Ministry of Health orders audit on drug availability

Interim Minister of Health, Cseke Attila, has ordered the urgent launch of an audit on the mechanism for monitoring and supervising drug availability, including the procedure for issuing special needs authorizations (ANS). In parallel, the Federation of Cancer Patients' Associations of Romania (FABC) warns that three oncology drugs are currently missing, and for another eight, supply disruptions are reported. The decision of the Ministry of Health comes after reporting problems regarding patients' access to drugs, especially in the oncology area. Cseke Attila also requested a full report on market monitoring and requested a review of the ANS issuance procedure.

• Ministry wants a real-time alert system

"It is unacceptable that Romania does not yet have a digital system that allows us to track the traceability of the medicine and know, in real time, when a stock reaches a critical level," said Cseke Attila, quoted in a press release from the Ministry of Health. The audit will target structures within the Ministry of Health, hospitals and the National Agency for Medicines and Medical Devices of Romania (ANMDMR). The minister also considers it necessary to verify the way in which the National Oncology Program is carried out. Cseke Attila requested a complete report from the ANMDMR on the monitoring and supervision of the medicine market. The document must identify existing problems and formulate proposals for improving IT solutions. The ministry aims to introduce an alert system that would signal in advance situations in which stocks of a medicine reach a critical level. "We need a system that alerts us before we have a crisis, not after it occurs. We need clear and real-time data, not estimates and information that arrive with a delay,” the minister said.

• The threshold for special needs authorization could be increased

The Ministry of Health is also considering amending the procedure for issuing and reauthorizing ANS, as well as the order in force. One of the changes being considered is increasing the minimum stock level from which the procedure can be triggered. Currently, the threshold is 10%, and the authorities are considering setting a higher level, to allow for faster intervention in the event of a risk of unavailability of a medicine. "If a medicine is already at a very low level in stock, we cannot treat this situation as if there were no risk to patients. We will modify the current threshold. The rules must allow us to intervene earlier and protect patients' access to treatment,” said Cseke Attila. The minister claims that the measures aim to move to a faster and more transparent monitoring mechanism, based on data available in real time.

• FABC: Three oncology drugs missing

At the same time, the Federation of Cancer Patients' Associations of Romania sent an open letter to the interim Prime Minister Ilie Bolojan and the president of CNAS, Horaţiu Moldovan, in which it warns of the risks generated by the lack of oncology drugs. According to the FABC, three oncology drugs are currently missing, and eight others are experiencing supply disruptions. "In just 24 hours, following information received from the territory from our member associations, we identified three drugs that are missing and eight other drugs with repeated and long-term discontinuities," the federation said. FABC claims that these situations can cause treatment to be postponed and affect the health of oncology patients. The federation states that the official list of discontinuities of the ANMDMR confirms supply problems for several active substances used in oncology and hemato-oncology.

• Patients demand public data on stocks

The Federation complains that cancer patients have been facing uncertainty regarding access to investigations, treatments and medicines for several years. "For a cancer patient, a discontinuity of a few weeks does not mean a simple supply problem, but delayed treatment, a disease that can progress, lost therapeutic opportunities and, sometimes, lost lives,” claims the FABC. The organization states that statements according to which medicines are not lacking do not correspond to the information received from patients and member associations in the territory. In this context, the FABC calls on the authorities to publish transparently the stock situation and discontinuities for essential oncology medicines, as well as to immediately identify supply solutions for products that are missing or pose a risk of treatment interruption. The Federation also demands clarification of the situation of approved therapies that are not yet effectively available. transferable to patients, as well as the establishment of a permanent mechanism for dialogue with patient organizations.

• Verifying the situation directly in hospitals

The Federation argues that the authorities must verify information on the availability of medicines, including at the level of hospitals and pharmacies, and not only through administrative reports. "We ask you, before any statement according to which "there is no shortage of medicines', to actually verify the situation in hospitals and pharmacies where patients seek treatment," reads the letter sent to the interim prime minister and the president of CNAS. FABC believes that new oncology therapies can significantly influence the evolution of the disease and asks the authorities to treat supply issues as a priority.