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Biologic Medications and the Specialty Pharma, Part 3

Life Sciences


This blog is the third in a series of articles that discusses the challenges, risks and best practices for maintaining proper product temperatures for biologic medications in the specialty pharmacy. This blog presents best practices for temperature control and monitoring in the specialty pharmacy.

A Practical Guide to Maintaining Product Efficacy

As discussed in this series, there are a myriad of different legal and accreditation guidelines for controlling and monitoring temperatures in biologics.

Based on these widely differing laws and regulations, how can pharmacists ensure that they are remaining compliant in a way that best assures patient safety throughout their chain of responsibility? What key standards should they follow to avoid compromising product and patient health?

The answer is to implement a qualified risk-based quality management process that all employees in a specialty pharmacy can follow. This will assure the quality of biologic pharmaceuticals, as well as product efficacy and the therapeutic benefit of the prescribed drugs. This kind of process presents a practical guide that:

  • Ensures the proper temperature management during the handling, storage and distribution of specialty pharmaceutical products per the manufacturer’s specific stated label temperature requirements.
  • Assists pharmacists and technicians in complying with mandated obligations, including state board of pharmacy regulations and accreditation requirements such as those administered by URAC.
  • Provides pharmacists and technicians with industry-accepted best practices like USP standards.

Here is a quick glance at what a comprehensive quality management process would include in a pharmacy:

Overall guidelines

  • Pharmacy risk assessment. To understand their level of compliance, specialty pharmacies must assess the existing risk associated with their storage and handling environments, as well as its shipping protocols, for specialty pharmaceuticals.
  • Standard procedures and protocols. Operational protocols and internal SOPs for the storage, handling and distribution of these products must be established, set in place and monitored. This includes guidelines for the operation of the refrigeration units—down to the level of best practices for opening and closing refrigeration doors—as well as for the conformity and placement thermal packaging pack-out materials.

Storage and handling guidelines

  • Equipment validation. To ensure proper temperatures, refrigeration and storage equipment must be fully operational and have scheduled periodic preventive maintenance inspections and servicing, along with appropriate documentation.
  • Electronic temperature monitoring. A key best practice is the continuous monitoring of product temperatures using electronic temperature monitoring technology with excursion alarm capabilities. Electronic monitoring devices should be used in all refrigerators, compounding rooms, freezers and product handling areas to assure the proper temperatures are aligned with the manufacturer’s stated requirements. The devices should be properly validated and calibrated, which ensures their accuracy. The devices should also continuously download and save temperature data so that it can be reviewed when excursions occur or to ensure proper maintenance of the equipment and environment.
  • Mapping studies. Thermal map studies should periodically be conducted on all areas to ensure that a consistent, uniform and compliant temperature is maintained wherever the product is located.
  • Alert policies and protocols. There should also be policies in place so temperature excursion alarms are properly addressed. There should be a record of all necessary data (date, time, equipment, location and responsible authority) so any corrective and preventative actions (CAPA) can be put in place. For instance, the CDC recommends that an alarm system be linked to a smart device so a responsible person on the pharmacy team can quickly address issues such as a power outage or a mechanical issue with a refrigeration unit.

Distribution and packaging guidelines

  • Shipping processes. For DtP or physician shipments, there needs to be an assessment of the environmental changes during shipments and the time in transit, including the actual time allowed for delivery and patient acceptance. Based on this information, the proper procedures and packaging can be put in place to protect the products throughout this entire cycle.
  • Shipping studies. To ensure proper distribution, shipping studies can be performed during both a summer and winter season to generate a hot and cold profile and include any specific geographic shipping routes and location. The results of these assessments can identify vulnerable points, such as improper packaging or storage during shipping. The studies can be compared with the current thermal packaging validation documentation from the manufacturer, and subsequent changes can be made to assure proper temperature control for each direct shipment based on the findings of the study.
  • Packing materials. Thermal packaging is required for most biologic product shipments. Pharmacy employees must be aware of the impact of other packaging materials, such as gel packs or dunnage, on the products as well. Temperature monitoring devices should be included in packages to see if temperature excursions occur during the product’s shipping cycle.

The above guidelines include requirements already in place for some state boards, and draw on URAC accreditation requirements as well as USP standards, all of which are continually evolving as the market changes.

While achieving compliance can be a complex task, the insights and guidelines offered here provide specialty pharmacists and technicians with the best approach for maintaining product quality, potency and efficacy. Ensuring that equipment and packaging are in compliance, and that temperatures are maintained in each phase through the use of electronic monitoring devices during the storage, handling and distribution are the best ways for specialty pharmacies to ensure patient safety.

To learn more on this topic, read the first blog in the series on why proper temperature control is an imperative practice for the specialty pharmacy, or the second blog which focuses on how the risks associated with temperature excursions are often underestimated, and how a lack of understanding of the full ramifications of them can lead to compromised products.