US Pharm. 2024;49(3):22-28.

ABSTRACT: The number of fatal and nonfatal drug overdoses continues to increase in the United States. Disparities in drug overdose deaths across racial and ethnic groups and income inequality continue to widen. Pharmacists play a critical role in addressing the nation’s growing challenges related to substance use disorder by acting to lessen the stigma surrounding substance use, serving as allies in harm reduction, and advocating for patients. Harm reduction tools in pharmacy practice include naloxone, sterile syringe access, and preexposure prophylaxis for HIV prevention. Harm reduction organizations are an effective community-based resource that pharmacists should keep in mind when assisting patients. All of these tools and resources can help pharmacists combat health disparities related to the opioid epidemic and advance health equity.

The number of fatal and nonfatal drug overdoses continues to increase in the United States. In 2021, more than 106,000 people died from drug overdoses.¹ Disparities in drug overdose deaths across racial and ethnic groups and income inequality continue to widen.² The National Center for Drug Abuse Statistics reported that as of 2020, more than 37 million Americans aged >12 years were currently (within the past 30 days) using drugs.³ Approximately 59 million of those aged >12 years reported using illicit drugs or misusing prescription drugs in the past year, and more than 138 million reported using illicit drugs in their lifetime. Additionally, 24.7% of persons with substance use disorders have an opioid use disorder (OUD), including prescription pain relievers or heroin.³

Substance use is highest (39%) among persons aged 18 to 25 years, compared with 34% of those aged 26 to 29 years. Substance use disorders are more likely to affect young males, with 22% of males and 17% of females using illicit or misusing prescription drugs within the past year. It is reported that 70% of individuals who try an illicit drug before age 13 years develop a substance use disorder within the next 7 years.³

More than 9 million Americans aged >12 years have misused opioids at least once in a 12-month period, and 96% of those who misuse opioids use prescription pain relievers. Approximately 7% use heroin, and 4% use both heroin and prescription medications, with hydrocodone being the most prescribed opioid. In 2020, the Centers for Medicare and Medicaid Services expanded Medicare coverage to include opioid treatment programs delivering medication-assisted treatment (MAT).³

Also on the increase has been injection drug use, which has led to tens of thousands of viral hepatitis infections each year and contributes to new HIV infections. Nearly 3.7 million Americans reported injecting a drug in the past year. Injection drug use can transmit infectious diseases such as viral hepatitis, HIV, and other blood-borne pathogens via needles and syringes used by an infected individual. From 2010 to 2019, there was a 4.9-fold increase in new hepatitis C (HepC) infections due to injection drug use, with the greatest increase in persons aged 20 to 39 years. The estimated cost of caring for patients with chronic HepC is approximately $15 billion annually. From 2014 to 2019, there was a 12% increase in new HIV infections in persons who inject drugs. Notably, the estimated lifetime cost of treating one patient with HIV exceeds $500,000. Unsafe injections can also result in skin and soft-tissue infections, abscesses, and endocarditis. Hospitalizations due to substance use–related infections are in excess of $700 million each year. For individuals who inject drugs such as opioids, sterile injections can prevent spread of disease.⁴

The National Center for Health Statistics’ CDC WONDER database reports on deaths involving drugs commonly associated with fatal overdose. Between 1999 and 2021, there was a steady increase in the number of overdose-related deaths. In 2021 alone, more than 106,000 individuals in the U.S. died from drug-involved overdose, including both illicit drugs and prescription opioids.¹ West Virginia had the highest rate of overdose deaths, at 51.5 deaths per 100,000 people. Delaware, Maryland, Pennsylvania, and Ohio had 43.8, 37.2, 36.1, and 35.9 deaths per 100,000 people, respectively.³

Drug overdose data reveal a widening disparity between different population groups. The CDC notes that in 2020, in counties with more income inequality, overdose death rates for the black population were more than two times as high as in counties with less income inequality. Overdose death rates in older black men were nearly seven times as high as those in older white men. Overdose death rates for younger American Indian and Alaska Native (AI/AN) women were almost two times those of younger white women. In 1 year, overdose death rates measured by the number of drug overdose deaths per 100,000 people increased by 44% in the black population and 39% in the AI/AN population. Also, a lower proportion of persons from racial and ethnic minority groups, compared with the white population, receive treatment.² Another challenge in the treatment of substance use disorder is that racial and ethnic minority groups have less access to proven treatments. This is attributable to more than just lack of availability of services, as communities with a greater capacity to provide care had the highest death rates, with trends worse for the black and AI/AN populations. Income inequalities for racial and ethnic minorities are another barrier to accessing treatment and support.² These statistics highlight the need for services that can help individuals who have substance use disorder, particularly those affected by racial and ethnic disparities.

