Viewed individually, each medication rule, regulation, standard and guideline has its fair share of advocates and critics. It’s the sum of their parts, however, that often keeps compliance officers up at night.
The regulatory labyrinth is particularly poignant to William Vaughan, RN, BSN, vice president, education and clinical affairs for Remedi SeniorCare. Vaughan joined the pharmacy services provider after a 26-year career as a certified federal health facility surveyor and chief nurse for Maryland’s Office of Health Care Quality.
“There are certainly rules out there that are troubling. But it’s the aggregate of the rules and the many bodies that oversee a nursing home that really are,” Vaughan says. “The mix isn’t particularly helpful. A nursing home has to abide by CMS rules and individual state rules. The nurses have to abide by a different set of rules, the doctors have to follow the board of pharmacy rules, and the DEA comes into play when you have controlled drugs.
“The fact is, often those rules are either silent, provide little or no specific direction, or conflict with other rules.”
As a result, facilities may often rely on word of mouth that spreads from a blog or social media post when struggling to comply and avoid citations on a certain medication management rule. It’s not uncommon for “urban legends” to grow up around what Vaughan calls these “silent rules.”
Consider a Maryland state regulation called “Administration of Medications for Leave of Absence of 24 Hours or Less.” While the rule requires a licensed nurse to prepare medications to be sent with a resident during a short-term leave of absence, conflicting pharmacy dispensing rules abound.
“Nurses fear taking pills out of a blister card and putting them into a different container because they know the board of pharmacy considers that act as dispensing a drug, and only a pharmacist can do that,” he explains.
The agency ultimately amended the rule that permitted dispensing meds for lengths of absence of less than 24 hours, providing it was done so under “reasonable” conditions.
Some of the most impactful regs are found in the federal Requirements of Participation for the Medicare and Medicaid programs.
“Over the past 30 years, we finally got into a happy balance in terms of interpretation and compliance,” observes Jennifer Hardesty, PharmD, FASCP, chief clinical officer and corporate compliance officer for Remedi SeniorCare. “With this new rule, some facilities are hesitant to push back against surveyors and [states’] interpretations vary widely.”
Vaughan isn’t alone in his concern about conflicting waste management rules. Consider the current “Sub Part B” EPA amendments and “USP 800” recommendations. The former deals with disposing of hazardous drug waste by nursing homes (including a national ban on discarding drugs in toilets as of August 21), while the latter addresses the handling of hazardous drugs by healthcare personnel in all settings.
Stephen Creasy, PharmD., director of clinical services for PharMerica, believes both rules are significant because they fundamentally alter how certain hazardous medications have to be handled from delivery to disposal. The problem is “each regulation is from a different organization, has separate timelines for implementation depending upon the state, and has differing definitions of what constitutes hazardous,” he says.
Rule interpretations from state to state also are “vastly different,” he adds.
The rules also carry onerous financial burdens, as well as “increased higher liability concerns if appropriate precautions aren’t taken to ensure proper education and training of personnel as well as awareness of state-specific regulations, which may be stricter than federal,” Creasy adds.
Another set of regulations — the DEA’s “21 CFR Final Rule” — enables long-term care facility staff, managed under DEA-registrant consultant pharmacists, to dispose of residents’ pharmaceutical waste, including controlled substances, on their behalf.
“Previously, the disposition of ultimate users’ medications in these settings was fraught with diversion due to the lack of authorized oversight by clinical staff, says Dennis Halligan, vice president of marketing for Sharps Compliance Inc.
Many facilities choosing to participate in disposal programs will need to update their policies and procedures on the management of residents’ unused, unwanted or expired medications, he adds.
No one disputes the value of reining in the decades-old practice of over-prescribing antibiotics. It has led to myriad strains of multidrug resistant pathogens. The problem? “Implementing effective programs in long-term care is difficult,” says Marti Wdowicki, PharmD., director of clinical operations for PharMerica.
“Current technology doesn’t lend itself to effective tracking and subsequent trending of both antibiotic utilization, Clostridioides difficile infection rates and hospitalizations related to resistant antimicrobial organisms,” she says.
