Temperature-Sensitive Medications

Pharmacists can improve patient adherence by providing education on the importance of keeping medications within proper temperature range.

I have type 1 diabetes mellitus—and have had it since 1986. I consider myself fortunate as I have been able to maintain good glycemic control over the years. Now, 27 years after my diagnosis, I am still without complications, but it has not been easy. The lows, the highs, the counting carbs, timing of 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.

Throughout the years, I have attempted to heed my endocrinologist’s warnings about the importance of keeping my insulin below 86° F. I always carried my insulin in an insulated icepack and strived to replace it within 8 hours—before the ice melted. In warm weather, I could never go longer than 8 hours away from a freezer from which I could replace the ice. It was a metaphoric 8-hour chain to refrigeration. Despite my best efforts, I apparently did not always replace the ice in time. Despite my usual intake of carb units and dosage of insulin, my blood glucose levels sometimes skyrocketed.

At first, I thought it was a fluke. My insulin looked the same, was not warm when I inspected it, and was obviously still working—at least to some degree. So, I continued to use the same insulin for several days. During this time, my blood sugars were out of control. It was only after I went to the pharmacy, spent a great deal of money, and replaced the insulin (insulin, beyond the prescribed dose, is not covered by insurance) that I was able to bring things back into control. This pattern happened often until I learned how to better deal with the issue of the temperature sensitivity of my medication.

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. Insulin is only 1 of scores of temperature-sensitive medications on which people depend. Of the top 10 medications prescribed, all 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.

Many medications have recommended storage at room temperature, defined as between 68° and 77°F. These same medications also allow for temporary “excursion” periods ranging as low as 59°F and as high as 86°F. Temperatures above and beyond this range can have a significant effect on each medication. For example, diazepam loses 25% of its potency when stored over 98°F. Lorazepam loses 75% of its potency at that temperature.

The risks are great if any medication is compromised by exposure to temperatures beyond its safe range. The loss of efficacy can result in many issues compromising the health of the patient. With some medications, the stakes are even higher. If epinephrine, for example, is exposed to repetitive heating and cooling, it can lose 64% of its efficacy. If a compromised dose of epinephrine is used to treat a patient suffering from a serious anaphylactic reaction, it may not work as intended, resulting in possible death.

Fortunately, the supply chain for temperature-sensitive medications in the UnitedStates has proved to be safe. Regulation and strong quality control have ensured that temperature-sensitive medications safely reach and are safely stored by the pharmacy. Mail order pharmacies have developed algorithms to ensure that sufficient ice and insulation are included so that the medication reaches the patient intact and at the proper storage temperature. Express Scripts, for example, uses more than 20 million pounds of ice per year!

It is with the patient, because of lack of awareness and adherence, where there is the greatest opportunity for medications to lose their efficacy due to exposure to heat. And it is with the pharmaceutical professional who dispenses the medication where there is the greatest opportunity to minimize this risk. By first becoming as knowledgeable as possible on this important subject and then passing on that knowledge to the patient, the trusted pharmacist is in a unique position to provide this important service to those that he or she serves.

WHAT THE PHARMACIST SHOULD KNOW

The pharmacist should 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 usually 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 (some insulin brands are for up to 42 days), 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 aren’t aware of the temperature constraints at all.

While it is important that the pharmacist know the storage temperature for the medications prescribed, it is most important that the pharmacist pass this information on to the patient. It cannot be assumed that the physician told the patient. It cannot be assumed that the patient already knows. It cannot be assumed that the patient will look it up. There are also conflicts with advertisements purporting that some types of insulin do not need a cooler—without a clear reminder that the medication still needs to be kept at or below 86°F.

I discovered that the most practical way for me to keep my insulin cool was with an evaporative medication cooler. We are now the United States distributor of the FRIO® evaporative medication cooling case. In our business, we frequently receive calls from patients who are completely unaware of the upper temperature limit for their medications—and this is the select segment of the population that has the presence of mind to inquire about a cooler.

WHAT THE PHARMACIST SHOULD TELL PATIENTS

It is vital that the pharmacist educate each patient on the temperature specifications of their medication. It is also important that the pharmacist emphasize the importance of keeping 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 also beneficial to patients if the pharmacy can provide practical tips as to how to keep their medication cool. As it may take time to go over this during a consultation, I recommend that the pharmacy prepare a “Helpful Tips” list. The pharmacist, or pharmacy assistant, should personally hand this to the patient while verbally emphasizing the importance of the temperature issue.

The list should include the following tips:

1. Know the safe temperature storage range for each of your medications.

2. Store medications in the coolest area of the house. Do not place medications in an area of sunlight.

3. Medications that should be refrigerated should be kept between 36° and 46°F at all times.

4. For mail order medications, be sure the medication is not left in the mailbox for more than a day. It can get above 140°F in a mailbox on a hot summer day. Although the mail order pharmacy puts in enough ice and insulation to account for that day of heat, it does not account for cooling when the medication is in the mailbox for several days.

5. When driving, keep your medication in the climate-controlled interior of the car, not the trunk.

6. When parked, do not keep your medication inside a hot car; it can also get above 140°F inside a parked car.

7. When flying, never pack medications in check-in luggage. Always keep your medication in your carry-on bag.

8. If you need to carry your medication with you (traveling or just during the length of the day), use a medication cooler. There are ice pack coolers which will keep your medication cool for up to 8 hours (between activations) and evaporative coolers, which will keep your medication cool for 2 to 3 days (between activations).

9. Inspect your medications before you take them. If they have any change in form, if the coating appears different, or if the pills are stuck together, the integrity of the medication is likely compromised. If insulin is cloudy, it is compromised. It is important to note that there can still be a decrease in efficacy even if there is not a visible difference.

Issues relating to temperature-sensitive medications are serious—and they are affecting more and more people. Pharmacist awareness, coupled with proper patient education and counseling by the pharmaceutical staff, can all but eliminate the consequences of this issue and improve the quality of life for all patients served. SPT

About the Author

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