Single Point of Truth (SPOT)


Published on 06 Dec 2018

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Single Point of Truth (SPOT)

Source PNA Group - Author: Frank Harmsen

Accurate pharmaceutical product information is a vital element of modern healthcare. Whether youare a manufacturer, a regulator, a patient, or a doctor: reliable information about your medication iskey. In Europe, the Summary of Product Characteristics (SPC) is the vehicle to provide thisinformation. Currently, the process of creating or updating an SPC and the related patientinformation leaflet can be labor-intensive and inefficient.

The blue sky to solve this problem would be that all data on product information - as approved by for example EMA or FDA - is centrally accessible and maintained as structured data. Therefore,BrightPharma, in collaboration with the Dutch Medicines Evaluation Board and additional pharmastakeholders, introduces the SPoT. The SPoT is a structured, classified information model andassociated data scheme, such that every data element is stored exactly once and is consideredtrustful by all stakeholders. This means that a lot less time on checking, updating and reviewing is required, as information is submitted first-time-right. To obtain the SPoT, standardization of data,processes and rules about medicines is necessary, underpinned by a semantic framework identifyingthe meaning of all this pharmaceutical knowledge. Many mandated fields of medicinal productinformation are already standardized based on global standards like ICD10, ATC codes, MedDRAcodes, SNOMED and so on. Brightpharma has the trackrecord and the vision to introduce the SPoTBrightPharma provides a proven classification & ontology methodology and supporting tools, basedon more than 30 years of experience in regulatory environments, pharmaceutical pathways andimplementing innovative concepts for capturing and disseminating knowledge. BrightPharma hasalready presented to the Dutch Medicines Board (MEB/CBG) and some pharmaceutical companiespromising prototypes covering a number of SPCs, which can be upscaled to the full range of SPCs.

A SPoT has advantages for all stakeholders, for example:

Manufacturers: all teams working on SPC info submit structured product information directly into aSPoT via authorized access levels.

Regulatory bodies: use the same SPoT and let algorithms run required assessments on changes.Releasing automatically generated SPCs and/or patient leaflet will be much easier and faster andrequire only a final human check.

PCPs: use the same SPoT as uniform, up-to-date data store for - artificial intelligent - digital patientservices. By assuring interoperability, direct SPC connectivity with Electronic Health Records can beachieved. Thus, patient leaflet updates may be connected into a patient’s record, allowing forprecision checks of individual relevancy of for instance medication information updates.

Key facts in 2018:
• EMA 1302 drugs registered.
• # SPCs can go above 20.000 per EU country, patient leaflets not included.
• SPCs updates takes about 660 regulatory authority employees per year in region Europe.
• > 500 company regulatory affairs representatives in region Europe spend about 40% of their timeon SPC updates.
• It takes approximately 1 year before new information reaches the customer (end-to-end process:update/review/approval à artwork implementation à stock First Expired First Out to patient).

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Category: EA