Psychotropic Medication Utilization Parametersfor Children And Youth In .

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Psychotropic Medication Utilization Parametersfor Children and Youth in Foster Care(5th Version)Developed by:Texas Department of Family and Protective ServicesandThe University of Texas at Austin College of Pharmacywith review and input provided by: Federation of Texas Psychiatry Texas Pediatric Society Texas Academy of Family Physicians Texas Medical AssociationandRutgers University-Center for Education and Researchon Mental Health TherapeuticsMarch 2016(Tables Updated July 2016)

Psychotropic Medication Utilization Parameters2Table of Contents Introduction and General Principles. 3-6 Criteria Indicating Need for Further Review of a Child's Clinical Status 7 Psychotropic Medication Tables. 8-17 Glossary.18 References. 19-22 Web Link References. 23 Members of the Ad Hoc Working Group.24 Acknowledgements and Web Address for the Parameters Document. 25March 2016(Tables Updated July 2016)

Psychotropic Medication Utilization Parameters3Psychotropic Medication Utilization Parametersfor Children and Youth in Foster CareIntroduction and General PrinciplesThe use of psychotropic medications by children and youth is anissue confronting parents, othercaregivers, and health care professionalsacross the United States. Children andyouth in foster care, in particular, havemultiple needs, including those related toemotional or psychological stress. They typically have experienced abusive, neglectful,serial or chaotic caretaking environments.Birth family history is often not available.These children often present with a fluidityof different symptoms over time reflectiveof past traumatic events that may mimicmany psychiatric disorders and result indifficulties with attachment, mood regulation, behavioral control, and other areas offunctioning.Because of the complex issues involved inthe lives of foster children, it is importantthat a comprehensive evaluation be performed before beginning treatment for amental or behavioral disorder. Except inthe case of an emergency, a child shouldreceive a thorough health history, psychosocial assessment, mental status exam,and physical exam before prescribing apsychotropic medication. The physicalassessment should be performed by a physician or another healthcare professionalqualified to perform such an assessment.It is recognized that in some emergencysituations, it may be in the best interest ofthe child to prescribe psychotropic medications before a physical exam can actually beperformed. In these situations, a thoroughhealth history should be performed to assessfor significant medical disorders and pastresponse to medications, and a physicalevaluation should be performed as soon aspossible. A thorough psychosocial assessment should be performed by an appropriately qualified mental health clinician(masters or doctoral level), a psychiatrist/child psychiatrist, or a primary care physician with experience in providing mentalhealth care to children and youth. Thechild’s symptoms and functioning should beassessed across multiple domains, and theassessment should be developmentally ageappropriate. It is very important that information about the child’s history, includinghistory of trauma and current functioningbe made available to the treating physicianin a timely manner, either through an adultwho is well-informed about the child orthrough a comprehensive medical record.It is critical to meet the individual needsof patients and their families in a culturally competent manner. This indicates aneed to address communication issues aswell as differences in perspective on issuessuch as behavior and mental functioning.Interpretation of clinical symptoms anddecisions concerning treatment should,whenever possible, be informed by thechild’s developmental history of trauma,neglect or abuse and the timing of thesestressors. In general, optimal outcomes areachieved with well-coordinated team basedcare with members of different professions(e.g., child psychiatrist, child psychologist, social worker, primary care physician,etc.) each contributing their particularexpertise to the treatment plan and followup. Additionally, at present there are nobiomarkers to assist with the diagnosis ofmental disorders, and imaging (e.g., MRI)and other tests (e.g., EEG) are not generallyhelpful in making a clinical diagnosis of amental disorder.The role of non-pharmacological interventions should be considered beforebeginning a psychotropic medication,except in urgent situations such as suicidal ideation, psychosis, self-injuriousMarch 2016(Tables Updated July 2016)behavior, physical aggression that isacutely dangerous to others, or severeimpulsivity endangering the child or others; when there is marked disturbance ofpsychophysiological functioning (such asprofound sleep disturbance), or when thechild shows marked anxiety, isolation, orwithdrawal. Given the history of trauma,unusual stress and change in environmental circumstances associated with being achild in foster care, psychotherapy shouldgenerally begin before or concurrent withprescription of a psychotropic medication.Referral for trauma-informed, evidencebased psychotherapy should be consideredwhen available and appropriate. Equallyimportant, the role of the health care provider and the health care environment’spotential to exacerbate a child’s symptoms,given their respective trauma history, shouldbe considered and minimized. Patient andcaregiver education should be providedabout the condition to be treated, treatmentoptions (non- pharmacological and pharmacological), treatment expectations, andpotential side effects that may occur duringthe prescription of psychotropic medications.It is recognized that many psychotropicmedications do not have Food and DrugAdministration (FDA) approved labeling for use in children. The FDA has astatutory mandate to determine whetherpharmaceutical company sponsored researchindicates that a medication is safe and effective for those indications that are listed inthe approved product labeling. The FDAassures that information in the approvedproduct labeling is accurate, and limits themanufacturer’s marketing to the information contained in the approved labeling.The FDA does not regulate physician andother health provider practice. In fact,

