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© 2021 MJH Life Sciences and Pharmaceutical Executive. All rights reserved.
© 2021 MJH Life Sciences™ and Pharmaceutical Executive. All rights reserved.
The Identification of Medicinal Products (IDMP) software industry has talked up the broader potential of data-driven processes — i.e., beyond regulatory compliance. Pharma companies and their software providers have an important role to play in realizing these opportunities — through their approach to data-driven information management and transparency. Biotechs, free from legacy systems and processes, might even lead the way. Frits Stulp discusses the foundations that need to be laid now for lasting transformation of pharma information access in the real world.
For the people who use pharma products — from patients themselves, to the clinicians prescribing them, the pharmacies dispensing them, and the payers and insurers approving and settling the bills –—the adoption of international data standards could pave the way for more informed choice. And, although the link may not seem immediately apparent, the ISO IDMP data standards currently being implemented in the EU, provide the mechanism for this shift. That’s as long as the industry encompasses the potential as part of their internal IT and process adjustments.
Consider students who wake up with a sore throat or fever, and a mobile device in their hands. Especially after the extended waiting times during the pandemic, their first port of call is more likely to be Google or Amazon than a health line or doctor’s surgery. Unless something needs to be professionally prescribed, their choice of medicine will be dictated by search listings, customer reviews and price. A drone might drop it to their door the same day, so that they never need to get out of bed.
Granted, this example is more applicable to consumer drugs, but a specialist cancer nurse once admitted that she, too, would turn to Google to check the specific oncology-related advice about possible drug interactions when dispensing medicine to patients, if that information wasn’t otherwise readily to hand. These kinds of scenarios are likely to become steadily more common too, as society demands free choice/for patients to have informed influence over their own care.
This, then, is a call to action to the pharma industry to provide that information in a readily and usable format, and to regulatory agencies to become the ‘go-to’ place for approved information.
It is in such situations that data standards like ISO IDMP for medicinal products, being implemented currently in the EU but with growing support internationally, offer to make such choices more viable — supported by accessible and reliable information, in an agreed global format, which can be understood by clinicians, pharmacists and the general public (as well as regulators, payers, insurers and so on).
In due course, consideration for all stakeholders will be essential for life sciences companies, and their IDMP plans and decisions today will be instrumental in dictating how well they can adapt to the new world of more transparent healthcare that is centered around the patient.
The not-for-profit organization, CTADHL,1 has made it a mission to promote a new era of ‘health literacy’ through global collaboration and partnerships. Among its activities, it is working towards harmonization and adoption of ISO IDMP around the world — between EMA/EU requirements and those of the US FDA, for instance, and by the World Health Organization (WHO). We are also seeing a lot more clinical discussion now about the need for cross-border prescribing, aided by an interoperable data set which describes medicines in a uniform way from country to country so that prescriptions from other territories can be understood and exact equivalents identified.
As biopharma innovation becomes more mainstream, and as more personalized treatments feature more commonly, more tailored information on drug suitability and counter-indications will become important.
In the crowded market for medicinal products, the need for custom, personalized products is growing. The absence of new big blockbuster drugs is helping to drive this development, inviting the industry to better understand their patients. Unless each variant of a product has its own data stamp, clinicians won’t be able to safely prescribe it. At the same time, patients will increasingly expect to more fully understand for themselves the characteristics of products, the available alternatives and how these compare, and how a given product addresses or targets their situation. Standardized data will be essential in enabling all of this.
So where are pharma companies today in regard to this new global, data-enabled healthcare ecosystem, which places the patient at the center?
Although some pharma companies are making the right noises about patient centricity today and working hard to provide better resources for their customers, in many cases the gap between the information provided by pharma brands and that patients actually need and receive remains considerable.
Too often, patient information leaflets and equivalent digital resources are treated as marketing material or compliance-oriented activity, rather than something that empowers patients to make informed choices. Currently, it tends to be the market regulators — as labeling/leaflet gatekeepers and public guardians — rather than the pharma companies themselves that are advocating for patient-centricity in published patient information.
To change the emphasis, software needs to embrace and promote use of data standards, enabling better insights, actionable reporting on adverse drug events, product shortages, and more. This rich and actionable data, and reliable data analytics, are crucial to enable improved, safer medicines.
Keeping a broad perspective when rolling out IDMP projects is an important first step in staying open to optimal external information provision and international data exchange across national, regional and global healthcare ecosystems. Other opportunities include greater integration with patient forums, where allowed, so that pharma companies can meet current and future customers where they are and provide relevant and helpful information to them at the point of need.
Understanding what patients — and other stakeholders across the healthcare environment — need is critical. The European Medicines Agency, which has an active interest in patient advocacy, aims to help here, by facilitating conversations between healthcare providers, pharma companies and patients, towards better outcomes for all.
For pharma companies, proactive interventions in the form of better external information which is fit for purpose will help build stronger and more trusted relationships, by demonstrating that their priority and focus is the health and wellbeing of patients.
But it may well be biotechs/biopharma startups that show the way, thanks to their relative freedom, unencumbered by legacy products, data and regulatory records. These companies won’t be as dependent on expensive, specialist tools: rather they will be able to take advantage of a fresh approach to object-based information, external collaboration and harmonized data exchange, underpinned by IDMP.
Since these data standards are something all companies must embrace, it follows that these more dynamic, younger companies could take data-based process innovation to the next level — and lead by example.
Frits Stulp is Managing Director of Iperion.