- Drug Overdose Prevention Program Guidelines for Implementation
- Responsibilities of the Program's Official Designee
- Definition and Responsibilities of the Program's Health Care Professional (HCP)
- Affiliated Prescribers
- Individuals to be Trained as Drug Overdose Responders
- Training Protocol
- Qualifications of Trainers
- Training Records
- Refresher Course
- Naloxone Kits
- Purchase of Naloxone Kit Supplies
- Instructions Regarding Use or Loss of Naloxone Kit
- Refill Protocol
- Storage of Naloxone
- Drug Overdose Reversals
- Maintaining Program Records
Drug overdose is recognized as a significant problem in Illinois and recent legislation addresses this serious issue. The Public Act 096-0361 (20 ILCS 301/5-23 new) is a new life-saving law that took effect on January 1, 2010, and makes 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. Naloxone is a prescription medicine that reverses an overdose by blocking heroin (or other opioids) in the brain for 30 to 90 minutes. Naloxone comes in multi-dose vials, 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 heroin users, their families, and friends in several programs in the United States, including Baltimore, Chicago, New Mexico, and San Francisco. Published data has shown that hundreds of individuals participating in these programs have successfully reversed an overdose.
Because of its particular pharmacological properties, heroin carries an especially high risk of death from overdose as compared to other drugs of abuse. The number of heroin mentions increased in Chicago hospital emergency departments (EDs) by over 176% from 1995 to 2002 (USDHHS, 2002). For the years 1998 to 2002, the Chicago metropolitan statistical area (MSA) had the most total heroin ED admission mentions of any MSA in the Drug Abuse Warning Network (DAWN), which includes New York City. The number of people who died from heroin or other opiates in the Chicago MSA increased by 57% from 1996 (224) to 2001 (352) (USDHHS, 2002). The number of people who died from heroin and other opiates in the Chicago MSA during 2001 was the second highest among the MSAs represented in DAWN. ED mentions for heroin continued to rise from 2004 (about 22,000) to 2008 (about 24,000). Estimated overdose from heroin rose in Chicago from 4,546 in 2007 to 5,198 in 2008. That heroin use continues to be extremely problematic is evidenced in the fact that in 2010 heroin is the most commonly cited primary drug for individuals entering substance abuse treatment.
This Public Act 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. Potential enrollees include DASA Treatment Programs, licensed prescribing practitioners, for profit community-based organizations, not-for-profit community-based organizations, hospitals, local health departments, urgent care facilities and faith-based organizations. Agencies or programs must enroll with the Illinois Department of Human Services, Division of Alcoholism and Substance Abuse in order to operate a Drug Overdose Prevention Program. 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 training for drug overdose prevention responders.
The guidelines are divided into two sections (1) Program Guidelines for Implementation, and (2) Enrollment and Reporting Forms.
Drug overdose and in particular opioid overdose is a serious public health issue in Illinois. Drug overdose is the second leading cause of accidental death in the United States (Center for Disease Control and Prevention). Overdose deaths from opioids or other drugs are very often preventable, as long as a witness to an overdose recognizes what is happening and knows how to respond appropriately. When an individual is experiencing an opioid overdose, they become sedated and gradually lose the urge to breathe. Most drug overdoses are not instantaneous and the majority of overdose fatalities are preventable, especially if witnesses have had appropriate training and are prepared to respond in a safe and effective manner. Response includes contacting emergency medical services and providing resuscitation. Resuscitation consists of rescue breathing, and/or administration of an FDA-approved drug (i.e., naloxone) to immediately reverse the effects of heroin overdose.
These Drug Overdose Prevention Program Guidelines for Implementation were created to assist programs enrolling as Illinois Drug Overdose Prevention Programs to develop policies and procedures and curriculum for training within Illinois laws and regulations. The enrollment package explains who will be responsible for reporting data back to the Illinois Department of Human Services, Division of Alcoholism and Substance Abuse (IDHS/DASA). The guidelines are divided into two sections, (1) Program Guidelines for Implementation and (2) Enrollment and Reporting forms.
