687
Views
6
CrossRef citations to date
0
Altmetric
Clinical Focus: Neurological and Psychiatric Disorders - Review

Safety and efficacy considerations due to misuse of extended-release formulations of stimulant medications

&
Pages 672-681 | Received 08 Jun 2016, Accepted 26 Jul 2016, Published online: 16 Aug 2016

References

  • Connolly JJ, Glessner JT, Elia J, et al. ADHD & pharmacotherapy: past, present and future: a review of the changing landscape of drug therapy for attention deficit hyperactivity disorder. Ther Innov Regul Sci. 2015;49(5):632–642.
  • Adler LD, Nierenberg AA. Review of medication adherence in children and adults with ADHD. Postgrad Med. 2010;122(1):184–191.
  • Kessler RC, Adler L, Barkley R, et al. The prevalence and correlates of adult ADHD in the United States: results from the national comorbidity survey replication. Am J Psychiatry. 2006;163(4):716–723.
  • Willcutt EG. The prevalence of DSM-IV attention-deficit/hyperactivity disorder: a meta-analytic review. Neurotherapeutics. 2012;9(3):490–499.
  • Kessler RC, Berglund P, Demler O, et al. Lifetime prevalence and age-of-onset distributions of DSM-IV disorders in the National Comorbidity Survey Replication. Arch Gen Psychiatry. 2005;62(6):593–602.
  • Antshel KM, Hargrave TM, Simonescu M, et al. Advances in understanding and treating ADHD. BMC Med. 2011;9: 72.
  • Uchida M, Spencer TJ, Faraone SV, et al. Adult outcome of ADHD: an overview of results from the MGH longitudinal family studies of pediatrically and psychiatrically referred youth with and without ADHD of both sexes. J Atten Disord. 2015 Sep 22.
  • Subcommittee on Attention-Deficit/Hyperactivity Disorder, Steering Committee on Quality Improvement and Management, Wolraich M, et al. ADHD: clinical practice guideline for the diagnosis, evaluation, and treatment of attention-deficit/hyperactivity disorder in children and adolescents. Pediatrics. 2011;128(5):1007–1022. Epub 2011 Oct 16.
  • Pliszka S. Practice parameter for the assessment and treatment of children and adolescents with attention-deficit/hyperactivity disorder. J Am Acad Child Adolesc Psychiatry. 2007;46(7):894–921.
  • Rabito-Alcon MF, Correas-Lauffer J. Treatment guidelines for attention deficit and hyperactivity disorder: a critical review. Actas Esp Psiquiatr. 2014;42(6):315–324.
  • Barbaresi WJ, Katusic SK, Colligan RC, et al. Modifiers of long-term school outcomes for children with attention-deficit/hyperactivity disorder: does treatment with stimulant medication make a difference? Results from a population-based study. J Dev Behav Pediatr. 2007;28(4):274–287.
  • Meszaros A, Czobor P, Balint S, et al. Pharmacotherapy of adult attention deficit hyperactivity disorder (ADHD): a meta-analysis. Int J Neuropsychopharmacol. 2009;12(8):1137–1147.
  • De Sousa A, Kalra G. Drug therapy of attention deficit hyperactivity disorder: current trends. Mens Sana Monogr. 2012;10(1):45–69.
  • Lopez FA, Leroux JR. Long-acting stimulants for treatment of attention-deficit/hyperactivity disorder: a focus on extended-release formulations and the prodrug lisdexamfetamine dimesylate to address continuing clinical challenges. Atten Defic Hyperact Disord. 2013;5(3):249–265.
  • May DE, Kratochvil CJ. Attention-deficit hyperactivity disorder: recent advances in paediatric pharmacotherapy. Drugs. 2010;70(1):15–40.
  • Brams M, Mao AR, Doyle RL. Onset of efficacy of long-acting psychostimulants in pediatric attention-deficit/hyperactivity disorder. Postgrad Med. 2008;120(3):69–88.
  • Wilens TE, Adler LA, Adams J, et al. Misuse and diversion of stimulants prescribed for ADHD: a systematic review of the literature. J Am Acad Child Adolesc Psychiatry. 2008;47(1):21–31.
  • National Institute on Drug Abuse, National Institutes of Health, U.S. Department of Health and Human Services. Drug facts: drug-related hospital emergency room visits [ updated 2011 May]. Available from: https://www.drugabuse.gov/publications/drugfacts/drug-related-hospital-emergency-room-visits.
