The United States currently is facing a mental health and substance use disorder crisis. Approximately one in five adults experiences a mental health condition annually (
1). However, less than half of all patients with a psychiatric disorder receive treatment in the United States. The picture is even more grim for patients with a substance use disorder, with <11% receiving treatment (
2). Nearly eight million people have a co-occurring diagnosis of both a substance use disorder and another mental health condition (
3). Homelessness, affected by rising housing costs and stagnant wages, is another epidemic in the United States. More than half a million people are homeless, with more than half of homeless individuals having a serious mental illness or substance use disorder (
4,
5). Patients with medical-psychiatric comorbid conditions or medical complexity also tend to have higher health care use and increased costs (
6). In the face of this increased need for psychiatric services, the United States is experiencing a severe shortage in behavioral health providers with no immediate plan to remedy this issue.
The psychiatric pharmacist profession has existed for about 50 years and became a recognized pharmacy specialty in 1992 (
7). Recently, the National Council for Behavioral Health Medical Director Institute addressed the psychiatrist shortage by endorsing midlevel behavioral health professionals as a tactic to alleviate this shortage and to improve patient access to care. These professionals include psychiatric nurse practitioners, psychiatric physician assistants, and board-certified psychiatric pharmacists (BCPPs), who all can work within their scope of practice to help provide care to the millions of patients accessing treatment (
8). Frogner et al. (
9) also advocated for psychiatric pharmacists as a strategy to offset the psychiatrist shortage in a team-oriented approach for patients with complex psychiatric, substance use disorder, and medical conditions. Given the dire need to expand access to care and the endorsement of the National Council for Behavioral Health Medical Director Institute, optimizing collaboration with BCPPs could be a critical part of the solution to improving U.S. mental health care.
BCPPs are clinically trained pharmacists with specialized training and experience in psychiatric pharmacy and patient care. Many have completed 2 years of postdoctoral residency training from accredited programs and have subsequently achieved their board certification through rigorous examination (
10,
11). BCPPs work in myriad clinical settings such as hospitals, clinics, and assertive community treatment teams, often providing direct patient care (
12). Regardless of practice setting, patient care provision and medication safety are top priorities of BCPPs. Most BCPPs spend the bulk of their time consulting with psychiatrists or other physicians or health team members and working directly with patients. Pharmacists who are not BCPPs may engage and serve patients with psychiatric and substance use disorders in community pharmacies or other health care settings; however, BCPPs have advanced clinical skills and in-depth clinical psychopharmacology knowledge that are best used for direct pharmacy care provision.
Similarly to physician assistants and nurse practitioners, BCPPs have collaborative roles with providers as part of team-based care. By working collaboratively with multidisciplinary teams to optimize pharmacotherapy, BCPPs provide medication management and monitoring for potential adverse drug reactions and interactions. BCPPs also educate families and patients on medications and teach medical and pharmacy trainees. Additionally, pursuant to scope-of-practice laws and regulations governed by the states, a BCPP can perform patient assessments; order and interpret medication therapy–related tests; evaluate and manage disease states; initiate, adjust, and discontinue medication therapy; and refer patients to other health care providers. These duties are performed in collaboration with a diagnosing prescriber. Nearly all states have laws enabling a collaborative practice agreement with a physician for collaboratively managed medication prescribing, although exact terminology for this agreement varies among states (
13). BCPPs often serve as the medication expert on the health care team, and in doing so, they expand care access, improve medication-related outcomes, and help reduce health care costs (
14).
The role of BCPPs may be unknown to some in the mental health care arena, and the rationale of this article is to bring attention to BCPPs and to provide examples of specific evidence-based psychiatric services in which BCPP involvement could be beneficial to treatment teams. Of note, current terminology used to describe the roles and functions of most pharmacists is unclear at best, with differing definitions and qualifications depending on setting, organization, and state regulations. However, BCPPs are a distinct pharmacist group as defined by the criteria for board certification (
11). Therefore, the general term “pharmacists” is used to refer to all licensed pharmacists rather than attempt to distinguish and define groups of pharmacists, which is beyond the scope of this article. Although all pharmacists are critical members of health care teams and have been shown to improve patient outcomes in many settings, in this article, we highlight the specific value and opportunity that BCPPs can provide, in addition to the general services they deliver as part of the larger pharmacist community (
14).
