Digital package leaflet: Your ally when taking medication
Understand what changes with the new format approved by ANVISA
With the implementation of the digital package leaflet, we have further confirmed that the digitalization of healthcare is advancing on several fronts, impacting our lives in different ways. The pilot project, approved by the National Health Surveillance Agency (Anvisa), was developed to improve patients' experience when consulting information about their medications.
Find out what the digital package leaflet is for: With the digital package leaflet, it is easier to access data on medicines on different electronic devices, such as cell phones and computers, as well as incorporating an important gain in terms of safety for consumers and health professionals: faster updating of the content. This functionality is very important, as various pieces of information, such as dosage, drug interactions and side effects, are updated whenever there are changes and advances in clinical research.
In this new format, the leaflets are more interactive, guaranteeing a pleasant and informative experience. They can contain graphics, explanatory videos and differentials for accessibility: the option to read aloud and increase the font of the text, for example. All of this has been designed to offer more clarity and precision, which contributes to people's autonomy in relation to their treatment.
The news doesn't stop there. Digital package leaflets reinforce sustainable practice in the pharmaceutical industry, as the reduction in the use of paper and ink leads to lower carbon emissions and the use of natural resources, since the process involves different stages, such as production, printing and transportation. As a result, there is a reduction in the disposal of materials and leaflet updates become more agile.
Digital leaflet: everything you need to know
A digital leaflet will be covered in the following situations:
- Packaging for free medicine samples
- Medicines destined for healthcare establishments (except pharmacies and drugstores). For example: outpatient clinics, home care services and clinics, as they are used under the supervision of health professionals.
- Over-the-counter medicine (OTC), marketed in multipacks. This is already covered by specific legislation, which allows it to be marketed without accompanying leaflets, as it is low risk.
- Medicines destined for the government, packaged in containers bearing the government's own markings (Ministry of Health).
It's worth emphasizing that, despite digitalization, patients can still request the traditional printed package leaflet from pharmacies and directly from the Customer Service Department of the laboratories that make the medicines.
Accessing the package leaflet is easy. Simply direct your cell phone to the QR Code on the packaging or go to the pharmaceutical companies' websites.
Sources:
https://www.in.gov.br/en/web/dou/-/resolucao-rdc-n-885-de-10-de-julho-de-2024-571714213