Monitoring Physical Health and Side-Effects of Psychotherapeutic Medications in Adults and Children: An Integrated Approach
←
→
Page content transcription
If your browser does not render page correctly, please read the page content below
2018 Monitoring Physical Health and Side-Effects of Psychotherapeutic Medications in Adults and Children: An Integrated Approach Florida Medicaid Drug Therapy Management Program for Behavioral Health medicaidmentalhealth.org
Please visit our website to view: n Electronic versions of our guidelines (available in full or part) n News and announcements n Video presentations n n Alerts of recent publications and related literature n Resources and tools n Current projects T medicaidmentalhealth.org For more information and a full list of references, visit our website at medicaidmentalhealth.org These guidelines are available in the public domain and do not require permission from the authors for use. However, we request when using any of its content that the publication is cited as follows: 2018 Monitoring the Physical Health and Side-Effects of Psychotherapeutic Medications in Adults and Children: An Integrated Approach (2018). The University of South Florida, Florida Medicaid Drug Therapy Management Program sponsored by the Florida Agency for Health Care Administration. © March 2018 medicaidmentalhealth.org
Table of Contents General Topics Introduction ....................................................................................................................................................................................3 Principles of Practice.....................................................................................................................................................................5 Physical Disease and Mental Illness....................................................................................................................................14 Weight Change and Metabolic Concerns Associated with Psychotherapeutic Medications.................16 QTc Prolongation Associated with Psychotherapeutic Medications .................................................................24 Hyperprolactinemia Associated with Psychotherapeutic Medications............................................................25 Infectious Diseases: Risk Factors and Screening Recommendations.................................................................26 Substance Use Disorders.........................................................................................................................................................28 Special Populations: Women of Childbearing Age......................................................................................................39 Prevention Strategies................................................................................................................................................................44 Social Determinants of Health and Potential Barriers to Effective Treatment................................................46 List of Tables Table 1. Child and Adolescent Assessment Scales................................................................................................ 6 Table 2. Adult Assessment Scales.................................................................................................................................. 8 Table 3. Recommended Assessments at Baseline and Subsequent Follow-up Monitoring........... 10 Table 4. Recommended Laboratory Monitoring................................................................................................. 11 Table 5. Normal Laboratory Values in Adults for Selected Measures......................................................... 12 Table 6. Modifiable Risk Factors in Individuals with Severe Mental Illness.............................................. 14 Table 7. Studies Examining Weight Change Associated with Psychotherapeutic Medications used in the Treatment of Serious Mental Illness............................................................................................. 17 Table 8. Antipsychotic Medications and Metabolic Syndrome Risk............................................................ 21 Table 9: Waist Circumference and Race/Ethnicity............................................................................................... 21 Table 10. Risk Factors and Screening Recommendations for Selected Infectious Diseases.............. 26 Table 11. Drugs that May Cause False-Positive Results in Screening (Immunoassay) Testing........... 31 Table 12. Medications for Maintenance of Abstinence in Alcohol Use Disorders................................... 34 Table 13. Medication Assisted Therapy for Opioid Use Disorders: Methadone versus Buprenorphine..................................................................................................................................... 36 Table 14. Nicotine Replacement Therapies and Other Medication-Assisted Treatment for Tobacco Use Disorders.................................................................................................................................... 37 Table 15. Safety of Psychotherapeutic Medications in Pregnancy and Lactation.................................. 40 Table 16. Suggested Educational Tools and Strategies....................................................................................... 44 medicaidmentalhealth.org
Table of Contents List of Boxes Box 1. Physical Diseases with Increased Frequency in Serious Mental Illness........................................... 15 Box 2. ADA Target Goals for Blood Pressure, Lipid, and Glycemic Control..................................................23 Box 3. Risk factors associated with QT prolongation to evaluate for*...........................................................24 Box 4. Behaviors that Increase Suspicion for Drug Misuse or Dependency...............................................29 Box 5. When Urine Drug Screening Should be Obtained...................................................................................30 Box 6. Potential Barriers to Effective Treatment......................................................................................................46 medicaidmentalhealth.org Page 2
