News and Educations

Adverse Drug Reaction Report for 2014


The Agency for Medicinal Products and Medical Devices (HALMED) published on 8th May 2015 on its web pages the Adverse Drug Reaction Report for 2014. The report is accessible in Croatian in the Pharmacovigilance/Adverse Drug Reaction Reports section of the web site or here.

The report was drafted under Medicinal Products Law (Official Gazette, No 76/13, 90/14) and corresponding Ordinance on Pharmacovigilance (Official Gazette, No 83/13) based on which HALMED monitors adverse reactions reported in the Republic of Croatia. It is mandatory for healthcare professionals and marketing authorisation holders to report adverse reactions. HALMED has also received a number of adverse reactions directly from patients.

The number of suspected adverse reactions is an indicator of the reporting system quality and every further report signifies a further information for users and healthcare professionals. Thanks to the joint efforts of HALMED and all healthcare professionals, patients and marketing authorisation holders that regularly report suspected adverse reactions, the Republic of Croatia has currently been ranked on the high 16th place according to the quality and number of reports, per million inhabitants, among 115 countries in the world participating in the WHO Programme of adverse reaction monitoring.

During 2014, HALMED received 3112 suspected adverse drug reaction reports in the Republic of Croatia. Out of this, 2658 reports were collected through spontaneous reporting by healthcare professionals and patients directly to HALMED, by marketing authorisation holders or Croatian Public Health Institute. The total number of suspected adverse reaction reports is increased as compared to 2013, where 2491 reports were collected.

53.5% of all suspected adverse reaction reports were from doctors. There is a slight decline in this reporter group as compared to the year 2013 where 55% of reports were from doctors. On the other hand, the reporting trend from pharmacists from previous years has been continuing and they represent 37% of all reports in 2014 which is the highest percentage noted ever. There is a declining trend among HALMED reporters regarding marketing authorisation holders, where they represent 23%, as compared to29% in 2013.

The number of reports from patients in 2014 is 187, which represents even 6% of all reports, exactly as in 2013. This speaks to the fact that the public educational campaign that HALMED was running among patients and users of medicines in 2013 with the aim of promoting the importance of adverse reaction reporting, achieved a more permanent impact on patient reporting.

The number of reports from hospital settings in 2014 was 425, and the percentage was 14% of all total reports. Even though, the number of these reports has increased as compared to 2013 (11%), HALMED concludes that the current number from hospital settings is further being too low. As a solution to this, there is a need for integration of reporting systems into hospitals’ IT systems, as well as for further education on adverse reaction reporting. First steps in resolving too low percentage of reports were done in 2014 through fostering co-operation with Croatian health Insurance Fund, and the complete integration of reporting systems from software solutions for primary medical practice, pharmacies, hospital IT systems (BIS) and software solutions for hospital that do not have BIS (BSN) is expected in several few years.

The three most common medicines groups according to suspected adverse drug reaction reports in 2014 are J (medicines for systemic infections and vaccines), C (medicines for cardio-vascular system) and L (cytostatic medicines).

There is a significant number of reports of adverse reactions that do not fulfil the criteria of serious adverse reactions from those that do fulfil such criteria (71% non-serious vs only 29% of serious), which is a trend that we notice in the recent years as a result of decrease of reports from pharmacists. It is important to emphasize that non-serious adverse reactions do not automatically mean adverse reactions that are not severe, as even these adverse reactions also may diminish the quality of patient’s life. By reporting non-serious adverse reactions, a better comprehensiveness of all adverse reactions is achieved that impacts the quality of individual life.

The highest adverse reaction report number in 2014was noted for organic system General disorders and reactions on the application site with 16.9% of total reports. Followed by the organic system Disorders of gastrointestinal tract (16.4%) and Skin disorders and subcutaneous tissue (14.3%).

The most commonly reported adverse reactions are nausea, redness, itching and rash, which are adverse reactions typical for conventional medicinal products.