A proposed state rule in Oklahoma that could have major implications for million. Of Americans who receive prescription drugs through. The mail is facing fierce opposition from some powerful industry groups.
Representatives of CVS Health, the nation’s largest health care company. And a trade group of companies that manage prescription. Drug plans descended on a state pharmacy. Board meeting in Oklahoma City last week to oppose approval of the nation. First detailed rules aimed at protecting prescriptions. Medicines from extreme temperatures during shipping to patients.
Still more companies, the National Health Care Agency, state business associations. And a postal worker union have submitted written opposition. To the rule — including a pharmaceutical company that served on the committee that drafted it.
“In the four and a half, five years I’ve been with the board, we’ve never had this much public comment. The state pharmacy board’s executive director, Marty Hendrick. Told todaystrend news after the meeting.
The board unanimously approved the rule in a 4-0 vote. But the unusual lobbying presence. At its meeting suggests a tougher fight as the rule goes. To Oklahoma’s business-friendly Republican legislature and governor for final approval.
With Texas regulators at a board of pharmacy meeting Tuesday to discuss strengthening. Their rules on temperature control in shipping. Such fights could soon begin across the country.
The proposed Oklahoma rule is the first to set clear guidelines. All pharmacies shipping or delivering drugs are required. To use packaging tested to ensure that drugs do not go beyond their safe temperature range.
Which could potentially reduce their effectiveness. It would require that suppliers be able to assess the safety of a drug if delivery is delayed. And mandate that patients receive shipping and delivery notifications.
An todaystrend news investigation in 2020 found that oversight of shipping from pharmacies. To patients is largely a system of blind faith. And that some drugs may suffer potential damage from. At the time, most state pharmacy boards.
The regulators responsible for drug safety administered by pharmacies. Did not have specific rules for how pharmacies should deliver drugs to customers, rarely asked. About the process in their inspections, and many said it was simply to ensure safe shipping. to the pharmacy.
Mail-order pharmacy has become a booming business, with profits growing. Fhe number two decades ago, according to federal data.
The delivery boom and the increasing frequency of.. Have raised concerns about temperature safety. By regulators like the Oklahoma and Texas boards and requested studies by pharmacy schools.
The Oklahoma board’s Hendricks noted that many companies already consider temperature. Often using specially designed packaging to weather control for. Acertain period of time, or inexpensive devices that can track whether packages arrive. An unsafe temperature. The new rule would clarify that such safeguards must be used for all drugs shipped to or within the state.
“If everybody does it right, there’s really nothing to change anybody’s shipping pattern,” Hendricks said. “These rules are meant to be a safety and guideline only.”
But opposition to the rule has taken many forms. Many focusing on costs and whether companies that deliver drugs. To patients should face safety regulations that don’t apply to other parts of the supply chain.
Lobbyist Audrey Renegar spoke on behalf of the Pharmaceutical Care Management Association. Which represents pharmacy benefit managers (PBMs) — companies
And often operate their own mail-order pharmacies. He called the language of the rule “not based on science and evidence. But [it] appears to be based on speculation and an attempt to solve a perceived problem.”
Renegar argued that the board did not adequately consider the economic impact and asked to withdraw the rule.To the entire pharmaceutical supply chain, which falls under multiple regulators.
Greg Lopes, a spokesman for the trade group, told Renegade todaystrend news that “the proposed rule is based on. Aflawed economic impact Oklahoma analysis. Fails to consider the multifaceted nature of the pharmaceutical supply chain. And will only increase costs for Oklahomans.”