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Pharmacies warned to observe opioid regulations

Between May and November 2009, the teenager filled numerous prescriptions for Oxycodone and Oxycontin at a New Mexico pharmacy. The prescriptions were all valid, signed by a licensed physician.

If the teenager had been taking the opioids as directed, each prescription would have been sufficient for a certain number of days. But often the teenager arrived at the pharmacy with a new prescription before the last one should have run out. At least some of the prescriptions bore notations saying “OK to fill early” or words to that effect. Seven times over the course of four months the pharmacy filled prescriptions early.

The teenager’s prescriptions were covered by Medicaid, so she could get the pills for free – if she waited. Medicaid didn’t permit early fills. But that financial incentive wasn’t always enough to make her wait. In September, she paid $1,107 in cash to fill a script early. The next month, she again offered to pay cash, just three days before she would have received the same pills for free. That time, the pharmacy called the doctor to make sure the early fill was really okay.

On top of pain medication, the teenager was also filling prescriptions for Alprazolam, an anti-anxiety drug. According to WebMD, Alprazolam can slow a person’s breathing, an effect potentially magnified if the drug is taken with opioids. The Court of Appeals’ recent opinion in the case, from which I’m drawing these facts, is blunt: “When used in conjunction with other CNS depressants (such as Oxycontin and Oxycodone), Alprazolam can be toxic even at low concentrations.”

As you’ve probably guessed, this story doesn’t end happily. The teenager died of “multiple drug toxicity” on December 1, 2009, just 19 years old.

As the Court of Appeals notes, “The nation’s ongoing ‘opioid crisis’ (is) the subject of news reports and commentary almost daily.” The Journal of the American Medical Association reports that “the amount of opioids prescribed in 2015 [was] more than 3 times higher than in 1999.” 2015 saw 33,091 opioid-overdose deaths in the U.S., about half involving prescription drugs. With so much suffering, there is plenty of blame to go around. The teenager’s estate sued the doctor and the doctor’s clinic, and also added claims against the pharmacy.

The pharmacy’s argument against legal liability was straightforward. The prescriptions it filled were signed by licensed physicians and in every way valid. It’s not a pharmacist’s job to second-guess a doctor’s treatment decisions. Imagine how obnoxious it would be if the person behind the counter said, “Well, I disagree with your doctor about this choice of medication. I’m not going to fill your prescription.” A pharmacist who did that would arguably be practicing medicine without a license, and that’s a felony offense. A pharmacist’s paramount professional responsibility is simply to fill legitimate prescriptions with scrupulous accuracy, which the pharmacy did.

The teenager’s estate argued that more is required of a pharmacy. Its argument was supported by the state Board of Pharmacy’s regulations. Under the regulations, a pharmacist is required to be alert for signs of “clinical abuse/misuse” of opioids. Specifically, pharmacists should be suspicious whenever a patient fills an opioid prescription early or pays cash despite the existence of insurance, two things the teenager in this case did repeatedly. Once suspicions are aroused, the pharmacist is required to obtain the patient’s prescription history (known as a PMP report). And then? The regulations require the pharmacist to exercise professional judgment to decide whether to consult with the doctor or counsel the patient, and to document the decision-making process. No more forceful intervention is required.

The Court of Appeals agreed with the teenager’s estate that the standard of care owed by all New Mexico pharmacists to their patients includes strict compliance with the regulations. And the record before it did not reveal whether the pharmacy had complied in this case. That’s because the trial judge decided the case before trial on an incomplete factual record. In reversing the grant of summary judgment, the Court of Appeals didn’t find the pharmacy liable but only sent the case back to the trial court for more evidence. Specifically, the trial court was to determine whether the pharmacy did, in fact, take the steps laid out in the regulations. Even if the pharmacy fell short, a serious question would remain whether the lack of a PMP report and follow-up documentation really contributed in any meaningful way to the teenager’s sad end.

While this particular case continues, New Mexico’s other pharmacies are reminded that strict compliance with the opioid regulations can be an effective antidote to claims of legal liability.

If there are topics you would like to see Joel Jacobsen cover in future columns, please write him at legal.column.tips@gmail.com

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