1. Purpose
  2. Introduction
  3. Drug Overdose Prevention Program Guidelines for Implementation
    1. Responsibilities of the Program's Official Designee
    2. Definition and Responsibilities of the Program's Health Care Professional (HCP)
    3. Affiliated Prescribers
    4. Individuals to be Trained as Drug Overdose Responders
    5. Trainers
    6. Training Protocol
  4. Qualifications of Trainers
    1. Training Records
    2. Naloxone Kits
    3. Purchase of Naloxone Kit Supplies
    4. Instructions Regarding Use or Loss of Naloxone Kit
    5. Refill Protocol
  5. Storage of Naloxone
    1. Maintaining Program Records
  6. Drug Overdose Reversals and Naloxone Reporting Form

Purpose

Drug overdose is recognized as a significant problem in Illinois. The Public Act 096-0361 (20 ILCS 301/5-23 new) took effect on January 1, 2010, and making it legal in Illinois for non-medical persons to administer naloxone to another individual in order to prevent an opioid/heroin overdose from becoming fatal. The Public Act 099-0480 is an enhancement of The Public Act 096-0361 and took effect on September 9, 2015, eliminating 26 additional pieces of legislation. Naloxone is a prescription medicine that reverses an overdose by blocking opioids such as heroin, morphine, oxycodone, hydrocodone and other opioids in the brain for 30 to 90 minutes. Naloxone comes in multi-dose vials, single dose vials, an auto-injector, and pre-filled syringes and is administered by injection. It is also available in nasal spray form. Naloxone has been successfully prescribed and distributed to many heroin and opiate dependent users, their families, and friends in several programs throughout the United States. Published data has shown that the individuals participating in these programs have responded to countless successful reversals.

Because of its particular pharmacological properties, heroin and opioids carry an especially high risk of death from overdose as compared to other drugs of abuse. Overdose death rates have exploded across the country during the past several years, with a boom in heroin and prescription drug use widely credited as the drivers of this lethal trend. Between 2000 and 2014, the rate of deaths from drug overdose increased by 137 percent nationally. In Illinois, the average age- adjusted rate of overdose deaths increased by nearly 66 percent, according to data from the Centers for Disease Control and Prevention (CDC).

According to Illinois 2014, Public Health data, Illinois has one of the higher rates of death from heroine and opioid use. Illinois is one of 16 states in which more people die of drug overdoses than car accidents. Heroin is the most commonly cited drug among primary drug treatment admissions in Illinois. The highest rate of Emergency Room admissions are said to be due to misuse of heroin and prescription opioids.

Introduction

Public Act 099-0480 allows the Illinois Department of Human Services (IDHS), Division of Alcoholism and Substance Abuse (DASA) to establish and authorize programs to distribute naloxone. IDHS/DASA has developed guidelines to inform programs about how to become enrolled as a Drug Overdose Prevention Program (DOPP). Potential enrollees include DASA Treatment Programs, licensed prescribing practitioners, for profit community-based organizations, not-for- profit community-based organizations, hospitals, local health departments, health care providers, including FQHCs and Health Care for the Homeless clinics, urgent care facilities, faith-based organizations. Agencies engaged with incarcerated individuals, such as jails, prisons, probation and parole, problem-solving courts, and police and sheriff departments are also invited to enroll as a Drug Overdose Prevention Program.

Agencies or programs must enroll with the Illinois Department of Human Services, Division of Alcoholism and Substance Abuse in order to operate a DOPP. DHS/DASA is providing Drug Overdose Prevention Guidelines to help enrolled programs take the steps necessary to operate a Drug Overdose Prevention Program. The Guidelines will also provide information about naloxone and the education for drug overdose prevention responders.

The guidelines are divided into two sections (1) Program Guidelines for Implementation, and (2) Enrollment Package and Reporting Forms.

