Oct 8, 2019

The Importance of Safety and Cold-Chain Management in Preparing Drug Treatments

Drug therapies for vision loss are providing true hope for those living with vision loss; however, recent concerns about the use of off-label injections to treat blinding eye diseases in BC have underlined the importance of ensuring that ophthalmic treatments need to be safe, effective, and properly handled at all stages of drug preparation.

Drug preparation is a complex process, and people who rely on ophthalmic medications need to have confidence that the preparation they’re receiving has been properly managed throughout the entire process: from compounding the drug, to transporting it, to storing and handling it at a physician’s office. That’s why it’s so important for laboratories that prepare the drugs to meet the highest possible standards of safety. In this interview, we sat down with Andrea Bau, Chief of Staff at Specialty Pharma Solutions, to discuss the importance of safety and cold-chain management in preparing and handling drug treatments.

Why is safety such an important part of the drug preparation process?

Andrea Bau: Ophthalmic treatments that need to be injected into the eye, such as anti-VEGF treatments, must be completely “aseptic” – that is, free from bacteria and microorganisms – so that it’s safe for the person receiving the treatment. Preparing these treatments requires a high degree of skill from compounding technicians, state-of-the-art laboratories, and sophisticated equipment, which all make the preparation of sterile compounds an expensive and complicated venture. As a result, there are very few pharmacy laboratories that are capable of compounding aseptic preparations.

How do you ensure that laboratories are sterile?

AB: The United States Pharmacopeia (USP) and Canada’s National Association of Pharmacy Regulatory Authorities (NAPRA) have developed strict guidelines that laboratories must adhere to in order to produce sterile medication. A facility that prepares aseptic compounds must follow rigorous quality control and quality assurance procedures to ensure safety and efficacy. Not only does the compounding process and laboratory have to meet high standards of quality assurance, but the transportation and delivery methods of produced medications must meet high standards as well.

What is “cold chain management”?

AB: Some medications need to be maintained at specific refrigeration temperatures in order to be effective, and this temperature has to be maintained from the time the medication is prepared through transportation, storage, and delivery. Cold chain management is when we monitor the medication to ensure it remains at a stable temperature. Once a cold-chain medication arrives at its destination, it needs to be monitored right up until it’s delivered into the patient’s eye – we provide specially outfitted refrigerators with alarm systems that alert staff if the temperature of the medication drops out of the approved range.

What are some of the challenges in maintaining an aseptic or controlled environment for medications?

AB: We work closely with clinics to ensure that drugs are kept in the proper conditions through preparation to delivery. This involves having contingency plans in place for unexpected emergencies, like power outages, and ensuring that drug preparation facilities and technicians meet the highest possible safety and quality standards.

What else should people who rely on aseptic drugs know about the supply and cold chain management process?

AB: Safety and quality are of the utmost importance in preparing aseptic medications, which is why patients and physicians should know that their ophthalmic preparations are coming from an accredited facility that meets strict safety standards. People should have confidence in the preparation they’re receiving, and confidence comes from knowing that preparations have been properly handled from beginning to end.

This interview has been edited for length and clarity.