Effectively Recognizing and Managing ADHD in Adolescents. Educational Objectives

Transcription

1 Educational Objectives After completing this activity, the participant should be better able to: Explain how the proper recognition and management of ADHD in adolescents by MCOs can improve clinical outcomes and reduce the economic burden of disease Indicate the link between ADHD and the most common psychiatric comorbidities Describe current ADHD guidelines and treatment protocols Outline opportunities to maximize health plan performance for the ADHD HEDIS measure State examples of ADHD quality improvement strategies for MCOs Effectively Recognizing and Managing ADHD in Adolescents Timothy E. Wilens, M.D Clinical & Research Program in Pediatric Psychopharmacology Massachusetts General Hospital Harvard Medical School 1

2 Overview Estimated prevalence: 6 to 8% of children 6% of adolescents 4% of adults 4:1 male to female ratio in children and adolescents Treatment utilization varies widely within and between cultures, ethnicities, and socioeconomic status Goldman LS, et al. JAMA 1998;279: Barkley RA. In: Mash EJ, Barkley RA. eds. Treatment of Childhood Disorders. New York; Guildford Press ADHD Subtypes DSM-IV-TR* ADHD subtypes Combined subtype (50 75%) Primarily inattentive (20 30%) Increases with age Primarily hyperactive impulsive (<15%) *DSM-IV-TR: Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision. American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders. 4 th Edition, Text Revision. Washington, DC. American Psychiatric Association. 2000;48: Etiology ADHD is a heterogeneous behavioral disorder with multiple possible etiologies Neuroanatomic Neurochemical Genetic origins ADHD CNS insults Environmental factors Biederman J, Faraone SV. Lancet 2005;336:

3 DSM-IV Diagnostic Criteria for ADHD 1. Either (1) Symptoms of inattention, or (2) symptoms of hyperactivity-impulsivity or (3) both 2. Onset <7 years of age (childhood-onset) 3. >6 months of disturbance 4. Cross-situational (home, work, school) 5. Impairment in functioning American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders. 4 th Edition, Text Revision. Washington, DC. American Psychiatric Association. 2000;48: Clinical Presentation in an Adolescent (13-18 Years of Age) May seem restless rather than hyperactive Problems with attention, task completion, shifting of activities prematurely School work disorganized and shows poor follow-through; fails to work independently Seems emotionally immature Has poor self-esteem Has poor peer relationships May engage in irresponsible or risky behavior Wolraich ML, et al. Pediatrics. 2005;115: Barkley RA. Attention-Deficit Hyperactivity Disorder: A Handbook for Diagnosis and Treatment. 3rd ed. New York, NY: Guilford Press; Barkley RA, et al. J Am Acad Child Adolesc Psychiatry. 1991;30: ADHD Developmental Trends by Age Symptoms of ADHD decline and change from childhood to adulthood Children Adults Motoric hyperactivity Low frustration tolerance Impulsiveness Distractibility Shifting of activities Fidgetiness Impatience Restlessness Inattentiveness Wolraich et al. Pediatrics. 2005;115: Millstein et al. J Attention Disorder

4 Evidence of Persistence of ADHD Into Adulthood Percentage * Age at diagnosis 6 to 17 4 to 12 6 to 12 6 to 12 6 to 18 Age at followup 10 to to to to to 28 *Same cohort as study 1 at 10-year follow-up. Biederman J, et al. Arch Gen Psychiatry. 1996;53: Barkley RA, et al. J Am Acad Child Adolesc Psychiatry. 1990;29: Gittelman R, et al. Arch Gen Psychiatry. 1985;42: Weiss G, et al. J Am Acad Child Psychiatry. 1985;24: Biederman J, et al. Psychol Med. 2006;36; Common Co-occurring Conditions Oppositional defiant disorder (ODD) Conduct disorder (CD) Anxiety disorders Generalized anxiety disorder Obsessive-compulsive disorder (OCD) Posttraumatic stress disorder (PTSD) Depression Bipolar disorder Tic disorder Learning disabilities Cumulative Morbidity Risks for Psychiatric Disorders in Young Men With ADHD Cumulative morbidity risk ADHD Control Biederman J, et al. Psychol Med. 2006;36: * * MDD BPD OCD Tic disorders ODD 10-year follow-up of males with ADHD (n = 112) and case controls (n = 105) Mean age at follow-up: 22 years MDD = major depressive disorder; BPD = bipolar disorder; OCD = obsessive-compulsive disorder; ODD = oppositional defiant disorder; CD = conduct disorder. * * * CD *ADHD vs Control, P<.001 P =.004 4