Psychotropic Medication Utilization Parametersthe FDA has stated that it does “not limitthe manner in which a practitioner mayprescribe an approved drug.” Studies andexpert clinical experience often supportthe use of a medication for an “off-label”use. Physicians should utilize the availableevidence, expert opinion, their own clinicalexperience, and exercise their clinical judgment in prescribing what is best for eachindividual patient. To that end, clear documentation of the physician’s rationale in themedical record facilitates continuity of careand minimizes misinterpretation.Role of Primary CareProvidersPrimary care providers play a valuable rolein the care of youth with mental disorders.Not only are they the clinicians most likelyto initially interact with children who are indistress due to an emotional or psychiatricdisorder, but also an inadequate numberof child psychiatrists are available to meetall children’s mental health needs. Primarycare clinicians are in an excellent position toperform screenings of children for potentialmental disorders, and they should be able todiagnose and treat relatively straightforwardsituations such as uncomplicated ADHD,anxiety, or depression. Primary care providers should provide advice to youth in fostercare and their care givers about handlingfeelings and behaviors, recognizing the needfor help, making decisions regarding healthylife styles, and the available treatments forchildhood mental disorders. As always,consideration should be given regardingthe need for referral for counseling, psychotherapy, or behavioral therapy. Primarycare providers vary in their training, clinicalexperience, and confidence to address mental disorders in children. Short courses andintensive skills oriented seminars may bebeneficial in assisting primary care cliniciansin caring for children with mental disorders. Active liaisons with child psychiatristswho are available for phone consultationor referral can be beneficial in assistingprimary care clinicians to meet the mentalhealth needs of children. “The management of common presentations of ADHD,depression and anxiety, psychotherapyreferral, psychopharmcology and appro-4priate child psychiatry referral are withinthe scope of general pediatric practice”(Southammakosane 2015). In addition, theAmerican Academy of Pediatrics has recently provided a policy statement (“HealthCare Issues for Children and Adolescents inFoster Care and Kinship Care”) which canbe found 36/4/e1131 General principles regardingthe use of psychotropic medications in children include:Whenever possible, trauma-informed,evidence-based psychotherapy, shouldbegin before or concurrent with theprescription of psychotropic medication. Before starting psychopharmacologicaltreatment in preschool-aged childreneven more emphasis should be placedon treatment with non-psychopharmacological interventions. Assessment ofparent functioning and mental healthneeds, in addition to training parentsin evidence-based behavior management can also reduce the need for theuse of medication. Medication management should becollaborative. Youth, as well as caregivers, should be involved in decisionmaking about treatment, in accordancewith their developmental level. Parentsproviding informed consent should beengaged, and where applicable, othercaregivers, family, and child relatedagencies should be involved. During the prescription of psychotropic medication, the presence or absenceof medication side effects should bedocumented in the child’s medicalrecord at each visit. Appropriate monitoring of indices suchas height, weight, blood pressure, orlaboratory findings should be documented. Monotherapy regimens for a givendisorder or specific target symptomsshould usually be tried before polypharmacy regimens. While the goal isto use as few psychotropic medicationsas can be used to appropriately addressthe child’s clinical status, it is recognized that the presence of psychiatriccomorbidities may affect the number of A DSM-5 psychiatric diagnosis shouldbe made before the prescribing of psychotropic medications. Clearly defined target symptoms andtreatment goals for the use of psychotropic medications should be identifiedand documented in the medical recordat the time of or before beginningtreatment with a psychotropic medication. These target symptoms and treatment goals should be assessed at eachclinic visit with the child and caregiverin a culturally and linguistically appropriate manner. Whenever possible,standardized clinical rating scales (clinician, patient, primary caregiver, teachers, and other care providers) or othermeasures should be used to quantifythe response of the child’s target symptoms to treatment and the progressmade toward treatment goals. In making a decision regarding whetherto prescribe a psychotropic medicationin a specific child, the clinician shouldcarefully consider potential side effects,including those that are uncommonbut potentially severe, and evaluate theoverall benefit to risk ratio of pharmacotherapy.Except in the case of an emergency,informed consent should be obtainedfrom the appropriate party(s) beforebeginning psychotropic medication.Informed consent to treatment withpsychotropic medication entails diagnosis, expected benefits and risks ofMarch 2016(Tables Updated July 2016)treatment, including common sideeffects, discussion of laboratory findings, and uncommon but potentiallysevere adverse events. Alternative treatments, the risks associated with notreatment, and the overall potentialbenefit to risk ratio of treatment shouldbe discussed.

