BETHESDA, MD 24 Jul 2014—The response to Rhode Island's crisis of opioid-related overdose deaths includes a collaborative practice model through which a single physician authorizes the dispensing of naloxone kits at multiple pharmacies to anyone who may encounter an overdose victim.
The program began in 2012 as a pilot project at four Walgreens pharmacies before expanding last year to all 26 Walgreens pharmacies in the state, said University of Rhode Island Clinical Associate Professor of Pharmacy Jeffrey Bratberg.
Now, anyone can walk into any of the chain's pharmacies in the state and leave with a naloxone kit and training in its use without first obtaining a prescription for the drug.
Bratberg helped present the idea for the collaborative practice model to the state board of pharmacy and has been raising awareness among healthcare providers about the importance of making naloxone widely available to prevent overdose deaths.
"It's my new passion," said Bratberg, an infectious diseases specialist who is also active in public health issues.
In all, Bratberg said, 79 Walgreens pharmacists in Rhode Island have completed an online training module for naloxone dispensing and signed the collaborative practice agreement overseen by Miriam Hospital physician Josiah Rich.
Rich is also codirector of the Center for Prisoner Health and Human Rights, based at the hospital.
The online training module was developed by a student at the University of Rhode Island College of Pharmacy. Bratberg said the training module is freely available for viewing or can be completed for continuing education credits through the university for a small fee.
"It's been used worldwide—there's people in Australia who've done it," he said. "Last spring, I got calls from Utah, and Maryland, and Virginia, and lots of other states that are very interested, and I just direct them to the program."
Bratberg said some states may not be able to craft collaborative practice agreements that allow a single physician to authorize dozens of pharmacists at multiple sites to dispense naloxone.
"In other states, the prescriber needs to have a relationship with the patient," he noted. But he said nothing should prevent a prescriber from recognizing patients in the practice who are at risk for opioid addiction and ensuring that they have access to naloxone.
Bratberg urged pharmacists to learn about naloxone as a remedy for opioid overdose because the country is flooded with opioids, and patients are dying as a predictable result of exposure to these highly addictive drugs.
And he noted that pharmacists are the last check in an opioid-prescribing process "that gets people dependent and leads to addiction."
The numbers. Centers for Disease Control and Prevention (CDC) Director Thomas Frieden said on July 1 that 259 million prescriptions for opioid drugs were dispensed at pharmacies during 2012.
"That's enough for every American adult to have their own bottle of pills," Frieden said.
Rhode Island ranks in the middle nationally for opioid prescribing, with about 90 prescriptions filled per 100 population in 2012, according to CDC.
CDC in 2011 declared that opioid overdosage deaths were at an epidemic level nationwide. According to the agency, about 110 Americans died of a drug overdose every day during 2011, and prescription opioids were a factor in nearly 17,000 overdose deaths that year.
Rhode Island's health department in March announced that 50 opioid-related deaths had been reported in the state since the start of the year. The department enacted emergency regulations at that time and called expanded access to naloxone an "immediately necessary priority to save lives."
Bratberg said overdose deaths nowadays aren't limited to stereotypical i.v. drug users—anyone may succumb to addiction.
He said that during a presentation he gave to about 100 pharmacists in Connecticut, half of the participants raised their hands when he asked if they knew someone who suffered or died from opioid overdose.
"That was shocking to me, even knowing the exposure and knowing what's happening," Bratberg said.
Enter naloxone. Naloxone hydrochloride, an opiate antagonist that rapidly reverses the effects of opioids on the respiratory and central nervous systems, was approved by FDA in 1971. The drug is indicated for intravenous, intramuscular, or subcutaneous injection but has also been widely administered intranasally using a syringe and atomizer.
FDA in April approved Evzio, a naloxone autoinjector device marketed by Richmond, Virginia–based Kaleo Inc. that delivers an intramuscular or subcutaneous dose of the drug.
According to CDC, naloxone distribution through community-based opioid prevention programs resulted in the reversal of 10,171 overdoses from 1996 through 2010.
Under its March emergency regulations, Rhode Island allowed prescribers "to issue a non-patient-specific order to numerous organizations, such as police departments," to increase the availability of naloxone at the scene of an overdose—a model similar to that used at Walgreens.
State police officers in Rhode Island now carry a naloxone kit, assembled by the state's disaster medical assistance team, in their cruisers and have been trained in intranasal administration of the drug. The police department in May announced that a trooper had administered an intranasal dose of the drug to an overdose victim during a traffic stop and saved the person's life.
In Massachusetts, which declared an opioid-related public health emergency in March, all first responders are authorized to carry naloxone, and pharmacies may use a standing order, signed by a collaborating state-licensed physician, to dispense "naloxone rescue kits" to the general public.
New York Attorney General Eric Schneiderman in April announced the launch of a program to expand the availability of naloxone to law enforcement agencies in the state. And New York City on July 1 graduated the first class of police officers to be trained in the use of naloxone, according to the police department.
U.S. Attorney General Eric Holder has urged law enforcement agencies to train their personnel in naloxone administration and to equip them with the drug. A total of 19 states had passed some sort of naloxone access law as of April 2014, according to the White House Office of National Drug Control Policy.
Bratberg said law enforcement and public health efforts to increase access to naloxone are part of the broader goal of making the antidote a routine part of opioid prescribing and use.
"The ultimate goal is to have the public, everyone, asking [for naloxone]; for the prescriber to say, 'Do you want naloxone with that?' and write a prescription; and the pharmacist to say, 'Do you want naloxone with that?' and either initiate a prescription or ask the prescriber for one; or have the patient say, 'I'm really worried about how many opioids my family member is on—I'd like to have naloxone in my house and be trained on it,'" Bratberg said.
"You never know when you're going to truly save a life," he said.