First Responder Agencies: OPTIONAL Naloxone Program In collaboration with the Massachusetts Department of Public Health, Bureau of Substance Abuse Services and Office of HIV/AIDS “HOW TO COMPLY” There has been amendments made to 105 CMR171.000, Massachusetts First Responder Training, and 105 CMR 700.000, Implementation of M.G.L. c. 94C. These amendments permit municipalities to register with DPH in order for first responders to carry and administer naloxone, and also set out the training requirements for first responder agencies that choose to utilize naloxone. Naloxone is a drug that reverses the effects of an opioid overdose. Emergency Amendments to 105 CMR 700.000: Implementation of M.G.L. c. 94C Drug Control Regulations “NALOXONE OR OTHER OPIOID ANTAGONIST APPROVED BY THE DEPARTMENT” 700.004: Registration Requirements Emergency Amendments to 105 CMR 171.000: First Responder Training Regulations What does a first responder agency need if it chooses to have a naloxone program? A. Memorandum of agreement (MOA) for medical oversight B. Training for its first responders, meeting requirements of A/R 2-100 C. Massachusetts Controlled Substances Registration D. Naloxone and atomizers for nasal administration, or Evzio auto-injectors in accordance with Statewide Treatment Protocol 2.14 (which provides standing order) A. Memorandum of agreement for medical oversight i. If your first responder agency has an MOA with a hospital to carry AEDs or EpiPens, update that current MOA to include naloxone. ii. If your first responder agency does not have an MOA and carries and uses AEDs and/or EpiPens please be advised that you must have such an MOA with a hospital, under the First Responder Training Regulations, at 105 CMR 171.225 (AED) and 105 CMR 171.225 (EpiPen). See: http://www.mass.gov/eohhs/docs/dph/regs/105cmr171.pdf. iii. If you are going to now get an MOA with a hospital, to cover your current AED and/or EpiPen program, the Department recommends you have it cover naloxone use as well. To get an MOA with a hospital, approach your local hospital, or your local ambulance service, for assistance. Make sure the hospital knows that the MOA is for a first responder agency, and must address the requirements for such MOAs in the First Responder Training regulations, as cited above. iv. If you do not carry AEDs or EpiPens, and do not have an MOA with a hospital: • The Department recommends you attempt to obtain an MOA with a hospital for medical oversight of the naloxone program, because it is the most efficient and sustainable way in the long term, for your first responders to get appropriate medical oversight, training and your agency to get naloxone and atomizer kit (through hospital pharmacy). Follow the recommendations in A. iii., above. • If you have difficulty obtaining an MOA for medical oversight with a hospital, you have the option, during this public health emergency, for naloxone only, of obtaining an MOA for oversight with a medical director. See 105 CMR 171.227. To try this approach, contact your local ambulance service for a recommendation of a medical director with experience in EMS or first responder agency oversight. • If you have difficulty obtaining an MOA with either a hospital or a medical director, contact the Department, at [email protected], for assistance with finding a medical director. A. Steps to Obtaining a Memorandum of Agreement for Medical Oversight Update your existing MOA to include naloxone YES START HERE Do you have an MOA with a hospital to carry AEDs or EpiPens? NO You must have an MOA with a hospital to carry AED or EpiPens YES Do your First Responders carry AEDs or EpiPens? NO Talk to your local hospital or your ambulance service for assistance Obtain an MOA with a hospital for medical oversight of the naloxone program; this is the most efficient and sustainable way for your first responders to have oversight, training and supplies (naloxone and atomizer kit through hospital pharmacy) Were you able to obtain an MOA with a hospital to carry AEDs, EpiPens and naloxone? You are now ready to proceed with MCSR registration and training steps YES YES Were you able to obtain an MOA with a hospital? NO NO If you cannot get an MOA with a hospital, you can, for naloxone only, have an MOA for medical oversight with a medical director. To do this, contact your local ambulance service for assistance of a medical director You are now ready Were you able to to proceed with YES obtain an MOA with MCSR registration a medical director? and training steps NO If you cannot obtain an MOA with a hospital or a medical director, contact the Department, at the email listed below, for help finding a medical director for your program during the public health emergency B. Training for First Responders – See 105 CMR 171.165 i. Training must be approved by your medical director. ii. Training must meet the minimum curriculum requirements of Administrative Requirement 2-100, http://www.mass.gov/eohhs/docs/dph/emergencyservices/ar/2-100.pdf C. Massachusetts Controlled Substances Registration – Required under 105 CMR700.003(D) Print out MCSR form for municipalities at: http://www.mass.gov/eohhs/docs/dph/quality/drugcontrol/naloxone-nerveantidote-epi-form.pdf i. Complete and send in with fee, if fee is applicable. During the pendency of the public health emergency, if a municipality is registering ONLY for naloxone (that is, your first responder agency does NOT carry nerve agents or EpiPens) the fee is waived. But if the application is to obtain a DCP registration for more than naloxone, as required by 105 CMR 700.003(D), the fee is still applicable. The form and fee is required to be completed annually. D. Naloxone and atomizers for nasal administration, or Evzio autoinjectors in accordance with Statewide Treatment Protocol 2.14 i. If you have an MOA with a hospital, your first responder agency obtains your supply of naloxone and atomizer kit from the hospital’s pharmacy. ii. If you have an MOA with a medical director, follow his or her instructions on which pharmacy to access for obtaining your supply of naloxone and atomizer kit. iii. First responders are authorized to administer nasal naloxone as a standing order, under Statewide Treatment Protocol 2.14. See: http://www.mass.gov/eohhs/docs/dph/emergencyservices/emergency-protocols-substance-abuse-overdose.pdf. There is no need for a separate medical order from a physician. Department contact: [email protected] Emergency Protocols Standing Order How Do I Purchase Naloxone? 1. Establish an MOA with a local hospital and hospital pharmacy which includes dispensing and replenishing the naloxone 2. If that is not possible, you can purchase the amount needed to respond to potential emergencies before you would be able to restock (a few kits per vehicle or first aid kit). 3. Obtain a copy of the “Commonwealth of Massachusetts Board of Registration in Medicine Active License” from the physician who is providing the medical oversight for your department. You will be required to fax and submit a copy to the pharmaceutical company. 4. Contact a pharmaceutical retailer and set up an account. 5. You will need a finalized Massachusetts Controlled Substance Registration (MCSR) in place before deploying the kits. Where Can I Purchase Naloxone? Some Options Include: MooreMedical 1-800-234-1464 www.mooremedical.com (Suggested: Item #11216 & Item #74042) BoundTree Medical 1-800-533-0523 https://www.boundtree.com/naloxone-group-19176-335.aspx Mckesson http://www.mckesson.com/ Southeastern Emergency Equipment 1-800-334-6656 http://sfadmin.seequip.com/storefrontCommerce/ Example of reporting form
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