5 Academic and Behavioral Impairments Continue in Adolescence 15 25% of children have poor academic outcome 1 5 Almost 30% of ADHD subjects fail grades 2 46% of ADHD pupils suspended 2 25% of persistently antisocial Gittelman R, et al. Arch Gen Psychiatry. 1985;42: Barkley RA. Attention-Deficit Hyperactivity Disorder. A Handbook for Diagnosis and Treatment, 2 nd ed. New York: Guilford Press; Mannuzza S, et al. J Am Acad Child Adolesc Psychiatry. 1997;36: Mannuzza S, et al. Arch Gen Psychiatry. 1993;50: Weiss G, Hechtman L. Hyperactive Children Grown Up. 2nd ed. New York: Guilford Press Mannuzza S, et al. Arch Gen Psychiatry. 1989;46: Mannuzza S and Klein RG. Child Adolesc Psychiatr Clin N Am. 2000;9: Barkley RA. Attention-Deficit Hyperactivity Disorder. A Handbook for Diagnosis and Treatment, 2nd ed. New York: Guilford Press; Fischer M, et al. J Abnorm Child Psychol. 2002;30(5): ADHD Adolescents and Driving License suspended Speeding violations Other traffic violations Accidents Fault Injuries More damage Barkley RA, et al. Pediatrics. 1993;92: Cox D, et al. J Nerv Ment Dis. 2000;188; Barkley RA, et al. Pediatrics. 1996;98: Murphy K, Barkley RA. Comp Psychiatry. 1996;37: Increased likelihood of outcome compared with age-matched controls ADHD: Risk of Substance Abuse Sharp rise in Substance Abuse between mid-adolescence and adulthood 60% 55% Percent Increase in Risk 50% 40% 30% 20% 10% 27% 15% 15% Control ADHD 0% Youth Adults Biederman J, et al. J Am Acad Child Adolesc Psychiatry. 1997;36: Biederman J, et al. Am J Psychiatry. 1995;152: Wilens TE, et al. J Nerv Ment Disord. 1997;185:

6 Sexual Behavior Casual sex past year P = 0.01 Casual sex + infrequent condom use P = 0.02 >4 sex partners (lifetime) P <0.001 Pregnancy P < Participants (%) Control (n = 111) ADHD (n = 175) Young men (aged 18 26) with and without childhood ADHD; self-reports Flory K, et al. J Clin Child Adolesc Psychology. 2006;35: Criminality P <0.001 P = ADHD Control Participants (%) P = P <0.001 P = P <0.001 P = P = Stolen property Assault with fists Assault with weapon Carried concealed weapon Ever arrested Arrested twice or more Misdemeanor arrest Felony arrest ADHD: n = 147; 87% Male; mean age = 21.1 Control: n = 73; 92% Male; mean age = 20.5 Barkley RA, et al. J Child Psychol Psychiatry 2004;45: Neurobiology of ADHD Smaller frontal lobes, basal ganglia, cerebellar vermus Delay in white matter/frontal tract maturation Abnormal PET and fmri studies (multiple) Abnormal DAT binding Abnormal dopamine transmission Genetic studies (multiple) Twin > 0.80 concordance Candidate genes (D4, D2, DAT, SNAP, 5HT) PET: Positron Emission Tomography; fmri: Functional magnetic resonance imaging; DAT: Dopamine transporter; SNAP: S- nitroso-n-acetylpenicillamine; 5HT: 5-hydroxytryptamine Faraone SV, et al. Am J Psych 1999;156: Zametkin AJ, Liotta W. J Clin Psych 1998;59 Suppl 7: Ernst M, et al. Am J Psychiatry. 1999;156: Casetellanos FX, et al. JAMA 2002;288: Faraone SV, et al. Biol Psychiatry. 2005;57:

