Tag: Ohio Board of Pharmacy

  • Governor DeWine Announces New Effort to Improve Care Coordination and Reduce Fatal Drug Overdoses

    Governor DeWine Announces New Effort to Improve Care Coordination and Reduce Fatal Drug Overdoses

    Columbus, Ohio – Ohio Governor Mike DeWine and Ohio Board of Pharmacy Executive Director Steven Schierholt announced today that Ohio’s prescription drug monitoring program, known as the Ohio Automated Rx Reporting System (OARRS), will begin alerting healthcare providers about patients who have experienced a non-fatal drug overdose. These alerts are intended to improve care coordination and promote access to medication for opioid use disorder and other tools to prevent fatal overdoses.

    “The goal of this alert is to give us an extra chance to save someone’s life,” said Governor DeWine. “The research shows us that people who have recently experienced a non-fatal overdose are at a higher risk to overdose again in the near future, and that they often have regular interactions with the healthcare system – including pharmacists and prescribers. This new alert system will be a valuable tool allowing our healthcare providers the opportunity to educate and offer treatment and prevention options to these individuals before a tragedy occurs.”

    The data provided to OARRS is being reported by Ohio hospitals via the Ohio Department of Health because of a rule change announced by Governor DeWine earlier this year.  Using this data, the OARRS system will now flag for prescribers and pharmacists of any patient who experienced a non-fatal drug overdose and was discharged from an Ohio emergency department on or after April 8, 2024. The alerts will only be available for OARRS users who are prescribers and pharmacists.

    “Data from state prescription drug monitoring programs, such as OARRS, continues to be an invaluable resource for healthcare providers,” said Ohio Board of Pharmacy Executive Director Steven W. Schierholt. “With this alert, we are encouraging prescribers and pharmacists to engage with their patients and offer proven interventions that will prevent fatal drug overdoses in the future.”

    Among Ohioans who died in 2022 from an unintentional drug overdose, at least 32% experienced a prior non-fatal overdose. Among the same population, 26% received a prescription for a controlled substance from a healthcare provider within 60 days of their death. These interactions with the healthcare system reinforce the need to ensure high-risk patients have access to interventions such as overdose reversal medications (e.g., naloxone) and medication for opioid use disorder.

    Established in 2006, OARRS is a statewide database that collects information on all prescriptions for controlled substances that are dispensed by pharmacies or furnished by prescribers in Ohio. To assist healthcare providers in using this new alert, the Board of Pharmacy has developed training materials that can be accessed by visiting: Pharmacy.Ohio.gov/NFOD.

    According to DeWine, “This new alert system is another example of Governor DeWine’s ongoing and comprehensive efforts to prevent overdose deaths and fight drug addiction. Ohio’s coordinated efforts are achieving encouraging results.”

    Governor DeWine recently announced newly verified data from the Ohio Department of Health (ODH), demonstrating that Ohio experienced a 9% decline in the number of overdose deaths last year.

    ODH’s 2023 Ohio Unintentional Drug Overdose Report also shows that Ohio has now outperformed national overdose death trends for two years in a row. In 2023, Ohio’s 9% decrease in overdose deaths was better than the 2% decrease seen nationwide. In 2022, Ohio’s 5% decrease in overdose deaths was better than the 1% increase seen nationwide.

  • Ohio Board of Pharmacy launches tool to help those living with disabilities

    Ohio Board of Pharmacy launches tool to help those living with disabilities

    By:  Ohio Capital Journal

    The Ohio Board of Pharmacy on Monday launched a tool to help people with low vision, hearing loss, or who face language barriers find pharmacies that can serve them.

    For many, the pharmacy is the most frequent point of contact with the healthcare system. Pharmacists can consult about their medications and help them manage chronic conditions such as hypertension and diabetes.

    The new website will help people with accessibility challenges find pharmacies that can serve their specific needs.

    For example, for patients with low vision can find pharmacies that provide oversize-font labels, prescription readers and braille labels.

    It can point those with hearing loss to pharmacies that have video-relay services and teletypewriters. And it can tell non-English speakers where to find pharmacies with translation services for Spanish, Chinese, Nepali, Somali, and other languages.

    GET THE MORNING HEADLINES.

     

    In a statement, Board of Pharmacy Executive Director Steven W. Schierholt said the new webpage is an attempt to make pharmacy services more widely accessibility.

    “The launch of this convenient online search tool highlights the Board’s ongoing commitment to ensure pharmacy services are accessible to all Ohioans,” he said. “The Board is hopeful that this new webpage will help patients and their loved ones quickly identify pharmacies offering services they need to keep them healthy and safe.”

