E-Rezept for controlled drugs: what the BtMVV amendment means for pharmacies

Where things stand: controlled drugs stay on paper for now

Since 1 January 2024, electronic prescriptions have generally been mandatory for prescription-only medicines covered by statutory health insurance. Controlled-drug prescriptions are not yet part of the regular E-Rezept process. The current gematik FAQ says a pilot is planned for early 2027, followed by nationwide introduction.

The legal basis for this is the Betäubungsmittel-Verschreibungsverordnung (BtMVV). It governs how controlled drugs are prescribed, dispensed and recorded. Regular controlled-drug prescriptions are currently generally issued on the official three-part form. This paper prescription is different from the token printout of a regular E-Rezept.

For pharmacies, this means that alongside electronic prescriptions, prescriptions for controlled drugs are still arriving on paper for the time being.

What the BtMVV amendment proposes

The reform is intended to establish the legal framework for electronic controlled-drug prescriptions and associated records. The Federal Ministry of Health’s BtMVV procedure page documents drafts and related materials. Implementation requires the applicable law, technical processes and released software to align. A political announcement or cabinet decision alone does not mean the service has launched nationwide.

In its concept paper, gematik refers to a 5th amending ordinance to the BtMVV that the Federal Ministry of Health is working on. It uses this as the basis for describing the planned processes.

Digital processes may reduce manual transfers. They do not replace pharmaceutical checks or the specific documentation and control duties for controlled drugs.

Pilot planned for early 2027; nationwide launch still to follow

Gematik identifies early 2027 as the planned pilot period. Its FAQ does not specify an exact nationwide introduction date. Use that planning window as an indication; an older concept draft is not a binding instruction for dispensing today.

The gematik concept for the E-BtM-Rezept

In September 2025, gematik released a pre-publication of its functional concept for the feature „Elektronische Verschreibung von Betäubungsmitteln (E-BtM-Rezept)“ (electronic prescribing of controlled drugs). The document covers issuing, redeeming and documenting controlled drug prescriptions from doctors and dentists, as well as special cases such as corrections and emergency prescriptions.

The linked document is a preliminary draft from the Draft_eBtM_Rezept_25_1 series. It explains the concept at that stage. Specific software changes must follow current specifications and releases from your pharmacy management system provider (AVS, Apothekenverwaltungssysteme).

Useful for your preparation: gematik is also providing three demonstrators. They show the workflows in fictitious practice and pharmacy management systems and give you a first impression of what the process might look like on screen.

Which pharmacy workflows the concept draft describes

The overview below summarises the processes described in the gematik concept and shows what your team should look out for. It explains the linked 2025 concept draft and may differ from the solution ultimately introduced.

Retrieval and proof of dispensing

The concept describes retrieval most clearly for emergency prescriptions: as soon as the practice has signed the prescription, the pharmacy retrieves it from the Telematikinfrastruktur (TI), the secure network of the German healthcare system. It then completes the workflow and documents the E-BtM proof of dispensing. Exactly how retrieval will work technically in standard cases is left to the technical concept.

Partial quantities with special codes S and ST

For E-BtM prescriptions carrying the special codes S or ST, the concept provides for a separate rule on documenting partial quantities in the pharmaceutical billing agreement under § 300 SGB V (Book V of the German Social Code). The pharmacy must record the time of dispensing electronically for the first and every subsequent partial quantity.

Important for billing: the receipt from the E-Rezept specialist service (Fachdienst) is only retrieved once the last partial quantity has been dispensed. It may therefore make sense to agree within the team who keeps track of these cases until the final partial quantity.

Emergency prescriptions: when no E-BtM-Rezept can be issued

Current rules: Section 8(6) BtMVV permits emergency prescriptions only under specific conditions, limited to the quantity required for the emergency and excluding cases under Section 5. They must carry the required emergency designation. The pharmacy informs the prescriber without delay and, where possible, before dispensing; the required BtM prescription must follow without delay. This is not a general substitute for every technical outage.

