Abstract
Background: The development of systems to ensure appropriate and informed use of medicines in children is a global priority. Current pharmacovigilance systems, such as the UK Yellow Card Scheme, are limited by opportunistic reporting of adverse drug reactions (ADRs), lack of a denominator and lower than expected reporting rates.
Objective: To develop a pharmacovigilance system able to target specific patient populations such as children, and specific medicines of interest, using specialist medical clinics.
Methods: Between January and March 2010, parents of 578 children (3–16 years of age) receiving pharmacological therapy for attention-deficit hyperactivity disorder and attending a child and adolescent clinic in the UK were sent an ADR questionnaire to elicit information on possible ADRs associated with their child’s medication use. Two approaches, free text and a symptom tick list, were used to elicit possible ADRs.
Results: Two hundred and seven questionnaires were returned, of which 200 were evaluable, giving a response rate of 35.9%. 123 questionnaires reported a total of 213 free-text ADRs perceived by the parents to be due to the medications under study. Two-thirds of reported ADRs were considered to be ongoing at the time of reporting. Duration of reported ADRs ranged from 1 week to 3 years. 81 returned questionnaires reported 134 different ADRs for methylphenidate monotherapy. For methylphenidate, the most frequently reported ADRs were loss of appetite (34.3%), headache (17.9%), mood and emotional problems (14.9%), stomach upset (14.9%), sleep disturbance (10.4%), and rash and other skin problems (5.2%). 467 possible drug-related symptoms were reported using the tick-list approach. Using the tick list, the most frequently reported symptoms were mood and emotional problems (28.1% [131/467]), stomach and abdominal problems (13.3% [62/467]), insomnia (12.8% [60/467]) and lack of appetite (12.6% [59/467]). The symptom tick list identified a broader range of possible adverse effects not reported as free-text ADRs, such as schooling difficulties, hearing problems, cough and blurred vision.
Conclusions: The results of our study demonstrate the feasibility of using specialist clinics to target both at-risk patient populations and/or medicines of interest. We have also clearly demonstrated the practicality and feasibility of parental reporting. Parents reported common and less common ADRs, such as suicidal ideation, using both the free text and symptom tick-list approach.
Similar content being viewed by others
References
American Psychiatric Association. Diagnostic and statistical manual of mental disorders. 4th ed. Washington, DC: American Psychiatric Association, 1994
Ford T, Goodman R, Meltzer H. The British child and adolescent mental health survey 1999: the prevalence of DSM-IV disorders. J Am Acad Child Adolesc Psychiatry 2003; 42: 1203–11
NHS. ADHD: services over Scotland. Report of the service profiling exercise. March 2007 [online]. Available from URL: http://www.nhshealthquality.org/nhsqis/files/ADHD_ServicesOverScotland_MAR07.pdf [Accessed 2009 Nov 13]
Ross C, Davies P, Whitehouse W. Melatonin treatment for sleep disorders in children with neuro developmental disorders: an observational study. Dev Med Child Neurol 2002; 4: 339–44
Meijer WM, Faber A, den Ban EV, et al. Current issues around the pharmacotherapy of ADHD in children and adults. Pharm World Sci 2009; 31: 509–16
Harpin VA. The effect of ADHD on the life of an individual, their family, and community from preschool to adult life. Arch Dis Child 2005; 90 Suppl.: i2-7
Lerner M, Wigal T. “Long-term safety of stimulant medications used to treat children with ADHD”. Pediatr Ann 2008; 37(1): 37–45
BMA. Reporting adverse drug reactions: a guide for healthcare professionals. London: BMA, 2006 May [online]. Available from URL: http://www.bma.org.uk/images/ADRFinal_tcm41-20713.pdf. [Accessed 2009 Dec 16]
Goldman SA. Limitations and strengths of spontaneous reports data. Clin Ther 1998; 20 Suppl. C: C40-4
