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Pharmaceutical Technology Europe
Having an effective and granular data management process in place will enable companies to meet the requirements of IDMP as well as help usher in a new age of digital-based identification, in which organizations can easily share data across borders.
The pharmaceutical industry is approaching a time of significant change in policy on data handling. The Identification of Medicinal Products (IDMP) stipulates that organizations must standardize how they generate, archive, and transfer information on everything from drug ingredients to brand guidelines and patenting (1). The central goal of the regulation is to ensure patients are safe by unifying communications and encouraging cross-industry collaboration.
What’s particularly concerning for many companies is that their data management may not be prepared for this industry-wide standardization drive. Achieving regulatory compliance will require that they can achieve a 360-degree view over their data, whether the data reside in the cloud or on premise.
Under current norms, separate companies will use different nomenclatures for medicines, and use varying ways of recording dose, administration routes and measurement units. Individual medicines are also often classified differently across multiple manufacturers, while branding regularly changes across different countries. One common example is that while paracetamol’s generic name is acetaminophen, it is also sold as Tylenol or Panadol in the US. While this difference is often understood by pharmaceutical staff, it leads to unnecessary silos in databases, which makes it harder to discover and record multiple medicines of the same family. This in turn increases the complexity of data management programs, making it harder to quickly find trends across brands and muddies supply chain data, making it difficult to notice shortages and falsified drugs.
Multiple companies also currently use manual data-entry, wasting a lot of admin time. Each organization must enter and archive the relevant data for its portfolio, first in its proprietary system and then in the format of all other organizations or agencies with which it does business. This is expensive, and increases the chance that human actions will cause manual error.
As a result, industry information is often hard to read and difficult to trust. Duplications, poor labelling and failures in production standards are increasingly hard to discover. Decision-making is then based on inaccurate information. On top of this, the lengthy processes needed to manage these vast amounts of data mean slower decision making and a sluggish industry, with more obstacles to jump before new drugs become available. The ultimate result is that patients have longer to wait before treatments can be accessed.
Clearly change is needed. Pharmaceutical organizations must take control of their data if they are to get a clear view of all the data linked to their medicines, as well as organizing and storing it in line with the IDMP guidelines. Before standardization can be possible, companies must implement a resilient data management process to ensure data is complete and reliable. IDMP data are highly fragmented by internal processes, which could cause duplications, contradictions and ambiguity. Focusing on improving data quality will be a key element of any IDMP data management drive.
First up, organizations must be able to find their master data (in other words, information involved in the basic functions of the business). Organizations will need to pay particular attention to data on the ingredients in each drug, its packaging, the company producing and selling it, and reference information around its measurement, dose, and governing body. Once the company has identified all relevant data points in these four areas, it must process them in a systemized manner, to ensure all information is easily discoverable at any time. It’s also key that data is gathered from right across the business, so any inconsistencies can be automatically discovered and dealt with.
There is an essential part for technology to play in this process. With data volumes increasing every year and the industry moving towards a digital-first model, regulatory compliance will depend on automatic data management. Pharmaceutical organizations must enable themselves to feed masses of information into an automated, intelligent software to produce actionable, regimented datasets for inspection and assignment. The level of systematic organization required by IDMP will be hard to achieve manually, given the size of the industry and the sheer volume of important information generated every year by new medicines and significant changes to existing ones. It will be essential for IDMP project leaders to consider the role of data management in achieving their goals.
Contracting partners and suppliers also have key parts to play. The wide remit of IDMP implies information must also come from outsourcing partners such as contract research organizations (CROs) and contract manufacturing organizations (CMOs), as well as materials suppliers. Although CROs already understand the competitive importance of data, other partners may not yet be competing on data. Instead of viewing delivering IDMP data as run-of-the-mill business expense, forward-looking CMOs and suppliers can boost their core offerings with valuable data sets as a competitive advantage. Operating company sponsors can also feel the benefit, not only in terms of compliance, but also by using the same data for collaboration in supply chain planning, looking for improved forecasting benefits and ensuring timely delivery and inventory reduction from partner to partner.
Large system integrators (SIs) are also increasingly willing to partner on IDMP compliance. The application of the ISO standards will probably differ around the world, and the IDMP data model is dynamic. As a result, many SIs are developing service offerings built on data management to ensure that their technology is always up to speed and can operate as a global solution rather than a regional one. These services usually include tech hosting, data model maintenance, and the application of controlled vocabularies. Operating companies who are not yet ready to embrace data management as a core part of governance will benefit from the broad experience made available by specialized services which combine data management and regulatory know-how.
Building a strong data management system seems like a difficult challenge to some, but there are a lot of benefits to be gained. IDMP is not just another regulation, it is the primary standard that will underpin multiple future regulations and industry initiatives. In terms of public health, improved visibility into the spread of medicines will help authorities to monitor the effects of new drugs entering the market much more efficiently. IDMP will also help to improve tracking of nascent medicine shortages and fake drugs, helping local services to deal with the causes before they take hold, as well as making it more difficult for fraudulent companies to evade the law. The same applies to batch recalls and inspections. When a supplier has to recall multiple shipments from the supply chain, a more in-depth data management system will help to greatly accelerate the process of locating the specific items.
The end consumer also benefits, gaining the ability to use cross-border electronic prescriptions in the European Union, for example, which enables patients to get the right drugs outside their home nation as a result of standardized information. International prescriptions can also reduce the workload for health workers aiding overseas patients.
There is a great deal at stake with this regulation. The pharmaceutical industry has a responsibility to provide the best possible service to its customers and end-user patients. With an effective and granular data management process in place, companies will be well-placed not only to meet the requirements of IDMP, but also to help usher in a new age of digital-based identification, in which organizations can easily share data across borders. Now is the time for management to invest in a thorough overhaul of information processes, or risk being left behind by an increasingly connected industry.
1. EMA, Implementation of ISO IDMP standards, accessed Feb. 28, 2017.
Monica McDonnell is director strategic business development Europe at Informatica.