Thalidomide / lenalidomide: mandatory special prescription form
In the wake of the European marketing authorisation of the thalidomide and lenalidomide medicinal products, Thalidomide Celgene™ and Revlimid®, Germany has regulated the prescription and dispensing modalities for thalidomide and lenalidomide medicinal products by changing the pharmaceutical prescription order / Arzneimittelverschreibungsverordnung (AMVV) / and pharmacy operating rules / Apothekenbetriebsordnug (ApBetrO)/.
- Since 08 February 2009, the following regulation has been enacted in Germany for any medicinal products containing the active substances thalidomide or lenalidomide: only the numbered two-part special prescription form of the BfArM, referred to as “T-prescription form“, may be used. T-prescription form may not be used for the prescription of any other medicinal product.
- The BfArM hands out T-prescription forms only to individual physicians who have provided evidence to the BfArM of their medical licence and who have submitted a declaration stating that they have received the medical information sheets about thalidomide and lenalidomide, that they will follow the pertinent safety measures and that they have the knowledge necessary to be able to prescribe medicinal products of this type.
- Physicians receiving T-prescriptions by the BfArM are registered in the T-Register (database-aided). By consecutive T-prescription numbers
/ T-Rezeptnummer / prescription forms are assigned to the individual physician to whom they were issued by the BfArM so that they can be traced back to each physician.
- A pharmacy will dispense thalidomide or lenalidomide pharmaceuticals only if the prescribing physician has explicitely confirmed, by marking the respective two fields on the T-prescription, that all safety requirements in the SmPC / Fachinformation / of the relevant product will be met and that the patient has been given the relevant medical information material.
- The prescribing physician is required to specify in the designated fields on the T-prescription form whether the prescription is intended for in-label use or for off-label use.
- Thalidomide and lenalidomide pharmaceuticals are excluded from the mail order system / Versandhandel / in Germany.
- A quantitative evaluation of in-label use and off-label use of thalidomide and lenalidomide pharmaceuticals is made by the BfArM T-Register-unit on the basis of the T-prescription copies (second page of T-prescription form) sent to the BfArM by pharmacies every three months.
- The statistical results will be communicated to the European Medicines Agency (EMA) every six months.