At the time of writing (the spring of 2016), i.e. over 18 months after the publication of the GEBU article on the use of methylphenidate by adults, this drug is increasingly being prescribed to adults suffering from ‘ADHD’. The registration authority has not authorised the drug to be marketed for this indication, but apparently this agency is unable to communicate the refusal of such trade authorisations to doctors, pharmacists and users. Does the registration authority also regard rejected indications as ‘trade secrets’? And if so, should not legislation be introduced to ensure that this information is also made publicly available?
Even though the registration authority has refused marketing authorisation, the remarkable situation has arisen that European psychiatrists have included medical treatment with methylphenidate as the drug of first choice in their guideline on ‘ADHD’ among adults.6
The Dutch health inspectorate does not consider itself responsible for monitoring the prescription of drugs for which a marketing authorisation has been refused.
Off-label use of drugs is covered by Dutch health insurance unless a drug has not been authorised for any indication, or if, after authorisation, the evaluation for the Dutch drug reimbursement system (Geneesmiddelenvergoedingssysteem or GVS) has concluded that it should be reimbursed only for limited indications. The Dutch National Health Care Institute has imposed no limitations for methylphenidate, and the drug has been authorised in the Netherlands, albeit for a different use. This implies that the use of methylphenidate by adults is covered by Dutch health insurance to the maximum limit indicated in the GVS.
In practice, medications that have been authorised for use by adults are usually prescribed off-label to children. The situation for methylphenidate for adults with ‘ADHD’ is different: methylphenidate has been authorised for the treatment of children and adolescents with ‘ADHD’, but not for adults with ‘ADHD’. Nevertheless, health insurers do reimburse the use of methylphenidate by adults with ‘ADHD’, even though no authorisation has been issued for this indication.
It is difficult to understand the positions taken by the abovementioned parties, i.e. the registration authority, the developers of the European psychiatric guidelines, the Dutch health inspectorate and the health insurers. We regularly wonder how is this possible. It seems not unlikely that the current situation, i.e. off-label prescription of a drug for which marketing authorisation has been refused, causes confusion among patients and doctors. Apparently, none of the above parties is able to communicate the refusal of authorisation to the professional associations. Does this mean that the manufacturer is the only party able to do so as long as the drug has been authorised?
Randomised placebo-controlled studies into the medical treatment of psychiatric disorders have shown that the effect of placebos is considerable. This has been shown, inter alia, for antidepressants (Gebu 2002; 36: 51-59), ADHD drugs for children (Gebu 2012; 46: 121-129) and drugs for the treatment of dementia (Gebu 2005; 39: 137-138). Nevertheless, these drugs are being prescribed on a massive scale. This suggests that both doctors and patients feel a need to use placebos. It is understandable that psychiatrists do not like to be in a situation where they have nothing to offer, and want to provide their patients with some medication, even if it is only a placebo. However, the registration authority has concluded that the balance between efficacy and side-effects of methylphenidate to treat ‘ADHD’ among adults is negative, in other words, the drug has more side-effects than effects. Such a drug is not a placebo but a nocebo. It is not for nothing that this drug is controlled under the Dutch opiates act and cannot be moved across national borders without a Schengen declaration. It appears that the safety of this drug for patients is being disregarded.
- Productinformatie methylfenidaat (Concerta®), via: www.cbg-meb.nl, Geneesmiddeleninformatiebank.
- Dehue T. Betere mensen. Amsterdam: Atlas Contact, 2014.
- Kooij SJJ, et al. European consensus statement on diagnosis and treatment of adult ADHD: The European Network Adult ADHD. BMC Psychiatry 2010; 10: 67.
*The literature refers to the Dutch text