Exploring the harm reduction paradigm: the role of Board-Certified Psychiatric Pharmacists

Substance use disorders (SUDs) are chronic disorders characterized by continued drug seeking and use despite negative consequences.¹  The cyclic nature of addiction, a neurochemical disorder, stems from initial hyperactivation followed by hypoactivation of the dopamine reward system.²  Over time, continued use of a substance leads to the development of tolerance or the need for more substance to produce the desired effect. In the absence of the substance of choice, people who use drugs (PWUD) may develop uncomfortable and potentially dangerous withdrawal symptoms that often lead to a return to use. As the SUD progresses and increases in severity, the ability to experience pleasure without the substance declines and may result in the development of anhedonia,^3,4  a lack of pleasure in activities that were previously enjoyed. Chronic substance use changes the brain, demonstrating that addiction is a medical disorder rather than moral ineptitude.^5,6  In 2022, the Substance Abuse and Mental Health Services Administration (SAMHSA) estimated that over 48 million Americans over the age of 12 years met the criteria for a SUD, yet only 14.9% received treatment.⁷ 

Deaths related to SUDs continue to rise. Provisional data from the Centers for Disease Control and Prevention (CDC) indicate that more than 109 000 people died from a drug-related overdose in 2022, with around 80 000 involving opioids.⁸  Currently, synthetic opioids, such as fentanyl and its analogs, are driving the increased rate. The number of deaths related to fentanyl has surged nearly 7.5 times, escalating from 9580 deaths in 2015 to nearly 71 000 in 2021.⁹  The lethality of fentanyl is exacerbated by the presence of the veterinary tranquilizer xylazine, known as “tranq,” an adulterant in the fentanyl supply. Overdose deaths involving xylazine in the United States (US) have been increasing in recent years, escalating from 102 in 2018 to 3468 in 2021.¹⁰  Along with the risk of overdose, people with SUDs are at an increased risk for developing cardiovascular disease, co-occurring psychiatric disorders, infectious diseases, and poor overall well-being, all of which may fuel the cycle of use.¹¹ 

To significantly reduce mortality and adverse consequences linked to substance misuse, both clinicians and public health officials advocate for the adoption of a proactive harm reduction (HR) approach.^12,13  The White House Office of National Drug Control Policy advocates for HR, which is considered 1 of the 4 strategic priorities of the US Department of Health and Human Services Overdose Prevention Strategy.¹⁴  Additionally, the American Association of Psychiatric Pharmacists endorses the adoption of a proactive HR approach. As vital members of the treatment team for patients with SUDs, Board-Certified Psychiatric Pharmacists (BCPPs) have demonstrated their ability to provide opioid use disorder treatment.¹⁵  They are also well-suited to educate patients and the treatment team on HR principles and implement HR practices to reduce the risk of death. A harm reduction attitude acknowledges that abstinence is not always the ultimate goal and focuses instead on improving the well-being of people who use substances.¹⁶  The goals of this manuscript were to further contextualize HR practice in substance use treatment, provide guidance on implementing evidence-based HR strategies, and outline how psychiatric pharmacists can take an active role in applying HR principles and practices when treating patients with SUDs. The aim was to provide a nonprescriptive framework for HR adoption to foster implementation and innovation across various BCPP practice settings.

Harm reduction is an overarching philosophy and approach to reducing adverse individual and societal consequences of potentially unsafe behaviors, including ongoing substance use. SAMHSA recently released a draft Harm Reduction Framework publication, which defines HR “as a practical and transformative approach that incorporates community-driven public health strategies – including prevention, risk reduction, and health promotion – to empower PWUD and their families with the choice to live healthy, self-directed, and purpose-filled lives. Harm reduction centers the lived and living experience of PWUD, especially those in underserved communities, in these strategies and the practices that flow from them.”¹⁴  The roots of HR go back at least several centuries, yet the HIV epidemic in the 1980s catalyzed the adoption of HR as a public health approach to drug policy on an international level.^17,18  Six principles that capture the essence of HR have been identified for use in healthcare as follows: humanism, pragmatism, individualism, autonomy, incrementalism, and accountability without termination.¹⁹  While supporting abstinence, HR transcends the narrow limitations of a zero-tolerance approach to substance use treatment by offering a spectrum of options. In other words, HR embraces meeting patients “where they are at” to get them to where they want to be. Harm reduction thereby recognizes the individual’s needs and strengths and celebrates any steps toward positive change (individualism, incrementalism). It recognizes SUDs as chronic diseases with the patient being the agent of change; abstinence may not be a desired goal for an individual at a certain time, yet making drug use safer can be (autonomy, pragmatism). Harm reduction dismisses the notion of drug use and return to use as a moral failing, offers continued engagement in care, methods to increase safety, and access to services despite ongoing use simply as it is, a human right (humanism, accountability without termination). Harm reduction and SUD treatment sit on a continuum of care with bidirectional movement typical of chronic diseases and can be used in concert. These principles overlap with shared decision-making and person-centered care, which are best practices in managing chronic medical illnesses.²⁰ 

