The mental health sector in Georgia is facing numerous systemic challenges, among which the availability and quality of medications remain some of the most pressing issues. Market shortages and flawed quality control mechanisms directly impact the effectiveness of patient treatment and the stability of their condition. The lack of basic medications and the current quota system often hinder the full therapeutic process, essentially putting the health of thousands of people at risk.
Psychiatrist Eka Chkonia spoke with us regarding these issues, the necessity of drug quality control, and the risks associated with shortages. In this interview, she discusses the current challenges in detail, the importance of bioequivalence studies, and the essential steps the country must take to improve psychiatric services.
Ms. Eka, how does the shortage of psychotropic medications on the market and their replacement with local or less familiar alternatives affect the stability of patient treatment?
Today, there is a shortage of a wide range of medications. Many drugs that have been in practice for a long time—and whose original forms are quite inexpensive—are, for some reason, not registered in Georgia or are supplied with significant delays. Another serious problem is that original medications often leave the market and are replaced by generics (analogs) that differ significantly in quality.
In Georgia, bioequivalence studies are not required when registering a generic or during local production. This means the manufacturer is not obligated to prove that their analog is as effective as the original drug. To register, it is sufficient only to show that the medicine contains the active substance. Because of this, the quality of drugs is very unstable; a patient may take the medication, but it might have no therapeutic effect at all.
This is very dangerous. Imagine a person taking a high-quality original medication for blood pressure that suddenly becomes unavailable and is replaced by a low-quality analog. If the analog fails to stabilize the blood pressure, symptoms may return, and a stroke could occur. The same happens in psychiatry. If we switch a person with psychosis, whose condition is more or less stabilized, to a low-quality analog, their condition will inevitably worsen.
Tremendous effort is required to convince a patient that they need treatment. When we achieve results and then the condition deteriorates again due to a medication swap, it damages not only the patient’s health but also their trust in the doctor and the treatment process.
Which specific types of conditions are becoming the most difficult to manage given the current quota restrictions?
This problem is particularly acute for severe, chronic forms of psychosis. There are approximately 70,000 people in Georgia with this diagnosis who benefit from the state program. Within the program, usually the cheapest, older-generation antipsychotics are imported. During such treatment, an auxiliary agent—a so-called “corrector”—is essential; without it, the patient develops extrapyramidal disorders and severe symptoms similar to Parkinsonism. It turns out that without this inexpensive auxiliary drug, we physically cannot conduct the treatment.
In reality, what happened was that this essential and inexpensive medication was replaced in outpatient clinics with alternative agents that are ten times more expensive. As a result, the budget covers fewer patients, and many are left without basic, necessary medication. Additionally, the state imposes quotas on so-called “green prescription” drugs. Only a fixed quantity enters the country because there is a fear of misuse. Since control mechanisms in pharmacies are weak, the state chose to simply allow less quantity into the country, which primarily harms the patients.
What challenges does a psychiatrist face when state regulations and quotas limit the availability of specific, clinically proven medications?
The psychiatrist is faced with the fact that they lack the proper tools. As mentioned, the shortage affects antidepressants and antipsychotics, as well as “correctors.” For example, drugs subject to special registration are often in short supply. Their injectable forms are even harder to find. There are virtually no medications on the market considered “first-choice” by international guidelines for severe anxiety and agitation, despite them being long-tested and inexpensive options.
What is the way forward to improve the current situation?
To rectify the situation, it is essential to import medications in sufficient quantities, establish strict quality control mechanisms, and mandate bioequivalence studies, as is standard in European countries. Any drug imported or produced locally must be properly tested, and its quality must be verified. The mechanisms and regulations regarding drugs must improve so that doctors have the means to offer patients high-quality and stable treatment.
