Hemophilia products in the pharmacy

Since 1 September 2020, people with hemophilia in Germany obtain their clotting factors from a pharmacy instead of directly from the hemophilia treatment center. For the pharmacy this means three duties under Section 17 (6a) of the Pharmacy Operations Regulation (ApBetrO): it records purchase and dispensing batch by batch, it reports every dispensing with product, batch, quantity, date and patient details to the prescribing physician, and it retains these records for thirty years. The report may be electronic or in writing; software with a scanner produces record and report in a single step.

Legal status: September 2026

Why clotting factors trigger special duties in the pharmacy

Until August 2020 most people with hemophilia in Germany did not obtain their factor products through a pharmacy: the hemophilia centers ordered them directly from the manufacturer and handed them to their patients. The Act for More Safety in the Supply of Medicines (GSAV) ended that exception. Since 1 September 2020 pharmaceutical companies may no longer supply clotting factor preparations directly to physicians; Section 47 of the Medicinal Products Act (AMG) expressly excludes them from direct distribution. The route now runs through the pharmacy.^{3, 6}

With the distribution channel, part of the traceability chain moved into the pharmacy. Clotting factors are blood products or recombinant medicinal products given over decades; every batch must be traceable to the individual patient. The duties that rested with the center alone until 2020 are now shared between pharmacy, patient and physician. The pharmacy's duty to report to the prescribing physician was introduced by the GSAV as early as 16 August 2019; it became relevant in practice with the change of distribution channel a year later.^{1, 8}

For the individual pharmacy this remains a rare event: a few thousand people in Germany live with severe hemophilia, and many of them are supplied by a small number of specialized pharmacies. Precisely because the case is rare, it pays to define the workflow once instead of working it out at every dispensing.

The duties at a glance

Four duties of the pharmacy from a single provision, plus their counterparts for patient and physician. The table gives the provisions in short form.

Who	What	Legal basis	Deadline
Pharmacy – purchase	Records, when obtaining blood preparations, sera from human blood and hemophilia medicines: name, batch designation and quantity, date of purchase, name or company and address of the supplier.	Section 17 (6a) sentence 1 ApBetrO¹	at every purchase
Pharmacy – dispensing	Records at dispensing: name, batch designation and quantity, date of dispensing, name and address of the prescribing physician, surname, first name, date of birth and address of the patient.	Section 17 (6a) sentence 1 ApBetrO¹	at every dispensing
Pharmacy – report	Transmits to the prescribing physician after dispensing a hemophilia medicine: name of the medicine, batch designation and quantity, date of dispensing, surname, first name, date of birth and place of residence of the patient – electronically or in writing.	Section 17 (6a) sentences 2 and 3 ApBetrO¹	after dispensing
Pharmacy – retention	Retains the records of purchase, dispensing and report.	Section 22 (4) ApBetrO²	30 years
Patient in home treatment	Documents every administration; the physician providing long-term treatment checks the documentation at least once a year. The pharmacy report is the counterpart against which the center reconciles these records.	Section 14 (2a) TFG⁴	annual physician review
Prescribing physician, hemophilia center	Brings pharmacy report and patient documentation together and reports patient numbers and total consumption annually to the German Hemophilia Registry.	Section 21 (1a), Section 21a TFG^{5, 10}	by 1 July of the following year

The workflow in the pharmacy: from prescription to report

Seven steps, four of which are documented. The workflow applies to community pharmacies; hospital pharmacies supplying a center in their own building know it in a similar form.