Introduction Introduction Individuals with serious mental illness (SMI) including schizophrenia, schizoaffective disorder, bipolar disorder, and major depressive disorder are prone to many different physical health problems. Although physical health problems are also prevalent in the general population, they have a greater impact on individuals with serious mental illness. Many factors contribute to the poor physical health of individuals with serious mental illness, including disparities in health care access and utilization, as well as provision of health care services. Studies have shown that individuals with serious mental illness have an excess mortality, being two to three times as high as that of the general population. This mortality gap translates to a 13 to 30 year shortened life expectancy. Furthermore, among women of childbearing age, mental illness not only affects the mother’s well being, but may also have significant effects on fetal outcomes, particularly when patients do not receive recommended care during pregnancy. Based on the complex behavioral and other health needs of the SMI population, an integrated approach is critical for reducing morbidity and early mortality. The Substance Abuse and Mental Health Services Administration (SAMHSA) defines an integrated approach to care as “the systematic coordination” of mental health, substance abuse, and primary care services. Integrated care bridges the gap that often occurs between the medical and behavioral health care systems, and produces the best health outcomes for individuals with SMI. There are different models and levels of integrated care that providers can adopt depending on their practice setting and its available resources. The most feasible for many providers treating individuals with SMI is the clinical practice integration approach in which collaboration is built into service protocols and there are mechanisms to consult and collaborate with other providers. There is no one model of integration that works best for individuals with SMI. Ultimately, integration efforts should incorporate the patient perspective and be matched to the patients’ needs. When treating patients with serious mental illness, clinicians must be prudent in making treatment decisions, be aware of patients’ concomitant physical illnesses, and be cognizant of potential medication side effects that may exacerbate physical health conditions present. When patients have physical health conditions that may be affected by the use of psychiatric medications, clinicians should use their best judgment in making decisions regarding patient care based on integration of evidence from the literature and clinical experience as well as the individual patient’s symptoms and risk factors. In creating this publication, the goal was to provide monitoring recommendations based on the most recent available evidence in order to administer better quality care and help minimize the potential adverse health effects of psychiatric medications, while ultimately improving patients’ overall health and well-being. medicaidmentalhealth.org Page 3
Introduction Process for Creating the Guidelines Every two years, the Florida Medicaid Drug Therapy Management Program brings together a diverse array of stakeholders and experts to update the guidelines. This year’s group of stakeholders known as the Florida Expert Panel was comprised of: Florida primary care providers, psychiatrists— including providers from community mental health centers and medical directors of health plans— ARNPs, academicians, and pharmacists. The 2018 Florida Expert Panel met in Tampa, Florida on February 17, 2018 to review and update the guidelines first published in 2014 and revised in 2016. The panel listened to presentations on the latest evidence-based practices, discussed the guidelines, proposed revisions, and reached a consensus about whether to revise and adopt a particular set of guideline recommendations. Thus, the final guidelines are a product of an in-depth review of the literature with an emphasis on the highest level of clinical evidence (e.g., randomized controlled trials, systematic reviews) and expert panel consensus on the strength of the evidence. The names of the meeting attendees and meeting presentations are available on the program website at www.medicaidmentalhealth.org. Financial disclosures are available upon request. Organization This publication provides information regarding common physical health conditions that occur with greater frequency in the seriously mentally ill population, documents screening/monitoring recommendations for these physical health conditions, provides guidelines regarding management of pregnant/lactating women, and explores potential barriers that may adversely affect healthcare delivery, as well as treatment adherence in this population. Disclaimer The 2018 Monitoring Physical Health and Side-Effects of Psychiatric Medications in Adults and Children: An Integrated Approach guidelines reflect the current state of knowledge at the time of publication on effective and appropriate care. The inevitable changes in the state of scientific information and technology mandate that periodic review, updating, and revisions will be needed. These guidelines may not apply to all patients; therefore, each guideline must be adapted and tailored to the individual patient. Proper use, adaptation, modifications, or decisions to disregard these or other guidelines, in whole or in part, are entirely the responsibility of the clinician who uses these guidelines. The authors and expert panel members bear no responsibility for treatment decisions and outcomes based on the use of these guidelines. medicaidmentalhealth.org Page 4
Principles of Practice Note: Strongly recommend coordination of care between primary care, psychiatry, specialists, and other providers to facilitate optimal outcomes. Comprehensive Assessment nnA comprehensive health assessment includes: FF A full medical history FF An assessment of psychiatric co-occurring disorders and physical comorbidities FF An assessment for trauma, suicide, violence, and substance use disorders FF Assessment of pregnancy intentions in women of childbearing age FF Assessment of a patient’s social determinants of health (e.g., health literacy, transportation, food insecurity, housing stability) FF Relevant medical work-up, physical examination, and nutritional status evaluation nnSerious behavioral health conditions are chronic in nature; therefore a long-term, continuous management plan of chronic conditions is essential: FF Measurement-based care to assess symptoms, side-effects, and adherence FF Integration of psychiatrists and primary care providers FF In pregnant and post-partum patients, integration of psychiatrists and obstetrician- gynecologists FF Collaborative/shared decision-making with patients and family/caregivers FF Psychosocial assessment FF Assess of social support system (housing, family, other caregivers, etc.) FF Evaluate the factors that pose a risk to the continuity of care (medication adherence, social determinants of health, etc.) FF Assess involvement with legal system and interact with law enforcement as needed medicaidmentalhealth.org Page 5