Psychotropic Medication Utilization Parameterspsychotropic medications that are prescribed. When polypharmacy regimensare needed, addition of medicationsshould occur in a systematic orderlyprocess, accompanied by on-goingmonitoring, evaluation, and documentation. The goal remains to minimizepolypharmacy while maximizing therapeutic outcomes. Medications should be initiated at thelower end of the recommended doserange and titrated carefully as needed. Only one medication should bechanged at a time, unless a clinicallyappropriate reason to do otherwise isdocumented in the medical record.(Note: starting a new medication andbeginning the dose taper of a currentmedication is considered one medication change). The use of “prn” or as needed prescriptions is discouraged. If they are used,the situation indicating need for theadministration of a prn medicationshould be clearly indicated as well asthe maximum dosage in a 24 hourperiod and in a week. The frequencyof administration should be monitoredto assure that these do not becomeregularly scheduled medications unlessclinically indicated. The frequency of clinician follow-upshould be appropriate for the severityof the child’s condition and adequateto monitor response to treatment,including: symptoms, behavior, function, and potential medication sideeffects. At a minimum, a child receiving psychotropic medication should beseen by the clinician at least once everyninety days.The potential for emergent suicidality should be carefully evaluated andmonitored, particularly in depressedchildren and adolescents as well asthose initiating antidepressants, thosehaving a history of suicidal behavioror deliberate self-harm and those witha history of anxiety or substance abusedisorders. If the prescribing clinician is not achild psychiatrist, referral to or consultation with a child psychiatrist, ora general psychiatrist with significantexperience in treating children, shouldoccur if the child’s clinical status hasnot shown meaningful improvementwithin a timeframe that is appropriatefor the child’s diagnosis and the medication regimen being used. Before adding additional psychotropicmedications to a regimen, the childshould be assessed for adequate medication adherence, appropriateness ofmedication daily dosage, accuracy ofthe diagnosis, the occurrence of comorbid disorders (including substanceabuse and general medical disorders),and the influence of psychosocialstressors. If a medication has not resulted inimprovement in a child’s target symptoms (or rating scale score), discontinuethat medication rather than adding asecond medication to it. If a medication is being used in achild for a primary target symptom ofaggression associated with a DSM-5non-psychotic diagnosis (e.g., conductdisorder, oppositional defiant disorder,intermittent explosive disorder), andthe behavior disturbance has been inremission for six months, then serious consideration should be given toslow tapering and discontinuation ofthe medication. If the medication iscontinued in this situation, the necessity for continued treatment shouldbe evaluated and documented in themedical record at a minimum of everysix months. The clinician should clearly documentcare provided in the child’s medical record, including history, mentalstatus assessment, physical findings(when relevant), impressions, rationalefor medications prescribed, adequatelaboratory monitoring specific to thedrug(s) prescribed at intervals requiredspecific to the prescribed drug andpotential known risks, medicationMarch 2016(Tables Updated July 2016)5response, presence or absence of sideeffects, treatment plan, and intendeduse of prescribed medications.Use of Psychotropic Medication in Preschool Age ChildrenThe use of psychotropic medication inyoung children of preschool ages is a practice that is limited by the lack of evidenceavailable for use of these agents in this agegroup. The Preschool PsychopharmacologyWorking Group (PPWG) published guidelines (Gleason 2007) summarizing availableevidence for use of psychotropic medications in this age group. The PPWG wasestablished in response to the clinical needsof preschoolers being treated with psychopharmacological agents and the absence ofsystematic practice guidelines for this agegroup, with its central purpose to attemptto promote an evidence-based, informed,and clinically sound approach when considering medications in preschool-agedchildren.The PPWG guidelines emphasize consideration of multiple different factors whendeciding on whether to prescribe psychotropic medications to preschool-aged children.Such factors include the assessment anddiagnostic methods utilized in evaluatingthe child for psychiatric symptoms/illness,the current state of knowledge regarding theimpact of psychotropic medication use onchildhood neurodevelopmental processes,the regulatory and ethical contexts of use ofpsychotropic medications in small children(including available safety information andFDA status), and the existing evidence basefor use of psychotropic medication in preschool aged children.The publication includes specific guidelinesand algorithm schematics developed by thePPWG to help guide treatment decisionsfor a number of psychiatric disorders thatmay present in preschool-aged children,including Attention-Deficit HyperactivityDisorder, Disruptive Behavioral Disorders,Major Depressive Disorder, BipolarDisorder, Anxiety Disorders, Post-TraumaticStress Disorder, Obsessive-CompulsiveDisorder, Pervasive Developmental

