Paediatric methylphenidate (Ritalin®) restrictive conditions of prescription in France

Methylphenidate (Ritalin ®, Novartis Pharma, 92500 Rueil Malmaison Cedex, France) is the only psychostimulant approved in France, since July 1995, for the treatment of attention deficit hyperactivity disorder (ADHD) in children aged 6 years and over. It is available only as a short-acting 10-mg tablet. Prescription and distribution conditions are restricted, with hospital-only prescription for the initial treatment and yearly consultations. Only neurologists, psychiatrists and paediatricians are allowed to prescribe methylphenidate, which is covered by the ‘narcotics’ schedule. Drugs in this schedule, have a high abuse potential with severe psychological or physical-dependence liability. Consequently, pharmacists dispense methylphenidate, for period of 28 days, with ‘secured’ prescriptions. The initial prescription can be renewed by a family practitioner for a maximum period of one year. We used the French pharmacovigilance database of spontaneous adverse drug reactions (ADRs) reported between July 1995 and December 2001 to evaluate the safety of methylphenidate. Among the 21 ADRs reported, assessment was possible for 16 of them caused by methylphenidate (14 children and 2 adults). Most ADRs were mild, resolved promptly, and affected children (10 boys and 4 girls, medium age, 9.07; range, 5–13) treated with customary doses. Eight ADRs were neurological or psychiatric reactions (convulsions [n = 2], irritability/agitation [n = 1], insomnia [n = 1], tics [n = 1], tiredness [n = 1] and headache [n = 1]). One of them concerned a girl who used to present with hyperactivity during the drug day-off. Four cutaneous ADRs were reported (three eruptions and one alopecia) with rapid recovery. In the context of a suicide attempt, a 13-year-old-girl ingested 100 mg of methylphenidate without sequelae. Two ADRs occurred in adults: one intentional overdose with 600 mg of methylphenidate with complete recovery and one consisting of pulmonary hypertension. The incidence of ADRs for methylphenidate in France did not increase during the 6 years studied. In France, the number of patients treated with methylphenidate is estimated to be around 4 500 in 2001 (1 800 in 1997) [1]. Of which, approximately 0.03% (0.019% in 1997–0.047% in 2001) were 6–18-year-old-schoolchildren [2], quite similar to British data in 1995 [3]. In contrast, in the USA, methylphenidate use in public schools is much greater and increasing. Approximately 2.8% (or 1.5 million) of US youths aged 5–18 were prescribed methylphenidate in mid-1995 [4]. The prevalence of methylphenidate treatment for ADHD in Maryland was estimated to be 3.07% of public school students in 1998 [5]. The prevalence of psychostimulant medication usage (methylphenidate particularly), in preschool-aged US children more than doubled in 5 years [6]. These variations can relate to different reasons. Substantial differences in prevalance and assessment of ADHD [7], in Europe, diagnostic criteria used in the diagnosis is the ICD-10 clinical description, which is more restrictive than the DSM IV criteria of the American Psychiatric Association used mostly in the USA [8, 9]. Treatment of this heterogeneous and controversial disorder of unknown aetiology is not widely accepted in some European countries, for several reasons: confusions in the definition and understanding of the disorder, public hostility with regards to the use of psychotropic medication (especially psychostimulants) in children and lack of data about the safety of methylphenidate in long-term use. Legislative differences between countries are also relevant. For example, in Maryland (USA) prescriptions for methylphenidate are written legally by paediatricians, family practitioners, psychiatrists, neurologists and nurse practitioners [5]. In the UK, there are no guidelines as to who is responsible for the prescribing and monitoring of methylphenidate. General practitioners, as well as specialists, can initiate and monitor the treatment. Although, the National Institute for Clinical Excellence advised that ‘treatment with methylphenidate should only be initiated by child and adolescent psychiatrists or paediatricians with expertise in Attention Deficit/Hyperactivity Disorder, but continued prescribing and monitoring may be performed by general practitioners, under shared care arrangements with specialists’[10]. General practitioners share the same view [11]. Thus, a large scale of practitioners may lead to overdiagnosis of ADHD, an overuse or an inappropriate prescription of methylphenidate. Poulin [12] and Garland [13] report a non-medical stimulant use of a subset of adolescents whom apparently misused or abused their stimulant treatment for its recreational potential or currency as a street drug. In the absence of good published data on long-term treatment, the current French prescription and dispensing regulations could be a model for other countries.