Medicinal products containing lenalidomide, pomalidomide, or thalidomide as the active substance may only be prescribed on special prescription forms, so-called T-prescriptions.
Lenalidomide (June 2007), pomalidomide (August 2013), and thalidomide (April 2008) were licensed in centralised European procedures for the treatment of multiple myeloma, a cancer of the bone marrow. In addition to the proof of their efficacy, these active substances were found to be teratogenic (potential of causing malformations of embryo or foetus).
Thalidomide was responsible for the "Contergan catastrophe". In order to prevent the recurrence of malformations in newborn infants under such treatments, the European Commission has obligated the EU Member States in its licensing decisions, to adhere to special safety measures.
In Germany, these measures are laid down in the Ordinance on the Prescription of Medicinal Products ("Arzneimittelverschreibungsverordnung", AMVV) (Section 3a AMVV) and the Ordinance on the Operation of Pharmacies ("Apothekenbetriebsordnung", ApBetrO) (Section 17 sub-sections 2b and 6b ApBetrO) as well as in the BfArM's announcements.
Physicians who want to prescribe medicinal products with the active substances lenalidomide, pomalidomide, or thalidomide have to request T-prescription forms from the BfArM in writing.
Information material (patient brochure, Summary of Product Characteristics, Package Leaflet, treatment record booklet, checklists etc.) can be requested from the respective marketing authorisation holder. Such information concerning thalidomide can also be found on this homepage:
Pharmacies are obligated to keep carbon copies of the T-prescriptions of medicinal products they have dispensed. These carbon copies are then to be sent to the BfArM in at least weekly intervals.
The BfArM analyses the prescribing behaviour, especially with regard to total consumption as well as in-label and off-label use, and transmits this information semi-annually to the European Medicines Agency (EMA).