Number of the month18,4

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Date: 07.05.2018

ABOUT US

Mission

The DAPI - German Institute for Drug Use Evaluation (Deutsches Arzneipruefungsinstitut e.V. (DAPI)) is registered at the local court in Frankfurt at Main (registration no. 7519). It is recognized as a non-for-profit association by the fiscal authorities of Hofheim at Taunus.

The DAPI is active in the areas of pharmacoeconomy and pharmacoepidemiology. It is engaged in the appraisal of medicines and drug supply. For this purpose, analyses of pharmacy claims data from the German Statutory Health Insurance Funds (Gesetzliche Krankenversicherung, GKV) are performed and expert opinions are generated. According to the regulations of the association (Satzung), the objectives are to perform and to support science and research and to support public health. This is realized by establishing, maintaining and managing a pharmaceutical institute which is engaged in the scientific assessment of drugs and other medicinal products. By performing studies, analyses and expert opinions based on drug use evaluation, the DAPI supports organizations and institutions in the health care sector. Hereby, the DAPI contributes to improved medication safety and quality of care.

The DAPI DataWarehouse

Reports, analyses and studies of the DAPI are based on its own DataWarehouse which comprises claims data of prescribed medicinal products dispensed at community pharmacies in Germany at the expense of the Statutory Health Insurance Funds (GKV). For Germany, this database is unique with respect to completeness of population and period covered. Roughly 90 % of Germany's population is insured by the GKV system. The DAPI receives anonymized claims data from eight major data processing centers (clearing houses; Rechenzentren) in Germany since 2000, covering over 80% of all community pharmacies in Germany. Currently, the database contains 10 billion claims data from GKV-insured patients and is growing at a rate of about 600 million entries per year.

The DAPI receives data on a monthly basis. Figure 1 shows the current data flow. Community pharmacies transmit prescriptions to data processing centers. These clearing houses process the data and anonymize them by removing personalized data. Afterwards, the data of the different data processing centers are fed into the DAPI data warehouse and supplemented with information from the ABDA (Federal Union of German Associations of Pharmacists) database (ABDATA).

 

Figure 1: Processing of claims data from community pharmacies into the DAPI DataWarehouse.

What kind of data is stored in the DAPI DataWarehouse?

The DAPI DataWarehouse contains information about medicinal products retrieved from ambulatory care prescription (Figure 2).

Figure 2: Standardized prescription form used for all drugs prescribed at the expense of the statutory health insurance scheme. Green circles indicate items that are available in the DAPI DataWarehouse. Items that are not available are blinded in black.

The most important claims data available are:

1)   Date of birth (year only)
2)   Type of health insurance company (only statutory health insurance companies are included)
3)   Type of insured person (e.g. member, family member, retired)
4)   Region of the prescribing physician (17 regions; mostly representing the 16 Federal States); derived from (4)
5)   Date of prescription
6)   Date of dispensing at the community pharmacy
7)   Unified product code ("Pharmazentralnummer", PZN): a unique identifier for medicinal products that unequivocally defines each drug package, e.g. with regard to name, active ingredient(s), strength, dosage form, package size, price, and pharmaceutical company.
Product code for medical devices („Hilfsmittelpositionsnummer“): a unique identifier for medical devices in which product group, site of application, sub group, mode of application and product are encoded.
8)   Number of prescribed packages per item
9)   Price of the dispensed medicinal product
10) Total price of all dispensed medicinal products
11)  Patient’s co-payment
Information whether the medicinal product e.g.,...
12) ... is a vaccine ("Impfstoff");
      ... is prescribed for consulting hour need (consultation overhead) - medicinal products used in physician offices, hence, not prescribed for an individual patient, but for use at a medical practice only  ("Spr.-St. Bedarf" = "Sprechstundenbedarf")
13)  ... was prescribed due to an occupational accident
       ... was prescribed and dispensed during emergency services
14)  ...is excluded from substitution by another generic (comparable drug covered by a rebate contract) by the prescribing physician (nec-aut-idem)

In the DAPI DataWarehouse, the prescription data are linked to the ABDA-database containing a complete inventory of German medicinal products and other items which can be traded by pharmacies. A linkage is possible via the product code (PZN). Bi-monthly, updated information from the ABDA database is fed into the DataWarehouse. This process allows historical backtracking of changes in characteristics of a medicinal product (e. g. price) and allows connection of prescription data with the characteristics of a medicinal product valid at the month of prescribing.

The most important information provided by the ABDA database for each individual medicinal product is:

  • Brand name
  • Pharmaceutical form (e.g. tablet, capsule, ointment)
  • Package size (e.g. number of units (e.g. tablets), weight or volume) and unit (e.g. mg, ml)
  • Ingredients of  the medicinal product, including quantity of the active substance e.g. per dosage, per unit volume, or per unit of weight (strength)
  • Classification of active substance(s) according to ATC-code (Anatomical Therapeutic Chemical classification system), issued by the World Health Organization (WHO)
  • Defined daily dose (DDD)
  • ABDATA-indications (mixed classification according to chemical, pharmacological and therapeutic aspects)
  • Status of medical product: drug status, narcotic-/controlled substance, biotechnology product (biosimilar), prescription requirement, imported product, rebate product etc.
  • Pricing information: purchase price, VAT, sales price (unified price for all drugs prescribed by physicians and reimbursed by the GKV valid for all pharmacies in Germany), rebates and deductions, wholesaler's discount, manufacturer's discount, information about assignment to fixed (reference) price groups with fixed prices and fixed price steps
  • Information about provider

Of note, the claims data in the DAPI DataWarehouse only comprise medicinal products that were dispensed by community pharmacies at the expense of the statutory health insurance scheme. Thus, they do not contain information about drugs used for self-medication (OTC), non-GKV prescriptions (about 10% of the German population is privately insured), and drugs dispensed to patients during hospitalization. Furthermore, no information about diagnosis or other Patient characteristics such as laboratory data is available.

What kind of analyses does the DAPI perform and for whom?

The DAPI provides its member organizations with routine evaluations on a regular basis. They comprise market surveys according to various criteria, e. g. drug classes (ATC-code) or drug products. In addition, routine evaluations address specific subjects such as vaccines or regional analyses (regions according to the regional association of statutory health insurance accredited physicians, which are basically identical with the Federal States of Germany) and type of health insurance fund.

Results from analyses of various topics are available here: Zahl des Monats (number of the month).

The DAPI can also provide individual evaluations upon request. Important study results are published and are available here.

Individual requests submitted to the DAPI vary with regard to questions and aims. For-profit driven requests will not be accepted. Our evaluations are always scientifically sound and independent. Recipients of analyses include Departments of Health, health authorities, politicians, academics, health insurance funds, other health care institutions, research institutions and health care professionals.

Scientific network

We are a partner center of the ENCePP scientific network which is coordinated by the European Medicines Agency (link to DAPI as ENCePP Research centre). We are dedicated to excellence in research by adhering to the ENCePP Guide on Methodological Standards and promoting scientific independence and transparency. We register studies in the ENCePP E-Register of Studies, a publicly accessible resource for the registration of pharmacoepidemiological and pharmacovigilance studies.

Protection of data privacy

Protection of data privacy and anonymity of insured individuals are imperative to the DAPI. Legal basis of statistics and investigations is § 300 Social Code Book V (SGB V) which allows processing of anonymized data from pharmacy claims data.

For inquiries to the DAPI, we provide evaluations only. Transfer of original data is excluded. The search strategies, results from analyses as well as any explanation necessary for understanding the results are intellectual property of the DAPI.