Parents report on stimulant-treated children in the Netherlands: Initiation of treatment and follow-up care

Transcription

1 3 Parents report on stimulant-treated children in the Netherlands: Initiation of treatment and follow-up care Adrianne Faber Luuk J Kalverdijk Lolkje TW de Jong-van den Berg Jacqueline G Hugtenburg Ruud B Minderaa Hilde Tobi J Child Adolesc Psychopharmacol, in press

2 Chapter 3 Abstract Objectives To describe current practices around initiation and follow-up care of stimulant treatment among stimulant-treated children in a nationwide survey among parents. Methods 115 pharmacies detected current stimulant users <16 years in their pharmacy information system and sent parents a questionnaire on their child s stimulant treatment. Results Parents returned 924 of 1307 questionnaires (71%). The median age of the stimulant users was 10 years and 85% were boys. 91% was diagnosed with attention-deficit/hyperactivity disorder (ADHD). In 77% of the cases, child or parents received other therapy besides stimulants. 21% received psychotropic co-medication; melatonin (11%) and antipsychotics (7%) were mentioned most frequently. Stimulant use was primarily initiated by child psychiatrists (51%) and pediatricians (32%), but most children received repeat prescriptions from GPs (61%). Of the 924 children, 19% did not receive any follow-up care. Transfer of prescribing responsibility increased the risk of not receiving follow-up care. The 732 children (79%) who were monitored visited a physician approximately twice a year. During follow-up visits pediatricians performed physical check-ups significantly more often. Conclusions Stimulant treatment in the Netherlands is mainly initiated by specialists such as child psychiatrists and pediatricians. In the current study, follow-up care for stimulant-treated children in the Netherlands appeared poor, suggesting an urgent need for improvement. 26

3 Initiation of treatment and follow-up care Introduction Stimulants are the first choice pharmacotherapeutic intervention in the treatment of attention-deficit/hyperactivity disorder (ADHD) and the most frequently used psychotropic medication in children. The considerable increase of stimulant use in several Western countries in the nineties, as evident from prescription database research, has resulted in public concern about the appropriateness of stimulant treatment in children [1-4]. These concerns were further heightened by the increased use in preschoolers and the increased duration of stimulant therapy [1,3]. Although stimulants have been used since the 1960s, still the impact of long-term stimulant use is unclear [5]. The largest and longest randomized clinical trial of stimulant medication in children with ADHD had a duration of 14 months and showed continuous effectiveness and frequent, yet minimal harmful, side-effects [6]. However, 14 months is still relatively short compared to the duration of time that many children are prescribed stimulant medication. As the general prevalence increased, both in the lay media and medical journals questions were raised about the appropriateness of the treatment and the competence of the initiating physician [2,7,8]. A study from the USA reported that family practitioners prescribed stimulants more often than pediatrics and psychiatrists, and Miller et al. reported that between 1990 and % of the first stimulant prescriptions in Canada were prescribed by GPs [2,9]. In the Netherlands, the lay media claimed excessive prescribing of stimulant medication by GPs, which caused considerable concern and discussion. Thereupon the Health Council of the Netherlands stated that initiation of stimulant treatment should be restricted to physicians experienced and trained in diagnosing and treating ADHD and co-morbid disorders, like child psychiatrists and pediatricians [10]. Several treatment guidelines for ADHD recommend that multimodal interventions, most of the time including stimulant medication, should be available to all children and usually are indicated [11-14]. Guidelines mostly rely on the results of the largest randomized controlled trial of ADHD treatment, the Multimodal Treatment Study of Children with ADHD [6]. In the MTA stimulant medication alone and stimulants combined with behavioral therapy were found to be superior in improving ADHD symptoms compared to care as usual. Several factors were thought to account for this difference, like monthly check-ups and dose titration strategies in the medication management arm, while children treated in the care as usual arm visited their physician on average 2.3 times per year. It is generally agreed that optimal stimulant treatment presupposes regular contact of the treating physician with the child, parents and school, using rating scales for monitoring effectiveness, adjusting stimulant dose if necessary and looking after possible side-effects. However, studies from the USA suggest that treatment services offered to children with ADHD may be determined by the 27

