ABDA Calls for Uniform Regulations for T-Prescriptions

The German Federal Association of Pharmacists (ABDA) has expressed concerns regarding potential inconsistencies in the upcoming regulations for T-prescriptions, particularly as they relate to electronic and paper formats. Since January 1, 2024, electronic prescriptions (E-prescriptions) have been mandatory for standard medical prescriptions, and from July 1, 2024, T-prescriptions are also expected to be issued electronically.

The proposed amendments to the Medicines Prescription Regulation (AMVV) include provisions for T-prescriptions to be issued electronically via the telematics infrastructure. However, the ABDA has criticized the draft regulations for requiring different mandatory information depending on whether the prescription is in paper or electronic form.

The 22nd amendment to the AMVV outlines that T-prescriptions, which are categorized as special prescriptions, will be allowed in electronic format. While the validity period for both electronic and paper T-prescriptions remains the same--up to six days from the date of issuance--there are notable differences in the information required on each format.

Specifically, under the new electronic prescription rules, doctors will need to indicate whether the treatment falls outside the approved application area. In contrast, when using the traditional paper form, physicians must check a box to confirm that the treatment is within the approved area. The ABDA argues that this requirement is unnecessary, citing that off-label use occurs in less than 1.5% of cases.

The ABDA has further stated that having different minimum requirements for electronic and paper T-prescriptions is impractical. Such discrepancies could create uncertainties for pharmacists reviewing T-prescriptions, increasing the likelihood of reimbursement issues with health insurance providers.

The organization advocates for standardizing the prescription requirements regardless of the format used, suggesting that physicians should only need to indicate if a treatment is outside the approved application area when necessary.

Previously, in December 2024, the ABDA raised these concerns with the Federal Ministry of Health (BMG) regarding the draft regulations, but their feedback was not incorporated. They are now reiterating their position as the Health Committee of the Federal Council considers the amendment on its agenda.

The implementation of electronic T-prescriptions is anticipated to simplify the prescribing process for physicians. Unlike paper prescriptions, electronic versions will not require doctors to confirm that the necessary medical information about specific medications, such as Lenalidomide, Pomalidomide, or Thalidomid, is available, nor will they need to validate compliance with security measures as per current guidelines.

According to the BMG, eliminating these requirements could save medical professionals approximately EUR1,300 annually.