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Is the SmPC still relevant in the digital age?

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Post-pandemic, we have been forced to rethink the way in which medicines information is disseminated and consumed

For many years, the SmPC (Summary of Product Characteristics) has been used as a regulatory approved document of medicinal product information for healthcare professionals (HCPs) on how to use medicines safely and effectively.

But with a plethora of information now available digitally, is the full SmPC still relevant, and does it still suit the needs of HCPs requiring specific information about a medicine?

datapharm surveyed 241 UK healthcare professionals on how they engage with medicines information, and the findings have provided some compelling insights.

The SmPC is a key driver of effective decision making

Strikingly, 85% of HCPs surveyed said they look at the SmPC at least a few times per week. There are a variety of reasons for doing so – this can be part of the prescribing process (69% of respondents), to check interactions with other medicines (49%) or to check change information from previous SmPC versions (44%).

When checking change information from previous SmPC versions, part of this process may involve requesting more information from the Pharma company to understand an omission or change in information (for example, omission of information on storage conditions). So when the Pharma company needs to pinpoint why something has changed, comparing the latest SmPC with an older version it is ideally made straightforward by referencing a single source of truth.

It’s important to look at the full SmPC

Pharma companies traditionally relied on the truncated version of Prescribing Information (commonly referred to as Abbreviated PI or short PI) to provide the requisite amount of prescribing information in a compact format while meeting their regulatory obligations. However, the Abbreviated PI is difficult to use – comments from the survey included that “the words look very crowded” in this condensed format.

In the survey, HCPs were asked what information they are interested in when looking at information about a medicine. The full SmPC information was ranked as being most important overall when compared with just the information on dosage and administration, contraindications, active substances or side effects.

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HCPs prefer digitally delivered content

When HCPs were asked which format they prefer to receive medicine information in, there was an overwhelming preference for digital – 86% preferred “Digital” while 11% said “Both”. A significant number (40%) also said they never read the printed materials physically handed to them by Pharma representatives.

So, what are the compelling reasons for going digital? Digital tools make access to data easier and faster, while minimizing errors in information. There may still be a small number of cases where printed materials are appropriate in PIL form – for example, with elderly patients who don’t have access or the ability to use electronic formats.

However, increasing reliance on digital formats means there will be less unnecessary paper waste, in turn reducing financial costs and supporting environmental sustainabilityand less risk from outdated physical forms of product information in circulation.

In short, Pharma should consider a digital-only approach but offer print on-demand for those who require it.

Get a deeper understanding of how HCPs engage with medicines information

Above all, it’s rewarding for both regulators and Pharma to hear that the SmPC is serving its purpose and provides the important medicines information in an easily consumable format.

To discover more about how HCPs responded in the survey, read Datapharm’s whitepaper, “Making Medicines Information Meaningful: Revisiting The SmPC”.

About Datapharm:

datapharm runs emc (electronic medicines compendium), the UK’s most comprehensive, trusted source of information on medicines. The fast-growing SaaS company provides innovative regulatory, compliance and commercial software solutions to support the Life Sciences and wider Healthcare sectors, and is trusted by over 300 Pharma customers in the UK.

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