Gov. Paul LePage’s administration has yet to produce the regulations needed to implement a law that passed more than 2 ½ years ago allowing public health groups to distribute free doses of the overdose reversal drug naloxone.
The law, which passed the Legislature in June 2015 and became law without LePage’s signature, authorized organizations that work with “populations at high risk for a drug overdose” to establish overdose prevention programs through which they train drug users and others in administering naloxone, known commonly as Narcan, and distribute it to them at no cost.
Under the law, it’s the responsibility of Maine’s Department of Health and Human Services to develop rules that specify the kinds of organizations that can distribute naloxone, the protocol for establishing distribution programs, and requirements for the training they give before distributing the overdose antidote.
However, more than 2 ½ years after the law’s passage, no such rules have taken effect.
DHHS has not submitted the required rules to the attorney general’s office for a legal review, a required step before rules can take effect, said Melissa O’Neal, a spokeswoman for the attorney general’s office. Kristen Muszynski, a spokeswoman for the secretary of state’s office, confirmed there are no rules on file to implement the 2 ½-year-old law. Agencies must file rules with the secretary of state’s office before they can take effect.
A spokeswoman for DHHS, Emily Spencer, didn’t respond to repeated requests for comment from the BDN on the status of the rules to implement the naloxone distribution programs. A request for comment from Mary Mayhew, who served as DHHS commissioner when the 2015 law passed and is now running for governor as a Republican, went unanswered Monday.
“Nobody anticipated that it would be two, three years later that we’d still be waiting,” said Patty Hamilton, public health director for the city of Bangor. “Who knew that it would take this long?”
Hamilton took steps after the 2015 law’s passage to distribute naloxone through Bangor’s public health department. With no rules in place, however, city lawyers didn’t allow the program to move forward. City officials expected rules would soon be forthcoming from DHHS, Hamilton said.
Without those rules, the law “wasn’t clear about whether we could do it, and we didn’t want to run the risk of running afoul of the law,” she said.
The rules DHHS must produce are considered “routine technical,” so the agency is required to write the regulations, accept and respond to public comments on the proposed rules, and secure a legal sign-off from the attorney general’s office before the rules can take effect. No legislative approval of the rules is required.
The rules required of DHHS are distinct from rules approved last week by the Maine Board of Pharmacy allowing pharmacists to dispense naloxone without a doctor’s prescription.
Even with no rules governing naloxone distribution programs, the nonprofit Health Equity Alliance, which works with drug users throughout much of eastern Maine, started distributing naloxone in May 2016, giving out 252 naloxone kits that year, at least 60 of which were used to reverse overdoses, according to the group.
“Given the administration’s position on naloxone issues, we didn’t feel like waiting was an option,” said Ross Hicks, the alliance’s harm reduction specialist.
In 2016, LePage vetoed legislation allowing pharmacists to dispense naloxone without prescriptions, and authorizing police officers and firefighters to carry the drug, writing in his veto message, “Naloxone does not truly save lives; it merely extends them until the next overdose.” His administration has also acted slowly to implement a range of other legislatively approved initiatives to expand addiction treatment options. And, more recently, LePage allowed rules implementing the 2016 law — the Legislature overrode his veto to pass it — to linger in his office for five months without approving them so they could take effect.
Some 376 people died of drug overdoses in Maine in 2016, a 38 percent increase over 2015, when 272 people died from overdoses. As of mid-2017, the state was averaging about one overdose death per day, according to figures from the attorney general’s office.
The Health Equity Alliance continues its distribution effort in the absence of DHHS rules.
“We were able to boil it down and get naloxone into the hands of people who are at high risk or around people who are at high risk,” Hicks said. “We just can’t do it in compliance with rules because there are none.”
When they distribute naloxone, Health Equity Alliance staff train those picking up the overdose antidote to administer it and to minimize the risk that an overdose will occur. The alliance has purchased naloxone with the help of fundraising in the Bangor area and by applying for grants. The alliance runs the risk, however, of carrying out a program that doesn’t comply with the rules the state ultimately establishes.
“We would just like to do it without worrying about breaking the law,” Hicks said.
Hicks said he would adjust the Health Equity Alliance’s program to conform with state rules if they came out. The new state rules authorizing pharmacies to sell naloxone without a prescription are important, Hicks said. It’s also important that naloxone be available to those who might not visit a pharmacy and are unable to afford the drug, he said.
“People freak out about going to the pharmacy or talking to their doctor, especially if they themselves are using drugs,” he said. “We’re kind of a safe place. They’re able to talk to us without worrying about being judged or anything.”
This story appears through a media sharing agreement with Bangor Daily News.