{"id":16070,"date":"2026-04-06T13:20:36","date_gmt":"2026-04-06T09:20:36","guid":{"rendered":"https:\/\/medscriptum.org\/?p=16070"},"modified":"2026-04-06T13:42:32","modified_gmt":"2026-04-06T09:42:32","slug":"the-regulations-for-prescribing-and-dispensing-psychotropic-drugs-have-been-tightened-an-interview-with-manana-eliashvili","status":"publish","type":"post","link":"https:\/\/medscriptum.org\/en\/the-regulations-for-prescribing-and-dispensing-psychotropic-drugs-have-been-tightened-an-interview-with-manana-eliashvili\/","title":{"rendered":"The regulations for prescribing and dispensing psychotropic drugs have been tightened \u2013 An interview with Manana Eliashvili"},"content":{"rendered":"

On April 1 of this year, amendments to the Minister of Health’s Decree \u211601-31\/N (dated April 8, 2022) came into force<\/a>. These changes concern the circulation rules for Form N2 electronic prescriptions for psychotropic medications and pharmaceutical products equated to substances under special control.<\/p>\n

According to the new regulation, medications for adult patients will be dispensed in no more than a 14-day supply<\/b>, while minors are allowed up to a 30-day supply<\/b>. Furthermore, doctors are now required to justify the necessity of the prescription within the patient’s medical documentation.<\/p>\n

The aim of these changes is to tighten control over the circulation of psychotropic drugs and prevent their misuse. However, we spoke with Ms. Manana Eliashvili<\/b>, head of the Rustavi Mental Health Center, about the systemic challenges these new requirements pose to the mental health field.<\/p>\n

How will these changes affect the continuity of treatment for patients with mental health issues?<\/h3>\n

The changes regarding prescription durations and the obligation for clinical justification will clearly create financial, administrative, and logistical barriers for patients. This will lead to a formal, and often clinically unjustified, dependency on the medical system.<\/p>\n

Given the limited accessibility of psychotropic medications under special control and the shortage of psychiatric services in the country\u2014especially in the regions\u2014these restrictions increase the risk of involuntary treatment interruption. Any disruption in therapeutic continuity directly correlates with the progression of the disease.<\/p>\n

How realistic are the maximum limits on dispensed medication quantities from a clinical practice perspective?<\/h3>\n

In psychopharmacology, different medications have different purposes, mechanisms of action, and risk profiles. Ignoring this complexity and imposing undifferentiated restrictions contradicts evidence-based clinical practice.<\/p>\n

Additionally, the 30-day limit set for patients under 18 highlights a logical inconsistency: if 30 days is clinically acceptable for minors, by what criteria was only 14 days determined for adults? We have not heard a convincing answer or supporting argumentation for this.<\/p>\n

In your assessment, will these changes actually reduce the misuse of psychotropic medications?<\/h3>\n

The effectiveness of these changes in reducing misuse is mixed. A positive aspect is the doctor’s obligation to provide a detailed justification for the prescription, which is essentially a part of clinical standards. In the past, a legal vacuum existed where providing only a diagnosis was sufficient, creating a risk of excessive and clinically unjustified prescriptions. This led to the suspension of licenses for several medical professionals.<\/p>\n

However, the main systemic flaw of the regulation lies in its “one-size-fits-all” nature. Total bureaucratic restrictions often fail to eliminate the essence of misuse; instead, they simply localize the problem\u2014potentially pushing patients toward the illegal market or toward synthetic, pharmacologically unregulated analogs with psychoactive properties. Furthermore, out of fear of administrative sanctions, a doctor might sometimes prefer to prescribe a “bureaucratically safe” alternative instead of the clinically optimal medication, which could significantly increase treatment costs.<\/p>\n

What are the primary difficulties doctors might face while implementing the new regulation?<\/h3>\n

One of the fundamental principles of psychopharmacology is monotherapy\u2014selecting the minimum effective dose based on the patient’s individual needs. However, the regulation applies a uniform approach to different groups of medications, which creates contradictions.<\/p>\n

