Form and Substance
A number of IT providers are already promoting compliance solutions for the identification of medicinal products, despite the fact that many final details of the new requirements are not yet known.
Is it premature to invest now?
There is no question that the International Organisation of Standardisation (ISO) will enforce the identification of medicinal products (IDMP). However, shifting deadlines have led to uncertainty about when this will happen. It is understandable that the authorities are keen to confirm this, but that does not make planning and prioritising budgets any less frustrating for the companies involved.
At present, life sciences companies have more than a year before they need to concern themselves with full compliance. To keep track, firms should keep an eye on the EMA’s website for the latest updates and could also join the Institute for Research and Innovation in Social Services (IRISS) Forum (1,2). IRISS is a not-for-profit body of pharmaceutical organisations and technology vendors set up as a platform to promote stakeholder discussion around evolving regulatory submissions standards, user requirements and practical global implementation issues for the mutual benefit of industry, government agencies and public health.
Somewhat surprisingly, the delays to final IDMP guidance have not deterred technology and service providers from promoting their software and solutions. This is particularly puzzling given that some of the dictionary definitions are yet to be locked in. Manufacturers should not try to finalise database and submission systems until the final IDMP parameters are known. However, important groundwork does need to be covered in the meantime.
IDMP is an ambitious project on such a broad scale that getting everything in order will take time. Unless companies can deliver the quality and reliability EMA and ISO have envisaged, they will compromise the payback on their investment and the desired benefit to patients, whose safety IDMP is designed to ensure. This is achievable through the creation of a definitive, harmonised record of approved and marketed drugs based on standard definitions and terminology.
As such, IDMP will be central to mass- scale, cross-border pharmacovigilance. Its slow start is down to the ISO’s ambitions for the standards, which are grander and more comprehensive than previous attempts at electronic publishing requirements, under the remit of Regulatory Affairs. This implicates that data preparation will now touch all corners of the organisation, as well as outlying parties including in-country affiliates and supply chain partners. All have a part to play in ensuring that core systems and applications contain the latest, most accurate information – consistency and reliability are paramount.
The upside of spending time on the preparation to order content is that life sciences companies stand to gain from this effort in many other ways. By investing in a central, definitive master resource of product data, they are creating new possibilities for the business and its operations because that data could have value in other scenarios, such as portfolio planning and improved operational management.
However, that is only if the information is high-quality and robustly tested. This is the contribution that companies need to be making now, irrespective of whether IDMP filing timelines may shift again and of the final specifications that have yet to be agreed.
Forward-thinking companies are treating the current hiatus around IDMP as an opportunity to quantify the data preparation task ahead. First, they need to identify the sources of all the content, the different formats that it is held in and where it resides within the global organisation. By creating a comprehensive inventory of documents and file types, businesses can start to understand the size and scope of the undertaking and begin to determine how to tackle it.
This preliminary process offers a number of issues, including which and where the most up-to-date version of a document is – this might be in Regulatory Affairs, Legal or Marketing – and which management system it is in. Very few organisations have a single comprehensive centralised system for holding content. In fact, many have a number of processes for different departments, so bringing information together, or trying to compare one version with another, is unlikely to be easily achievable.
One exercise must be to itemise the contrasting software platforms and determine what is where. If the company has been subject to mergers and acquisition activity, or has amassed different legacy infrastructures over the years, all of this will add to the complexity of content management. Across the wider ecosystem, contract manufacturers, CROs, local representative offices, translation companies and other service providers will also need to be surveyed for contributing product information.
Then there are the fragmented assets distributed across people’s desktops, attached to emails or kept in folders on servers without a common naming convention. If documents are PDFs and do not contain selectable text, its content will be impossible to extract and re-use, as machines will be unable to read it. Use of non-Unicode fonts – those that are displayed differently or incorrectly across software and operating systems – could also interfere with readability. Languages, spellings and corrupted content could compromise consistency and accuracy as organisations work towards a definitive record of correct, current product information.
Files may have been broken up by regulatory teams, too, so that a master product information file, running to 30-40 pages of detail on a drug, may also exist as a series of separate Word files – containing, for example, the content for labelling, box content and patient literature – intended for the graphic design team. If these have been copied and pasted manually and updated separately, the scope for variation will multiply.
This kind of endeavour needs to be carried out now. Companies should not buy an IDMP software system until the standards have been finalised. In fact, many vendors have confirmed ‘they will be supporting IDMP’ and are advertising it already although they cannot have a solution yet.
Early Sources of Efficiency
Inevitably, organisations will need help to complete the groundwork, but they are not yet at a point where an all-encompassing product is possible. In any case, how content or data will ultimately be used is secondary at this point – the priority is ensuring that the data is correct, complete and clean. This offers better outcomes and return on investment for companies, too, as how they might later use that consolidated content is not limited. Whether the later application is IDMP submission or something more operational and internal, the output’s quality will be intrinsically linked to the input’s.
One practical way to get ahead is to harness automation in the preparation of data by identifying and selecting the definitive source documents; checking for updates; and aligning languages, fonts and other intricacies. Sophisticated tools are available that reliably and precisely compare files in different formats for the possible information they contain. This ability to quickly contrast content of similar documents from multiple sources in large batches could help save firms vast amounts of time in this substantial preparatory stage of getting the company’s product data assets in order.
Beyond that, what vendors are offering today is largely smoke and mirrors. It is too early to have a definitive database that companies can use to submit to the IDMP. Furthermore, that final task will be relatively easy compared to the foundation work that needs to be done now. The last step will simply be to compare pre-compliant content with the final specifications – ideally with an ability to filter and flag key words (controlled vocabularies) to ensure that quality checks will be efficient and reliable.
As long as all source materials have been accounted for, cross-referenced and checked and labelling and other materials can be verified as accurate and up to scratch, firms will stand themselves in good stead for what is to come.
This article is taken from Innovations in Pharmaceutical Technology July 2017, pages 20-21. © Samedan Ltd
1. Visit: www.ema.europa.eu/ema/index. jsp?curl=pages/regulation/general/ general_content_000645.jsp
2. Visit: www.iriss-forum.org