Updated at 4:16 p.m. Sept. 2 with information from pharmacies — According to a spokesperson with the state department that oversees the Missouri Board of Pharmacy, Missouri pharmacies do not have to wait for final rules from the board before distributing the opioid overdose antidote naloxone without a prescription.
“The new provisions are ‘self-executing’ and do not require a Board rule for implementation. This means pharmacists with a valid protocol are authorized to dispense naloxone, as of [Aug. 28, 2016],” said Yaryna Klimchak with the Missouri Department of Insurance, Financial Institutions & Professional Registration.
Klimchak said the state pharmacy board decided not to require rules during it’s July board meeting, meaning the only thing Missouri pharmacies are required to do before offering naloxone without a prescription is find a doctor willing to oversee their pharmacists. That involves updating their physician protocols; pharmacies that offer flu shots already have a protocol in place.
However online guidelines published by the state pharmacy board recommend that pharmacists receive training before dispensing naloxone and that pharmacists educate patients before giving them antidote.
“The Board is in the process of reviewing applicable protocol standards,” the online guideline says. “In the interim, the Board suggests that naloxone protocols include provisions / requirements for:
• Pharmacist education and training
• Emergency notification and documentation
• Patient education and counseling, and
• Protocol review, signatures and timeframe.”
Spokespersons for Walgreens and CVS told St. Louis Public Radio last week that they were reviewing Missouri’s naloxone requirements and hoped to offer the antidote without a prescription in Missouri in the future. Both Walgreens and CVS offer naloxone without a prescription in a number of other states and are working to do the same in Missouri and Illinois.
Contacted again after the law went into effect, Walgreens' Paul Caruso said the company is in the process of updating its physician protocols. Erin Britt of CVS said her company has to train all of its Missouri pharmacists before taking advantage of the law.
Paul Simon of Schnucks told St. Louis Public Radio Wednesday that the lack of new pharmacy board rules didn't change anything for Schnucks — the grocery chain is still looking at what it would take to offer naloxone without a prescription and deciding whether to do so.
An alert sent Monday by the state pharmacy board to all pharmacists licensed in Missouri may have provided clarity. It provided a link to its online naloxone guidelines and told pharmacists that “Missouri licensed pharmacists dispensing naloxone under the new law do not have to notify the Board and no additional license/certification is required.”
Ron Fitzwater, the CEO of the Missouri Pharmacy Association, originally told St. Louis Public Radio that the Missouri Board of Pharmacy would be issuing rules based on the new law, a process that would take several months.
But Tuesday Fitzwater said what he thought would be rules are instead recommendations.
Original story from Aug. 28 — It will likely be months before members of the public can get the opioid overdose antidote naloxone at Missouri pharmacies without a prescription.
A new state law expanding access to the live-saving drug went into effect Sunday, but according to Missouri Pharmacy Association CEO Ron Fitzwater the state’s pharmacy board still has to create rules based on the law.
With the alarming rise in opioid overdose deaths in recent years, there’s been a push nationwide to increase access to naloxone, also known as Narcan. The antidote is highly effective at reversing an overdose on heroin, prescription painkillers or other opioids, but it must be administered within five to 10 minutes. Once someone has stopped breathing and their heart has stopped beating, it is usually too late.
“The Board of Pharmacy will push it as fast as they can get the approval up the system through the Department of Professional Registration, through the governor’s office, to get the proposed rules put out and then there’s a comment period,” Fitzwater said. “But I would anticipate anywhere from 90 to 180 days to get the final rules in place.”
Once those rules are in place, pharmacies will have to analyze them and follow its requirements.
If Missouri follows Illinois’ timeline, it could be a year or more before the first pharmacies in the state offer the antidote without a prescription.
Illinois’ law allowing anyone to purchase naloxone at a pharmacy without a prescription went into effect in September 2015, but the state’s regulations didn’t come out until the following spring. One of the requirements is that pharmacists undergo training before they can sell the antidote.
“It helps get the pharmacists understanding what the new law is and how that state protocol works, and steps them through what they need to counsel a patient on,” said Garth Reynolds, the executive director of the Illinois Pharmacists Association, which developed the training with Southern Illinois University-Edwardsville faculty.
Reynolds said a number of pharmacies have gone through the training, but he wasn’t sure whether any pharmacies were yet offering naloxone without a prescription.
Spokespersons for Walgreens and CVS said their companies were still working to comply with Illinois’ regulations.
Walgreens, CVS and Schnucks also told St. Louis Public Radio they are looking into Missouri’s requirements.
But in the meantime both Reynolds and Fitzwater stressed that naloxone is available with a prescription in both states.
“Nothing before this law was passed in September prevented people getting access to naloxone. We could always get it through an individual prescription,” Reynolds said of Illinois. “But what this has done is allowed it so that [there are fewer] barriers to getting more readable access to it in getting it as quickly as they can for people who feel they need to have it in their home or business.”
However, Fitzwater said Missouri’s new law does expand who doctors can prescribe the antidote to once the law is fully implemented.
“Most pharmacies have it in stock and as long as they have a valid prescription will continue to dispense it. This will just broaden, once it’s fully implemented, who they can dispense it to,” Fitzwater said. “They would have had to prescribe it directly to the patient (before). And as you well know, there’s not a lot of use for the patient having it because they would be the one in the overdose situation.”
One potential complication for pharmacies wanting to take advantage of the law in Missouri is that each individual pharmacist will have to make arrangements with individual doctors who agree to oversee the pharmacist in what’s called a physician’s protocol. They are also needed for administering flu shots.
Reynold’s said Illinois has one physician’s protocol for naloxone issued by the state’s health department that covers all of the pharmacies.
But in Missouri a blanket protocol isn’t possible because state law requires individual protocols between doctors and pharmacists located within 50 miles of each other.
Follow Camille Phillips on Twitter: @cmpcamille.
