In the premises of the Oncology Hospital in Tirana, the struggle between life and death is perhaps stronger than anywhere else, but what is most painful are the shortcomings in the provision of services.
The Supreme State Audit Office has revealed an alarming situation in the management of oncology drugs at the "Mother Teresa" University Hospital Center and in the responsible structures of the health system. The latest audit report highlights serious problems that endanger the lives of patients with tumor diseases, highlighting the lack of drugs, expired drugs and the lack of control over the supply and distribution of medications.
The KLSH audit found that the approval process for antitumor drugs is long and inefficient, creating delays in supply and increasing the risk for patients requiring urgent treatment. 46% of drugs authorized for marketing in Albania were never imported during the audit period. Meanwhile, for vital drugs such as Actinomycin D, used in the treatment of pediatric tumors, there is neither a contract nor a supply, leaving hundreds of patients at the mercy of fate.
"From the review of 25 cases of approval of marketing authorization for antitumor drugs, it was found that the current procedure provided for in Article 12 of Law No. 105/2014 "On Medicines and Pharmaceutical Services", as amended, is long and inefficient. Delays impede rapid institutional response in situations where urgent decision-making is required, especially for antitumor drugs. The current process creates a regulatory vacuum and limits the operational flexibility of the AKBPM, negatively affecting the timely supply of drugs to the market and increasing the risk for patients in urgent need of treatment.
From the data made available by the Distribution Sector on the import of medicines, it resulted that out of 253 antitumor medicines authorized for marketing in the Republic of Albania, 116 of them, or 46%, were never imported during the audit period, January 2021 - March 2025, in violation of Article 16, point 6 and Article 32, point 1 of Law No. 105/2014.
From the review of the submitted documentation and letters sent by the Pharmaceutical Service Directorate of QSUNT, it is found that delays occur most frequently in the periods when the existing Contractual Agreement (CA) ends and a new one has not yet been concluded, creating uncovered periods in supply and increasing emergency situations.
The audit conducted on the management and availability of the drug Actinomycin D 0.5 mg at the "Mother Teresa" University Hospital Center, which does not have a contract or marketing authorization, highlights the lack of measures taken to secure the drug Actinomycin D and similar drugs, which makes it impossible to treat patients, violating the principle of protecting the public interest and the right to health care based on the Constitution of the Republic of Albania, Article 55. Through state mechanisms, the state has the duty and right to secure medications and disease treatment protocols in order to protect the public interest.
"For the period under audit, the drug Actinomycin D 0.5 mg was partially secured. In the opinion of the audit team, securing it in these ways does not provide full assurance regarding the manner of storage of this medication and consequently its effect. In conditions where no procedure has been documented for the receipt of the drug, it was impossible to physically verify the remaining quantity of the drug, given that no entry was made in the inventory," the report states.
More alarming is the situation when the report identifies drugs with past expiration dates that continue to be kept in the electronic system, endangering patient safety and presenting irresponsible stock management. While duplicate prescriptions and uses outside of any protocol were found, raising suspicions of intentional abuse.
"From the verifications carried out on 28.02.2025 at the Central Pharmacy and on 13.03.2025 at the Pharmaceutical Blocks, there was no result of checking the physical inventories and comparing them with the data in the system for drugs used in the treatment of tumor diseases. It was found that, for example, "Doxorubicin" 50 mg (2mg/ml) - vial, although the physical quantity was in accordance with the records in the system, the expiration date noted in the system did not match the one physically verified due to non-compliance with the FIFO principle.
It is evident that 19 vials of Ifosfamide 1 g and 602 vials of Methotrexate in two dosage forms: Solution for injection and infusion x 500 mg (in 10 ml or 20 ml) with 372 vials and Solution for injection x 50 mg / 2 ml with 230 vials, despite having expired, are still in the Pentaho system, posing a risk of maintaining expired stocks in the system and artificially increasing the state of drugs in the system, despite the provisions of Article 4 of the supply contracts.
The systems resulted in duplicate prescriptions during the day, lack of complete and clear records, incorrect discharges of medications to other patients, shortages of medications based on the ratio of quantity requested - quantity discharged, repeated and unfulfilled requests more than once for the same patient, extended periods of lack of a medication, inventory of the date results differently (difference in progressive status quantity - system inventory), etc.
"From the audit regarding the drug Pertuzumab + Trastuzumab in the dosage forms 1200 mg + 600 mg, 15 ml and 600 mg + 600 mg – 10 ml, cases were identified where the situation was 0 for a period longer than 1 week, or a low quantity was previously unchanged for at least one week before supply, indicating drug shortages or minimally low quantities which endanger the treatment of patients. Referring to the tests carried out, also in the case of the drug Phesgo in both dosage forms, cases of duplicate prescriptions and confusion between patients were identified," the report states.
Also, the sector responsible for the preparation of oncology drugs does not have standard regulations and uses outdated equipment, which is not maintained and does not guarantee the correct dosage of drugs.
Meanwhile, the National Agency for Medicines and Medical Devices has not conducted any inspections in hospital pharmacies during the period 2022–2024. Meanwhile, the laboratory at this institution has not conducted analyses to certify medicines for marketing during 2021, 2023 and 2024.
"The Inspection Sector of the AKBPM and during the period 2022–2024, no inspection was carried out in closed network pharmacies (hospitals), contrary to the requirements of Article 61 of Law No. 105/2014, as amended; Article 3, letter "h" of the Regulation on the functioning of the AKBPM; Article 1, point 3, of Order No. 660, dated 20.09.2018, "On the approval of the Regulation on Good Storage and Distribution Practices of Medicines.
The audit found that the Control Laboratory at the AKBPM did not conduct laboratory analyses for antitumor drugs submitted for marketing authorization during the years 2021, 2023 and 2024, except for 8 analyses recorded in 2023, in violation of Article 10 (ç) of the Agency's Internal Regulation. For this period, standardized working procedures, defined deadlines for the performance of analyses and methodologies for the selection of samples for control are also lacking.
From the audit of the functioning of the Kapak Sector, the sector established in 2019 and responsible for the process of preparing oncology drugs, it results that there is a lack of regulations/instructions on the preparation of drugs such as a standard work procedure or process map.
"The audit conducted in the Caps Sector at the "Mother Teresa" University Hospital Center found that this sector only has manual equipment and not specialized and automated equipment for the preparation, dosing and precise mixing of cytostatic drugs. Furthermore, the sector's technical equipment has not been maintained or calibrated since the moment of their inclusion in the inventory," the report states.
The HSE also finds that the budget allocated for the purchase of medicines is underfunded and is one of the causes that has led to the shortage of medicines.
"From the audit of budget expenditures for the purchase of goods and services, for program 07330 "Secondary hospital care service", based on the reviewed documentation and official correspondence of the institutions themselves, the budget allocated to the health sector (respectively for medicines) results in underfunding, which brings the risk of a shortage of medicines and, consequently, the continuation of therapy in accordance with disease treatment protocols," the report states.
