Hospitals and medical facilities across the nation are dealing with shortages of medications and supplies on a daily basis. The American Society of Health-System Pharmacists (ASHP) defines a drug shortage as “a supply issue that affects how the pharmacy prepares or dispenses a drug product or influences patient care when prescribers must use an alternative agent.”1
The reasons behind drug shortages are varied and complex. According to the FDA the leading causes of drug shortages as manufacturing problems (43%), delays in manufacturing or shipping (15%), and lack of availability of the active pharmaceutical ingredient (10%).1,2,3,4
ASHP introduced a Phased approach to planning for drug product shortages.1 Two important steps when utilizing this approach are Information system changes and technological changes (e.g. bar coding). For each step, we will discuss IT-based strategies to address drug shortages.
- Information system changes:
Multiple order sets and treatment protocols will need to be reviewed and changed to support new practices. Switching some intermittent infusion antibiotics to intravenous slow push in an effort to reduce small-volume parenteral solution utilization serves as a good example.
Double checking any system changes is highly recommended to avoid patient harm in the midst of an urgent response to a critical medication shortage.
Hospitals and healthcare systems can utilize similar opportunities to evaluate current formulary options and routine practices to apply changes that can be utilized even after the shortage is resolved.
Different options of Clinical Decision Support (CDS) rules and alerts (hard stop and soft stop alerts) can be used to notify the provider of any drastic change to avoid any patient harm. In similar cases, alerts carry more importance to patient care than the risk of alert fatigue which will justify using them.
- Technological changes:
Urgent changes to different automation systems and electronic health records are necessary to continue utilizing barcode medication scanning throughout the continuum of medication use system (from receiving until administration).
Smart alerts can be used within different technological solutions to make sure medications are being distributed correctly amongst the different systems. For example, having multiple concentrations of specific medication loaded in an Automated Dispensing Cabinet carries a huge risk of loading the wrong concentration to the wrong pocket all the way to nursing administering the wrong dose due to the wrong concentration.
Updates to the medication infusion smart pump library will be required to support all these changes. Other available options within the institution that would support a short term solution-change until the shortage is resolved should be considered. One example is utilizing other types of pumps for medication delivery (PCA or CADD).
In specific situations, out of the box solutions for medication delivery might help avoid the need for huge changes to an information system. For example, administering medication using a Buretrol® IV solution set will help nursing administer the medication similarly to utilizing intermittent infusion with minimal changes to the system. However, similar decisions should be made after extensive discussion with affected departments.
Standardization wherever possible is a key to help mitigate the risk associated with urgent changes. Also, documentation is very important to keep track of changes so they can be reversed once the shortage is resolved. Committees that review and approve system changes within any health system might provide expedited review for any system changes needed urgently in response to a critical shortage. It would be beneficial to go back and provide full review of the changes to make sure the risk of patient harm is minimal.
Communicating information about the shortage, alternative therapies, and implementation plans within the pharmacy and with other departments should occur utilizing the most effective means available. Pharmacy personal should be aware of all changes applied to the system as it is imperative to support the medication use system and prevent patient harm due to system changes. The goal of having open, clear, and sustained communication with other department is crucial to ensure patient safety and prevent medication errors caused by confusion.
Conclusion:
Understanding the downstream implications a drug shortage is the key to developing an effective response to any shortage situation. Since hospitals and medical facilities are dealing with recurrent shortages, developing a global strategy that can be used to face any drug shortage would be beneficial.
Authors:
Published on behalf of the Inpatient Workgroup for the Clinical Application SAG:
Andrew Liu, Pharm.D., CPHIMS. Informatics Pharmacist. Rush University Medical Center. Chicago, IL
Butch Parks, B.S.Pharm., M.S. Senior Consultant. HealthmarkIT. Springdale, AR
Hesham Mourad, Pharm.D., BCPS, BCCCP, CPHIMS, Pharmacy Informatics Team Leader. Mayo Clinic. Jacksonville, FL
Kathy Yount, B.S.Pharm., R.Ph. Clinical Informatics Pharmacist. Deaconess Hospital. Evansville, IN
Marie-Elsie Ade, Pharm.D., M.H.A., M.S., BI. Director of Pharmacy. Baptist Health South Florida. Cutler Bay, FL
Paolo Valerio, Pharm.D. PGY-2 Health System Pharmacy Administration Resident. Allegheny General Hospital. Pittsburgh, PA
Raymond Chan, Pharm.D. Pharmacy IS Specialist. Sentara Healthcare. Virginia Beach, VA
References:
- Fox ER, Birt A, James KB, et al. ASHP guidelines on managing drug product shortages in hospitals and health systems. Am J Health-Syst Pharm. 2009; 66:1399–406.
- Jensen V, Kimzey LM, Goldberger MJ. FDA’s role in responding to drug shortages. Am J Health-Syst Pharm. 2002; 59:1423–5.
- Fox ER, Sweet BV, Jensen V. Drug Shortages: A Complex Health Care Crisis. Mayo Clinic Proc. 2014.89(3):361-373.
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US Department of Health and Human Services, Food and Drug Administration (October 31, 2011). A Review of FDA's Approach to Medical Product Shortages. Retrieved from
- ASHP and the University of Utah Drug Information Service (2017, October 18). Small-Volume Parenteral Solutions Shortages Suggestions for Management and Conservation. Retrieved from: https://www.ashp.org/-/media/assets/drug-shortages/docs/drug-shortages-svp-shortages-suggestions-for-management-conservation.ashx?la=en&hash=D6BB06DB8AD5891E7EAE628E3B22015591430B75
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Edillo PN. Drug Shortages: A Pharmacy Informatics Perspective. Pharmacy Purchasing and Products. April 2011 - Vol. 8 No. 4.