Can my medication be damaged by heat during shipping?

We recently received this question from a concerned patient:

Hello. It's been a hot summer. I've recently started taking a very expensive medication that keeps me alive. There is no generic equivalent currently available in the U.S. I am, therefore, considering ordering this medication from a Canadian pharmacy. My concern is that the 2-3 weeks it would take for the medication to arrive means that it could spend long hours in a sweltering, hot mail truck, losing potency and effectiveness with every hour spent out-of-range (20ºC to 25ºC). If I order this medication from a Canadian pharmacy, what can be done to ensure that it spends as little time as possible in out-of-range temperatures? This issue does not appear to be addressed on the pharmacychecker.com website. Thank you." 

Our Answer:

A completely valid concern. 

Although PharmacyChecker does have standards and policy requirements for shipping refrigerated medications, we do not currently have strict international shipment policies on room temperature medications. PharmacyChecker Inspection Standard 7.2 dictates that “Dispensed medications must be suitably packaged for mailing to prevent deterioration or crushing. Bubble wrap or filler must be used to prevent movement inside cardboard cartons.”

Even in regard to domestic shipments within the United States, there are no federal laws or regulations for temperature requirements for non-refrigerated medications from pharmacies to patients. 

This is a real problem addressed in depth recently by The People’s Pharmacy: Prescription Heat Damage: Is Your Medicine Cooking in a Delivery Truck? 

A 2023 study in The Journal of the American Pharmacists Association sheds a lot of light on this issue and the challenges we face in shipping medications even domestically. See: Evaluation of temperature excursions from USP <659> recommendations during mail transit - Journal of the American Pharmacists Association (japha.org)

Highlights from this journal article include that in the United States:

• Almost 40% of pharmacy sales were through mail-order in 2017.
• Domestically-shipped packages tested during this 2023 study spent an average of 68.3% of their time out of temperature range.
• Package temperatures were outside of range regardless of shipping method, carrier, or season.
• If medications are exposed to temperature excursions outside of the standards set by the United States Pharmacopeia (USP), there is the possibility of medication instability.

Please note that the USP traditionally defines controlled room temperature as 20°C to 25°C (68°F to 77°F), with a wider range of 15°C to 30°C (59°F to 86°F) for mild excursions. However, the appropriate temperature range may vary, depending on the specific medication. Some medications may permit a wider temperature range, while others may have more restrictive storage requirements. 

For that reason, patients should check the storage, stability, or shelf-life sections of a specific medication’s package labeling or prescribing information rather than assume that every room-temperature medication must remain between 20°C and 25°C at all times. Some packaging labels may also include information about shipping conditions. A medication’s expiration date is based on stability studies within certain conditions. 

Interestingly, the USP included additional conditions for the definition of controlled room temperature in its proposed revised guidance, stating that temporary temperature spikes of up to 40°C (104°F) may be permissible as long as the duration is not more than 24 hours

So, what are patients who order meds through the mail supposed to do?

If you are concerned about the shipping conditions of your prescribed medications or your medication’s integrity, in general, speak with your doctor or pharmacist. They can guide you on how to closely monitor for any symptoms or changes in the effectiveness of your therapy.

Once your medication arrives, look for signs that the medication is compromised. The medicine may appear discolored or stick together. If medications are exposed to high temperatures, you may also see other changes in the medicine as it breaks down. You may notice changes in texture and an unpleasant taste. 

Work closely with your chosen pharmacy to confirm and coordinate delivery methods and timeframes. Voice your concerns. For example, you may choose to utilize expedited shipping, see if the pharmacy would be amenable to including extra barriers between your medicine and the package or attach a temperature monitor to your medicine, etc. 

PharmacyChecker’s takeaway

PharmacyChecker frequently revises and considers emerging research regarding the safety of mailing prescription medicines. More research must be done to determine the effects of solid dosage forms that have experienced out-of-range temperatures during transport.

Please always discuss your concerns with your pharmacy and prescribers to determine the next best steps for you. Keep your healthcare team in the loop to help you safely take your medications.