Pharmacists gain recognition for role in naloxone access
FDA meeting and state laws on public health issue
Gov. Terry McAuliffe of Virginia signed HB 1458 into law this April. Designed to increase access to naloxone for opioid users and their families, the new legislation makes pharmacists an additional access point.
Virginia is among 24 states with either active legislation or proposed legislation to give pharmacists some level of authority to dispense naloxone at their discretion. Additional states may soon follow suit. In July, FDA hosted experts from health care, academia, government, industry, and patient advocacy groups at a scientific session to discuss issues related to naloxone access and uptake. Presentations on the current and future role for pharmacists were met with enthusiasm. Nationwide, public health experts are engaged in an ongoing dialogue on how to optimize naloxone use to prevent opioid deaths. Increasingly, pharmacists are gaining recognition for the part they can play in this public health issue.
“The public certainly looks at a pharmacist as a vital first line for health care, not just for cough and cold, but in emergency situations as well,” said Timothy Musselman, PharmD, Executive Director of the Virginia Pharmacists Association.
State laws vary
Pharmacists’ authority to dispense naloxone without a prescription varies by state. In Virginia, pharmacists who want to stock and dispense the drug must have a signed standing order from a prescriber. Pharmacists can dispense naloxone in accordance with protocol and under conditions described in the order.
“The standing order could be written broadly to allow a pharmacist to dispense naloxone to anyone who requests it or to anyone who is at risk of overdose,” said Caroline Juran, BSPharm, Executive Director of the Virginia Board of Pharmacy.
In many cases, an opioid or heroin user’s loved one requests naloxone to keep on hand in case of an overdose. In Virginia, people who accept the medication must receive counseling from the pharmacist or complete the Virginia Department of Behavioral Health and Developmental Services’ naloxone education program.
“The majority of opioid overdoses are witnessed,” said Jeffrey Bratberg, PharmD, BCPS, Clinical Professor at the University of Rhode Island College of Pharmacy. “It’s about getting the people in that household to recognize the signs of overdose and equipping them to [administer naloxone].”
Naloxone saves lives
Prescription opioid overdoses killed 16,235 people in 2013. Heroin overdose killed another 8,257. Overdoses can be accidental and the result of legitimately obtained prescription drugs, or the result of abuse of prescription opioids or heroin. When administered in time, naloxone can stop the effects of these drugs and prevent death.
A survey of 136 organizations that provide naloxone kits and training to laypeople found that, from 1996 to 2014, the organizations distributed 152,283 naloxone kits, which reversed at least 26,463 overdoses. The World Health Organization recommends that people likely to witness an overdose have access to naloxone and training in its proper use. Pharmacists know and have relationships with patients or their family members who pick up opioid prescriptions. Legislation that makes pharmacists a point of access for naloxone allows them to play a key role in a growing public health concern.
“Allowing pharmacists to dispense naloxone pursuant to a standing order will potentially increase access to naloxone, prevent unnecessary deaths, and provide an opportunity for patients to receive appropriate treatment,” said Juran.
While many states authorize pharmacists to stock and dispense naloxone at their discretion, that doesn’t mean that pharmacists will. A number of barriers remain.
At the recent FDA scientific session on naloxone, pharmacists expressed concern about the time and cost involved in certifications required in their states. Others acknowledged that dispensing naloxone in their pharmacies is a challenge because the time required for counseling may not be billable.
Stigma is also a significant barrier. It not only keeps patients and families from picking up naloxone prescriptions, but it also keeps some pharmacists from filling them. Similar to initial reactions to needle exchange programs, critics of naloxone programs believe the antidote will only increase drug use.
“That isn’t the public health perspective at all,” said Krystalyn K. Weaver, PharmD, Director of Policy and State Relations for the National Alliance of State Pharmacy Associations. Weaver presented at the FDA meeting.
“We need more education about how naloxone is saving lives,” she said. “It’s a ‘first do no harm’ perspective. We need to let people live long enough to get to rehab someday.”