Ohio regulator’s proposed pharmacy rules draw mixed response

New regs meant to promote safety at understaffed stores

By: - October 2, 2023 4:55 am
A CVS store. Photo by Lynne Terry, Oregon Capital Chronicle, States Newsroom.

A CVS store. Photo by Lynne Terry, Oregon Capital Chronicle, States Newsroom.

After first saying the Ohio Board of Pharmacy didn’t have the authority to impose sweeping new regulations, pharmacy giant CVS now says it’s OK with much of what the agency wants to do.

Meanwhile, the group that represents small chains and independent pharmacists supports the effort, but fears that the proposed rules would place more of a burden on them when they weren’t part of the problem that led to the draft regulations in the first place. 

The board on Oct. 10 will consider comments on the rules, which it proposed after it found a number of violations that threatened patient safety at CVS pharmacies across Ohio. Board of Pharmacy inspectors found that the stores were so badly understaffed that they were the scenes of mass quitting, making the problem even worse.

Inspectors also found that the remaining workers were so harried that they didn’t have time to keep proper track of dangerous drugs — including opioids — or to remove expired or adulterated drugs from the shelves. In addition, they found several instances in which CVS medication labels gave patients the wrong instructions and one instance in which a patient was harmed by being given the wrong drug.

Perhaps even worse, the CVS stores the inspectors cited had backlogs that were so bad that prescriptions often weren’t filled for a week after being submitted. In one case, filling the script took a full month.

Current and former CVS employees told the Capital Journal that as they struggled to fill scripts, they were bombarded with demands from upper management to push ancillary services such as vaccines and to sell medical devices such as CPAP machines. The employees said that even when adequate staffing was available, CVS district managers ordered them to squeeze down employee hours.

CVS didn’t respond when asked about the employees’ contention that regional and district managers receive bonuses that are partly based on controlling costs — including payroll.

The pharmacy board cited the dozen or so CVS stores with hundreds of violations, each of which carries possible penalties ranging from small fines to license suspensions. And as those await adjudication, the board proposed a set of rules aimed at keeping such problems due to understaffing from recurring.

Among them:

  • A 72-hour limit to fill prescriptions except in cases such as when drugs are unavailable
  • A prohibition of “the use of quotas in the provision of ancillary services in an outpatient pharmacy”
  • And a rule giving pharmacists greater authority to suspend non-core services if they believe they’re getting in the way of prompt, safe delivery of medications
  • Importantly, the rules would expressly prohibit retaliation against workers who follow the new guidelines.

CVS’s staffing problems seem particularly acute after it bought and closed competitors at least since 2016 and moved their customers’ prescriptions into its stores. Then, facing retail headwinds, CVS in 2021 announced that nationally it would close 300 of its own stores in each of the next three years. 

In at least some instances in Ohio, the company moved prescriptions from the stores that it closed to the closest CVS stores that remained. According to board-of-pharmacy inspection reports, CVS in some cases didn’t add much or any staff to help the pharmacies cope with the additional business.

Last November — when a subset of the rule changes were proposed and before the CVS citations were publicized — CVS said that the state’s pharmacy regulator didn’t have the legal authority to prohibit quotas for ancillary services such as vaccines.

“Nowhere in (the laws giving the board authority to regulate pharmacies) does the Ohio Legislature contemplate the Ohio State Board of Pharmacy having the authority to regulate the business practices of entities engaged in the practice of pharmacy, which (affect) how said businesses optimize the delivery of pharmaceutical care,” the company’s written comment said.

But earlier this month, a group representing community pharmacies, the Ohio Pharmacists Association, said the Board of Pharmacy clearly has such authority.

“… the State of Ohio Board of Pharmacy has standing to regulate the practice of pharmacy through an authorized business entity (Sec 4729.161),” wrote the group’s executive director, David Burke. “Specifically, Terminal Distributor of Dangerous Drugs License (TDDD) holders are required to utilize the services of a pharmacist, and provide the ability of the pharmacist to practice in a safe and effective manner. Within this framework, the pharmacist is required to be in full and actual charge of the pharmacy.”

Burke would have reason to know. Not only is he a pharmacist, until the end of 2020 he was a member of the state Senate, which of course helps make the laws.

But even before Burke wrote that, a perhaps-chastened CVS had softened its position.

“CVS supports the idea of not allowing individual quotas in the provision of ancillary services,” John Long, the company’s director of regulatory services, wrote on Sept. 10. “CVS also supports the Board’s allowance of pharmacies using metrics to support the overall business planning and for the use of metrics in the proper scheduling and staffing to help serve the patients and communities that CVS proudly serves.”

In an interview, Burke said that his group’s members are concerned about the proposed rules in that they weren’t cited for egregious, staffing-related problems, but they might face more of a regulatory burden anyway.

“Our pharmacists are worried that they’re going to get caught up equally when they’re not the problem here,” he said.

That said, Burke explained that there is a larger context in which the pharmacy board is promulgating rules in response to pharmacies that are so understaffed that they can’t even fill prescriptions in a timely manner.

In the law “practice of pharmacy” lists eight or nine different things, “only one of which is filling a prescription,” Burke said. “They include counseling, medication therapy management, checks for drug interactions — all the things pharmacists are actually trained to do in school. You don’t go to school for six or seven years just to learn to count by five.”

He said he’s most concerned about the effect that a huge, bottom-line obsessed chain like CVS is having on the practice of pharmacy as a whole.

“We will be working very closely with the Board of Pharmacy because what’s happening here is a degradation of the practice of pharmacy,” Burke said. “That’s where I get disturbed. These aren’t just incidents happening in a retail setting. They are the degradation of a profession that I love.”



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Marty Schladen
Marty Schladen

Marty Schladen has been a reporter for decades, working in Indiana, Texas and other places before returning to his native Ohio to work at The Columbus Dispatch in 2017. He's won state and national journalism awards for investigations into utility regulation, public corruption, the environment, prescription drug spending and other matters.