By Naveen Sarabu, Director, Product Management and Strategy, Liaison Healthcare Informatics
The European Medicines Agency’s (EMA) ambitious initiative to uniquely identify drug products and their attributes worldwide requires that pharmaceuticals embark upon equally ambitious initiatives in order to achieve compliance. And with the ISO IDMP (Identification of Medicinal Products) standard taking effect in 2016, there is very little time for those governed by the mandate to design and implement the enterprise-wide data management processes needed to aggregate, cleanse, validate and ultimately syndicate product data.
There are five standards developed containing the data elements and structures for unique identification and exchange of regulated medicinal products for human use. These are: ISO 11615, ISO 11616, ISO 11238, ISO 11239, and ISO 11240. The EMA is the first one to adopt these standards and the USA is expected to require it next. The penalties for non-compliance have not been announced yet but various field experts expect them to be severe and based off of a certain percentage of revenues for the medicinal products sold in the EU.
With minimal time available, yet maximum effort required, it may come as a relief to learn that pharma companies don’t have to go it alone. One new approach that is emerging is data Platform as a Service (dPaaS) — that provides an attractive alternative to building out IDMP compliance in-house. dPaaS is a holistic cloud service approach that unifies integration and data management operations and delivers them as a fully managed service. Without the need to invest in additional hardware, software or staff, companies using this model have the ability to:
- Extract various pieces of product data (e.g. manufacturing information, product formulation, dosage) from the disparate systems and their formats (e.g. XML, IDoc, EDI) in which they reside
- Cleanse, harmonize and aggregate data using sophisticated data governance and stewardship tools
- Transform the resulting single trusted view of product data into the XEVMPD schema for delivery to EMA
- Leverage the work done for IDMP to other enterprise data management needs.
By leveraging this approach, pharma companies will acquire the architecture and expertise it needs to meet the challenging timeframe for IDMP compliance and be a key contributor to the worthwhile goal of improving patient safety.