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Helping Patients Through ADHD Medication Shortages and Discontinuation Grcevich 113022.pptx

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Helping Patients Through ADHD Medication Shortages and Discontinuation Grcevich 113022.pptx

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In this presentation, Dr. Stephen Grcevich will identify reasons for current shortages of immediate and extended-release Adderall, examine implications of the “authorized” Concerta generic being discontinued in January 2023 and discuss treatment options for patients who are unable to access ADHD medications on which they have been stabilized.

In this presentation, Dr. Stephen Grcevich will identify reasons for current shortages of immediate and extended-release Adderall, examine implications of the “authorized” Concerta generic being discontinued in January 2023 and discuss treatment options for patients who are unable to access ADHD medications on which they have been stabilized.

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Helping Patients Through ADHD Medication Shortages and Discontinuation Grcevich 113022.pptx

  1. 1. Helping Patients Through ADHD Medication Shortages and Discontinuation Stephen Grcevich, MD Child and Adolescent Psychiatry Associate Professor of Psychiatry, NEOMED Presented for Stark County MHAR Board November 30, 2022
  2. 2. Learning Objectives • Identify reasons for current shortages of immediate and extended-release Adderall • Examine implications of “authorized” Concerta generic being discontinued in January 2023 • Explore treatment options for patients who are unable to access ADHD medications on which they have been stabilized
  3. 3. Why are we experiencing a shortage of extended and immediate-release Adderall? • Manufacturing issues at Teva (labor shortage) in Summer, 2022 • Surge in use by adults during COVID, fueled by launch of telemedicine platforms offering ADHD meds • Cascading effects of DEA production quotas assigned to individual manufacturers
  4. 4. Who uses Adderall? How did Adderall use change during COVID? Source: Trilliant Health, June 19, 2022
  5. 5. Regulation waivers during COVID fueled startup companies offering ADHD treatment
  6. 6. The government’s role in ADHD medication shortages • DEA sets “Aggregate Production Quota” (APQ) for controlled substances – divided among brand, generic manufacturers • Other companies can’t quickly respond to demand if one company has a production issue • WSJ reports DEA “doesn’t plan to increase production quotas” in 2023, citing concerns about young adults abusing medication Source: Wall Street Journal, October 14, 2022
  7. 7. Do stimulants cause long term changes in brain function? • Study examined long- term changes in DA transporter in never- treated adults with ADHD after 12 months on Concerta vs. controls • 24% increase in DA transporter in caudate and putamen after 12 months (significant) • Does long term use of ADHD medication make ADHD symptoms worse when medication is stopped? • More studies needed of other medications, impact upon functional impairment Wang G-J, Volkow ND, Wigal T, Kollins SH, Newcorn JH, et al. (2013) PLoS ONE 8(5): e63023. doi:10.1371/journal.pone.0063023
  8. 8. Back to the basics: Factors in selecting medication for ADHD patients: • What will be the right drug? • Amphetamine? • D-amphetamine vs. racemic mix 0f d- and l- • Methylphenidate? • Non-stimulant? • Is dose sufficient to achieve the desired response? • With the right duration of action? • And the right delivery system? • Capsules, chewables, tablets, liquids, patch? Grcevich S. Future Neurology 2006; 1(5) 525-534
  9. 9. Adapted from Wilens TE, Spencer T. In: Tarter et al, eds. Handbook of Substance Abuse: Neurobehavioral Pharmacology. New York, NY: Kluwer Academic Publishers; 1998:501. Stimulant Mechanisms of Action
  10. 10. Differential Response to Stimulants Arnold LE. J Atten Disord. 2000;3:200-211. 0 10 20 30 40 50 Best response (%) Meta-Analysis of Within-subject Comparative Trials Evaluating Response to Stimulant Medications AMP=amphetamine MPH=methylphenidate AMP MPH Equal response to either stimulant 28% 16% 41%
  11. 11. Implications of Arnold Study: • Patients with uncomplicated ADHD should try another stimulant from the alternate category if they fail an initial trial. • Sub-optimal responders (improved, but not normalized) to a stimulant may also benefit from a trial of a different stimulant from the alternate category.
  12. 12. d- vs. l- amphetamine • 100% d-amphetamine • Vyvanse • Dexedrine • Zenzedi • 75/25% racemic mix of d- and l-amphetamine • Adderall, Adderall XR • Mydayis • Adzenys XR-ODT • 50/50% racemic mix of d- and l- amphetamine • Evekeo
