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null Fimea and Valvira provide pharmacies and physicians with guidance on conditions for prescription of ADHD medication and Sic notations

Fimea and Valvira provide pharmacies and physicians with guidance on conditions for prescription of ADHD medication and Sic notations

1.3.2021

The Finnish Medicines Agency Fimea and the National Supervisory Authority for Welfare and Health Valvira have provided pharmacies and physicians, respectively, with guidance on conditions for prescription concerning the prescription and dispensing of ADHD medication. The guidance also reminds of the principles of use of Sic notations.  The preparatory work has been guided by the Ministry of Social Affairs and Health.

The guidance reminds that Fimea may incorporate conditions to the marketing authorisation of a medicinal product when these are necessary to ensure the correct and safe use of the medicinal product. A summary of product characteristics (SPC) in line with the marketing authorisation may already include a condition for prescription. These conditions must be respected in the prescription of drugs.

There have been challenges with compliance with conditions for prescription because some of them have left room for interpretation as to what kind of specialisation or familiarity is required from the prescribing physician. Especially conditions for prescription of ADHD medication have caused problems with interpretation. The guidance provided by Fimea and Valvira clarifies the principles of prescribing ADHD medication to be taken into account in the updating of the conditions for prescription for ADHD medication. The authorities do not comment on progressive patient care and ADHD medication.

The guidance also reminds that a Sic notation in the prescription does not override a condition for prescription concerning a medicinal product. A Sic notation may be used, for example, when a prescriber wants to let a pharmacy know that they have intentionally exceeded the dosage instructions provided in the summary of product characteristics (SPC) or when the prescription deviates from widely accepted clinical practices.

If a prescription is not appropriate and does not comply with the conditions for prescription, the pharmacy must contact the prescriber. When necessary, the prescriber must cooperate with the pharmaceutical staff of pharmacies to ensure medication counselling for patients as well as safe, efficient and cost-effective pharmacotherapy. Cooperation between physicians and pharmacies must ensure implementation and continuation of appropriate pharmacotherapy.

Read more:

Fimea’s circular to pharmacies

Valvira’s guidance to prescribers (in Finnish)

Further information:

apteekit@fimea.fi (issues related to the operation of pharmacies)

Jukka Sallinen, Head of Unit, Fimea, jukka.sallinen@fimea.fi, +358 (0)29 522 3410 (issues related to marketing authorisations and conditions for prescription)

Kaisa Riala, Head of Unit, Valvira, kaisa.riala@valvira.fi, +358 (0)295 209 381 (supervision of prescribing practices)