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Knowledge
Digital documentation in hemophilia care

Who documents and reports what, which German laws govern it, and what changed in 2020.

In German hemophilia care, every administration of a clotting factor product is subject to documentation and reporting duties. The treating physician documents every administration batch by batch under Section 14 of the German Transfusion Act; in home treatment the patient keeps this documentation personally. The pharmacy reports every dispensing to the prescribing physician under Section 17 (6a) of the German Pharmacy Operating Regulations. The hemophilia treatment center reports annually to the German Hemophilia Registry. These records must be kept for thirty years. Electronic diaries and pharmacy software now map this chain digitally.

Legal status: September 2026

Why documentation in hemophilia is regulated so strictly

Clotting factor concentrates are blood products or recombinant medicinal products administered regularly over decades. The German Transfusion Act of 1998 drew the conclusion from the HIV and hepatitis C infections caused by blood products in the 1980s: every batch must be traceable from the manufacturer to the individual patient, for the entire period in which late effects can occur. This is why patient-related records must be kept for thirty years.1

What sets hemophilia apart is the nature of the therapy. Most products are administered intravenously, and hemophilia is practically the only condition in which patients learn in early childhood to give themselves these injections. Otherwise, intravenous administration is reserved for medical professionals in medical facilities. Subcutaneous therapies have been added in recent years, but intravenous home treatment remains the rule. The documentation therefore does not originate in the practice but in the patients’ everyday lives – and still has to meet the batch documentation requirements that apply to these medicinal products.

Who documents and reports what

Three parties, five duties, one act and one regulation. The table summarizes the provisions.

WhoWhatLegal basisDeadline
Treating physician Documents every administration of blood products and of medicinal products for the specific therapy of clotting disorders in hemophilia: patient identification, batch designation, PZN or name and manufacturer, date and time of administration. Section 14 (1) and (2) TFG1 30 years, then anonymize
Patient in home treatment Keeps the documentation personally; the physician reviews it at least once a year. Section 14 (2a) TFG1 annual review by the physician
Pharmacy Documents acquisition and dispensing and, after dispensing a hemophilia medicinal product, reports to the prescribing physician: name of the product, batch designation and quantity, date of dispensing, and the patient’s surname, first name, date of birth and place of residence – electronically or in writing. Section 17 (6) and (6a) ApBetrO2 30 years (Section 22 (4) ApBetrO)3
Hemophilia treatment center (treating physician) Reports to the German Hemophilia Registry the number of patients by disease severity and age group and the total quantity of medicinal products administered. Section 21 (1a), Section 21a TFG4, 5 by July 1 of the following year
Hemophilia treatment center (treating physician) Reports consumption and expiry of blood products and hemophilia medicinal products to the Paul-Ehrlich-Institut. Section 21 (1) TFG4 by March 1 of the following year

The path of the data since 2020

Until August 2020, most patients received their factor products directly from the hemophilia treatment center. The German act for more safety in the supply of medicines (GSAV) abolished this exception from the pharmacy distribution channel; since September 1, 2020, clotting factors for the treatment of hemophilia are dispensed through pharmacies.6 With the distribution channel, the documentation chain changed. It has had seven steps since then:

  1. The center issues the prescription to the patient.
  2. The patient fills the prescription at a pharmacy, usually one specializing in hemophilia products.
  3. The pharmacy obtains the product with manufacturer data from the manufacturer or specialty wholesaler and documents the acquisition.
  4. The pharmacy dispenses the product and records product, batch designation, quantity and date of dispensing.
  5. The pharmacy reports the dispensing with the patient details to the prescribing physician (Section 17 (6a) ApBetrO).
  6. The patient documents every administration in home treatment and transmits the records to the center, which reviews them at least annually (Section 14 TFG).
  7. The center consolidates the treatment documentation and reports annually to the German Hemophilia Registry (Section 21 (1a) TFG).

The pharmacy’s report contains the complete patient details because Section 17 (6a) ApBetrO requires them: surname, first name, date of birth and place of residence are named explicitly. This is not a matter of expediency but a legal obligation of the pharmacy. Pseudonymized data would not satisfy it – and would moreover prevent the assignment at the center and the registry report.2

The reporting duty applies only to medicinal products for the specific therapy of clotting disorders in hemophilia, not to other blood preparations such as human albumin.7

The German Hemophilia Registry

The German Hemophilia Registry (Deutsches Hämophilieregister, DHR) is the national patient registry for congenital hemostatic disorders. It has existed since December 2008 and is operated by the Paul-Ehrlich-Institut together with the Society of Thrombosis and Haemostasis Research (GTH), the German Hemophilia Society (DHG) and the Interessengemeinschaft Hämophiler (IGH). Since August 1, 2019, it has had its own legal basis in Section 21a TFG; the details are governed by the German Hemophilia Registry Ordinance. More than 130 facilities report data annually on more than 17,000 patients with hemophilia A and B, von Willebrand disease and other factor deficiencies.5

For the centers, the registry report is where the quality of documentation shows: consumption, bleeds and treatment regimens can only be reported if they were recorded completely over the year. Electronic diaries that continuously consolidate consumption per patient shorten this step from weeks to hours.

