On April 1 of this year, amendments to the Minister of Health’s Decree №01-31/N (dated April 8, 2022) came into effect. These changes concern the circulation rules for Form N2 electronic prescriptions for psychotropic medications and pharmaceutical products equated to substances under special control.
Under the new regulation, adult patients may be dispensed no more than a 14-day supply of medication, while minors are limited to a 30-day supply. Furthermore, doctors are now required to provide a formal clinical justification for the necessity of the prescription within the patient’s medical documentation.
While the stated goal of these changes is to tighten control over the circulation of psychotropic drugs and prevent misuse, they also present significant systemic challenges. We spoke with Ms. Manana Eliashvili, head of the Rustavi Mental Health Center, to discuss the impact on the mental health sector.
How will these changes affect the continuity of care for patients with mental health conditions?
The changes regarding prescription durations and the mandatory clinical justification will undoubtedly create financial, administrative, and logistical barriers for patients. They force a formal—and often clinically unjustified—dependence on the medical system.
Given the limited availability of psychotropic medications under special control and the shortage of psychiatric services in the country, particularly in the regions, these restrictions increase the risk of involuntary treatment interruption. Any disruption in therapeutic continuity is directly proportional to the risk of disease progression.
How realistic are these maximum dispensing limits when considering clinical practice?
In psychopharmacology, different medications serve different purposes with unique mechanisms of action and risk profiles. Ignoring this complexity and imposing undifferentiated restrictions contradicts evidence-based clinical practice.
Furthermore, the 30-day limit for patients under 18 highlights a logical inconsistency: if a 30-day supply is clinically acceptable for minors, what was the criteria for restricting adults to only 14 days? We have yet to hear a convincing answer or clinical argument for this distinction.
In your assessment, will these changes effectively reduce the misuse of psychotropic medications?
The effectiveness is mixed. A positive aspect is the requirement for doctors to justify prescriptions in detail; this is essentially part of standard clinical practice. The previous legal vacuum, where a diagnosis alone was sufficient, created a risk of excessive or clinically unsubstantiated prescribing—which in the past led to the suspension of licenses for some medical personnel.
However, the main systemic flaw lies in the regulation’s unified nature. Total bureaucratic restriction often fails to eliminate the root of misuse; instead, it simply localizes the problem. This can push patients toward the illegal market or toward synthetic, pharmacologically unregulated analogs with psychoactive properties. Additionally, for fear of administrative sanctions, doctors may occasionally opt for a “bureaucratically safe” alternative instead of the clinically optimal medication, which could significantly increase treatment costs.
What are the primary difficulties doctors might face when implementing these regulations?
A core principle of psychopharmacology is monotherapy—selecting the minimum effective dose based on individual patient needs. However, the regulation applies a “one-size-fits-all” approach to different classes of drugs, which creates contradictions.
For instance, with long-term use of benzodiazepines (such as Diazepam, Lorazepam, Tazepam, Clonazepam, etc.), tolerance and dependence develop, so they are generally not recommended for more than two months. In this case, the required justification aligns with clinical principles.
The picture is entirely different for a drug like Cyclodol (Trihexyphenidyl). It is used in the treatment of psychotic disorders alongside primary antipsychotics to manage extrapyramidal side effects, and its intake is essential. The current regulatory framework forces a doctor to formally re-justify the same clinical decision every two weeks, even when the patient’s condition and therapeutic needs remain unchanged. This places a heavy administrative burden on doctors and reduces the time available for therapeutic interaction and psychosocial intervention. Notably, medical staff in state programs will have to perform these additional duties without extra compensation.
How will these changes affect vulnerable groups, such as the socially disadvantaged or those living in regions with limited access to doctors?
Analyzing the situation in the regions is critical. Given the structural inequality in access to mental health services and medication shortages, these new restrictions will become a source of deeper socio-economic marginalization.
For example, the Rustavi Mental Health Center provides state-funded services for the entire Kvemo Kartli region. We have outpatient clinics in Rustavi, Marneuli, and Bolnisi. Recently, following the tightened regulations, the only authorized retail pharmacy remaining in Kvemo Kartli that dispenses these medications is the one affiliated with our facility. Consequently, patients from across the region must travel to Rustavi to fill their prescriptions. Now, they must essentially visit a doctor every two weeks (often in different cities) and then travel to Rustavi to get their medicine. For many, this will become an insurmountable physical and financial barrier.
What additional steps are needed to ensure that the use of psychotropic drugs is both safe and accessible for patients?
The challenges are numerous and require a comprehensive approach. It is essential to modernize psychiatric infrastructure, optimize sector funding, address the shortage of psychiatric personnel, and ensure access to quality-controlled medications with mandatory bioequivalence studies.
The systemic integration of telemedicine is also critically important. This would allow stable, chronic patients to renew prescriptions via remote consultations, effectively removing geographical barriers and ensuring continuity of care for those with limited mobility.
