The relationship between physicians and pharmacists is an important one.

But when pharmacies introduce one-size-fits-all limits on prescriptions, or demand medical information before they’ll fill a prescription, many doctors believe they’re tiptoeing toward a physician’s domain. And worries over what’s been termed a national opioid epidemic is leading to new state and corporate pharmacy policies that could blur the line between the practice of pharmacy and the practice of medicine — and strain that important physician-pharmacist relationship.

Waco otolaryngologist Charles Guy, DO, says he recently experienced a “ridiculous” case of pharmacist overreach thanks to Walmart policy.

Dr. Guy’s office called in a prescription for a cancer surgery patient. In the hospital, Dr. Guy had been using Norco — a combination of hydrocodone and acetaminophen — to manage the patient’s pain.

But a few hours after discharging the patient, Dr. Guy got word from the pharmacy that it wouldn’t fill the prescription because it exceeded the corporate policy for morphine milligram equivalents (MMEs). In May 2018, Walmart announced a new policy limiting initial acute pain prescriptions to a seven-day supply and 50 MMEs per day.

Dr. Guy told Texas Medicine that he had explained to the pharmacist he wasn’t “writing for an overdose, or a lethal amount, or anything risky. The pharmacist agreed, but said, ‘This is our policy, and we can’t fill it. But if you were to change the frequency, then we can fill it.’”

Exasperated, Dr. Guy gave in and switched the prescription — from one to two doses by mouth every four to six hours, to just one dose every four hours. The pharmacist filled the prescription.

“I let them know that I thought it was ridiculous, and they’re telling me how to prescribe medicine to my patient,” Dr. Guy told Texas Medicine. “Having them reach out if there is a true concern and a valid concern, I think, is a better relationship than setting a policy system-wide [that’s] not really thinking about the patient or the physician-patient relationship, or even the pharmacy-patient relationship.”

Other physicians have alerted the Texas Medical Association about problems getting pain prescriptions filled at Walmart pharmacies. Nor is Walmart the only major pharmacy to introduce sweeping opioid prescription restrictions. CVS Health has instituted a similar policy change. And physicians worry new rules adopted by the Texas State Board of Pharmacy (TSBP), which create “red flag factors” pharmacists must evaluate to detect non-therapeutic prescriptions, may sow distrust between prescribers and pharmacists — and encourage the latter to veer toward the practice of medicine. (See “TSBP Red Flags,” page 42.)

TMA has shared concerns over the policies with the Texas Department of Insurance and the Centers for Medicare & Medicaid Services. In late September, Texas Medical Board (TMB) President Sherif Zaafran, MD, in a series of tweets, appeared to signal the board’s willingness to intervene.

“We don’t want overzealousness.”

The new pharmacy policies appear to reflect widespread concern over excessive opioid prescribing.

Walmart media relations did not make anyone available for an interview for this story following email and phone inquiries by Texas Medicine.

Walmart did respond in September to a letter from the American Medical Association (AMA) concerning Walmart’s new policy. Paul Beahm, Walmart’s senior vice president of health and wellness operations, wrote that the policy was informed by Centers for Disease Control and Prevention (CDC) guidelines. (See “CDC Opioid Recommendations,” above.)

“Like the AMA, we believe that clinical decision making regarding the prescribing of opioids should be based on a relationship between the clinician and patient, and an understanding of the patient’s clinical situation, functioning, and life context,” Mr. Beahm wrote. He said Walmart would “continue to empower our pharmacists to work with their patients’ prescribers and use their professional judgment (to the extent they can within the confines of any applicable law) in those cases.”

In a response to that letter, AMA CEO James Madara, MD, criticized the “one-size-fits-all corporate policy [Walmart] implemented rather than a patient-centered understanding of the complexities surrounding pain. … Having the corporate entity determine what is — and is not — acceptable clinical practice is deeply troubling.”

CVS Health also invoked CDC guidelines last year when it announced that its pharmacy benefit manager, CVS Caremark, would place a seven-day limit on opioids for “certain acute prescriptions for patients who are new to therapy,” as well as other new policies, including “limiting the daily dosage of opioids dispensed based on the strength of the opioid.” Those policies took effect Feb. 1, 2018. CVS Health also declined an interview request.

