Why IDMP should empower a new era of improved patient choice
Talk abounds among IDMP software vendors about the transformative power of data-driven processes across life sciences. But true transformation demands that any vision for change extends beyond single organisations, and beyond regulatory exchange. Frits Stulp of Iperion – a Deloitte business, sounds a call for action for new data standardisation to drive a new wave of informed choice for patients, physicians and other stakeholders across the healthcare ecosystem.
The link may not seem immediately apparent, but the ISO IDMP data standards currently being implemented across the EU offer an important facilitator for change in the way that patients, and stakeholders right across the healthcare ecosystem, will engage with and choose treatments in future. That’s as long as the industry encompasses the potential as part of their internal IT and process adjustments.
Consider the way many patients now already view and decide on their own treatments in the modern world. Take the young adult waking up with a sore throat or fever, and a mobile device readily to hand. In the digital era, especially post-pandemic, their first port of call is more likely to be Google or Amazon than a 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 even drop it to their door the same day, so that they never need to get out of bed.
While this illustration relates to consumer drugs, the internet is connecting all kinds of healthcare stakeholders to the information they need now. A specialist cancer nurse once admitted that she, too, has been known to Google the specific oncology-related advice about possible drug interactions when dispensing medicine to patients, if that information isn’t otherwise readily to hand. Such scenarios are likely to become increasingly common 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 useable 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).
Maintaining profile, remaining relevant
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 centred around the patient.
Not-for-profit organisation CTADHL 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 harmonisation 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.
In the crowded market for medicinal products, the need for custom, personalised products is growing.
As biopharma innovation becomes more mainstream, and as personalised 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, personalised 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 the characteristics of products, the available alternatives and how they compare, and how a given product addresses or targets their situation. Standardised 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 centre?
Putting patient centricity into practice
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 labelling/leaflet gatekeepers and public guardians – rather than the pharma companies 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 will be critical to redefining their experiences moving forwards.
A trailblazer role for biotechs
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.
It could turn out to be biotechs and biopharma startups that lead the way, thanks to their relative freedom – unencumbered by legacy products, data and regulatory records. These companies aren’t likely to 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 harmonised data exchange, underpinned by IDMP.
Given that these data standards are something all companies must embrace, it follows that these more dynamic companies could be the first to take data-based process innovation to the next level – showing the more established players what’s possible.
Frits Stulp is managing eirector of Iperion - a Deloitte business, where he leads a team of regulatory/IDMP experts active in various projects to deliver value to both pharmaceutical companies as well as regulators. In addition to having more than two decades’ industry and consultancy experience, Frits is regarded internationally as a subject matter expert on IDMP and he proactively shares his rich knowledge and experience wherever he can.
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