    However, working against accessibility is a wave of pharmacy closures. For the better part of a decade, independent and small-chain pharmacies have said that huge prescription middlemen — CVS Caremark, OptumRx and and Express Scripts — have been driving them from the field with low reimbursements, fees and clawbacks.

    More recently, large chain pharmacies have been closing in droves.

    CVS is at the end of a three-year process in which it closed 900 pharmacies across the country. Walmart last year asked 16,000 of its pharmacists to cut their hours.

    Bankrupt Rite Aid this year announced the closures of hundreds of stores in Ohio and Michigan. And Walgreens this year said it would close “a significant portion” of 2,000 underperforming stores. That prompted Dave Burke, executive director of the Ohio Pharmacists Association, to say he was worried that pharmacy is becoming an untenable business.

    “If Walgreens can’t make a go of this in 25% of their locations, my fear is that this becomes a much larger problem where other people who provide pharmacy services exit the market in whole or in  part,” he said in September.

    The Federal Trade Commission is investigating whether the giant health conglomerates that own the three big pharmacy middlemen are engaged in anticompetitive practices.

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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.

    Ohio Capital Journal is part of States Newsroom, the nation’s largest state-focused nonprofit news organization.

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  • “Corners are cut to dispense prescriptions,” CVS employee tells Ohio Board of Pharmacy

    “Corners are cut to dispense prescriptions,” CVS employee tells Ohio Board of Pharmacy

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

    After years of buying and closing competitors, CVS understaffing leads to chaos and delays, Ohio regulator says

    BY: Ohio Capital Journal

    At least eight CVS pharmacies in Ohio are so understaffed that they have seen rampant turnover, dirty conditions, lack of controls over dangerous drugs and wait times as long as a month for prescriptions, according to reports by the Ohio Board of Pharmacy.

    The waits have been so long that a harried CVS pharmacist in Wooster said he was “actively triaging prescriptions to ensure lifesaving, life-sustaining medications are filled in a timely manner.”

    In one case, pharmacy workers told inspectors they begged their superiors — unsuccessfully — to close their pharmacies so they could catch up. In another, a pharmacy did intermittently close, making it impossible for patients to get their medicines during the closures.

    In another instance, Board of Pharmacy inspectors couldn’t tell if employees were stealing controlled substances. In yet another, they couldn’t tell if CVS was improperly billing insurers for scripts it didn’t fill.

    And in several additional cases, inspectors repeatedly found expired and adulterated drugs on pharmacy shelves and filled prescriptions that gave patients the wrong instructions.

    “Corners are cut to dispense prescriptions,” at least one employee at Toledo’s CVS store No. 10246 told investigators last year. Workers there added, “Supervisors/District Managers do not respond to staff calls for help,” the report said.

    The accounts come from inspection reports going back to 2020 that the Capital Journal obtained under the Ohio Public Records Act. At least some of the inspections came in response to patient complaints to the board, which licenses Ohio pharmacies.

    The inspections come after CVS — already the nation’s largest pharmacy retailer — has for years bought up competitors, closed them and moved the prescriptions of the closed pharmacies to existing CVS stores. Critics raised concerns about the practice, known as “buy and close,” at least as early as 2019.

    “Staff at this location was not increased,” a pharmacist at Dayton’s CVS store No. 2528 said last September after the store had absorbed two other closed pharmacies’ prescriptions. She quit the following month.

    For its part, CVS didn’t answer questions about specific allegations in the reports, which it referred to as “isolated incidents.”

    “We’re working with the Board of Pharmacy to resolve allegations of isolated incidents, most of which date back a year or more,” Amy Thibault, director of communications for CVS Pharmacy said in an email Wednesday. “The health and well-being of our patients is our number one priority.”

    Rampant turnover

    Pharmacies across the country found themselves under siege as the coronavirus pandemic took hold in the spring of 2020. They were conducting tests and, when they became available, providing COVID vaccines in addition to already administering those for flu and shingles.

    At the same time, some pharmacy employees were reluctant to work face-to-face with the public in a health care setting — especially before there were vaccines against a disease that has killed more than 1 million Americans.

    But according to the Board of Pharmacy reports, turnover in the CVS stores they investigated seemed particularly bad. And it seemed to be linked to stress from overwork — as well as the parent corporation’s inability or unwillingness to do anything about it.

    For example, when an inspector arrived at CVS store No. 2063 in Canton on Sept. 13, 2020, the staff was so harried that it took them 20 minutes to even acknowledge the inspector. The staff said that the store had lost a pharmacist and six technicians “within a short time.”

    As workers scrambled, they sweltered in a pharmacy in which the air conditioning unit was broken and an alarm in a drug cooler failed to warn them that it was too warm at 46.4 degrees Fahrenheit.