Paper or digital: what practice shows

The classic tool of home treatment is the paper diary that the patient brings to the check-up. It has three well-known weaknesses: it is incomplete, because entries are added late or forgotten; it is delayed, because the center only sees the course months later; and it is laborious to evaluate, because the data have to be typed up before they can be used for registry reporting and treatment decisions.

Electronic diaries address all three points. An analysis of treatment data from the electronic substitution diary smart medication, published in 2019 in the journal Hämostaseologie, reports on 663 patients from 30 German hemophilia treatment centers since 2012. From the documented factor consumption and joint bleeds, groups of patients could be distinguished for whom an adjustment of therapy or additional care was indicated – before the next appointment rather than after it.8 A study from Bonn with a different electronic diary found, after switching from paper, a 23 percent higher rate of submitted records and markedly higher documentation adherence, especially among adolescents and young adults.9

For the pharmacy, in turn, digital capture replaces copying batch numbers by hand: the data matrix code on the pack contains the PZN, batch designation and expiry date; a scanner reads all three in one step, and the report to the physician goes out immediately after dispensing – instead of as a fax at the weekend.

What digital tools must deliver in this chain

  • Batch-accurate capture with PZN, batch designation, date and time, as Section 14 TFG requires for the physician’s documentation, and in the pharmacy additionally quantity and date of dispensing.
  • Complete patient details in the pharmacy report, because Section 17 (6a) ApBetrO requires them – together with data handling that satisfies data protection: encryption, servers in Germany, access only for the parties involved.
  • Medical device status for diaries whose evaluations feed into treatment decisions.
  • Independence from manufacturer and product: patients switch products; the documentation must not be tied to one manufacturer.
  • Interfaces between patient, center, pharmacy and registry, so that the same administration is not recorded three times.
  • Everyday usability: works offline, no app store required, minimal effort for standard prophylaxis.
  • Thirty years of availability of the records – exportability and an operator that takes the retention period seriously.

How smart medication maps the chain

smart medication’s applications grew along this chain. smart medication eDiary is the electronic substitution diary for home treatment, registered as a medical device and free of charge for patients and physicians; OneClick reduces the documentation of standard prophylaxis to one click. ScanDoc handles batch capture by scanner in the pharmacy and the report to the center under Section 17 (6a) ApBetrO; centers without a connection receive the report as a fax from the same software. Via interfaces, pharmacy report and patient diary come together at the center and can be reported to the German Hemophilia Registry.

The interfaces are not limited to our own diary: the digital diary florio HAEMO, opens in a new tab is connected as well, so the documentation chain is also closed for patients who use a diary other than eDiary. For gene therapy, which brings its own documentation requirements, smart medication Gene provides a dedicated platform; what centers must document there is described on the knowledge page Gene therapy for hemophilia: documentation and collaboration between centers.

Frequently asked questions

Do I as a patient have to document my factor administrations myself?
Yes. Section 14 (2a) of the German Transfusion Act stipulates that in home treatment the patient keeps the documentation personally. The treating physician must review it at least once a year. Product, batch designation, date and time of each administration must be recorded.
What must the pharmacy report when dispensing hemophilia products?
Under Section 17 (6a) of the German Pharmacy Operating Regulations, after dispensing the pharmacy reports to the prescribing physician the name of the product, batch designation and quantity, the date of dispensing and the patient’s surname, first name, date of birth and place of residence – electronically or in writing. The duty applies to medicinal products for the specific therapy of clotting disorders in hemophilia.
How long must the records be kept?
Thirty years. This applies to the patient-related documentation of administration under Section 14 (3) TFG as well as to the pharmacy’s records for the report under Section 22 (4) ApBetrO. Records kept longer must be anonymized.
What changed with the GSAV?
The German act for more safety in the supply of medicines abolished the exception from the pharmacy distribution channel for hemophilia medicinal products. Since September 1, 2020, clotting factors are dispensed through pharmacies instead of directly by the center. With the distribution channel came the pharmacy’s reporting duty towards the prescribing physician.
What is the German Hemophilia Registry and who reports to it?
The DHR is the national registry for congenital hemostatic disorders, operated since 2008 by the Paul-Ehrlich-Institut with GTH, DHG and IGH, with a legal basis in Section 21a TFG since 2019. Treating physicians report by July 1 of the following year the number of their patients by severity and age group and the total quantity of medicinal products administered. More than 130 facilities report data on more than 17,000 patients.
May the pharmacy report pseudonymized data?
No. Section 17 (6a) ApBetrO obliges the pharmacy to transmit the patient’s surname, first name, date of birth and place of residence; the details are named explicitly. Only with them can the center assign the dispensing to the patient and complete the registry report. Protecting these data is therefore a matter of secure transmission and storage, not of pseudonymization.
Does an electronic diary legally replace the paper diary?
The German Transfusion Act does not prescribe a form but contents, deadlines and the annual review by the physician. An electronic diary meets the requirements if it captures the prescribed details, keeps the records available for thirty years and enables the center’s review. For diaries whose evaluations feed into treatment decisions, registration as a medical device is decisive.
Does all this also apply to von Willebrand disease and other factor deficiencies?
Yes. The German Hemophilia Registry expects reports on the administration of all products that also treat other factor deficiencies: besides hemophilia A and B, von Willebrand disease and deficiencies of factors I, II, V, VII, X, XI and XIII. For the centers’ practice this means: what is substituted is documented and reported.

