Emergency naloxone treatment distributed to tens of thousands of first responders since Health Canada interim order a year ago
MISSISSAUGA, ON, July 5, 2017 /CNW/ - One year after its introduction in Canada to help combat the opioid crisis, tens of thousands of first responders and hundreds of government agencies and community organizations have come to rely on NARCAN™ naloxone Nasal Spray to treat overdose victims in emergency situations.
NARCAN™ Nasal Spray has been shipped to every province and territory, including:
- All front-line RCMP officers across Canada
- More than 75 regional or municipal police services, including all 11 municipal police services in British Columbia and more than half of all forces in Ontario
- More than 50 Canadian Border Service Agency (CBSA) locations
- Police and fire services throughout Atlantic Canada
- Municipal governments, hospitals, schools and recovery treatment centres nationwide
Tomorrow, Adapt Pharma Canada, makers of NARCAN™ Nasal Spray, marks the one-year anniversary of the introduction of NARCAN™ (naloxone HCl) Nasal Spray 4 mg under a special federal Interim Order.1
"As one of the largest homeless support organizations in Canada, we've seen the heartbreaking impact of opioid addiction and overdoses," said Shayne Williams, Executive Director of the Lookout Emergency Aid Society, which provides housing and support to eleven communities in the B.C. Lower Mainland. "NARCAN™ Nasal Spray has been an important addition this year to the emergency tools available to our staff, who find themselves regularly rescuing vulnerable people."
NARCAN™ Nasal Spray is a ready-to-use, needle-free device that requires no assembly and no medical training and is available without a prescription.2 While not a substitute for appropriate medical care, NARCAN™ Nasal Spray delivers a dose of 4mg of naloxone in a concentrated 0.1 ml spray to temporarily reverse an overdose in emergency situations.2
"The opioid epidemic and the human toll it is taking on communities and families is tragic," said David Renwick, General Manager of Adapt Pharma Canada. "Naloxone in the right hands at the right time can help treat overdose victims in emergency situations. We remain committed to supporting those on the frontline of this crisis and the incredible work they are doing for their communities."
NARCAN™ Nasal Spray Entered Canada under Interim Order
An Interim Order was signed on July 6, 2016 authorizing the importation and sale of NARCAN™ Nasal Spray from the U.S. for use in the emergency treatment of known or suspected opioid overdoses in Canada.1
As the Interim Order ends, Adapt Pharma has developed Canadian packaging and labeling, as approved by Health Canada on October 3, 2016, and is now available for order in Canada. Any U.S. labeled NARCAN™ Nasal Spray can continue to be used as needed until its expiration date.
ABOUT NARCAN™ (naloxone HCl) NASAL SPRAY1
Naloxone Hydrochloride Nasal Spray is a pure opioid antagonist indicated for emergency use outside of a hospital to reverse known or suspected opioid overdose, as manifested by respiratory and/or severe central nervous system depression.
Naloxone Hydrochloride Nasal Spray can be administered by a bystander (non-health care professional) before emergency medical assistance becomes available, but it is not intended to be a substitute for professional medical care. Emergency medical assistance (calling 911) should be requested immediately when an opioid overdose is suspected, before administering naloxone.
In clinical studies, nasal edema, nasal inflammation, nasal dryness, nasal congestion, muscle spasms, musculoskeletal pain, headache, dizziness, constipation, nausea, toothache, rhinalgia, xeroderma, and blood pressure increase were reported.
The availability of NARCAN™ Nasal Spray in Canada under the Interim Order signed by the Minister of Health in July 2016 underpins the goal of Health Canada to expedite community access to naloxone and equip first responders and the general public with the ability to readily and rapidly reverse an opioid overdose.
Adapt Pharma Canada Ltd. has established dedicated distribution channels that allow first responders, public health organizations, and individuals to readily access NARCAN™ Nasal Spray. Adapt Customer Support can be reached at 1-877-870-2726 or by e-mail [email protected].