Horen B, Montastruc JL, Lapeyre-Mestre M. Adverse drug reactions and off-label drug use in paediatric outpatients. Br J Clin Pharmacol 2002; 54(6): 665–70
Mosholder AD, Gelperin K, Hammad TA, et al. Hallucinations and other psychotic symptoms associated with the use of attention-deficit/hyperactivity disorder drugs in children. Pediatrics 2009; 123: 611–6
Tobaiqy M, Bond C, Helms P, et al. A pilot study to evaluate a community pharmacy based monitoring system to identify adverse drug reactions associated with paediatric medicines use. Eur J Clin Pharmacol 2010; 66(6): 627–32
Stewart D, Helms PJ, Bond CM, et al. Monitoring adverse drug reactions in children using community pharmacies: a pilot study. Br J Clin Pharmacol 2005; 59: 677–83
Tobaiqy M, Stewart D, Helms PJ, et al. Views of parents and pharmacists following participation in a paediatric pharmacovigilance study. Pharm World Sci 2010; 32(3): 334–8
Wallin J, Sjovall J. Detection of adverse drug reactions in a clinical trial using two types of questioning. Clin Ther 1981; 3: 450–2
Wallander MA, Dimenas E, Svardsudd K, et al. Evaluation of three methods of symptom reporting in a clinical trial of felodipine. Eur J Clin Pharmacol 1991; 41: 187–96
Bent S, Padula A, Avins LA. Brief communication: better ways to question patients about adverse medical events: a randomized, controlled trial. Ann Intern Med 2006 Feb; 144: 257–61
Graham J, Coghill D. Adverse effects of pharmaco-therapies for attention-deficit hyperactivity disorder: epidemiology, prevention and management. CNS Drugs 2008; 22(3): 213–37
Lucas AR, Weiss M. Methylphenidate hallucinosis. JAMA 1971; 217: 1079–81
Bloom AS, Russell LJ, Weisskopf B, et al. Methylphenidate-induced delusional disorder in a child with attention deficit disorder with hyperactivity. J Am Acad Child Adolesc Psychiatry 1988; 27: 88–9
Cherland E, Fitzpatrick R. “Psychotic side effects of psychostimulants: a 5-year review” (PDF). Can J Psychiatry 1999; 44(8): 811–3
Safer D, Allen R, Barr E. Side effects of methylphenidate and dexamphetamine in children with attention deficit hyperactivity disorder: a double-blind, crossover trial. Pediatrics 1997; 100(4): 662–6
Golinko B. Side effects of dextroamphetamine and methylphenidate in hyperactive children: a brief review. Prog Neuropsychopharmacol Biol Psychiatry 1984; 8: 1–8
Faraone SV, Biederman J, Morley CP, et al. Effect of stimulants on height and weight: a review of the literature. J Am Acad Child Adolesc Psychiatry 2008; 47(9): 994–1009
Vitiello B. Long-term effects of stimulant medications on the brain: possible relevance to the treatment of attention-deficit/hyperactivity disorder. J Child Adolesc Psychopharmacol 2001; 11: 25–34
The Electronic Medicines Compendium. Concerta XL: summary of product characteristics (SPC) [online]. Available from URL: http://www.medicines.org.uk/EMC/searchresults.aspx?term=methylphenidate&searchtype=QuickSearch [Accessed 2009 Nov 13]
MHRA. Download Drug Analysis Prints (DAPs) [online]. Available from URL: http://www.mhra.gov.uk/home/groups/public/documents/sentineldocuments/dap_1293013819922.pdf [Accessed 2009 Nov 13]
Consumers’ adverse medicine events line [online]. Available from URL: http://www.nps.org.au/consumers/publications/medicines_talk/mt8/consumers_adverse_medicines_events_line [Accessed 2010 Feb 7]
Acknowledgements
We would like to thank Dr Carol Gilmour, all clinic and medical staff, and respondents who took part in the research. No sources of funding were used to prepare this manuscript. None of the authors have any conflicts of interest to declare.
Author information
Authors and Affiliations
Corresponding author
Electronic supplementary material
Rights and permissions
About this article
Cite this article
Tobaiqy, M., Stewart, D., Helms, P. et al. Parental Reporting of Adverse Drug Reactions Associated with Attention-Deficit Hyperactivity Disorder (ADHD) Medications in Children Attending Specialist Paediatric Clinics in the UK. Drug-Safety 34, 211–219 (2011). https://doi.org/10.2165/11586050-000000000-00000
Published:
Issue Date:
DOI: https://doi.org/10.2165/11586050-000000000-00000