Injecting Pharmaceutical Skill Into Schizophrenia Care

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You Asked for It! CEAN ONGOING CE PROGRAMof the University of ConnecticutSchool of PharmacyEDUCATIONAL OBJECTIVESAfter participating in this activity pharmacists will beable to: Discuss how schizophrenia's propensity to cause internal conflict and subjective distress often leads to nonadherence and use patient centered approaches toimprove care Implement pharmacologic approaches to address suboptimal outcomes for persons with schizophrenia Identify situations in which oral, long-acting injectable(LAI) antipsychotics, or a combination of both are reasonable choices Compare available long-acting injectable antipsychotic agents' indications, risks and benefits, pharmacokinetic profiles, dosing, and administration techniques inthe pharmacy Discuss emerging opportunities for pharmacists administer and monitor LAI antipsychotic medicationAfter participating in this activity pharmacy technicianswill be able to: Discuss the association between schizophrenia diagnosis and medication adherence List long-acting injectable drugs used in schizophrenia, and address inventory management issues Recognize when to refer patients to the pharmacistfor help with their schizophrenia Determine the best way to help patients engage in apatient assistance programThe University of Connecticut School of Pharmacy is accredited by the Accreditation Council for Pharmacy Education as aprovider of continuing pharmacy education.Pharmacists and pharmacy technicians are eligible to participatein this application-based activity and will receive up to 0.2 CEU(2 contact hours) for completing the activity, passing the quizwith a grade of 70% or better, and completing an online evaluation. Statements of credit are available via the CPE Monitor online system and your participation will be recorded with CPEMonitor within 72 hours of submission Can Stock Photo / Jegas RaInjecting Pharmaceutical Skillinto Schizophrenia CareABSTRACT: Schizophrenia is a severe, persistent mental illness that affects 0.3%to 0.7% of the U.S. population. Individuals with schizophrenia often lack insightinto their illness and struggle with periods of adequate and inadequate symptomcontrol. Individuals are often stigmatized by a community that is uncomfortablewith schizophrenia's symptoms due to fear and misunderstanding. The antipsychotics that have been developed over the last 60 or more years have numerousside effects and require close monitoring. Lack of insight, stigma, and side effectsput individuals with schizophrenia at high risk for medication nonadherence,poor clinical outcomes, and costly hospitalizations. More antipsychotics areavailable in long-acting injectable formulations. These delayed-release formulations allow patients to maintain therapeutic levels of antipsychotics for weeks tomonths after an injection. Such properties can help improve medication adherence. In some states, pharmacists can administer LAIAs in community pharmacies and improve patient access to these valuable medications.FACULTY: Nathaniel Rickles, PharmD, PhD, BCPP, Associate Clinical Professor, and Kristin Waters,PharmD, BCPS, BCPP, Assistant Clinical Professor, University of ConnecticutACPE UAN: Y DISCLOSURE: The authors have no actual or potential conflicts of interest associated withthis article.Grant funding: Funded by an educational grantfrom Alkermes, Inc.Cost: FREEDISCLOSURE OF DISCUSSIONS of OFF-LABEL and INVESTIGATIONAL DRUG USE: This activity maycontain discussion of off label/unapproved use of drugs. The content and views presented in this educational program are those of the faculty and do not necessarily represent those of the Universityof Connecticut School of Pharmacy. Please refer to the official prescribing information for each product for discussion of approved indications, contraindications, and warnings.INITIAL RELEASE DATE: November 15, 2019EXPIRATION DATE: November 15, 2021To obtain CPE credit, visit the UConn Online CECenterhttps://pharmacyce.uconn.edu/login.php.Use your NABP E-profile ID and the session code19YC61-ABC36 for pharmacists or19YC61-CBA88 for pharmacy techniciansto access the online quiz and evaluation. Firsttime users must pre-register in the Online CE Center. Test results will be displayed immediately andyour participation will be recorded with CPE Monitor within 72 hours of completing the requirements.For questions concerning the online CPE activities, email joanne.nault@uconn.edu.INTRODUCTIONSchizophrenia is a chronic, debilitating, serious mental illness (SMI) that affectsapproximately 0.3 to 0.7% of the global population. Patients with schizophreniahave a significant decline in life expectancy. In a comparison of 220 unique disease conditions, acute schizophrenia was shown to impose the highest degree ofdisability.1 Schizophrenia’s economic burden is high, with an approximated costof 155.7 billion in the United States in 2013.2Pharmacists and pharmacy technicians may hold attitudes or beliefs aboutschizophrenia that are more negative than their beliefs about other SMIs such asmajor depression and bipolar disorder. Although these beliefs may not necessarily be stigmatizing, they may impact the pharmacy staff member’s ability to

