A proposed state regulation in Oklahoma could have a big impact on millions of Americans who get their prescription drugs by mail, and is facing fierce opposition from some powerful industry groups. increase.
Representatives of CVS Health, the nation’s largest health care company, and the group of companies that run prescription drug programs attended a meeting of the state pharmacy board in Oklahoma City last week to discuss a policy aimed at protecting prescriptions. Opposed to approval of detailed rules for the first time in the United States. Dosing from extreme temperatures during transport to the patient.
Additionally, a number of businesses, national health agencies, state trade associations, and the Postal Workers’ Union have filed letters opposing the rule. Among them was one of his pharmacy companies, which was a member of the committee that drafted this rule.
Marty Hendrick, executive director of the State Pharmacy Commission, told NBC News after the meeting:
The board unanimously approved the rule by a 4-0 vote, but the unusual lobbying presence at the conference meant the rule was heading to Oklahoma’s business-friendly Republican Congress and governor for final approval. It suggests that the more difficult battles will come as time goes on.
Texas regulators are discussing tougher regulations for temperature control in shipments. pharmacy board On Tuesday, such battles could soon be played out across the country.
The proposed Oklahoma rule is the first to set clear guidelines for temperature safety during drug shipments from pharmacies to patients. All pharmacies that ship or deliver drugs must use packaging that has been tested to ensure that drugs do not exceed safe temperature ranges. This can make the drug less effective. It will also require that healthcare providers be able to assess the safety of medicines in the event of delivery delays, and that patients receive delivery and notification of delivery.
This is a 2020 NBC News study that found that oversight of pharmacy-to-patient delivery is largely a system of blind trust, with some medicines being exposed to potential exposure to heat waves and subzero temperatures during delivery. after it was discovered that it could be exposed to serious damage. At the time, most state pharmacy commissions (regulatory bodies responsible for the safety of medicines handled by pharmacies) did not have specific rules about how pharmacies should ship their customers’ medicines. up to the pharmacy to ensure safe delivery.
Mail-order pharmacies are a booming business, with profits skyrocketing in recent years for some of America’s largest companies, with over 26 million people receiving their medications in the mail in 2017. That’s more than double what he was 20 years ago, according to federal data.
A delivery boom and an increase in the frequency of temperature extremes, like last week’s nationwide cold front, have raised concerns about temperature safety by regulators such as commissions in Oklahoma and Texas. inspired research by the Faculty of Pharmacy.
Oklahoma commissioner Hendricks said many companies already take temperature into account when delivering medicines, especially refrigerated medicines, to patients, and many have specially designed air conditioning systems to control the weather for a period of time. I pointed out that they use cheap devices that allow you to track packages and whether or not they have arrived. unsafe temperature. The new rule clarifies that such safety methods must be used for all drugs shipped within or within the state.
“If everyone was doing it right, nothing would change shipping patterns,” says Hendricks. “These rules are enforced as a matter of safety and guidance.”
Opposition to the rule, however, has taken many forms, many focused on cost and whether it is fair for companies shipping medicines to patients to face safety regulations that do not apply to the rest of the supply chain. I was guessing
Lobbyist Audrey Renegher represents pharmacy benefit managers (PBMs), who manage prescription drug plans for more than 275 million Americans and often operate their own mail-order pharmacies. Lectured on behalf of the Pharmaceutical Care Management Association.She describes the rule’s language as “not based on science or evidence, but rather [it] It seems to be based on speculation and attempts to solve perceived problems. ”
Renegar argued that the board did not fully consider the economic implications and sought to withdraw the rule, saying it would be ineffective unless applied across the drug supply chain, which is subject to multiple regulatory authorities.
Greg Lopes, a spokesperson for the industry group, told NBC News, “The proposed rule is based on a flawed economic impact analysis, fails to take into account the multi-faceted nature of the pharmaceutical supply chain, and It just adds to the cost,” he repeatedly told NBC News. Oklahoma. ”
Several Board and Task Force Committee members who spoke out expressed their dissatisfaction with the PBM’s opposition. Jay Kinnard, a Temperature Task Force pharmacist who works for the Health System at the University of Oklahoma, noted the effort the board put into getting large pharmacies and pharmacy interest managers to help draft the rule. .
“There was a PBM representative there who went along all the steps and said, ‘Yeah, I agree with this.’ was all wrong,” he said.
That company was Express Scripts, a pharmacy benefits manager and a large mail-order pharmacy. Richard Palombo, Senior Director of Regulatory Affairs, was the only representative of his PBM to write the rules on the task force.
Palombo was negotiating the wording of the proposed rule with representatives from Walgreens (another major pharmacy company, but not the pharmacy’s benefits manager), according to two people present at the task force meeting. Express Scripts did not attend the board meeting last week, but provided the longest written public comment.
In its comments, the company proposed several amendments to the proposed rule, arguing that the temperature standards cited in the rule were for storage rather than shipping. It asked the board instead to require it to comply with existing certification standards it already has in place, telling the board that if the standards are “vague or impose an Please note that you may be subject to legal challenges if you A pharmacy that delivers across state lines.
Express Scripts, a member of the trade association PCMA, did not respond to a request for comment.
Walgreens, another major healthcare company on the task force, did not provide public comment on the rule.
PCMA member CVS Health argued in writing that the commission’s rules “seek to resolve perceived problems that are not based on scientific evidence or data.”
The company has touted decades of secure delivery and a proprietary packaging system for over 400 medicines, but following the rule would result in additional costs for labor, freight, supplies and redistribution of prescriptions. , estimated to cost an estimated $550,000 to $750,000 a month.
Like PCMA’s Renegar, CVS Health’s executive director of pharmacy regulatory affairs, Lauren Paul, told the board that if temperature safety standards in pharmacy shipments change, so must the rest of the supply chain. I said yes and gave an example. A pharmacy that receives warm medicines from wholesalers.
“If you require a pharmacy to ship this way, you [the pharmacy] Receive their medicines, they feel warm, and the pharmacist can refuse them.
Director Hendricks objected. “So it hinders access to drugs that may not work. [requirement] — Isn’t that fine? ”
Another board member stepped in to point out that temperature control in manufacturer and wholesaler shipments is subject to federal regulation and is outside the control of the board.
The Oklahoma Legislature will hold a vote on the rule in the coming months.
