Purpose of This Guideline
Date of current publication: September 25, 2023
Lead author: Judith Griffin, MD
Writing group: Susan D. Whitley, MD; Timothy J. Wiegand, MD; Sharon L. Stancliff, MD; Charles J. Gonzalez, MD; Christopher J. Hoffmann, MD, MPH
Committee: Substance Use Guidelines Committee
Date of original publication: August 29, 2019
This guideline on harm reduction was developed by the New York State Department of Health AIDS Institute (NYSDOH AI) to guide primary care clinicians and other clinical practitioners in integrating harm reduction principles into the treatment and care of adults with substance use and substance use disorders (SUDs).
By providing evidence-based guidelines on treatment of substance use and SUDs, the NYSDOH AI, and the Substance Use Guidelines Committee aim to increase the availability of treatment in general medical settings. With this guideline, the committee aims to promulgate a harm reduction approach to medical care of patients who use substances or have SUDs and to:
- Promote adoption of practical harm reduction strategies to reduce the negative consequences associated with drug and alcohol use.
- Increase awareness and use of NYSDOH and local/regional harm reduction resources.
- Support healthcare clinicians in recognizing and addressing the effects of stigma, which can pose a barrier to individuals seeking substance use treatment and harm reduction services.
Role of primary care clinicians: Primary care clinicians in New York State play an essential role in identifying substance use in patients, counseling patients about risky substance use, and expanding access to evidence-based treatment. SUDs are chronic conditions that can be successfully managed in primary care or other outpatient settings.
In the clinical context, harm reduction is an approach based on the use of practical strategies to reduce the negative consequences associated with substance use. It is founded on respect for and the rights of those individuals who use drugs (adapted from the National Harm Reduction Coalition). A harm reduction approach promotes positive changes beyond abstinence, which may include reducing substance use and using safely to reduce disease acquisition and transmission, and emphasizes the avoidance of coercion, discrimination, and bias in the clinical care of people with SUDs.
The NYSDOH AI and this committee strongly advocate a harm reduction approach in the care of all individuals who use substances, including those with a diagnosed SUD. The recommendations are based on emerging evidence and the extensive clinical experience of this committee.
Racial and Ethnic Disparities
Studies conducted before the COVID-19 pandemic documented racial or ethnic disparities in access to evidence-based opioid use disorder (OUD) treatment Goedel, et al. 2020; Lagisetty, et al. 2019 and opioid overdose mortality rates Friedman, et al. 2022; Larochelle, et al. 2021. These disparities in access to treatment and mortality appear to have worsened during the COVID-19 pandemic Kariisa, et al. 2022; Nguyen, et al. 2022; Khatri, et al. 2021.
Because people of color experience a disproportionate level of harm associated with substance use and repercussions related to use, it is essential to expand access to evidence-based harm reduction services and treatment for people of color who use substances. Clinicians can work directly with patients and their families and regular social contacts to provide naloxone and other harm reduction services when indicated and refer patients to appropriate community-based organizations for further support.
Harm Reduction During the COVID-19 Pandemic
The COVID-19 pandemic had devastating consequences for people who use substances, with unprecedented increases in overdose deaths CDC 2023; Kouimtsidis, et al. 2021; Krawczyk, et al. 2021. In the United States, in the 12 months ending in April 2021, the Centers for Disease Control and Prevention reported 75,673 opioid-related overdose deaths compared with 56,064 deaths in the preceding 12-month period CDC 2021. In 2019, 2,939 overdose deaths (14.9 per 100,000 population) occurred among New York State residents, which is nearly triple the rate in 2010 NYSDOH 2021. Preliminary 2020 data indicate the rate continues to increase; in New York State (excluding New York City), there were 2,521 (22.5 per 100,000 population) opioid-related deaths NYSDOH 2022.
Harm reduction interventions were implemented in response to COVID-19. For example, under the federal COVID Public Health Emergency (PHE), telemedicine was used to initiate medication for OUD treatment, thus expanding and protecting access to evidence-based treatment Jones, et al. 2022; Tofighi, et al. 2022; Wang, et al. 2021. The ability to initiate medication for OUD treatment via telehealth after the conclusion of the COVID PHE remains unclear at this time; PHE exemptions for telehealth have been extended through 2024 while new regulations are under review. Other harm reduction services implemented in response to the pandemic include home and mail-order delivery programs for naloxone distribution and syringe exchange.