4 Chapter 3 type of treating physician rather than by established standards of care [9,15]. Hence, the gap between what is classified as care as usual in the MTA study and the care as usual in any regional setting warrants further investigation. Most in-depth research on initialization and follow-up of stimulant treatment is limited to groups of children selected for their diagnosis with ADHD, or their visits to certain officebased physicians [16-19]. Consequently, the results of these studies cannot be generalized to the total population of stimulant-treated children, nor to an international setting. The societal turmoil in The Netherlands, however, was based on studies from North America, as no information was available on the Dutch situation. Hence a nationwide survey was initiated to describe current practices around initiation and follow-up of stimulant treatment in children. Parents of stimulant-treated children were inquired after the initiation and follow-up care of stimulant treatment, using community pharmacies for recruitment to avoid bias for the initiating or treating physician. Methods The survey included only parents of stimulant-treated children in To obtain a nationwide sample of stimulant users irrespective of the prescribing physician, pharmacies were used for detecting stimulant users in their pharmacy information system and for sending a questionnaire to their parents or caregivers. All legal citizens of the Netherlands have a health insurance covering doctor fees, hospital stays, counseling, physical therapy, medication and other non-pharmacological treatments (e.g. treatments provided by clinical psychologists). Not all prescription drugs are fully reimbursed by each insurance company. Since all prescriptions from medical doctors are entered in the pharmacy database regardless of particular health insurance or reimbursement status of the medication, the pharmacy is a reliable source for detecting medication users. At the time of this study, immediate-release methylphenidate tablets and dexamphetamine compounded capsules were fully reimbursed. OROS-methylphenidate tablets became available in 2003, but required a co-payment from the patient. The study design and response patterns have been described in detail elsewhere [20]. In short, a nationwide sample of 115 pharmacies detected current users of methylphenidate and dexamphetamine in their computer system and sent a questionnaire to the parents in May Current users were defined as children younger than 16 years to whom at least two stimulant prescriptions were dispensed between November 1, 2002 and May 1, 2003, of which at least one prescription was in When this detection resulted in more than 15 28

5 Initiation of treatment and follow-up care current users, pharmacists used a random table provided by the researchers to select 15 children. In this way the maximum number of participants per pharmacy was manageable. The questionnaire contained open-ended and multiple choice questions and was tested among ten parents. Questions dealt with the key symptoms for stimulant treatment and the type of physician involved in prescribing stimulants. We also asked the parents whether their child would visit a doctor or was expected to visit a doctor with regard to the use of stimulant medication. In case the child received this follow-up care, parents were questioned about the frequency of visits and about physical examination and evaluation of effectiveness of stimulant treatment during the most recent visit. Furthermore, questions were asked about the child s age and sex, education, psychiatric diagnoses, co-medication and nonpharmacological therapy. The protocol was approved by the Medical Ethics Board of the University Medical Centre Groningen. Questionnaires were regarded unsuitable for analysis when the child was 16 years or older or when children of 12 years or older had not given written permission to send in the questionnaire. To investigate factors that might be associated with receiving follow-up care Pearson Chi Square or one-way ANOVA tests (two-tailed) were used and a p-value < 0.05 was considered statistical significant. Questionnaires were analyzed using SPSS Results Demographic characteristics Of 1307 questionnaires sent out by 115 pharmacies, 924 returned questionnaires were suitable for analysis (response rate: 71%). In 86% of the cases questionnaires were completed by the child s mother. Dutch was the first language for nearly all responding parents (97%). The median age of the stimulant-treated children was 10 years and the maleto-female ratio was approximately 5.5:1 (Table 1). Diagnosis and treatment The vast majority of the children (91%) were diagnosed with attention-deficit/hyperactivity disorder (ADHD) (Table 1). Parent who reported no ADHD diagnosis, reported mainly pervasive developmental disorder (44/84) and learning disorder (12/84) for diagnosis. Furthermore, 11 of the 84 parents reported that no diagnosis was established yet. Twentyeight percent of the children had two or more psychiatric diagnoses. Of the 924 children, 540 had received non-pharmacological therapy besides stimulants (58%). Therapy consisted of non-intensive training with a maximum of 2 hours per week in 49% of these children, and/or 29

6 Chapter 3 Table 1. Characteristics of current stimulant-treated children (N=924). Characteristic Category Age 1st quartile 9 years 2nd quartile (median) 10 years 3rd quartile 12 years % N Sex Boys Education Special education Assistance at school, but no special education Current diagnosis Attention-deficit/hyperactivity disorder Pervasive developmental disorder Learning disorder Oppositional defiant disorder Anxiety disorder Other No diagnosis (yet) Unknown or more diagnoses Psychotropic co-medication Yes Melatonin Antipsychotics Clonidine Antiepileptics Antidepressants Hypnotics/anxiolytics (excl. melatonin) Time since 1st stimulant prescription < 1 year to 2 years years Unknown Key symptoms for stimulant treatment Inattention Hyperactivity Impulsiveness Learning problems Anxiety Depression Sleep problems Tics Other

