smart medication DocuScan: GSAV-compliant documentation of hemophilia preparations for pharmacies, doctors, treatment centers and patients

Objective With the German Act for Improved Safety in the Supply of Medicines (GSAV), the previous exemption from the pharmacy distribution channel (direct delivery of the manufacturer to doctors and hospitals) for medicines to treat patients with hemophilia was withdrawn in Germany with effect from September 1, 2020. The factor preparations are no longer dispensed to patients by doctors, but by pharmacies. The new regulation of the distribution channel results in extensive requirements for the documentation of the dispensed preparations by the pharmacist and immediate reporting to the prescribing physician.

Material and Methods The DocuScan platform was developed to support pharmacies and physicians in meeting the legal requirements and to optimize the necessary processes. The new platform simplifies data entry and documentation processes on all sides. Doctors and pharmacies that have access to DocuScan benefit from highly optimized processes. Patients can transfer relevant information about the preparations dispensed directly into the electronic diaries where they can record their consumption. The consumption documented in the electronic patient diaries is in turn available to the doctor/treatment center for therapy monitoring and reporting to the German Hemophilia Registry.

Results In a 3-month pilot phase DocuScan was tested and validated with 7 selected pharmacies before the GSAV came into force. Leading haemophilia centers and also patient organizations were involved in the development of DocuScan as well. Currently, more than 100 pharmacies specialized in hemophilia care already use DocuScan.

Conclusion DocuScan enables pharmacies to efficiently implement the legal requirements for the documentation of hemophilia preparations. The combination of DocuScan with the electronic diary ensures complete and consistent documentation from the dispensing in the pharmacy, the consumption by the patient, the therapy monitoring by the physician to the reporting to the German Hemophilia Register in high quality.

Publication History

Article published online:
18 June 2021