Medical Refrigerator Monitoring USP 800 Compliance

The new United States Pharmacopeia (USP) Chapter 800 Hazardous Drugs (HD): Handling in Healthcare Settings standards was published on December 1, 2019. The new chapter generated some uncertainty concerning the most suitable refrigerator monitoring guidelines for hazardous drugs. There are more than 200 substances determined as hazardous drugs (HDs). These drugs are detrimental to human health and pose both acute and long-term consequences. Accidental exposure to these HDs might alter DNA, cause cancer and infertility, affect embryo development, or damage organs. More than 8 million healthcare staff encounter hazardous drugs in the United States yearly.

What is United States Pharmacopeia (USP)?

The USP General Chapter 800 contains the standards to ensure the safe handling of hazardous drugs. They aim to minimize the risks and exposure of these drugs to healthcare personnel, patients, and the environment. It also describes various exigencies and responsibilities of proper HD handling, engineering controls, facility management, decontaminating, deactivating, and cleaning procedures, spill control, and documentation.

These guidelines were developed in coordination with several agencies like the USP Compounding with Hazardous Drugs Expert Panel, USP Compounding Expert Committee, CDC, and FDA.

Who is Affected by USP 800?

The new regulations will cover healthcare staff and other entities who come in contact with HDs. These entities can include hospitals, pharmacies, and health systems. Pharmacists, veterinary staff, physicians, surgeons, home health aides, among others, are also considered at risk for HD exposure.

Why is this Happening?

These guidelines aim to protect healthcare personnel and patients who come in contact with hazardous drugs. People need to be aware of the risks involved with unregulated HD practices. Mishandling can lead to life-threatening events and heavy legal repercussions. Non-compliance can lead to suspensions, fines, and loss of licenses.

Mishandling of HDs can occur during storing, shipment, dispensing, or even administering. Due to the heavy dangers that surround HDs, USP 800 aims to cover any regulatory oversight that was encountered previously. HD must all be stored in a temperature-controlled facility or medical refrigerators. The chapter includes the guidelines regarding medical refrigerator monitoring.

Any workers that come into contact with HDs must receive HD training and take the necessary assessment for their comprehension of their training.

USP 800 Impact on Refrigeration

If a drug shows one or more characteristics in humans or animals like teratogenicity or developmental toxicity, carcinogenicity, genotoxicity, reproductive toxicity, organ toxicity at low doses, or toxicity and structure profiles of newly released drugs that are similar to existing hazardous drugs, as per the National Institute for Occupational Safety and Health (NIOSH), they are classified as hazardous.

Facilities are required to comply with USP 800, and may HDs require refrigeration. There is no universal standard USP 800 compliant refrigerator brand. Regardless, guidelines for refrigerator monitoring should be considered when choosing a refrigerator for hazardous drug storage.

Refrigerator Storage

Don’t store non-hazardous and hazardous drugs in the same location to avoid contamination. USP 800 also indicates that refrigerated anti-neoplastic HDs must be stored in a refrigerator with a negative pressure area. USP 800 does not have any specific recommendations for a refrigeration system. Compressors refrigerators are not a condition for HD storage.

Refrigerator Vents and Air Circulation

A refrigerator positioned in a negative pressure buffer room should be placed with an exhaust adjacent to the compressor and behind the refrigerator unit itself. It is also recommended to place low-wall returns near the refrigerator. This will aid in sweeping out any particles brought by the refrigerator and the supplies stored inside when they are removed.

Pass-Through Refrigerators

It is not advisable to use a refrigerator pass-through. Other methods of containment, like sealed containers, can be used by the entity for proper HD containment and suitable environmental control.

Inside a negative pressure room, pass-through refrigerators cannot be used. However, for positive pressure USP 797 clean rooms that conduct non-hazardous compounding, pass-through refrigerators may be appropriate.

Mistakes to Avoid When Complying with USP 800

1. No Space Allocation for Non-Sterile Hazardous Drug (HD) Compounding

Nurses often perform manipulation or pill crushing of non-sterile HDs on the patient floor. Previously, the staff was not required to perform these in a negative pressure environment. However, USP 800 indicates that it is necessary for these functions to be performed within a powder under and in a negative pressure segregated compounding area. Since this is a new issuance, hospitals have not yet incorporated how it affects their day-to-day workflow. Aside from needing additional space to conduct this procedure, a hospital-wide adjustment is also needed.