7 Initiation of treatment and follow-up care Table 1. Continued Characteristic Category % N Prescriber 1st stimulant prescription Child psychiatrist Pediatrician GP Other Unknown Is stimulant treatment monitored? Yes No Unknown physical therapy (34%) and/or intensive training for more than 2 hours per week (27%). Parents received counseling for the behavioral problems of their child in 571 cases (62%), being primarily individual parent training (78%), home training (33%) and/or group-based parent training (20%). In almost a quarter of the cases (23%), neither child nor parents received other therapy besides stimulants. 21% of the children received psychotropic comedication, including melatonin. In case melatonin was excluded 12% received psychotropic co-medication. Melatonin (10.8%) and antipsychotics (7.3%) were the most frequently mentioned co-medication. According to the parents, the child s inattention, hyperactivity, impulsiveness and/or learning problems were the key symptoms for stimulant treatment (Table 1). Stimulant treatment was primarily initiated by child psychiatrists and pediatricians. GPs provided repeat prescriptions for 61% of the children, child psychiatrists and pediatricians for 30% and 21% respectively. Fifteen percent of the children received repeat prescriptions from 2 or more different types of physicians. According to 264 parents (29%), their child experienced annoying side effects; sleep problems (52%) and loss of appetite (42%) were the most frequently mentioned side effects by these parents. More than half of the children used stimulants for over two years. Follow-up care Almost one out of five children (19%) did not receive follow-up care concerning treatment with stimulants (Table 1), meaning that no appointment was scheduled or requested by the medical doctor according to the parents. Children who received the first stimulant prescription and repeat prescriptions from the same type of physician, were significantly more likely to receive follow-up care than children with a transfer of prescribers (Table 2). 31

8 Chapter 3 Table 2. Factors associated with follow-up care (n = 924). Factor Category Follow-up care yes (%) or mean (sd) Test df p Total 79.2 Age child mean (sd) Follow-up care, no 10.9 y (sd 2.3) t-test Follow-up care, yes 10.4 y (sd 2.5) Gender child Male 79.4 Χ Female 78.0 Special education No 79.1 Χ Yes 79.5 Time since 1st stimulant prescription < 1 year 81.4 Χ years year 77.8 Number of diagnoses Χ or more 80.2 Psychotropic co-medication No 78.0 Χ Yes 83.9 Physician 1st stimulant prescription also involved in prescribing repeat prescriptions No 71.5 Χ 2 1 <0.001 Yes 84.8 Furthermore, children receiving follow-up care were slightly younger (p=0.02). No statistical significant association was found between receiving follow-up care and gender, special education, time since first stimulant prescription, the number of diagnoses and use of psychotropic co-medication. The 732 children who received follow-up care visited a physician on average twice a year, usually a child psychiatrist or a pediatrician (Table 3), and 5.3% visited two different types of physicians for follow-up care. The mean number of follow-up visits decreased with an increased period of stimulant use, from 3 visits per year for children who had used stimulants less than one year to 2 visits per year for children who had used stimulants for 1-2 years and 2 years or longer (one-way ANOVA, df 2, p<0.001). During follow-up visits pediatricians (93%) performed physical check-ups significantly more often than GPs (82%), child psychiatrists (80%) and other physicians (59%) (Χ 2 test, df 3, p<0.001). During the most recent visit, in 179 of 732 cases (25%) behavior rating scales 32

9 Initiation of treatment and follow-up care were used to evaluate the effectiveness of stimulant treatment. Usually both parents and teacher were asked to complete a rating scale. The use of rating scales declined with an increased period of stimulant use, from 41% among children who had used stimulants less than one year to 15% among children who had used stimulants for 2 years or longer (Χ 2 test, df 2, p<0.001). No statistical significant association was found between the use of rating scales and the type of physician visited. Table 3. Follow-up characteristics (N=732). Characteristic follow-up Category Number of follow-up visits per year 1st quartile 2 2nd quartile (median) 2 3rd quartile 4 % N Type of physician visited for follow-up Child psychiatrist Pediatrician GP Other Physical examination during last visit Weight Length Blood pressure Physician inquired about side effects Yes Evaluation effectiveness stimulant treatment by means of standardized questionnaire during last visit Yes Rating scale parents only Rating scale teacher only Rating scale both parents and teacher Discussion Stimulant treatment was primarily initiated by specialists (e.g. child psychiatrists and pediatricians), while GPs took care of most of the repeat prescriptions. Nearly one in every five current stimulant-treated children did not receive any follow-up care aimed at their stimulant use. 33