Principles of Practice Measurement-Based Care for Behavioral Health Conditions nnQuestionnaires and rating scales are strongly recommended for the initial diagnostic assessment and evaluation of treatment outcomes. These instruments can be helpful in providing supplemental information to the provider’s clinical judgment. nnIntegration of rating scales into routine clinical practice and for all follow-up appointments is also strongly suggested. nnClinicians should use rating scales to assess symptom severity during the initial evaluation and treatment, when medication changes are implemented, and/or when the patient reports a change in symptoms. Notes: • Effort should be made to communicate between primary care providers, psychiatrists, caseworkers, and other team members to ensure integrated care. • Prior to initiating any intervention (e.g., psychosocial, medication), assess and document the risks/benefits of treatment. • Education should be age-appropriate and targeted to the condition. Measurement Scales Internet links to the following psychiatric assessment scales are available on the Program website at www.medicaidmentalhealth.org. These scales were selected because they are brief and can be completed in the primary care office. Table 1. Child and Adolescent Assessment Scales Condition/ Type of Name of Scale Age range # of Items Symptoms Assessment ADHD ADHD Rating Scale IV – Home Version Parent rating 5-17 18 ADHD Parent rating 55 NICHQ Vanderbilt Assessment Scales 6-12 Teaching rating 43 Anxiety Severity Measure for Generalized Patient self- 11-17 10 Anxiety Disorder report Cognitive, emotional & Pediatric Symptom Checklist (PSC) Parent rating 4-16 35 behavior problems Depression PHQ-9 Modified for Adolescents Patient self- 11-17 9 (PHQ-A) report Depression Center for Epidemiological Studies Patient self- 6-17 20 Depression Scale for Children (CES-DC) report Manic symptoms Child Mania Rating Scale Patent rating 5-17 21 Mental health DSM-5 Parent/Guardian-Rated Level domains across 1 Cross-Cutting Symptom Measure- Parent rating 6 -17 25 psychiatric Child diagnoses medicaidmentalhealth.org Page 6
Principles of Practice Table 1. Child and Adolescent Assessment Scales (continued) Condition/ Type of Name of Scale Age range # of Items Symptoms Assessment Mental health domains across DSM-5 Self-Rated Level 1 Cross- Patient self- 11-17 25 psychiatric Cutting Symptom Measure—Child report diagnoses Patient self-report PTSD Child PTSD Symptom Scale (CPSS) 8-18 24 or clinician administered Substance use Patient self- The CRAFFT Screening Interview 13-18 9 (Alcohol & drugs) report Substance use Patient self- Drug Use Questionnaire (DAST-20) 13-18 20 (Drugs) report Symptom severity Brief Psychiatric Rating Scale for across mental Clinician rating 3-18 21 Children (BPRS-C) health domains medicaidmentalhealth.org Page 7
Principles of Practice Table 2. Adult Assessment Scales Condition/ Type of Name of Scale # of Items Symptoms Assessment Anxiety/general Generalized Anxiety Disorder 7-item (GAD-7) Patient self-report 7 scale Anxiety/general Severity Measure for Generalized Anxiety Patient self-report 10 Disorder-Adult Anxiety/panic Severity Measure for Panic Disorder Patient self-report 10 Bipolar disorder/ Young Mania Rating Scale (YMRS) Clinician rating 11 manic symptoms Bipolar disorder The Mood Disorder Questionnaire (MDQ) Patient self-report 16 Childhood Adverse Childhood Experiences (ACE) Patient self-report 10 trauma Questionnaire Depression Patient Health Questionnaire (PHQ-9) Patient self-report 9 Depression Beck Depression Inventory (BDI) Patient self-report 21 Depression Hamilton Rating Scale for Depression (HAM-D) Clinician rating 21 Difficulties/ disability due to World Health Organization Disability Patient self-report 36 mental health Assessment Scale 2.0 conditions Global rating of illness severity Clinical Global Impression Scale (CGI) Clinician rating 3 and response to treatment Mental health domains across DSM-5 Self-Rated Level 1 Cross-Cutting Patient self-report 23 psychiatric Symptom Measures-Adult diagnosis Psychosis Clinician-Rated Dimensions of Psychosis Clinician rating 8 Symptom Severity Psychotic Brief Psychiatric Rating Scale (BPRS) Clinician rating 18 disorders PTSD National Stressful Events Survey PTSD Short Patient self-report 9 Scale (NSESS) PTSD Post-traumatic Stress Disorder Checklist Patient self-report 20 for DSM-5 (PCL-5) medicaidmentalhealth.org Page 8
Principles of Practice Table 2. Adult Assessment Scales (continued) Condition/ Type of Name of Scale # of Items Symptoms Assessment Substance use The Alcohol Use Disorders Identification Test Patient self-report 3, 10 (Alcohol) (AUDIT-C, AUDIT) Substance use Tolerance, Annoyed, Cut Down, Eye-Opener Patient self-report 4 (Alcohol) (T-ACE) Questionnaire Substance use (Alcohol Tolerance, Worried, Eye-Opener, Amnesia, Cut Patient self-report 5 use during Down (TWEAK) Questionnaire pregnancy) Substance use NIDA Drug Use Screening Tool: Quick Screen Patient self-report 4 (Alcohol & drugs) Substance use The CRAFFT Screening Interview Patient self-report 9 (Alcohol & drugs) Substance Drug Abuse Screen Test (DAST-10) Patient self-report 10 (Drugs) Substance use Opioid Risk Tool Patient self-report 10 (Opioids) Screening, Brief Intervention, and Referral to Treatment (SBIRT): Screening, Brief Intervention, and Referral to Treatment (SBIRT) is an evidence-based practice for providing early intervention and treatment to individuals at risk for developing substance use disorders. SBIRT can be implemented in the primary care setting. For more information regarding SBIRT, visit http://www.samhsa.gov/sbirt and see the Substance Use Disorders section in these guidelines. medicaidmentalhealth.org Page 9
Principles of Practice General Recommendations: Baseline Monitoring of Physical Health in Patients with Serious Mental Illness (SMI) Table 3. Recommended Assessments at Baseline and Subsequent Follow-up Monitoring Assessment Baseline Follow-up Assessments Vital signs (blood pressure, pulse, weight, Each visit including calculation of body mass index) Lifestyle behaviors: smoking, diet, exercise, Each visit substance use, sleep Personal/family history: hypertension, diabetes, cardiovascular disease, cerebrovascular disease As clinically indicated (stroke), cancer, epilepsy, Parkinson’s disease, thyroid disease Dental history As clinically indicated Sexual/reproductive function At 3 months and 6 monthly thereafter Recommended Monitoring As Needed Based on Clinical Presentation: nnWaist circumference nnSedation nnParkinsonism Screen (e.g., SAS or ESRS) nnAkathisia Screen (e.g., AIMS or ESRS) nnElectrocardiogram (ECG) Note: Prior to considering medication management, clinicians should weigh the risks and benefits of treatment, including the risk for interactions with other medications (both prescribed and over-the-counter), herbal supplements, and foods (e.g., grapefruit) that may increase or decrease drug levels. To check drug-drug interactions, visit: https://reference.medscape.com/drug- interactionchecker. medicaidmentalhealth.org Page 10