    “Pharmacy staff and an assistant store manager stated they have asked district leaders to close the store down temporarily to get caught up filling prescriptions as well as clean and organize the pharmacy, but this request was denied,” the report said.

    When an inspector returned to the pharmacy on Oct. 29, 2021, things had only gotten worse.

    “All pharmacy staff that was present for the September 2021 inspection quit or transferred out of CVS #2063,” the report said.

    Even more alarmingly, understaffing there created delays that easily could have harmed patients’ health — despite workers’ best efforts to “triage” which prescriptions to fill first.

    “The pharmacy was over a month behind in filling prescriptions,” the report said.

    Especially bad at CVS

    During the pandemic, conditions were universally difficult for pharmacies, but CVS might have been a special case.

    An owner of an independent pharmacy in Northern Ohio said things were rough for everybody, and that he’s still having trouble keeping enough pharmacy technicians on his staff. But, he said, that never led him to consider temporary closures, or anything like the delays filling prescriptions and other problems seen at some CVS stores.

    The pharmacist depends on CVS Caremark — the corporation’s gargantuan pharmacy benefit manager — for his business and asked not to be named. But, he said, he’s talked to CVS pharmacists who have been under pressure so great that it affected their mental health.

    The stress appeared to extend even to the upper ranks of CVS’s pharmacy operation.

    In July 2021, Ken Sidwell became leader of the district which includes Canton CVS store #2063. When he was interviewed by the Board of Pharmacy, he said the store was short-staffed when he got the job.

    Just three months later, Sidwell was gone. On Oct. 29, 2021, the new district leader, Kenneth Cook, told the Board of Pharmacy that the store “is in the process of hiring new pharmacy staff as well as transferring staff from an overstaffed CVS location.”

    CVS spokeswoman Thibault said the company’s policies ensure that its stores are not dangerously short of pharmacy workers.

    “Decisions about staffing, labor hours, workflow process, technology enhancements and other operational factors are made to ensure we have appropriate levels of staffing and resources in place at our pharmacies,” she said. “We have comprehensive policies and procedures in place to support prescription safety and we continue to make important strides, including using technology to support our pharmacy teams.”

    Buy and close

    Not only is CVS the nation’s largest pharmacy retailer, its parent corporation also owns Aetna, a top-10 insurer. It’s also buying up medical centers and physicians practices, helping to make it the nation’s sixth-largest corporation.

    And crucially for pharmacies everywhere, CVS owns the nation’s largest pharmacy benefit manager, CVS Caremark. It and Express Scripts and OptumRx are estimated to control more than 80% of the marketplace and they’re under investigation for possible anti-competitive practices by the Federal Trade Commission.

    Pharmacy benefit managers, or PBMs, act as middlemen for insurers in the drug supply chain. They decide which drugs are covered, so they have great power to negotiate huge, non-transparent rebates and other discounts from drugmakers.

    At the same time, they create pharmacy networks. And, because they control access to so many millions of patients, most small-chain and independent pharmacists think they have little choice about contracting with them on whatever terms the big PBMs choose.

    “Take-it-or-leave-it” contracts, the pharmacists call them.

    CVS has long said that it maintains strict firewalls between its retail and PBM operations, but small pharmacy operations in Ohio and elsewhere aren’t so sure.

    After seeing their reimbursements from CVS Caremark plummet in late 2016, CVS’s “Acquisition Unit” in 2017 sent many of its competitor pharmacies letters saying that it knew times were hard for them and offering to buy them out.

    In many instances, CVS didn’t put its sign on the store it had just purchased. CVS instead closed the stores and folded all of their prescriptions into an existing CVS pharmacy.

    Some pharmacists call the practice “buy and close.”

    In 2019, when CVS bought 20 stores owned by Medina-based Ritzman Pharmacy and closed all but three, critics said it was classic buy-and-close.

    Two of the now-closed pharmacies were in Wooster, one of the cities in which inspectors now find problems in a still-open CVS pharmacy. Three more — in Sugarcreek, Millersburg and Dover — were to the rural south of Canton and Massillon, where CVS stores found themselves seriously stretched in the years since.

    Mount Vernon-based Conway’s Pharmacy in 2019 partnered with Knox County to open a pharmacy in Danville on the edge of Amish Country after CVS bought and closed the only pharmacy there a few years earlier. The closure meant that Danville residents — many poor, disabled or both — had to drive 20 minutes or more to get their medicines or to consult with a pharmacist.

    Such practices have fueled fears that pharmacy deserts are being created in Ohio and elsewhere.