SOCIAL DETERMINANTS OF HEALTH

Social determinants of health (SDOH) greatly impact access to care and contribute to health disparities and inequities.⁵ SDOH are conditions in the environments where people are born, live, learn, work, play, worship, and age that influence health, functioning, and quality-of-life outcomes and risks. SDOH can be categorized into five domains: economic stability, education access and quality, healthcare access and quality, neighborhood and built environment, and social and community context.⁵

The domain of healthcare access and quality aims to increase access to comprehensive, high-quality healthcare services, including harm reduction tools. In the U.S., one in 10 people lacks health insurance and is therefore less likely to have a primary care provider or be able to afford healthcare services and medications.⁶ Those with OUD may not be able to access recommended healthcare programs and services.

HARM REDUCTION

Harm reduction, as defined by the National Harm Reduction Coalition, is “a set of practical strategies and ideas aimed at reducing negative consequences associated with drug use.”⁷ The National Harm Reduction Coalition has delineated eight foundational harm reduction principles (TABLE 1), such as recognizing that licit and illicit drug use is part of society and choosing to minimize the harmful effects of drug use instead of ignoring or condemning it.⁷ Harm reduction programs can be implemented by community or peer-led organizations or health departments.⁸ Examples of harm reduction tools in pharmacy practice include naloxone, sterile syringe access, and preexposure prophylaxis (PrEP) for HIV prevention. Expanding access to these harm reduction tools can help prevent negative consequences associated with drug use and address inequities in overdose-related morbidity and mortality.

HARM REDUCTION TOOLS

Naloxone

Naloxone, a rapid-acting opioid antagonist, is used by first responders, friends, family members, and bystanders to reverse an opioid overdose. It is available in several dosage forms, most commonly as a nasal spray. Within 2 to 3 minutes of administration, normal respiration in someone whose breathing has stopped or slowed can be restored.⁹ A naloxone distribution program in Massachusetts reduced opioid-overdose deaths by about 11% in 19 communities that implemented the program, and this decrease did not coincide with an increase in opioid use.¹⁰ Additionally, a national study showed that opioid overdose deaths decreased by 14% in states that enacted naloxone access laws.¹¹

All 50 states, the District of Columbia, and Puerto Rico allow an individual to obtain naloxone without a prescription in some form; however, laws vary widely by jurisdiction.¹² As of July 2022, 33 states have a standing order (no individual prescription necessary) for naloxone; 14 states and the District of Columbia do not have a standing order, but the prescriber and pharmacist can enter into a standing-order agreement for naloxone on their own terms. Some states, such as Idaho and Oregon, allow pharmacists to prescribe and dispense naloxone to individuals who do not have a prescription. Oklahoma law directly authorizes pharmacists to dispense naloxone to individuals without a prescription. In Puerto Rico, naloxone can be sold without a prescription. More than half of states do not have naloxone insurance requirements, which may include requiring coverage, not requiring prior authorizations, and placing one formulation of naloxone on the lowest tier of the insurer’s drug formulary. These requirements are placed on private insurance and/or Medicaid in less than half of states.

Laws also vary in the level of immunity they extend to naloxone prescribers. Although most states provide immunity from civil liability, criminal liability, and professional disciplinary actions, 14 states and the District of Columbia do not, and three states do not address prescriber immunity.¹² In 49 states, some form of immunity is granted to laypeople who administer naloxone; however, 11 states grant immunity from civil liability only, and Nebraska and Puerto Rico provide immunity from criminal liability only.¹² Differences in naloxone access laws in the areas of insurance requirements, immunity, and standing orders raise concerns about equitable access to naloxone.

The FDA has taken steps to increase access to naloxone. In November 2022, the FDA announced that its preliminary assessment was that some naloxone products were potentially safe and effective for OTC use.¹³ In February 2023, an FDA advisory committee unanimously approved the sale and distribution of naloxone nasal spray without a prescription.^13,14 Following this, in March 2023, the FDA approved naloxone nasal spray for OTC use. It is predicted that the OTC formulation of naloxone will improve the accessibility of this life-saving drug and help prevent additional opioid overdose deaths.¹³

Sterile Syringe Access

Syringe service programs (SSPs) are community-based harm-reduction programs that provide a wide range of services to people who use drugs (PWUD).⁴ These services may include not only access to and disposal of sterile syringes and injection equipment, education for people who inject drugs, and substance use treatment, but also vaccination, testing, and connection to care and treatment for infectious diseases such as HIV and HepC.^4,15 SSPs are safe and effective, decrease costs, do not increase illicit drug use or crime, and are associated with a 50% reduction in HIV and HepC.^16,17 Individuals who utilize SSPs are five times more likely to enter drug treatment and about three times more likely to stop using drugs than those not utilizing these programs.^18-20 SSPs that distribute naloxone can also help reduce opioid overdose deaths. In addition to the aforementioned benefits, SSPs protect the public by providing a safe place for the disposal of used needles and syringes.⁴

