Missouri just created new rules when it comes to getting medication in the mail. Although many view it as a step in the right direction, some safety advocates say more needs to be done to protect patients and families.
The Missouri Board of Pharmacy established new guidelines that require pharmacies to have written policies on mail-order medication.
"(The Board) is trying to just put in black and white that folks that are mailing pharmaceuticals need to be responsible about that," said Bill Morrissey, a partner at Kilgore's Pharmacy in Columbia. "And take care of their patients and keep their best interests in mind."
If medication is exposed to extreme temperatures, it can become less effective, putting patients in danger.
Loretta Boesing, who's from St. Francois County, said medication transported in extreme heat put her son's life at risk.
Boesing, who lives in Park Hills, is the executive director of Unite for Safe Medications. Boesing's son, Wesley, required a liver transplant when he was 2 years old.
Boesing said her son's life depends on medication taken every 12 hours. Wesley's body started to reject the transplant after he took medication that was shipped in a bag in 102-degree heat. Boesing was forced to take her son to the hospital yet again.
"We had to go through that fear of losing him a second time," Boesing said.
At first, nurses thought Wesley needed new medication. But after doctors gave him the same medication he took at home, Boesing said he was fine. She believes the life-saving medication, shipped only in a bag, was damaged by extreme heat.
Many delivery trucks aren't temperature controlled. Federal inspectors have documented heat indexes of 126 degrees in the back of trucks, NBC News reports. Temperature isn't a blanket concern for all medication, Morrissey said. But for specialty medication, like the one Boesing's son takes, it can be. Both extreme cold and heat can can be damaging to some medications, Morrissey said.
"Chemicals, pharmaceuticals, that sort of thing will break down over time," Morrissey said. "Just like a chemical reaction, heat can sometimes speed that up."
The new rules require pharmacies to have written policies and procedures for shipping medication and notifying patients of shipments and deliveries. This includes shipping medication in "proper packaging."
The rules also now require a written policy on what to do if it's suspected medication was damaged by a "temperature excursion." The pharmacy board defines that as any deviation from the manufacturer's temperature specifications or allowed excursion ranges.
If a written policy isn't available, the board said industry standards should be used. There must also be instructions for patients to determine if medication is damaged because of temperature conditions, under the new rules.
Pharmacies must also provide contact information for the Missouri Pharmacy Board under the new rules, which went into effect Dec. 30. The board regulates Missouri pharmacies.
Kilgore's Pharmacy already had such policies in place, Morrissey said. The board already has a rule that says medication should be shipped according to Federal Drug Administration or U.S. Pharmacopeia standards, Boesing said. U.S. Pharmacopeia is a nonprofit group that helps set medication standards.
"The Board of Pharmacy's new rule, the only thing it really does, is require policies and procedures showing that they're meeting that regulation," Boesing said. "That should have already been there."
Boesing said the issue lies with large, mail-order pharmacies that operate nationwide. Many of these companies are owned by pharmacy benefit managers, or PBMs. In theory, PBMs are supposed to negotiate the best prices on medication for customers.
But a New York Times investigation finds PBMs often do the opposite, driving patients toward pricier drugs and putting local drug stores out of business. Boesing said these companies regularly flaunt FDA guidelines to safely ship medication.
Boesing said a local independent pharmacy now delivers her son's medication in a temperature-controlled vehicle. She said she appreciates the board taking action but hopes it does more in the future.
"As a mom, I want to know when I get my son's medications, or when other patients are getting their medications by mail, they've been properly stored," Boesing said.