The SUD treatment approach should mirror how chronic medical illnesses are managed. For example, the American Diabetes Association guidelines for adults with diabetes discuss the importance of working with a patient to develop healthy eating patterns and individualize meal plans based on needs and preferences.²⁰  It is not expected that simple or added sugars will be completely eliminated from the diet in a patient with type II diabetes to see a reduction in A1c, and patients will not be discharged from treatment if readiness for change to improve blood sugars is low. Further, although a reduction in the Patient Health Questionnaire (PHQ-9) or Generalized Anxiety Disorder Assessment (GAD-7) rating scale serves as a marker for improvement in depression and anxiety, it is recognized that remission cannot always be achieved. Recognizing that such an outcome is unattainable for many, a reduction in symptoms while working with the patient in a whole-health framework can lead to desirable outcomes for the individual and society, such as increased quality of life and decreased risk of hospitalization and death by suicide.

Harm reduction is viewed negatively by opponents, including healthcare professionals, because of stigma and social injustices when applied to the already disenfranchised group of PWUD. However, when applied to any other disease state or aspect of life, HR is considered a standard of practice or a necessary safety measure. Fire extinguishers, helmets, seatbelts, and sunscreen are a few HR practices integrated into daily lives. In fact, the criminal justice system punishes those who do not use seatbelts but may criminalize HR methods (see “Regulatory Status” in Table 1) aimed at increasing the safety of PWUD, such as fentanyl test strips or overdose prevention centers.

Harm reduction continues to face controversy, with opponents believing the framework enables or condones drug use despite published data refuting this and demonstrating positive medical outcomes.^21–23  Results from a study comparing outcomes between treatment-engaged and nontreatment-engaged PWUD in a syringe exchange program found reductions in percent days of heroin and cocaine use in both groups over 4 months, with larger reductions in the treatment group.²¹  This not only demonstrates that HR does not increase drug use, but can decrease it, even when a patient is not ready for treatment. In a study of nontreated individuals actively injecting opioids, a personalized overdose education and naloxone distribution (OEND) intervention resulted in substantial reductions in self-reported opioid use and overdose risk factors over 12 months. The reports included a 70.5% decrease in opioid dose escalations, a 27.2% decrease in injection use, a 15.5% decrease in concurrent benzodiazepine use, a 15.9% decrease in concurrent alcohol use, and an 18% decline in same use patterns postabstinence.²³  In addition, 65% of participants reported naloxone use on either themselves or another person. Thus, incorporating HR into practice is critical to reducing morbidity and mortality. It is imperative we acknowledge biases and turn toward the evidence to do what we set out to do as healthcare professionals: help save lives.

The current HR landscape in the US includes a myriad of strategies to ameliorate drug-related harm. One widely accepted and used practice is the distribution of naloxone to reduce opioid overdose-related deaths. The rise of the opioid epidemic from prescription opioids in the 1990s to heroin in 2010 and synthetic opioids, namely illicitly manufactured fentanyl, in 2013, has led to one of the largest public health responses with the establishment and expansion of OEND programs across the country.²⁴  The major elements of OEND programs are educating individuals and their support systems on preventing and identifying opioid overdoses, responding to an overdose by contacting emergency medical services and administering naloxone, and providing rescue breathing/cardiopulmonary resuscitation. A systematic review of community OEND programs in the US, Canada, and Europe found that most programs experienced a 100% survival rate after naloxone was administered.²⁵  Most OEND programs reviewed were offered in syringe services programs (SSPs) and SUD treatment settings with others in HIV education centers, prisons, pain management clinics, primary care clinics, by paramedics, and through mobile SUD services. This not only demonstrates the effectiveness of naloxone in saving lives but also supports the wide implementation of this critical public health approach. In 2023, through a unanimous decision, the FDA approved over-the-counter status of naloxone (3 and 4 mg) by priority review, conveying the message: Everyone needs access to naloxone, and they need it now.^26,27  Detailed information on additional HR strategies, such as SSPs, drug test strips, and infectious disease prevention, may be found in Table 1. Local health departments have been instrumental in expanding access to HR interventions, and any of the strategies discussed here could benefit from coordination with these agencies.

