Adverse Drug Reactions Report for 2009
30.05.2010
On 31 May 2010, the Agency for Medicinal Products and Medical Devices (HALMED) posted on its website the Annual Report on Spontaneous Reporting of Adverse Drug Reactions for 2009. It is available only in Croatian language from the Reports-Adverse Drug Reactions link.
The Report was drafted in accordance with the Medicinal Products Act (Official Gazette Nos. 71/07 and 45/09) and the accompanying Ordinance on Pharmacovigilance (Official Gazette No. 125/09), pursuant to which HALMED monitors adverse drug reactions (ADRs) in the Republic of Croatia that are related to the marketed medicinal products and the medicinal products in clinical trials, which healthcare professionals, marketing authorisation holders and clinical trial authorisation holders have an obligation to report.
As of the second half of 2009, ADR notifications can be sent to the HALMED by patients, too, as set forth in the new Ordinance on Pharmacovigilance (Official Gazette No 125/09).
Due to the joint effort of the HALMED and all the healthcare professionals who regularly notify suspected ADRs, the Republic of Croatia is, by the quality and quantity of ADR notifications expressed per million inhabitants, among the top 20 countries participating in the WHO Programme for International Drug Monitoring.
In 2009, the HALMED received a total of 1544 ADR notifications. This represents a minor decrease of 8% in the total number of notifications in comparison with 2008, when more than 1680 notifications were received.
This decrease is due to a lower number of vaccine-related ADR notifications, whereas the number of ADR notifications related to other medicines is actually on the rise. In 2008, there were 654 vaccine-related ADR notifications compared to 389 in 2009, whereas the ADR notifications related to other medicinal products rose from 611 in 2008 to 776 in 2009.
Such an increase in the non-vaccine related ADR notifications is an indicator of a higher awareness among the healthcare professionals of the importance of ADR reporting, as well as the result of the continuing education implemented by the HALMED.
The lower number of the vaccine-related ADRs is the result of the regulatory activities and the consequent changes in the mandatory vaccination schedule.
Medical specialists account for the majority of notifiers in 2009, although the number of notifications received by the HALMED from pediatricians has been halved due to the fact that in 2008 pediatricians were notifying primarily ADRs related to the vaccines included in the vaccination schedule at that time.
The total number of notifications received from pharmacists rose significantly, accounting for 19% of all notifications in 2009, compared to only 7% in 2008.
The notifications received from the marketing authorisation holders account for 16.5%, with a constant upward trend when comparing the data from 2005 until today.
The number of notifications from hospital institutions is the highest since the HALMED started monitoring the spontaneous ADR reporting. It is well-known that the majority of serious ADRs are recorded in hospitalized patients so it is necessary to continue encouraging ADR reporting by hospital institutions.
In comparison with 2008, the data for 2009 showed a decrease in the number of the medicine/vaccine-related suspected serious ADR notifications when compared to the non-serious ADRs.
The highest number of notified ADRs relate to the medicinal products from Group J (antibiotics and vaccines). Ranked second in 2009 by number of notifications are the medicinal products from Group N (nervous system), and third are the medicinal products from Group C (cardiovascular medicines), which are also the most frequently prescribed medicinal products in the Republic of Croatia.
By organ systems, ADRs are mostly related to the General Disorders and Administration Site Conditions, followed by Digestive System Disorders, Nervous System Disorders and Skin and Subcutaneous Tissue Disorders.
