Patients should always have safe options to access their medications without taking unnecessary risks.

Temperatures are just one of the over one-hundred risks with mail-order pharmacy, but the neglect of ensuring proper temperature storage exposes most corporate mail-order pharmacies for their lack of patient care.

In a recent news report, a Veterans Administration spokesperson gave a misleading statement that temperatures on a package of eye drops did not matter until after the package was opened. This would be similar to stating that that the storage of your milk doesn’t matter until after it’s opened. It’s such an obvious false or misleading statement. I’m concerned that this statement could cost some patients their lives upon taking medications that have been exposed to freezing or high heat.

The veteran's medication was Restasis eye drops. He noticed that they seemed to no longer be as effective after being shipped in only a bag and left sitting in the hot, southern Texas, sun.

Sadly, the news reporter didn't do a further investigation as I did.

After contacting the manufacturer of Restasis, the temperatures on the label DO apply during shipping, prior to the medication being opened. Feel free to check for yourself. The phone number for Restasis is 800-433-8871 Per the representative at Restasis, the medication shouldn't freeze as this could change the molecules. Yet, this medication is shipped in only a bag year-round. Per the representative at Restasis, the highest that this medication has been tested is up to 104 degrees. Although, the manufacturer doesn't suggest ever storing the medications outside of the temperature ranges on the label of 59- 86 degrees. Many have stated that the medications can degrade in ways beyond just potency. When shipped at such temperature extremes some medications can become toxic and others fatal. In southern Texas, the temperatures of mailboxes and trucks can reach well over 120 degrees.

The Veteran in the video put his life on the line for all Americans, and this is the poor quality of pharmaceutical care that he receives in return. Unacceptable. This is unacceptable for any patient.

The good news is that I believe that one-day justice will be served and there are clarifications being made to the somewhat blurry recommendations that the State Boards of Pharmacy use to scapegoat adequate regulations to protect the patients being forced to mail-order pharmacy. 

I am referring to the recommendations set by the United States Pharmacopeia (USP). USP, not at all related to USP the brown trucks, creates recommendations that the State Boards of Pharmacy and the FDA often adhere to in their rules and regulations.

If the State Boards of Pharmacy enforced USP’s recommendations, many lives would be saved instead of being a risk. Sadly, the corruption within our State Boards of Pharmacy feels massive as they turn their backs to the patients whose lives they hold in their hands and ignore the fact that most medications are being shipped in only bags year-round without any protection from the freezing or trucks and mail-boxes that reach up to 170 degrees.

Here is how you can help today. USP is accepting comments to clarify recommendations to General Chapter 659. This chapter discusses temperature storage and the mean kinetic temperature of medications during storage which also applies to shipping. State Boards such as the Florida State Board of Pharmacy has used USP’s mean kinetic temperature as a way to uphold unsafe standards. Further clarification of mean kinetic temperature during storage and shipping is fully warranted.

This summer, temperature data loggers were shipped across our nation. During the hot summer heat, none of the data loggers returned had a mean kinetic temperature within the acceptable range of USP during transport.  Also, there are unlimited temperature excursions or times when medications are exceeding the proven safe temperature ranges during transport from the wholesaler to the patient. As medications are left on doorsteps and in the direct sun or freezing temperatures, it is crucial that regulations and guidance ensure proper medication handling and that patients are warned when their medications are unsafe to use.

Standard shipping methods aren’t providing safe protection and the mail-order pharmacies have been caught multiple times brushing off the concerns and complaints regarding the temperatures of medications. Instead, as they did with me for my son who is now in liver transplant rejection, they will often tell the patient that it is safe to take the medications. Although, no one is tracking the temperatures of the inside of the vehicle and mail-boxes. If mail-order pharmacies are tracking temperature, they are obviously and mostly using a system similar to the National Weather Service or outside air temperatures. That’s the equivalent to equating the temperature of the oven by using the temperature of the kitchen.

Here is a link with instructions on how to comment on USPs recommended changes. Will you please help me by submitting a comment to USP's recommended changes of General Chapter 659? I feel that the changes will help provide patients with protection, but more must be done to ensure proper temperature storage to patients.

As we fight for safe access and improved pharmaceutical care, we will continue to fight to stop the forcing of mail-order pharmacy. Please contact me if you have any questions or concerns.

Other ways to help: 

• Share the petition and educate others of the many risks
• Join independent pharmacists and state pharmacy associations who are fighting against issues with pharmacy benefit managers (PBMs) in your state.
• If you want to share your mail-order pharmacy issues or concerns, please do. My email is Loretta@uniteforsafemeds.com
• You may also help by making a donation to our nonprofit, Unite for Safe Medications.