News and Educations

Adverse Reactions Report for 2012


On 15 March 2013, the Agency for Medicinal Products and Medical Devices (HALMED) made available on its internet pages the Adverse reaction report for 2012. The report is available in the Pharmacovigilance/Adverse reaction reports section, or here.

The report was prepared under the Medicines Act (Official Gazette No 71/07., 45/09. and 124/11.) and the corresponding Ordinance on pharmacovigilance (Official Gazette, No 125/09.), according to which HALMED receives reports of adverse reactions detected in Croatia by health care professionals and marketing authorisation holders who are obliged to report it. HALMED also receives direct reports to medicinal products from patients.

The number of suspected adverse reactions indicates quality of the reporting system and every additional report means an additional information about the medicine for its users and health care providers. Thanks to the concerted effort of HALMED and all health care professionals, patients and marketing authorisation holders who regularly report all suspected adverse reactions, the Republic of Croatia with about 500 reports/million inhabitants was ranked highly on the 16th place out of 110 countries participating in 2012 in the WHO’s Programme of ADRs monitoring in terms of quality and number of reports, expressed per million inhabitants.

In 2012, HALMED received totally 1923 suspected adverse reaction reports in Croatia. 1784 reports were received through spontaneous reporting from health care professionals and directly from patients, through marketing authorisation holders or the Croatian Institute for Public Health. The total report number has shown a slight decrease of 6% as compared to the year 2011 (1923 reports vs. 2040 reports in 2011).

Almost two thirds of adverse reaction reports received in HALMED in two 2012 were from physicians; in this year also, reports were received from non-specialists, or doctors working in primary care. The number of reports by pharmacists increased 21% as compared to the year 2011, which represents almost one third of all reports. HALMED received 659 reports from marketing authorisation holders, which means 34% of the total number of reports. That is the highest share of industry reports, ever received in HALMED, which indicates that marketing authorisation holders take their role seriously in monitoring and surveilling of safety profiles of their products on the market.

The utmost change in 2012 related to reporting sources was the threefold increase in reports from patients as compared to 2011. Throughout the 2012, HALMED received 45 report from patients/product users or their attorneys, representing a bit more than 2% of all reports. The reporting from patients/product users or their attorneys is based under the Ordinance of pharmacovigilance from 2009. The increase of reporting from patients may be explained by the fact that the Agency for Medicinal Products and Medical Devices (HALMED) started to use an application from the Uppsala Monitoring Centre which is a collaborating centre of the WHO, providing an online access for reporting suspected adverse reactions from patients. Consequently, the Republic of Croatia placed itself into a limited number of countries having implemented that type of reporting from patients. The increased number of reported suspected adverse reactions from patients is due to the implementation of the aforementioned online application system indicating that patients recognise their role and importance of adverse reaction reporting.

The three most reported groups of medicines in previous years remain on top also during 2012, according to the adverse reaction number and share. However, they show a stagnation in absolute values (groups N - medicines for central nervous system, C - for cardiovascular system) or drop in number of reports (J group - medicines for system infections).

In 2012, the number of adverse reactions that do not fulfil neither of criteria to be classified as a serious adverse reaction, is significantly higher than those that do fulfil such criteria (56% vs. 44% serious adverse reactions).

When classified to organic systems, the highest share of adverse reaction belong to the group Disorders of gastrointestinal tract (15.8% vs. 14% in 2011), General disorders and application site adverse reactions (14.7% vs. 15% in 2011) followed by Skin and subcutaneous tissue disorders with a 12.4% and Central nervous system disorders with 10.5% of the total adverse reaction share.

In comparison to 2011, the same adverse reactions are placed top ten with somewhat changed total adverse reaction share. In 2012, the major part is comprised from adverse reactions like nausea, diarrhea and vomiting which are adverse reactions typical for classic synthetic medicines.