Start of a new HALMED’s campaign on promoting the importance of package leaflet reading and reporting of ADRs


The Agency for Medicinal Products and Medical Devices (HALMED) has started a public education campaign aimed at promoting the importance of package leaflet reading and ADR reporting among patients and end consumers. The aim of the campaign is to inform citizens that, alongside the information provided by a qualified healthcare professional, additional information may be obtained through package leaflet reading and to motivate them to get actively involved in the medication and monitoring of safe use of medicines by reporting ADRs. This approach will further contribute to the improvement of the safe use of medicines and more efficient health care for patients and overall public health.

The campaign will intensively be carried out at the national level from the beginning of September to the end of October this year through billboard, press ads, radio spots, on-line banners, posters in doctors’ waiting rooms and information leaflets on ADRs reporting that will be available in pharmacies throughout the country.

Through this campaign HALMED calls on patients to read the package leaflet, where all the important information needed for a correct use of the medicine, is contained, including known and discovered adverse reactions.

Also, in the case they have experienced a suspected adverse reaction, patients may reported directly to HALMED via an on-line application, sending the fulfilled forms by courier, fax or e-mail. The guide for reporting ADRs with additional information is available here. Reports to ADRs are extremely important to HALMED, as they are used in a continuous evaluation of safe use of medicines throughout its life cycle, or period when the product is on the market. By reporting the ADRs, every patient may directly contribute to the improvement of the safe use of medicines for everyone.

The importance of the package leaflet reading

The package leaflet contains the most necessary information, indispensable for the proper use of the medicine, written in a clear and to the patient easily understandable way. In order to use the medicine in a correct manner, the patient must be informed about it. However, studies have shown that only 1 out of four patients reads the entire package leaflet before the use of the medicine never used before. Persons that always read the package leaflet are usually above 65, even though there are many among them who don’t read the leaflet Women are somewhat more careful when taking medicines, so they pay more attention to read the leaflet than men. Patients usually pay attention to parts of the leaflet that refer to dosing and side-effects. Unfortunately, to less attention is paid to the part that relates to warnings. Therefore, HALMED recognizes the need for additional information and public education about the importance of the reading of the package leaflet.

The value of adverse reactions reported from patients

Reporting from patients is an important additional source of information that together with reporting from healthcare professionals facilitates the creation of a "clearer picture” of the medicine and contributes to more rapid discovering of new, previously unknown adverse reactions. They may provide the information on how medicines are used and how adverse reactions impact the patient’s life quality. Also, they may indicate problems with excipients contained in medicinal products and potential interactions, help in discovering new and unusual adverse reactions, whereas reporting of unexpected benefits of a certain product may serve as a roadmap for the treatment of other conditions.

The role of the Agency for Medicinal Products and Medical Devices

The Agency for Medicinal Products and Medical Devices (HALMED) is a competent authority responsible for granting marketing authorisations for medicinal products in Croatia. The aim of HALMED is to protect the public health by ensuring safe, effective and good quality medicinal products. To this end we evaluate medicines safety after placing the product on the market, where reporting of suspected adverse reactions is a precious information source. In line with the new knowledge, and where appropriate information in the package leaflet (i.e., dosing restriction, additional warnings etc.) is being updated.

Croatian citizens may find information on medicinal products on HALMED’s internet pages in the For Patients section, where they can access the database of all medicinal products authorised in Croatia with their detailed information, including the package leaflet, as well as report an adverse reaction via an on-line application.