Can you control your data? Preparing to comply with IDMP
Posted: 22 November 2016 | | 1 comment
Informatica’s Monica McDonnell gives the lowdown on the Identification of Medicinal Products new regulations and how to manage big data all across Europe…
The upcoming introduction of the Identification of Medicinal Products (IDMP) regulation across Europe poses a serious challenge to the pharmaceutical industry.
Under the new regulation, pharmaceutical companies will be required to standardise the way they record, store and share key information on their products. Data management for everything from ingredients and manufacturer to dosage and branding will need to be unified, with the aim of enabling smoother information sharing and collaboration across borders in the industry.
Ultimately, this will benefit patients, as it speeds up access the right medicines and helps the industry avoid regional shortages.
However, for many companies, achieving this goal will be a challenging process. Many pharmaceuticals simply aren’t prepared to bring their data into line in such a comprehensive manner.
Compliance with IDMP will require organisations to get a deep, 360-degree view into their data, wherever it resides -in the cloud or on-premise.
Where to begin?
At present, different organisations use a variety of vocabularies to refer to medicine variables including dosage form, route of administration and units of measurement. Substances themselves are also often classified under different names across different manufacturers, and brand names frequently change across nationalities.
For example, paracetamol is also known by the generic name acetaminophen, and is marketed as both Tylenol and Panadol in the USA.
Although the equivalence is often tacitly understood by industry professionals, this discrepancy leads to unnecessary fragmentation in data banks, making it harder to find and classify multiple medicines of the same variety.
This inconsistency only complicates data management processes, limiting the ability to rapidly identify trends across medicinal brands and clouding the view of the supply chain, making it harder to identify shortages and counterfeit medicines.
Many organisations also currently operate a manual data-entry system, wasting a great deal of administration time. Not only must each company enter and store the relevant data points for its medicines in its own system, but it must also then re-enter that data in line with the format of all other organisations or agencies with which it does business.
This is a costly task, and increases the number of human touch-points through which data must pass. This raises the likelihood of manual error.
Industry data is broadly speaking difficult to read and hard to rely on, with duplications, mislabeling and failures in production standards becoming increasingly hard to spot and address. This leads to a risk of decision-making based on inaccurate information.
What’s more, the manual processes required to manage such vast amounts of information lead to slower decision-making and a more sluggish industry, with more hurdles to clear before new medicines are made available.
The ultimate result is that patients have longer to wait before treatments can be accessed.
Getting control over essential data
Clearly this state of affairs demands that pharmaceutical organisations take control of their data, especially if they are to gain a clear picture of all the information linked to their products and organise and store it in line with IDMP.
Before standardisation can be achieved, it’s essential that companies adopt a strong data management strategy in order to provide complete and reliable data. IDMP data is highly fragmented by internal process – causing duplications, contradictions and ambiguous meanings.
A focus on improving data quality so that it is fit for submission will be a key component of any IDMP data management strategy.
To do this, they must be able to identify their master data – information which plays a key role in the basic functioning of the company. Companies will need to take particular notice of information on the substances in each product, its packaging, the organisation producing and selling it and referential data concerning its measurement, dosage and governing bodies.
Once the organisation has identified all relevant data points in these four key areas, it must then compile and store them in a systemised format, to ensure that all data is made easily available on demand. It’s also important that information is gathered from across the whole enterprise, so that any duplication or inconsistency between departments can be automatically identified and eliminated.
There is a key role for technology to play in this process. As data volumes increase year-on-year with new products coming to market and the industry increasingly moving to a digital-first approach, efficient regulatory compliance will be dependent on automation of data management. Pharmaceutical companies must be able to feed masses of data into an automated, intelligent system which can then produce actionable, organised datasets for classification.
The level of systematic organisation required by IDMP will be very difficult to achieve with manpower alone – given the scale of the industry and the amount of essential data generated by new products each year.
It will be key for IDMP project leaders to consider the role data management technology can play in achieving their goals.
The end goal
Implementing a robust data management system may appear to be a daunting prospect to some, but there is a great deal of benefit to be gained.
IDMP is not just another regulation, it is the primary medicinal description standard that will underpin many future regulations and industry initiatives.
From a public health perspective, increased visibility into the dissemination of medicines will help authorities to more efficiently monitor the effects of new drugs entering the market. IDMP will also help to improve tracking of potential drug shortages and falsified medicines, enabling local health services to address the causes early rather than attempting to fight the symptoms, as well as making it harder for fraudulent companies to evade law enforcement.
Batch recalls and inspections
The same applies to batch recalls and inspections – if a supplier needs to recall several shipments which have already embarked on the supply chain, a more thorough data management regime will help to massively speed up the process of locating the items in question.
End consumer benefits
There will also be benefits to the end consumer, including the ability to implement cross-border electronic prescriptions of medicines in EU, enabling patients to access the right products outside their home country through standardised data.
This can also contribute to a reduced workload for health services workers servicing overseas patients. This regulation is much more than an administrative exercise.
The pharmaceutical industry must be committed to providing patients with the best possible service and the fastest access to the right medicines. By implementing a far-reaching, efficient data management strategy, companies will be in the best position to make essential data available on time, wherever it is required.
A new era of digital identification will speed up cross-border data sharing and help overcome the threat of shortages and fake medicines.
Pharmaceutical executives have an opportunity to strike while the iron is hot and initiate a thorough overhaul of data management. Those that don’t will find it difficult to participate in a progressive, interconnected industry that is increasingly collaborating across individual organisations.
About the author
Monica McDonnell is director of strategic business development Europe at Informatica. She completed a masters in computer science at the University of Oxford before embarking on a career which has seen her working as an industry consultant at Teradata, i2 Technologies and Spearhead Systems Consultants. She joined Informatica in 2013.
Good article Monica and a very comprehensive approach of IDMP.
What bothers me is the way regulations will impose both standards (ISO for IDMP and GS1 for traceability)to live together. Because there may be an overlapping (ex: packaging, route for delivering…).