  13. 13. Studies comparing d-, l- amphetamine isomers • Arnold (1976)-randomized, crossover study, N=31 • d- and L- isomers are equally efficacious, (non-significant trend toward d-AMP > L-AMP) • Trend toward L-AMP more effective in “undersocialized, aggressive” children 28% of drug responders preferred L-AMP • James (2001)-randomized, crossover study (N=35) comparing d-AMP IR, d-AMP ER, MAS-IR. • MAS-IR produced most robust effects in AM, only d-AMP improved cognitive performance in analog classroom after 4 hours • Sagvolden, Xu (2008) -animal model study • d-amphetamine improved SHR overactivity, impulsiveness as well as sustained attention, • Behavioral effects of l-amphetamine were relatively more specific for improving sustained attention than for the other 2 symptoms. Arnold LE et al. Arch Gen Psychiatry. 1976;33(3):292-301. James RS et al. J Am Acad Child Adolesc Psychiatry. 2001;40(11):1268–1276. Sagvolden T, Xu T. Behavioral and Brain Functions 2008, 4:3 doi:10.1186/1744-9081-4-3
  14. 14. Discontinuation of the “authorized” Patriot generic Concerta • FDA guidelines have given generic companies more flexibility in creating “equivalent” extended- release stimulants • Generic versions of Concerta using different drug delivery systems are essentially different products • Authorized Concerta generic using OROS drug delivery system is being discontinued on 1/13/2023 Source: FDA Publication, May 2019 https://www.fda.gov/media/124334/download
  15. 15. Impacts of the drug delivery system: • How soon does the product work? • How long does the product work? • When does the patient experience maximum benefit during the day? • Relationship to undesirable side effects • Impacts upon adherence
  16. 16. Analog classroom study of Concerta™ Impact upon math performance 0 5 10 15 20 25 30 35 40 45 50 8:15 9:20 10:30 12:30 14:05 16:00 17:15 18:20 19:10 Placebo OROS MPH (all doses) TID MPH (all doses) Class period Change in number of math problems completed Pelham WE et al. Pediatrics 2001; 107(6) e105.
  17. 17. Analog classroom study of Focalin XR: Impact upon math performance Turnbow JM et al. US Psychiatric and Mental Health Conference; 2005; Las Vegas, NV Change From Predose in Number of Math Problems Correctly Solved -30 -20 -10 0 10 20 30 40 50 60 70 0 0.5 1 2 3 4 5 6 7 8 9 10 11 12 Focalin XR Placebo -30 -20 -10 0 10 20 30 40 50 60 70 0 0.5 1 2 3 4 5 6 7 8 9 10 11 12 Mean Change From Predose, Math Correct Hours Postdose * * * * * * * * * * * * * Improvement
  18. 18. Laboratory Classroom Mean Change from Pre-Dose in Number of Math Problems Correct Analog classroom study of Daytrana™ Impact upon math performance -20 -15 -10 -5 0 5 10 15 20 25 30 35 40 0 1 2 3 4 5 6 7 8 9 10 11 12 Time (hr) Mean Change Score Placebo Transdermal MPH Patch applied Patch removed Wigal et al. Poster presented at the AACAP Annual Meeting, Toronto. October 21, 2005. Improvement * P < .001 Transdermal MPH vs placebo at all measured post-dose time points. * * * * * * * * N=79
  19. 19. What do we do for our patients? • Review of medication history • Consideration of other amphetamine-based stimulants • Consideration of methylphenidate-based stimulants • Consideration of non-stimulant medications • Is this an opportunity to optimize treatment?
  20. 20. Cost of Generic Adderall XR, Concerta alternatives • Adderall XR 20 mg • $28.31-$53.41 • Vyvanse 50 mg • $354.50-$374.99 • Adzenys XR-ODT 12.5 mg • $381.13-$382.63 • Concerta 54 mg • $436.04-$479.03 • Methylphenidate ER 54 mg (generic Concerta) • $34.94-$103.10 Source - GoodRx Manufacturer coupons may reduce cost
  21. 21. What am I doing for my patients on Adderall, Concerta? • Adderall XR • Switching to IR Adderall (more available, flexibility in dosing with tablets) • Consider Focalin XR in patients who are partial/incomplete responders who have never had a methylphenidate trial • Consider Evekeo as alternative if IR not available and patient has demonstrated preferential AMP response • Offer families option of trying to prior authorize Adzenys XR-ODT • Concerta • Would consider Adderall XR in patients who are partial/incomplete responders who have never had an amphetamine trial once shortages resolve • Consider Focalin XR/Ritalin LA (with immediate-release boosters) in patients with demonstrated preferential response to MPH • Option to try to prior authorize brand Concerta? • I don’t start new patients on Concerta because of unpredictability of generics
  22. 22. Contact information • drgrcevich@fcbtf.com • sgrcevich@neomed.edu Twitter: @drgrcevich LinkedIn:https://www.linkedin.com/in/step hen-grcevich-md/
  23. 23. Approved medications for ADHD (November 2022) Approved Not Approved Non-Stimulant Intuniv Kapvay Qelbree Strattera IR Clonidine IR Guanfacine (Tenex) Nuvigil/Provigil Tricyclics Venlafaxine (Effexor) Wellbutrin Stimulants Amphetamine Short Acting Long Acting Intermediate Adderall Desoxyn Dexedrine Dextrostat Evekeo Evekeo ODT Procentra (liquid) Zenzedi Adderall XR Adzenys XR ODT Dexedrine Spansules Dynavel XR (liquid) Mydayis Vyvanse Vyvanse Chewables Methylphenidate Short Acting Long Acting Intermediate Focalin Methylin Chewable Methylin Oral Solution Ritalin Adhansia XR Aptenzio XR Azstarys Concerta Contempla XR ODT Daytrana (patch) Focalin XR Jornay PM Metadate CD Metadate ER Methylin ER Quillichew ER Quillivant XR Ritalin LA Ritalin SR

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