Is SmPC still relevant in the digital age?

After the pandemic, we have had to rethink the way drug information is disseminated and consumed

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

But with so much information now available digitally, does a complete SmPC system still fit, and does it still fit the needs of healthcare providers who need specific information about a medication?

datafarm The survey included 241 UK healthcare professionals about how they handle drug information, and the findings offer some compelling insights.

SMPC is a key driver of effective decision making

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

When checking change information from previous SmPC versions, part of this process may include requesting more information from the pharmaceutical company to understand omissions or changes in information (eg, omission of information about storage conditions). So when a drug company needs to determine why something should be changed, Compare the latest SmPC with an older version Ideally, it is evident by pointing to a single source of truth.

It is important to have a look at the full SmPC

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

In the survey, healthcare physicians were asked what information they were most interested in looking at information about a drug. Complete SmPC information was rated as most important overall when compared only with information regarding dosage and administration, contraindications, active substances, or side effects.

Healthcare providers prefer digitally delivered content

When healthcare practitioners were asked what format they preferred to receive medical information in, there was a significant preference for the digital format – 86% preferred “digital” while 11% said “both”. A significant number (40%) also said they had never read printed materials handed to them by pharmaceutical company representatives.

So, what are the compelling reasons for moving to digital technology? Digital tools make accessing data easier and faster, while reducing errors in information. There may still be a small number of cases where printed materials would fit in a PIL form – eg, with elderly patients who do not have access to or 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 reduces financial costs and Supporting environmental sustainabilityand less risk than older physical forms of circulating product information.

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 providers interact with drug information

Above all, it is rewarding for both regulators and pharmaceutical companies to hear that SmPC serves its purpose and provides important drug information in an easy-to-consume format.

To discover more about how healthcare physicians responded to the survey, read DataPharm’s white paper,”Making drug information meaningful: SmPC revisited.

About Datapharm:

datafarm It runs the EMC (Electronic Medicines Digest), the UK’s most comprehensive and authoritative information source on medicines. A rapidly growing SaaS company providing innovative business and organizational software solutions to support the life sciences and wider healthcare sectors, trusted by over 300 UK Pharma customers.

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