The audit conducted by the Supreme State Audit Office on the Compulsory Health Insurance Fund (FSDKSH) for 2024 highlights significant structural, procedural and functional deficiencies in the management, monitoring and control of reimbursable medicines. According to the report, for the audited period, a total of 45 findings with organizational measures, 3 findings with economic effects and 6 administrative measures were identified, which indicate ongoing weaknesses in the implementation of contractual obligations and internal control mechanisms.
Lack of price verification and control of reimbursable drugs
The audit of the control reports carried out in pharmaceutical warehouses shows that the control group has not carried out the verification foreseen in point 2 of the control program, which is directly related to the implementation of the prices approved in the List of Reimbursable Medicines (LBR) and the marketing of medicines in accordance with the security stamp. This deficiency has undermined the transparency and integrity of financial control, preventing an objective assessment of the compatibility of reference prices with real marketing prices.
Failure to comply with this contractual obligation conflicts with the provisions of Article 18 of the relevant contracts, which provide for the termination of the contract in the event of repeated marketing of medicines at prices above those approved for more than a period of no less than one year.
Inventory of medicines and lack of documentation of expiration dates
The audit found that in the physical inventory record for control purposes, only the physical quantities of medicines were recorded, while the documentation of the expiration date for each of them is missing. This deficiency constitutes a fundamental problem in the control process, as it makes it impossible to objectively assess the effective availability of medicines and comply with the requirements of Article 5 of the contracts regarding the provision of the minimum required stocks for the first and only alternative medicines included in the LBR.
As a result, the analysis of drug availability and the quality of the control process are compromised in terms of transparency, accuracy, and reliability.
Lack of medicines in hospital pharmacies
From the 2024 audit in the hospital pharmacies of the QSUT, Durrës, Shkodër, Elbasan and Korçë, deficiencies in the inventory procedure and concrete shortages of single and first-line alternative drugs were found. For the QSUT, the inventory conducted on 20.02.2024 included only 8% of consumption, while the control period was from 07.12.2022 to 20.02.2024.
For 26 drugs, 14 of which are "only alternative" and 12 "first alternative", there was no availability either at the beginning of the inventory on 07.12.2022 or at the end on 20.02.2024, without this being reflected as a problem in the management structures of FSDKSH.
In hospital pharmacies, concrete quantitative differences were found: 400 units in Durrës, 185 units in Shkodër, 1,015 units in Elbasan and 517 units in Korça. In addition, concrete shortages of single alternative drugs were identified: 4 drugs in Durrës, 11 in Shkodër, 9 in Elbasan and 7 in Korça, without being identified by the control groups and without administrative measures being taken against the contract importing warehouses.
Serious problems in the "e-depot" system and fictitious drug releases
The audit on the functioning of the "e-depot" system for 2024 highlights serious shortcomings in the registration, monitoring and control of the entry and exit of medicines. Pharmaceutical importers imported medicines classified as "hospital" in an amount of 3,690,084 units, worth 3,225,256,356 lek, of which 159,760 units with a reimbursable value of 60,485,872 lek were distributed in the open network, in violation of tripartite contracts and legal provisions.
In 207 transactions recorded in the system, 102,778 units of drugs with an expiration date identical to the date of sale were found in 37 sales invoices, while in 170 other invoices 143,598 units of drugs with an expiration date from 1 to 5 days from the date of sale were found. This situation has created a high risk for patient safety and the quality of pharmacological treatment.
Unjustified financial differences and unjustified refunds
From the audit of the conclusion of new contracts for 2024, it was found that for the entity "PP" 8,913,213 units worth 217,781,840 lek were registered as "initial inventory opening", while the physical inventory results in an unjustified difference of 8,871,835 units worth 216,948,302 lek.
It was also found that some pharmacies have benefited from full reimbursement from FSDKSH for medicines purchased without purchase costs, through zero-value invoices, benefiting from a commercial margin of up to 24% for retail trade and 8% for wholesale trade, according to VKM no. 489 and VKM no. 491. This has brought unjustified financial benefit and has violated the fundamental objective of the reimbursement scheme.
Lack of penalties and weaknesses in internal control
Despite the fact that 7 cases of lack of single alternative drugs and 16 cases of lack of first alternative drugs were found, the penalties provided for in the contracts, which provide for penalties of up to 7,000,000 lek for lack of single alternatives and 8,000,000 lek for lack of first alternative, were not applied. For repeated cases, the contracts provide for punitive measures up to termination of the contract, which have not been implemented.
The audit finds that the lack of these actions reflected the malfunctioning of internal control and oversight mechanisms, as well as a lack of institutional commitment to guaranteeing a sustainable supply of medicines.
Main recommendations
In conclusion, the SAI recommends strengthening the internal control of the FSDKSH, standardizing and fully documenting physical inventories, including expiration dates, increasing monitoring of the “e-depo” system, as well as rigorously implementing contractual penalties in case of repeated violations. It also requires a review of reimbursement practices to avoid unjustified financial benefits and to guarantee that public funds are used only to cover the real costs of medicines for citizens. /ekofin.al