Moreover, “prescribing clinicians must decide, without the benefit of STAT lab results available in acute-care settings, between treating or not treating with antibiotic therapy,” Wdowicki adds. “No clinician wants to prescribe an antibiotic that results in a life-threatening C. diff infection or resistant antimicrobial organism. They also don’t want to be the prescriber who doesn’t prescribe an antibiotic and the patient decompensates quickly and requires hospitalization or worse.”
Myriad new medical management rules curtailing antipsychotics’ use in nursing homes are seen as a positive step. But many facilities are swirling in self-doubt and interpretation woes.
Some believe the regulations are having a chilling effect, but Tracy Humble, RN, BSN, vice president of care services for The Compliance Store, doesn’t agree.
“Antipsychotic regulations remain a significant challenge for skilled nursing centers,” she says. “They are expected to achieve administering reductions but physician prescribing habits have not changed to support this goal.”
Marci Wayman, Pharm.D., consultant pharmacist for Turenne PharMedCo Pharmacy Services, says the rules are problematic.
“The CMS regulation regarding PRN psychotropic orders has been a big challenge for me and some of the facilities I service,” she says. “I find the facilities understand the requirements, but their hospice providers do not. We continually have conversations regarding CMS expectations on end of use dates for PRN psychotropics and that this regulation does apply to hospice patients.”
Joe Kramer, vice president of sales for Geri-Care Pharmaceuticals Corp., supports the new rules around antipsychotics, including requirements for psychologist monitoring and gradual dose reduction measures.
He lauds the growing number of pharmacies now offering monthly medication audits that help reduce medication errors and fines.
Among the stickiest of all current rules involve new standards and Quality Measures for Medication Management.
Rod Baird, founder of Gehrimed, believes the standards “create added complexity for facilities, prescribers, and pharmacists — which are difficult to implement in the absence of an integrated collaborative care model.
There are no provisions in the Medicare regulations to either fund, or reward via shared quality measures, that collaborative model,” he says.
“In the absence of overarching guidance/incentives from CMS, each facility, its vendors and partners, are left to their own devices to create a shared-care model out of their own pockets,” Baird adds. “This is both illogical and largely unworkable.”
Baird also asserts that nursing homes with tightly integrated care networks, and higher functioning patient populations, are likely to be relatively successful. Meanwhile, “those treating lower income patient populations face greater difficulties in forging the collaborative models that are needed.”
New quality rules around drug regimen reviews (DRRs) also are thorny.
Those addressed in Section 3401 0f the Affordable Care Act are intended to improve resident safety through more stringent medication reconciliation, especially through transitions of care.
But Huan Nguyen, vice president, business development, long-term care for Swisslog Healthcare, asserts that greater visibility into residents’ medication protocols comes at the cost of facilities’ financial solvency.
In addition to punitive reimbursement rate cuts around reconciliation infractions, “facilities are unable to support consultations with pharmacists at the turn of every event, from admission to discharge to transfer for procedure,” he adds.
Moreover, Nguyen believes facilities experiencing low occupancy rates, facing a staffing shortage and trying to adhere to the law could easily buckle from the conflicting stressors.
“In the face of what was envisioned as a preventative measure for patient residents, the reality may be compromised patient safety,” he says.
Peer-level communications in the nursing home industry very often yields invaluable advice around geriatric practice. But all too often, it’s risky to base your facility’s compliance to a complex standard or rule based on a tip from a fellow nursing director or administrator.
“Don’t practice based on rumor, ‘urban legend’ and untested regulatory direction,” Vaughan urges. “From a pharmacy standpoint, we want people to practice based on evidence. And a great resource for that is a consultant pharmacist and medical director.”
Wdowicki urges facilities to engage internal “champions” for various aspects of compliance.
Other advice includes establishing compliance checklists. Also engage in consistent and regular monitoring and audits, and training and enlisting of non-licensed personnel to assist with them.
She also suggests providers apply for civil money penalty (CMP) fund grants to reward those facilities that “get it right. We hear so much about the violations and what went wrong, yet there are many heroic facilities out there that are doing a great job,” Wdowicki adds.
Dispensing advice on regulations, meanwhile, usually begins and ends with the common refrain about simplifying and listening more to the providers that bear the consequences of violating them.
“As a 20-year regulator, I can tell you this: The regulations should be written in a way that readable interpretations should suffice,” says Vaughan.