Saving Lives by Preventing Adverse Drug Reactions

Over 2 million Adverse Drug Reactions (ADRs) are reported in the US alone and this is considered to be the fourth leading cause of death in the US. ADRs result in over 100,000 deaths and several emergency visits and hospitalization. Major causes of ADRs include off-label use, drug interactions, medical errors, data integrity and counterfeit drugs. Today, European Medical Agency (EMA) is spearheading an initiative called Identification of Medicinal Products (IDMP) to address and prevent Adverse Drug Reactions. IDMP drives safety across the care continuum (Clinical Trials - post launch Pharmacovigilance).

IDMP is a regulatory frame work that aims to standardize and uniquely identify medical products across the globe. It also aims to provide a global database of medical products that can be accessed in real time to accurately identify registered medicinal products in a variety of scenarios including Adverse Drug Reactions and fighting Counterfeit drugs.

IDMP Framework

IDMP is comprised of five different ISO standards each addressing a specific area. These standards will drive international standardization and harmonization of master data elements, formats and terminologies for unique identification and exchange of information on medicinal products. IDMP is being implemented in a phased manner across the EU and need to be complied with by any organization involved in development and marketing of medicinal products in EU member countries.

Saving Lives by Preventing Adverse Drug Reactions

IDMP Deadlines and Non-Compliance Implications:

EMA is still firming up the implementation time lines as of July 2016. It is generally expected that IDMP implementation guides will be released in early 2017. Non-compliance with IDMP regulations can result in huge penalties sometimes upto 5 % of the company's revenue.

Implementation Challenges:

IDMP is a cross functional enterprise-wide endeavor requiring deep and specialized expertise, often not readily available in many organizations.
IDMP data resides in multiple systems and documents within an enterprise, varying in format and structure, requiring extensive data wrangling.
No reliable COTS based solution exits for IDMP compliance. The custom solutions varies greatly in cost and complexity depending on various factors including number of medicinal products, markets and implementation partners.

Transformative Solution to IDMP Compliance:

While many approaches can be used to achieve IDMP compliance, I believe that Master Data Management & Governance (MDMG) based solution is the most robust that can be a catalyst to a larger enterprise-wide transformation. Implemented in a phased manner, this approach addresses the immediate need for IDMP compliance and on the long run, harmonize and standardize enterprise-wide master data.

Phase one of MDMG based approach, involves creating a layer of data abstraction on top of multiple enterprise systems that contain IDMP relevant data. This layer would transform and standardize data from multiple data sources into an IDMP compliant, submission ready data format that resides in the MDM repository. This repository then serves as an enterprise wide "Gold Source" for IDMP compliant data that can be syndicated and consumed by other systems such as manufacturing, labelling etc.

Phase two of MDMG approach would extend the functionality of MDM system and governance framework, to other enterprise master data entities within the organization. This phased approach reduces risk and complexity of an enterprise-wide MDMG initiative, while readily addressing the immediate need of IDMP compliance. This approach will provide better return on investment (ROI) and a lower Total Cost of Ownership (TCO).

About the Author

Sujan Thanjavuru heads Life Sciences Strategy and Business Transformation portfolio at Wipro Ltd. Past two decades, he has been orchestrating complex transformation programs including Post Merger Integrations(PMI), Application Rationalization(APR), Business Process Re-engineering (BPR) and Centers of Excellence (CoEs), in highly matrixed fortune 500 companies. He specializes in Enterprise Transformation, Project Portfolio Management, eClinical, Supply Chain Management, Enterprise Information Management and Product Development across the Biopharmaceutical Value Chain.

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