HALMED and IMROH started formal cooperation in the field of monitoring of drug overdoses
The Head of Agency for Medicinal Products and Medical Devices of Croatia (HALMED), Siniša Tomić, PhD, Assoc. Prof., and the Head of Institute for Medical Research and Occupational Health (IMROH), Ana Lucić Vrdoljak, PhD, have on 7 March 2016 signed a cooperation agreement.
The cooperation is being established in order to achieve more efficient monitoring of adverse drug reactions, particularly those associated with drug poisoning, i.e. drug overdoses. The aim of cooperation is to improve the safety of use of medicinal products and protection of public health.
Within this cooperation, IMROH’s experts will regularly forward information on suspected poisoning with medicinal products to HALMED’s experts, who will process this information as adverse drug reactions reports and submit them to the national, European and worldwide adverse drug reaction database.
By using the information provided by IMROH, HALMED will be able to detect factors related to medicinal products, which could influenced with the aim of reducing the risk of drug overdoses. The measures that HALMED can put in place to contribute to the reduction of that risk include, for example, the change of type, size and design of packaging, the inclusion of warnings on the packaging, changes in the prescription status of medicinal products, changes to product information as well as informing and education of physicians, pharmacists and patients.
Since HALMED receives on an annual basis an exceptionally small number of reports of suspected adverse drug reactions due to drug overdose, it is unfortunately difficult to put in place measures for reduction of the risk of drug overdose. On the other hand, IMROH, which provides professional assistance in the treatment of poisoning, annually receives a significant number of calls for cases of poisoning with medicinal products. Therefore, HALMED and IMROH expect that the activities planned within this collaboration will contribute to the safety of medicinal products and the protection of public health.
HALMED will inform on results of this cooperation in its annual report on adverse drug reactions which is published every year on its website.
Additional information on reporting of adverse drug reactions due to drug overdose
Adverse drug reaction is every response to a medicinal product which is noxious and unintended. This includes adverse reactions arising from use of the product within or outside the terms of the marketing authorisation (including overdose, off-label use, misuse, abuse and medication errors) and adverse reactions arising from occupational exposure.
HALMED monitors suspected adverse drug reactions reported in the Republic of Croatia, which healthcare professionals and marketing authorisation holders are obliged to report, and it also receives reports of suspected adverse reactions directly from patients themselves. Based on received reports of adverse reactions, HALMED evaluates safety signals, i.e. if there exists a causal relationship between the medicinal product and the reported adverse reaction. The evaluation of safety signals is a part of standard pharmacovigilance activities, through which the benefit-risk balance of medicinal products is actively monitored and managed.
According to the Annual Report on Spontaneous Reporting of Adverse Drug Reactions for 2014, in 2014 HALMED received 3112 reports of suspected adverse reactions to medicinal products and vaccines. Among these reports, only 14 of were due to suspicions of drug overdose. This includes cases of both accidental and intentional overdose, as well as symptomatic and asymptomatic cases.
Additional information on Poison Control Centre
IMROH's Poison Control Centre is a public health service providing professional assistance in treatment of poisoning, primarily via a 24-hour telephone information service. Employees of the Poison Control Centre answer telephone calls primarily from medical institutions and healthcare professionals in Croatia, although the Centre is also at the disposal of the general public and to callers from abroad. IMROH publishes annual reports, which include the number of calls received by the Poison Control Centre, as well as profiles of cases of poisoning, in the magazine Archive for Occupational Hygiene and Toxicology.
According to the Annual report of the Poison Control Centre for the period between 1 January and 31 December 2014, the Centre received 1883 calls concerning suspicions of poisoning. In most of the cases, 677 of them, poisoning was caused by medicinal products. This includes cases of both accidental and intentional overdose, as well as symptomatic and asymptomatic cases.
Information for patients and public
- HALMED is reminding patients that they should consult a physician if they suspect that they are experiencing an adverse drug reaction, including adverse reactions resulting from drug overdose. If adverse reaction is life-threatening, patients should immediately seek emergency medical assistance.
- Information on poisoning caused by medicinal products is available via a 24-hour telephone information service of the Poison Control Centre.
- By reporting adverse reactions patients are directly contributing to the safe use of medicinal products; HALMED thus invites patients to report any suspected adverse reaction directly to HALMED. The procedure of reporting adverse drug reactions is described on HALMED's website.
- Patients who contacted the Poison Control Centre for advice during 2016 might be contacted by HALMED for additional information on suspected adverse reactions. All additional information collected this way is valuable for the evaluation of individual cases and contributes to the safe use of medicinal products.
Information for healthcare professionals
- HALMED reminds healthcare professionals that they are obliged to report any adverse drug reaction, including adverse reactions that are results of drug overdose. Adverse drug reaction reporting procedure is described on HALMED's website. The reporting of adverse reactions is awarded with points by the Croatian Medical Chamber and Croatian Chamber of Pharmacists.
- Professional advice in case of poisoning, including poisoning with medicinal products, is available via the 24-hour telephone information service of the Poison Control Centre.
- Healthcare professionals who contacted the Poison Control Centre for advice during 2016 might be contacted by HALMED for additional information on suspected adverse reactions. All additional information collected this way is valuable for the evaluation of individual cases and contributes to the safe use of medicinal products.
Information for marketing authorisation holders
- HALMED will submit the reports of drug overdose which led to adverse reactions to the EudraVigilance database and make reports available to marketing authorisation holders, in accordance with the provisions of the European guideline Guideline on good pharmacovigilance practices: Module VI - Management and reporting of adverse reactions to medicinal products.
- HALMED will make the reports of drug overdose which did not lead to adverse reactions available to marketing authorisation holders, so they could perform their obligations in accordance with the provisions of the European guideline Guideline on good pharmacovigilance practices (GVP): Module VII - Periodic safety update report and Guideline on good pharmacovigilance practices: Module V - Risk management systems.
- HALMED is reminding marketing authorisation holders that the reports of drug overdose which do not lead to adverse reactions are not to be sent to the EudraVigilance database, according to VI.B.6.3.