This is my plea to the Texas Board of Pharmacy. I planned to speak for 5 minutes, so when they cut it to 3 minutes, I didn't get to say all that I needed. This is what I wish they would hear.
First, thank you to the Board of Pharmacy for taking much-needed action and addressing this critical issue that is risking lives today.
A 90-year-old veteran concerned about this issue of improper storage of medications quoted Edmond Burke as he stated, “The only thing necessary for the triumph of evil is for good men to do nothing.” The veteran's story was one of many shared with NBC on this issue.
What is happening to America's s pharmacy and medication access today shouldn't have been allowed.
In 1998, NABP Boards of Pharmacy protected what would become billion-dollar corporate profits over patients after being alerted that meds were being shipped in only a bag in trucks and mailboxes that reached up to 170 degrees.
NABP did nothing.
PBMs continued to gain power and began forcing the most critical of patients, like my son, to their own mail order pharmacies risking the lives of patients with delays and improper temperature control.
Every patient forced to mail order pharmacy as the only coverage option and has undergone days of delays, lack of temperature control, or being forced to an understaffed pharmacy deserves justice and protection.
These are the basics of pharmaceutical care. If there is something today that boards can regulate and ensure the safety of, it should be these issues.
PBMs power would've never been able to grow to the point that we are seeing today if these issues had been adequately regulated from the start.
At the last BOP meeting in Oklahoma, PCMA, the lobbyists association for Optum Rx, CVS Caremark, and Express Scripts claimed that temperature regulation based was not based on science. This is not true.
Shouldn't a million-dollar association lobbying for billion-dollar corporations such as Optum RX, CVS Caremark, and Express Scripts, which hold millions of patients' lives in their hands, know that temperature matters? Many scientific studies show what can occur when medications are shipped at 120-170 degrees without protection, that medications can break down and lose potency.
Medications may be studied at higher temperatures of up to 120 degrees for an accelerated stability study. That by no means indicates that medications should reach those temperatures. The accelerated temperature study only guarantees that the medication will be stable when stored at room temperature over the drug's shelf life. When you expose the medications to higher temperature extremes, medications break down not slowly but exponentially with every degree increase. Studies show that meds can increase known carcinogens when exposed to temperature extremes.
Expiration dates may no longer be guaranteed when meds are shipped in such temperature extremes. This is fraud. This is dangerous.
If, as a mom and advocate, I can reach out to scientists, experts, and professors and find out the truth, so can they.
The rural letter carriers association for USPS in Oklahoma also claimed the same. Please know that 2 USPS board members have held seats on the Boards of Cigna that have merged now with Express Scripts.
CVS lobbyists in OK spoke against the regulation and said they're receiving meds hot/warm to touch from wholesalers. How can they tell their pharmacists to ship meds any differently? Shame on CVS, FDA, and any wholesalers or manufacturers for failing us. Although I know the Boards don't regulate wholesalers and manufacturers, this statement should bring another sense of urgency to the issue. Medications that are already at risk of being adulterated are at risk of being further degraded as meds are at the most significant risk as they are often shipped in 2-5 days in these temperatures in only bags as meds are left in hot mailboxes and on porches in direct sunlight, and as patients have been unethically forced to bake their medications as the only option of coverage.
Sadly, most board members already know this. Most of America is still not warned and is unaware of the risks, because just like I did when I gave my son that transplant medication from the bottle that was warm to touch, they trusted that the regularity authorities such as the FDA to regulate and ensure their safety of meds in transit. They are not warned that the State Boards exist and are supposed to regulate the issue. Many are so alarmed when they find out the truth.
What would happen to me if I put my son's life-saving medications in unsafe temperatures knowing his life would be at risk? It should be no different for a CEO or the lobbyists here today when the corporations that they work for force to their own mail order pharmacies as the only option of coverage.
Recently, a mother from KY noticed her daughter's med sitting in only a bag on her porch. Using a temperature sensor, she showed the meds at 95 degrees.
To her surprise, that porch was cooler than the back of the trucks.
She called the mail order pharmacy. The pharmacists tried to assure her it was safe to give her child.
Thankfully, we have pharmacists, some of whom even work for mail order pharmacies, that support us. They, too, want their policies and procedures to change, so they help us outreach for additional stability studies that may be performed on the drug. The stability study showed her daughter’s brand-name drug was only tested and proved stable up to 104 degrees. On a 90-degree day, the trucks and mailboxes reach well over 120 degrees.
She asked the rep what temperature the medication was exposed to in the truck. The mail order pharmacists couldn't answer because no one is tracking it. Yet, this pharmacy still denied this mother an icepack because it wasn't supposed to be "cool/refrigerated." As if exposing medications to temperatures of 120-170 degrees, two times room temperature is just okay. The pharmacist transferred her to another department as he couldn't do anything to allow this mother the right to protect her child's med from the extreme heat.
Dear Boards of Pharmacy members here today, patients need you.
Today, doctors and patients don't know that when conditions worsen, it could be from improper storage of medications. Sometimes, the only way to know is to play this unethical game and if our child or patients face serious health issues.
One patient stated she couldn't file a complaint to the Texas Board of Pharmacy because she didn't show evidence of harm. For patients, a lower potency medication may not impact them that day. The consequences for patients like my son can lead them to a slow decline. Each episode of liver transplant rejection for my son means his body has a higher chance of eventually fighting off his transplanted organ. My son's labs indicate may be in rejection today. Although he's home and the transplant team overseeing his care, I didn't want to leave him, but the FDA and most State Boards give us no option but for the most chronic of patients to take the lead.
The proposed regulation today is a start in the right direction. I hope the Board doesn't stop here. This is not the final destination for ensuring the safe storage of meds during transit.
The rule should further define which USP guideline the regulation is referring to. What are manufacturers’ guidelines? Most drug manufacturers, especially generic ones, wouldn't say it's safe to ship medications in temperatures of 120-170 degrees. Even if there were extended stability studies, most manufacturers wouldn't say it's safe to store meds in high temperatures.
How will the mail order pharmacy and patient know if that guideline or regulation are met? If they don't know, and patients don't know, the regulation will only look good on paper, just like the storage range currently on the bottle that says “excursions permitted up to 86 degrees.”
Regarding the terms to allow temperature sensors and packaging "as necessary," Without defining necessary can give mail order pharmacies a loophole. PBMs pharmacies will do nothing because they've proven that the only thing they feel necessary is their profits.
Due to this issue being overlooked for so long, we know it will take time to get to where we need to be, so please move forward today and start thinking about realistic goals. Start envisioning medications appropriately stored throughout the supply chain. Think about it for a moment. We can and will get there. I feel it deeply in my heart. Today, it starts with you.
Thank you,
Loretta Boesing
Patient Advocate
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