Trauma is more common among people with an SUD Bartholow and Huffman 2021; Karsberg, et al. 2021; Zarse, et al. 2019, and this population is more likely to experience trauma in healthcare settings Aronowitz and Meisel 2022; Simon, et al. 2020. The effect of trauma on the health and well-being of individuals and communities is gaining increasing visibility and attention CDC 2022; Robert Wood Johnson Foundation 2022; Center for Youth Wellness 2017. Trauma results from an event, series of events, or set of circumstances that is experienced (or perceived) by an individual as physically or emotionally harmful or life-threatening and that has lasting adverse effects on the individual’s functioning and mental, physical, social, emotional, or spiritual well-being SAMHSA 2014. Historical trauma refers to cumulative traumatic experience and associated harms extending over an individual life span and across generations. In a trauma-informed approach, clinicians recognize the signs of trauma and avoid retraumatizing patients. For more information, see the Center for Health Care Strategies Trauma-Informed Care Implementation Resource Center.
Implementing Substance Use Harm Reduction
Implementing Substance Use Harm Reduction
Abbreviations: HCV, hepatitis C virus; NLX, naloxone; PEP, post-exposure prophylaxis; PrEP, pre-exposure prophylaxis; SUD, substance use disorder.
Harm Reduction Approach
Substance use or SUDs, whether treated or not, do not preclude delivery of primary care services. Regardless of a patient’s desire to engage in treatment for substance use as part of their medical care, every clinic visit is an opportunity to provide primary care with attention to screening for sexually transmitted and injection drug use-associated diseases, including HIV and HCV, vaccinations, and sexual health services. See NYSDOH AI guidelines:
- HIV Testing
- Hepatitis C Virus Screening, Testing, and Diagnosis in Adults
- PrEP to Prevent HIV and Promote Sexual Health
- PEP to Prevent HIV Infection
Working with a patient who uses substances to implement an appropriate harm reduction/treatment plan involves balancing many factors, and choice may be limited by availability and other practical considerations. Some individuals may perceive substance use to be more helpful or pleasurable than harmful. Asking about and understanding the perceived benefits of substance use can help the clinician identify other ways for the patient to obtain the same or similar benefits and tailor a successful treatment plan.
Harm reduction/treatment goals: Traditionally, SUD treatment providers have considered abstinence the primary goal of treatment, but this approach is evolving. Changing the pattern of or reducing an individual’s substance use has measurable health benefits and contributes to increased function, even if the individual continues to use the substance of choice or other substances Charlet and Heinz 2017; Lea, et al. 2017; Collins(a), et al. 2015; Collins(b), et al. 2015; Gjersing and Bretteville-Jensen 2013.
For some individuals with a SUD, the use of other substances can reduce the use of the more problematic substance. There is increasing interest in the use of cannabis, cannabidiol, and other substances to reduce the compulsion to use opioids Chye, et al. 2019; Socías, et al. 2017. Choosing cannabis may be a harm reduction strategy for some patients who use opioids because fewer risks are associated with cannabis use.
One example of harm reduction counseling is to review with the patient any potential interactions between the substance(s) a patient uses and medications taken for other conditions and dispel misinformation about drug-drug interactions Kalichman(a), et al. 2022. In studies among individuals with HIV, intentional nonadherence to ART is associated with the belief that alcohol and other drugs interact with ART medications Kalichman(a), et al. 2022; Kalichman(b), et al. 2022; El-Krab and Kalichman 2021. If no significant interactions exist, patients should be encouraged to take all medications as prescribed even when using substances.
Based on individual patient needs and priorities and available clinical resources, clinicians should offer or refer patients for harm reduction services. Services may include primary or specialty medical care, education and counseling on safer drug use, development of an overdose safety plan including access to NLX, provision of sterile drug use equipment, provision of fentanyl and xylazine test strips or other options for drug checking, and referrals to social support resources.