7 Treatment Considerations in Adolescents with ADHD Psychoeducation Educational intervention/remediation Counseling Supportive problem-directed therapy Cognitive/behavioral intervention Coaching Family therapy Medication Wolraich et al. Pediatrics 2005:115: Treatment Considerations for Adolescents With ADHD Adolescents are neither children nor adults Adolescents often need to feel in control of condition and treatment Problems negotiating treatment alliance Adherence In selecting medication Tailor treatment to fit adolescent s schedule Keep treatment private/out of school Consider and discuss risk for substance abuse, misuse, and diversion Wolraich et al. Pediatrics 2005:115: Pharmacologic Treatments Approved for ADHD Methylphenidate-based formulations Methylprenidate (Concerta ) Methylprenidate (Ritalin ) Methylprenidate (Metadate CD) Methylprenidate (Ritalin LA) Dexmethylphenidate (Focalin XR) Methylphenidate (Daytrana ) Amphetamine-based treatments Mixed amphetamine salts (Adderall XR ) Mixed amphetamine salts (Adderall ) Dextroamphetamine (Dexedrine Spansule) Lisdexamfetamine dimesylate (Vyvanse ) Nonstimulant Atomoxetine (Strattera ) Duration of effect ~12 hours 3 4 hours 8 10 hours ~8 hours 3 4 (8 10) hours ~12 hours (worn for 9) hours 4 6 hours 6 8 hours 12 hours Up to 24 hours Physicians Desk Reference. 59th ed. Montvale, NJ: Thomson PDR;

8 Dosing Stimulants Start with low dose to establish tolerability Titrate until no further improvement is seen or until significant side effects are noted Underdosing is a common concern (methylphenidate) No simple association between optimal dosage and age, weight, or blood levels, although adolescents and adults usually require a higher dose than do children If an effective medication seems to become less effective as a child reaches adolescence, try increasing the dose Potential for Abuse Nonstimulants (eg, atomoxetine, bupropion) are less likely to be misused or diverted than stimulants The slower the uptake into the brain, the lower the abuse liability of the stimulant Long-acting formulations of stimulants are less likely to be misused or diverted than immediate-release formulations Volkow ND, et al. Nature 1997;386: Spencer TJ, et al. Am J Psychiatry. 2006;163: ADHD and Substance Abuse Risk for SUD (%) Survival Curve: Risk for Substance Use Disorder (SUD) Onset in Adults With Untreated ADHD 100 ADHD 90 Control P 0.05, ADHD vs 50 control at endpoint 40 Earlier onset Higher risk Age at onset (years) Wilens T, et al. J Nerv Ment Dis. 1997;185:

9 Pharmacotherapy and Substance Abuse With Stimulants Fear: Stimulant therapy may lead to substance abuse Fact: Untreated ADHD is a significant risk factor for substance abuse in adolescence Pharmacotherapy for ADHD may be protective against substance abuse Biederman J, et al. Pediatrics. 1999;104:20; Wilens et al. Pediatrics. 2003;11: Faraone SV, Wilens T. J Clin Psychiatry. 2003;64(suppl 11):9-13. Misuse and Diversion of Stimulants Adolescents with ADHD are more likely to misuse or divert their medication than are non-adhd adolescents taking psychoactive drugs Misused 5% 22% Got high Used too much 5% 5% 10% No ADHD (n = 43) ADHD (n = 55) 22% Sold 0% 11% 0% 5% 10% 15% 20% 25% Patients Wilens T, et al. J Am Acad Child Adolesc Psychiatry. 2006;45: Characteristics of ADHD Patients Who Misuse or Divert Medication ADHD patients with comorbid CD or SUD are more likely to misuse or divert their medication. All ADHD (N = 55) 31% 53% SUD CD Misuse (n = 12) 58% 75% Divert (n = 6) 83% 83% 0% 20% 40% 60% 80% 100% Patients Wilens T, et al. J Am Acad Child Adolesc Psychiatry. 2006;45:

