Regulatory Decision Summary for S.O.S. NALOXONE HYDROCHLORIDE INJECTION

Recently (summer 2015), Canadian provincial and territory governments requested that Health Canada considers making naloxone available without a prescription to increase its accessibility by opioid users, first responders and bystanders for use in emergency situations to reverse opioid overdoses (OD). Such increased access required to remove naloxone from Health Canada’s Prescription Drug List but only for this specific situation/indication. All other uses/indications of naloxone would remain with a prescription status. A Benefit-Harm-Uncertainty (BHU) assessment was unilaterally initiated by Health Canada to establish whether the switch could be done safely. The focus of the BHU assessment was on making naloxone available without a prescription to be used without the oversight of a health care professional and outside of hospital setting. More specifically, as required by the Food and Drug Regulations (regulation C.01.040.3), the BHU assessment evaluated if naloxone administration required any of the following three categories of requirement:

1. supervision by a practitioner is necessary;
2. the level of uncertainty respecting the drug, its use or its effects justifies supervision by a practitioner; or
3. use of the drug can cause harm to human or animal health or a risk to public health and the harm or the risk can be mitigated by a practitioner’s supervision.

The BHU assessment recommended that naloxone for emergency use to reverse opioid ODs outside hospital setting be exempted from the Prescription Drug List and the Health Canada Prescription Drug Status Committee (PDSC) concurred with the BHU assessment recommendations. Therefore, the benefit-risk profile of naloxone for the aforementioned indication and condition of use was already determined. The last stage of the BHU assessment, which was the main purpose of this NDS, was to adapt the Product Monograph for the non-prescription S.O.S. Naloxone Hydrochloride Injection to account for the fact that S.O.S Naloxone Hydrochloride Injection will be administered by bystanders. The Product Monograph was extensively modified following many rounds of negotiations between Health Canada and Sandoz in order to incorporate the safety issues raised in the BHU assessment and to address the fact that naloxone will be used by bystanders. Considering the final agreed upon Product Monograph (March 14, 2016), the BHU profile of non-prescription S.O.S Naloxone Hydrochloride Injection when used under the conditions described in the Product Monograph is favorable.