Is the SmPC still relevant in the digital age?



In the wake of the pandemic, we have been forced to rethink the way drug information is disseminated and consumed

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

But with the wealth of information now available in digital form, is the entire SmPC still relevant and does it still meet the needs of healthcare professionals who require specific drug information?

Datapharm surveyed 241 UK healthcare professionals about how they deal with drug information, and the findings provided some compelling insights.

SmPC is a key enabler of effective decision making

Astonishingly, 85% of health professionals surveyed said they review SmPC at least several times a week. There are various reasons for this – this could be part of the prescribing process (69% of respondents), checking interactions with other medicines (49%) or checking information about a change from previous versions of the SPC (44%).

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When checking change information from previous versions of the summary of product description, part of this process may include requesting additional information from the pharmaceutical company to understand the absence or change of information (for example, omission of information on storage conditions). So when a Pharma company needs to specify why something has changed, comparing the latest SmPC to an older version, it is ideally simply by referring to a single source of truth.

It is important to look at the entire SmPC

Pharmaceutical companies have traditionally relied on an abbreviated version of prescribing information (commonly referred to as an abbreviated PI or short PI) to provide the required amount of prescribing information in a compact format while meeting their regulatory obligations. However, abbreviated PI is difficult to use – comments from the survey included that “words seem very crowded” in this condensed format.

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In the survey, healthcare professionals were asked what information they were interested in when looking at drug information. Full SmPC data were ranked most important overall compared to only information on dose and administration, contraindications, active substances or side effects.

Healthcare professionals prefer digitally delivered content

When healthcare professionals were asked which format they preferred to receive drug information, 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 to go digital? Digital tools make access to data easier and faster, and minimize 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 do not have access to or the ability to use electronic formats.

However, the increasing reliance on digital formats means that there will be less unnecessary waste of paper, which in turn will reduce financial costs and support environmental sustainability, as well as less risk of obsolete physical forms of product information in circulation.

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

Gain a deeper understanding of how healthcare professionals use drug information

Above all, it is beneficial for both regulators and pharma to hear that the SmPC is serving its purpose and providing important drug information in an easily digestible format.

To learn more about how healthcare professionals responded to the survey, read Datapharm’s white paper, Making Medicines Information Meaningful: Revisiting the SmPC.

About Datapharm:

Datapharm runs emc (Electronic Medicines Collection), the UK’s most comprehensive, trusted source of medicines information. 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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