Principles of Practice Table 4. Recommended laboratory monitoring Parameter Recommendation Complete blood count with differential At baseline, then as indicated (e.g., treatment with clozapine) (CBC with diff) Complete metabolic panel (CMP) At baseline, then as indicated Fasting lipid profile All patients over 40 years at baseline and annually thereafter, or sooner as indicated (e.g., cardiac history, obesity, diabetes, hypertension) Folate As clinically indicated Hemoglobin A1c (HbA1c) All patients over 40 years at baseline and annually thereafter, or sooner as indicated Prolactin As clinically indicated (e.g., amenorrhea/oligomenorrhea, poor sexual function, osteopenia/osteoporosis) Thyroid stimulating hormone (TSH) As clinically indicated Urine Drug Screen As clinically indicated Vitamin B12 As clinically indicated Vitamin D As clinically indicated Notes: Abbreviations: SAS = Simpson-Angus Scale; ESRS = Extrapyramidal Symptom Rating Scale; AIMS = Abnormal Involuntary Movement Scale. These scales are available at www.medicaidmentalhealth.org. There are many reasons patients may require testing earlier or more often than the recommendations noted above. If monitoring has been obtained by primary care provider, obtain records. Studies have shown that waist circumference is a better predictor of cardiovascular risk compared to Body Mass Index (BMI). Check blood pressure (BP) and pulse during titration with clozapine and quetiapine. For more information about clozapine monitoring, visit the Clozapine REMS Program at www.clozapinerems.com. medicaidmentalhealth.org Page 11
Principles of Practice Table 5. Normal laboratory values in adults for selected measures Measure Normal Range* Basic Metabolic Panel Blood urea nitrogen (BUN) 7 – 20 mg/dL Bicarbonate (HCO3 ), total - 18 – 30 mEq/L Creatinine 0.8 – 1.3 mg/dL Glucose 70 – 100 mg/dL Serum chloride (Cl-) 95 – 105 mmol/L Serum potassium (K ) + 3.5 – 5.0 mmol/L Serum sodium (Na+) 135 – 145 mmol/L Complete Blood Count Measure Normal Range* Hemoglobin Males: 13 – 17 g/dL Females: 12 – 15 g/dL Hematocrit (Hct) Males: 40 – 54% Females: 36 – 46 % Mean corpuscular volume (MCV) 80 – 100 fL Platelets 150 – 400 x 109/L Red Blood Cells (RBCs) Males: 4.32 – 5.72 x 1012 cells /L Females: 3.90 – 5.03 x 1012 cells/L White Blood Cells (WBCs) 4 – 10 x 109/L Endocrine Measure Normal Range* Glucose 70 – 100 mg/dL Hemoglobin A1c (Hgb A1c) 5.6% and below Lipids Measure Normal Range* High density lipoprotein (HDL) Above 50 mg/dL Low density lipoprotein 85 – 125 mg/dL Total cholesterol 3.5 – 5.5 mmol/L Triglycerides 50 – 150 mg/dL medicaidmentalhealth.org Page 12
Principles of Practice Table 5. Normal laboratory values in adults for selected measures (continued) Liver function tests Measure Normal Range* Albumin 3.5 – 5.0 g/dL Alkaline phosphatase 20 – 90 Units/L Alanine Aminotransferase (ALT) 10 – 30 Units/L Aspartate aminotransferase (AST) 5 – 30 Units/L Bilirubin, direct 0 – 6 micromols/L Bilirubin, total 2 – 20 micromols/L Total protein 60 – 80 g/L Renal function Measure Normal Range* Blood urea nitrogen (BUN) 7 – 20 mg/dL Creatinine 0.8 – 1.3 mg/dL Estimated glomerular filtration rate Above 90% (eGFR) *Note: Normal laboratory values may vary by facility. Always use the facility’s laboratory value guidelines for testing and interpretation. medicaidmentalhealth.org Page 13
Physical Disease and Mental Illness Among individuals with serious mental illness, physical health problems including cardiovascular disease, metabolic disorders, infectious diseases, respiratory illnesses, and sexual dysfunction occur with greater frequency, especially when compared to the general population. Furthermore, individuals with serious mental illnesses such as schizophrenia and bipolar disorder have a greater relative risk of modifiable risk factors for cardiovascular disease. Relative risk is defined as the ratio of the probability of a particular event occurring in one group compared to the probability of that same event occurring in a comparison group. In this section, the guidelines provide an overview of the physical ailments that occur with greater frequency among individuals with serious mental illness, review psychiatric medication side effects that may contribute to or exacerbate these physical conditions, and provide monitoring recommendations in order to better evaluate and treat these physical health issues with the goal of better health outcomes. Note: Strongly recommend coordination of care between primary care, psychiatry, specialists, and other providers to facilitate optimal outcomes. Table 6. Modifiable Risk Factors in Individuals with Severe Mental Illness Modifiable Risk Schizophrenia Bipolar Disorder Factors Prevalence rate Relative risk Prevalence rate Relative risk Smoking 50 – 80% 2 – 3 times the risk 54 – 68% 2 – 3 times the risk Obesity 45 – 55% 1.5 – 2 times the risk 21 – 49% 1 – 2 times the risk Metabolic 37 – 63% 2 – 3 times the risk 30 – 49% 2 – 3 times the risk Syndrome Dyslipidemia 25 – 69% ≤ 5 times the risk 23 – 38% ≤ 3 time the risk Hypertension 19 – 58% 2 – 3 times the risk 35 – 61% 2 – 3 times the risk Diabetes Mellitus 10 – 15% 2 – 3 times the risk 8 – 17% 1.5 – 3 times the risk Adapted from Hert, et al., 2011a. Physical Illness in patients with severe mental disorders: I. Prevalence, impact of medications and disparities in health care. World Psychiatry, 10(1): 52-77.disparities in health care. World Psychiatry, 10(1): 52-77. Note. The relative risk is compared to the general population. medicaidmentalhealth.org Page 14
Physical Disease and Mental Illness Box 1. Physical Diseases with Increased Frequency in Serious Mental Illness Cardiovascular diseases – stroke, myocardial infarction, hypertension, other cardiac and vascular diseases Nutritional and metabolic diseases – obesity, hyperlipidemia, metabolic syndrome, diabetes mellitus Bacterial infections and mycoses – tuberculosis Viral diseases – HIV, Hepatitis B, Hepatitis C Neoplasms – obesity-related cancers (e.g., breast, stomach)* and smoking-related cancers (e.g., lung) Dental problems – poor dental status Respiratory tract diseases – COPD, impaired lung function Urological conditions and male reproductive issues – sexual dysfunction Female reproductive issues and pregnancy complications – obstetric complications, sexual dysfunction Adapted from Hert, et al., 2011a. *Note: Evidence regarding obesity-related cancers is conflicting; some studies indicate similar incidence of these cancers to the general population but with increased mortality among individuals with SMI, while other reports indicate increased rates of obesity-related cancers among individuals with SMI. medicaidmentalhealth.org Page 15