Key Areas for Which BCPPs Currently Work and Could Improve Access and Care
Opioid Use Disorder
Opioid use disorder is a national emergency and can only be adequately addressed by enlisting all available resources. Approximately 400,000 people died from an opioid overdose from 1999 to 2017 in the United States, and the annual death rate in 2017 increased sixfold since 1999 (
15). In the United States, 130 individuals die each day from an opioid overdose (
14). In 2017, 2.1 million people ages ≥12 years met the diagnostic criteria for opioid use disorder (
16). Medications such as methadone, buprenorphine-naloxone, and naltrexone extended-release injection (XR-NTX) are evidence-based treatments for patients with opioid use disorder and are proven to decrease morbidity and mortality rates and to increase treatment retention (
17). However, numerous sources cite stigma, insufficient professional education, and legal and regulatory restrictions as ongoing barriers to prescribing evidence-based medication, particularly buprenorphine-naloxone. Lack of time and staff support are also commonly noted. Pharmacists are medication experts and one of the most accessible health care professionals, yet they are underutilized in fighting this epidemic.
Pharmacists already save lives by making naloxone, the antidote for opioid overdose, available to the community and by educating the public and other health care professionals. As of January 2019, all 50 states and the District of Columbia have expanded naloxone access in community pharmacies (
18). Although state laws vary, most allow pharmacists to dispense naloxone directly without a written prescription. States allowing pharmacists to dispense naloxone directly to patients without a prescription significantly reduced the number of fatal overdoses within ≥3 years of the legislation (
19). Expanded naloxone is particularly crucial in rural areas, where emergency care access may be limited.
In many states, pharmacists also work collaboratively with treatment teams by administering long-acting injectables (LAIs). XR-NTX, a nonopioid medication effective in managing opioid craving and preventing relapse while offering enhanced adherence, must be administered monthly by a health care professional. An extended-release injectable formulation of buprenorphine-naloxone is also available. Pharmacist administration of LAIs allows for expanded access to medication for patients with opioid use disorder and may help them adhere to treatment (
20,
21). All states could enact legislation allowing pharmacists to administer prescribed injectables.
Working collaboratively with the treatment team and practicing at the full extent of the education, training, and license, BCPPs can further optimize care of patients with opioid use disorder by expanding access to evidence-based treatment through the direct provision of services and improving medication safety. Buprenorphine-naloxone is underused in part because of prescribing restrictions and the limited number of Drug Addiction Treatment Act (DATA)-waivered prescribers. Although pharmacists are not currently included in the DATA waiver, under a collaborative practice agreement with a prescriber, BCPPs can manage medication monitoring, optimize medication selection, improve safety, and expand access to care for patients with opioid use disorder and other comorbid conditions, especially in areas with a shortage of health care professionals. This authorization is especially critical because about 64% of patients with opioid use disorder have a mental illness, and >26% have a comorbid substance use disorder, requiring complex medication regimens and monitoring (
22). Using new strategies is a key to increasing treatment access for patients with opioid use disorder. The physician-pharmacist collaborative model has been cited as an innovative solution to addressing workforce needs for patients with opioid use disorder and can help close the existing treatment gap (
17).
Antipsychotic Use Among Children
Approximately 6% of adolescents in the United States have been prescribed a psychotropic medication in the past year, with about 0.8% of the entire adolescent population receiving such medications (
23,
24). Young patients represent a vulnerable group who are often sensitive to adverse effects of antipsychotic treatment. Although use of these medications may be highly effective for target symptoms, the prevention and management of adverse effects and drug interactions should be carefully monitored.