The Program Guidelines for Implementation explain what elements are needed to develop a Drug Overdose Prevention Program 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 Drug Overdose Prevention Program and the target population they intend to serve. The guidelines describe the program staff responsibilities and training guidelines for the use of Naloxone. All Drug Overdose Prevention 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, there are Drug Overdose Prevention Program Enrollment and Reporting Forms that are required for programs that plan to use Naloxone. The Enrollment Forms will allow IDHS/DASA to keep track of prevention programs, trained responders and drug overdose response incidents in Illinois. Each program must complete the program enrollment forms and submit to the IDHS/DASA before they begin training drug overdose prevention responders. The enrollment will be valid for three years and then Programs must re-enroll. Enrolled Programs will receive an enrollment certificate upon submission of these forms.
For more information on the Drug Overdose Prevention Program, or to enroll as an Illinois Drug Overdose Prevention Program, please contact the Illinois Department of Human Services, Division of Alcoholism and Substance Abuse, Richard Weisskopf at (312) 814-6380, Richard.Weisskopf@illinois.gov or Lillian Pickup, R.N. at (312) 814-2436, Lillian.Pickup@illinois.gov.
Drug Overdose Prevention Program Guidelines for Implementation
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 which is consistent with the training materials 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 drug overdose prevention program 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;
- 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 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. If a training participant appears unable to adequately understand the training instruction, they should be invited to return another time.
Trainers may be program employees or volunteers and must demonstrate competence in the content and skills of the Drug Overdose Prevention Program 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.
Illinois Programs that are enrolled and authorized to be a Drug Overdose Prevention Program are required to have a training manual 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 illegal and highly dangerous and that complete abstinence from illegal 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.
The minimum content to be included in the drug overdose prevention training is:
- What are opioids and how do they work?
- Overview of opioid drug overdose.
- Other drugs that can cause drug overdose.
- Risk factors for opioid drug overdose.
- Signs of opioid drug overdose.
- What is naloxone and how is it to be used and stored.
- Steps to take when responding to an opioid drug overdose.
- Complications that may occur in overdose prevention and how to handle them.
- The importance of abstinence and how to support access to treatment for drug problems.
- Important elements of the Drug Overdose Prevention Program.
An essential component of drug overdose prevention training is "hands on" demonstration and practice of the skills needed to help an individual who has overdosed. Practicing these skills during training will give the overdose responder confidence that they can perform them in a real life and death situation. Drug Overdose Responders will require training to learn how to:
- Check for breathing;
- Provide stimulation to arouse a person;
- Place in Recovery Position to prevent choking;
- Provide rescue breathing;
- Administer naloxone and monitor for response;
- Provide ongoing support and monitoring to the individual who has overdosed;
- Call for additional services and interact with EMS;
- Other interventions as indicated; and
- Completing naloxone administration records.
Drug overdose prevention training 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 in the training.
Drug overdose prevention training 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.
The training manual should describe the minimum duration and frequency of drug overdose prevention training in order for a potential drug overdose responder to successfully complete the training program. 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).
The training manual should describe the nature and frequency of any required or voluntary supervision or monitoring for drug Overdose Responders. The goal of this supervision or monitoring is to provide support to Overdose Responders and maintain program safety and efficacy. This oversight might include additional training updates.
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 curriculum material must be completed 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.
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.
Drug Overdose Responders will be required to take a refresher training in order to retain their status at a minimum every three years. Training records should be checked for currency of training status when drug Overdose Responders request a new naloxone kit. Refresher courses may be offered prior to the expiration of three (3) years to ensure current knowledge regarding drug overdose protocols and ability of the drug overdose responder to administer naloxone.
Each naloxone kit shall contain a minimum of:
- One (1) multi-dose naloxone medication vial and two 3 cc or larger syringes with 1 in or longer, 23 gauge or larger needles; or
- Two (2) individual dose prefilled syringes of naloxone; or
- Nasal dispensing equipment and medication equal to two doses of naloxone; and
- Two (2) alcohol swabs.
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 the correct type of syringes.
- 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.
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.
Drug Overdose Responders will receive naloxone kits as needed based on the policies and procedures established by the Enrolled Drug Overdose Prevention Program. All drug Overdose Responders must be current in their training requirements before receiving their initial naloxone kit or replacement kits.
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.
Drug Overdose Reversals
All drug overdose reversals will be recorded on the form 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 sent to the IDHS/DASA 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.
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 and location of the training, the name of the trainer and the names of the drug Overdose Responders in attendance;
- 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;
- 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.