Psychotropic Medication Utilization ParametersDisorders, and Primary Sleep Disorders.The working group’s key points andguidelines are similar to the general principles regarding the use of psychotropicmedication in children already detailed inthis paper. However, the working group’salgorithms put more emphasis on treatingpreschool-aged children with non-psychopharmacological interventions (for up to12 weeks) before starting psychopharmacological treatment, in an effort to be verycautious in introducing psychopharmacological interventions to rapidly developingpreschoolers.The working group also emphasizes theneed to assess parent functioning and mental health needs, in addition to trainingparents in evidence-based behavior management, since parent behavior and functioning can have a large impact on behavior andsymptoms in preschool-aged children.Distinguishing between Levelsof Warnings Associated withMedication Adverse EffectsPsychotropic medications have the potentialfor adverse effects, some that are treatmentlimiting. Some adverse effects are detectedprior to marketing, and are included in theFDA approved product labeling providedby the manufacturers. When looking atproduct labeling, these adverse effects willbe listed in the “Warnings and Precautions”section. As well, the “Adverse Reactions”section of the product labeling will outlinethose adverse effects reported during clinical trials, as well as those discovered duringpost-marketing evaluation. Many tertiarydrug information resources also list common adverse effects and precautions for usewith psychotropic medications.At times, post-marketing evaluation maydetect critical adverse effects associated withsignificant morbidity and mortality. TheFood and Drug Administration (FDA) mayrequire manufacturers to revise productlabeling to indicate these critical adverseeffects. If found to be particularly signifi-6cant, these effects are demarcated by a boxoutlining the information at the very beginning of the product labeling, and have, inturn, been named boxed warnings. Boxedwarnings are the strongest warning requiredby the FDA. It is important for cliniciansto be familiar with all medication adverseeffects, including boxed warnings, in orderto appropriately monitor patients andminimize the risk of their occurrence. Themedication tables include boxed warningsas well as other potential adverse effects.The list of potential adverse effects in thetables should not be considered exhaustive, and the clinician should consult theFDA approved product labeling and otherreliable sources for information regardingmedication adverse effects.Usual Recommended Doses ofCommon Psychotropic MedicationsThe FDA has in recent years taken additional measures to try to help patients avoidserious adverse events. New guides calledMedication Guides have been developed,and are specific to particular medicationand medication classes. Medication Guidesadvise patients and caregivers regardingpossible adverse effects associated withclasses of medications, and include precautions that they or healthcare providersmay take while taking/prescribing certainclasses of medications. The FDA requiresthat Medication Guides be issued with certain prescribed medications and biologicalproducts when the Agency determines thatcertain information is necessary to preventserious adverse effects, that patient decisionmaking should be informed by information about a known serious side effectwith a product, or when patient adherenceto directions for the use of a product areessential to its effectiveness. During thedrug distribution process, if a MedicationGuide has been developed for a certain classof medications, then one must be providedwith every new prescription and refill ofthat medication.The tables are intended to serve as aresource for clinicians. The tables are notintended to serve as comprehensive druginformation references or a substitute forsound clinical judgment in the care of individual patients. Circumstances may dictatethe need for the use of higher doses in specific patients. In these cases, careful documentation of the rationale for the higherdose should occur, and careful monitoringand documentation of response to treatment should be performed. If the use ofhigher medication doses does not result inimprovement in the patient’s clinical statuswithin a reasonable time period (e.g., 2-4weeks), then the dosage should be decreasedand other treatment options considered.Copies of the Medication Guides for psychotropic medications can be accessed onthe FDA website tmMarch 2016(Tables Updated July 2016)The attached medication charts areintended to reflect usual doses and briefmedication information for commonlyused psychotropic medications. The tablescontain two columns for maximum recommended doses in children and adolescents– the maximum recommended in theFDA approved product labeling, and themaximum recommended in medical andpharmacological literature sources. The preferred drug list of medications potentiallyprescribed for foster children is the same asfor all other Texas Medicaid recipients.Not all medications prescribed by cliniciansfor psychiatric diagnoses in children andadolescents are included in the followingtables. However, in general, medicationsnot listed do not have adequate efficacy andsafety information available to support ausual maximum dose recommendation.See Psychotropic Medication Tablesbeginning on page 8.

