MOHLTC and MCSCS describe actions taken in opioid crisis
MISSISSAUGA, ON, April 11, 2017 /CNW/ - Adapt Pharma Canada, the makers of NARCAN™ (naloxone) Nasal Spray 4mg, applaud the Ontario government for its commitment to taking action in the opioid crisis.
Today, the Ministry of Health and Long-Term Care (MOHLTC) and the Ministry of Community Safety and Correctional Services (MCSCS) detailed steps they have taken to provide access to naloxone, including NARCAN™ Nasal Spray, used to treat opioid overdose victims through public health centres, pharmacies and correctional facilities.
At today’s event, held at a Shoppers Drug Mart in Toronto, Dr. Eric Hoskins, Minister of Health and Long-Term Care, and Marie-France Lalonde, Minister of Community Safety and Correctional Services, discussed the severity of the opioid crisis in Ontario and its impact on the healthcare system, and drew awareness to the availability of naloxone at free sites in over 200 cities in Ontario.
“We applaud the Ontario government for taking the necessary steps to ensure Ontarians have access to emergency naloxone,” said David Renwick, General Manager, Adapt Pharma Canada. “NARCAN™ Nasal Spray is just is one component in addressing the opioid crisis. We look forward to working with the Ontario government to get naloxone to those who need it most.”
The provincial government has created a searchable website where people can find where to get naloxone kits in their community and how to use them: https://www.ontario.ca/page/get-naloxone-kits-free.
NARCAN™ Nasal Spray has been available in Canada since July 6, 2016, when the federal health minister executed an Interim Order for the immediate importing and sale of NARCAN™ Nasal Spray. In October of the same year, the treatment was approved to be sold without a prescription.
NARCAN™ Nasal Spray is a ready-to-use, needle-free device that requires no assembly and no medical training.1 While not a substitute for appropriate medical care, it delivers a dose of 4mg of naloxone in a concentrated 0.1 ml spray to temporarily reverse an overdose in emergency situations.1
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 adaptcanada@customer-support.ca.
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.
General
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.
Special Populations
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 (http://hc-sc.gc.ca/dhp-mps/medeff/index-eng.php); | |
| • | By calling 1-866-234-2345 (toll-free); | |
| • | By completing a Consumer Side Effect Reporting Form and sending it by: | |
| Mail to: | Canada Vigilance Program | |
| Health Canada, Postal Locator 1908C | ||
| Ottawa, ON | ||
| K1A 0K9 | ||
| 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.
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| 1 NARCAN® Nasal Spray. Product Monograph. Available at: https://www.narcan.com/pdf/NARCAN-Prescribing-Information.pdf. Accessed March 2017. |
SOURCE Adapt Pharma 
For further information: or to arrange an interview, please contact: Amanda Federchuk, 416-355-7410, amanda.federchuk@ketchum.com