10 Chapter 3 In our study, 12% of the parents reported that stimulant treatment had been initiated by a GP, which is a low percentage compared to 41% in Canada [2]. Therefore, general concerns about the competence of the initiating physician appear to be unnecessary for the Dutch situation. According to the parents, stimulants were mainly used for ADHD, the indication for which these drugs are licensed. Of the children 28% had two or more psychiatric diagnoses, which is a low percentage compared to co-morbidity rates of over 50% reported elsewhere [21,22]. The presently reported low figures may be partially explained by under diagnosis of psychiatric disorders in this general population, a population in which not all children are thoroughly screened by child psychiatrists. For the majority of the children (77%) stimulant treatment was or had previously been combined with non-pharmacological therapy for the child and/or the parents. A study from the USA reported that in 47% of the visits stimulant users received mental health counseling and 22% psychotherapy [17]. The 21% psychotropic co-medication in the present study is consistent with the 19-25% in other studies, although it is unclear if these two studies included melatonin [23,24]. Another study from the Netherlands, based on a prescription database however, reported only 15% psychotropic co-medication among stimulant users [25]. Part of this difference may be attributable to incomplete data on melatonin as OTC medication in prescription databases. We were surprised to find that over 10% of the stimulant-treated children used melatonin, probably for sleep problems. Like many other hypnotics, melatonin is not approved for use in children. Actually, melatonin is not approved in the Netherlands at all, and safety data are lacking. All the more a reason for carefully monitoring these children. As far as we know, no literature is available about the prevalence of melatonin use in other countries. It would be interesting to study whether the frequent use of melatonin in stimulant-treated children is a typical Dutch phenomenon. The fact that almost 20% of the stimulant-treated children in our study were not monitored is worrisome. Transfer of prescribing responsibility, in most cases from specialist to GP, increased the risk of not receiving any follow-up care. These findings call for efforts to improve collaboration between primary and secondary care. At this point we agree with Ball et al. that GPs might take over prescribing responsibility after initiation and perform physical monitoring, but only in close liaison with the treating specialist [26]. However, our data show that having one prescriber is not a guarantee for receiving follow-up care. So, all prescribers, in particular child psychiatrists and GPs, need to reconsider the follow-up care they provide in addition to improving collaboration between specialists and GPs/other care providers. The children who did receive follow-up care visited a physician on average twice a year, which is similar to a study from the USA among children, with recently identified 34

11 Initiation of treatment and follow-up care ADHD, but in sharp contrast to the monthly check-ups in medication management arms of the MTA study [6,19]. Pediatricians were more likely to measure weight, length and blood pressure during a follow-up visit than child psychiatrists and GPs, probably because pediatricians perform these check-ups routinely. Other studies also reported differences between different types of physicians and type of follow-up services offered [9,15,17]. However, opposite to our findings, Hoagwood et al reported follow-up care was more likely to be provided by psychiatrists than GPs and pediatricians [9,17]. Our study described initiation and follow-up care of stimulant treatment in a populationbased sample of stimulant-treated youths in the Netherlands. However, the way study participants were recruited has some limitations. For some children initiation of stimulant treatment occurred more than two years before the survey, which might have introduced recall bias in their parents. It should be mentioned that the questionnaire was not available in minority languages, which might have hindered non-native speakers to respond. Another limitation of our study is that no information was available on how the child was assessed, no statements could be made about the appropriateness of the ADHD diagnosis. Nonetheless, the median age and male-to-female ratio in our sample recruited via community pharmacies, were very similar to those reported in studies based on large dispensing databases, on visits to office based physicians and in children identified with ADHD [2,16,25,27]. In the presented analyses, the nesting of children in pharmacies was ignored. This was done for several reasons: first the limited number of children per pharmacy (needed to guarantee high participation rates of the pharmacies) would have given numerical problems and secondly, many of the variables of interest were nominal. Lastly, there was no evidence of a pharmacy effect as investigated by: looking into variation, chi-square tests, and ANOVAs. Conclusions Stimulant treatment in the Netherlands is mainly initiated by specialists like child psychiatrists and pediatricians. Thus, major concern about GPs starting treatment frequently appears unnecessary. However, our study demonstrated that we should not only focus on the initiation of stimulant treatment, but even more on the follow-up care. This follow-up care for stimulant-treated children in the Netherlands appeared poor, suggesting an urgent need for improvement. A closer collaboration between primary and secondary care, supported by multidisciplinary guidelines clearly describing the criteria of good follow-up care and the responsibilities of different professionals involved, may be a good start to this improvement. 35