The prescription arrives. It is usually issued by the hemophilia center that treats the patient long term; in an emergency or during a hospital stay it may come from another physician. The pharmacy checks the prescription like any other and clarifies open points with the prescribing practice.
The pharmacy orders the product from the manufacturer or a specialized wholesaler. Clotting factors are rarely kept in stock; delivery and storage conditions depend on the individual product.
On receipt of goods the pharmacy records the purchase: name, batch designation, quantity, date, supplier. The Data Matrix code on the pack contains the pharmaceutical registration number (PZN), batch designation and expiry date; a scanner reads all three in one pass.¹
At dispensing the pharmacy records product, batch, quantity and date, plus the prescribing physician and the patient details.¹
Counseling is part of it: storage at home, taking the product along when traveling, keeping the treatment diary in which the patient notes every administration. A patient who writes the batch into the diary helps the center reconcile it with the pharmacy report.
After dispensing, the report goes to the prescribing physician: name of the medicine, batch designation and quantity, date of dispensing, surname, first name, date of birth and place of residence of the patient. The law allows electronic and written form and sets no deadline; reporting immediately after dispensing makes sense so that the center has it before the patient documents the first dose.¹
The records of purchase, dispensing and report remain available in the pharmacy for thirty years.²

Two distinctions matter. First: purchase and dispensing must be recorded for all blood preparations, sera from human blood, preparations from other substances of human origin and hemophilia medicines. The report to the physician is required only for medicines for the specific therapy of coagulation disorders in hemophilia – not for human albumin or immunoglobulins, for instance.^{1, 7}

Second: the recipient of the report is the prescribing physician, even if that is not the hemophilia physician. If another physician prescribed, for example in a hospital, Section 14 (3a) of the Transfusion Act obliges that institution to pass on the reason for treatment and its documentation to the physician treating the hemophilia. The pharmacy therefore reports to the prescriber; forwarding to the center is then the prescriber's task.^{1, 4}

What happens to the report at the center

The pharmacy report is one of two sources from which the hemophilia center reconstructs a patient's factor consumption. The other is the treatment diary in which the patient records every dose in home treatment and which the physician reviews at least annually. If dispensed quantity and documented doses match, the chain is closed; discrepancies point to forgotten entries, remaining stock or supply problems and are a topic for the next appointment.^{4, 9}

Both sources feed the annual report to the German Hemophilia Registry (DHR) at the Paul-Ehrlich-Institut: patient numbers by severity and age group and the total quantity of medicines administered, due by 1 July of the following year. More than 130 institutions report data on over 17,000 patients. For the pharmacy this means: a complete, prompt report saves the center follow-up queries and the patient questions at the next check-up.^{5, 10}

How the whole chain of center, patient, pharmacy and registry fits together is described on the knowledge page Digital documentation in hemophilia care.

Form, fax or software: how pharmacies report today

The law prescribes content, not form. In practice three routes have emerged. The first is a completed form sent by fax or post to the prescribing practice; pharmacy portals provide templates. It works without preparation, but every dispensing means copying by hand, every batch number is a source of error, and proof of transmission lies in the fax log.

The second route is recording in the pharmacy management system. It captures batches on receipt of goods and at dispensing, provided the batch is scanned; the report to the physician usually remains a separate step outside the system.

The third route is an application built specifically for these medicines: a scanner reads the Data Matrix code on the pack, the software adds patient and physician from the prescription, generates the report in a standardized form and transmits it encrypted to the center as soon as dispensing is confirmed. Centers without a connection receive the same report as a fax from the application. Record and report thus arise from one step, and retention over thirty years lies with the operator of the application rather than in a filing cabinet.

How pharmacies recognize a solution that holds up

All details of Section 17 (6a) ApBetrO in one step: name, batch, quantity, date, supplier, prescribing physician, patient – without a second entry for the report.
Report immediately after dispensing, electronically, with proof of time and recipient; a fax fallback for centers not yet connected.
Batch capture by scanner instead of copying: the Data Matrix code delivers PZN, batch designation and expiry date without error.
Thirty years of availability of the records, with export capability and an operator that commits to that period.
Data protection matching the data: the report contains name, date of birth and place of residence. Encrypted transmission and storage, servers in Germany, a permission model that shows each staff member only their part.
No intervention in existing systems: an application that runs in the browser alongside the pharmacy management system can be introduced without an IT project.
Training of pharmacy staff and a contact person for the rare case, so that dispensing does not depend on one person in the pharmacy.
Extensibility to further groups of medicines with documentation duties, so the pharmacy does not need a separate tool for every duty.

