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Environmental Monitoring Q&A | Rosemary Kalenze, PharmD, Altru Health System

Q: What does environmental monitoring look like in your pharmacy settings?

It looks different depending upon the setting but is important and required in each. In all settings we continuously monitor the temperature of the ambient spaces, refrigerators, and freezers. We also monitor humidity of our storage and medication preparation areas.

Q: How does environmental monitoring factor into your packaging and shipping processes?
We have worked with a third-party vendor to validate our shipping models to ensure that all
medications sent to our patients stay within the acceptable temperature range for the duration of the shipment. This includes both refrigerated and room-temperature products.

Q: What considerations are made when packaging a medication shipment?
In North Dakota, we have extremely cold winters and our summers can also see extreme heat. Depending on the time of year, our packing methods may be quite different to keep our products at ideal temperatures. We worked to validate our refrigerated and room temperature medication shipments in a variety of conditions to determine a reliable standard packing method for each season.

Q: What technology do you use to support environmental monitoring in your facility?
All of our medication storage areas are under constant humidity and temperature monitoring. This data is available on a health system dashboard and alerts are pushed through to our facilities and leaders when readings are trending out of range. This allows our teams to activate an action plan to keep our medications in proper storage conditions.

Q: How are you contacted if there is a problem with environmental readings?
Our refrigeration monitors relay a text message to the leaders anytime a refrigerator or freezer is out of range. This includes the readings to allow us to make an informed, immediate decision any time of day or night. If room temperature or humidity is out of the range, our facilities team will either contact the area directly or if after hours, the leader will be called at home to initiate an action plan.

Q: What technology and materials do you use in shipping?
To initially configure our pack-out methods we include electronic data trackers in the test shipments which record and transmit temperature for the duration of the shipment. This allows us to adjust our pack out materials until we achieve the desired temperature range for a given duration. We use frozen and/or room-temperature ice packs, bubble wrap, boxed-Styrofoam coolers or padded mailing envelopes. We spot check our methods semi-annually using electronic data trackers.

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 Q: How do you determine the safe limits for temperature and humidity?
 We look to USP 659 Packaging and Storage Requirements, USP 795 for nonsterile compounding, as well as specific product   manufacturer guidance.

 Q: Who in your health system is involved with environmental monitoring?
 Our facilities team is in charge of the maintenance and monitoring of environmental controls. Leaders of all areas are   responsible for determining their parameters, creating policies to ensure compliance with regulatory bodies and for activating   emergency plans when needed. Our inpatient pharmacy IV room coordinator is responsible for validating and monitoring staff   competency, developing and maintaining policies, and collaborating with facilities on all clean room USP 797/800 activities.

Q: Why is environmental monitoring important in your work?
We need to be sure that the medications we give our patients are in perfect condition. Our patients trust that we are giving them medication that has been handled properly and is going to be effective. Tight environmental monitoring allows us the confidence to know we are meeting this expectation.

Rosemary Kalenze, PharmD, Outpatient Pharmacy Manager, Altru Health System 

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Rosemary Kalenze, PharmD is the manager of outpatient pharmacy services at Altru Health System in Grand Forks, North Dakota. This includes Specialty Pharmacy, Retail Pharmacy, Home Infusion and Ambulatory Care Pharmacy. Rosemary has been an outpatient pharmacist for 19 years in Alaska, New York, and North Dakota.

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