For instance, with the long-term use of benzodiazepines<\/b> (such as Diazepam, Lorazepam, Tazepam, Clonazepam, etc.), tolerance and dependence develop, which is why they are generally not recommended for more than two months. Therefore, the justification required by the regulation for this group aligns with clinical principles.<\/p>\n

The picture is entirely different for a drug like Cyclodol (Trihexyphenidyl)<\/b>. It is used alongside primary medications (neuroleptics) in treating psychotic disorders to correct extrapyramidal complications, and its intake is essential. The current regulatory framework forces a doctor to repeatedly and formally justify the same clinical decision every two weeks, even when the patient’s condition and therapeutic needs remain unchanged. This places an administrative burden on doctors and reduces the time intended for patient-doctor therapeutic interaction and psychosocial intervention. Notably, medical personnel involved in state programs will have to perform these additional duties without extra compensation.<\/p>\n

How do these changes affect vulnerable groups and those in regions with limited access to doctors?<\/h3>\n

Analyzing the reality of the regions is critical. Given the structural inequality in access to mental health services and medication shortages, these new restrictions become a source of deeper socio-economic marginalization.<\/p>\n

For example, the Rustavi Mental Health Center provides services to the entire Kvemo Kartli region under the state program. We have outpatient offices in Rustavi, Marneuli, and Bolnisi. Following the tightened regulations, only one authorized retail pharmacy remains in Kvemo Kartli that supplies these specific medications to state-program patients. Consequently, patients from all districts of Kvemo Kartli must travel to Rustavi to get their medication. Now, they practically have to visit a doctor every two weeks (in various cities) and then travel to Rustavi to receive the medicine, which could become an insurmountable physical and financial barrier for many.<\/p>\n

What additional steps are needed to ensure that the use of psychotropic drugs is both safe and accessible?<\/h3>\n

The challenges are numerous and require a comprehensive approach. It is necessary to modernize psychiatric infrastructure, optimize sector funding, eliminate the shortage of psychiatric staff, ensure access to medications, and implement strict quality control and mandatory bioequivalence studies.<\/p>\n

The systemic integration of telemedicine<\/b> is also critically important. This would allow for prescription renewals based on remote consultations for stable chronic patients, effectively removing geographic barriers and ensuring treatment continuity for those with limited mobility.<\/p>\n","protected":false},"excerpt":{"rendered":"

On April 1 of this year, amendments to the Minister of Health’s Decree \u211601-31\/N (dated April 8, 2022) came into force. These changes concern the circulation rules for Form N2 electronic prescriptions for psychotropic medications and pharmaceutical products equated to substances under special control. According to the new regulation, medications for adult patients will be […]<\/p>\n","protected":false},"author":29,"featured_media":16082,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[1653,1631,1594,1645,1665,1657],"tags":[5053,5056],"class_list":["post-16070","post","type-post","status-publish","format-standard","has-post-thumbnail","category-interview","category-neurology","category-news","category-psychiatry","category-public-health","category-science","tag-psychotropic-drugs","tag-manana-eliashvili"],"acf":[],"_links":{"self":[{"href":"https:\/\/medscriptum.org\/en\/wp-json\/wp\/v2\/posts\/16070","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/medscriptum.org\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/medscriptum.org\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/medscriptum.org\/en\/wp-json\/wp\/v2\/users\/29"}],"replies":[{"embeddable":true,"href":"https:\/\/medscriptum.org\/en\/wp-json\/wp\/v2\/comments?post=16070"}],"version-history":[{"count":1,"href":"https:\/\/medscriptum.org\/en\/wp-json\/wp\/v2\/posts\/16070\/revisions"}],"predecessor-version":[{"id":16083,"href":"https:\/\/medscriptum.org\/en\/wp-json\/wp\/v2\/posts\/16070\/revisions\/16083"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/medscriptum.org\/en\/wp-json\/wp\/v2\/media\/16082"}],"wp:attachment":[{"href":"https:\/\/medscriptum.org\/en\/wp-json\/wp\/v2\/media?parent=16070"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/medscriptum.org\/en\/wp-json\/wp\/v2\/categories?post=16070"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/medscriptum.org\/en\/wp-json\/wp\/v2\/tags?post=16070"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}