Patients in Bosnia and Herzegovina most frequently reported adverse reactions to COVID-19 vaccines and drugs for malignant diseases

(Patria) - During the past four years, the Agency for Medicines and Medical Devices of Bosnia and Herzegovina (ALM BiH) received a total of 1,662 reports of suspected adverse drug reactions, most of which
related to COVID-19 vaccines and drugs used to treat malignant diseases - antineoplastics.

As the Agency pointed out, 89 reports were received in 2020, 807 a year later, while 543 reports were received in 2022. Last year, according to their data, the number of reports was 223, Nezavisne novine reports.

- During 2021 and 2022, the largest number of reports related to vaccines used for passive immunisation of the population in the fight against the pandemic disease COVID-19 - stated the ALM BiH.
As they added, the largest number of reports of adverse effects related to drugs used to treat malignant diseases - antineoplastics.

- Drugs from this group are most often cytostatics that do not have a sufficiently selective effect, which is why they damage not only malignant cells but also healthy ones - they state.

Also, according to the Agency's data, in the observed period, the highest percentage of reported adverse effects were expected, i.e., adverse effects that were previously known and described in the patient information leaflet and in the summary of product characteristics.

- The most commonly reported adverse reactions are mild and transient: urticaria, rash, nausea, diarrhoea, abdominal pain... - said the Agency.

Magdalina Janković, Master of Pharmacy, certified advisor for non-medicinal nutrition of infants and children and founder and content creator of the Instagram page "babypharm_", emphasises that reporting all adverse drug reactions is extremely important because drugs continue to be monitored after they receive marketing authorisation.

- It is very important to have a large sample of patients, and therefore even the smallest adverse effect should not be neglected. Also, some adverse effects may only manifest after long-term use, which is not possible during testing conducted before marketing. Data on rare serious adverse effects, toxic effects of chronic therapy, use of the drug in special patient categories, for example in children, the elderly or pregnant women, or interactions with other drugs, are often incomplete or not available at all - said Janković.

She adds that patients can report adverse effects to their doctor or pharmacist, who are obliged to fill out forms and send them to the Agency for Medicines and Medical Devices of Bosnia and Herzegovina for review, or they can independently find the form on the website of the Agency for Medicines and Medical Devices of Bosnia and Herzegovina, fill it out and send it.

From the Banja Luka Health Centre, they point out that drug manufacturers, healthcare institutions and healthcare workers are obliged to report any suspicion of an adverse drug reaction to the Agency for Medicines and Medical Devices of Bosnia and Herzegovina.