    Lack of accountability

    The constant churn in CVS staffing found by Board of Pharmacy investigators led to breakdowns in accounting for dangerous drugs, including opioids, the inspection reports said.

    For example, between June 10 and Sept. 22, 2022 Dayton’s CVS store No. 2528 reported 75 oxycodone, 100 hydromorphone and 70 amphetamine pills were missing. In each instance, “CVS Pharmacy was unable to determine a reason for the loss,” the inspection report said.

    For most of that period, no “Responsible Person” was in charge.

    The role is as the name implies. The Ohio Administrative Code says, “The Responsible Person shall be responsible for the practice of the profession of pharmacy, including, but not limited to, the supervision and control of dangerous drugs as required…”

    That person would normally be the managing pharmacist at a drugstore. But for months after May 26, 2022, there was no such person at the Dayton CVS, according to the report. Inspectors interviewed pharmacist Jean Getter, who said she was asked to serve as temporary manager after the previous Responsible Person, pharmacist Tyler Philo, left.

    Getter said that even though she wasn’t the Responsible Person, she asked for help sorting out the safe that contained controlled substances because “it was a mess.”

    “She asked the previous Responsible Person and also the District Leader about cleaning up the safe, but it never happened,” the report said.

    An inventory of dangerous drugs is supposed to be conducted whenever there is a change of Responsible Person at a pharmacy, but that kept not happening at the Dayton CVS, Getter said.

    “No one ever became the permanent Responsible Person, which is why Ms. Getter left CVS in August,” the report said.

    Then Pharmacy Board investigators interviewed Philo, the previous Responsible Person and learned something even more confounding.

    “He was not aware (four months after he left that) he was still listed as the Responsible Person for CVS Pharmacy #2528,” the report said.

    Controlled substances

    Board of Pharmacy inspectors also found serious potential problems in CVS stores’ tracking controlled drugs — including the kinds of drugs that have fueled Ohio’s opioid crisis.

    Some problems were as simple as leaving deliveries of dangerous drugs at the front of the store for nine hours because pharmacy staffers were too busy to get them. But others might have been more sophisticated.

    At Toledo CVS store No. 10246, inspectors conducted, Multiple audits consisting of 241 controlled substances were conducted by representatives from the Board between on or about November 11, 2021 and on or about April 27, 2022.”

    In 42% of cases, they found that too much or too little of the drugs had been provided. They discovered “significant losses” of amphetamines and the painkiller tramadol.

    “Additional losses and overages were discovered, some of which were reported to the board, but many were not reported at all, or not reported in a timely fashion,” report said. It added that auditing what happened to controlled substances was difficult “because CVS records showed multiple significant inventory adjustments and changes in medication counts…”

    Counterintuitively, investigators found that on some days when controlled substances were delivered to the Toledo pharmacy, inventories of the drugs actually went down. That might indicate “diversion” — a term used in the industry for stealing drugs.

    “It remains questionable if counts were entered as negative numbers in error, or if staff were entering negative numbers to mask the diversion of drugs received on that day,” the report said.

    In the same store, inspectors discovered chaotic conditions.

    On repeated visits, inspectors found “expired/adulterated” medications on pharmacy shelves and workers told them they hadn’t had time to address the issue. The inspectors also painted a picture of general chaos.

    “Shelving for drug storage had collapsed and medications were crushed beneath the shelving units. Drug stock crowded the aisle floors,” the report said, adding, “The counter used for non-sterile compounding was overflowing with (over-the-counter) medications and return-to-stock bottles. Staff food and beverages were also stored in this area. Moldy/rotting food was found on the counter.”

    Beyond delays and lacking controls, inspectors found another problem at the store that could endanger patients’ health.

    Inspectors on March 3, 2022 reviewed 49 prescriptions filled at the store. They found that seven “had errors in the directions to patients.”

    And when inspectors talked to employees, they heard echoes of the complaints at other CVS pharmacies they’d visited.

    • “The pharmacy is always short staffed.”
    • “The workplace was described as hectic. There is no downtime to catch up on tasks.”
    • “Morale among store employees is poor.”

    Delays and questions about improper billing

    When inspectors visited CVS store No. 8248 in Massillon in late 2021, they found a pharmacy so understaffed that “the pharmacy would close intermittently,” meaning “patients were unable to pick-up/receive their prescriptions.”

    They again found confusion over who was legally responsible.

    “The Responsible Person, Abbey Yannerella, was listed as the Responsible Person at this location as well as CVS #2063; however, she was no longer working at” the Massillon store, the report said.

    They found something else that raised serious questions.