How ScanDoc covers the workflow

smart medication ScanDoc is an application for pharmacies that dispense blood products and clotting factor preparations. smart medication provides the scanner, sets up the software and trains the team; no installation is needed, ScanDoc runs in the browser. The scanner captures PZN, batch designation and expiry date from the Data Matrix code, the software adds the physician and patient details required under ApBetrO and the Transfusion Act, and transmits the report encrypted to the hemophilia center immediately after dispensing. Centers not yet connected receive the report as a fax sent directly from ScanDoc.

The data are stored exclusively in encrypted form in an ISO 27001-certified data center in Germany; a permission model governs who in the pharmacy sees what. Statistics on dispensings and patients are available to the pharmacy at any time, and contracts, consent forms and supply mandates can be filed with the patient in ScanDoc and managed there. Many German pharmacies specializing in hemophilia products work this way (list by state); those planning to start find the way via the contact page.

Frequently asked questions from pharmacies

Which medicines are subject to the report to the physician?

Medicines for the specific therapy of coagulation disorders in hemophilia, i.e. clotting factor concentrates and the other hemophilia medicines. Purchase and dispensing of other blood preparations, sera from human blood and preparations from substances of human origin must also be recorded, but not reported to the physician. Human albumin or immunoglobulins do not trigger the reporting duty.

What exactly must the report contain?

The name of the medicine, the batch designation and the quantity dispensed, the date of dispensing, and the surname, first name, date of birth and place of residence of the patient. All five items are named expressly in Section 17 (6a) sentence 2 ApBetrO.

When and in what form must the report be made?

After dispensing, electronically or in writing. The regulation sets no deadline. Since the center reconciles the report with the patient's diary, reporting immediately after dispensing is the sensible standard.

May the pharmacy transmit the patient's name and place of residence without consent?

Yes. The transmission is a statutory duty of the pharmacy under Section 17 (6a) ApBetrO and needs no separate consent. The patient should know that the report is made; the pharmacy best informs them at the first dispensing. Pseudonymized details do not satisfy the provision.

Who receives the report if the hemophilia center did not prescribe?

The prescribing physician – that is the wording of the regulation. If a hospital prescribed, for example, its institution is obliged under Section 14 (3a) of the Transfusion Act to pass on the reason for treatment and its documentation to the physician treating the hemophilia. The pharmacy may inform the center in addition, but is not required to.

What must be recorded on receipt of goods?

Name, batch designation and quantity, the date of purchase, and the name or company and address of the supplier. A pharmacy that scans the batch on receipt has it at hand at dispensing without entering it again.

How long must the pharmacy retain the records?

Thirty years, under Section 22 (4) ApBetrO. The period matches the retention of the physician's administration records under Section 14 (3) of the Transfusion Act. With electronic records it therefore matters who guarantees availability over that period.

Does the pharmacy report replace the patient's treatment diary?

No. The diary documents administration, the report documents dispensing. Together they give the center the complete chain and the basis for the annual report to the German Hemophilia Registry. The pharmacy can encourage the patient to record every dose with its batch.