  • Chen LY, Crum RM, Strain EC, et al. Prescriptions, nonmedical use, and emergency department visits involving prescription stimulants. J Clin Psychiatry. 2016;77(3):e297–e304.
  • Lakhan SE, Kirchgessner A. Prescription stimulants in individuals with and without attention deficit hyperactivity disorder: misuse, cognitive impact, and adverse effects. Brain Behav. 2012;2(5):661–677.
  • Lennernas H. Ethanol-drug absorption interaction: potential for a significant effect on the plasma pharmacokinetics of ethanol vulnerable formulations. Mol Pharm. 2009;6(5):1429–1440.
  • Cassidy TA, Varughese S, Russo L, et al. Nonmedical use and diversion of ADHD stimulants among U.S. adults ages 18-49: a national internet survey. J Atten Disord. 2015;19(7):630–640.
  • Jedinger N, Khinast J, Roblegg E. The design of controlled-release formulations resistant to alcohol-induced dose dumping–a review. Eur J Pharm Biopharm. 2014;87(2):217–226.
  • Varum FJ, Hatton GB, Basit AW. Food, physiology and drug delivery. Int J Pharm. 2013;457(2):446–460.
  • Silver LB. Update on ADHD medications. Secondary update on ADHD medications 2015. 2002. Available from: http://www.ldonline.org/article/5972/.
  • Pleak RR. Adverse effects of chewing methylphenidate. Am J Psychiatry. 1995;152(5):811.
  • FDA. Guidance for industry bioavailability and bioequivalence studies submitted in NDAs or INDs — general considerations. Rockville (MD): Food and Drug Administration; [updated 2014]. Available from: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM389370.pdf.
  • Anand O, Yu LX, Conner DP, et al. Dissolution testing for generic drugs: an FDA perspective. AAPS J. 2011;13(3):328–335.
  • Vowles KE, McEntee ML, Julnes PS, et al. Rates of opioid misuse, abuse, and addiction in chronic pain: a systematic review and data synthesis. Pain. 2015;156(4):569–576.
  • Pfizer Inc. Avinza® [package insert]. Morphine sulphate. New York (NY): Pfizer inc; 2014.
  • Walden M, Nicholls FA, Smith KJ, et al. The effect of ethanol on the release of opioids from oral prolonged-release preparations. Drug Dev Ind Pharm. 2007;33(10):1101–1111.
  • FDA. Product-specific recommendations for generic drug development [updated 2016 July]. Available from: http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm075207.htm.
  • Califf RM, Woodcock J, Ostroff S. A proactive response to prescription opioid abuse. N Engl J Med. 2016;374:1480–1485.
  • Centers for Disease Control and Prevention. Attention-deficit /hyperactivity disorder (ADHD). Secondary attention-deficit /hyperactivity disorder (ADHD) July 8, 2015. Available from: http://www.cdc.gov/ncbddd/adhd/research.html.
  • Chavez B, Sopko MA Jr., Ehret MJ, et al. An update on central nervous system stimulant formulations in children and adolescents with attention-deficit/hyperactivity disorder. Ann Pharmacother. 2009;43(6):1084–1095.
  • Childress AC, Sallee FR. Attention-deficit/hyperactivity disorder with inadequate response to stimulants: approaches to management. CNS Drugs. 2014;28(2):121–129.
  • Pliszka SR. Pharmacologic treatment of attention-deficit/hyperactivity disorder: efficacy, safety and mechanisms of action. Neuropsychol Rev. 2007;17(1):61–72.
  • Barbaresi WJ, Katusic SK, Colligan RC, et al. Long-term stimulant medication treatment of attention-deficit/hyperactivity disorder: results from a population-based study. J Dev Behav Pediatr. 2014;35(7):448–457.
  • Zuvekas SH, Vitiello B. Stimulant medication use in children: a 12-year perspective. Am J Psychiatry. 2012;169(2):160–166.
  • Centers for Disease Control and Prevention. Mental health in the United States. Prevalence of diagnosis and medication treatment for attention-deficit/hyperactivity disorder–United States, 2003. MMWR Morb Mortal Wkly Rep. 2005;54(34):842–847.
  • Scahill L, Carroll D, Burke K. Methylphenidate: mechanism of action and clinical update. J Child Adolesc Psychiatr Nurs. 2004;17(2):85–86.
  • Volkow ND, Swanson JM. Variables that affect the clinical use and abuse of methylphenidate in the treatment of ADHD. Am J Psychiatry. 2003;160(11):1909–1918.
