The nation's first rule to ensure shipped medications are protected from heating up or cooling down too much is facing strong opposition, including CVS Health, healthcare organizations and trade groups, NBC News reported Feb. 8.
Oklahoma's pharmacy board introduced the rule in late 2022, and in early February, the board approved it with a 4-0 vote. The vote followed a public meeting that felt a heavy presence of lobbying groups opposing the rule, according to NBC News.
Among the dissidents were CVS Health; the Pharmaceutical Care Management Association, which represents pharmacy benefit managers; Express Scripts, a mail-order pharmacy and a PBM; state business associations; and a postal workers union.
Complaints centered around the cost and whether it's fair to place the responsibility on companies when other supply chain components don't face the same regulation risk.
"In the four and a half, five years I've been with the board, we've never encountered this much in public comment," Marty Hendrick, the board's executive director, told NBC News after the Feb. 1 meeting.
When prescriptions are shipped, pharmacies are responsible for ensuring the "products are shipped according to the manufacturer's labeled storage requirements," according to the new rule.
The rule states that, for same-day prescription drug deliveries, drivers are responsible for ensuring pharmaceuticals in transit are within temperature requirements. Ice blocks and warm water containers are also allowed for "when weather extremes are anticipated."
For shipped prescriptions, "any pharmacy which ships medications to residents of Oklahoma must provide evidence to [Oklahoma pharmacy board] upon request that the shipping system meets the definition of a qualified packaging system for each category (frozen, refrigerated, room temperature) of medications shipped."
If the state passed the proposed legislation, providers would be able to assess a medication's safety if delivery is delayed, and it would mandate that patients get shipping and delivery notifications.
The rule is intended to protect medications that require specific temperature ranges. For instance, azithromycin — also called Z-paks — needs to be stored between 59 and 86 degrees, and Lipitor (atorvastatin) and Crestor (rosuvastatin) both require storage temperatures between 68 and 77 degrees, according to The Lawton Constitution.
The Texas pharmacy board is also discussing a potential rule, and during a Feb. 7 meeting, people shared concerns and praises about a tentative temperature shipping rule.