurses who provide patient care at the bedside. Their frustration is heightened when there are unexpected shortages. We can diffuse this frustration by reaching out to key prescribers and nursing leaders in anticipation of a pending shortage. Furthermore, by inviting them to participate in response planning, we can encourage their involvement and promote their perception of control over the developing situation. They may be aware of practices that contribute to waste or inefficient distribution and can offer suggestions to eliminate these practices. They can be good partners in identifying high priority patient populations that will be affected by critical shortages. These partners may be able to help notify their colleagues and extend the reach of communication about shortage management plans. Additionally, once good relationships are forged, they can continue to serve as valuable resources and partnerships in developing future initiatives.
Stimulus for Desired Change
Successfully implementing an initiative usually requires good process development, an effective and compelling proposal, and support from the pharmacists, nurses, and prescribers who will be affected by the change. There are times when an item affected by shortage could drive implementation of an initiative that may not have had the support it needed to proceed under other circumstances. The importance of good process development should be emphasized to avoid compromising patient safety and to maintain momentum to adopt the initiative indefinitely.
Drug supply interruptions are becoming routine and are associated with hardships. Hardships are often accompanied by opportunities. Let's embrace these opportunities and utilize them to demonstrate the value of our profession.