    The store in October 2021 had more than 2,000 prescriptions waiting to be filled, the oldest of which had been waiting for 13 days. A month later, the pharmacist on duty told inspectors that after scripts go unfilled for 14 days, they’re “deleted from the queue.”

    The inspectors found one such prescription that was labeled “Print Ready.”

    “The prescription’s status indicating ‘Print Ready’ means the prescription was processed through insurance,” the report said. “When a prescription is deleted from the queue, the pharmacy does not reverse the insurance claim.”

    CVS didn’t respond directly when asked how often scenarios like this occur — or whether it routinely bills insurers for prescriptions it fails to fill for two weeks and then deletes from its system.

    On Nov. 28, 2021 a new Responsible Person, pharmacist Nayan Patel, had been named. He told investigators that the deletion of prescriptions after 14 days was a requirement of the U.S. Centers for Medicare and Medicaid Services. He added that the scripts are placed back into the queue after their deletion.

    However, “When asked to explain this process further, he could not elaborate,” the report said.

    Then on Feb. 4, 2022, the Board of Pharmacy learned that Patel was Responsible Person for two CVS pharmacies without the special permission required by the board. When the board notified a CVS district leader of that fact, “The district leader notified the board Mr. Patel is no longer the Responsible Person of” Massillon CVS store No. 8248, the report said.

    Penalties

    The board has notified CVS that it can impose penalties ranging from fines to revoking their licenses as a “Terminal Distributor of Dangerous Drugs” at each of the locations in which it found violations.

    So far, CVS store #3613 in Columbus received a $1,000 fine and a written reprimand last August, Board of Pharmacy spokesman Cameron McNamee said in an email Thursday. The violations outlined in that report seem considerably less severe than those found in some other CVS pharmacies.

    Violations found at CVS’s Canton store No. 2063 — where staff turnover was particularly rampant — are slated to be considered at the board’s Nov. 7-8 meeting McNamee said.

    Hearings for the other stores are yet to be scheduled.


    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.

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  • Attorney General DeWine files lawsuit against opioid distributors for practices fueling opioid diversion

    Attorney General DeWine files lawsuit against opioid distributors for practices fueling opioid diversion

    Columbus, Ohio – Ohio Attorney General Mike DeWine today filed a lawsuit against four major prescription opioid distributors in Madison County Court of Common Pleas. The lawsuit alleges that the drug companies engaged in unsafe distribution practices that ignored their responsibility under law to provide effective controls against opioid diversion.

    “We believe the evidence will show that these companies ignored their duties as drug distributors to ensure that opioids were not being diverted for improper use. They knew the amount of opioids allowed to flow into Ohio far exceeded what could be consumed for medically-necessary purposes, but they did nothing to stop it,” said Ohio Attorney General Mike DeWine. “And much like the drug manufacturers who continue to fail to do the right thing, these distributors are doing precious little to take responsibility for their actions and help pay for the damage they have caused.”

    In 2016, the last year for which data is available, an average of more than 76 opioid doses was distributed for every man, woman, and child in Madison County.

    The four distributors which are listed as defendants include:

    • McKesson Corporation
    • Cardinal Health, Inc., and its subsidiaries
    • AmerisourceBergen Drug Corporation
    • Miami-Luken, Inc.

    The lawsuit alleges, among several counts, that the drug companies were negligent and created a public nuisance by using unsafe distribution practices and by irresponsibly oversupplying the market in and around Ohio with highly-addictive prescription opioids. The companies are alleged to have failed to act upon their responsibilities under both federal and Ohio law to stop such orders that would result in oversupply and report these suspicious orders to the United States Drug Enforcement Agency (DEA) and the Ohio Board of Pharmacy. The lawsuit also alleges that the companies should have known that the volume of opioids supplied far exceeded what could be responsibly used in markets in Ohio and would likely have contributed to the opioids being illegally diverted and abused. This behavior directly fueled the opioid epidemic Ohio is currently facing.

    In the lawsuit, Attorney General DeWine is seeking a number of remedies including punitive damages as well as compensatory damages for costs incurred by Ohio for its increased spending for healthcare, criminal justice, social services, and education. The lawsuit also seeks to enjoin the defendants from further improper conduct by complying with reporting requirements for suspicious orders and to undertake more complete reporting of suspicious orders to the DEA and the Ohio Board of Pharmacy as well as the Ohio Attorney General’s Office.

    The lawsuit was filed in Madison County, which has consistently had a higher number of opioids distributed to it than the statewide average. In 2016, the last year for which data is available, an average of more than 76 opioid doses was distributed for every man, woman, and child in Madison County, a rate that was 39% higher than the Ohio statewide average for that year.

    A copy of the lawsuit is available on the Ohio Attorney General’s website.