Naloxone Hydrochloride Nasal Spray is available as 4 mg/0.1 mL single-dose sprayer, carton of 2 devices.
Please see Indications and Important Safety Information below.
The full product monograph for NARCAN™ Nasal Spray is available at http://www.narcan.com/pdf/NARCAN-Prescribing-Information.pdf
NARCAN™ NASAL SPRAY IMPORTANT SAFETY INFORMATION1
WARNINGS AND PRECAUTIONS
Serious Warnings/ Precautions
Emergency medical assistance (calling 911) should be requested immediately when an opioid overdose is suspected, before using naloxone.
Individuals with a satisfactory response to an initial dose of naloxone should be kept under continued surveillance.
Caregivers administering naloxone should be prepared to act in response to or assist the patient in cases of potential adverse reactions such as aggressive reactions, convulsions and vomiting. Special attention is warranted if naloxone is administered to a neonate or a pregnant woman.
In the absence of opioids, in opioid naïve people, naloxone administration shows essentially no pharmacologic activity. In opioid dependent people, naloxone may trigger an acute opioid withdrawal syndrome.
The effectiveness of naloxone has not been assessed in people with intranasal conditions such as abnormal nasal anatomy, nasal symptoms (i.e., blocked and/or runny nose, nasal polyps, etc.) or in people having a product sprayed into the nasal cavity prior to naloxone administration.
Naloxone does not counteract overdoses due to: barbiturates, benzodiazepines, psychostimulants (e.g., cocaine, amphetamines, methylphenidate, etc.), alcohol, or any other non-opioid drug such as non-opioid tranquilizers, anesthetics or sedatives. Naloxone is not effective against respiratory depression due to non-opioid drugs.
Naloxone Hydrochloride Nasal Spray should be administered with caution to persons who are known or suspected to be physically dependent on opioids.
Pregnant Women: There are no adequate and well-controlled studies in pregnant women. Administration of naloxone to an opioid-dependent pregnant woman may induce an acute opioid withdrawal syndrome, which may precipitate preterm labor or fetal distress. Naloxone should be used during pregnancy only if clearly needed.
Nursing Women: It is not known whether naloxone is excreted in human milk. Studies in nursing mothers have shown that naloxone does not affect prolactin or oxytocin hormone levels.
Pediatrics: Naloxone administration may cause an acute opioid withdrawal syndrome which may be life threatening in opioid dependent neonates if not recognized and properly treated. Clinical data is limited and naloxone should be administered to a neonate only if clearly needed. As for any use of naloxone, emergency medical assistance should be requested immediately, before administering naloxone in a neonate.
Geriatrics (> 65 years of age): Geriatric patients have a greater frequency of decreased hepatic, renal, or cardiac function and of concomitant disease or other drug therapy. Therefore, the systemic exposure of naloxone hydrochloride can be higher in these patients.
Reporting Side Effects
You can help improve the safe use of health products for Canadians by reporting serious and unexpected side effects to Health Canada. Your report may help to identify new side effects and change the product safety information.
3 ways to report:
- Online at MedEffect (https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada.html);
- By calling 1-866-234-2345 (toll-free);
- By completing a Consumer Side Effect Reporting Form and sending it by:
Fax to 1-866-678-6789 (toll-free), or
Mail to: Canada Vigilance Program
Health Canada, Postal Locator 1908C
Postage paid labels and the Consumer Side Effect Reporting Form are available at MedEffect.
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.
1 Government of Canada. Federal Interim Order. Available at: https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/announcements/notice-availability-naloxone-hydrochloride-nasal-spray-narcan-canada.html. Accessed June 2017.
2 NARCAN™ Nasal Spray. Product Monograph. Available at: https://www.narcan.com/pdf/NARCAN-Prescribing-Information.pdf. Accessed June 2017.
SOURCE Adapt Pharma
For further information: For media inquiries: Amanda Federchuk, 416-355-7410, [email protected]