Old drug, new life: Naloxone access expands to community pharmacies 


Innovations

When giving talks on naloxone, Jeffrey Bratberg, PharmD, BCPS, asks the audience, “How many of you dispensed opioids today?” All hands go up. “How many of you dispensed an opioid to someone you thought might not be using it correctly?” Everyone’s hand stays up. 


Any pharmacist who dispenses any prescription opioid—and any pharmacist who lives in a state that permits OTC sales of sterile syringes likely is serving some people who are misusing illicit substances, such as heroin—can target these patients for overdose education, and prevention, and naloxone, Bratberg told Pharmacy Today. He is Clinical Professor of Pharmacy Practice at the University of Rhode Island (URI) College of Pharmacy and an infectious disease clinical specialist at Roger Williams Medical Center.




Audrey DiRaimo, PharmD, CVS/pharmacy Manager, and Jeffrey Bratberg, PharmD, BCPS.

In 2012, health care providers wrote 159 million prescriptions for opioids, and a total of 41,502 deaths in the United States were caused by drug poisoning, of which 16,007 involved opioid analgesics and 5,925 involved heroin, according to CDC; prescription opioid abuse costs were about $55.7 billion in 2007. “Probably in the last 2 years, things have really picked up as policy makers started recognizing the human toll of the opioid overdose death epidemic. And it started percolating into the state legislature, and even national news,” Bratberg said. Pharmacists are becoming aware of naloxone again, he noted.

In 2014, APhA’s House of Delegates adopted policy on controlled substances and other medications with the potential for abuse and use of opioid reversal agents—policy that he helped draft and approve (see sidebar).


“There are millions of people at risk. There are thousands of people dying. They’re dying everywhere,” Bratberg said. “Anyone who’s concerned about drug safety should consider deploying naloxone as the effective antidote that it is to protect the patient.”


Three pharmacy-based programs


Pharmacy-based naloxone access programs have sprung up in pockets throughout the country. This article looks at the mix of issues faced by three such programs in Rhode Island, New Mexico, and North Carolina—all among the handful of states that have both naloxone access and drug overdose Good Samaritan laws.


First approved by FDA in 1971, naloxone is an antidote for opioid overdose. It is an opioid receptor antagonist at mu, kappa, and delta receptors that works at the opioid receptor to displace opioid agonists. It shows little to no agonist activity, and it shows little to no pharmacological effect in patients who have not received opioids. Three ways of administering naloxone are with an I.M. naloxone rescue kit, an intranasal naloxone rescue kit, or a naloxone handheld auto-injector (Evzio—Kaléo) that was approved by FDA in 2014.



Bratberg discusses intranasal naloxone administration technique with DiRaimo.

Information on naloxone use—such as a search box for the closest take-home naloxone program; patient, pharmacist, and prescriber education (e.g., URI College of Pharmacy continuing professional education); videos; and additional materials—is available via the Prescribe to Prevent website that was compiled by several naloxone access and overdose prevention advocates, including pharmacists, prescribers, public health workers, lawyers, and researchers. Information on state laws related to naloxone administration is available on the LawAtlas website.

It takes a village


These leading naloxone pharmacy programs began in just the past few years as community and statewide coalition responses to the national prescription drug abuse epidemic.


Rhode Island

In 2011, Bratberg’s future colleagues, including researchers and physicians, told the state board of pharmacy that Rhode Island—the nation’s smallest state—had an overdose death emergency. “We needed a way to get pharmacists to expand access to naloxone through the collaborative practice agreement [CPA] regulations,” his colleagues said—“and the plan was accepted by the board. But nothing happened.” 


But by September 2012, a series of connections and events led to Walgreens agreeing to stock naloxone in a four-store pilot program. With state board of pharmacy approval of a naloxone CPA that requires at least one prescriber and every participating pharmacist, the Rhode Island Pharmacy Foundation paid for 10 pharmacists to be trained using Bratberg’s student pharmacist’s rotation project to author the URI College of Pharmacy continuing professional education (that was referenced above).

