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Strategies for Managing Parenteral Nutrition Shortages


April 2016 - Vol.13 No. 4 - Page #12

Parenteral nutrition (PN), a critical element of nutrition care, provides IV nutrients to patients who have nonfunctional gastrointestinal tracts or patients whose nutrition needs cannot be met with oral diets or enteral nutrition (EN). In the critically ill, PN provides protein and calories to help balance metabolic alterations that occur during hypermetabolic states such as lean tissue catabolism, acute phase protein production, and elevated resting energy expenditures.

Originally referred to as IV hyperalimentation, PN is a complex IV treatment that can contain up to 40 nutrient components, including amino acids, dextrose, IV fat emulsion, electrolytes, vitamins, and minerals. Because this large number of components may result in questionable stability and unknown compatibility when administered with medications, proper PN compounding is vital. In fact, severe patient harm and death have been reported when PN is improperly compounded or if calculations are incorrect. For example, one case report describes a patient developing pulmonary emboli containing calcium phosphate precipitates, attributed to improper PN compounding techniques and possible storage at an incorrect temperature.1 To avert risk, it is critical that PNs be compounded correctly and that hospitals have access to all PN components, many of which have experienced shortages in recent years.

The State of PN Drug Shortages

Shortages of PN components have been an ongoing concern for the past decade. Due the chronic nature of these shortages, proper management, including utilization of drug shortages resources and expert recommendations, is fundamental. Most PN components have been in short supply or unavailable at some point in recent years. The American Society for Parenteral and Enteral Nutrition (A.S.P.E.N.), American Society of Health-System Pharmacists (ASHP), and the US Food and Drug Administration (FDA) are endeavoring to provide practitioners with effective methods for managing drug shortages.

Recent shortages include electrolytes, L-cysteine, IV fat emulsions, multivitamins for injection, and trace elements.

  • Electrolytes. Electrolyte disorders are common with fluctuations in serum electrolyte concentrations attributable to a variety of issues including metabolic disturbances, acute organ damage, and concomitant medications. Many malnourished patients have poor electrolyte stores in their bodies, and must have electrolytes supplemented in order to safely administer nutrition support. If electrolytes are not replenished in a deficient patient, the initiation of PN may lead to respiratory failure, arrhythmias, and acid base disturbances.
  • L-cysteine. L-cysteine is a conditionally essential amino acid in preterm infants, who cannot convert methionine to cysteine. L-cysteine can cause further acidification of the PN admixture, which improves calcium and phosphate solubility.
  • IV fat emulsions. Patients who receive all nutrition from PN must receive 100 grams of fat per week to prevent essential fatty acid deficiency (EFAD). The development of EFAD can present as dry, scaly skin, alopecia, and anemia. This fat is provided by IV fat emulsion administered based on patient clinical status and comorbid disease state history.
  • Multivitamins for injection. The administration of multivitamin infusion in patients receiving PN provides supplementation of nutrients that are being utilized by the body for increased metabolic demands and subsequent tissue depletion of nutrients.
  • Trace elements. Multitrace element administration in PN patients helps supplement trace elements that are being utilized by the body as enzyme activators, cofactors for protein formation, and glucose tolerance factor.

Impact of PN Shortages

PN product shortages have been linked to increased staff hours, inability to meet patient micro– and macro-nutrient needs, as well as increased patient morbidity, mortality, and length of stay (LOS).2 Moreover, an Institute for Safe Medication Practices (ISMP) survey detailed medication errors associated with the inability to obtain PN components or alternative products during the shortage.3 Common contributing factors leading to errors included mix-ups between electrolyte salts; confusion between pediatric and adult alternative products; concentration differences with alternative products; and changes not made to protocols, templates, labels, automated compounding devices, or order entry systems. A discussion of the impact of drug shortages on surgery patients receiving PN noted a longer LOS, a trend toward longer courses of PN therapy, increased laboratory draws, fewer lipid calories received by patients, and higher hospital costs. The study concluded that PN shortages have a negative impact on patient outcomes and lead to more aggressive management strategies.4

The literature clearly illustrates the need for effective management strategies to minimize the negative consequences of PN shortages.

Shortage Management Strategies

The utility of the electronic health record (EHR) continues to evolve in health care, and can be an effective means of communicating drug shortages to staff. Many health systems have developed drug shortage notifications in their EHR systems; however, the expertise to utilize the EHR for this purpose is not yet universal. EHR vendors should work toward the goal of making this feature readily available to all users.

Both the FDA and ASHP have resources available on their Web sites for monitoring and addressing drug shortages. The FDA’s Center for Drug Evaluation and Research (CDER) is responsible for coordinating all activities related to the prevention and mitigation of shortages and receives updates on manufacturers’ reported ability to supply the market in addition to sales data on specific products. A list of drugs on shortage is available on CDER’s Web site. Manufacturers are required to report shortages to the FDA; in addition, reports also are received from health care professionals, patients, and professional organizations through the drug shortage email account (drugshortages@fda.hhs.gov) or by phone (888-INFOFDA).