  • Baroni A, Castellanos FX. Stimulants, cognition and ADHD. Curr Opin Behav Sci. 2015;4(August):109–114.
  • Rubia K, Alegria AA, Cubillo AI, et al. Effects of stimulants on brain function in attention-deficit/hyperactivity disorder: a systematic review and meta-analysis. Biol Psychiatry. 2014;76(8):616–628. Epub 2013 Oct 24.
  • McElroy SL, Hudson JI, Mitchell JE, et al. Efficacy and safety of lisdexamfetamine for treatment of adults with moderate to severe binge-eating disorder: a randomized clinical trial. JAMA Psychiatry. 2015;72(3):235–246.
  • Keshen A, Ivanova I. Reduction of bulimia nervosa symptoms after psychostimulant initiation in patients with comorbid ADHD: five case reports. Eat Disord. 2013;21(4):360–369.
  • Thorpy MJ. Update on therapy for narcolepsy. Curr Treat Options Neurol. 2015;17(5):347.
  • Gowda CR, Lundt LP. Mechanism of action of narcolepsy medications. CNS Spectr. 2014;19 Suppl 1:25–33; quiz 25–27, 34.
  • Cunningham JW, Wiviott SD. Modern obesity pharmacotherapy: weighing cardiovascular risk and benefit. Clin Cardiol. 2014;37(11):693–699.
  • Sinita E, Coghill D. The use of stimulant medications for non-core aspects of ADHD and in other disorders. Neuropharmacology. 2014;87:161–172. 2014 Jun 18.
  • Olfson M. New options in the pharmacological management of attention-deficit/hyperactivity disorder. Am J Manag Care. 2004;10(4 Suppl):S117–S124.
  • Feldman M, Belanger S. Extended-release medications for children and adolescents with attention-deficit hyperactivity disorder. Paediatr Child Health. 2009;14(9):593–602.
  • Hodgkins P, Shaw M, Coghill D, et al. Amfetamine and methylphenidate medications for attention-deficit/hyperactivity disorder: complementary treatment options. Eur Child Adolesc Psychiatry. 2012;21(9):477–492.
  • Novartis Pharmaceuticals. Ritalin® and Ritalin SR® [package insert]. Hydrochloride methylphenidate hydrochloride tablets and sustained release tablets. East Hanover (NJ): Novartis Pharmaceuticals; 2013.
  • Noven Therapeutics. Daytrana® [package insert]. Methylphenidate transdermal system. Miami (FL): Noven Therapeutics; 2013.
  • NextWave Pharmaceuticals. Quillichew ER® [package insert]. Methylphenidate hydrochloride extended-release chewable tablets. Cupertino (CA): NextWave Pharmaceuticals, Inc.; 2015.
  • Mallinckrodt. Methylin ER® [package insert]. Methylphenidate hydrochloride extended-release tablets. Hazelwood (MO): Mallinckrodt; 2015.
  • Novartis Pharmaceuticals. Ritalin LA® [package insert]. Methylphenidate hydrochloride extended-release capsules. East Hanover (NJ): Novartis Pharmaceuticals; 2013.
  • Rhodes Pharmaceuticals. Aptensio XR® [package insert]. Methylphenidate hydrochloride extended-release capsules. Coventry (RI): Rhodes Pharmaceuticals L.P; 2015.
  • Janssen Pharmaceuticals. Concerta® [package insert]. Methylphenidate HCl extended-release tablets. Titusville (NJ): Janssen Pharmaceuticals; 2015.
  • NextWave Pharmaceuticals. Quillivant XR® [package insert]. QUILLIVANT XR- methylphenidate hydrochloride powder, for suspension. Cupertino (CA): NextWave Pharmaceuticals, Inc.; 2015.
  • Novartis Pharmaceuticals. Focalin XR® [package insert]. Dexmethylphenidate hydrochloride extended-release capsules. East Hanover (NJ): Novartis Pharmaceuticals; 2015.
  • UCB. Metdate CD® [package insert]. Methylphenidate HCl extended-release capsules. Smyrna (GA): UCB; 2014.
  • Amedra Pharmaceuticals. Dexedrine Spansule® [package insert]. Dextroamphetamine sulfate sustained release capsules. Horsham (PA): Amedra Pharmaceuticals; 2015.
  • Shire. Vyvanse® [package insert]. Lisdexamfetamine dimesylate. Wayne (PA): Shire; 2015.
