Welcome to the UH EMS Institute’s weekly Pharmacy Phriday continuing education column. In this week’s edition, we’ll review the storage of medications. The weather over the past month has been quite a challenge. Wind chills were quite challenging, creating “feels like” temperatures in the single digits. These temperature extremes create hazards not only for providers and patients, but also create concerns regarding equipment and supplies, including medications. Although it has warmed throughout the week, winter is still here, and colder temperatures will return.
Proper storage of medications, including IV fluids, must be a consideration during these weather extremes. Medications may have limited tolerances for temperature extremes and lose effectiveness or even become unsafe for patient use. Studies have shown that ambulance interiors frequently experience temperature extremes outside of the United States Pharmacopeia National Formulary (USP-NF) recommended ranges for storage of most medications, 59°F-86°F. These temperature extremes can occur both in these cold winter months and during the hot summer months.
Efforts must be made to avoid such temperature extremes in the back of the ambulances to avoid degradation of medications. Additional considerations should also be made when treating a patient in the outdoor environment, such as during extrication from an MVA, outdoor falls, cold water rescue scenes, or other outdoor emergencies.
Other factors, including light, humidity, and packaging, also influence the shelf life and sterility of a drug. Shelf life is the time during which the potency is expected to be greater than or equal to 90% of the drug’s initial potency at manufacture. It assumes that the drug is maintained at optimal storage conditions. Extremes of temperature, high humidity, loss of integrity of original packaging, and exposure to light can all potentially shorten this period.
Another area of consideration regarding the storage of dangerous drugs includes security issues. This concern is addressed by the Ohio Board of Pharmacy through the Ohio Administrative Code (OAC). The OAC, section 4729:5-14-03 Security and control of dangerous drugs, states that “A licensed EMS organization shall provide effective controls and procedures to deter and detect the diversion of dangerous drugs.”
EMS agencies should regularly review their established EMS agency’s restocking, storing, record-keeping, and administrative policies related to dangerous drugs and controlled substances and be sure they meet current standards and regulations. An inspection guide is available from the Ohio Board of Pharmacy as a reference and states:
“Pursuant to section 3719.13 of the Revised Code and rule 4729:5-3-03 of the Administrative Code, a location licensed by the State Board of Pharmacy as a terminal distributor of dangerous drugs is subject to an on-site inspection by the Board. An authorized Board agent may, without notice, carry out an on-site inspection or investigation of an entity licensed by the Board.”
The inspection guide is useful in preparing for such possible inspections.
And of course, personnel must be sure to strictly adhere to these rules and policies. Any evidence of discrepancies, tampering, adulteration, theft, or other misuse should be immediately reported following department policies, including notifying EMS Medical Direction.
For complete rules and regulations established by the Ohio Board of Pharmacy, information can be accessed here.
Thank you for all your contributions this past year. Here’s to a happy and safe new year!
The UH EMS-I Team
University Hospitals
Dear Colleagues,
Welcome to the UH EMS Institute weekly Pharmacy Phriday continuing education column. In this week’s edition, we do not review a specific medication but the topic of the storage of our medications. This past weekend the weather was quite a challenge. Wind chills were quite challenging, creating “feel-like” temperatures in the teens. These temperature extremes create hazards not only for providers and patients but create concerns regarding equipment and supplies, including medications. And though it has warmed up throughout the week, winter is still approaching, and colder temperatures will return.
Proper storage of medications, including IV fluids, must be a consideration during these weather extremes. Medications may have limited tolerances for temperature extremes, lose effectiveness, or even become unsafe for patient use. Studies have shown that ambulance interiors frequently experience temperature extremes outside of the United States Pharmacopeia National Formulary (USP-NF) recommended ranges for storage of most medications, 59-86 °F. These temperature extremes can occur both in these cold winter months as well as during the hot summer months we experience in this area. (In the United States, standards for medicines are set by the United States Pharmacopeial Convention Inc. (USP), a nongovernment entity that establishes standards intended to ensure the quality of medicines and other healthcare technologies. Among other things, the USP prescribes the packaging, storage, and distribution of medications.)
Efforts must be made to avoid such temperature extremes in the back of the ambulances to avoid the degradation of medications. Additional considerations should also be made when treating a patient in the outdoor environment, such as during extrication from an MVA, outdoor falls, cold water rescue scenes, or other outdoor emergencies.
Other factors, including light, humidity, and packaging, also influence a drug’s shelf life and sterility. Shelf life is the time during which the potency is expected to be greater than or equal to 90% of the drug’s initial potency at manufacture. It assumes that the drug is maintained at optimal storage conditions. Extremes of temperature, high humidity, loss of integrity of original packaging, and exposure to light can all potentially shorten this period.
The Ohio Board of Pharmacy rules and regulations also address the storage of dangerous drugs in the ambulance. Another area of consideration regarding the storage of dangerous drugs addressed by the Ohio Board of Pharmacy includes security issues. Ohio Administrative Code requires all dangerous drugs to be secured in a tamper-evident manner, with access limited to EMS personnel based on certification status. A few exceptions exist for some products, such as solutions labeled for irrigation use, saline solutions, and sterile water, just to name a few, if they are stored in a sealed (by the manufacturer), tamper-evident manner.
Personnel should strictly adhere to their established EMS agency and departmental restocking, storing, record-keeping, and administrative policies related to dangerous drugs and controlled substances. Any evidence of discrepancies, tampering, adulteration, theft or other misuses should be immediately reported following department policies, including notifying EMS Medical Direction. For complete rules and regulations established by the Ohio Board of Pharmacy, information can be accessed at their site. The link to a FAQ’s document can also be very helpful.
In closing, the University Hospitals EMS Training & Disaster Preparedness Institute would like to extend our deepest sympathies to the family of FF Johnny Tetrick, who died in the Line of Duty last Saturday, November 19, 2022, as well as to the Cleveland Division of Fire and their families.
Sincerely,
The UH EMS-I Team
University Hospitals