10 Possible Predictors of Misuse of ADHD Medications Signals alerting to the possible motivation to misuse ADHD agents include Competitiveness of the college environment 1 Other drug use 2 Presence of: Current ADHD and depressive symptoms 3,4,5 Neuropsychological deficits 5 1. McCabe SE, et al. Addict Behav 2005;30: White BP et al. J Am Coll Health 2006;54: Poulin C. Addiction 2007;102: Upadhyaya HP, et al. J Child Adolesc Psychopharmacol 2005 ;15 : Wiens TE, et al. J Am Acad Child Adolesc Psychiatry 2008: In press. OROS MPH (90 mg) & IR MPH (40 mg): Feel an Effect 25 Feel an Effect * * * * IR-MPH OROS-MPH N=6 per group. Time (hrs) *p < p < IR: extended release; OROS = osmotically controlled-release oral delivery system Spencer TJ, et al. Am J Psychiatry. 2006;163: Does Stimulant Treatment Effect Neural Activity? ADHD associated with dysfunction of the dorsal anterior midcingulate cortex (damcc) and other cingulofrontoparietal regions associated with attention Stimulants are effective therapy for ADHD Study conducted to determine if stimulant treatment effects neural activity damcc activation during the Multi-Source Interference Task measured by functional MRI (fmri) in 21 adults with ADHD treated for 6 weeks MPH OROS (n=11) Placebo (n=10) Bush G, et al. Arch Gen Psychiatry. 2008;65:

11 Treatment with OROS MPH Increased Activation in Regions Associated with Attention MPH OROS treatment elicited increased activation of the cingulofrontoparietal network including: Dorsal anterior midcingulate cortex (damcc) bilaterally Right-sided dorsolateral prefrontal cortex (DLPFC) Bilateral superior parietal cortices (Parietal) Bush G, et al. Arch Gen Psychiatry. 2008;65: Sagittal Axial Coronal ADHD Treatment Summary In Adolescents Methylphenidate, mixed amphetamine salts, and atomoxetine are all safe and efficacious in adolescents with ADHD MPH has the most clinical trial data Long-acting forms of methylphenidate and mixed amphetamine salts are also safe and effective and are thought to have a lower risk of abuse compared to immediate-release forms Atomoxetine is the only FDA-approved nonstimulant for ADHD Treatment Plan (continued) Management of comorbid disorders Psychotherapy Medication Substance abuse treatment programs Assistance with time management and organization (consult ADHD coaches or therapists) Psychosocial treatments Family therapy or parent management training Individual therapy Vocational assessment/career counseling 11

12 Adolescent ADHD Summary ADHD is frequently persistent into adolescence Common domains of impairment Academic underachievement Family functioning Driving Adolescents with ADHD respond favorably to treatment Medication is fundamental to treatment Medications in ADHD Improve ADHD symptoms Improve functional outcomes (family, driving, social) Reduce risk for substance abuse Permit many to succeed and go to college Managed Care Strategies to Improve ADHD Outcomes Jeffrey D. Dunn, PharmD, MBA Formulary and Contract Manager SelectHealth Plans (formerly IHC Health Plans, Inc.) ADHD is a Common Diagnoses in Children Less Than 18 Years Old Percent of children <18 years old with diagnosis 2006 National Health Interview Survey 20% 15% 10% 5% 0% Asthma 0.14 (n=73,493) Respiratory Allergy 0.12 Learning Disability (n=73,493) Respiratory Allergy Learning Disability ADHD (n=61,354) ADHD (n=61,354) Asthma Bloom B, Cohen RA. Vital Health Stat ;234:

13 Consequences of Untreated ADHD Increase with Age ADHD only Low Self- Esteem Disruptive Behavior Poor Social Skills Learning Delay Oppositional Defiant Disorder Mood Disorder Challenging Behavior Antisocial Behavior School Exclusion Substance Abuse Conduct Disorder Lack of Motivation Complex Learning Disorder Age (years) Kewley GD. Attention Deficit Hyperactivity Disorder (ADHD): Recognition,Reality and Resolution. Oxon, United Kingdom: David Fulton Publishers;2002. Impact of ADHD in Childhood and Adolescence Compared to non-adhd Peers Health Care Use 50% Bicycle accidents 1 33% Emergency visits 2 >4x Vehicle accidents 3 Society 2X > Risk for SUD 6 Earlier onset of SUD 7 More likely to continue SUD into adulthood 8 School/Work 46% Expelled 4 35% Dropped out 4 Lower occupational status 5 Family >4x h Sibling fighting 9 >4x h Separation/divorce in adulthood DiScala C, et al. Pediatrics : Liebson CL, et al. JAMA 2001; Barkley RA, et al. Pediatrics 1996;98: Barkley RA, et al. J Am Acad Child Adolesc Psychiatry 1990;29: Mannuzza S, et al. J Am Acad Child Adolesc Psychiatry 1997;36: Biederman J, et al. J Am Acad Child Adolesc Psychiatry 1997;36: Pomerleau OF, et al. J Subst Abuse 1995;7: Wilens T, et al. Psychiatr Serv 1995;46:761-3, Mash EJ, Johnston C. J Consult Clin Psychol 1983;51: Barkley RA, et al. J Child Psychol Psychiatry 1991;32: ADHD Associated with Lower Educational Achievement and Income 100% 75% 50% 25% Fulltime Employed by Academic Achievement 34% 30% 22% 77% 72% 65% 56% 55% 100,000 80,000 60,000 40,000 20,000 Average Income by Academic Achievement 29.5K 23.8K 38.7K * 46.7K 63.0K 66.6K 52.4K ** 91.3K 0% Less than high school High school; some college College; some post grad p<.001 for all comparisons. Post-grad degree 0 ADHD (n=500) No ADHD (n=501) Less than high school High school; some college College; Post-grad some post degree grad *p<.05; **p<001. Biederman J, Faraone SV. MedGenMed. 2006;8:12. 13