Weight Change and Metabolic Side-Effects of Psychotherapeutic Medications Note: Strongly recommend coordination of care between primary care, psychiatry, specialists, and other providers to facilitate optimal outcomes. Weight Change and Metabolic Concerns Associated with Psychotherapeutic Medications Weight changes are the most difficult issues patients and clinicians contend with and can have an effect on patient compliance with a particular regimen. Individual psychiatric medications, including those in the antidepressant, mood stabilizer, and antipsychotic classes, have been shown to have differential effects on weight gain. Management of medication-induced weight gain and other metabolic problems depends on multiple factors, including response to different antipsychotics, severity of the metabolic disturbance, and patient willingness to implement lifestyle changes. Individuals with new-onset diabetes should receive an evaluation by a primary care provider. Potential options to manage medication-induced metabolic side effects include: nnDiet and exercise, including referral to a certified nutritionist if clinically indicated nnSwitching to an antipsychotic with lower potential for weight gain or dyslipidemia (e.g., switch from olanzapine or risperidone to ziprasidone) nnMedication management if more conservative measures are ineffective (e.g., antihypertensives for hypertension and statins for dyslipidemia) Initial randomized trials have also shown evidence that metformin may be effective in helping patients with schizophrenia lose weight. These trials found that twelve to sixteen weeks of metformin given at 750 mg/day or higher led to loss of approximately 50 percent of weight gain induced by antipsychotic treatment, and metformin combined with lifestyle changes had more effect than metformin alone in two of the trials. Metformin is indicated as an adjunct to diet and exercise to improve glycemic control in adults and children with Type 2 diabetes mellitus. Metformin is not yet FDA-indicated for psychotropic medication-induced weight gain and is contraindicated in individuals with known hypersensitivity or metabolic acidosis. Metformin has traditionally been contraindicated in chronic kidney disease; however, based on recent evidence and recommendations, metformin may be used with caution and close clinical supervision in individuals with a GFR >30 mL/min. The primary concern is the risk for lactic acidosis in this population. medicaidmentalhealth.org Page 16
Weight Change and Metabolic Side-Effects of Psychotherapeutic Medications Table 7. Studies Examining Weight Change Associated with Psychotherapeutic Medications used in the Treatment of Serious Mental Illness Antidepressants Weight loss FF Sertraline (Zoloft) – Patients in controlled trials had minimal (1-2 pound) weight loss compared to smaller changes with placebo. No weight change FF Citalopram (Celexa) – Short-term placebo-controlled trial showed average weight loss of 0.5 kg with citalopram versus 0.2 kg weight gain with placebo in post-marketing studies; No significant changes in body mass in post-marketing Selective studies Serotonin Reuptake FF Escitalopram (Lexapro) – No difference from placebo-treated patients in Inhibitors (SSRIs) premarketing trials. FF Fluoxetine (Prozac) – No overall associated weight changes; weight loss of 0.35 kg reported in acute-phase treatment, at 38 weeks, 2 kg weight gain with fluoxetine versus 2.5 kg weight gain with placebo. Weight gain FF Paroxetine (Paxil) – Of the SSRIs, paroxetine is most likely to cause weight gain. Fava, et al. showed >7% increase in weight from baseline compared with patients taking sertraline or fluoxetine. Weight loss FF Duloxetine (Cymbalta) – In acute placebo-controlled studies, duloxetine treated patients had average change of -0.5 kg compared with 0.2 kg for Serotonin placebo treated patients. No consistent relationship between duloxetine dose Norepinephrine and weight change. Similar acute mean weight changes seen in duloxetine Reuptake versus fluoxetine treated patients (-0.7 kg versus -0.6 kg respectively). Inhibitors (SNRIs) FF Venlafaxine (Effexor) – Weight loss of up to 7% of body weight compared to placebo during up to 12 weeks of treatment in studies of patients with MDD, GAD, SAD, and panic disorders. No weight change FF Nortriptyline (Pamelor) – Meta-analysis of 257 RCTs found non-significant weight change with nortriptyline. Tricyclic Weight gain Antidepressants (TCAs) FF Amitriptyline (Elavil) – Meta-analysis of 257 RCTs found average of 1.8 kg weight gain. FF Imipramine (Tofranil) – Average of 4.5 kg weight gain over one year in patients treated for panic disorder. Weight loss FF Bupropion (Wellbutrin) – Meta-analysis of 257 RCTs found average of 1.3 kg Other weight loss. antidepressants Weight gain FF Mirtazapine (Remeron) – Meta-analysis of 257 RCTs found average of 1.5 kg weight gain. medicaidmentalhealth.org Page 17
Weight Change and Metabolic Side-Effects of Psychotherapeutic Medications Table 7. Studies Examining Weight Change Associated with Psychotherapeutic Medications used in the Treatment of Serious Mental Illness (continued) Anticonvulsants/Mood Stabilizers Weight loss FF Lamotrigine (Lamictal) – Mean weight loss of 4.2 kg at week 52 of therapy in obese patients; mean weight loss of 0.5 kg in non-obese patients at week 52. FF Topiramate (Topamax) – Meta-analysis of 257 RCTs found average of 3.8 kg weight loss. FF Zonisamide (Zonegran) – Meta-analysis of 257 RCTs found average of 7.7 kg weight loss. Weight gain FF Carbamazepine (Tegretol) – Meta-analysis of 257 RCTs found average of 1.0 kg weight gain. FF Gabapentin (Neurontin) – Meta-analysis of 257 RCTs found average of 2.2 kg weight gain. FF Lithium (Eskalith, Lithobid) – Mean weight gain of 6.1 kg at week 52 of lithium therapy in obese patients; mean weight gain of 1.1 kg in non-obese † patients at week 52. FF Valproic Acid (Valproate, Valpro, Depakene) – Weight gain of 0.49 kg after 3 weeks of treatment with up to 1500 mg/day versus placebo in healthy volunteers. Antipsychotics Weight gain FF Chlorpromazine (Thorazine) – Meta-analysis estimated mean weight gain of 2.10 kg at 10-weeks of treatment. Typical Antipsychotics FF Fluphenazine (Prolixn) – Meta-analysis estimated mean weight gain of 0.43 kg at 10-weeks of treatment. FF Haloperidol (Haldol) – Meta-analysis estimated mean weight gain of 0.48 kg at 10-weeks of treatment. medicaidmentalhealth.org Page 18
