AUGUSTA — The LePage administration on Thursday approved long-delayed rules allowing individuals to obtain the overdose reversal drug naloxone without a prescription, but did so only after the Maine Board of Pharmacy raised the minimum age to 21.
Six months after first approving the policy, the board voted unanimously again Thursday morning, but this time restricted non-prescription sales of naloxone to people 21 or older in order to appease objections raised by Gov. Paul LePage. A senior staff member in LePage’s office signed the rules a few hours later.
It could still be months before eligible Mainers can purchase naloxone – also known by the brand name Narcan – because the board will open a 30-day public comment period and then has 120 days to formally adopt the rules, although the board can act faster. The delays come at a time when Maine, like many others states, is struggling to cope with record numbers of drug overdose deaths linked to a surge in heroin and prescription opioid abuse.
Still, Thursday’s thaw on the rules moves Maine one step closer to adopting a policy already in place in most states, but that has been stalled in bureaucratic and political limbo for about a year and a half in Maine.
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“It’s progress, certainly, over not having the rules whatsoever,” said Kenney Miller, executive director of the Maine Health Equity Alliance, which runs needle exchange programs and distributes naloxone to at-risk clients. “But the timeline is still troubling because it will be a few more months before this is going into effect.”
Miller and others involved in the debate over Maine’s response to the opioid crisis also questioned the rationale behind the board’s decision to increase the minimum age from 18 to 21.
“Eighteen- to 21-year-olds are at higher risk of overdose,” said Dr. Mark Publicker, a Portland-based addiction treatment specialist and past president of the Northern New England Society of Addiction Medicine. “They are less experienced, they have less of a support system and are more likely to inject together.” So increasing the age “without reason,” Publicker said, could increase the likelihood of young people dying.
MINIMUM AGE CHANGE ‘A PETULANT ACTION’
Naloxone quickly reverses the deadly effects of an opiate overdose and has been administered thousands of times in Maine in recent years, largely by emergency responders. Yet Maine is one of the few states in the nation not to allow pharmacists to dispense naloxone without a prescription.
The new rules will allow people either at risk of an overdose – whether because of drug abuse or because they take high-dosage prescription opioids – as well as family members or close friends of at-risk individuals to purchase naloxone. Pharmacists, in turn, must complete a two-hour training session in order to dispense naloxone without a prescription and then provide detailed instructions to recipients on spotting an overdose, administering the drug and contacting emergency personnel.
Lawmakers passed a bill instructing the Board of Pharmacy to craft the rules in 2016. But the board sent the rules back to the Legislature because members said some language was unclear, forcing lawmakers to pass an amended bill last year.
House Speaker Sara Gideon, D-Freeport, said she was grateful for the “clarity,” but that increasing the minimum age from 18 to 21 was inconsistent with the naloxone dispensation law passed by the Legislature in 2016. Gideon vowed to continue working “to ensure the Board of Pharmacy follows the law.”
“Addiction knows no age. Overdoses can strike at 18 or 19 or 29 or 54,” Gideon said in a prepared statement. “And in every instance, at every age, we should do everything in our power to save every life possible. What the Board of Pharmacy did today has no basis in medical research or expert opinion, it was merely a petulant action at the behest of Gov. LePage that directly contradicts legislative intent.”
LEPAGE’S RATIONALE CALLED ‘INDEFENSIBLE’
Maine recorded at least 376 drug overdose deaths in 2016 – an average of more than one death per day – with the vast majority caused by heroin, prescription opiates or the synthetic opiate fentanyl. Roughly 2 percent of opioid-related overdose deaths that year – or six out of 317 deaths – involved victims under 21, according to information provided Thursday by the Maine Attorney General’s Office.
Although totals for 2017 have not yet been released by that office, figures for the first half of the year showed Maine was on a similarly grim pace of roughly one overdose death per day.
LePage has consistently opposed allowing Mainers to purchase naloxone without a prescription and he had vetoed the 2016 bill, only to see his veto overridden by the Legislature.
“Naloxone does not truly save lives; it merely extends them until the next overdose,” LePage wrote in his veto letter. “Creating a situation where an addict has a heroin needle in one hand and a shot of naloxone in the other produces a sense of normalcy and security around heroin use that serves only to perpetuate the cycle of addiction.”
He repeated that argument as recently as Tuesday during an interview on Maine Public. And earlier in the week, LePage told the New England Cable News Network that he opposed the 18-year-old age threshold in the rules because Maine recently raised the legal age to buy tobacco products from 18 to 21. He said he believed the minimum age for buying naloxone also should be 21, although the drug has no physiological effect on a person unless they are suffering from an opioid-induced overdose.
Publicker called that rationale “indefensible” because, unlike tobacco or alcohol, naloxone is a non-addictive drug that actually saves lives. Publicker also took offense at LePage’s repeated statements that naloxone doesn’t save lives but only extends them.
“What, exactly, is the matter with extending a person’s life?” Publicker said. “A cardiac surgery is usually only extending a person’s life, not curing them. . . . So extending a life, especially for a young person, strikes me as a good thing.”
AMONG STATES, MAINE’S AN OUTLIER
There are conflicting views about whether LePage should have been given any role in approving the rules allowing pharmacists to sell naloxone without a prescription.
Attorney General Janet Mills said the Board of Pharmacy could publish and finalize the rules without LePage, but board chairman Joe Bruno said the board was following protocol in awaiting the governor’s approval. LePage, meanwhile, said on several occasions that he didn’t know anything about the rules, but then commented earlier this week that he did not believe they even required his signature.
Amid the confusion, Walgreens and some other pharmacies in Maine obtained “standing orders” from a physician to dispense naloxone without an individual prescription, while others, including CVS and Hannaford, have said they were waiting for the final rules.
More than 40 other states allow naloxone to be dispensed without a prescription, making Maine a national outlier despite the severity of the opioid crisis in the state.
LePage spokeswoman Julie Rabinowitz said the amended rules were consistent with the governor’s stance that Mainers should have to be 21 to buy naloxone if they need to be 21 to buy cigarettes or alcohol.
Rabinowitz said LePage directed his senior policy adviser for matters under the jurisdiction of the Department of Professional and Financial Regulation to sign off on the rules after verifying that the age to buy naloxone over the counter without a prescription had been raised to 21.
“Note: The governor himself does not sign rules, that is done by policy advisers for the respective agency after consultation with the governor,” Rabinowitz said in a prepared statement. “As such, today’s rule sign-off is consistent with the manner in which previous rules have been approved by the Governor’s Office following the standards set forth in the (Administrative and Procedures Act).”
Kevin Miller can be contacted at 791-6312 or at:
Twitter: KevinMillerPPH
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