Drug Overdose Prevention Program Guidelines for Implementation

The Program Guidelines for Implementation explain what elements are needed to develop a DOPP that uses naloxone to reverse opioid overdose. The elements in the guidelines can be used to develop Program policies and procedures and should be tailored by the programs after carefully considering their goals for becoming a DOPP and the target population they intend to serve. The guidelines describe the program staff responsibilities and training guidelines for the distribution and use of naloxone. All DOPP Programs should have their policies and procedures internally approved, dated and signed by the responsible authority.

In addition to the Drug Overdose Prevention Program Guidelines for Implementation, the Drug Overdose Prevention Program Enrollment Package (IL 444-2051) and Drug Overdose Reversal and Naloxone Reporting Forms (Il 444-2053) are required for programs that plan to distribute naloxone.

The Enrollment Package consists of an Enrollment Form and Attestation Page clearly outlining expectations and requirements of the program. Each program must complete the program enrollment package including the enrollment form and Attestation page and submit to the IDHS/DASA before they begin training drug overdose prevention responders. The enrollment will be valid for five years and then Programs must re-enroll. Enrolled Programs will receive an enrollment certificate upon submission of these forms.

The Quarterly Report will allow IDHS/DASA to keep track of Overdose Prevention Programs and Sites, number of trained responders and number of naloxone kits distributed in Illinois. This is a spreadsheet to be completed quarterly by each Program.

Drug Overdose Reversal and Naloxone Reporting Form will allow IDHS/DASA to keep track of the drug overdose response incidents in Illinois. All drug overdose reversals will be recorded on the Drug Overdose Reversal and Naloxone Reporting Form, and will be reviewed and signed by the Program's Official Designee and Health Care Professional. Copies of these reports will be emailed to the IDHS/DASA on a monthly basis to DHS.DASA.coordinator@illinois.gov

All forms mentioned above can be found on p. 2 of the 2016 Guidelines for Implementation report and can also be accessed and completed on the IDHS/DASA website.

For more information on the DOPP, or how to enroll as an Illinois Drug Overdose Prevention Program, please contact the Illinois Department of Human Services, Division of Alcoholism and Substance Abuse, Rosie Gianforte at (312) 814-2136, or Brian Pacwa at (312) 814-6529, Brian.Pacwa@illinois.gov

Email all completed forms to: DHS.DOPP.coordinator@illinois.gov

These Program Guidelines for Implementation may be used by drug overdose prevention programs in Illinois to help develop their own policies and procedures and to understand the responsibilities of an Enrolled Drug Overdose Prevention Program. A safe and successful Drug Overdose Prevention Program will demonstrate a shared leadership responsibility between the Program's Official Designee and the Program's identified Health Care Professional. The Program's Official Designee is identified on the Program Enrollment form as the primary contact for the Program. Effective program leadership of the Drug Overdose Prevention Program will require a collaborative effort of these leaders.

Responsibilities of the Program's Official Designee

The Program's Official Designee will manage and have overall responsibility for the program and will:

  • Identify an Illinois licensed physician, physician assistant, or nurse practitioner to function as the programs Health Care Professional (HCP) to oversee the prescribing aspects of the drug overdose prevention program. The HCP shall also provide clinical consultation, and expertise for medical issues related to the program;
  • In consultation with the HCP approve Affiliated Prescribers for the program;
  • Maintain program documentation of HCP and Affiliated Prescribers credentials and licenses;
  • Develop a training curriculum based on the SAMHSA Tool kit which is consistent with the guidelines of the Illinois Department of Human Services, Division of Alcoholism and Substance Abuse (IDHS/DASA);
  • Identify and select persons to be trained as drug Overdose Responders (ORs);
  • Ensure that all trained drug Overdose Responders successfully complete all components of the training program;
  • Maintain DOPP records including trained drug overdose responder training records and training completion logs, drug overdose prevention program usage records and inventories of drug overdose prevention program supplies and materials;
  • Provide liaison with local emergency medical services (EMS), where appropriate;
  • Review all drug overdose reports in conjunction with the HCP, particularly those involving opioid antagonist administration and report all administrations of an opioid antagonist on forms prescribed by IDHS/DASA;
  • Ensure that the program's enrollment with the IDHS/DASA remains up-to-date; Receive and reply to a 30 day reminder of certification expiration from IDHS/DASA
  • Ensure that IDHS/DASA is notified in a timely fashion of all changes in the information contained on the program's enrollment form, including names and contact information for the Program's Official Designee, Health Care Professional and Affiliated Prescribers, as well as sites at which the program operates;
  • Update training program content, materials and protocols as needed;
  • Approve and provide ongoing supervision of the trainers; and
  • Oversee procurement and storage of naloxone with appropriate records and develop policies and procedures for the distribution of naloxone kits to drug Overdose Responders.