Weight Change and Metabolic Side-Effects of Psychotherapeutic Medications Table 7. Studies Examining Weight Change Associated with Psychotherapeutic Medications used in the Treatment of Serious Mental Illness (continued) Antipsychotics Weight gain FF Aripiprazole (Abilify) – 3-month cohort study of first-time use of atypical antipsychotics in children and adolescents reported mean weight gain of 4.4 kg. 6-month RCT reported mean weight gain of 0.40 kg with aripiprazole. A meta-analysis of metabolic effects associated with atypical antipsychotic treatment in children and adolescents found olanzapine, risperidone and aripiprazole were all associated with statistically significant weight gain. Olanzapine was associated with the most weight gain and aripiprazole was the least. FF Asenapine (Saphris) – A double-blind placebo-controlled study found mean weight gain of 0.9 kg compared to placebo. FF Brexpiprazole (Rexulti) – Weight gain with brexpiprazole was moderate (1.45 and 1.28 kg for 2 and 4 mg, respectively, versus 0.42 kg for placebo at week 6). FF Cariprazine (Vraylar) – Mean weight gain at endpoint of 6-week in patients with schizophrenia: 0.8 kg with 1.5-3 mg/day, 1kg with ≥4.5 mg/day versus 0.3 kg with placebo. FF Clozapine (Clozaril) – 6-week open-label study reported average weight gain of 2.5 kg. FF Iloperidone (Fanapt) – Mean change from baseline of 2.1 kg increase at endpoint. FF Lurasidone (Latuda) – The mean weight gain observed across 6-week trial in Atypical patients with schizophrenia was 0.43 kg for lurasidone versus mean weight loss Antipsychotics of 0.02 kg for placebo. FF Olanzapine (Zyprexa) – Meta-analysis of 257 RCTs found average of 2.4 kg weight gain. A 3-month cohort study of first-time use of atypical antipsychotics in children and adolescents reported mean weight gain of 8.5 kg. CATIE trial found an average weight gain of 2 lbs (0.9 kg) per month, more than any other treatment group (quetiapine, risperidone, ziprasidone, or perphenazine). A meta- analysis of metabolic effects associated with atypical antipsychotic treatment in children and adolescents found olanzapine, risperidone and aripiprazole were all associated with statistically significant weight gain. Olanzapine was associated with the most weight gain and aripiprazole was the least. FF Paliperidone (Invega) – 6-month RCT reported mean weight gain of 2.3 kg for paliperidone ER. FF Quetiapine (Seroquel) – Meta-analysis of 257 RCTs found average of 1.1 kg weight gain. FF Risperidone (Risperdal) – Meta-analysis of 257 RCTs found average of 0.8 kg weight gain. A meta-analysis of metabolic effects associated with atypical antipsychotic treatment in children and adolescents found olanzapine, risperidone and aripiprazole were all associated with statistically significant weight gain. Olanzapine was associated with the most weight gain and aripiprazole was the least. FF Ziprasidone (Geodon) – Meta-analysis found mean weight gain of 0.04 kg. Note: 1 kilogram = 2.2 pounds. Medications under each category (weight loss, no weight change, weight gain) are listed alphabetically. medicaidmentalhealth.org Page 19
Prediabetes and Metabolic Syndrome Note: Strongly recommend coordination of care between primary care, psychiatry, specialists, and other providers to facilitate optimal outcomes. Prediabetes Prediabetes identifies individuals who are at increased risk for type 2 diabetes and cardiovascular disease but do not yet meet the criteria for type 2 diabetes. The American Diabetes Association (ADA) defines prediabetes as individuals who: nnHave an impaired fasting glucose of 100 – 125 mg/dL (which is lower than the World Health Organization’s criteria of 110-125 mg/dL), and/or nnHave an impaired glucose tolerance defined by a 2-hour plasma glucose of between 100- 199 mg/dL after a 75g oral glucose load, and/or nnHave a hemoglobin A1c between 5.7% and 6.4% Note: Refer for further care and/or initiate treatment as clinically indicated if impaired fasting glucose, impaired glucose tolerance, or elevated HgA1c (>5.7%). Metabolic Syndrome According to the American Heart Association and the National Heart, Lung, and Blood Institute, there are five factors that make up metabolic syndrome: nnLarge waist size (40 inches or larger for men, 35 inches or larger for women) nnHigh triglycerides (either 150 mg/dL or higher or using a cholesterol medication) nnLow levels of high-density lipoprotein or HDL (HDL less than 40 mg/dL for men, less than 50 mg/dL for women, or any patient using a cholesterol medication) nnHigh blood pressure (blood pressure of 135/85 mmHg or greater or using a blood pressure medication) nnHigh fasting glucose level (100 mg/dL or higher) The following tables review antipsychotic medication effects on development of metabolic syndrome, review cutoff waist circumference values in different ethnic populations, and provide recommended guidelines for management of these risk factors when they are present. medicaidmentalhealth.org Page 20
Prediabetes and Metabolic Syndrome Table 8. Antipsychotic Medications and Metabolic Syndrome Risk Medication Low Mild Moderate High Typical Antipsychotics Chlorpromazine (Thorazine) — — — 4 Haloperidol (Haldol) 4 — — — Perphenazine (Trilafon) 4 — — — Atypical Antipsychotics Aripiprazole (Abilify) 4 — — — Asenapine (Saphris)* 4 — — — Brexpiprazole (Rexulti) — 4 — — Cariprazine (Vraylar) — 4 — — Clozapine (Clozaril) — — — 4 Iloperidone (Fanapt)* — 4 — — Lurasidone (Latuda)* 4 — — — Olanzapine (Zyprexa) — — — 4 Quetiapine (Seroquel) — — 4 — Risperidone (Risperdal) — 4 — — Ziprasidone (Geodon) 4 — — — Adapted from Hert, et al., 2011a. Note. mg/dL =milligrams per deciliter; mmHg =millimeters of mercury; mg/dL = milligrams per deciliter. *Limited data with these medications. Some of the second-generation antipsychotics above have not been extensively studied with regard to metabolic syndrome. Ethnicity-Specific Cutoff Values of Waist Circumference Indicating Abdominal Obesity Annual monitoring is recommended in a primary care setting. Table 9. Waist Circumference and Race/Ethnicity Females Males North Americans ≥88 cm (≥ 35 in) ≥102 cm (≥ 40 in) European, Mediterranean, Middle ≥80 cm (≥ 32 in) ≥94 cm (≥ 37 in) Eastern, Sub-Saharan Africans South Asians, Chinese, Ethnic ≥80 cm (≥ 32 in) ≥90 cm (≥ 35 in) South and Central Americans Japanese ≥82-85 cm (≥ 32-34 in) ≥90 cm (≥ 35 in) Adapted from Hert, et al., 2011a. Note. cm = centimeter; in = inch. medicaidmentalhealth.org Page 21
Metabolic and Cardiovascular Health Issues Type 2 Diabetes Mellitus and Hypertension: Diagnostic Criteria Any of the following: nnFasting plasma glucose ≥126 mg/dL *Note: Fasting is defined as no caloric intake for ≥8 hours. In absence of unequivocal hyperglycemia, result to be confirmed by repeat testing. nn2-hour plasma glucose ≥200 mg/dL during oral glucose tolerance test with glucose load containing equivalent of 75 g anhydrous glucose dissolved in water *Note: In absence of unequivocal hyperglycemia, result to be confirmed by repeat testing. nnHemoglobin A1c ≥6.5% nnRandom plasma glucose ≥200 mg/dL in individuals with symptomatic hyperglycemia or hyperglycemic crisis Diagnostic Criteria for Hypertension nnNormal blood pressure:
Metabolic and Cardiovascular Health Issues ADA Target Goals and ASCVD Risk Calculator Note: Strongly recommend coordination of care between primary care, psychiatry, specialists, and other providers to facilitate optimal outcomes. The following recommendations were adapted from the American Diabetes Association (ADA). Box 2. ADA Target Goals for Blood Pressure, Lipid, and Glycemic Control FF Blood pressure: Systolic 10%. Link to ASCVD Risk Calculator: http://tools.acc.org/ASCVD-Risk-Estimator-Plus/#!/calculate/estimate/ medicaidmentalhealth.org Page 23
