HomeHealthMedicineIs the SmPC still relevant in the digital age?

Is the SmPC still relevant in the digital age?

After the pandemic, we are forced to rethink the way information about medicines is disseminated and consumed

The SmPC (Summary of Product Characteristics) has been used for many years as a legally approved drug information document for healthcare professionals (HCPs) on how to use medicines safely and effectively.

But with an abundance of information now available digitally, is the full SmPC still relevant and does it still meet the needs of healthcare providers who require specific information about a medicine?

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

The SmPC is an important driver for effective decision-making

It is striking that 85% of the healthcare providers surveyed indicate that they view the SmPC at least a few times a week. There are several reasons for doing this – this could 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 reviewing change information from previous SmPC versions, part of this process may include requesting more information from the pharmaceutical company to understand an omission or change in information (e.g. omission of storage conditions information). So when the pharmaceutical company needs to determine why something has changed, comparing the latest SmPC with an older version it is ideally made simple by reference to a single source of truth.

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It is important to view the full SmPC

Pharmaceutical companies have traditionally relied on the abbreviated version of prescribing information (commonly referred to as abbreviated PI or short PI) 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 – comments from the survey included that “the words look very busy” in this abbreviated format.

The survey asked healthcare providers what information they are interested in when looking at information about a medicine. The full SmPC information was ranked as the most important overall compared to only the information on dosage and administration, contraindications, active substances or side effects.

HCPs prefer digitally delivered content

When healthcare providers were asked which format they preferred to receive drug 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 that were physically handed to them by Pharma representatives.

So, what are the compelling reasons to go digital? Digital tools make accessing data easier and faster while minimizing information errors. There may still be a small number of cases where printed material is appropriate in PIL form – for example, in elderly patients who do not have access to or are unable to use electronic formats.

However, due to the increasing dependence on digital formats, less unnecessary paper will be wasted, which in turn will reduce financial costs supporting environmental sustainabilityand reduced risk from 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 better understanding of how healthcare providers handle information about medicines

Most importantly, it is rewarding for both regulators and pharma to hear that the SmPC is serving its purpose and providing the important drug information in an easy to consume format.

To discover more about how HCPs responded to the survey, read Datapharm’s white paper,”Making drug information meaningful: rethinking the Summary of Product Characteristics”.

About Datapharm:

Datapharm runs EMC (Electronic Medicine Compendium), the UK’s most comprehensive, reliable source of information on medicines. The fast-growing SaaS company provides innovative regulatory, compliance and commercial software solutions to support the life sciences and broader healthcare sectors, and is trusted by over 300 pharmaceutical customers in the UK.



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