Definition and Responsibilities of the Program's Health Care Professional (HCP)

The Health Care Professional has responsibility for clinical oversight for the program and is defined in 20 ILCS 301/5-23 (d) subsection (4) as:

  • a physician licensed in Illinois to practice medicine in all its branches;
  • a physician assistant who has been delegated the authority for prescription or dispensation of an opioid antidote by his or her supervising physician;
  • an advanced practice registered nurse who has a written collaborative agreement with a collaborating physician that authorizes the prescription or dispensation of an opioid antidote; or
  • an advanced practice nurse who practices in a hospital or ambulatory surgical treatment center and possesses appropriate clinical privileges in accordance with the Nurse Practice Act.

Responsibilities of the Program's Health Care Professional

  • Provide clinical consultation, expertise, oversight and liaison concerning medical and clinical issues related to the Drug Overdose Prevention Program;
  • Provide consultation to ensure that all trained drug Overdose Responders receive all information required for training;
  • In conjunction with the Program's Official Designee maintain a description of how the organization will provide training information, how employees or volunteers providing information will be trained and the standards for documenting the provision of required training information;
  • Adapt and approve training program content, materials and protocols; and
  • Review reports of all administrations of an opioid antagonist.

Affiliated Prescribers

Affiliated prescribers may also prescribe or dispense naloxone and must be Illinois licensed physicians, nurse practitioners or physician assistants as described in 20 ILCS 301/5-23 (d) subsection (4). The affiliated prescribers must be knowledgeable regarding the following: drug overdose prevention program policies, procedures and record keeping; opioid drug overdose training content, materials and protocols; and administration and storage of naloxone. They must report all of their drug overdose prevention program-related activities to the Program's Official Designee and must complete all required documentation and of record keeping.

Individuals to be Trained as Drug Overdose Responders

It is the intention of the Program Guidelines for Implementation to encourage the development of a wide network of trained drug Overdose Responders. Successful overdose prevention will require that people who are the closest to individuals at risk for overdose become trained responders. These people may be peers, family members, friends or neighbors. Therefore, all those who are interested in becoming trained drug Overdose Responders may be eligible to be trained.

Trainers

Trainers may be program employees or volunteers and must demonstrate competence in the content and skills of the DOPP before providing training to drug Overdose Responders. Each trainer's competence on the training protocols must be approved by the Program's Official Designee in consultation with the HCP and the program must maintain documentation of the trainer's proficiency to provide training on all of the information for drug Overdose Responders. Each trainer will be supervised by the HCP or by an Affiliated Prescriber who has specifically been delegated the responsibility of supervising trainers.

Training Protocol

Illinois Programs that are enrolled and authorized to be a Drug Overdose Prevention Program are required to have a training manual or training slides and provide training to individuals who will become trained drug Overdose Responders. The goal of training is to teach drug Overdose Responders what steps to take when they witness a drug overdose including: drug overdose prevention; how to recognize a drug overdose; how to perform rescue breathing and resuscitation; opioid antidote dosage and administration, the importance of calling 911, care for the drug overdose victim after administration of the drug overdose antidote; and other issues as necessary.

