The two Belgian royal academies of medicine, the Académie royale de Médecine de Belgique and the Koninklijke Academie voor Geneeskunde van België, recently issued an opinion on naloxone (Narcan) use at the request of the Belgian Federal Minister of Public Health. The Belgian academies of medicine recommend, as a matter of priority, that topical naloxone (nasal spray), which can be easily administered in emergency situations, even by nonphysicians, be made readily available. Specialized drug addiction centers should be provided with naloxone for prescription by the physicians in charge. At present, Belgium does not have a program that makes naloxone available to opioid users (illegal or prescription) in an easily administrable form.
But, as the opinion states, “the goal of making naloxone available in Belgium goes far beyond reducing the risks for opioid users. In fact, patients with chronic pain, children of drug addicts, healthcare personnel, paramedics, police officers, and firefighters can also suffer opioid overdoses. Even just skin contact with some synthetic derivatives of fentanyl can prove fatal.” However, currently only an injectable form in bulk packaging is authorized and marketed in Belgium. Naloxone nasal spray has received European marketing authorization but is not yet marketed in Belgium.
MediQuality interviewed Jean-Louis Vincent, MD, PhD, professor of intensive care at the Free University of Brussels, about the availability of naloxone. “We hope the academies’ opinion will help move the marketing authorization process forward because the product is authorized in Europe and is already available in many countries,” he said. “It seems crucial to make this form available in Belgium, given its ease of administration, even by nonphysicians.” Vincent is also chairman of the International Symposium on Intensive Care and Emergency Medicine (ISICEM).
“In fact, in November 2014, the World Health Organization (WHO) advocated making naloxone widely available to drug users and those close to them to enable rapid treatment of opiate overdoses. I have always carried naloxone in my doctor’s bag, and it has sometimes been administered ‘blind’ without being certain that the person was in an opiate-induced coma. I’m saying this to underscore the product’s lack of side effects, which makes it possible to safely administer it this way. Obviously, doctors and healthcare professionals quickly learn to recognize the symptoms of opioid overdoses, which include very constricted pupils the size of a pinhead.”
Vincent, who participated in drafting the opinion of the academies of medicine, emphasized that “The United Nations Office on Drugs and Crime, in collaboration with WHO, has launched a joint action, the S-O-S Initiative, Stop Overdose Safely, which encourages member states to foster initiatives aimed at preventing opiate-related deaths. This initiative recommends the use of naloxone as an antidote, as has been recognized for over 40 years. On the webpages of the best practice portal of the European Monitoring Centre for Drugs and Drug Addiction, which list the latest scientific publications on the subject, naloxone is rated as ‘likely to be beneficial’ for the prevention of overdoses.”
Vincent explained the product’s indication. “Use of a large variety of opioids (methadone, heroin, buprenorphine, etc) is widespread, whether it be illegally or therapeutically, as in the case of major or chronic pain. Sometimes, when pain is extreme, patients can overdose without realizing it. Poisoning is common and justifies a quick and effective therapeutic agent that has limited side effects. Naloxone rapidly antagonizes the effects of an overdose. This antagonism affects all opiate receptors and corrects respiratory depression owing to natural and synthetic narcotics. However, it has no effect on heroin-induced acute pulmonary edema. Naloxone is effective on overdoses of codeine, dextropropoxyphene, dextromethorphan, dihydrocodeine, fentanyl, heroin, loperamide, methadone, morphine, pethidine, pentazocine, and tramadol. After intravenous administration, its onset of action is 2 or 3 minutes. It has a duration of action of 45 minutes and a half-life of 30 to 100 minutes. In adults, a starting dose of 0.4 to 2 mg intravenously is recommended. This dose should be repeated every 2 to 3 minutes until symptoms improve. The diagnosis should be questioned if respiratory depression does not improve after administration of 10 mg. If symptoms do improve, Narcan can be given as an infusion at a dose of 0.4 to 4 mg/h, depending on the symptomatology. When the infusion ends, the patient must be kept under observation for at least 2 hours. If respiratory depression recurs, the same administration regimen (bolus plus infusion) should be resumed. In drug addicts, naloxone may trigger an acute withdrawal syndrome, including nausea, vomiting, excessive sweating, tremors, tachycardia, and hypertension.”
What are the possible side effects of naloxone? “Naloxone acts by binding to the brain receptors used by opioids, which dislodges the latter. In this way, it reverses or blocks the effects of opioids on the body. Naloxone produces an effect only if opioids are present in the body. It has no agonistic effect. Used alone, naloxone has no pharmacological effects of its own. It can cause side effects such as aggressive behavior, seizures, body aches, diarrhea, and accelerated heart rate,” Vincent explained. ” But these symptoms are rare, and the drug’s therapeutic index is favorable, which is why it can be administered multiple times, as it is not uncommon to see patients fall back into an opioid-induced coma after a period of remission.”
This article was translated from MediQuality.
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