Sterile syringes and needles and other drug equipment: Harm reduction includes the provision of or referral for sterile needles and syringes Bowman, et al. 2013. Sharing injection equipment can transmit bloodborne diseases, such as HIV and HCV; in the United States, injection drug use is the leading cause of HCV infection CDC 2018. Syringe access has been associated with dramatic reductions in HIV transmission; as syringe exchange was expanded in New York City, HIV seroincidence decreased to 1 per 100 person-years from 4 per 100 person-years Des Jarlais and Carrieri 2016. Syringe exchange has also been associated with reductions in HCV transmission Saab, et al. 2018; Des Jarlais, et al. 2005. Unsterile injection equipment is associated with soft tissue infections, including methicillin-resistant Staphylococcus aureus (MRSA), Candida albicans, and Staphylococcus aureus Hartnett, et al. 2019. It is also important for individuals who use drugs to have access to safe and sterile supplies beyond syringes, including alcohol swabs, ascorbic acid, sterile water, sterile cookers, sterile filters, tourniquets, straight stems, push sticks, brass screens, bowl pipes, mouthpieces, foil, paper straws, and benzalkonium wipes.
Opioid Overdose Prevention
Clinicians should provide patient education on the risks of overdose and discuss strategies to reduce overdose risk. See Box 1, below, for resources in New York State and the NYSDOH resource Your health and life matter. Build a safety plan.
Fentanyl: Fentanyl, a synthetic opioid, is a common and often unidentified additive to heroin and other drugs such as cocaine, methamphetamine, and counterfeit pills that look like various opioid analgesics and benzodiazepines Colon-Berezin, et al. 2019. Because fentanyl is much more potent than heroin, it increases the likelihood of a fatal opioid overdose. Clinicians should advise individuals who use drugs, both opioids and other drugs, on how to avoid an overdose: assume all products sold as heroin or other opioids will contain fentanyl and that stimulants and counterfeit pills may contain fentanyl, check drugs before use with a fentanyl test strip, avoid using alone, start with a small amount, carry NLX to reverse opioid overdoses, and avoid mixing drugs. If patients do use alone, counsel them to arrange for someone to check in with them; check-ins can be scheduled using phone- and web-based apps, such as Never Use Alone Inc.
Drug checking: Testing drugs with specialized equipment at a test site or with fentanyl test strips provides the chemical content of drugs before use. Some NYS Authorized Syringe Exchange Sites offer fentanyl test strips and drug checking with on-site gas chromatography-mass spectrometry machines that separate and detect chemical compounds.
Fentanyl test strips may promote safer use practices because individuals who are aware that drugs contain fentanyl may opt to use a smaller amount, change the mode of administration, or not use. Clinicians should discuss fentanyl test strips with patients who use opioids and other substances, such as methamphetamines, because of the presence of fentanyl in the nonprescription drug supply.
False-positive results erroneously showing the presence of fentanyl can occur when substances have been cut with high levels of diphenhydramine, methamphetamine, or 3,4-methylenedioxy-methamphetamine (MDMA) Lockwood, et al. 2021. Clinicians should counsel patients on how to use fentanyl test strips correctly, particularly when testing methamphetamines; if dilution is not performed correctly when testing methamphetamines, false-positive results may result. For more information on using fentanyl test strips, see NYC Health How to Test Your Drugs Using Fentanyl Test Strips.
Naloxone: Clinicians should prescribe or ensure access to NLX for individuals at risk of experiencing or witnessing an opioid overdose. As an opioid antagonist, NLX displaces other opioids from opioid receptors but does not cause opioid effects and does not have the potential for misuse. Clinicians should also encourage patients’ family members, friends, or other regular contacts to have NLX on hand and be trained to use it for reversing opioid overdose. The nasal spray formulation of NLX (“Narcan”) can be administered by laypeople and bystanders to reverse an opioid overdose safely and effectively. In New York State, intranasal NLX is covered by Medicaid, and the NYSDOH Naloxone Co-payment Assistance Program (see Box 1, below) covers a portion of the cost for patients with private insurance who have a copay for NLX. NLX is also distributed free of charge and regardless of insurance status by NYSDOH-Registered Opioid Overdose Prevention Programs.
