Naloxone: Liability, regulatory concerns for pharmacists

As the epidemic of opioid abuse and heroin use in the United States continues, when it comes to dispensing naloxone to treat overdose, in many states pharmacists are on the front lines. So you need to be aware of the liability and regulatory considerations connected with naloxone.

Christopher HerndonThose concerns were the focus of a discussion at the meeting of the American Pharmacists Association held in Baltimore this year, moderated by Christopher Herndon, PharmD, BCPS, associate professor in the Department of Pharmacy Practice at Southern Illinois University, Edwardsville, School of Pharmacy.

Some states provide immunity to prescribers and dispensers of naloxone, Herndon said. Others allow a physician to issue standing orders for naloxone prescriptions, enabling pharmacists to dispense as needed to patients at risk of respiratory depression. Yet other states allow prescribing to a third party (e.g., a family member of a drug abuser).

Naloxone can be administered by intravenous, intramuscular, and subcutaneous injection; intranasal spray; and intramuscular autoinjection. Adverse reactions are minimal, although severe withdrawal symptoms may result from the overdose. If a long-acting opioid was taken, more than one dose of naloxone may be needed.

During the discussion, Anthony Tommasello, RPh, PhD, medical affairs manager with Indivior in Richmond, Va., advised pharmacists not think of naloxone only as a rescue drug to be used for a heroin overdose. “This is not just about heroin users … it is about the widespread use of opiates throughout the population,” Tommasello said. “[The] individuals at risk of overdose include people who are recipients of chronic high-dose opioid pain management in various forms.”

Community education can help reduce deaths from unintentional opioid overdose, Tommasello added. Citing a study by Walley et al, he said, “As the community became more educated about the availability and use of intravenous naloxone, there was a significant reduction in death rates from opioids.”¹

Opioid-related hospital admissions and deaths have trended upwards in recent years as retail sales of these drugs increased, Tommasello noted. Also, implementation of PDMPs for opioids has been accompanied by an increase in heroin use, he added.

Jeffrey FudinJeffrey Fudin, PharmD, DAAPM, FASHP, a clinical pharmacy specialist and PGY2 pain residency director at Stratton VA Medical Center in Albany, N.Y., addressed other key issues, including whether naloxone administration routes are interchangeable.

Edwards et al. found that naloxone is used correctly more often with certain routes of adminstration.² Specifically, 90% of patients were able to use an autoinjector correctly a week after being trained, compared to approximately 57% who used the intranasal route.

Intranasal administration may be adversely affected by a deviated septum or an infection. Intramuscular injection has about the same response rate as intravenous injection, while intranasal can take a minute or two longer, he added.

On the other hand, intranasal administration eliminates the need for needles and the risk of exposure to bloodborne pathogens, and the nose is usually easy to access in an unconscious patient. 

References

1. Walley AY, Xuan Z, Hackman HH, et al. Opioid overdose rates and implementation of overdose education and nasal naloxone distribution in Massachusetts: Interrupted time series analysis. BMJ. Jan. 31, 2013; 346:f174.

2. Edwards, ET, Edwards ES, Davis E, et al. Comparative usability study of a novel auto-injector and an intranasal system for naloxone delivery. Pain Ther. 2015 Jun;4(1):89-105.