Psychotropic Medication Utilization ParametersT7Criteria Indicating Need for Further Reviewof a Child’s Clinical Statushe following situations indicate a need for review of a patient’s clinical care. These parameters do not necessarily indicate that treatment is inappropriate, but they do indicate a need for further review.For a child being prescribed a psychotropic medication, any of the following suggests the need for additional review of a patient’sclinical status:1. Absence of a thorough assessment for the DSM-5 diagnosis(es) in the child’s medical record2. Four (4) or more psychotropic medications prescribed concomitantly (side effect medications are not included in this count)3. Prescribing of: Two (2) or more concomitant stimulants * Two (2) or more concomitant alpha agonists * Two (2) or more concomitant antidepressants Two (2) or more concomitant antipsychotics Three (3) or more concomitant mood stabilizers* The prescription of a long-acting and an immediate-release stimulant or alpha agonist of the same chemical entity does notconstitute concomitant prescribing.Note: When switching psychotropics, medication overlaps and cross taper should occur in a timely fashion, generally within 4weeks.4. The prescribed psychotropic medication is not consistent with appropriate care for the patient’s diagnosed mental disorder orwith documented target symptoms usually associated with a therapeutic response to the medication prescribed.5. Psychotropic polypharmacy (2 or more medications) for a given mental disorder is prescribed before utilizing psychotropic monotherapy6. The psychotropic medication dose exceeds usual recommended doses (literature based maximum dosages in these tables).7. Psychotropic medications are prescribed for children of very young age, including children receiving the following medications with anage of: Stimulants:Less than three (3) years of age Alpha Agonists Less than four (4) years of age Antidepressants: Less than four (4) years of age Mood Stabilizers: Less than four (4) years of age Antipsychotics: Less than five (5) years of age8. Prescribing by a primary care provider who has not documented previous specialty training for a diagnosis other than the following (unless recommended by a psychiatrist consultant): Attention Deficit Hyperactive Disorder (ADHD) Uncomplicated anxiety disorders Uncomplicated depression9. Antipsychotic medication(s) prescribed continuously without appropriate monitoring of glucose and lipids at least every 6months.March 2016(Tables Updated July 2016)

