Pediatricians reported the most adverse drug effects

Last year, the Agency for Medicines and Medical Devices (CALIMS) received 162 reports of adverse effects of drugs, which is an increase compared to the previous year by almost 15 percent. The most frequently reported adverse effects are redness at the site of application of certain vaccines, then pain and swelling, then rash, fever, lack of therapeutic effect and itching. The process of procuring reagents for the analysis of vitamin D is ongoing, until then a refund can be made, the FZO told "Vijesta"

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They are procuring seasonal flu vaccines: Montefarm, Photo: Arhiva Vijesti
They are procuring seasonal flu vaccines: Montefarm, Photo: Arhiva Vijesti
Disclaimer: The translations are mostly done through AI translator and might not be 100% accurate.

Due to the lack of reagents, patients from all Montenegrin cities have not been able to do vitamin D analysis, which is only done in the Clinical Center (KC).

Patients who are suspected of having certain diagnoses or are being treated for rheumatological and endocrinological diseases, as well as autoimmune diseases, are instructed to determine vitamin D...

The Health Insurance Fund told "Vijesta" that the procurement of this reagent is carried out by KC and that they are aware that the procurement procedure is underway and that it will be completed by mid-June.

"For all laboratory analyzes that cannot be performed at a certain moment in the Center for Disease Control or other public health institutions, all insured persons can receive a full refund from the Fund, according to the actual cost of the analysis, including vitamin D," they answered.

In mid-May, KC announced a tender for the procurement of medical consumables - reagents and equipment for laboratory diagnostics, and the annual needs are worth 1.855.800 euros. That tender also requested reagents for vitamin D - 28.500 units. The public opening of offers, as written in the documentation, is scheduled for June 22, while the decision on the most favorable offer will be made within 90 days... The supply of medical equipment and consumables to the health system is good, and we have no information from public health institutions. and insured persons that there are shortages of these products, claim the FZO.

At the end of last month, KC announced a tender for the procurement of medical consumables for several organizational units...

Health workers reported the most adverse effects

The Agency for Medicines and Medical Devices (CALIMS) received 162 reports of adverse drug reactions last year, which is an increase compared to the previous year by almost 15 percent....

In the annual report of Calims, it is written that health workers most often reported adverse effects in 2019, so the number of such spontaneous reports was 157.

"In 2019, there was a slight increase in the number of reports of adverse drug effects that were forwarded to the CALIMS address by healthcare workers directly or through representatives of drug manufacturers. An analysis of the number of reports of adverse drug effects in 2019 indicates that there is still a very small number of reports that were submitted to CALIMS by the persons responsible for pharmacovigilance of drug license holders, who are legally obliged to have a pharmacovigilance system and to continuously improve it," the report says.

In 2019, the largest number of reports of adverse effects were submitted by pediatricians. According to the report, it is about health workers who, since the establishment of CALIMS, represent a significant category of health workers, reporters of adverse drug effects, especially adverse events after immunization, that is, the administration of vaccines.

"Physicians from Health Centers represent a significant group of adverse drug event reporters (selected doctors for adults, children) who report adverse events mainly through the Integral Health Information System". Pediatricians sent the most applications (36), followed by family medicine doctors (20), oncologists 16, neurologists 11.

Last year, the most applications came from KC, 51, then from health centers Bijelo Polje and Herceg Novi - 17 each, from the special hospital for lung diseases Brezovik 12...

Most of the reports in 2019 related to medicines, 79 percent, and the rest to side effects after the administration of the vaccine, which are not serious and are expected. The CALIMS report states that 39 percent of the reports met at least one of the seriousness criteria, while 57 percent of the cases involved side effects that were not serious in nature.

The most frequently reported side effects are redness at the site of vaccine application, followed by pain and swelling, followed by rash, fever, lack of therapeutic effect and itching.

"Analyzing the structure of reports according to the gender of the patient, it was determined that in 2019, a greater number of reports of adverse effects related to women, which is also the case in the European and global database of adverse drug reactions," the document states.

The majority of reports, according to the age structure, related to adverse effects in patients between 45 and 64 years of age.

Over 30.000 doses for mandatory flu vaccination

The pharmacy institution "Montefarm" last month announced a tender for the procurement of a seasonal flu vaccine.

For the first time, a special vaccine was requested for compulsory vaccination of children between the ages of six and 36 months - 1000 doses with an estimated value of 7.000 euros.

"Montefarm" also requested a flu vaccine for the mandatory immunization of persons over the age of three, namely 30.000 doses worth 210.000 euros.

At the end of last month, a decision was made on the most favorable bidder, Farmalab.

In previous years, Montefarm ordered mainly about 20.000 doses of vaccine for those over six months old with chronic diseases, over 65 years old, healthcare workers...

Last year, 22.700 doses were ordered, but a shortage was noted at the end of the year, so an additional 3000 were purchased.

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