Proposed future process: The electronic concept also considers exceptions, including technical problems during home visits or TI outages. The applicable conditions and fallback procedures must be checked against the final legal and implementation requirements.

Under the concept draft, the practice would subsequently issue the correct E-BtM prescription and make it available to the dispensing pharmacy. For home visits and TI outages, the draft concept, which is still at the concept stage, describes the following process for the pharmacy:

1. Dispense based on the printout According to the draft, the pharmacy dispenses the controlled drug in accordance with § 8 (6) BtMVV on the basis of the hand-signed patient printout.

2. Keep the access data safe Under the concept, this means the pharmacy already holds the prescription ID and access code for the prepared E-BtM emergency prescription.

3. Check the signature The plan is for the pharmacy to be able to check during the dispensing process whether the practice has signed the emergency prescription in the meantime.

4. Complete the case As soon as the prescription has been signed, the pharmacy is to retrieve it, complete the workflow and document the E-BtM proof of dispensing.

This part deserves particular attention, because according to the concept the pharmacy can only close the case once the practice has signed the emergency prescription.

Preparing your team for the E-Rezept for controlled drugs

Even without a fixed start date, there are some steps you can take now. That way, you avoid having to make the switch under time pressure later on.

1. Review the concept and demonstrators Have one designated person get to grips with the gematik concept and work through the demonstrators.

2. Talk to your AVS provider Ask when updates are expected and how partial quantities and emergency prescriptions will be handled.

3. Assign responsibilities Decide who regularly checks partial-quantity cases and emergency prescriptions that are still to be submitted.

4. Prepare standard operating procedure updates Draft the required additions. Activate new dispensing and documentation steps only after the necessary legal and technical clearance.

5. Plan training Everyone who dispenses controlled drugs should have run through the new process at least once before go-live.

You'll find general guidance on TI connection and AVS updates in the checklist Implementing the E-Rezept step by step. Controlled-drug documentation belongs in the designated, lawfully configured documentation system; clarify its implementation with your AVS provider. To make sure organisational checks, such as reviewing open cases, don't slip through the cracks, digital task management with clear accountability can help. In the Mediloon shift planner, you can schedule tasks as well as shifts, and in the employee app staff can see their shift and their tasks. This does not replace controlled drug documentation; it simply helps distribute work within the team. The exact range of features depends on the configuration in use.

Patient communication: be clear about what applies

Patients hear about the change in the media but rarely know the details. Expect questions at the counter and on the phone. A few consistent key messages help:

• Until the switch, controlled drugs will continue to be prescribed on paper.

• Gematik plans the pilot for early 2027. This is not a fixed nationwide introduction date.

• Even after the switch, the concept provides for a paper prescription in exceptional cases, such as home visits or TI outages, which can be redeemed at the pharmacy.

• For questions about how things work in an individual case, the pharmacy team is happy to help in person.

For recurring standard questions, such as opening hours, a chatbot can take pressure off the phone. The article AI chatbots in the pharmacy: possibilities and limits explains what such a system can and cannot do. Mediloon's chatbot Medi answers standard questions via WhatsApp, the website and the app, and hands conversations over to the pharmacy team together with the chat history. The exact range of features depends on the configuration in use.

Frequently asked questions

Sources

• Gematik: E-Rezept FAQ – current status and pilot planning, accessed 6 November 2026

• Federal Ministry of Health: BtMVV procedure and documents, updated 4 November 2026

• BtMVV: current consolidated text, accessed 6 November 2026

1. Feature: Verschreibung von Betäubungsmitteln (E-BtM), gemF_eRp_eBTM_V1.0.0_CC – gematik

2. E-Rezept: Mit App zum elektronischen Rezept – KKH, 12.02.2026

3. Prerelease: Draft_eBtM_Rezept_25_1 – gematik, 17.09.2025

4. Das elektronische Rezept – eRezept – BKK Mahle, 25.03.2026