  • Tris Pharma. Dyanavel® XR [package insert]. Amphetamine extended-release oral suspension. Monmouth Junction (NJ): Tris Pharma; 2015.
  • Shire. Adderall XR® [package insert]. Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate capsules. Wayne (PA): Shire; 2015.
  • Neos Therapeutics. Adzenys XR-ODT® [package insert]. Amphetamine extended-release orally disintegrating tablets. Grand Prairie (TX): Neos Therapeutics; 2016.
  • Sikes C, Adcock S, Stark JG, et al. Alcohol does not alter the pharmacokinetics and plasma concentrations of a novel extended-release orally disintegrating tablet formulation of amphetamine for treatment of ADHD. Annual Meeting of the American Professional Society of ADHD and Related Disorders; 2016; Washington, DC.
  • Robb AS, Findling RL, Childress AC, et al. Efficacy, safety, and tolerability of a novel methylphenidate extended-release oral suspension (MEROS) in ADHD. J Atten Disord. 2014.
  • Tris Pharma I. TRI102 in the treatment of children with attention deficit hyperactivity disorder (ADHD): a laboratory classroom study. In: Clinical Trials N, ed., 2015.
  • Upstate pharma, LLC. Metadate ER® [Prescribing information]. Smyrna (GA): Upstate pharma, LLC; Secondary Metadate ER® [Prescribing information]. Smyrna, GA: Upstate pharma, LLC. updated 2014.
  • Yonezawa Y, Ishida S, Sunada H. Release from or through a wax matrix system. VI. Analysis and prediction of the entire release process of the wax matrix tablet. Chem Pharm Bull (Tokyo). 2005;53(8):915–918.
  • Transdermal methylphenidate (Daytrana) for ADHD. Med Lett Drugs Ther. 2006;48(1237):49–51.
  • Childress A, Tran C. Current investigational drugs for the treatment of attention-deficit/hyperactivity disorder. Expert Opin Investig Drugs. 2016;25(4):463–474.
  • Childress AC, Sallee FR. The use of lisdexamfetamine dimesylate for the treatment of ADHD. Expert Rev Neurother. 2012;12(1):13–26.
  • Cassidy TA, McNaughton EC, Varughese S, et al. Nonmedical use of prescription ADHD stimulant medications among adults in a substance abuse treatment population: early findings from the NAVIPPRO surveillance system. J Atten Disord. 2015;19(4):275–283.
  • Clemow DB, Walker DJ. The potential for misuse and abuse of medications in ADHD: a review. Postgrad Med. 2014;126(5):64–81.
  • Novak SP, Kroutil LA, Williams RL, et al. The nonmedical use of prescription ADHD medications: results from a national Internet panel. Subst Abuse Treat Prev Policy. 2007;2: 32.
  • Zulauf CA, Sprich SE, Safren SA, et al. The complicated relationship between attention deficit/hyperactivity disorder and substance use disorders. Curr Psychiatry Rep. 2014;16(3):436.
  • Jester JM, Nigg JT, Buu A, et al. Trajectories of childhood aggression and inattention/hyperactivity: differential effects on substance abuse in adolescence. J Am Acad Child Adolesc Psychiatry. 2008;47(10):1158–1165.
  • Lee SS, Humphreys KL, Flory K, et al. Prospective association of childhood attention-deficit/hyperactivity disorder (ADHD) and substance use and abuse/dependence: a meta-analytic review. Clin Psychol Rev. 2011;31(3):328–341.
  • Auiler JF, Liu K, Lynch JM, et al. Effect of food on early drug exposure from extended-release stimulants: results from the Concerta, Adderall XR Food Evaluation (CAFE) Study. Curr Med Res Opin. 2002;18(5):311–316.
  • Barrett SP, Pihl RO. Oral methylphenidate-alcohol co-abuse. J Clin Psychopharmacol. 2002;22(6):633–634.
  • Barrett SP, Darredeau C, Pihl RO. Patterns of simultaneous polysubstance use in drug using university students. Hum Psychopharmacol. 2006;21(4):255–263.
  • Green R, Moore D. ‘Kiddie drugs’ and controlled pleasure: recreational use of dexamphetamine in a social network of young Australians. Int J Drug Policy. 2009;20(5):402–408. Epub 2009 Jan 24.
  • Jiao X, Velez S, Ringstad J, et al. Myocardial infarction associated with adderall XR and alcohol use in a young man. J Am Board Fam Med. 2009;22(2):197–201.
