TECHNOLOGICAL DEMAND 1:
Personalized Prescription System "Personalized Drug Prescription System" PPS

Summary table of the technological challenge 1

Subproject/Technological ChallengeInnovation SectorProducts and tasks
1. Personalized Prescription System (PPS)
(joint management of variables involved in the response to drugs: 1a-1b-1c-1d-1e-1f)
TICS. e-Health1a). Interactions Database (regulatory recommendations, clinically relevant).
1b). Clinical Data Base: physiopathology, antecedents, evaluation and clinical evolution.
1c). Analytical Biomarkers Database: Biochemistry, Hematology, Urine, etc., routine checkup.1d). [Connection] Genetic Biomarkers Database (2b)
1e). [Connection] Pharmacological and other biomarker database (3b)
1f). [Connection] Database of clinical response markers and Adverse Reactions (5b)
1g). [Interconnection] between them in the environment of JARA
1h). Software and drug selection algorithms.

For more information:
https://www.boe.es/diario_boe/txt.php?id=BOE-A-2018-8151
*JARA Electronic Clinical History, Extremadura Health Service (SES)

Current situation:

At this time part of the information necessary for the “guided” prescription is available in the digital clinical record environment; another must be produced and integrated into it (e.g. pharmacogenetics). Until now, analyzes of biomarkers involved in response to drugs have been interpreted manually, or with some application, isolated from the electronic medical record environment. Therefore, a technological tool is required, able to obtain the information contained in the electronic medical background, to evaluate it and to offer the most appropriate active principle for a determined situation at the moment of prescription.
In short, personalize the prescription module of the Electronic Health Record, giving it the competence to capture the necessary information for choosing the right drug in a given situation.

Objective:

To develop an electronic prescription module that allows the personalized selection of the most appropriate active ingredient in each situation. Integrated in the Electronic Clinical Record, specifically in Jara (SES).

Functionality required by the suggested solutions:

Computer program, integrated into the Electronic Medical Record, specifically in the prescription module (Jara, SES), able to capture all information likely to increase the efficacy and safety of drugs and other elements used in therapeutics, at least the one included in the documents of the competent Medicines Regulatory Agencies (EMA, AEMPS). When appropriate, it should include relevant information regarding:

  1. Clinically relevant interactions: drugs / drugs / food / medicinal herbs / environment, etc.
  2. Clinical: Personal and Family Background, physiopathological condition, other data from the individual’s life (habits, etc.), relevant electronic medical record regarding drug response
  3. Routine analytical data (hematology, biochemistry, urine, etc.)
  4. Pharmacogenetic biomarkers
  5. Plasma levels of drugs and other relevant biomarkers (physiological, microbiome, etc.), intestinal perfusion, and any other element that may be determinant in the selection process’ optimization of a certain active principle
  6. Adverse reactions and therapeutic failures. Collection of the available information in the Electronic Medical Record (Clinical, Analytical, etc.), at least the determinant in the decision making, and connection with the new ones created with pharmacogenetic biomarkers, pharmacokinetics, interactions, etc.

Generation of data and an algorithm for decision making. It is expected to include at least one database of:

  1. relevant interactions
  2. clinical data
  3. analytical data (biochemistry, hematology, urine, those included in the routine, etc.); and connection to the other databases able to be consulted when selecting an active principle and developed in other Subprojects
  4. Genetic Biomarkers
  5. Pharmacological and analytical (microbiome, etc.)
  6. Adverse Reactions and Clinical Response.

Algorithm: [Interactions + Clinic + Analytical + Genetic + Pharmacological] / Adverse Reactions and Response

The generation of personal and secure access to data (personal card, etc.), integration in the digital medical record, possible adaptation to other prescription systems, especially in Europe and Latin America, will be valued.
Additionally, the possibility of developing a professional training program for its use will be valued.

Summary of products and tasks (Table 1):

Group 1: Databases from the Clinical Record, Guidelines and Regulation
  • 1a). Database of Interactions (regulatory recommendations, clinically relevant)
  • 1b). Clinical Database: phisiopathology, antecedents, evaluation and clinical evolution.
  • 1c). Database of Biomarkers of Biochemistry and Hematology, Urine, etc., routine
Group 2: Software and Algorithms
  • 1d). [Connection] Databases of regulatory recommendations: genetic biomarkers (Subpr. 2)
  • 1e). [Connection] Databases of pharmacological and analytical biomarkers (Subproject 3)
  • 1f). [Connection] Database of Adverse Reaction and clinical response markers (Subpr. 4)
  • 1g). [Interconnection] between them in JARA environment
  • 1h). Software and algorithms for drug selection based on queries in 1a-1b-1c-1d (+ data generated in Subpr 2) -1e (+ data generated in Subproject 3) to predict Adverse Reactions (data generated in Subpr.4)

Summary of Databases of consultation for creation of the PPS in MEDEA

USE OF INFORMATION EXISTING IN THE CLINICAL RECORD

  1. CLINICAL: ext of the clinical record (personal and family antecedents, evolution, physical examination). Physiopathological data (pregnancy, lactation, illnesses, etc.) Coding data of the discharge report.
  2. ANALYTICS: Analytical data: biochemistry, hematology, urine systematics.
NEW CREATION DATABASES
  1. GENETICS: Creation of a Database with genetic biomarkers and another relevant one included in the Technical Data Sheet [BDFT]. Genetic database (from Challenge 2) [BDG]. Development of data interpretation algorithm of the [BDGa vs BDFTa] genes / drugs.
  2. PHARMACOLOGISTS: Database of analytical and microbiological markers (from Challenge 3) [BDAyM]. Development of data interpretation algorithm of the [BDAa and BDMa with respect to BDFTa]
  3. ADVERSE REACTIONS: Database of Adverse Reactions related to biomarkers (clinical, analytical, genetic, interactions or pharmacological)
OTHER DATABASES
  1. INTERACTIONS: Database of interactions drug / drug / food / medicinal plants / nutritional supplements etc. [BDI] Development of interaction data interpretation algorithm [BDGa vs BDIa].

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