National Drug File or National Medicinal Product Catalogue ?
An electronic medicinal product reference catalogue is an electronic dictionary of medications available for prescribing and dispensing . The key aim of the catalogue is to provide a consistent approach to the identification and naming of medicines prescribed and dispensed.
A data model is a formal description of how data may be structured and accessed for a given business process. Data models provide a structure for data used within information systems and provide formal definitions for the structure of the data. If a data model is used consistently across systems, then compatibility of data can be achieved.
The scope of a data model should include those classes and the attributes required to identify individual medicinal products that are available within the Irish healthcare sector, for the treatment or alleviation of discomfort in patients in both primary and secondary care.
The naming ( ‘Drug’, ‘Formulary’, 'Product’ ) is critical in Pharmacy but general consensus is that it should be renamed from National Drug File to National Medicinal Product Catalogue.
Who Operates & Maintains A Medicinal Product Catalogue?
Number of catalogues available e.g.
- Health Product Regulatory Authority (HPRA)
- Primary Care Reimbursement Scheme ( PCRS )
- Irish Pharmacy Union (IPU )
- Helix Health
- Irish Medicines Formulary ( IMF )
- International Companies – provide product files to hospitals supporting implementation of vendor's system(s)
- Hospitals – some hospitals public & private create , own & maintain their own product catalogue .
What Groups Require Medicinal Product Catalogues ?
- GP’s - GP s/w vendors provide a file or access to one either their own or utilise IPU catalogue
- Pharmacy - IPU members get monthly download of IPU file or Pharmacy s/w vendors supply their own or utilise IPU file.
- Hospitals & other Health services, - Pharmacy & many other hospital systems mostly utilise one supplied by s/w vendor or IPU product file under license or have developed their own
- National Projects currently in train e.g. Maternal & Newborn Clinical Management System , Hospital ,National Oncology project , New Children’s Hospital will all require Medicinal Catalogue(s).
- State Agencies
Are There Standard(s) or Models Defined?
A number of relevant initiatives at European level and Nationally undertaken and ongoing in this area.
The ePrescription pilots implemented as part of the European epSOS project identified the “delivery” problem of medicinal products (MPs) as one in urgent need for a solution .
EU - OpenMedicine Horizon 2020
Horizon 2020 is the biggest EU Research and Innovation programme ever with nearly €80 billion of funding available over 7 years (2014 to 2020) . One of the initiatives under the Programme is OpenMedicine that is looking at a European medical product database to enable cross border prescribing.
The Health Products Regulatory Authority ( HPRA ) is one of the core partners and Ireland’s representative in the ÒpenMedicine project
Nationally – Health Information & Quality Authority ( HIQA ) Standard
Following a review of implementations of data models in other jurisdictions including Australia and the United Kingdom and standards developed by the Internal Standards Organisation, a data model for an Electronic Medicinal Product Reference Catalogue was developed by HIQA in collaboration with their eHealth Standards Advisory Group (eSAG) and a technical subgroup supporting the work of the eSAG.
Following consultation with all parties HIQA published a detailed data model for an electronic medicinal product reference catalogue in March 2015.
The model consists of three ‘virtual’ concepts and three ‘actual’ concepts, as illustrated in the Figure 1 below.
The first horizontal axis represents the active ingredients or chemical compounds that are in the medicinal products.
The second horizontal axis, the product level, represents creams, tablets, vials. They are the active ingredients with form, strength, route of administration and manufacturer information added.
The third horizontal axis, the package level contains information on medication packs available on the market. At this level representing how the creams and tablets and vials of medication are packaged together
The full details about the model & data structures are available to view and download.
A National Medicinal Product Catalogue is a key deliverable of the ePharmacy Programme.
Input has been sought from chief pharmacists & other organisations & agencies with expertise in the area around a standard based centralised model that will be centrally managed and controlled but will be available to all care areas .
A review of existing files and the option of developing the National Catalogue using a collaborative approach is currently being investigated .