Naloxone Prescribed With Every Opioid?

As opioid-related deaths across the country skyrocket, more and more state, national, and international groups are calling for widespread community access to naloxone, a drug that reverses opioid overdose.

While naloxone has traditionally been administered in a hospital or medical setting by trained emergency responders, the drug is now available as a “take-home” product that can be administered in the event of an emergency by a family member or others.

Experts discussed the opioid epidemic and the need for an opioid emergency plan — which could include a prescription for naloxone — during a supported satellite symposium at the American Academy of Pain Medicine (AAPM) 2016 Annual Meeting. The session was funded by Kaléo Inc, whichmakes a naloxone product.

Life-threatening Emergencies

Some patients taking opioids are at increased risk for opioid-induced respiratory depression (OIRD), which can be life-threatening. OIRD can lead to hypoxia, which may cause brain damage within 4 minutes, as well as coma and death.

During the session, Michael Brennan, MD, Department of Medicine, Bridgeport Hospital, and chief medical officer, The Pain Center, Fairfield, Connecticut, described the case of a 5-year-old who stepped on a fentanyl patch left on the kitchen floor. By the time he got emergency medical attention, it was too late, and he died of respiratory depression.

From 2004 to 2011, there was a 225% increase (from 1596 to 5187) in the number of emergency department (ED) admissions for accidental ingestion of prescription opioids by children 5 years and under, said Dr Brennan.

This is in addition to the adult overdose cases. In 2010, 135,971 adult visits to the ED were related to opioids. The average length of hospital stay was 3.8 days. Up to 10% of these patients required mechanical ventilation.

Home Accidents

Most opioid emergencies occur in the home, and most are witnessed, usually by close friends, a “significant other,” or family member, “who can perhaps intervene,” said Dr Brennan.

Some emergencies result in accidental death. Delegates heard that in 2014, 18,893 deaths were related to opioid prescriptions in the United States, or 52 deaths every day, and of these, 84.2% were unintentional. That represents a 16% increase over the previous year.

The US Food and Drug Administration (FDA) has approved two products that reverse opioid overdose: a naloxone nasal spray (Narcan, Adapt Pharma Inc) and naloxone auto-injector (Evzio, Kaléo Inc). Another approved product is a combination of oxycodone and naloxone and has abuse deterrent properties (Targiniq ER, Purdue Pharma LP).

Risk factors associated with OIRD include comorbidities such as chronic obstructive pulmonary disease and kidney or liver disease, which might interfere with the metabolism or elimination of an opioid, according to Eric Edwards, MD, PhD, chief medical officer and vice president of research and development, Kaléo Inc.

In addition, he said, patients with a history of a substance abuse are at increased risk, as are patients who are also taking a benzodiazepine and anyone with a psychiatric disorder such as depression, anxiety, or bipolar disorder.

“They should have an opioid emergency plan in place and take-home naloxone available.”

Having opioids in the household where there’s a concern about an accidental opioid emergency is another risk factor, said Dr Edwards.

While “some practitioners have chosen to take a universal precautionary approach” and prescribe naloxone along with every opioid prescription, and not just to those at higher risk, the decision to do so is up to the individual practitioner, he said.

According to another speaker, Mark Kallgren, MD, medical director, pain medicine, Oregon Anesthesiology Group, Portland, many patients like to keep one auto-injector at home and an extra for the car if they spend a lot of time on the road or if they go on vacation.

Delegates at the session asked several questions. One wanted to know the legal liability of someone who administers naloxone to a stranger. Dr Edwards pointed out that “many states have passed Good Samaritan protection laws to allow administration to someone else without legal repercussion.”

He stressed that prescribing naloxone is “is in accordance with” guidelines of medical societies, state governments, and other groups calling for readily accessible naloxone. Among these groups are the American Medical Association, Centers for Disease Control and Prevention, FDA, and World Health Organization, as well as the AAPM.

Asked about naloxone being injected into an opioid-naive individual, Dr Edwards said that nothing would happen. “It only works when opioids are on board.”

But if administered accidentally to someone who is receiving an opioid and is not having a life-threatening emergency, that person would go into withdrawal, he said.

Speakers also addressed concerns that prescribing naloxone means that the opioid dose is too high or that it encourages opioid abuse.

Another delegate asked whether prescribing naloxone means that the physician doesn’t trust the patient.

“I tell patients that I’m giving it ([he naloxone prescription] to them because I care, and this is part of our safety approach,” said Dr Brennan. “I tell them it’s not that I don’t trust them, but I don’t trust the world around us.”

Doctors don’t always have control over the environment in which their patients live, he added. Just in the last 3 years, seven or eight of his patients ended up in the hospital with accidental opioid-related toxicity. He said he doesn’t know what medications other physicians are prescribing to his patients and he doesn’t trust the pharmacist to check for drug-drug interactions.

You never have a fire, but it doesn’t mean you don’t have a fire extinguisher available, just in case.

The same trust issue came up several years ago when drug testing came along, but it’s now universally accepted, said Dr Brennan.

Nobody questions a doctor who prescribes an epinephrine auto-injector to an patient with an allergy or quick-acting nitroglycerine to a patient with a heart condition.

“You never have a fire, but it doesn’t mean you don’t have a fire extinguisher available, just in case,” said Dr Edwards.

American Academy of Pain Medicine (AAPM) 2016 Annual Meeting