14 ADHD Associated with Greater Use of Hospital Care Proportion requiring hospital services 100% 75% 50% 25% Population based Cohort Study of Adolescents (Mean Age: 15.3 years) ADHD No ADHD n=4119 p< % 18% p= % 33% p= % 74% 0% In-patient Care Out-patient Care ED Admission Leibson CL, et al. JAMA 2001;285: Presence of ADHD Increases Health Care Utilization Costs Patients 3-17 Years of Age Enrolled in the Group Health Cooperative Costs per patient per year $1,500 $1,200 $900 $600 $300 $0 No ADHD (n=11,968) ADHD (n=2,992) *p <0.001 vs. no ADHD $427* $245 Primary Care $222 * $20 Mental Health Care $335 * $66 Pharmacy $1,465* $690 Total Guevara J, et al. Pediatrics 2001;108: ADHD Diagnostic and Treatment Guidelines Organizations with ADHD Practice Guidelines AAP Practice Guideline May 2000 AACAP Practice Parameters October 1997 NIH Consensus Statement February 2000 AAP: American Academy of Pediatricians AACAP: American Academy of Child and Adolescent Psychiatry NIH: National Institutes of Health 14

15 Are Providers Using the Guidelines? Survey of 1374 physicians indicated 92% of pediatricians and 60% of primary care physicians were familiar with the AAP guidelines Only 26% used all 4 diagnostic components in the guidelines DSM criteria Parent surveys Teacher surveys Assessment for co-existing conditions Rushton JL, et al. Pediatrics 2004;114:e23-e28. Approach to ADHD Treatment ADHD is highly treatable 1 Combination of behavioral and pharmacological approaches most effective to control symptoms 1 Stimulants remain 1st line treatment 1 Any individual stimulant effective in ~70% of ADHD patients 2 Many who fail to respond to one may respond to another 2,3 Stimulants generally safe and well tolerated 3 Non-stimulating agents recently introduced 1. American Academy of Pediatrics. Pediatrics. 2001; US Department of Health and Human Services, Scott-Levin Inc., Physician Drug and Diagnosis Audit (PDDA), American Academy of Pediatrics (AAP): ADHD Treatment Goals Immediate and long-term control of symptoms Decreased disruptive behaviors Improved academic performance Increased independence Improved self-esteem Improvements in relationships American Academy of Pediatrics. Pediatrics. 2001;

16 AAP Treatment Plan Begin patient and family education about ADHD immediately after diagnosis Implement home, work, school, and lifestyle adjustments Initiate therapy with appropriate medication targeting symptoms Identify and manage comorbid conditions Psychotherapy or cognitive therapy Substance abuse treatment American Academy of Pediatrics. Pediatrics. 2001; Pharmacologic Intervention in ADHD Methylphenidate Stimulants Amphetamine Short Acting SODAS MPH Dexmethylphenidate Intermediate Long Acting MPH SR OROS MPH MPH SR Diffucaps MPH MPH LA Dexmethylphenidate XR MPH transdermal patch Short Acting Dextroamphetamine Dextroamphetamine tabs Intermediate Dextroamphetamine ER MAS Long Acting MAS XR Nonstimulant Approved Not Approved Atomoxetine TCA Modafinil; Bupropion Guanfacine; Clonidine Venlafaxine SODAS = spheroidal oral drug absorption system; MPH = methylphenidate; SR = sustained release; ER = extended release; OROS = osmotically controlled-release oral delivery system; LA = long acting; XR = extended release; TCA = tricyclic antidepressants Drug Therapy of ADHD is Highly Cost-Effective For the routine treatment of children with ADHD, medication management is more cost-effective than behavioral treatment or combined medication + behavioral therapy* *From the Multimodal Treatment Study of Children with ADHD (n=579 children years of age treated for 14 months) Jensen PS, et al. Am J Psychiatry 2005;162:

