Room-temperature Storage of Medications Labeled for Refrigeration

Victor Cohen; Samantha P. Jellinek; Leftherios Teperikidis; Elliot Berkovits; William M. Goldman

Disclosures

Am J Health Syst Pharm. 2007;64(16):1711-1715. 

In This Article

Abstract and Introduction

Purpose: Data regarding the recommended maximum duration that refrigerated medications available in hospital pharmacies may be stored safely at room temperature were collected and compiled in a tabular format.
Methods: During May and June of 2006, the prescribing information for medications labeled for refrigeration as obtained from the supplier were reviewed for data addressing room-temperature storage. Telephone surveys of the products' manufacturers were conducted when this information was not available in the prescribing information. Medications were included in the review if they were labeled to be stored at 2-8 °C and purchased by the pharmacy department for uses indicated on the hospital formulary. Frozen antibiotics thawed in the refrigerator and extemporaneously compounded medications were excluded. Information was compiled and arranged in tabular format. The U.S. Pharmacopeia's definition of room temperature (20-25 °C [68-77 °F]) was used for this review.
Results: Of the 189 medications listed in AHFS Drug Information 2006 for storage in a refrigerator, 89 were present in the pharmacy department's refrigerator. Since six manufacturers were unable to provide information for 10 medications, only 79 medications were included in the review. This table may help to avoid unnecessary drug loss and expenditures due to improper storage temperatures.
Conclusion: Information regarding the room-temperature storage of 79 medications labeled for refrigerated storage was compiled.

The U.S. Pharmacopeia's Med-marx medication-error-reporting system has received nearly 1000 reports involving errors associated with refrigerated medications.[1] Many of these reports were a result of nursing staff not realizing that certain medications required refrigeration. Subsequent errors involved delayed administration of medications to patients and inappropriate storage of expensive medications (e.g., epoetin alfa). Recommendations based on a review of these errors suggested displaying a table on the outside of the refrigerator door listing common refrigerated items for that particular unit.[1]

Inappropriate vaccine storage has been implicated in numerous reports of vaccine-related adverse events.[2] For example, two days after receiving a pneumococcal polysaccharide vaccination that had not been refrigerated, a patient developed dizziness, racing heart, jerking of the limbs, and "pins and needles" from head to toe, resulting in a persistent and significant disability. In another case, a patient developed a cluster of 20 painful and itchy vesicles on an erythematous base on the midposterior lateral forearm after receiving varicella vaccine that was not properly refrigerated.[2]

In 1975, Wolfert and Cox[3] recognized that pharmacists were often asked about the stability of refrigerated medications that are accidentally stored at room-temperature. However, because product labeling was insufficient regarding room-temperature stability and pharmacists were not routinely able to predict stability based on the physicochemical properties of the medications, the authors surveyed manufacturers about room-temperature storage of selected medications labeled for refrigeration. This information was then compiled into a table for use as a guide to control drug storage within the authors' institution.

In 1983, Vogenberg and Souney[4] compiled a similar table describing the acceptable duration of storage of medications labeled for refrigeration when refrigerated (2-8 °C) after 24 hours of storage at room-temperature, when stored in a cool place (8-15 °C), and when stored at room-temperature (15-30 °C).

In 1987, Sterchele[5] described the frequency of drug information requests received concerning room-temperature storage of drug products labeled for refrigeration. The author reported that this information was not easily retrievable and often incomplete and compiled an updated table to supplement the previously available information on the topic. Only 22 of 36 manufacturers replied with information about 39 products, and most manufacturers did not provide data for storage in "a cool place," as it was unrecognized as a method for storage. In 1990, Dalton-Bunnow and Halvachs[6] updated the available data. In 2006, Cobos Campos et al.[7] compiled written information from drug manufacturers about the room-temperature storage of 83 medications labeled for refrigeration. This information was limited by the fact that it was collected outside of the United States and published in the Spanish medical literature.

The objective of this study was to provide an updated table of the maximum acceptable duration that medications labeled for refrigeration may be stored at room-temperature.

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