Safer drug consumption services (SCS) are specially designated sites where individuals can use preobtained drugs safely with the support of trained personnel.²¹ There are >100 SCS programs worldwide, and over the past 30 years they have demonstrated that SCS can prevent overdose, HIV and HepC transmission, and injection-related infections. SCS also serve as public disposal sites for used syringes.²¹ In November 2021, the two first legally recognized SCS programs in the U.S. launched in New York City as Overdose Prevention Centers.²² These programs offer services such as harm reduction, health and wellness measures such as HepC and HIV testing, meals and showers, and case management. More than 500 lives have been saved since these programs began operating in November 2021.²²

Both SSPs and SCS face numerous barriers in implementation and practice, including legal constraints, limited hours, neighborhood resistance, and stigma.²³ One strategy to increase access to syringe access is through nonprescription sales of syringes at community pharmacies.²³ Pharmacies are an ideal setting for this harm reduction service because they are highly accessible and pharmacists are skilled health professionals. Additionally, offering sterile syringe services in the community pharmacy, alongside routine healthcare services such as medications and supplies for acute and chronic conditions, helps destigmatize harm reduction. New York State’s Expanded Syringe Access Program (ESAP), which was established in 2000, allows licensed pharmacies, healthcare facilities, and healthcare practitioners to sell or furnish hypodermic needles or syringes to anyone aged >18 years without a patient-specific prescription.²⁴ ESAP also enables safe disposal of used syringes, lessening the likelihood of their being disposed of in public places. A greater number of options for syringe access is predictive of lower-risk behaviors in injection drug use. For example, safe syringe disposal increased in New York after ESAP was established.²⁵

HIV Prevention

Advances in HIV treatment, testing, and prevention have led to declines in overall HIV infection rates in the U.S.; however, HIV continues to affect some groups disproportionately.²⁶ The rate of new HIV infections among black persons and Hispanic/Latino persons is nearly eight times and nearly four times as high, respectively, as the rate among white persons.²⁶ PrEP can be a valuable tool for preventing HIV infection, particularly in communities of color that continue to experience a disproportionate burden of disease or new cases.

PrEP consists of medication that is initiated before and continued throughout periods of potential exposure to HIV.²⁶ It is safe and effective when taken as prescribed. Among PWUD, PrEP has been shown to reduce the risk of HIV infection by 74%.²⁷ There are three FDA-approved regimens for PrEP: emtricitabine/tenofovir disoproxil fumarate (oral), emtricitabine/tenofovir alafenamide (oral), and cabotegravir extended-release (injectable); however, only emtricitabine/tenofovir disoproxil fumarate is approved for preventing HIV infection in patients whose exposure to HIV infection is through IV drug use (i.e., sharing injection equipment or reusing needles).²⁶

Pharmacies are an important access point for PrEP, and many states have standing order laws that permit either direct authority to pharmacists to prescribe, dispense, and administer PrEP to patients or collaborative practice agreements sufficiently broad to allow pharmacists to prescribe PrEP.²⁸ Access to PrEP through insurance coverage is inequitable, however, as coverage remains uneven across racial and ethnic groups, age groups, and the transgender population.²⁶ The federal Ready, Set, PrEP program provides free PrEP to eligible patients living in the U.S.²⁹ Pharmacists should also be aware of patient assistance programs offering free PrEP through drug manufacturers and PrEP availability through 340B or other locally available drug-discount programs.

CHALLENGES IN OUD MANAGEMENT AND HARM REDUCTION

Stigma surrounding PWUD may be related to an ungrounded belief that substance use disorder is a moral failure rather than a chronic, treatable disease. Stigma can negatively impact individuals with substance use disorder by lessening their willingness to seek treatment, and it can negatively impact healthcare professionals’ willingness to screen for and address substance use disorder in practice. Additionally, stigma may make policymakers less inclined to allocate resources for substance use treatment.³⁰

A study that surveyed Indiana pharmacist preceptors’ knowledge and perceptions of MAT identified knowledge gaps in FDA-approved MAT products for OUD, the need to enter an opioid-free period before initiating treatment with buprenorphine and naltrexone, pregnancy recommendations, and treatment of severe OUD.³¹ Pharmacists generally had positive perceptions of MAT for OUD, but they expressed concerns about possible misuse and diversion.³¹ A review of pharmacist attitudes toward naloxone found that pharmacists supported a naloxone standing order and believed that naloxone should be dispensed to individuals at risk for an opioid overdose; however, negative attitudes toward harm reduction measures have also been documented among pharmacists.^23,32

A qualitative study of community pharmacists in the U.S. found that pharmacists endorsed harm reduction approaches in varying degrees.²³ Pharmacists expressed ambivalence about nonprescription sales of syringes to PWUD. Many expressed concerns about facilitating substance use and attracting PWUD to their pharmacy. Some of these concerns were a result of laws or company policy, but in other cases, pharmacists made decisions regarding nonprescription syringe sales on an individual basis, often scrutinizing patients who looked “suspicious” or exhibited a “suspicious” appearance or behavior and questioning their reason for purchase.²³ Pharmacists play a critical role in supporting the substance use community; however, negative perceptions and stigmatizing practices can impede access to critical harm reduction measures that are well documented to save lives and prevent infection.