ASHP’s Guidelines on Managing Drug Product Shortages in Hospitals and Health Systems discusses raw and bulk material unavailability, FDA enforcement actions, voluntary recalls, changes in product formulations or manufacturers, and economic decisions as some of the factors contributing to drug shortages.5 The guidelines recommend a phased approach to decision-making for product shortages, including the following key steps: operational assessment, therapeutic assessment, shortage impact analysis, establishing a final plan, and then communication and implementation of this plan (www.ashp.org/doclibrary/bestpractices/procuregdlshortages.aspx). In addition, the ASHP Web site provides health care practitioners with resources to manage drug shortages, along with therapeutic alternatives and lists of available products. ASHP also receives drug shortage reports from health care professionals, caregivers, and drug manufacturers.

Timely reporting of drug shortages and adverse events related to shortages enables proper investigation and verification by the appropriate organizations. Reporting to the FDA, ASHP, and ISMP also can help these organizations notify health care professionals so that drug shortage considerations and recommendations can be utilized before shortages adversely affect patients.6 Consumers and health care practitioners are urged to report shortage-related adverse events to the ISMP National Medication Errors Reporting Program (www.ismp.org/reporterrors.asp).7,8

Pharmacists play a key role in minimizing the effects of shortages related to PN products. Personnel involved in product procurement should work closely with individuals who prescribe and compound PN to keep them abreast of current and/or expected product shortages. When a shortage occurs, use of PN should be limited to those patients with appropriate indications. In addition, consider the use of standardized, commercially available PN products.

Conclusion

Because economic, manufacturing, and quality issues are ongoing, drug shortages will continue to hinder the delivery of PN in the United States for the foreseeable future. Utilizing drug shortage resources from national organizations allows practitioners to efficiently monitor and manage PN shortages. Ensuring that patient safety remains at the top of health care professionals’ radar is critical to appropriate shortage management.


Phil Ayers, PharmD, BCNSP, FASHP, is a clinical specialist in nutrition support and serves as chief of clinical pharmacy services in the department of pharmacy at Baptist Health Systems in Jackson, Mississippi. He also is a clinical associate professor at the University of Mississippi School of Pharmacy. In addition, Phil serves as secretary-treasurer for the board of directors of A.S.P.E.N., and is the current president of the Mississippi Pharmacists Association (MPhA). Phil received his BS in pharmacy and his PharmD from the University of Mississippi.

Andrew Mays, PharmD, is a clinical pharmacy specialist at Mississippi Baptist Medical Center and is a clinical assistant professor at the University of Mississippi School of Pharmacy. He serves as the central vice president for the Mississippi Society of Health-System Pharmacists and president of the Mississippi Society for Parenteral and Enteral Nutrition. Andrew received his PharmD from the University of Mississippi and he completed a pharmacy practice residency at North Mississippi Medical Center in Tupelo, Mississippi.


References

  1. Knowles JB, Cusson G, Smith M, et al. Pulmonary deposition of calcium phosphate crystals as a complication of home total parenteral nutrition. JPEN J Parenter Enteral Nutr. 1989;13(2):209-213.
  2. Boullata JI, Guenter P, Mirtallo JM. A parenteral nutrition use survey with gap analysis. JPEN J Parenter Enteral Nutr. 2013;37:212-222.
  3. Institute for Safe Medication Practices Web site. ISMP Survey Links Parenteral Nutrition Component Shortages to Adverse Outcomes. https://www.ismp.org/pressroom/PR20140213-2.pdf. Accessed March 9, 2016.
  4. Bible JR, Evans DC, Payne B, et al. Impact of drug shortages on patients receiving parenteral nutrition after laparotomy. JPEN J Parenter Enteral Nutr. 2014;38(suppl 2):65S-71S.
  5. ASHP Expert Panel on Drug Product Shortages, Fox ER, Birt A, et al. ASHP guidelines on managing drug product shortages in hospitals and health systems. Am J Health-Syst Pharm. 2009;66(15):1399-1406.
  6. American Society of Health-System Pharmacists Web site. Drug Shortages. http://www.ashp.org/shortages. Accessed March 9, 2016.
  7. Food and Drug Administration Web site. Frequently Asked Questions About Drug Shortages. http://www.fda.gov/Drugs/DrugSafety/DrugShortages/ucm050796.htm. Accessed March 9, 2016.
  8. A.S.P.E.N. Web site. Parenteral Nutrition Electrolyte and Mineral Product Shortage Considerations. http://www.nutritioncare.org/News/General_News/Parenteral_Nutrition_Electrolyte_and_Mineral_Product_Shortage_Considerations. Accessed March 9, 2016.

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