By February 2010, the flood of illegal prescription pain medications in southern Ohio had gotten so bad that The Columbus Dispatch described it as an epidemic, noting that in 2008 Ohio pharmacists filled 2.7 million prescriptions for “high-powered painkillers such as OxyContin and Percocet,” nearly one for every four people in the state. They also filled 4.8 million prescriptions for Vicodin and other hydrocodone medications. The combination of high unemployment and poverty in Scioto country, combined with its proximity to Columbus, Kentucky, and West Virginia and “a track record of limited resources and uncooperative elected officials who have refused to help with drug investigations,” created the “perfect environment for illegitimate pain-management clinics” to flourish.
The State Medical Board of Ohio reported that 9.7 million doses of prescription pain medications were dispensed last year in the southern Ohio country of Scioto (population 79,000), or approximately 123 doses for each man, women, and child in the county. The Board also reported that between 1999-2008, there was a 360% increase in accidental over-dose deaths in Scioto County, 92% of which were due to prescription medications. Unintentional drug overdoses have been the leading cause of accidental death in Ohio since 2007, with fatal and non-fatal overdoses costing Ohio $3.6 billion annually.
In response, Ohio governor John Kasich recently signed into law Ohio House Bill 93, which was co-sponsored by Republican state reps Dave Burke and Terry Johnson. The law calls for a variety of new rules and measures designed to eliminate illegitimate “pill mills,” stop the high-volume in-office dispensing of controlled substances endemic to these practices, and strengthen the reporting requirements for physicians who prescribe prescription opioids and other medications.
According to an article in The Columbus Dispatch, this legislation will “help to combat southern Ohio's epidemic of prescription-drug abuse -- in part by making it harder for [suppliers] to get their hands on the pills.” The article states that the law “enhances the computerized Ohio Automated Rx Review System to help identify extensive prescription-drug use,” limits prescribers' ability to “personally furnish certain drugs,” improves “licensing of and law enforcement involving pain-management clinics,” and “develops a statewide prescription-drug ‘take-back’ program.”
Aaron Haslam, coordinator of the prescription drug abuse initiative at the Ohio Attorney General's Office, told the Plain Dealer that because of this legislation, "We will see more indictments, we will see more arrests, we will see more prosecutions and we will see more convictions."
“If you overprescribe, we’re going to come get you. This is about our children. It’s about our mothers and fathers. It’s really about Ohio families… These doctors are fantastic people but some of them are abusing their profession… and it is critical that the medical board maintain the integrity of the profession. So really the message is, if you’re out there breaking the law, you may get away with it for a while but these professionals, they’re gonna come get you.”
-- Ohio governor John Kasich, during a press conference commemorating the signing House Bill 93 into law
The Ohio State Medical Association (OSMA) released a statement announcing that the law will “require licensure of pain management clinics, authorize regulatory boards to establish standards for Ohio Automated Rx Reporting System (OARRS) review and severely restrict in-office dispensing of controlled substances to patients."
OSMA has also prepared several primers explaining the ways in which the new law will impact Ohio physicians.
Licensure of pain management clinics
A Pain Management Clinic will be defined in Ohio as “a facility where the primary component of the practice is treating pain or chronic pain and a majority of the patients are prescribed controlled substances for the treatment of pain.” Certain facilities (including hospitals, ambulatory surgery centers, and academic medical centers) are exempt. The calculation based upon the number of patients treated per month used to determine status as a pain management clinic excludes patients being treated with controlled substances “that are expected to last less than 30 days.”
Clinics are also required to keep patient log for each day the clinic is in operation, implement a quality assurance program “that objectively evaluates the quality of patient care” (the law also authorizes the Ohio State Medical Board to “establish a standard of care for chronic pain management”), and maintain detailed billing and patient medical records for seven years “that must be made available to the board for immediate review.”
The various state medical boards must establish standards for when a prescriber (or his or her “registered agent”) is required to review Ohio’s prescription drug monitoring program, known as the Ohio Automated Rx Reporting System (OARRS) prior to prescribing controlled substances. The requirements as written are quite broad, covering a wide range of situations and triggering factors. Physician are required to consult the OARRS database when they “become aware of or suspect drug abuse by the patient,” including when or if a physician “becomes aware of a patient with a known history of substance abuse, failed drug screenings, exceeding dosage amounts, withholding information relevant to prescribing, receiving drugs from multiple prescribers, frequent emergency department visits, requesting brand name over generic, reporting early prescriptions, appearing overly sedated or intoxicated, reporting theft or loss of drugs, sharing drugs with others, concurrently using illicit drugs, arrest record for drug offense, jailed after becoming a patient.”
Physicians are also required to review OARRS “when utilizing controlled substances for a chronic condition that exceeds twelve weeks” and document in a patient’s chart all OARRS reports.
In-office dispensing of controlled substances
The law prohibits physicians from personally furnishing (ie, dispensing in the office) to a patient “more than a 72-hour supply of controlled substances or more than a 2,500 dosage unit limit over a 30-day period to all patients in the practice.” Note, physician practices that are also registered pharmacies are exempt from this requirement.
All instances of in-office dispensing of controlled substances must also be accompanied by the physician filing an OARRS report that includes the names and other identifying information for the prescriber and patient; the name, strength, quantity, and number of days’ supply of the dispensed drug; and whether the drug is a new prescription or a refill.
The new law also calls for the establishment of a statewide drug take-back program. Specifically, it requires the state Pharmacy Board, Attorney General, and Department of Alcohol and Drug Addiction Services to “develop a program under which drugs are collected from the community for destruction or disposal."
Fallout in Ohio
A few days before the governor signed House Bill 93 into law, the US Drug Enforcement Administration (DEA) suspended the licenses of four doctors and a pharmacy in Scioto County, OH, to distribute controlled substances. The administrative action was “based on a preliminary finding by DEA that the continued registration of the doctors and pharmacy constitutes an imminent danger to public health and safety." One of the physicians, Margy Temponeras, MD, was described by the DEA as “one of the largest dispensers of controlled substances in the United States.” Under DEA rules, Temponeras and the other physicians are allowed to request a hearing and make their case for reinstatement. A profile of Temponeras published in the southern Ohio newspaper The Portsmouth Daily Times in 2010 portrayed a physician who claimed to be following the rules while trying to see to the needs of a large population of legitimate and underserved patients. Temponeras told the Times that all patients treated at her clinic must be referred by another physician (ie, no walk-ins) and are not allowed to bring their own medical records (all records must be sent by a referring physician). In the article, Temponeras and her staff claimed that because they checked all patients’ medical and criminal records, it took up to six weeks to see a physician at the clinic. They also said they use OARRS and the Kentucky state drug monitoring database KASPER (Kentucky All Scheduled Prescription Electronic Reporting, as well as the Indiana and West Virginia systems. The clinic’s compliance officer even claimed that the staff performed frequent spot checks that required patients to report to the office with their filled prescriptions within two hours, with patients who possessed fewer meds than they should being discharged from the practice.
As of this writing, no criminal charges had been brought against Temponeras or the other physicians.