2. Presuming that All Hazardous Drugs Can be Placed Inside the HD Buffer Room

Many layouts do away with placing a separate HD storage room and opting to place the hazardous drugs in the negative buffer room. USP authorizes this for drugs that are for sterile compounding only. This does not take into account the non-sterile hazardous drugs that require to be stored in a different negative pressure storage room. Unfortunately, transferring non-sterile hazardous drugs through sterile spaces increase the possibility of cross-contamination. All drugs stored outside the HD room should be given due consideration. The removal of all refrigerators and storage shelving will provide a cleanable space and reduce the risk of room contamination.

A long-term and exhaustive design necessitates a comprehensive understanding of which non-sterile hazardous drugs are used in a facility and the specific area where manipulation will be performed. HD storage rooms and non-sterile HD compounding can be placed within the same space in order to create a more efficient floor layout. The hospital can also conduct a National Institute for Occupational Safety and Health risk assessment for drugs that are not practical to be stored in negative pressure segregated compounding areas.

3. No Means for Maintaining Space Pressure Over the Life of the Rooms

USP 800 has determined a high and low limit on the HD buffer room pressures. The need to maintain a consistent pressure setting in these areas makes adjusting the airflow over the life of the rooms makes it more critical. In order to make things easier, dedicated terminal units for the return and supply or exhaust of each space should be used. This allows the airflow through the building control system to be adjusting without having the need to access the pharmacy ceiling space. Supply or exhaust fans that have a HEPA filter should also possess the ability for the fan’s speed to be adjusted while the filters are loading.

4. Lay-in Ceiling Installations Within a Compounding Room.

The USP standards provide for proper sealing requirements. Tiles should be sealed to the grid, and the grid should be adequately sealed to the wall. This provides for a sealed, clean environment, but it also reduces most of the accessibility benefits of a lay-in system. For facilities that have a gypsum board ceiling, access panels must be caulked and gasketed to preserve cleanability and space pressure.

5. Not Expanding the Wall Surrounding the Compounding Area

There has been a reduced range of allowable room pressures. Therefore it is important to have a properly sealed room. This reduces the airflow differential amount. Potential contamination sources are also decreased through the correct space sealing. Sealing fewer penetrations in a vertical wall is easier than sealing every speaker, sprinkler head, or ceiling fixture.

6. Presuming that the HD Receiving Area Can be Shared with the HD Storage Room.

Possible infection concerns can occur by sharing the HD storage room to receive hazardous drugs. Many shipments do not specifically designate hazardous drugs on shipping containers. Due to this, the containers must be opened in a separate receiving room. Infection control departments would not recommend opening shipping containers in the same area of unpacked drug storage.

Refrigerator Monitoring as per USP 800 Standard

During medical refrigerator monitoring, the industry standard is to place a sensor like Wireless Temperature Sensor with Glycol Buffer inside. The actual temperature of the liquid inside the vials is what should be monitored. It’s important to maintain pharmaceutical products within their required temperature, especially vaccines which have to be kept within 2 to 8 °C. These products are sensitive to freezing temperatures and cannot withstand long exposure above require temperature.

To avoid false alarms for drugs and vaccines that may still be viable, the sensor is placed in a jar of glycol. The liquid glycol simulates the rate of temperature change seen in the products. This happens during situations like when refrigerators’ compressor goes on and off, or when the door is opened and warm air is sucked inside. A standard sensor will send alerts if it detected a temperature excursion above 8 °C. However, AKCP Wireless temperature Sensor with Glycol Buffer will only send an alert if the liquid thermal mass temperature fluctuates during those situations.

Comply with USP 800 Standards with AKCPro Pharma-Mon Server. Place wireless temperature sensor in the refrigerator. This medical refrigerator monitoring system also detects the factors of temperature fluctuations, it sends alerts when left open or accessed. All data gathered by the sensor is sent to Pharma-Mon Server for graphing and report generation. The AKCPro Pharma-Mon Server also monitors the inventory inside the refrigerator, the product’s expiration dates, and batch numbers. You can also trace back a vaccine history from the refrigerator, transport, to the warehouse.

Conclusion

For the safety of staff and patients and for regulatory compliance, these standards are essential. Therefore, it is important to coordinate with partners who are aware of the relationship between the pharmacy’s layout and proper compounding procedures. This will avoid the repercussions that could occur for non-compliance to USP 800. By having a thorough understanding of how space operates, it will be easier to design a pharmacy that complies with the standards and cater to the hospital’s specific needs.

Reference Links:

https://blog.helmerinc.com/complying-with-usp-800-refrigerators

https://www.thermofisher.com/blog/life-in-the-lab/usp-pro-tip-think-refrigeration-before-renovation/

https://www.follettice.com/about/news-and-announcements/understanding-refrigeration-according-usp

https://www.helmerinc.com/usp-800

https://www.hendersonengineers.com/insight_article/usp-797-800-8-common-mistakes-to-avoid-when-complying/