12 Chapter 3 Acknowledgments This study was funded by the Dutch National Health Insurance Board. References 1. Zito JM, Safer DJ, dosreis S, Gardner JF, Boles M, Lynch F. Trends in the prescribing of psychotropic medications to preschoolers. JAMA 2000;283: Miller AR, Lalonde CE, McGrail KM, Armstrong RW. Prescription of methylphenidate to children and youth, Can Med Assoc J 2001;165: Schirm E, Tobi H, Zito JM, de Jong-van den Berg LTW. Psychotropic medication in children: A study from the Netherlands. Pediatrics 2001;108:e25 4. Reid R, Hakendorf P, Prosser B. Use of psychostimulant medication for ADHD in South Australia. J Am Acad Child Adolesc Psychiatry 2002;41: Hechtman L, Greenfield B. Long-term use of stimulants in children with Attention Deficit Hyperactivity Disorder. Safety, efficacy and long-term outcome. Pediatr Drugs 2003;5: The MTA Cooperative Group. A 14-month randomized clinical trial of treatment strategies for Attention- Deficit/Hyperactivity Disorder. Arch Gen Psychiatry 1999;56: Safer DJ. Are stimulants overprescribed for youths with ADHD? Ann Clin Psychiatry 12:55-62, Accardo P, Blondis TA. What's all the fuss about Ritalin? J Pediatr 2001;138: Hoagwood K, Kelleher KJ, Feil M, Corner DM. Treatment services for children with ADHD: A national perspective. J Am Acad Child Adolesc Psychiatry 2000;39: Health Council of the Netherlands. Diagnosis and treatment of ADHD. The Hague: publication no 2000/24, Dutch Psychiatric Association. Guideline diagnosing and treatment of ADHD (children and adolescents). Amsterdam: Boom, National Institute for Clinical Excellence. Guidance on the use of methylphenidate for Attention Deficit/Hyperactivity Disorder (ADHD) in childhood. London, American Academy of Pediatrics. Clinical practice guideline. Treatment of the school-aged child with Attention- Deficit/Hyperactivity Disorder. Pediatrics 2001;108: Taylor E, Döpfner M, Sergeant J, Asherson P, Banaschewski T, Buitelaar J, et al. European clinical guidelines for hyperkinetic disorder first upgrade. Eur Child Adolesc Psychiatry 2004;13,SI: Rushton JL, Fant KE, Clarck SJ. Use of practice guidelines in the primary care of children with Attention- Deficit/Hyperactivity Disorder. Pediatrics 2004;114:e Goodwin R, Gould MS, Blanco C, Olfson M. Prescription of psychotropic medications to youths in office-based practice. Psychiatr Serv 2001;52:

13 Initiation of treatment and follow-up care 17. Hoagwood K, Jensen PS, Feil M, Vitiello B, Bhatara VS. Medication management of stimulants in pediatric practice settings: A national perspective. J Dev Behav Pediatr 2000;21: DosReis S, Zito JM, Safer DJ, Soeken KL, Mitchel JW Jr, Ellwood LC, et al. Parental perceptions and satisfaction with stimulant medication for attention-deficit hyperactivity disorder. J Dev Behav Pediatr 2003;24: Gardner W, Kelleher KJ, Pajer KA, Campo JV. Follow-up care of children identified with ADHD by primary care clinicians: A prospective cohort study. J Pediatr 2004;145: Faber A, de Jong van den Berg LTW, Netjes KA, Kalverdijk LJ, Minderaa RB, Tobi H. Recruitment of parents and physicians of stimulant-using children via community pharmacies is successful. J Clin Epidemiol 2005;58: 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: Pliszka SR. Psychiatric comorbidities in children with Attention Deficit Hyperactivity Disorder. Implications for management. Paediatr Drugs 2003;5; Olfson M, Marcus SC, Weissman MM, Jensen PS. National trends in the use of psychotropic medications by children. J Am Acad Child Adolesc Psychiatry 2002;41: Bhatara VS, Feil M, Hoagwood K, Vitiello B, Zima B. Datapoints: Trends in combined pharmacotherapy with stimulants for children. Psychiatr Serv 2002;53: Faber A, de Jong- van den Berg LTW, van den Berg PB, Tobi H. Psychotropic co-medication among stimulanttreated children in the Netherlands. J Child Adolesc Psychopharmacol 2005;15: Ball C. Attention-deficit hyperactivity disorder and the use of methylphenidate. A survey of the views of general practitioners. Psychiatr Bull R Coll Psychiatr 2001;25: Sawyer MG, Rey JM, Graetz BW, Clarck JJ, Baghurst PA. Use of medication by young people with attentiondeficit/hyperactivity disorder. Med J Aust 2002;177:

14