Glossary

GSAV: Gesetz für mehr Sicherheit in der Arzneimittelversorgung, the Act for More Safety in the Supply of Medicines (2019). Introduced the pharmacy's reporting duty and ended direct distribution of clotting factors to physicians on 1 September 2020.
ApBetrO: Apothekenbetriebsordnung, the Pharmacy Operations Regulation. Section 17 (6a) governs records and reports for blood preparations and hemophilia medicines, Section 22 (4) retention for thirty years.
TFG: Transfusionsgesetz, the Transfusion Act. Governs documentation of administration (Section 14), home treatment (Section 14 (2a)) and reporting to registry and Paul-Ehrlich-Institut (Sections 21, 21a).
AMG: Arzneimittelgesetz, the Medicinal Products Act. Section 47 defines which medicines pharmaceutical companies may supply outside pharmacies; clotting factor preparations have been excluded since the GSAV.
Prescribing physician: Recipient of the pharmacy report under Section 17 (6a) ApBetrO – usually the hemophilia center, in individual cases another prescriber.
Hemophilia center: Specialized institution that treats people with hemophilia long term, reviews the documentation and reports to the registry.
Specialized wholesaler: Wholesaler supplying clotting factors and other blood products to pharmacies, often the supply route alongside the manufacturer.
Blood preparation: Medicinal product obtained from human blood. Purchase and dispensing must be recorded; the report to the physician applies only to hemophilia medicines.
Data Matrix code: Two-dimensional code on the pack containing PZN, batch designation and expiry date, read by a scanner.
PZN: Pharmazentralnummer, the unique identifier of a medicine pack in Germany.
Batch: The quantity of a medicine produced in one manufacturing run, identified by the batch designation. The basis of traceability.
Traceability: The ability to follow every batch from manufacturer to patient and back – the purpose of all record-keeping duties in Section 17 (6a) ApBetrO.
Home treatment: The physician-supervised self-administration of factor products by the patient at home, the standard form of hemophilia therapy.
Treatment diary: The diary in which patients record every factor administration as well as bleeds and procedures, on paper or electronically.
DHR: Deutsches Hämophilieregister, the German Hemophilia Registry at the Paul-Ehrlich-Institut, legal basis Section 21a TFG; reported by the treating physicians by 1 July of the following year.

Sources

Section 17 (6a) Apothekenbetriebsordnung (records at purchase and dispensing, report to the prescribing physician, form of the report), German. www.gesetze-im-internet.de/apobetro_1987/__17.html, opens in a new tab
Section 22 (4) Apothekenbetriebsordnung (retention for thirty years of records under Section 17 (6a)), German. www.gesetze-im-internet.de/apobetro_1987/__22.html, opens in a new tab
Section 47 (1) sentence 1 no. 2 letter a Arzneimittelgesetz (distribution channel; blood preparations to hospitals and physicians "with the exception of clotting factor preparations"), German. www.gesetze-im-internet.de/amg_1976/__47.html, opens in a new tab
Section 14 Transfusionsgesetz (documentation), subsections 2a, 3 and 3a, German. www.gesetze-im-internet.de/tfg/__14.html, opens in a new tab
Section 21 Transfusionsgesetz (coordinated reporting), subsection 1a, German. www.gesetze-im-internet.de/tfg/__21.html, opens in a new tab
Deutsche Apotheker Zeitung 33/2020: "Gerinnungsfaktoren aus der Apotheke" (pharmacy distribution channel from 1 September 2020); Federal Ministry of Health: GSAV, German. www.deutsche-apotheker-zeitung.de/daz-az/2020/daz-33-2020/gerinnungsfaktoren-aus-der-apotheke, opens in a new tab · www.bundesgesundheitsministerium.de/gsav, opens in a new tab
Apotheke Adhoc, 20 November 2020: clarification on the reporting duty under Section 17 (6a) ApBetrO – hemophilia medicines only, not human albumin, German. www.apotheke-adhoc.de/rubriken/detail/apo-tipp/klarstellung-bei-der-meldepflicht-nach-17-abs-6a-apbetro-meldepflicht-nur-fuer-haemophilie-arzneimi/, opens in a new tab
DeutschesApothekenPortal: "Meldung Hämophilie-Arzneimittel" – reporting duty since 16 August 2019, electronic or written, German. www.deutschesapothekenportal.de/kundenberatung/arztinformationen/meldung-haemophilie-arzneimittel, opens in a new tab
Deutsche Hämophiliegesellschaft: "GSAV" – workflow for patients since 1 September 2020, reconciliation of the pharmacy report with the treatment diary, emergency stock at the center, German. www.dhg.de/gsav.html, opens in a new tab
Paul-Ehrlich-Institut: German Hemophilia Registry (DHR) – legal basis Section 21a TFG, more than 130 reporting institutions and 17,000 patients, deadline 1 July, German. www.pei.de/DE/regulation/melden/dhr/dhr-node.html, opens in a new tab

Knowledge Hemophilia products in the pharmacy: from prescription to report