Q-T Prolongation Associated with Psychotherapeutic Medications Q-T Interval Prolongation The Q-T interval represents electrical depolarization and repolarization of the ventricles, and the Q-Tc is this value corrected for the patient’s heart rate. In clinical trials, a prolonged Q-Tc interval of greater than 500 milliseconds during therapy has been a threshold for concern. Clinically, a Q-Tc interval above 470 milliseconds in females and above 450 milliseconds in males is considered prolonged, and individual changes in Q-Tc intervals of 30 to 60 milliseconds from baseline should heighten suspicion of increased risk of arrhythmias. Though data are limited, a prolonged Q-Tc interval appears to be more common with tricyclic antidepressants than selective-serotonin reuptake inhibitors (SSRIs). Antipsychotic medications have also been reported to be associated with Q-Tc interval prolongation, particularly with ziprasidone and thioridazine, and to a lesser extent with haloperidol and quetiapine. EKG monitoring is recommended when administering antipsychotic medications in the presence of co-existing risk factors for QT interval prolongation such as older age, electrolyte disturbances (e.g., hypokalemia, hypomagnesemia), family history of sudden death, personal history of cardiac murmur, and/or use of concomitant medications known to prolong the QT interval. See table below for risk factors to evaluate for during initial assessment when considering use of antipsychotics or other medications with QT prolongation. Note: Strongly recommend coordination of care between primary care, psychiatry, specialists, and other providers to facilitate optimal outcomes. Box 3. Risk factors associated with QT prolongation to evaluate for* FF Older age (>65years) FF Electrolyte disturbances (e.g., hypokalemia, hypomagnesemia) FF Congenital long QT syndrome FF Family history of sudden death FF Personal history of heart murmur, shortness of breath with exertion, episodes of tachycardia at rest, irregular heartbeats FF Personal history of syncope FF Known cardiac disease (myocardial ischemia, congestive heart failure, cardiac arrhythmias, bradycardia) FF Concomitant Use of other medications known to prolong QT interval FF Concomitant medications known to inhibit metabolism of antipsychotic medications (i.e., cause increased serum concentrations of antipsychotic medications) FF History of liver disease FF Endocrine and metabolic disorders FF Central nervous system injury (e.g., stroke, infection, trauma) *Adapted from Shah AA, et al (2014). medicaidmentalhealth.org Page 24
Hyperprolactinemia Associated with Psychotherapeutic Medications Hyperprolactinemia Associated with Psychotherapeutic Medications Note: Strongly recommend coordination of care between primary care, psychiatry, specialists, and other providers to facilitate optimal outcomes. Antipsychotics such as risperidone are associated with hyperprolactinemia. Hyperprolactinemia may be asymptomatic or may be associated with a wide range of clinical effects, including decreased sexual and reproductive function (e.g., oligomenorrhea, amenorrhea), weight gain, decreased bone density, gynecomastia, and galactorrhea. If symptomatic, other medical causes of hyperprolactinemia (e.g., pituitary adenoma) should be ruled out. Patients taking antipsychotic medications should be assessed and monitored for signs and symptoms of hyperprolactinemia, with appropriate referrals when clinically indicated. Prolactin levels should particularly be monitored in male patients prescribed antipsychotic medications due to the concern for gynecomastia, which is potentially irreversible. Management of symptomatic medication-induced hyperprolactinemia includes referral to a specialist, reduction in the medication dose, discontinuation of the offending agent, or switch to a prolactin-sparing agent such as aripiprazole. medicaidmentalhealth.org Page 25
Infectious Disease: Risk Factors and Screening Recommendations Individuals with serious mental illness are often at increased risk for acquiring infectious diseases such as Hepatitis B, Hepatitis C, HIV, and tuberculosis due to a greater likelihood of engaging in high- risk behaviors such as using illicit substances and having multiple sexual partners. When planning to screen patients for infectious diseases, patients should be informed orally and in writing that testing will be performed. Unless they decline, they should receive explanation of the infection, how it can and cannot be acquired, the meaning of positive and negative test results, and the benefits and risks associated with treatment. They should also be offered the opportunity to ask questions and decline testing. This section reviews risk factors and screening recommendations for Hepatitis C (HCV), Hepatitis B (HBV), human immunodeficiency virus (HIV), and tuberculosis (TB). Note: Strongly recommend coordination of care between primary care, psychiatry, specialists, and other providers to facilitate optimal outcomes. Table 10. Risk Factors and Screening Recommendations for Selected Infectious Diseases Disease Risk Factors Screening/Treatment Recommendations FF Past/present drug use FF 1-time screening in all adults born FF Sex with injection drug user between 1945 and 1965 FF Blood transfusion before 1992 FF High-risk patients Hepatitis C (HCV) FF FDA approved treatment FF Other: Long-term dialysis, incarceration, intranasal drug use, getting an unregulated tattoo, infant of HCV positive mother FF Sexual contact with infected person FF Hepatitis B surface antigen FF Exposure to infectious bodily fluids (HBsAg) Hepatitis B (HBV) FF Prolonged, close personal contact with FF Either Hepatitis B core antibody infected person (anti-HBc) or hepatitis B surface antibody (anti-HBs) FF Perinatal exposure to infected Mother medicaidmentalhealth.org Page 26