The nasal spray formulation of NLX is typically prescribed and administered as a 4 mg dose. In 2021, the U.S. Food and Drug Administration (FDA) approved an 8 mg dose of NLX nasal spray and a 5 mg prefilled syringe of NLX for intramuscular or subcutaneous injection to treat opioid overdose, but few clinical data are available that clarify when a higher dose or alternative administration method is indicated FDA 2021. Preliminary data from a pilot study comparing administration of the 4 mg and 8 mg NLX doses by New York State police officers from March 26, 2022 to June 18, 2023, indicate that responders administered the same number of NLX doses regardless of the formulation and that the 8 mg dose is associated with a significantly higher risk of withdrawal symptoms than the 4 mg dose without any evidence of increased efficacy NYSDOH 2023.
The use of stimulants, either alone or in combination with other substances including opioids, has been increasing Han, et al. 2021, and no FDA-approved pharmacologic treatment is available specifically for stimulant use disorder. Individuals who use stimulants may be unknowingly exposed to fentanyl. As such, it is essential to offer NLX, fentanyl test strips, and other harm reduction strategies to patients who use nonprescription stimulants.
Overdose prevention centers (or sites): In December 2021, the first overdose prevention centers (OPCs) in the United States were opened in New York City. As of September 12, 2023, staff at the 2 New York City sites have reversed 1,008 overdoses, and a total of 3,719 individuals have used the sites; see OnPoint NYC.
OPCs, also known as “supervised injection facilities” or “supervised consumption sites” have been opened in 11 countries and are increasingly recognized as an evidence-based and cost-effective harm reduction intervention Samuels, et al. 2022. At an OPC, people can use drugs that they have obtained elsewhere under medical supervision. Sterile injection supplies are available, and staff are trained to monitor for overdose and administer oxygen, NLX, and other first-response care as needed. Additional medical and social services may be offered, including referrals to SUD treatment or other indicated services ICER 2021. Notably, an opinion study in the United States showed higher levels of support for “overdose prevention sites” than “supervised consumption sites” (45% vs. 29%), suggesting that using the term OPS (or OPC) may be preferred to foster public support Valencia, et al. 2021; Kennedy, et al. 2019; Barry, et al. 2018.
No fatal overdose has been reported in an OPC. Evidence demonstrates that OPCs are associated with improved outcomes, including reductions in overdose mortality ICER 2021; Levengood, et al. 2021; Kral, et al. 2020; Kennedy, et al. 2019, injection-related infections Valencia, et al. 2021, and injection risk behaviors, without increasing crime in the surrounding communities.
|Abbreviations: MATTERS, Medication for Addiction Treatment & Electronic Referrals; OASAS, Office of Addiction Services and Supports; STI, sexually transmitted infection.
|Box 1: Harm Reduction Resources in New York State (September 2023)|
|Sterile needles and syringes||
|Drug checking||Fentanyl test strips:
Xylazine test strips:
|Drug user health hubs||
Pharmacologic Treatment for Substance Use Disorder
A range of effective pharmacologic treatments is available for several SUDs, including alcohol Jonas, et al. 2014; Rösner, et al. 2010; Overman, et al. 2003, tobacco Anthenelli, et al. 2016; Piper, et al. 2009, and opioid use disorders Lee, et al. 2018; Mattick, et al. 2014. Clinicians should discuss with patients the pharmacologic treatments and different treatment settings available and help them understand the benefits and risks. In New York State, most drug treatment programs licensed by the Office of Addiction Services and Supports are mandated to provide pharmacotherapy when indicated OASAS 2022. Some patients may misunderstand or have biases against pharmacologic treatment, so it may be helpful to continue these discussions over time.
Because the patient may benefit from treatment, clinicians should not deny or discontinue SUD treatment if a patient continues to or returns to use Gjersing and Bretteville-Jensen 2013. In 2017, the FDA issued a drug safety communication urging caution in denying methadone or buprenorphine when patients are taking benzodiazepines, because the risk of opioid overdose is higher with no treatment than the risks of combining the medications FDA 2017.
