Is the SmPC still relevant in the digital age? - PharmaTimes

2 years ago 45

Post-pandemic, we person been forced to rethink the mode successful which medicines accusation is disseminated and consumed.

For galore years, the SmPC (Summary of Product Characteristics) has been utilized arsenic a regulatory approved papers of medicinal merchandise accusation for healthcare professionals (HCPs) connected however to usage medicines safely and effectively.

But with a plethora of accusation present disposable digitally, is the afloat SmPC inactive relevant, and does it inactive suit the needs of HCPs requiring circumstantial accusation astir a medicine?

Datapharm surveyed 241 UK healthcare professionals connected however they prosecute with medicines information, and the findings person provided immoderate compelling insights.

The SmPC is simply a cardinal operator of effectual determination making

Strikingly, 85% of HCPs surveyed said they look astatine the SmPC astatine slightest a fewer times per week. There are a assortment of reasons for doing truthful – this tin beryllium portion of the prescribing process (69% of respondents), to cheque interactions with different medicines (49%) oregon to cheque alteration accusation from erstwhile SmPC versions (44%).

When checking alteration accusation from erstwhile SmPC versions, portion of this process whitethorn impact requesting much accusation from the Pharma institution to recognize an omission oregon alteration successful accusation (for example, omission of accusation connected retention conditions). So erstwhile the Pharma institution needs to pinpoint wherefore thing has changed, comparing the latest SmPC with an older version it is ideally made straightforward by referencing a azygous root of truth.

It’s important to look astatine the afloat SmPC

Pharma companies traditionally relied connected the truncated mentation of Prescribing Information (commonly referred to arsenic Abbreviated PI oregon abbreviated PI) to supply the requisite magnitude of prescribing accusation successful a compact format portion gathering their regulatory obligations. However, the Abbreviated PI is hard to usage – comments from the survey included that “the words look precise crowded” successful this condensed format.

In the survey, HCPs were asked what accusation they are funny successful erstwhile looking astatine accusation astir a medicine. The afloat SmPC accusation was ranked arsenic being astir important wide erstwhile compared with conscionable the accusation connected dosage and administration, contraindications, progressive substances oregon broadside effects.

HCPs similar digitally delivered content

When HCPs were asked which format they similar to person medicine accusation in, determination was an overwhelming penchant for integer - 86% preferred “Digital” portion 11% said “Both”. A important fig (40%) besides said they ne'er work the printed materials physically handed to them by Pharma representatives.

So, what are the compelling reasons for going digital? Digital tools marque entree to information easier and faster, portion minimising errors successful information. There whitethorn inactive beryllium a tiny fig of cases wherever printed materials are due successful PIL signifier - for example, with aged patients who don’t person entree oregon the quality to usage physics formats.

However, expanding reliance connected integer formats means determination volition beryllium little unnecessary insubstantial wastage, successful crook reducing fiscal costs and supporting biology sustainability, and little hazard from outdated carnal forms of merchandise accusation successful circulation.

In short, Pharma should see a digital-only attack but connection people on-demand for those who necessitate it.

Get a deeper knowing of however HCPs prosecute with medicines information

Above all, it’s rewarding for some regulators and Pharma to perceive that the SmPC is serving its intent and provides the important medicines accusation successful an easy consumable format.

To observe much astir however HCPs responded successful the survey, work Datapharm’s whitepaper, “Making Medicines Information meaningful: Revisiting The SmPC”.

About Datapharm:

Datapharm runs emc (electronic medicines compendium), the UK’s astir comprehensive, trusted root of accusation connected medicines. The fast-growing SaaS institution provides innovative regulatory, compliance and commercialized bundle solutions to enactment the Life Sciences and wider Healthcare sectors, and is trusted by implicit 300 Pharma customers successful the UK.

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