After several patients with diabetes complained that they received older-made lancets from prescription pharmacies, "Montefarm" demanded new quantities of these medical devices, in automatic lancing devices - devices that painlessly and quickly draw blood for testing.
The lancets in question were delivered to pharmacies in early April this year, following a public procurement procedure.
"Montefarm" explains that these are manual, sterile lancets manufactured by Promisemed Hangzhou Meditech Co. Ltd., China, which were in the original factory packaging, within the expiration date and duly registered for sale in Montenegro, and were distributed to pharmacies in accordance with all applicable regulations.
When asked how it happened that older lancets ended up in pharmacies, they said that the tender defined the technical characteristics for universal lancets with diameters from 26G to 30G.
"Two valid offers were received in the procedure, which met all the requirements, and the offer from the manufacturer Promisemed was selected as the most favorable, in accordance with the Public Procurement Law," Montefarma said.
They say that after receiving information from the field, primarily from colleagues from pharmacies who relayed patient comments, they immediately checked the delivered lancets and specifications. They determined that the lancets were in accordance with the announced tender.
"However, in order to improve the user experience and enable easier and more practical blood sampling, we have requested additional delivery of lancets for use in automatic lancing devices, within the existing contract under the aforementioned tender. We expect new quantities soon and they will be available in Montefarm pharmacies," the response to "Vijesti" reads.
This institution emphasized that in this case they had no specific reports of adverse effects from patients, which is a legal requirement for the possible withdrawal of a medical device.
"All lancets delivered so far are safe to use and intended for sampling capillary blood from a finger," the institution says.
According to data from the Institute of Public Health, 2023 patients were treated for diabetes in Montenegro in 27.677, according to the records of selected doctors. According to the same records, the number of patients has increased by 19 percent in the last ten years.
The institute also estimates that 50.000 citizens in Montenegro suffer from diabetes.
According to the Health Insurance Fund Regulations, an insured person with diabetes on insulin therapy is approved for a self-monitoring device for blood sugar, diagnostic strips for the device, and lancets for taking blood from a finger, in accordance with the List of Devices.
An insured person who receives insulin once a day is entitled to 25 - 30 strips and 25 - 30 lancets per month.
When it comes to insured persons who receive insulin two or more times a day, insulin pump users and children under 18 are entitled to up to 200 strips and up to 200 lancets per month, and adults aged 18 to 25 are entitled to up to 100 strips and from 25 to 100 lancets per month.
A proposal for the purchase of the device is made by a subspecialist endocrinologist, and the prescription is prescribed by the chosen doctor.
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