SUD is a chronic health condition that requires long-term management, including pharmacologic treatment Saitz, et al. 2013, which should be continued for as long as it is beneficial to the patient. Patients may opt to discontinue medication, but clinicians should encourage resumption without suggesting or implying that discontinuation of pharmacologic treatment is the preferred approach.
Individualized follow-up during outpatient SUD treatment: Ongoing, regular follow-up is essential for support, encouragement, and modification of the treatment plan as needed.
- Follow-up within 2 weeks of treatment initiation allows tailoring of the treatment plan according to individual needs (e.g., change in dose of pharmacologic treatment, addition of support services).
- As patients stabilize on treatment, monthly or at least quarterly follow-up allows for ongoing evaluation to ensure that the patient’s goals are being met.
As with all diseases and disorders, patients who have a SUD may present with medical complexities beyond a clinician’s expertise. Adolescents may require specialty care, as may individuals who are pregnant or who have co-occurring psychiatric disorders. When individual patient factors complicate diagnosis and treatment, local and national resources are available for consultation and referral. For opioid-related issues, see Providers Clinical Support System or NYSDOH AI Provider Directory.
Avoiding Substance Use-Associated Discrimination
Avoiding Substance Use-Associated Discrimination
Stigma in the Healthcare Setting
Substance use-related stigma may prevent individuals from seeking or receiving treatment and harm reduction services Tsai, et al. 2019. In particular, people who use substances during pregnancy face significant stigma and may fear accessing medical care or other services as a result Schiff, et al. 2022; Wakeman, et al. 2021. Stigma among clinicians against people who use substances has been well documented Stone, et al. 2021; Tsai, et al. 2019; van Boekel, et al. 2013. Clinician bias has been associated with health disparities and can have profoundly negative effects FitzGerald and Hurst 2017; Hall, et al. 2015. In particular, the stigma associated with substance use may increase the risk of overdose, although the exact mechanism for this association is not well defined. In 1 study, enacted stigma (discrimination) was associated with an increased risk of opioid overdose but internalized stigma was not. This finding may suggest that enacted stigma could contribute to risk behaviors, such as using quickly or in multiple locations to avoid detection Latkin, et al. 2019; Cruz, et al. 2018.
It is often challenging for clinicians to recognize and set aside personal biases and to address biases with peers and colleagues. Consciously or unconsciously, negative or stigmatizing assumptions are often made about patient characteristics, such as race, ethnicity, gender, sexual orientation, mental health, and substance use Avery, et al. 2019; van Boekel, et al. 2013; Livingston, et al. 2012. Individuals who use substances may also be stigmatized by assumptions about substance use and criminal behavior. For more information, see the resources listed below.
To acknowledge and address stigma, clinicians are advised to consciously change their substance use-related vocabulary to avoid stigmatizing terms, to use neutral medical terms, and to help colleagues and staff adopt neutral language (see Box 2, below). For example, the term “dirty urine test” elicits a more negative reaction toward a patient than the more accurate and neutral term “opiate-positive test result” Kelly and Westerhoff 2010. Patients may choose to use stigmatizing words in describing themselves, but clinicians and staff should strive to use language that is respectful of the individual and easy to understand.
|Box 2: Changing the Language of Substance Use [a,b]|
|Neutral Term||Stigmatizing Term|
|Substance use||Substance abuse|
|Use of nonprescription medication or drug||Illicit drug use|
|Pharmacologic treatment||Medication-assisted treatment|
|A person who uses drugs, alcohol, or substances||Drug addict, drug abuser, alcoholic, junkie, crackhead, tweaker, etc.|
|A person who formerly used drugs or alcohol||A person who got clean|
|Negative or positive toxicology results||Clean or dirty toxicology results|
|A recurrence of use or return to use||Relapse|
Legal Protections for Individuals With Substance Use Disorder
The New York State Human Rights Law (NYSHRL) and the American With Disabilities Act (ADA) protect individuals with disabilities from discrimination in the workplace and housing. Under the NYSHRL and ADA, individuals taking prescribed medical treatment for SUD and those in recovery from SUD are considered disabled; for patients with OUD, see The Americans with Disabilities Act and the Opioid Crisis: Combating Discrimination Against People in Treatment or Recovery. The NYSHRL and the ADA exclude from protection individuals who are currently using illegal drugs.
