Notice: Interim policy on naloxone kits, and authorized re-administration time for naloxone products
Naloxone is a life-saving medication that, when used quickly, temporarily reverses the effects of opioid overdoses. Naloxone is a critical life saving tool for healthcare providers, community organizations and individuals across the country. This makes it an essential part of Canada's public health response to the opioid crisis. Ensuring the availability and accessibility of naloxone kits remains a top priority for Health Canada.
Naloxone kits typically contain:
- gloves
- syringes
- alcohol swabs
- instructions for use
- naloxone hydrochloride in a prefilled syringe, vial, ampoule or nasal spray device
Interim policy on packaging, labelling and sale of naloxone kits
Health Canada is introducing an interim policy after becoming aware that:
- some establishments that package, label and sell naloxone kits may not hold the required establishment licences
- some naloxone kits being sold in Canada contain drugs and medical devices that lack required product authorizations and labelling
The interim policy outlines conditions that must be met for Health Canada to exercise discretion with enforcing certain packaging, labelling and sale requirements under the Food and Drug Regulations and the Medical Devices Regulations for naloxone kits.
The interim policy will help to:
- ensure continued access to naloxone kits on the Canadian market
- maintain the quality, safety, efficacy and traceability of these kits
Health Canada approved labelling for naloxone
In Canada, all naloxone products approved for emergency use to reverse a known or suspected opioid overdose have been approved by Health Canada with dosing re-administration instructions of every 2 to 3 minutes, if needed. This applies to injectable solutions and nasal spray devices. Health Canada authorized these instructions, based on scientific evidence.
However, Health Canada is aware that some naloxone kits in Canada contain dosing instructions that advise a repeat dose anywhere between 3 to 5 minutes after the previous dose. It is important for those using these kits to know that subsequent doses of naloxone can be administered every 2 to 3 minutes. A repeat dose is generally needed if:
- the person's breathing doesn't improve
- they don't wake up after the initial dose
Delaying the administration of a repeat dose may result in permanent disability or death. This is why it is critical that naloxone kit labelling is clear and correct to ensure proper administration.
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