Economic Considerations of Drug Shortages

2016 - 6 December – Survive and Thrive
April Miller Quidley, PharmD, BCPS, FCCM, FCCP; Bryan Lizza, PharmD, BCCCP; Shauna Winters, PharmD, BCPS
Read about economic considerations of drug shortages.

Potential consequences of drug shortages in the intensive care unit (ICU) are numerous and have been extensively documented.1,2 While adverse patient outcomes related to drug product shortages are of paramount importance and have increased awareness of this issue, the financial implications of shortages can be significant. Multiple factors influence and contribute to unanticipated shortages, but with many of the inciting factors unknown or multifactorial in nature, little progress has been made in preventing the occurrence of drug shortages. As a result, it is necessary for healthcare systems to be able to rapidly adapt by performing therapeutic and operational assessments to minimize the impacts on patient care andfinances. In this article, we highlight some of the economic concerns associated with drug shortages and ways to minimize cost. Additionally, we present strategies that may be used to limit product consumption and waste.

Management of electrolytes is an essential issue for critically ill patients. Shortages of key electrolyte products have affected the cost of these products and led hospitals and health systems to seek out more costly alternatives. Recent shortages of concentrated calcium, magnesium, phosphate, potassium and sodium illustrate the key products whose availability has been reduced, creating issues with the preparation of parenteral nutrition solutions and the maintenance and replacement of electrolytes.3 Electrolyte replacement is not commonly a significant contributor to overall ICU drug costs, but in times of product shortage, cost becomes an important consideration. Often, during product shortages, institutions can purchase pre-compounded single electrolytes (such as magnesium, calcium and potassium) from centralized compounding pharmacies who are less impacted by product availability. These compounded preparations are essentially dilutions of concentrated electrolytes in bags for intravenous administration and, depending on the institution’s practice, may come at a premium cost. Many large institutions have made investments in facilities and staff to prepare these products at a reduced cost. Other institutions may purchase more pre-compounded products regardless of availability because it is a cost-effective alternative to preparing the solutions in-house.

An alternative to compounded products is nontraditional salt forms of electrolytes (for example, potassium phosphate versus sodium phosphate or sodium acetate versus sodium bicarbonate) based on product availability. Alternate formulations are also potentially useful in the preparation of parenteral nutrition solutions. When clinically feasible, the use of multi-electrolyte solutions may be more cost-effective because these products can be obtained relatively inexpensively and they contain multiple electrolytes. Clinicians should consider the standardization of these products when possible.

Vasoactive medication shortages are viewed as dire when considering the potential impacts on patient care and life-sustaining effects these medications can offer. When manufacturers of vasopressin began discontinuing production, many institutions nationwide began limiting access to these agents. The only vasopressin product currently available is Vasostrict, but the availability of this newer branded product does not come without a cost. Vasostrict has refrigeration storage restrictions and a short admixture expiration date, which can easily lead to increased product turnover and waste. The cost of Vasostrict far exceeds that of the traditional vasopressin products by nearly 100-fold, which has pushed institutions to evaluate ways to balance cost and appropriate drug therapy utilization. Some institutions have limited its availability by removing stock from patient care areas and maintaining minimal stock in the pharmacy. Additionally, the amount of drug dispensed in vasopressin continuous infusions can be decreased to reduce waste.

Other vasoactive products, such as dopamine, epinephrine, norepinephrine and nitroprusside, have recently been in shorter supply for reasons including manufacturer delays, plant closings and product discontinuation. These short supplies have caused clinicians to use alternative agents based on contractility, chronotropy, vasoconstriction and vasodilatory properties necessary for patients on an individual basis. This sometimes results in using multiple products to achieve the same response as would be achieved by a single agent. Institutions have invested additional resources to increasing stock of alternative agents in order to prevent adverse patient outcomes.

Antimicrobials are another medication class whose shortage can create critical issues and increased costs for ICUs. Shortages of antimicrobials have the potential to prevent clinicians from providing drug therapy with the most suitable antibiotic agent.4 Some antimicrobial agents that have been affected by manufacturer discontinuation and are unavailable or on allocation are amikacin,cefepime, cefotaxime, and tigecycline. While alternatives to these agents may exist, they may come at an increased cost. Additionally, while resolved now, a shortage of vancomycin prompted changes in its use at many institutions, including the use of newer, more expensive anti-methicillin-resistant Staphylococcus aureus agents. These therapeutic alternatives also created issues related to the use of agents discussed in antimicrobial stewardship guidelines. Shortages can cause overuse of agents that would normally be restricted or not recommended for therapy. Institutions may also go outside their formulary to obtain alternative antimicrobial products with similar pathogen coverage. Using alternative agents can result in increased direct drug costs due to purchase of non-contracted antimicrobial agents and more stock in other antimicrobials. In addition, implementing these alternatives results in increased costs related to staff time. Changes in antimicrobial use may also have the potential to create additional antimicrobial resistance, resulting in increased downstream costs for institutions in managing resistance.

With a multitude of factors contributing to drug shortages, it is expected that critical care clinicians will continue to deal with these issues for a variety of drugs in the future. Finding appropriate therapeutic alternatives is critical, but the economic issues associated with these shortages must not be overlooked. A multidisciplinary approach to management can help reduce the impacts of drug shortages on patient care and finances.

References

1.            Kaakeh R, Sweet BW, Reilly C, et al. Impact of drug shortages on U.S. health systems. Am J Health Syst Pharm. 2011 Oct 1;68(19):1811-1819.

2.            Gulbis BE, Ruiz MC, Denktas AE. The impact of drug shortages on the pharmacy, nursing, and medical staff’s ability to effectively care for critically ill patients. Crit Care Nurs Q. 2013 Oct-Dec; 36(4):400-406.

3.            American Society for Parenteral and Enteral Nutrition. Parenteral Nutrition Electrolyte and Mineral Product Shortage Considerations. Silver Spring, MD: American Society for Parenteral and Enteral Nutrition; 2016. https://www.nutritioncare.org/News/General_News/Parenteral_Nutrition_Electrolyte_and_Mineral_Product_Shortage_Considerations/. Accessed September 19, 2016.

4.            Gundlapalli AV, Beekmann SE, Graham DR, Polgreen PM; Infectious Diseases Society of America’s Emerging Infectious Disease Network. Perspectives and concerns regarding antimicrobial agent shortages among infectious disease specialists. Diagn Microbiol Infect Dis. 2013 Mar;75(3):256-259.