Meanwhile, TSBP rules that took effect earlier this year say a pharmacist must make “every reasonable effort to prevent inappropriate dispensing due to fraudulent, forged, invalid, or medically inappropriate prescriptions.” The rules include a list of 19 “red flag” factors to watch for. TMA helped mitigate the scope of the rules with its input during the comment period but remains concerned about many aspects of the final version.

TSBP also declined a Texas Medicine interview request.

But the Texas Pharmacy Association (TPA) says one of the least understood aspects of the physician-pharmacist relationship is the pharmacist’s corresponding responsibility, mandated by the U.S. Drug Enforcement Agency (DEA), to assess the medical purpose of a prescription for a controlled substance.

“It’s in no way pharmacists trying to intrude on the practice of medicine,” said Debbie Garza, TPA executive director. “It’s them trying to understand either diagnosis or a treatment plan or things like that because there’s something that caused them pause or question.”

The DEA takes an aggressive approach to address prescription legitimacy, she said, and is also aggressive in evaluating whether a pharmacy’s policies and procedures to mitigate illicit prescribing are effective.

“Granted, we don’t want overzealousness. We don’t want everybody asking to see an MRI, because with all due respect, a pharmacist can’t read an MRI,” Ms. Garza said. “But they may ask some questions that might make someone think we’re trying to interfere in the practice of medicine. But we need to be able to resolve those red flags or questions we have.”

Protecting the practice of medicine

That was Houston neurologist Kim Monday, MD’s recent experience with a Walmart pharmacist who demanded a trove of information before refilling a prescription for the same dose of hydrocodone her patient has taken since 2008. The patient also comes in for a visit every three months, with no signs of escalation, abuse, or diversion, Dr. Monday said.

The Angleton pharmacist told Dr. Monday he needed the patient’s diagnosis code, general results of diagnostic testing, the plan of care for the patient to reduce narcotic use, and a plan of care for long-term pain control.

Dr. Monday told the pharmacist that the results he was requesting required a medical degree to interpret, and she believed he was practicing medicine by refusing to prescribe.

“He said no he wasn’t, and this is his right as a pharmacist,” she said.

The patient eventually received her prescription. Dr. Monday provided TMA with an identifying number of the pharmacist she spoke to. Reached by phone at the Angleton Walmart, pharmacist Yonas Mengistu identified himself to Texas Medicine as the pharmacist with that number.

Mr. Mengistu says it’s part of a pharmacist’s prerogative to receive medical records and make a decision about whether a patient’s prescription is legitimate. He says he’s had conversations with many upset prescribers about the pharmacy’s inquiries on prescriptions: “Sometimes, they do yell at me.”

But pharmacists must make sure patients are taking opioids for the right reasons and that no harm comes to them, he said. “Giving a patient 180 of Norco or 120 of Norco every single month without having a treatment plan, that would be not a good thing,” Mr. Mengistu said. “So we ask … ‘What’s the treatment plan? Are you going to keep the patient on the same dose? Down the line, are you going to reduce the dose and wean the patient off of this medication?’”

He says for any chronic pain patient on an opioid, the pharmacy needs documentation, which includes information such as diagnosis codes and the patient’s treatment plan.

In an interview with Texas Medicine, Dr. Zaafran, the TMB President, said the board has received complaints about prescriptions being changed, “sometimes with the knowledge of the physician and sometimes not.” He said the board would be investigating over the next couple of months.

If pharmacists or others are changing a physician’s lawful prescription, Dr. Zaafran said, “there are very strong concerns that [this] may encroach on practicing medicine without a license. I just wanted to make sure that there’s a clear understanding that anybody, whether it’s a pharmacist or anyone else doing so, that would fall under the authority of the medical board, because now that is under the Medical Practice Act.

“The other thing that we also wanted to discuss is making sure that retailers who put in place policies that prohibit the dispensing of more than seven days — or whatever arbitrary number that’s out there — that no retail policy should supersede state or federal law,” Dr. Zaafran added.

“We want to make sure that that’s clear, and we want to make sure at the end of this whole process of reviewing this, that whatever statement is put out by different regulatory agencies, that that very clearly gives the pharmacist the protection that they need, that they are not being forced by another entity to be practicing beyond the scope of their specific license in dispensing medications appropriately.”

Tex Med. 2018;114(12):40-43

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