A fifth Walgreens store was added to the pilot program. In June 2013, Walgreens expanded its naloxone program into all 26 stores in the state; more pharmacists were trained online, and naloxone was stocked. 
By early 2014, a massive spike in deaths led to naloxone access through behavioral health and by law enforcement. In August 2014, CVS Health—which is headquartered in Rhode Island—began stocking naloxone in all of its more than 60 pharmacies in the state, and several hundred CVS pharmacists were trained online. A statewide protocol involving informed consent from each patient was approved—“and that’s where we are today,” he said.


New Mexico

John Hutchinson, PharmD, BCPS, is Director of Health Outreach for Holy Cross Hospital in Taos, NM. The 29-bed acute care rural hospital is the sole community provider and owns some physician practices. In 2008, New Mexico was the state with the highest overdose death rate, dropping to second highest in 2010 and third highest in 2012. North-central New Mexico, where Hutchinson lives, is the epicenter of drug overdose deaths in the state—most unintentional, and most from prescription opioids.


The whole community response, he explained, begins with limiting the volume of opioids in circulation through elements such as safe opioid prescribing (e.g., not concomitantly prescribing benzodiazepines and muscle relaxants, running a prescription drug monitoring report, urine testing for drugs); drop boxes and disposals strategically placed throughout the community; and prescribing guidelines in the emergency department. It continues with treatment and recovery, behavioral health, the courts, a strong 12-step community, and school-based drug prevention talks. “The solution has to extend beyond the walls of our institution, and so we’re trying to engage the community at large,” Hutchinson said.


In that big picture, naloxone can “keep people alive and get them referred to treatments, and get them help,” he continued. For more than a decade, the New Mexico Department of Health has dispensed intranasal naloxone as part of its needle exchange program. But in January 2013, Holy Cross Hospital started a community-based intranasal naloxone program that is funded by the state department of health. Led by Hutchinson, the program aims to reduce prescription drug overdose deaths and to use the prescriptive authority for naloxone that New Mexico was first in the nation to grant to pharmacists.

In a collaboration among community pharmacy, hospital pharmacy, local physician practices, and clinics, intranasal naloxone kits are assembled by a pharmacist and dispensed to high-risk patients at the point of care. As Today went to press, approximately 130 kits had been dispensed since the program began, and four successful reversals had been reported—with none of the kits used on the person the kit was dispensed to. “When we’re dispensing these kits, these people are being educated,” Hutchinson emphasized. “The education piece is critical.”

North Carolina

In North Carolina, Project Lazarus is a secular nonprofit—focused more on the chronic pain aspect of opioid overdose—that was founded by a hospice chaplain and expanded statewide in partnership with Community Care of North Carolina’s (CCNC) Chronic Pain Initiative. The Chronic Pain Initiative is a broad coalition that includes CCNC, the North Carolina Hospital Association, local hospitals and emergency departments, primary care physicians, faith-based programs, and law enforcement; CCNC is a nonprofit that provides population health and care management services for the state’s Medicaid patients through 14 networks in all 100 of the state’s counties.


In Project Lazarus, which is funded by grant money and run by CCNC, CCNC network pharmacists work with chronic pain coordinators to place the basic kits—a box containing two nasal atomizers, a step-by-step naloxone use guide, and an instructional DVD on overdose prevention—into mostly community pharmacies as well as physicians’ offices. When a community pharmacist fills a prescription for naloxone, he or she puts the naloxone in the kit and gives the completed kit to the patient, according to Theodore Pikoulas, PharmD, BCPP, Associate Director of Behavioral Health Pharmacy Programs at CCNC’s Raleigh headquarters. Pikoulas developed the four-page document for community pharmacists that explains how to order naloxone and how to educate patients about naloxone.



Carmen Oquendo, PharmD, Walgreens Pharmacy Manager, and Holly Cekala, Executive Director, RICARES (L–R).


CCNC network pharmacists also offer short, informal education for prescribers, including lunch-and-learns with physicians, on naloxone issues (e.g., what naloxone is, who is at risk for opioid overdose, and how to prescribe naloxone to a patient); and advocate for physicians to use the state prescription drug monitoring program.

Roadblocks on the path to 
public health


Pharmacists interested in getting naloxone into their communities may find themselves up against barriers that have already been experienced by others. 