provide optimal care. Because patients with schizophreniahave altered or disorganized thought processes, pharmacystaff must employ strong communication skills, sensitivity,and empathy when providing care to these patients. Can Stock Photo / KubkoMedication adherence and continuity of care continue to bemajor issues for patients with schizophrenia. Access to medication may be a barrier that contributes to nonadherence.Pharmacy staff is well-placed to recommend different approaches based on medications’ mechanisms of action or adverse effect profiles.This continuing education activity will improve pharmacystaff’s ability to optimize treatment for patients with schizophrenia while addressing negative beliefs about this patientpopulation. It will explore factors that contribute to nonadherence. It will also identify pharmacologic approaches forschizophrenia, including oral and long-acting injectable antipsychotics (LAIAs). After comparing the different LAIAs currently available, it will discuss the pharmacist’s role inadministering LAIAs and monitoring for adverse effects.Community Pharmacy Staff’s RoleCommunity pharmacy staff may hold a combination of stigmatizing and non-stigmatizing attitudes and beliefs aboutmental illnesses that vary by SMI. In general, communitypharmacy staffs’ beliefs and attitudes about depression andanxiety disorders are more positive than their beliefs and attitudes about schizophrenia.3Studies have found that pharmacists were significantly lesswilling to provide pharmacy services to consumers with mental illnesses than to consumers with cardiovascular diseasesand asthma.4,5 Pharmacists may feel uncomfortable discussing psychotropic medication use and mental illness symptoms with patients.6 The disparity in willingness to provideservices seems to emanate from pharmacists’ lack of knowledge of schizophrenia; discomfort with awkward or challenging behaviors; or lack of privacy in some communitypharmacies.6,7The concept of establishing pharmacist-managed clinics forLAIA administration is gaining momentum. However, patientsand providers may associate LAIAs with coercion or considerthem old-fashioned. Pharmacists can help reduce thatstigma.8 LAIAs generally improve adherence by preventingmissed doses and minimizing adverse effects associated withpeak drug levels. Clinicians can identify medication nonadherence earlier when patients miss a scheduled injection. Manypatients begin LAIA therapy during hospitalization to preventimmediate nonadherence at discharge. However, the drugsare costly (average wholesale price, 296– 1779 per dose in2009 dollars), and hospitals must absorb these costs in theper diem reimbursement cost.9 Healthcare systems mayUCONN You Asked for It Continuing Educationtherefore be more receptive to the idea of community-based injection services.Studies have shown that pharmacists can manage referred outpatients with services including adjusting the doses of and administering LAIAs while monitoring for adverse events includingmetabolic disturbances and extrapyramidal symptoms (EPS).These services are cost-effective.9 In addition, support programshave used convenient locations, often community pharmacies,where patients can receive monthly injections to improve adherence. These programs also increase patient engagement with other supportive activities.10PAUSE AND PONDER: A patient with schizophreniawas recently hospitalized and the psychiatrist startedtreatment with a LAIA. The patient has arrived to pick upA dose of the LAIA to be administered at his nextoutpatient appointment, and you tell him it will cost 300.The patient is visibly upset and states that he cannotafford the medication. What do you say to the patient andwhat actions do you take?SCHIZOPHRENIA: BACKGROUNDAs mentioned previously, schizophrenia is relatively rare. Schizophrenia’s cause is unknown, although several suspected causeshave been noted. These include perinatal insults, infectious or autoimmune causes, substance use during pregnancy (especiallycannabis or methamphetamine), and genetics.11Schizophrenia is a thought disorder characterized by symptomsthat fall into three primary domains: positive, negative, and cognitive symptoms (see Table 1).1 These symptoms typically beginduring the late teens to mid-30s and tend to occur later in womenthan men (median age late-20s vs. early to mid-20s).12 Unfortunately, symptoms in all three domains may contribute to medication nonadherence.November 2019Page 2

