Through direct purchases with electronic offer, the Guatemalan Social Security Institute (IGSS) managedOn August 3, two distributors were subject to investigation for the suspicion that they caused adverse reaction in patients.
The complaint filed at the Public Ministry, on November 21, 2017, by the Special Investigation Department of the Sub -Management of Integrity and Administrative Transparency of Social Security, to which the Periódico had access, revealed that after the purchases of March 1 the March 1Local Therapeutic Committees, which work in hospitals and IGSS clinics, began to receive drug -related notifications.
The complaints were monitored by the Institutional Pharmacovigilance program since there were doubts about the effects of that medicine.For this reason, a process began to document cases based on medical files, quantify and evaluate notifications in accordance with good pharmacovigilance practices.
In this case it was necessary to determine if there was an obvious suspicion of the poor product quality.
Research
From that moment on, there were meetings with authorities from the different medical units of the IGSS, the Central Therapeutic Commission and dependencies of the Ministry of Health such as the General Directorate of Regulation, Surveillance and Health Control, as well as the Regulation Departmentand control of pharmaceutical and related products to inform about the problem.
But, the IGSS also asked the health portfolio to verify the health registration of the medicine and determine its quality.
The Ministry of Health attended that application and in June, personnel of the Monitoring Unit and the Pharmacovigilance Unit took the drug samples in social security units that denounced the problem.
While this was happening, Social Security made a new purchase of metformin in July of that year, but also did not meet the quality demands so that again the Ministry of Health was applied for the purpose of taking product samples and verifying if it complied withWith the health requirements, this happened on October 5.
Answer the Ministry
The sub -management of integrity and administrative transparency received on October 26, a report backed by the Department of Regulation and Control of Pharmaceutical and Related Products and the General Directorate of Regulation, Surveillance and Health Control, related to the Metformin Lot acquired between theMarch 1 and August 3, 2017.
The document indicated that the drug breached with the average weight and dissolution of one hour, two hours and six hours according to the manufacturer's specifications.Also, this report detected incongruities in the data of the distributors registered in the Ministry of Health.
Following these processes, on November 16, the IGSS ordered to remove the medicine, bought in the lots under suspicion, in all medical units as a preventive measure and suspended any office or prescription of metformin of those distributors nationwide.Four days later, the sub -management of integrity and administrative transparency filed a criminal complaint in the Public Ministry (MP).
Carlos Contreras, president of the Board of Directors of the IGSS, explained that the National Health Laboratory (LNS) paid a report last January in which it guaranteed the quality of suspicious metformin.
He affirmed that this medicine had been withdrawn from the pharmacies of hospitals and social security clinics as a prevention measure.“TheComplaint in the Public Ministry for some presumption of crime, ”he said.
What is it?
Metformin is a drug used in the treatment of type 2 diabetes. This disease evolves when people fail to produce adequate blood sugar levels by means of diet or physical exercise.Patients with type 2 diabetes have difficulty synthesizing sufficient insulin in the pancreas or their organism responds inappropriately to the insulin it produces.Which causes an increase in blood glucose.
Direct purchases with electronic metformin offer made the IGSS between March 1 and August 3, 2017.