Glossary

TFG
German Transfusion Act (Transfusionsgesetz), since 1998. Governs collection, administration, documentation and reporting for blood products and hemophilia medicinal products.
ApBetrO
German Pharmacy Operating Regulations (Apothekenbetriebsordnung). Section 17 governs documentation and reporting on dispensing, Section 22 retention.
GSAV
German act for more safety in the supply of medicines (2019). Ended direct distribution of hemophilia medicinal products on September 1, 2020.
DHR
German Hemophilia Registry at the Paul-Ehrlich-Institut, legal basis Section 21a TFG.
PEI
Paul-Ehrlich-Institut, the German federal institute for vaccines and biomedicines; competent federal authority for blood products and the reporting system under Section 21 TFG.
GTH
Society of Thrombosis and Haemostasis Research, the scientific society for Germany, Austria and Switzerland.
DHG, IGH
Deutsche Hämophiliegesellschaft and Interessengemeinschaft Hämophiler, the two German patient organizations.
PZN
Pharmazentralnummer, the unique identifier of a medicinal product pack in Germany.
Batch
The quantity of a medicinal product produced in one manufacturing run, identified by the batch designation. The basis of traceability.
Data matrix code
Two-dimensional code on the pack containing PZN, batch designation and expiry date, read by scanner.
Home treatment
Physician-supervised self-administration of factor products by the patient at home, the standard in hemophilia therapy.
Prophylaxis
The preventive, regular administration of clotting factor to avoid bleeds, as opposed to on-demand treatment of a bleed.
Hemophilia treatment center
Specialized facility that cares for people with hemophilia, reviews the documentation and reports to the registry.
Substitution diary
The diary in which patients record every factor administration (substitution) as well as bleeds and procedures, on paper or electronically.

Sources (in German)

  1. Section 14 German Transfusion Act (documentation, data protection), paragraphs 1, 2, 2a and 3. www.gesetze-im-internet.de/tfg/__14.html, opens in a new tab
  2. Section 17 (6) and (6a) German Pharmacy Operating Regulations. www.gesetze-im-internet.de/apobetro_1987/__17.html, opens in a new tab
  3. Section 22 (4) German Pharmacy Operating Regulations (thirty-year retention of records under Section 17 (6a)). www.gesetze-im-internet.de/apobetro_1987/__22.html, opens in a new tab
  4. Section 21 German Transfusion Act (coordinated reporting system), paragraphs 1 and 1a. www.gesetze-im-internet.de/tfg/__21.html, opens in a new tab
  5. Paul-Ehrlich-Institut: German Hemophilia Registry (DHR) – legal basis Section 21a TFG, in operation since December 2008, more than 130 reporting facilities and 17,000 patients, deadline July 1. www.pei.de/DE/regulation/melden/dhr/dhr-node.html, opens in a new tab
  6. Deutsche Apotheker Zeitung, issue 33/2020: “Gerinnungsfaktoren aus der Apotheke” (pharmacy distribution channel from September 1, 2020); Federal Ministry of Health: GSAV. 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
  7. Apotheke Adhoc, November 20, 2020: “Klarstellung bei der Meldepflicht nach § 17 Abs. 6a ApBetrO” – hemophilia medicinal products only, not human albumin. 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
  8. Mondorf W. et al.: Smart Medication™, an Electronic Diary for Surveillance of Haemophilia Home Care and Optimization of Resource Distribution. Hämostaseologie 2019; 39(4): 339–346. doi.org/10.1055/s-0038-1675575, opens in a new tab
  9. Banchev A. et al.: Impact of Telemedicine Tools on Record Keeping and Compliance in Haemophilia Care. Hämostaseologie 2019; 39(4): 347–354 – a study of a different electronic diary, cited here as evidence for electronic diaries in general. doi.org/10.1055/s-0038-1676128, opens in a new tab