Table 1. Schizophrenia’s SymptomsPositive SymptomsNegative Symptoms Delusions Hallucinations Disorganized thoughts or speechCognitive Symptoms Blunted affect Alogia (reduced fluency of speech) Anhedonia (inability to experiencepleasure in normally pleasurable acts) Amotivation Avolition (a lack of interest or engagement in goal-directed behavior)All patients with schizophrenia present with different symptomcombinations. During an acute exacerbation, patients are morelikely to display predominantly positive symptoms. However,they often suffer with enduring negative symptoms and cognitive dysfunction between exacerbations. The result is overallfunctional impairment that decreases the likelihood of successful occupational and academic functioning, interpersonal relationships, and functioning in other areas of life.1 Memory impairment Decreased concentration Impaired executive functioningPause and Ponder: You work at a busy communitypharmacy. A patient you do not know has dropped off aprescription for an antipsychotic. While she waits for theprescription to be filled, you notice that she appears to betalking to herself and paces back and forth in the waitingarea. Other customers appear uncomfortable. What wouldyou do in this situation?Schizophrenia: Shared Decision MakingSchizophrenia and Medication AdherenceNational guidelines and mental health advocacy organizationsunderscore the need for shared decision-making (SDM) in antipsychotic prescribing. SDM is defined as “the conversationthat happens between patients and their healthcare professionals to reach a healthcare choice together.” It is especiallyimportant that patients with schizophrenia be involved in thedecision-making behind their care.A recent interview-based study examined mental health pharmacists’ views of and experiences with SDM.13 Pharmacists indicated that SDM often contributed to positive clinicaloutcomes (e.g. better adherence, service user satisfaction, andimproved therapeutic relations). Collectively, they believedthat SDM was essential to stigma-free clinical care. They alsoindicated, however, that clinicians do not use SDM as often asthey could. Barriers included a lack of knowledge about how toemploy SDM and time pressures on clinical staff. They expressed a desire for improved teamwork, greater patient engagement, and more interdisciplinary collaboration.13 Goodcontinuing education can galvanize SDM.Patients with first-break schizophrenia may present and respond to treatment quite differently than those with longstanding schizophrenia. All patients require a range of treatments (e.g. cognitive behavioral therapy, vocational help, family support, substance use intervention, and antipsychoticmedications). The treatment team, working closely with the patient to determine the patient’s history and preferences, mustindividualize the exact mix of services. Without support, peoplewith schizophrenia experience many treatment-preventableoutcomes. These may include relapse, multiple or chronichospitalization(s), comorbid substance use disorders, homelessness, adverse experiences with the legal system, estrangement from loved ones and society as a whole, and suicide.UCONN You Asked for It Continuing EducationNumerous studies have documented that medication adherenceamong patients with schizophrenia is usually poor, and the professional literature is replete with studies and opinion pieces.Systematic review indicates that approximately 40% of patientswith schizophrenia (and most likely more) are partially adherentor nonadherent with antipsychotic medications.14 The U.S. Department of Veterans Affairs, which provides care for a largepopulation of patients who have schizophrenia, documents that40% of patients fill less than 80% of their prescriptions.15,16Despite decades of study, adherence remains a major treatmentimpediment in schizophrenia. People with schizophrenia haveseveral problems that healthcare providers may fail toappreciate17-19: Impaired insight into illness Co-occurring substance use disorders Abnormal biopsychosocial-cultural filters that distortperception and cause internal conflict Withdrawal and diminished interactions with others Altered observation of others' behavior, and internalization of fewer functional behavioral models than thosewithout schizophrenia Pervasive stigma around treatment with antipsychoticmedications Complex medication regimens Significant adverse effect profiles of antipsychoticsImpaired insight is a primary reasons for nonadherence.20 Pooror absent insight can have many implications. Patients may notbe aware that they have a mental illness, and therefore may beunaware of the need for treatment or the consequences of notaccepting treatment.21 Patients who lack insight may minimize ordeny the need for treatment and develop negative attitudes towards medication. This increases the likelihood that the patientNovember 2019Page 3