17 Managed Care Considerations with ADHD Therapy Dosing flexibility and convenience Duration of action Short- vs. long-acting agents Risk for abuse or diversion Tolerability and safety Cost Access/reimbursement Pediatric vs. adult Polypharmacy Formulary management DACON, future generics, new products Considerations for Stimulants Stimulant usually chosen for most children and teens Efficacy supported by over 200 randomized, placebo-controlled, blinded clinical trials Most studies of short duration (i.e., 2-4 months) Few long term trials MPH and DEX have similar profiles DEX slightly more side effects, which are mild Mixed amphetamine salt preparation (Adderall) Recent withdrawal of long acting product in Canada Warning of use in children with cardiac conditions Selective nature of stimulants can vary from one agent to another Consider parent preference First Line Therapy Stimulants recommended as first line therapies Efficacy ranges from 68-80% 3-4% of patients experience side effects causing discontinuation Many generics available in the short-acting formulation Long-acting generics are not yet available Duration of effect ranges from 2-12 hours American Academy of Pediatrics. Pediatrics. 2001;

18 Second and Third Line Interventions Atomoxetine second line Effective in 50 60% of patients Similar side effects to stimulants Provides 24 hour coverage 1-3 weeks to reach effect Bupropion Fewer studies, more serious side effects Role of antidepressant effect 24 hour coverage with twice daily dosing 3-4 weeks to reach effect American Academy of Pediatrics. Pediatrics. 2001; Newer ADHD Pharmacotherapies MPH Formulations Methylprenidate (Concerta ) Methylprenidate (Metadate CD) Methylprenidate (Ritalin LA) Dexmethylphenidate [(Focalin (XR)] Methylprenidate (Daytrana ) Amphetamine Formulations Mixed amphetamine salts (Adderall XR) Dextroamphetamine (Dexedrine Spansules ) Mixed amphetamine salts (Adderall ) Lisdexamfetamine dimesylate (Vyvanse ) Non-Stimulants Atomoxetine (Strattera ) Duration of effect 12 hours 8-10 hours ~8 hours ~5 (10) hours hours 12 hours ~4 (8) hours 6-8 hours 12 hours 8-24 hours Dosing Schedule Once daily Once daily Once daily Twice (once) daily Once daily Once daily Multiple Twice daily Once daily Once/twice daily ADHD Drug Dosing Medication Methylprenidate (Ritalin) Starting Dose 5 mg Maximum Dose 60 mg Dosing Schedule TID Dexmethylphenidate (Focalin) 2.5 mg 10 mg BID Methylprenidate (Concerta) 18 mg 72 mg QD Methylprenidate (Metadate CD) 20 mg 60 mg QD Methylprenidate (Ritalin LA) 10 mg 60 mg QD Dexmethylphenidate (Focalin XR) 5 mg 20 mg QD Methylprenidate (Daytrana) 10 mg 30 mg QD Mixed amphetamine salts (Adderall) 2.5 to 5 mg 40 mg BID Mixed amphetamine salts (Adderall XR) 5 to 10 mg 30 mg QD Dextroamphetamine (Dexedrine) 2.5 to 5 mg 40 mg BID/TID Dextroamphetamine (Dexedrine Spansules) 5 mg 50 mg BID Lisdexamfetamine dimesylate (Vyvanse) 30 mg 70mg QD Atomoxetine (Strattera) 40mg 100 mg QD/BID Wilens TE, et al. Ann Rev Med. 2002;53:

