Volume 2025 | No. 2
SURVEYOR
PCAB (COMPOUNDING PHARMACY)
Compliance tips for:
TCRX6-D Frequency of the citation: 37%
■ A validated shipping system ensures the integrity of pharmaceuticals and compounded preparations is maintained during transit. These pharmaceuticals are often delivered by a third-party shipping service, but the standard also applies to nurses who transport medications to patients in the home. Distance, climate, geography, time of year, and the size/quality of the container are just some of the factors that may compromise or reduce the efficacy of a drug. ■ Organizations must define testing methods, test regularly, and document the results. Shipping validation is conducted internally or by a third party and addresses: ٝ Sanitation, light, and temperatures (room temperature, refrigerated, frozen) experienced during transit.
Nerd Newbies (understand the requirement)
Overview of the requirement: The organization’s shipping system must be validated to ensure pharmaceuticals and compounded preparations are maintained under appropriate conditions of sanitation, light, and temperature. Third- party or internal studies are conducted with consideration of environmental extremes encountered during transportation. Comment on deficiencies: Surveyors evaluate compliance through observation and staff interviews. Most deficiencies result from inadequate testing methods and a lack of training. Examples of ACHC Surveyor findings: ■ The organization does not have a validated shipping system to ensure pharmaceuticals are maintained under appropriate conditions. ■ Shipping testing methods are not conducted according to the storage conditions outlined in USP <659>: ٝ A reliable data tracker is not used to monitor temperature throughout the shipment. ٝ There is no documentation capturing the details of what was shipped, how it was packed, and the length of time of the shipment ■ Shipping studies were not performed during the hottest and coldest months. ■ Products labeled for frozen storage conditions are being shipped with testing applicable to refrigeration. ■ Upon interview, shipping personnel were not aware of: ٝ How shipping pack-outs were tested to ensure the medication arrives at the patient at the correct temperature. ٝ The number of ice packs and their placement in the package for each package configuration. ■ Pharmacy did not complete shipping validation testing for all types of packaging. They use boxes of different sizes and various sizes of kangaroo pouches.
ٝ Delivery containers, phase change material, insulation. ٝ Patient education on home storage requirements. ٝ Payload size/weight.
■ Ensure that shipping and courier containers are tested for each of the varying packing sizes. ■ Gather the appropriate data needed to conduct the mean kinetic temperature (MKT) when an excursion occurs to aid in determining the viability of the medication. ■ Develop and enforce a schedule for your pharmacy to conduct testing under extreme temperatures. Pay close attention to seasonal changes for all destinations and routes. ■ Audit shipping practices to confirm there have been no changes in cold chain products. If so, revalidate to ensure shipping temperatures are maintained. ■ Create a pack-out/shipping diagram to help personnel replicate the shipping and packing experience. ■ Evaluate the effectiveness of current training for shipping personnel. Update and educate as needed. ■ Conduct mock survey interviews with pharmacy staff responsible for packaging. Ask how pack-outs are done for different temperatures, how they determine when seasonal pack-outs need to change, and how shipping methods are tested. ■ Assess the competency of packaging personnel when conducting ship validation testing.
Nerd Apprentices (audit for excellence)
Nerd Trailblazers (prepare the path for others)
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