Volume 2024 | No. 2
SURVEYOR
PHARMACY
DRX7-9B
Tips for compliance:
n Shipping systems need to be validated by a third party or internal studies. The validation takes into consideration: Initial product start temperature. Payload size/weight.
Overview of the requirement:
Pharmaceuticals are maintained under appropriate sanitation, light, and temperature conditions during delivery as evidenced by the organization’s validated shipping system. Ambulatory Infusion, Infusion Nursing, Infusion Pharmacy with or without Sterile Compounding, Mail Order Pharmacy, Specialty Pharmacy with or without DME Compliance is assessed through observation, review of shipping records, response to interviews, and review of policies and procedures. Most deficiencies were cited missing policies and procedures addressing storage temperature pack-outs. Other findings identified issues with validating shipping tests for packaging used for all storage temperatures and environmental temperature extremes.
Types of insulation used and thickness of insulation. Weight of phase change material and start temperature.
Applicable services:
Various ambient temperatures experienced by the package in transit with the goal of keeping the pharmaceutical at the temperature described by the manufacturer, USP, and/or other applicable requirements. n Conduct shipping studies to include all means of transportation. n Develop written policies and procedures that include requirements for periodic testing to ensure containers stay within specified temperature ranges. n If storage temperatures are not within acceptable excursions for the duration of the shipping time, pharmacy staff must implement a corrective action plan that looks at adjusting their packing methods and documents the findings of the revalidation shipping test. n Develop a shipping test template for documenting the specific details of the shipping test and for recording the results at the conclusion of the test (e.g., pass or fail). The shipping verification template could also include an area for documenting the observation competency of the staff member conducting the shipping validation test. n Conduct shipping tests for each packaging size, storage temperature, and environmental temperature extremes experienced in different geographic areas the organization serves and during the hottest and coldest seasons n Educate personnel on the temperature validation studies that have been performed and the importance of not deviating from standardized pack-outs. n Complete training/education for all nursing staff that transport medication and periodically test the shipping methods to ensure that containers stay within specified temperature requirements when delivered by the nurse. Consider developing a packaging guide or graphic that the warehouse staff can easily reference to know precisely how to pack temperature- sensitive containers for the various pack-outs used, the pharmaceutical storage temperature requirements, and various environmental temperature ranges packages will be exposed to during shipping.
Comment on deficiencies:
Frequency of citation:
12%
Examples of surveyor findings:
n Written policies and procedures do not address the use of validated shipping systems by the organization to ensure that pharmaceuticals are maintained under appropriate conditions of sanitation, light, and temperature during deliveries. n The policies mention that the packing methods undergo testing for environmental extremes. However, the procedures lack detailed descriptions of how this testing is conducted against varied environmental extremes, especially during the hottest and coldest seasons in different geographic areas. n The policies do not specify what constitutes acceptable temperature excursions. n Delivery policy allows for delivery of refrigerated medications but does not address how to package the medications. n Documentation indicates the shipping tests were performed with a warm mark. However, details such as package size, duration of transit, the individual who packed it, and the validator of the results were missing. n The organization ships pharmaceuticals to all 50 states, but the high summer temperatures of other states were not considered in the shipping study. n Upon interview, personnel were not aware of the shipping test requirements. n There was missing evidence of testing being conducted for the three different refrigerated pack-outs used by the pharmacy to ship refrigerated items. n An unvalidated pack-out was observed as ambient gel packs were not used despite being part of the corporate shipping validation studies. n Although temperature integrity checks were conducted for four- to six-hour intervals, no evidence was provided to cover the entire 24-hour shipment duration. n Medications delivered by the nurses are not tracked or monitored for temperature control to ensure the integrity has not been compromised.
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