T-prescriptions
Tasks
Medicinal products containing lenalidomide, pomalidomide, or thalidomide as the active substance may only be prescribed on special prescription forms, so-called T-prescriptions. In Germany, control of the prescription and dispensing of these medicinal products belongs to the tasks of the Federal Opium Agency at the Federal Institute for Drugs and Medical Devices.
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.
Lenalidomide
Marketing authorisation on Revlimid®
Pomalidomide
Marketing authorisation on Imnovid®
Thalidomide
Marketing authorisation on Thalidomide Celgene®
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 Federal Institute for Drugs and Medical Devices announcements.
Physicians who want to prescribe medicinal products with the active substances lenalidomide, pomalidomide, or thalidomide have to request T-prescription forms from the Federal Institute for Drugs and Medical Devices in writing.
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 Federal Institute for Drugs and Medical Devices in at least weekly intervals.
Information material (patient brochures, summaries of product characteristics, package leaflets, treatment record booklets, checklists etc.) can be requested from the respective marketing authorisation holder.
Forms
The form for the initial request of T-prescriptions can be found under the following link:
Each delivery of T-prescriptions is accompanied by a form for the follow-up request for T-prescriptions. This form can also be found at the following link:
T-prescription template
The so-called "T-prescriptions" are special prescriptions that may only be used to prescribe drugs with the active substance lenalidomide, pomalidomide and thalidomide.
They have some special features compared to other prescriptions:
- They are in two parts (original and carbon copy).
- They are personalized.
- They are numbered (T prescription number).
- They contain boxes to tick, which means that the prescribing physicians confirm compliance with the legally prescribed safety regulations.
The T-prescription template is available for download here:
The form of the T-prescription has been published in accordance with Article 3a (6) AMVV (see Federal Gazette, official part of July 12, 2022).
The T-prescriptions have been issued in this form by the Federal Institute for Drugs and Medical Devices since August 8, 2022. The T-prescriptions issued before August 8, 2022 can still be used and are valid indefinitely.
T-prescription procedure
Physicians who wish to prescribe drugs with the active substance lenalidomide, pomalidomide or thalidomide for the first time must confirm to the Federal Institute for Drugs and Medical Devices that they are familiar with the medical information materials on lenalidomide, pomalidomide and thalidomide and that they will comply with all safety measures in accordance with the current technical information on corresponding finished drugs when prescribing them. In addition, they must also certify that they have sufficient expertise to prescribe according to Section 3a Ordinance on the Prescription of Medicinal Products "Arzneimittelverschreibungsverordnung" (AMVV).
A first request form is required for this purpose
completely filled in and sent by mail to the Federal Institute for Drugs and Medical Devices together with an officially certified copy of the licence to practise medicine.
Federal Institute for Drugs and Medical Devices will then send you the T-prescriptions.
What has to be observed when prescribing on T-prescriptions is regulated in Section 3a of the Ordinance on the Prescription of Medicinal Products (AMVV).
Patient Brochures
Patients being treated with lenalidomide, pomalidomide or thalidomide can find information on their therapy using the "Schulungsmaterial". The educational material are only available in German.
Information sheets and checklists
Physicians prescribing lenalidomide, pomalidomide, or thalidomide must adhere to the legally stipulated safety requirements and have to advise their patients extensively prior to beginning treatment.
The requirements of the pregnancy prevention programmes for thalidomide, lenalidomide and pomalidomide must be fulfilled by all female and male patients. The information material for physicians and patients is provided by the respective marketing authorisation holder.
Information sheets and checklists for the pregnancy prevention programmes that summarise the important information for each category of patient group (men, women of childbearing potential, and women of non-childbearing potential) can also be downloaded here (only available in German).