There are multiple reports published on HR measures; however, there is a paucity of formal guidance describing the implementation of HR programs. The recently released draft of the Harm Reduction Framework from SAMHSA is historic and takes an important step in describing best practices and principles in HR.¹⁴  Additionally, the importance of pharmacist involvement has been described by Kosobuski et al¹⁰³ :

While pharmacists in all applicable settings should be encouraged to engage in HR, BCPPs are well-positioned to lead this charge with their training in treating SUDs. Furthermore, the core elements of an HR program align closely with those of a psychotropic stewardship program (PSP).¹⁰⁴  PSPs prioritize optimizing psychiatric pharmacotherapy and monitoring, including SUDs, and place the patient at the center of the team. Following PSP guidance, the core elements of an HR program model the plan-do-study-act format (Figure).

The HR team should be centered around the patient and involve a multidisciplinary approach. Team members should include a BCPP, collaborating prescriber(s), peer support, and other interdisciplinary/ancillary support, such as social work, chaplain services, nursing, and technicians, to meaningfully engage patients and family members of PWUD. The BCPP is well-suited to serve as the team lead; however, another interdisciplinary team member with appropriate training may also fit this role. It is imperative to include peer support or those with lived/living experience and community resources to facilitate program design and to offer unparalleled support to patients and their families.¹⁴  Team members must be committed to the HR paradigm, positioned for patient interaction, and highly communicative with other team members to adapt services based on patient goals.

Leadership and committee support for HR is essential. They are responsible for developing a vision and mission for the program, establishing goals, evaluating regulatory requirements, approving specific services, securing funding and resources, and establishing policies and procedures. Because of this important role, the HR team should initially focus on collaborating with health-system leadership. Tips for success to gain leadership support include^41,105,106 :

• Identify a physician (or key stakeholder) champion to assist with justifying the need for new harm reduction services.

• Identify target interventions, starting with one service, and include potential funding sources.

• Funding will vary and may include grants or donated supplies from sources such as state or local health departments, other government agencies with a public health focus, community organizations, and schools or universities.

A thorough audit should be completed before program development and routinely for program revision to offer services that are applicable to the health-system or site. A strategic program review will include using population health to stratify individuals who may benefit from the service, identifying outcomes, and analyzing results to make necessary changes. For example, observing trends, such as increasing hepatitis C virus infection rates or a number of opioid overdoses resulting in emergency department visits, may point to an opportunity to evaluate current practices and assess where additional HR resources are needed.^41,107  Consultation should be available from the HR team to other health-system members to assist with questions and accessibility of services.

For an HR program to be successful, all team members should adhere to assigned tasks and deliverables to prioritize the key element of enhancing patient care. Responsibilities and expectations for each team member should be transparent, and the team leader(s) should cultivate accountability and follow-up.

The use of various services will be essential to the rollout and growth of an HR program. For in-depth descriptions of services, including prevention and treatment approaches, see Table 1. As the program evolves, additional HR offerings may be added to better care for the whole patient and target best outcomes. Partnering with organizations in the community, such as local health departments, will further optimize care. It is critical team members be cognizant of abstinence-oriented community resources that may present barriers to patient participation in harm reduction interventions, such as 12-step and transitional housing programs, and continue to engage those patients in care. Participation in services for the patient is voluntary and self-directed and should have the lowest requirements for access.¹⁴  Strong collaboration and communication of clinical team members across disciplines will encourage seamless program functioning.

