The European Commission’s push for digital health solutions promises numerous benefits, including better patient access and improved healthcare efficiency. However, it is important to ensure that this drive for digitalisation does not leave vulnerable populations behind.
The Risk of Excluding Vulnerable Patients
A recent revision of the General Pharmaceutical Regulation proposes relaxing rules for medicine safety information. Under the new proposal, medicine packaging may no longer need to include essential information leaflets, such as dosage instructions, side effects, and potential interactions, as long as a QR code is provided that links to this information online.
This digital shift may undermine patient safety, particularly for those who struggle with digital access or skills. The proposal would give individual EU countries the option to decide whether to keep printed leaflets, make them digital, or adopt a hybrid approach. Printed medical leaflets are a reliable, fail-safe method for ensuring that patients have access to crucial information when they need it.
A Dual Approach Is Necessary
A combination of both digital and printed solutions is the safest way forward to protect patients’ well-being. While the European Commission aims to provide digital healthcare access for all by 2030, a significant portion of the population remains digitally excluded. As it stands, 32% of Europeans lack basic digital skills, and only 57% of individuals aged 55-74 use the internet regularly.
Additionally, over 80% of EU citizens aged 65 and above use prescribed medications, with 45% of all prescriptions going to this age group. This demographic is particularly vulnerable to the digital divide, as many of them do not have the digital literacy or tools required to access online medical information. In rural areas, more than 60% of households were without access to high-capacity internet in 2021.
The Digital Divide Cannot Be Ignored
The disparity in digital access across Europe cannot be overlooked. As technology becomes more integrated into healthcare, it is critical to ensure that printed medical leaflets remain available to those who need them. Vulnerable patients, especially older adults and those in rural areas, should not be left without essential health information simply because they lack the necessary digital skills or resources.
Challenges with ‘Print on Demand’ Solutions
If the revised regulation is adopted and countries shift to a digital-only model, pharmacists would be expected to offer a “print on demand” option for patients who request it. However, this solution carries significant risks and challenges. First, it creates the possibility of errors in the information being printed, which could lead to dangerous mistakes. Second, it adds pressure to pharmacists, who would need to dedicate time and resources to print, manage, and distribute leaflets.
Patients who require printed leaflets would also face longer waits at pharmacies, and they would be burdened with multiple A4 pages to carry home. The estimated cost of producing these “print on demand” leaflets across the EU ranges between €1.68 billion and €3.495 billion annually, depending on whether the leaflets are printed in black or full color.
Risks of Digital-Only Access
Reliance on digital platforms to deliver medical information also exposes patients to additional risks. Technical issues such as server outages or cyberattacks could prevent access to vital medication information. Printed leaflets, however, are always available with the medication and do not require patients to have access to technology, ensuring they can read the information at any time.
Ensuring Access to Information for All
As discussions about the General Pharmaceutical Regulation continue, it is vital that patient safety remains the priority. We must ensure that digital solutions are available for those who can access them, but that printed solutions are also provided to guarantee that every patient receives the care and information they need. The right approach should balance digital innovation with the needs of vulnerable individuals who may not be able to fully benefit from digital health solutions. Only by ensuring that no one is left behind can we safeguard the health and safety of all patients.
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