Guidance for best practices for antipsychotic medications administered to children and adolescents endorses multidisciplinary care and the important role of the pharmacist in helping to treat this population (
25). Pharmacists have been shown to improve treatment and economic outcomes in mental health programs for children and adolescents (
26). The widespread use of antipsychotics among young patients and low rates of monitoring have led many state Medicaid programs to develop prior authorization programs to help ensure safe and effective care. More than one-third of U.S. programs use a multidisciplinary approach with a pharmacist working with physicians to optimize expertise and resources (
27). Additionally, guidelines from the American Academy of Pediatrics have recommended that pediatric residency training programs include mental health specialists as co-preceptors and team members in teaching clinics (
28). BCPPs could be a valuable part of this team because of their medication safety mindset and expertise in clinical psychopharmacology and evidence-based treatment approaches.
Involving BCPPs with clinical training in adolescent health and mental health issues is beneficial because pharmacists lacking this training sometimes report feeling ill-equipped to handle adolescent treatment issues (
29). Metabolic monitoring, prevention of adverse effects, and managing medication-related problems are critical areas in which BCPPs are trained to improve outcomes related to antipsychotic medication use among children and adolescents (
30,
31). In states with collaborative practice agreements, BCPPs could directly manage and monitor pharmacological treatments for patient caseloads designed by the physician-pharmacist collaboration.
LAI Antipsychotics
Nonadherence to antipsychotic medication is consistently identified as an important predictor of relapse in schizophrenia, influencing a patient’s ability to function well and enjoy a satisfactory quality of life (
32). More than two-thirds of people with schizophrenia are nonadherent to their antipsychotic medication, and 50% of those discharged from the inpatient setting may discontinue treatment within 6 months (
33,
34).
Within the previous 5 years, several LAI antipsychotics have been introduced in the United States. These evidence-based options address treatment nonadherence and have an important role in the management of schizophrenia. A review of 58 studies with >23,000 patients found that treatments with LAI antipsychotics are superior to oral antipsychotic treatment, with LAIs resulting in 20% lower hospitalization rates than with oral treatment (
35). Other studies have reported similar findings (
36,
37). In a study of >29,000 people, LAIs were associated with lower relapse rates, risk for treatment failure, and mortality rates (
38). LAI treatment is also more cost-effective than oral treatment (
39). It is critical to note that although LAIs may help address nonadherence and its consequences, LAIs can benefit patients in many additional ways. However, LAIs remain underused, and BCPPs could help improve patient access to these treatments (
40,
41).
Inclusion of pharmacists in decision making about and treatment with LAIs as part of collaborative teams providing services to patients with psychiatric and substance use disorders is quickly evolving. Initially involved in “depot clinics,” the pharmacist was included in the dosing and monitoring of patients for adverse events (
42,
43). Now, pharmacists have become care providers and extenders for patients in the community by administering monthly injections with LAIs in a more convenient setting for the patient, reducing yet one more barrier for the patient’s ability to adhere to medication (
44). Patients recognize the benefits of having pharmacists administer their LAIs, with >80% being as, or more, satisfied with the convenience; 77% reporting pharmacists as, or more, knowledgeable; and 93% being as, or more, trusting of the pharmacist than of other health care professionals (
45). After successful completion of state board of pharmacy requirements (e.g., approved coursework, basic life-support certification), pharmacists are permitted to administer LAIs in >50% of states and in another 10–15 states under collaborative practice agreements, medical orders, or standing orders (
46). Besides LAI administration, BCPPs can play an important role when patients who receive LAIs transition to other care settings. They could assist with dosing changes and could ensure that overlap with oral treatment is appropriately conducted and completed. In states with collaborative practice agreements, BCPPs could also assist with prescribing and monitoring.
Clozapine Use
Clozapine continues to be the most effective antipsychotic medication for patients with schizophrenia that is treatment resistant. Clozapine is an evidence-based medication treatment recommended by multiple treatment guidelines after two failed antipsychotic trials (
47–
50). Clozapine is the only antipsychotic medication with a U.S. Food and Drug Administration (FDA)-approved indication for reducing suicidality in schizophrenia, and it is associated with a lower mortality rate compared with those of other antipsychotic medications (
51). Clozapine has several adverse effects, some of which are potentially serious, including the risk for severe neutropenia in about 0.5% of the population (
52). The severe neutropenia risk led the FDA to require regular blood draws to monitor the absolute neutrophil count. This adverse effect is the basis for the rationale for the FDA-mandated risk evaluation and mitigation strategies (REMS) in clozapine treatment. Although it is an evidence-based treatment, clozapine is grossly underused in the United States not only because of the risk for severe neutropenia and the burden of frequent blood draws but also because of many additional barriers (
53).
