604 suspected adverse drug effects were reported

Last year, 604 reports of suspected adverse drug reactions were submitted to the Montenegrin Institute for Medicines and Medical Devices, which is over 300 percent more than in 2020.

The main reason for the increase in the number of reports submitted by health workers and patients is the mass immunization against the coronavirus, which, according to this institution, has attracted a lot of attention from the general and professional public from the aspect of monitoring the safety of the use of vaccines. They explained that the applications submitted confirmed the known safety profile of the vaccines and did not require regulatory action.

The CInMED report states that last year the criteria of the World Health Organization for a functional pharmacovigilance system were met, which, among other things, implies more than 200 applications per million inhabitants per year.

"Reports of adverse drug effects that arrive at the CInMED address, together with additional (follow-up) information provided by healthcare workers and representatives of drug manufacturers, are of good quality, i.e. in the majority of cases, they enable a reliable assessment of the cause-and-effect relationship between suspected drugs and manifested adverse effects. During the education for health workers, organized by CInMED, the importance of as much data as possible on the application is indicated and in this sense of cooperation with health workers regarding obtaining additional information, when it is available", the annual report states.

CInMED said that during 2021, most applications were submitted in April.

"During 2021, CInMED received a total of 548 applications through spontaneous reporting by health workers and patients, directly or indirectly through the license holder. 55 reports of adverse effects from post-marketing non-interventional studies and other studies involving organized data collection were also submitted, as well as one report from the literature. The total number of applications recorded an increase of 337.68 percent compared to 2020 (604 applications in 2021 and 138 applications in 2020)," the document reads.

It is stated that out of 548 spontaneously reported suspicions of an unwanted effect of the drug, in 441 cases the healthcare worker sent the report to CInMED, while 42 reports were submitted by patients, in direct communication with that institution.

"In 78 cases, the application was submitted to CInMED by the license holder/applicant for obtaining a drug/wholesale drug license (65 from spontaneous reporting, 12 reports from non-interventional trials and one report obtained by searching the relevant professional and scientific literature). "When it comes to spontaneous reports submitted by drug license holders, the primary reporters were healthcare professionals, except in one case when it was a patient," the report says.

Health workers submitted reports in about 80 percent of cases, and epidemiologists are the most numerous among them, who reported suspected adverse drug effects to CInMED in 206 cases. The selected doctors submitted 120 applications to this institution.

"The largest number of applications in the previous year were submitted by health workers of the Clinical Center of Montenegro, which is to be expected, considering the large number of employed health workers and the large number of patients treated in this institution," explained CInMED.

This institution analyzed the reported adverse effects by municipality, whereby this information was not submitted for 47 reports, and the expected largest number were sent from Podgorica.