Psychotropic Medication Utilization Parameters8Stimulants for treatment of ADHDDrug (generic)Drug(brand) Adderall Amphetamine mixedsalts*Evekeo InitialDosage Age 3-5 years:2.5 mg/day Age 6 years:5-10 mg/day Age 3-5 years:5mg/dayAdderall XRLiteratureBasedMaximumDosage Age 6-12 years:5-10 mg/dayAge 3-5 years:30 mg/dayAge 6 years: 50 kg: 60 mg/day Age 13 years:10 mg/dayAdzenys XR-ODT(oral disintegratingtablet)Amphetamine baseDyanavel XR(oral suspension) Age 6 years:6.3 mg/day(3.1 mg 5 mgAdderall XR) Age 6 years:2.5-5 mg/day(2.5 mg 4 mgAdderall XR)FDA Approved MaximumDosage for Children andAdolescentsApproved for children 3 years andolder:40 mg/dayScheduleApproved for children 6 years andolder:Age 13-17 years:12.5 mg/day Ages 6-12 years: 18.8 mg/dayOnce daily Ages 13-17 years: 12.5 mg/dayOnce dailyDexedrine Zenzedi Dextroamphetamine*Procentra (oral suspension)DexedrineSpansule LisdexamfetamineVyvanse Age 3-5 years:2.5 mg/day Age 6 years:5 mg twice daily Age 3-5 years:5 mg/dayAge 3-5 years:30 mg/dayApproved for children 3 years andolder:40 mg/dayOnce or twicedailyAge 6 years: 50 kg: 60 mg/day Age 3-5 years:10 mg/dayAge 3-5 years:30 mg/day Age 6 years:30 mg/dayAge 6 years:70 mg/dayApproved for children 6 years andolder:70 mg/day(Continued on Page 9)* Generic available** See the FDA approved product labeling for each medication for the full black box warnings. XR, extended-releaseMarch 2016(Tables Updated July 2016)Baseline andongoing: height,weight, heartrate, and bloodpressureBaseline:Assessmentusing a targetedcardiac historyof the childand the family,and a physicalexamination ofthe child withan EKG and/or a pediatriccardiologyconsult asindicated Hypertension Abusepotential Sudden deathand seriouscardiovascularevents (Onlyboxed warningfor amphetamine saltsand dextroamphetamine) Potential forpsychiatricadverse events(hallucinations,delusional thinking,mania, aggression,etc.) Stimulants do notappear to affectultimate adult height.If mild growthsuppression occurs,it is likely reversibleupon discontinuationof stimulant Tics Decreased appetiteand weight Sleep disturbanceAge 6 years:40 mg/day Age 6 years:5 mg/dayWarnings andPrecautions Risk of sudden deathin those with preexisting structuralcardiac abnormalitiesor other serious heartproblemsOnce dailyApproved for children 6 years andolder:20 mg/dayAge 6 years:20 mg/dayBlack BoxWarning**One to threetimes dailyApproved for children 6 years andolder:30 mg/dayAge 6-12 years:18.8 mg/dayPatientMonitoringParametersOnce daily

Psychotropic Medication Utilization Parameters9Stimulants for treatment of ADHD (continued)Drug (generic)Drug(brand) Ritalin Methylin (chewable and DosageFDA Approved MaximumDosage for Children andAdolescents Age 3-5 years:2.5 mg twice dailyScheduleBaseline/MonitoringBlack BoxWarningWarningsandPrecautionsSee aboveSee aboveSee aboveOne to threetimes daily Age 6 years:5 mg twice dailyRitalin SRMethylin ERAge 3 years:10 mg/dayMetadate ERAge 6 years: 50 kg:60 mg/dayRitalin LAMethylphenidate*Once dailyAge 3-5 years:20 mg/dayApproved for children 6 years andolder:60 mg/day 50 kg:100 mg/dayMetadate CDQuillivant XR(oral suspension) Age 3-5 years:10 mg/dayOnce daily Age 6 years:10-20 mg/dayQuilliChew ER(chewable)Aptensio XRConcerta Daytrana TDpatch Focalin Dexmethylphenidate*Focalin XRAge 3 years:18 mg/dayAge 3 years:10 mg/dayAge 3-5 years:36 mgAge 6 years:108 mg/dayAge 3-5 years:20 mgAge 6 years:30 mg/day Age 3-5 years:2.5mg/day Age 6 years:2.5 mg twice dailyAge 3-5 years:10 mg/day Age 3-5 years:5 mg/dayAge 6 years:50 mg/day Age 6 years:5-10 mg/dayApproved for children 6 years andolder: Age 6-12 years: 54 mg/dayOnce daily Age 13-17 years: lesser of 72 mg/day or 2 mg/kg/day, whicheveris lessApproved for children 6 years andolder: 30 mg/dayOnce dailyApproved for children 6 years andolder: 20 mg/

for Children and Youth in Foster Care 3. T. he use of psychotropic medica-tions by children and youth is an issue confronting parents, other . caregivers, and health care professionals across the United States. Children and youth in foster care, in particular, have multiple needs, including those related to emotional or psychological stress .

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