  • Mendelson J, Jones RT, Upton R, et al. Methamphetamine and ethanol interactions in humans. Clin Pharmacol Ther. 1995;57(5):559–568.
  • Hernandez-Lopez C, Farre M, Roset PN, et al. 3,4-Methylenedioxymethamphetamine (ecstasy) and alcohol interactions in humans: psychomotor performance, subjective effects, and pharmacokinetics. J Pharmacol Exp Ther. 2002;300(1):236–244.
  • McCabe SE, Teter CJ, Boyd CJ. Medical use, illicit use and diversion of prescription stimulant medication. J Psychoactive Drugs. 2006;38(1):43–56.
  • Barkla XM, McArdle PA, Newbury-Birch D. Are there any potentially dangerous pharmacological effects of combining ADHD medication with alcohol and drugs of abuse? A systematic review of the literature. BMC Psychiatry. 2015;15:270.
  • McKetin R, Chalmers J, Sunderland M, et al. Recreational drug use and binge drinking: stimulant but not cannabis intoxication is associated with excessive alcohol consumption. Drug Alcohol Rev. 2014;33(4):436–445.
  • Wilens TE, Adamson J, Monuteaux MC, et al. Effect of prior stimulant treatment for attention-deficit/hyperactivity disorder on subsequent risk for cigarette smoking and alcohol and drug use disorders in adolescents. Arch Pediatr Adolesc Med. 2008;162(10):916–921.
  • Miranda A, Colomer C, Berenguer C, et al. Substance use in young adults with ADHD: comorbidity and symptoms of inattention and hyperactivity/impulsivity. Int J Clin Health Psychol. 2016;16(2):157–165.
  • Biederman J, Monuteaux MC, Spencer T, et al. Do stimulants protect against psychiatric disorders in youth with ADHD? A 10-year follow-up study. Pediatrics. 2009;124(1):71–78.
  • Cone EJ. Ephemeral profiles of prescription drug and formulation tampering: evolving pseudoscience on the Internet. Drug Alcohol Depend. 2006;83 Suppl 1:S31–S39. Epub 2006 Feb 3.
  • Faraone SV, Upadhyaya HP. The effect of stimulant treatment for ADHD on later substance abuse and the potential for medication misuse, abuse, and diversion. J Clin Psychiatry. 2007;68(11):e28.
  • Schaeffer T. Abuse-deterrent formulations, an evolving technology against the abuse and misuse of opioid analgesics. J Med Toxicol. 2012;8(4):400–407.
  • Jasinski DR, Krishnan S. Human pharmacology of intravenous lisdexamfetamine dimesylate: abuse liability in adult stimulant abusers. J Psychopharmacol. 2009;23(4):410–418.
  • Johnson FK, Stark JG, Bieberdorf FA, et al. Relative oral bioavailability of morphine and naltrexone derived from crushed morphine sulfate and naltrexone hydrochloride extended-release capsules versus intact product and versus naltrexone solution: a single-dose, randomized-sequence, open-label, three-way crossover trial in healthy volunteers. Clin Ther. 2010;32(6):1149–1164.
  • Raffa RB, Pergolizzi JV Jr. Opioid formulations designed to resist/deter abuse. Drugs. 2010;70(13):1657–1675.
  • Bukstein O. Substance abuse in patients with attention-deficit/hyperactivity disorder. Medscape J Med. 2008;10(1):24.
  • Smith PC, Schmidt SM, Allensworth-Davies D, et al. A single-question screening test for drug use in primary care. Arch Intern Med. 2010;170(13):1155–1160.
  • U.S. Department of Health and Human Services, Public Health Service, Substance Abuse and Mental Health Services Administration, Center for Substance Abuse Treatment. Treatment for stimulant use disorders. Rockville (MD); 2014.
  • Rawson RA, McCann MJ, Flammino F, et al. A comparison of contingency management and cognitive-behavioral approaches for stimulant-dependent individuals. Addiction. 2006;101(2):267–274.
  • McHugh RK, Hearon BA, Otto MW. Cognitive behavioral therapy for substance use disorders. Psychiatr Clin North Am. 2010;33(3):511–525.
  • Trivedi MH, Greer TL, Grannemann BD, et al. Stimulant reduction intervention using dosed exercise (STRIDE) - CTN 0037: study protocol for a randomized controlled trial. Trials. 2011;12: 206. Epub Date. doi:10.1186/1745-6215-12-206.

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.