News and Educations

Adverse reaction report for 2013


The Agency for Medicinal Products and Medical Devices (HALMED) published on 18th April 2014 on its webpages the Adverse Reaction Report for 2013. The report is accessible in the Pharmacovigilance/Adverse reaction reports section, or here (in Croatian).

The report has been prepared under Medicinal Products Act (Official Gazette, No 76/13) and corresponding Ordinance on pharmacovigilance (Official Gazette, No 83/13) based on which HALMED monitors adverse reactions reported in the Republic of Croatia by healthcare professionals and marketing authorisation holders who are obliged to report it. HALMED also receives adverse reactions reported directly by patients.

The number of suspected adverse reaction reports is a quality indicator of the reporting system itself and every additional report represents additional information on the medicine for its users and healthcare professionals. Thanks to the concerted efforts of HALMED and all healthcare professionals, patients and marketing authorisation holders who regularly report suspected adverse reactions, according to the quality and number of reports, the Republic Croatia has been ranked high in the 14th place among 115 world countries participating in the WHO programme of adverse reactions monitoring.

During the 2013, HALMED received 2491 suspected adverse reaction reports in the Republic of Croatia. Out of this number, 1784 have been collected by spontaneous reporting from healthcare professionals and patients directly to HALMED, or via marketing authorisation holders or the Croatian Public Health Institute. The total number of reports notes a 30% increase as compared to 2012 (2491 reports versus 1923 in 2012).

Fifty-five percent (55%) of all suspected adverse reactions in 2013 were reported by doctors, which is lower than in 2012, where doctors made 63% of all reports. On the other side, an increasing trend by pharmacists that represented 34% in 2013 was noted. A slight decrease in reports by marketing authorisation holders that represented 29 % of all reports.

The great news in 2013 was an almost triple increase in patient reporting as compared to the previous year. During 2013, HALMED received 142 reports from patients/consumers of medicines or their legal representatives.

In September and October 2013 HALMED carried out a public educational campaign intended to promote the importance of package leaflet reading and adverse reaction reporting among patients and consumers of medicines. A direct impact of the campaign appeared to be visible in the latest quarter of the last year, when HALMED received 813 reports. It is interesting to note that the campaign motivated not only patients to report, but also an increase of reporting from healthcare professionals was recorded. In addition, instead of the expected drop in reporting after the campaign, a more durable impact on patient reporting was noted; HALMED received their 40 reports in the first quarter, which indicates that in 2014 a similar number of reports from patients may be collected.

The most three reported group of medicines in 2013 belong to the Group C (cardiovascular medicines), J (medicines against system infections and vaccines), N (medicines for nervous system). While groups C and J note a significant increase in number of reports, the group N notes a one third decrease in reports as compared to 2012.

In 2013, the number of adverse reactions that do not fulfil any criteria to be classified as serious adverse reaction is significantly higher than those that do fulfil those criteria (66% versus 34% serious adverse reactions).

The highest number of reports belong as in previous years to the following organ systems: the most reported adverse reactions belong to the group Skin and subcutaneous tissue disorders with 17 % share of all reports. Followed by Gastrointestinal disorders (16,3% versus 14% in 2012) and Common disorders and application site reaction (15,5% versus 15% in 2012).

As compared to 2012, the same adverse reactions are placed in first twenty places with somewhat different share in total number of reports. The most reported adverse reactions in 2013 were nausea, rash, diarrhoea and vomiting which are typical for conventional synthetic medicines.