Getting started

The conversation that pharmacists could start having is with the patient’s prescriber, Bratberg said. A phone call to the doctor—“Hi, I’m just sharing your concern for your patient’s safety, and I’d like to get a prescription for naloxone”—is a way to change prescribing behavior. He noted that all 50 states plus the District of Columbia allow pharmacies to stock all forms of naloxone, which is not a controlled substance. 
Pharmacists don’t have to reinvent the wheel. “I would reach out to my state association,” Hutchinson said. “Familiarize yourself with what is going on around your state, and then piggy-back off of the work that other people have done. … Look at the resources you have in your community. Gather those resources, and then bring them to bear.” He offered to answer questions at jhutchinson@taoshospital.org.

Stigma


Members of the Rhode Island Drug Overdose Prevention and Rescue Coalition—comprising public health, emergency medicine and epidemiology, pharmacy, law enforcement, behavioral health, and more— strategize statewide solutions for the opioid overdose epidemic.

Hutchinson has not encountered as much of a stigma barrier because “we have a more liberal population here in the north, and the overdose death rate is just so staggering in terms of numbers relative to the United States that it was not a far stretch to get the community and the physicians on board.”

But stigma around addiction exists in other parts of New Mexico and the United States. According to Pikoulas, some physicians aren’t willing to prescribe naloxone to the patient because of a belief that naloxone would be a safety net that would encourage risky behavior, while other physicians don’t realize that a patient with chronic pain—who is on multiple opioids, and medications that can interact with opioids—could benefit from naloxone.


“The stigma comes about by thinking that it’s those people,” Bratberg said, “and we shouldn’t be paying for their programs. ‘Addiction is not a disease, and addiction is something that you choose. You chose to go use drugs. Your life, as a result, is of your own design.’ I think the key turning point is realizing this is like: Do we not take care of people with diabetes because they ate the wrong foods, or had a genetic predisposition for the disease?” People with substance use disorders, he explained, should be treated as compassionately as people with diabetes. 


“The ultimate goal here is recovery,” Bratberg said. “People who die of an overdose did not deserve it. They deserve to live and to have their chronic disease managed.” Pharmacists can reduce stigma by treating all patients as people whose life is equally valued.


Funding

Pikoulas, Hutchinson, and Bratberg all noted that naloxone’s price has been doubled by the manufacturer because of the demand.
 Specific to North Carolina, although Medicaid and some private insurers cover the cost of the actual naloxone drug, “we’ve run into challenges getting the nasal atomizer covered,” Pikoulas said. Nasal atomizers are about $4 or $5 each on average, and each kit has two doses for a total of $8 to $10 in cost. It doesn’t seem like much, he explained, but it can be a substantial cost to patients who already have multiple medication copays each month or who don’t have insurance. Unlike states such as New Mexico that provide additional reimbursement for naloxone patient education, North Carolina public and commercial payers do not offer additional reimbursement.

The next step is to make Project Lazarus financially sustainable and “to figure out how to get naloxone in the hands of more people.” 
Time is also a barrier in Hutchinson’s state. While 15 minutes of patient education are funded by insurance in New Mexico, every insurer has a different reimbursement strategy for those 15 minutes that may not adequately pay for the pharmacist’s time. 
In Rhode Island, Bratberg said, Walgreens and CVS Health train patients on proper use of naloxone when they purchase the medication. “A patient can be trained to recognize overdose, call 911, rescue breathe, assemble and administer an intranasal kit, or draw up and inject an I.M. naloxone dose—in less than 5 minutes,” he said. “That actually was one of the big conversations we had when we were talking to CVS and Walgreens.”


State laws catch up


Roughly one-half of states don’t have a naloxone access law, but existing state laws that facilitate naloxone access can be categorized in several ways. According to the LawAtlas webpage cited above, these categories include the following: the jurisdiction has a naloxone law; prescribers are immune from criminal liability; prescribers are immune from civil liability; third-party prescriptions are authorized; prescription by standing order is authorized; lay administrator is immune from criminal prosecution; lay administrator is immune from civil liability; and criminal liability is removed from possession of naloxone.


“I feel very passionate that this is a very good niche for pharmacists to rise to the call, and take action—because this is everything that we’re about,” Hutchinson said. “It’s medication safety. It’s education. It’s saving lives. It’s community service. It’s everything in our creeds and oaths that we take as pharmacists.”