The Bulgarian Health Ministry will begin Sanctioning Drug Wholesalers due of the Shortage of Medicines

Health | January 20, 2023, Friday // 10:42|  views


There are serious gaps in the Specialized Electronic System for the Tracking and Analysis of Medicinal Products (SESPA) that compromise its data, including the ban list for the export of medicines of the Medicines Executive Agency (MEA).” This was found by "Information Service" after an audit ordered by the previous leadership of the Ministry of Health, announced the acting minister Asen Medzhidiev. Despite the identified gaps, no measures have been taken to eliminate them. The only thing that was done by his predecessor Asena Serbezova in this direction was the change of the formula, Medzhidiev pointed out.

Therefore, the Ministry of Health has started mass inspections, as there are already established drug wholesalers who did not correctly submit information to SESPA.

An administrative proceeding has been initiated against them, which may lead to the revocation of their license, Medzhidiev pointed out.

The audit of "Information Service" shows the following gaps in the information system for tracking and analyzing medicines in our country:

  • There is no technological tool to limit individual actions in case of non-submission or wrong submission.
  • The system does not use a time authentication service, only internal logs are kept without hash and protection.
  • The software base that SESPA uses is not licensed.
  • The system allows the submission of data backwards in time relative to the current moment. In testing, it was found to allow submission of data up to 180 days back, which greatly compromises its credibility and MEA blacklist positions.
  • The system does not have the ability to control and check available quantities against consumption.
  • There is no automated inventory calculation process.
  • The generation of the ban list is not automated and is done by manually running program scripts - that is, any administrator can enter the system and adjust it as it suits him. Changes made leave no trace.
  • Therefore, the Ministry of Health proposes a series of legislative changes, including - changing the algorithm for entering the system; shortening the terms for issuing permits for parallel import of medicines if a given medicine is in short supply; sealing the warehouses of wholesalers upon detection of violations.

The checks of the Medicines Executive Agency will continue until the law is changed and the loopholes in the system are removed,” Medzhidiev said.

He called on his predecessor Asena Serbezova to explain why no measures were taken under her administration to fix the problems in the drug tracking system.

The caretaker government starts preparing teams, sites and hangars for medical helicopters in our country. A working group has been formed between the Ministry of Health, the Ministry of Transport, the Ministry of Internal Affairs, the Ministry of Defense, the Ministry of Finance and the Ministry of Finance. The goal is that if a medical helicopter is available in Bulgaria, we will be ready immediately, explained Medzhidiev.

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Tags: Medzhidiev, system, health, medicines


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