IDMP is the hot topic in Pharma - The Oracle Solution helps Pharma companies to be prepared!

The Ambition of IDMP is Ultimate Patient Safety. IDMP stands for IDentification of Medicinal Products and is a new worldwide standard. IDMP is different from xEVMPD (xEVMPD = extended EudraVigilance Medicinal Product Dictionary: a pharmacovigilance initiative at the European level. IDMP takes a quantum leap beyond xEVMPD, as it goes into much more detail (hundreds of fields) about product information), as IDMP is a global standard while xEVMPD is European only. IDMP requires life sciences companies to provide the next level of transparency for specific medicinal products delivered to specific patients through complete, multi­level identification.

Europe is already mandating its use by mid-2016 and other regions are expected to follow. IDMP is defined by five standards created by the International Organization for Standardization (ISO): ISO 11615, ISO 11616, ISO 11238, ISO 11239, ISO 11240. ISO 11615 and 11616 define and differentiate "medicinal products" and "pharmaceutical products" which have "MPID" and "PhPID" numbers. ISO 11238 defines substances. ISO 11239 and 11240 define controlled vocabularies for pharmaceutical dose forms, units of presentation, routes of administration, packaging, and units of measurement. The ISO and ICH regions are currently developing Implementation Guides which will further define the details. The ISO standards are compatible with the US HL7 (Health Level Seven) standard.

Implementing IDMP involves regulatory affairs, safety, clinical development, and others:

• The product data will usually have to be sourced from many departments, transformed and cleaned, collated in a company product repository, and have any data gaps filled via data entry
• The central repository will have to be maintained using change control
• The repository data will be sent to regional/worldwide IDMP dictionary maintenance orgs
• Safety and clinical applications will consume the regional/worldwide IDMP dictionaries

This means that a 360° understanding of the investigational and authorized medicinal products delivered to patients in specific markets will allow health authorities, such as the European Medicines Agency (EMA), to take preventive and corrective actions that ensure patient safety.

Full disclosure means for Patients that they can get answers to questions such as:

• Where did you manufacture my drug?
• Where did you package my drug?
• Which qualified sources have you used?
• Where was the packaging printed?
• Which controls have you executed?
• Which formulation has been used?
• Did you have the approval to ship this product?
• What is the expiration date?

Full Disclosure means for Life Sciences Companies that they need to find a new way of managing the massive and consistent data set owned by multiple departments within their organization, with hundreds of fields defined in the data model.

There is currently uncertainty as to what aspects of IDMP will become mandatory in Europe on July 1st 2016. The European Medicines Agency (EMA) has announced in February 2015 that it is putting together a task force to oversee the implementation of new standards for identifying drugs and to develop a roadmap for EU-wide implementation of IDMP standards. However, our understanding is that:

1. Marketing Authorization Holders (MAHs) will have to submit product information reports with IDMP data to EMA for new applications and variations
2. When submitting an E2B(R3) report to EMA, MAHs will have to include IDMP information if it exists for any of the products in the ICSR (Individual Case Study Report (ICSR) is an adverse event report for an individual patient)
3. MAHs will have to be able to receive E2B(R3) reports from EMA that include IDMP information

IDMP should be seen as an opportunity for Life Sciences companies to progressively transform the way they operate towards cross-functional transparency for products. The early adoption of a comprehensive change control platform, combined with other Enterprise Applications, Data Sources integration and Analytics, provides the opportunity to get enhanced safety signal detection, enhanced product quality, to detect issues before the authorities, and implement a holistic benefit-risk management.

Developing IDMP Implementation Strategy steps should consist of a reduction of Manual Data Collection and Entry, proper Data Source Integration to achieve a single source of truth for Product Information, up to Cross-Functional Integration of People, Data, and Processes in a Change Control Platform.

But there are challenges! Effective collection of Medicinal Product Data requires the creation of a comprehensive Medicinal Product Repository from various sources, to be developed incl. Regulatory, Commercial, Safety departments: for this, a Data Transformation is required. The Collection must be maintained consistently over time: Controlled, automatic Updates to Medicinal Product Repository must be executed when changes occur. Medicinal Product Data must be propagated appropriately. It is necessary to synchronize various business applications with the Medicinal Product data. Finally, companies need to ensure communication with HA Gateway, to generate and send IDMP product messages, and provide audit trails of successful delivery.

The Oracle IDMP Enterprise Foundation Suite provides all required capabilities to enable a Closed-Loop Risk Management, in which a Life Science company can:

1. Receive & Code Adverse Events with IDMP (Adverse events are coded against specific products using Medicinal Product Information for Drug Dictionaries (MPID) and Pharmaceutical Product Identifiers (PhPIDs)
2. Detect & Manage Signals (Signals are detected, prioritized, and analyzed to decide if they are true risks)
3. Create Risk Minimization Plan (Risks are mapped to the IDMP data model and fed into dashboards for visualization)
4. Create Risk Minimization Plan (A risk mitigation/minimization plan is created in order to document the corrective & preventive actions)
5. Create Change (A change is initiated to fix the problem (add contra-indications, warning to leaflet)
6. Submit IDMP Product Report (Upon change authorization, IDMP product message is prepared and sent to the Health Authority)

The solution covers Enterprise Applications & Data Sources integrations (for example to CMC/Quality, ERP, RIMS, labeling, etc. and Other Enterprise Services such as LDAP, SSO, SMTP, etc), Middleware (with Data Transformation Services and Gateway Services), Applications (With Oracle Agile PLM for Change Control Excellence, Oracle Thesaurus Management System, and Oracle Argus for pharmacovigilance), and Analytics(with Oracle Product Lifecycle Analytics - OPLA, Argus Analytics, Clinical Development Analytics, etc.).