The BCPP can help play a role in expanding clozapine use. Clozapine clinics run or assisted by pharmacists that incorporate pharmacist expertise in the monitoring, recommendations, education, and other roles may lead to several benefits. These benefits include cost savings, higher continuation rates, patient and family satisfaction, and early intervention in cases of decompensation and suicidal ideation (
54). Pharmacists can play a role in the following areas: enrollment in and monitoring of the clozapine REMS system, coordination of laboratory services that include mobile phlebotomy, reminder calls for refills and laboratory tests, and interfacing with patients (
55). Additionally, the BCPP can assist with recommending dosage adjustments and cross-tapering with other antipsychotics, obtaining vital signs, assessing adherence, and administering standardized rating scales.
Monitoring for and addressing adverse effects, including coordination with medical management because of the medical complexity of some of the adverse effects, is another way in which BCPPs can play a role, in conjunction with psychiatrists, in providing patient care. Including pharmacists and particularly the BCPP in the clozapine treatment team could improve care and save costs because recommendations for improving clozapine use call on many key stakeholders to implement plans that provide much needed support and infrastructure to promote and manage this challenging agent effectively (
54,
56).
Transitions of Care and Care Coordination
Patients with psychiatric illnesses often experience poorer health outcomes than individuals in the general population. Higher rates of emergency department visits, hospital readmissions, uncontrolled chronic medical conditions, and medication nonadherence have been shown to disproportionately affect patients with psychiatric conditions (
57). On average, patients with serious mental illness in the United States die 10 years earlier than patients without such illness (
58). The vast majority of these deaths can be attributed to causes other than mental illness or substance use and include heart disease and other chronic diseases (
59). Lack of care coordination across the multiple layers of the health system may be partly to blame. The Centers for Medicare and Medicaid Services have defined a transition of care as the movement of a patient from one care setting to another. Such settings may include hospitals, ambulatory primary care or specialty care practices, long-term care facilities, home health, and rehabilitation facilities. Transitions increase the risk for adverse events because of the potential for miscommunication and gaps in care as responsibility is given to new parties (
60).
Patients with mental illness and substance use disorders may be especially vulnerable to care gaps in these transitions because of several factors: use of specialty care services, poorer health literacy, complex medical history and medication regimens, and suboptimal medical insurance coverage. Patients may leave a medical visit or a hospitalization with unclear medication instructions, an incomplete outpatient care plan, or a prescription for a medication that they cannot access or afford; these outcomes lead to poor medication adherence and, ultimately, poor health outcomes, including hospital readmission, suicide, and death from other causes (
61,
62).
The importance of coordinating care for patients with mental illness and substance use disorders across the entire health care team cannot be emphasized enough. It is critical that all team members know what is being prescribed to the patient, have access to laboratory and other testing results, and are aware of individual patient characteristics that can affect care (e.g., patient beliefs and values). The use of electronic medical records and data-sharing systems should be used to assist in care transitions and coordination.
A successful care transition depends on whether patients have been adequately educated about key elements of their care, such as diagnosis and follow-up plans (
63). Pharmacists offer solutions to enhance treatment outcomes associated with care transitions from one setting or specialty to another because they have the knowledge, expertise, and practical experience to help identify specific medications that increase the risk for problems during such transitions. Pharmacists are instrumental in reducing errors, emergency department visits, and hospital use when they are involved during the care transition into or out of the hospital (
64,
65). When the skills of a pharmacist are coupled with specialized knowledge in psychiatry, the impact of the BCPP is amplified. Because of their specialized insights, BCPPs can provide key education about medication regimens to patients with mental illness and substance use disorders, leading to reductions in emergency department visits (
66).