Employers and housing providers are prohibited from discriminating against individuals with disabilities under the NYSHRL. Employers are prohibited from denying a job opportunity to a qualified individual, terminating an employee because of a disability, and making inquiries about an individual’s disability, which includes questions about prescribed medical care for SUD. Employers are to provide reasonable accommodations to assist disabled people in performing their job functions. It is unlawful for housing providers to refuse to house or discriminate against a tenant because they are taking medical treatment for SUD or are in recovery from SUD.
Information about these protections and enforcement of the NYSHRL can be found at the New York State Division of Human Rights.
|ALL RECOMMENDATIONS: SUBSTANCE USE HARM REDUCTION IN MEDICAL CARE|
Implementing Substance Use Harm Reduction
Avoiding Substance Use-Associated Discrimination
Abbreviations: HCV, hepatitis C virus; NLX, naloxone; PEP, post-exposure prophylaxis; PrEP, pre-exposure prophylaxis; SUD, substance use disorder.
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Updates, Authorship, and Related Guidelines
|Updates, Authorship, and Related Guidelines|
|Date of original publication||August 29, 2019|
|Date of current publication||September 25, 2023|
|Highlights of changes, additions, and updates in the September 25, 2023 edition||
Updated text on opioid overdose prevention counseling and resources for obtaining fentanyl and xylazine test strips in New York State
|Intended users||Primary care clinicians and other practitioners in New York State with adult patients who use substances|
Judith Griffin, MD
Susan D. Whitley, MD; Timothy J. Wiegand, MD; Sharon L. Stancliff, MD; Charles J. Gonzalez, MD; Christopher J. Hoffmann, MD, MPH
|Author and writing group conflict of interest disclosures||There are no author or writing group conflict of interest disclosures|
|Developer and funder|
See Guideline Development and Recommendation Ratings Scheme, below.
|Related NYSDOH AI guidelines|
Guideline Development and Recommendation Ratings
|Guideline Development: New York State Department of Health AIDS Institute Clinical Guidelines Program|
|Program manager||Clinical Guidelines Program, Johns Hopkins University School of Medicine, Division of Infectious Diseases. See Program Leadership and Staff.|
|Mission||To produce and disseminate evidence-based, state-of-the-art clinical practice guidelines that establish uniform standards of care for practitioners who provide prevention or treatment of HIV, viral hepatitis, other sexually transmitted infections, and substance use disorders for adults throughout New York State in the wide array of settings in which those services are delivered.|
|Expert committees||The NYSDOH AI Medical Director invites and appoints committees of clinical and public health experts from throughout New York State to ensure that the guidelines are practical, immediately applicable, and meet the needs of care providers and stakeholders in all major regions of New York State, all relevant clinical practice settings, key New York State agencies, and community service organizations.|
|Disclosure and management of conflicts of interest||
|Evidence collection and review||
|Review and approval process||
|Recommendation Ratings Scheme|
|Strength||Quality of Evidence|
|A||Strong||1||Based on published results of at least 1 randomized clinical trial with clinical outcomes or validated laboratory endpoints.|
|B||Moderate||*||Based on either a self-evident conclusion; conclusive, published, in vitro data; or well-established practice that cannot be tested because ethics would preclude a clinical trial.|
|C||Optional||2||Based on published results of at least 1 well-designed, nonrandomized clinical trial or observational cohort study with long-term clinical outcomes.|
|2†||Extrapolated from published results of well-designed studies (including nonrandomized clinical trials) conducted in populations other than those specifically addressed by a recommendation. The source(s) of the extrapolated evidence and the rationale for the extrapolation are provided in the guideline text. One example would be results of studies conducted predominantly in a subpopulation (e.g., one gender) that the committee determines to be generalizable to the population under consideration in the guideline.|
|3||Based on committee expert opinion, with rationale provided in the guideline text.|