Infectious Disease: Risk Factors and Screen Recommendations Table 10. Risk Factors and Screening Recommendations for Selected Infectious Diseases (continued) Screening/Treatment Disease Risk Factors Recommendations FF Injection drug use/sharing needles FF All persons who seek evaluation FF Sexual contact- anal, vaginal or oral and treatment for sexually sex; men who have sex with men; transmitted infections (STIs) multiple partners; anonymous partners should be tested; consider rapid without using condom; sexual contact HIV test in this population as high with infected person; exchange sex for proportion of patients may not drugs/money; unprotected sex with return for HIV test results. at-risk individuals. FF Individuals suspected of recently Human acquired HIV infection- refer for FF History of STI (syphilis, genital herpes, Immunodeficiency immediate consultation with chlamydia, gonorrhea, bacterial Virus (HIV), infectious disease specialist for vaginosis, trichomoniasis) evaluation (history, physical FF Diagnosed with hepatitis, TB, or including gynecology exam in malaria women, chest radiography, and FF Blood transfusion or clotting factor lab tests - CBC, CMP, lipid profile, recipient in US between 1978 and 1985 urinalysis toxoplasma antibodies, testing for STIs and hepatitis, HIV genotype, CD4 count and viral load, and TB test). FF Individuals in contact with patient who FF TB testing generally is not has TB recommended in patients with FF Individuals from a country where TB is low risk of TB infection. common FF High risk patients should have FF Patients with HIV infection or problems medical evaluation- history/ that weaken the immune system physical, TB test, chest radiograph Tuberculosis (TB) at minimum and other laboratory FF Symptomatic patients (e.g., fever, tests as appropriate. productive cough, weight loss, night sweats, fatigue, and loss of appetite) FF Live/work in area where TB is common (e.g., homeless shelter, and/or prison/jail) FF Illicit drug users Adults aged 19 years or older should also receive immunizations recommended by the Centers for Disease Control (CDC), : nnInfluenza – 1 dose annually nnTetanus, diphtheria, pertussis (Td/Tdap) - Substitute Tdap for Td once, then Td booster every 10 years nnVaricella – 2 doses nnHuman papillomavirus (HPV) – 3 doses between 19 and 26 years old nnHerpes zoster – 2 doses of recombinant vaccine at 50 years old or older nnMeasles, mumps, rubella (MMR) – 1 or 2 doses depending on indication Notes. Other immunizations may be recommended for persons with a risk factor (medical, occupational, lifestyle, or other indication). See CDC website http://www.cdc.gov/vaccines/schedules/downloads/adult/adult-combined-schedule-bw.pdf and https://www.cdc.gov/vaccines/vpd/shingles/hcp/shingrix/recommendations.html. Page 27
Substance Use Disorders One in five individuals with a serious mental illness has a co-occurring substance use disorder. Similar to persons with SMI, individuals with substance use disorders are at risk for physical health problems such as cardiovascular disease, lung disease, hepatitis, HIV/AIDS, and cancer. The management of chronic disease is often complicated and more challenging in individuals with co-occurring disorders. For example, individuals who have depression, a substance use disorder, and medical comorbities are less likely to adhere to their treatment plan and medications for type 2 diabetes. Improvement of the health and functioning of these individuals requires the integration of care across primary care, mental health care, and substance use services. Many of the FDA-approved medications to help patients reduce alcohol or drug use, avoid relapse, and support abstinence (e.g., buprenorphine, naltrexone, and acamprosate) can be used in primary care settings which increases patient choice in being treated in the setting they are most comfortable. Conduct a comprehensive assessment. Refer to Principles of Practice. Note: Strongly recommend coordination of care between primary care, psychiatry, specialists, and other providers to facilitate optimal outcomes. Check E-FORCSE (the Electronic-Florida Online Reporting of Controlled Substance Evaluation Program, Florida’s state prescription monitoring program), ideally prior to prescribing any medications, but at a minimum when prescribing any controlled substance. Checking E-FORCSE is also recommended for all new patients, with follow-up E-FORCSE monitoring at least once per year for each patient. Screening, Brief Intervention, and Referral to Treatment (SBIRT) SBIRT is a model to assess and deliver early intervention and treatment to individuals with substance use disorders and those that are at risk of developing substance use disorders. nnScreening quickly assesses the severity of substance use and identifies the appropriate level of treatment nnBrief intervention focuses on increasing insight and awareness of substance use and motivation towards behavioral change nnReferral provides those needing treatment access to specialty care services Recommend screening for substance use disorders using validated questionnaires (see table in Principles of Practice) prior to patient visits. Obtain history of prescription, over-the-counter, and herbal medication use. Pre-Screening for Substance Use Disorders NIAAA/NIDA Pre-Screening Questions: nn“How many times in the past year have you had 4 or more drinks in a day?” (NIAAA) nn“How many times in the past year have you used an illegal drug or used a prescription medication for non-medical reasons?” (NIDA) Alcohol Use Disorders Identification Test (AUDIT): The Alcohol Use Disorders Identification Test (AUDIT) is a 10-item screening tool developed by the World Health Organization (WHO) to assess alcohol consumption, drinking behaviors, and alcohol-related problems. The AUDIT is available at: https://www.drugabuse.gov/sites/default/files/files/AUDIT.pdf. medicaidmentalhealth.org Page 28
Substance Use Substance Disorders: Use Screening Disorders and Identification Box 4. Behaviors that Increase Suspicion for Drug Misuse or Dependency FF Taking a controlled substance for a long time period FF Refusing to grant permission to obtain old records or communicate with previous providers FF Reluctance to undergo a comprehensive history, physical examination, or diagnostic testing (especially urine drug screens) FF Requesting a specific drug FF Professing multiple allergies to recommended medications FF Resisting other treatment options Other aberrant behaviors: FF Issuing threats or displaying anger FF Targeting appointments at the end of the day or during off hours (nights or weekends) FF Excessive flattery FF Calling and visiting a physician’s associates FF Repeatedly losing a prescription FF Requesting dose escalation FF Demonstrating noncompliance with prescription instructions FF Demonstrating other evidence of alcohol or illicit drug misuse *Adapted from Standridge JB, et al (2010). Urine Drug Screening: A valuable office procedure. For a list of screening tools for substance use disorders, refer to Principles of Practice. Laboratory Drug Screening and Confirmatory Testing Laboratory drug testing typically involves a two-step process: the initial drug screen for potentially positive specimens, followed by confirmatory testing of screened positive assays. Screening tests Screening tests can be done in the laboratory or onsite and usually use an immunoassay of urine or saliva. Screening tests indicate the presence or absence of a substance or its metabolite, but can also indicate the presence of a cross-reacting, chemically similar substance. Screening tests are either positive or negative and generally do not measure the specific levels of drugs, alcohol, or metabolites present. medicaidmentalhealth.org Page 29
You can also read