Electronic system access and computer-based surveillance should be used for optimal program implementation. These will aid in tracking supplies, identifying interventions, obtaining and analyzing data, and outcome reporting. Expansion of telehealth services, including mobile medication for opioid use disorder services, is highly encouraged to engage and retain people receiving care for SUDs.¹⁴ 

Continuous monitoring of the service should occur to ensure optimal functioning of the program. Monitoring the program will encompass several aspects and is not limited to the following: patients served, supply inventory, staffing requirements, evaluations of and updates to policies and procedures, and program outcomes. Key outcomes related to HR services, as outlined by the Core Outcome Set of Psychiatric Pharmacists, may include¹⁰⁸ :

• Optimized patient safety through surveillance

• Improved progress toward treatment goals

• Improved patient quality of life

• Improved patient medication access

Training/in-services will be necessary to educate those directly and indirectly involved in the program and should encompass the emerging paradigm and 6 principles of HR. These may be informal conversations or more formal presentations regarding new policies and procedures for the service. This should also include system-wide messaging to alert all staff of the new HR service and encourage referrals when appropriate. Additional means of providing program education or information include posters, handouts, and electronic messaging to staff and patients where applicable. Leadership and team members should be briefed routinely regarding program outcomes and changes. Education is a key component during program startup, evaluation, and revision.

Patient counseling and education is a well-known service provided by pharmacists, and it is important to further expand upon the impact a BCPP can have in the arena of provider education. Pharmacist-provided education, including HR initiatives, has been well described in the literature. Examples of pharmacists providing HR education to peers and other healthcare professionals occur in various settings, including health-systems and community pharmacies.^{41,103,109,110} 

One well-defined role that psychiatric pharmacists may serve in to further the knowledge of colleagues in HR and management of SUDs is academic detailing. Academic detailing is a one-on-one educational approach with providers to address knowledge gaps and shape prescribing and outcomes within their own practices.^109,111  An analysis of academic detailing provided by clinical pharmacists targeting OEND demonstrated that providers exposed to academic detailing had significantly higher incidence rates of prescribing naloxone compared with those not exposed.¹¹²  Also, clinical pharmacist practitioners in the Department of Veterans Affairs recently delivered more than 25 national webinars throughout their organization, which focused on incorporating HR into healthcare, developing SSPs, and ending stigma.⁴¹ 

Choosing the right words to describe SUDs and HR approaches can improve patient health outcomes and the likelihood that people will seek care.¹¹³  See Table 2 for examples of nonstigmatizing language. Psychiatric pharmacists should take an active role in using person-centered language and disseminating information on this topic.

Potential barriers exist to developing and implementing a pharmacist-led HR program. One of the most notable challenges is the continued stigma associated with PWUD and SUDs, even among healthcare professionals, which is why health-system collaboration is a core element of an HR program. Harm reduction team members are likely passionate and motivated toward providing strategies for their patients; however, there may be differing opinions from health-system leaders in prioritizing these initiatives. Leadership buy-in is important for advancing new programs, which will require direct costs of procuring appropriate supplies and indirect costs of work hours spent toward its expansion and away from existing obligations. Alternatively, health-system leadership may support HR strategies but be unable to provide funding for specific needs. Existing HR programs have outlined options to receive local, state, or grant funding; however, neither the specific monetary amount nor duration of availability are clearly stated. The ability to offer a comprehensive HR program or one that provides multiple strategies may also be limited by state or federal regulations. As described above in Table 1, certain approaches are not uniformly available in all states.

Most of these barriers can be overcome through program planning and education, as explained in greater depth in the American Association of Psychiatric Pharmacists Harm Reduction Toolkit.¹¹⁹  For example, stigma-reducing and sensitivity training can be offered for key stakeholders to not only demonstrate the importance of the provision of HR strategies, but also to show how the emerging paradigm in which person-centered care is being delivered. Standard operating procedures and policies can be written to ensure clear expectations, delegation of responsibilities, and compliance with legal regulations. Familiarity with available funding resources outside the health-system supporting such programming is also beneficial.

SUDs are medical conditions that remain prevalent in the US. With overdose-related deaths continuing to rise and the vast array of negative consequences associated with drug use, our communities and organizations need to adopt and expand HR approaches. Harm reduction embodies compassionate care and includes the goals of saving lives, reducing stigma and mistreatment, and improving outcomes and quality of life for people who use drugs. Harm reduction is person-centered, nonjudgmental, nonpunitive care that includes multiple strategies and minimizes barriers to accessing services. It is important to use a stepwise approach to creating and expanding services to ensure successful program development and optimal functioning. The plan-do-study-act method outlined in this paper should serve as an introductory guide and facilitate implementation or improvements to HR services that best fit the practice setting. Many challenges remain in the path of the HR movement; however, with increased education, advocacy, and persistence, BCPPs can increase the services available in our communities as trusted harm reductionists.

The authors thank the Board of Directors of the American Association of Psychiatric Pharmacists for their support of this project.