The program should maintain an up-to-date training curriculum, which includes at a minimum the content guidelines below, incorporates "hands on" demonstration and practice of drug overdose interventions and is tailored by the Program for its individualized needs. In addition, the training curriculum should:

  • Describe the qualifications of individuals who can provide the drug overdose prevention training (including the use of naloxone) to potential responders;
  • Describe the duration and frequency requirements of training;
  • Describe any required supervision or monitoring of drug Overdose Responders and program trainers;
  • Use available reference material to enhance training content;
  • Stress the importance that drug use is highly dangerous and that complete abstinence from illegal or non-prescribed drug use is the healthiest choice; and
  • Describe the training oversight responsibilities of the Program's Official Designee and HCP.

The following information describes the minimum content to be included in the training curriculum. The Program should have a training manual that is based on available references listed below and any other appropriate training materials.

http://www.health.state.ny.us/diseases/aids/harm_reduction/opioidprevention/index.htm

http://www.harmreduction.org/

http://www.harmreductionjournal.com/content/3/1/19

http://store.samhsa.gov/product/Opioid-Overdose-Prevention-Toolkit-Updated-2016/SMA16-4742

www.prescribetoprevent.org

http://harmreduction.org/issues/overdose-prevention/tools-best-practices/manuals-best-practice/od-manual/

http://www.health.ny.gov/diseases/aids/general/opioid_overdose_prevention/

http://www.mass.gov/eohhs/gov/departments/dph/programs/substance-abuse/prevention/naloxone-access.html

A DOPP training video and resource materials can be found on IDHS/DASA website.

The minimum content to be included in the drug overdose prevention training is:

  • Role of naloxone
  • Recognition of a potential opioid overdose
  • Confirmation of unresponsiveness with the sternal rub
  • Administration of naloxone and calling EMS
  • Re-administration of naloxone if response is inadequate
  • Ensuring that the revived person is monitored for several hours, preferably in a medical setting
  • Rescue position
  • The importance of abstinence and how to support access to treatment for drug problems.
  • Important elements of the Drug Overdose Prevention Program.
  • Legal status of naloxone
  • Naloxone administration reports and refills

Depending on the context and program design, there are several additional recommended educational elements for potential overdose responders:

  • Hands- on practice with a demonstration kit
  • Risk factors for overdose fatality
  • Illinois 911/Good Samaritan law
  • Resuscitation technique: As there is insufficient data to recommend one resuscitation method over another, HCPs will need to determine whether rescue breathing, chest compressions or full CPR education is most appropriate for inclusion in their training curricula.

Drug overdose prevention education should be tailored to needs of identified responders and the population and environment they may encounter. Specific cultural aspects of the community where the overdose prevention interventions may take place should be addressed.

Drug overdose prevention education should:

  • Take into account the overdose responder's previous education and medical knowledge.
  • Take into account the environment in which the training may take place.
  • Address specific cultural needs of the overdose responder and the cultural environment in which they may encounter individuals who have overdosed.
  • Provide individualized training aids and training approaches based on the overdose responder and the cultural environment in which they may encounter individuals who have overdosed.
  • Provide ample opportunity for question, answer periods, and have written information to address frequently asked questions.
  • Be adaptable in length and format, based on the needs of the potential overdose responder.
  • Completing naloxone administration records - Overdose Reversal and Naloxone Reporting Form (IL 444-2053) Email to: DHS.DOPP.Coordinator@illinois.gov

The training manual should describe the minimum duration and frequency of drug overdose prevention education. The Program's Official Designee in conjunction with the HCP must document their assurance that the drug overdose responder is prepared to provide drug overdose prevention interventions (see Standing Orders to Dispense and Administer Naloxone Form IL 444-2052).

Trainings may take place in a variety of settings, including on the street or in a more conventional classroom setting, but should be conducive to maximize the learning of drug Overdose Responders. The trainings may be in small groups or conducted one-on-one and the length of trainings may vary depending on the drug Overdose Responders familiarity with drug injection and drug overdose or on other factors. All of the minimum content for patient information must be communicated before drug Overdose Responders administer naloxone without supervision.

Qualifications of Trainers

The training manual should describe the qualifications, training experience, and specific knowledge and skill sets of the individuals who will provide drug overdose prevention training to potential drug Overdose Responders. Drug overdose prevention trainers should be able to demonstrate competence in the content and skills of drug overdose prevention.