BCPPs assist interprofessional teams within hospitals to implement a treatment plan that involves medications the patient with mental illness or substance use disorders can afford and obtain, and they reduce prescribing of potentially inappropriate therapies (
67–
69). BCPPs prevent errors and problems with prescription clarity in discharge medication orders as a patient is leaving the hospital. BCPPs in primary care settings make recommendations to primary care providers, ensuring proper monitoring of medications to reduce the risk for long-term medical complications (
70–
72). As mentioned above regarding the role of BCPPs in administering LAIs and clozapine, both these treatments are critical for care continuity during times of admission and discharge, and the BCPP can help logistically with these issues.
Yet, many of the transitional care interventions described in the medical literature are aimed at improving care coordination for patients discharged from a psychiatric hospitalization and omit the expertise of the BCPP. Multidisciplinary teams could include a BCPP to make headway in reducing medication errors, enhancing medication follow-up and safety monitoring, and improving the patient’s understanding of the medication aspects of their treatment plan during and after the transition. If medication benefits are to be maximized and the health of patients is to be improved, a BCPP could be in a position to have contact with every patient prescribed a psychotropic medication as they transition through care.
Opportunities and Challenges
In the previous sections, we have described five selected areas as examples of how BCPPs can play a role, presenting evidence on the benefits of such collaborations. However, as a specialized group in mental health and substance use disorder treatments, BCPPs can and currently do play roles in numerous different settings, health care environments, and diversified treatment teams that expand far beyond these examples, such as polypharmacy and patients with medical complexity or presenting to primary care with depression (
14). Another emerging area where BCPPs can provide help is pharmacogenomics. Pharmacists could be collaboratively called on to support appropriate use of pharmacogenomic information in individual care decisions and to provide assistance in designing health system policies and procedures for genetic testing and management of genetic data. Responsibilities could include testing recommendations for specific medications and individuals, interpreting results, recommending medication therapies, and providing a rationale for discouraging testing when evidence-based decisions will not be helped by testing (
73).
One challenge to this opportunity is how best to educate physicians and team members about what the advanced training of a BCPP means and how it may differ from those of other pharmacists who play very different roles in the health care system. A second obstacle is the state-to-state variation in collaborative practice agreements for more advanced prescribing services. Moreover, full use of these highly skilled specialty pharmacists is limited in some health care systems because of lack of reimbursement for direct patient care services. Better expansion, education, and outcomes studies illustrating the BCPP’s value could help advance the opportunity for inclusion of the pharmacist in billing models such as value-based care to pay for the services they provide. Our review included many literature examples of how BCPPs have improved access, outcomes, and costs; however, several examples we provided and noted were obtained from the general literature regarding pharmacists, speaking to the point that more BCPP-focused literature is needed. Last, BCPPs are a relatively small group, with currently about 1,300 achieving board certification in this profession (
11). Although better use of BCPPs can help expand care, they are only one component of a much bigger plan needed to meet the growing needs of patients with psychiatric and substance use disorders.
Conclusions
The shortage of behavioral health providers in the United States continues to contribute greatly to the untreated and undertreated needs of the large number of persons requiring treatment for psychiatric and substance use disorders. BCPPs, in collaboration with the physician and other members of the health care team, are well positioned to help meet some of these needs by virtue of their education, training, and specialized expertise in the area of pharmacotherapy. According to a report by the National Council for Behavioral Health Medical Director Institute, BCPPs may contribute to efforts aimed at increasing access to evidence-based care, managing health care costs, reducing stigma associated with mental health or substance use disorder treatment, and treating comorbid psychiatric and other general medical conditions to improve outcomes for patients (
8). Moreover, BCPPs could participate in the evidence-based training of future mental health providers by contributing to the areas of clinical psychopharmacology, pharmacogenomics, population health, and evaluation of the medical and psychiatric literature. We hope that this article not only serves as a reminder of the value that BCPPs can bring to care teams but also highlights an option for many providers who are trying to help all patients receive appropriate care. As this specialty continues to grow, the involvement of BCPPs in care can be optimized to meet the common goal of expanding access, improving outcomes, and minimizing costs of care.
Acknowledgments
The authors acknowledge the College of Psychiatric and Neurologic Pharmacists (CPNP) and Greg Payne, M.B.A., CPNP Director of Technology, for their support and assistance with this project.