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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
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
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
Who uses Adderall?
How did Adderall use change during COVID?
Source: Trilliant Health, June 19, 2022
Regulation waivers during COVID
fueled startup companies offering
ADHD treatment
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
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
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
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
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%
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.
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
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
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
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
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.
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
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
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?
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
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
Contact
information
• drgrcevich@fcbtf.com
• sgrcevich@neomed.edu
Twitter: @drgrcevich
LinkedIn:https://www.linkedin.com/in/step
hen-grcevich-md/
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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Helping Patients Through ADHD Medication Shortages and Discontinuation Grcevich 113022.pptx

  • 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. 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. 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. Who uses Adderall? How did Adderall use change during COVID? Source: Trilliant Health, June 19, 2022
  • 5. Regulation waivers during COVID fueled startup companies offering ADHD treatment
  • 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.
  • 8. 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
  • 9. 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
  • 10. 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
  • 11. 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%
  • 12. 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.
  • 13. 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
  • 14. 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
  • 15. 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
  • 16. 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
  • 17. 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.
  • 18. 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
  • 19. 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
  • 20. 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?
  • 21. 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
  • 22. 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
  • 23. Contact information • drgrcevich@fcbtf.com • sgrcevich@neomed.edu Twitter: @drgrcevich LinkedIn:https://www.linkedin.com/in/step hen-grcevich-md/
  • 24. 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