Patient education urged for temperature-sensitive medications

Dan Katzki

by Dan Katzki

I have type 1 diabetes and have had it since 1986. I consider myself fortunate because I have been able to maintain good glycemic control over the years. Now, 31 years after my diagnosis, I am still with few complications, but it has not been easy. Lows, highs, counting carbs, timing meals, variability caused by exercise are all challenges that I face every day. There is, however, no greater daily challenge than making sure that my insulin is kept cool and safe.

I was fortunate that my endocrinologists warned me about the importance of keeping my insulin below 86°F. I then needed to learn of a practical way of always keeping the insulin below that temperature.

My first solution was to carry my insulin in an insulated icepack, which proved to be a real challenge. Needing to replace the ice pack within 8 hours, I could never go longer than 8 hours away from a freezer. I had a metaphoric 8-hour-long chain to refrigeration. Despite my best efforts, I apparently did not always replace the ice in time. My blood glucose levels skyrocketed at times because my insulin lost efficacy due to being exposed to higher temperatures. This happened often until I learned how to better deal with the issue of the temperature sensitivity of my medication.

It is vital that endocrinologists and educators provide their newly diagnosed patients — who will need to live with the disease for the rest of their lives — proper education about the importance of keeping their medication within the proper temperature range and practical ways to accomplish that.

Temperature limits

I am not the only person dealing with the problem of keeping temperature-sensitive medications safe. I am one of millions of people dependent on insulin, only one of scores of temperature-sensitive medications on which people depend. In the world of diabetes alone, all of the injectables, including all insulins as well as therapies for type 2 diabetes, have upper temperature limits. With more and more people dependent on temperature-sensitive medications, and with summer temperatures seeming to be higher every year, this is a growing issue that needs immediate attention.

The risks are great if any medication is compromised by exposure to temperatures beyond its safe range. There are so many variables involved in diabetes management. The efficacy of the medication should not be one of them.

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Fortunately, the supply chain for temperature-sensitive medications in the United States has proved to be safe. Regulation and strong quality control have ensured that temperature-sensitive medications safely reach and are safely stored by pharmacies.

The greatest opportunity for medications to lose their efficacy due to exposure to heat is at the patient level. The greatest opportunity to minimize this risk is at the level of the endocrinologist or diabetes educator.

Cooling strategies

Every endocrinologist and educator needs to know the recommended safe storage temperatures for every medication dispensed. Temperature ranges for all prescription medications are readily available from various sources, including section 16 of the Full Prescribing Information document, which accompanies each prescription. This document is also available on the manufacturer’s website for that medication.

Sometimes, the specifications are a bit more complicated. Insulin, for example, has a specification that it cannot exceed 86°F. However, for storage beyond 28 days (and up to 56 days for some insulin brands), the insulin must be refrigerated. This is extremely important information, as the full spectrum of mistakes is made by patients. Some patients assume that their insulin always needs to be refrigerated. Some assume that regardless of how long it is stored, it just needs to be kept below 86°F. Some are not aware of the temperature constraints at all.

The medical professional must also be aware of practical ways for the patient to adhere to keeping the medication within the specified temperature ranges. I discovered that the most practical way for me to keep my insulin cool was by using an evaporative medication cooler. Instead of needing to re-freeze an icepack every few hours, I just needed to soak my cooler in water for a few minutes to receive days of cooling before the next activation. This was life-changing for me because it freed me from the 8-hour “chain” to refrigeration.

Tips for patients

It is important that health care providers know the storage temperature for the medications they prescribe, but it is most important that they pass this information on to the patient. It cannot be assumed that the patient already knows this information or that the pharmacist will let the patient know. It cannot be assumed that the patient will look it up. There is also confusion with advertisements purporting that some types of insulin do not need refrigeration — without a clear reminder that the medication still needs to be kept at or below 86°F.

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It is also important that the patient understands the need to keep the medication within that temperature range at all times. If insulin is kept within the proper temperature range for weeks, but within that time was exposed to an hour of 100°F, that insulin will have lost some efficacy.

It is beneficial to patients if health care providers can offer practical tips as to how to keep their medication cool. Since patient retention may diminish once they leave the office, I recommend that a “Helpful Tips” list be handed to every patient. The endocrinologist or diabetes educator should personally hand this to the patient while verbally emphasizing the importance of the temperature issue.

The list should include the following:

Know the safe temperature storage range for each of your medications.
Never store medications in an area of sunlight.
Medications that should be refrigerated should be kept between 36°F and 46°F. There may be an “excursion” period, which allows for a less-stringent temperature range (it is so important to let your patient know of this as it provides freedom that they would, otherwise, not be able to enjoy).
For mail order medications, be sure that the medication is not left in the mailbox for more than a day. Temperatures can get above 140°F in a mailbox on a hot summer day.
When driving, keep your medication in the climate-controlled interior of the car, not the trunk.
When parked, do not keep your medication inside a hot car. Temperatures can get above 140°F inside a parked car within minutes.
When flying, never pack medications in check-in luggage. Checked luggage can get lost. Always keep your medication in your carry-on bag.
When you carry or travel with your medication, use a medication cooler. There are ice pack coolers that will keep your medication cool for up to 8 hours (before needing to be refrozen) and evaporative coolers, which will keep your medication cool for 2 to 3 days (between activations).
Inspect your medications before you take them. If they have any change in form or color, the integrity of the medication is likely compromised. If insulin is cloudy, it is compromised. It is important to note that efficacy may be decreased even if there is not a visible difference.
Carry a letter from your physician and/or your prescription with you when traveling.

Issues relating to temperature-sensitive medications are serious, and they are affecting more and more people. Awareness, coupled with proper patient education and counseling, can help eliminate the consequences of this issue and improve the quality of life for all patients served.

Disclosure: Katzki is the chief operating officer of ReadyCare, the national distributor of the FRIO medication cooling case (www.FRIOCase.com).