Table 2. Results from CATIETime After StudyInitiation% Nonadherent to Prescribed AntipsychoticNo impairmentMinimal impairment6 months1712 months18 .012243729430.050.0007will self-discontinue medications.22 Non-pharmacologic methods such as cognitive behavioral therapy may have some benefit in improving the patient’s insight into his or her psychiatriccondition.23A large, prospective study (the CATIE trial, published in 2005)provided data regarding the effectiveness of first- and secondgeneration antipsychotics to treat schizophrenia. A recentanalysis of the CATIE trial’s data was conducted to estimatethe time to medication nonadherence (taking less than 80% ofmonthly medication) between patients with differing degreesof insight impairment.22 The researchers classified patients ashaving no impairment, minimal impairment, or moderate-tosevere impairment based on the insight item of the Positiveand Negative Syndrome Scale (PANSS) score. Table 2 presentsthe results of this analysis.At both six months and 18 months after treatment initiation,adherence to the prescribed antipsychotic differed significantly depending on the patients’ degree of insight. Time to medication nonadherence was also shorter (13.5 months) forpatients with moderate-to-severe impairment compared tothose with minimal (14.4 months) and no impairment (15.1months). Associations between insight and adherence remained significant after adjusting for illness severity, substance use, attitudes about medication, cognition, level ofhostility, and depression.Substance use is another factor that may have a major effecton adherence in patients with schizophrenia. A systematic review and meta-analysis published in 2018 suggests that 42% ofpatients with schizophrenia have comorbid substance usedisorders.24 Tobacco, alcohol, and cannabis use disorders areamong the most common in this patient population.24,25 Comorbid substance use disorders may contribute to moresymptom exacerbations including clinical relapse and need forhospitalization, treatment nonadherence, and suicide. Pharmacists are in a position to reduce or eliminate these risks byidentifying and recommending treatment for patients withconcomitant schizophrenia and substance use disorders.UCONN You Asked for It Continuing Education Can Stock Photo / lollojTREATMENT OF SCHIZOPHRENIAThe unique problems experienced by patients with schizophrenia mean that the clinical implications are complex17: Treatment to reduce and eliminate deficits requiresmore than just medication. Patients with schizophrenianeed time-intensive therapy and support for optimaltreatment. Simply eliminating psychotic symptoms may, from thepatient's point of view, move him from a more favorable psychotic condition back to a troublesome reality.Some people with schizophrenia prefer a psychoticstate to a relative drug-induced normality. This isknown as subjective distress. Many patients report feeling worse while taking medications. This may be caused by the medications’ adverse effects, but subjective distress seems to be agreater factor. Patients are more receptive to medication if cliniciansoffer different medications or a medication with fewer,different, or more tolerable adverse effects.November 2019Page 4

Pharmacologic ApproachesAntipsychotics remain the mainstay of pharmacologic treatmentof schizophrenia. However, approximately one-third of patientsrespond incompletely to these medications.3 Before diagnosing apatient as treatment-resistant, clinicians must rule out1: Medication nonadherence. As discussed previously, adherence poses a significant problem in the treatment ofthis SMI. Treatment with a LAIA may be a strategy to ensure patients receive adequate medication trials. Confusion regarding lack of efficacy versus intolerability Unclear diagnosis (substance use, psychiatric comorbidities, and somatic comorbidities may confound diagnosis) Pharmacokinetic anomalies due to rapid metabolism,drug–drug interactions, and drug–food interactionsAntipsychotic medications are categorized into two classes: firstgeneration (typical) antipsychotics (FGA) and second generation(atypical) antipsychotics (SGA; see Table 3).Prescribers must take patient-specific factors into accountwhen selecting a medication for each patient. They must consider previous medication trials, actual or potential adverse effects, and response to treatment. Consideration of patients’previous responses to medication trials is critical. For example,if a patient has responded poorly to a particular antipsychotic,either in terms of efficacy or adverse effects, it would be prudent to select an antipsychotic that is dissimilar to the first antipsychotic. On the other hand, if a patient has responded wellto an antipsychotic in the past, it would make sense to re-trythat medication.Evidence to support the use of multiple antipsychotics is lackingand contributes to significant risk of adverse effects. Three clinical situations may justify use of more than one antipsychotic26:1. Three or more failed trials of antipsychotic monotherapy2. Cross-titration of antipsychotic medications3. Augmentation of clozapineTreatment GuidelinesThere are no specific, comprehensive treatment guidelines foracute agitation in schizophrenia. For

Schizophrenia is a chronic, debilitating, serious mental illness (SMI) that affects approximately 0.3 to 0.7% of the global population. Patients with schizophrenia have a significant decline in life expectancy. In a comparison of 220 unique dis-ease conditions, acute schizophrenia was shown to impose the highest degree of

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