19 Drug Delivery Systems May Reduce Risk for Abuse and Diversion Newer delivery systems may reduce misuse liability Different formulations alter pharmacokinetics and/or limit access to the active drug by using Prodrugs [lisdexamfetamine dimesylate (Vyvanse)] Beaded preparations [methylprenidate (Adderall XR; Ritalin LA); dexmethylphenidate (Focalin XR)] Osmotic preparations [methylprenidate (Concerta; Metadate CD)] Transdermal delivery systems [methylprenidate (Daytrana)] Volkow ND, et al. Nature 1997;386: Spencer TJ, et al. Am J Psychiatry. 2006;163: Pharmacy Management Issues in the Treatment of ADHD Polypharmacy Combination of long-acting agents Combination of short-acting agents Use with modafinil (Provigil), sedative hypnotics, etc. Different doctors Suboptimal dosing High DACON Appropriate use vs. potential for abuse Off-label use Recommendations for Managing Polypharmacy Polypharmacy Limit to one long-acting agent at one time (a short-acting in combination could be allowed) Methylprenidate (Concerta; Adderall XR) would not be allowed at the same time Limit to one short-acting agent at one time (a long-acting in combination could be allowed) MPH IR and mixed amphetamine salts would not be allowed at the same time Dose optimization Methylprenidate (Concerta) 18 mg bid methylprenidate (Concerta) 36 mg qd or methylprenidate (Concerta) 18 mg qd + MPH IR qd Quantity limits One long-acting agent per day 19

20 Improving Adherence to Treatment 48% of patients 9-15 years of age discontinued therapy over 3 year period 1 Strategies to improve adherence 2 Educate patients and parents regarding anticipated results, benefits and possible adverse events Provide frequent follow-up early in treatment Strive for dose optimization Identify and treat comorbid conditions Dose response vs. titration Dosing needs to increase when patients get older and their weight increases 1. Wolraith EL, et al. Pediatrics. 2005;115: Grcevich S, et al. Presented at: The 53 rd Annual Meeting of the American Academy of Child and Adolescent Psychiatry; October 2006, San Diego, CA. Patient Monitoring Recommended Every 3-4 Months Optimal frequency of follow up is not well studied If intervals longer than 4 months Potential for medication to be continued even if its not effective Potential for medication to be prematurely discontinued or switched to another with greater potential for side effects American Academy of Childhood and Adolescent Psychiatry. J Am Acad Child Adolsec Psychiatry 2007;46: Monitoring for Adverse Events At all visits, patients should be monitored for Appetite, headache, abdominal pain, sleep, emergence of tics, mood changes, irritability Rebound phenomena Most side effects are responsive to changes in dose or timing American Academy of Childhood and Adolescent Psychiatry. J Am Acad Child Adolsec Psychiatry 2007;46:

21 HEDIS ADHD Measure Recently developed HEDIS measure for ADHD assesses follow-up care for children (6-12 years) prescribed ADHD therapy Initiation Phase Management Percentage of children with a prescription for ADHD medication who had one follow-up visit with a practitioner during the 30-day Initiation Phase Continuation and Maintenance Percentage of children with a prescription for ADHD medication, who remained on the medication for at least 210 days and had at least two follow-up visits in the nine months after the end of the Initiation Phase National Committee for Quality Assurance. The state of health care quality: Industry trends and analysis. Washington, DC Achievement of the HEDIS ADHD Measure Percent of Commercial Plans Achieving the ADHD Initiation Phase Performance Measure 40% Percent of Plans 30% 20% 10% 32% 33% 0% National Committee for Quality Assurance. The state of health care quality: Industry trends and analysis. Washington, DC Achieving the HEDIS ADHD Performance Measure Steps to improve performance on the HEDIS ADHD measure include Education and implementation of evidence-based care Registry of patients with current ADHD diagnosis to allow for long-term follow up Implementation of drug therapy management Drug utilization review Step edits Patient education to ensure maximizing adherence 21

22 Patient Management Plan Patient Management Plan Patient Education Materials 22

23 Physician Education Materials Summary Early and effective treatment minimizes the long-term negative effects of ADHD Fewer and less costly emergency department visits Fewer traffic accidents Better long term employment prospects Treatment choices now include Longer-acting agents New delivery systems Availability of non-stimulants New delivery system therapies Provide continuous treatment of symptoms Minimize abuse/diversion potential Enhance adherence Summary (continued) Greater adherence to practice guidelines is needed Patient and parent education Frequent monitoring Optimize dosing and medication choice Improvement is needed with patient care follow up Only 1/3 of all plans achieved the HEDIS performance measure for ADHD Implement drug therapy management Establish patient registry Implement guideline driven care 23