Training Records

At the conclusion of training, each person who has demonstrated adequate understanding of the course material will be recorded in the Drug Overdose Prevention Program training completion log. Active drug Overdose Responder status is dependent on the responder completing all written reports, supervision, and additional training as specified by the enrolled program.

Naloxone Kits

Each naloxone kit shall contain a minimum of:

  • #2 2 mL Luer-JetTM Luer-Lock needleless syringe (NDC 76329-3369-0) plus #2 mucosal atomizer devices (MAD-300) ·
  • #1 two-pack of two 4 mg/0.1 mL intranasal devices (NDC 69547-353-02)
  • #2 single-use 1 mL vials (NDC 00409-1215-01 OR NDC 67457-0292-02) OR #1 10mL multidose vial (NDC 00409-1219-01) PLUS #2 3 mL syringe w/ 23-25 gauge 1-1.5 inch IM needles
  • #1 two-pack of two 0.4 mg/0.4 mL prefilled auto-injector devices (NDC 60842-030-01)

Purchase of Naloxone Kit Supplies

  • Syringes may be purchased through medical supply houses or local drug stores. Prescriptions are not required. Be sure to purchase intramuscular needles (at most 25 gauge and at least 1 inch) with syringes that have at least a 3 mL volume.
  • Naloxone may be purchased from medical suppliers or your local drug store. A prescription or prescriber is required. If purchasing from a local drug store a few days advance notice may be required, as it may not be available at all locations. 
  • It is important to match the type of naloxone purchased and training of responders. Detailed information on naloxone sourcing can be found at: http://prescribetoprevent.org/pharmacists/pharmacy-basics/

Instructions Regarding Use or Loss of Naloxone Kit

Drug Overdose Responders will be strongly encouraged to report all use and any loss of their kits to the Program's Official Designee or designee, HCP, or affiliated prescriber. It is the goal of the Overdose Prevention Program that there is an accurate accounting of prescribed and distributed medications.

Refill Protocol

Drug Overdose Responders will receive naloxone kits as needed based on the policies and procedures established by the Enrolled Drug Overdose Prevention Program.

Storage of Naloxone

The Program's Official Designee will ensure that naloxone is stored safely consistent with the manufacturer's guidelines and that an adequate inventory of naloxone is maintained to meet reasonable projected demand. The naloxone inventory should be routinely assessed to ensure that drug Overdose Responders are furnished naloxone, which is at least 9 months-and preferably 12 months-prior to the expiration date.

Maintaining Program Records

Drug Overdose Prevention Programs will keep all forms and records for the program in organized files and available for review by IDHS/DASA as needed. Records should be handled in accordance with the agencies existing HR, HIPAA and administrative policies.

The Program's Official Designee will maintain:

  • A training completion log of all drug Overdose Responders with their name and the date of training completion;
  • A training log of all trainings with the dates of the training, the name of the trainer and the names of the drug Overdose Responders in attendance; Record quarterly the number of trained responders on Quarterly Report Form
  • A list of all persons who are designated trainers with verification by the Health Care Professional of their training competence;
  • Records pertaining to naloxone acquisition and storage;
  • All completed Standing Order to Dispense and Administer Naloxone Forms (IL444-2052);
  • Records regarding opioid antagonist administrations as detailed under Drug Overdose Reversals; and
  • A log of current affiliated prescribers, which includes their licensing credentials and any required collaborative agreements.

Drug Overdose Reversals and Naloxone Reporting Form

All drug overdose reversals will be recorded on the Drug Overdose Reversal and Naloxone Reporting Form (IL 444-2053) supplied by the IDHS/DASA and reviewed immediately or as soon as possible by the Program's Official Designee and Health Care Professional. Copies of these reports will be emailed to: DHS.DOPP.Coordinator@illinois.gov at IDHS/DASA within 5 days of administration or as a batch on a monthly basis If there are more than four reversals in a week or if there are specific concerns over either the strength or contamination of drugs in the area, the concern will be discussed with the HCP and reported immediately to the IDHS/DASA.