Racial or ethnic disparities in patient access to treatment for substance use disorder and other support services present another challenge in addressing the opioid epidemic.² These disparities stem from SDOH and structural racism. Income inequality and the lack of stable housing, transportation, and insurance further complicate access to care.²

In addition, polysubstance use and illicitly manufactured fentanyl (IMF) in the drug supply present another challenge in managing OUD and practicing harm reduction strategies.² Recently, xylazine—a nonopioid veterinary tranquilizer that is not approved for human use—has increasingly been found in the drug supply and is typically used in combination with other drugs, including IMF.³³ Xylazine has been found in drug samples in 36 states and the District of Columbia, and it has been implicated in almost one-third of overdose deaths in Philadelphia, Pennsylvania, in 2019.^34,35 In November 2022, the FDA issued a health alert warning clinicians about the serious risks associated with xylazine use.³³

These various challenges underscore the need for improved access to harm reduction services in order to prevent further morbidity and mortality.

THE PHARMACIST’S ROLE

It is the responsibility of healthcare professionals to address substance use stigma and connect patients to important harm reduction resources in their community to reduce harm associated with substance use and improve substance use treatment outcomes. The first step lies in understanding harm reduction principles and recognizing that substance use disorder is not a moral failure but a complex, chronic condition.

Another way that pharmacists can address substance use stigma is to use nonjudgmental language in their practice when discussing substance use with patients, colleagues, or the public. Healthcare professionals, particularly pharmacists, are often the first point of contact for an individual who has a substance use disorder, so the language they employ is important.³⁶ For example, using person-first language (e.g., “person with a substance use disorder” or “person who uses drugs” instead of “user” or “abuser”) is preferred because it puts the person—not the condition—first and maintains the individual’s integrity, showing that the disease is the problem, not the person. Some of the recommended terms and terms to be avoided are listed in TABLE 2.³⁷

Community pharmacies are important harm-reduction resources that can facilitate access to sterile syringes, naloxone, and PrEP. Using a socioecological approach to addressing the opioid epidemic, pharmacists can screen for patients who may need harm reduction resources, serve as a gatekeeper for harm reduction tools, and advocate for improved patient access to harm reduction services.³⁸ Pharmacists can also look up their state’s public health laws to review local naloxone access laws and can contact their state and city departments of health for information on locally available harm reduction programs for patients.

Harm reduction organizations are an effective community-based resource that pharmacists should keep in mind when assisting patients. One such organization is the Harm Reduction Coalition, whose mission is to “promote the health and dignity of individuals and communities affected by drug use.”³⁹ The goal of this national advocacy and capacity-building organization is to shift resources and power to those individuals who are most impacted by structural violence and racialized drug policies. The Harm Reduction Coalition has helped communities create, sustain, and expand evidence-based harm-reduction strategies.³⁹ TABLE 3 presents a comprehensive list of harm reduction resources for pharmacists.

Pharmacists can advocate for patients with substance use disorder by contacting local legislators, getting involved with community organizations, and bringing their expertise to bear in addressing the opioid epidemic. In their advocacy work, pharmacists can support improved access to treatment and recovery-support services, including low-barrier options such as telehealth and expansion of insurance coverage. They can also advocate for structural support that directly affects SDOH, such as housing assistance, transportation, and childcare, as these can help reduce barriers to accessing treatment and harm reduction services. Creating and supporting culturally tailored campaigns that help raise awareness of substance use disorder and harm reduction and lessen the stigma associated with both can also improve access. Advocating for reducing the criminalization of substance use disorder is another strategy for improving access to treatment. Finally, pharmacists can raise awareness about access to sterile syringes in a variety of settings, including SSPs and SCS as well as community pharmacies. These efforts can ultimately help prevent racial and ethnic disparities in overdose and advance health equity.³⁹

CONCLUSION

The rising number of PWUD and consequent overdoses contributing to the increased number of deaths is a catalyst for additional resources and services for individuals who have substance use disorders. Naloxone distribution programs, sterile syringe access, and PrEP are harm reduction tools that have been successful in helping patients. Because pharmacists are uniquely positioned to advocate for patients, educate patients about access opportunities, and take part in these programs, they can contribute greatly to providing quality care and advancing health equity.

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