Legal regulation and health control of psychotropic drugs

The use of psychotropic drugs in the treatment of depressive disorders, especially severe or refractory cases, is strictly linked to precise health regulations.

Given that these drugs act on the central nervous system and can induce significant adverse effects or lead to dependence, they must be administered under specialized medical supervision.

Many of them—such as tricyclic antidepressants, selective serotonin reuptake inhibitors (SSRIs), atypical antipsychotics, and enhancers such as lithium or ketamine—are classified as specially controlled drugs, meaning that they can only be dispensed with a professional prescription.

Health control and therapeutic protocols

In clinical practice, it is essential to follow protocols for the dosage, duration, and combination of psychotropic drugs to ensure their efficacy and minimize risks. One of the challenges is the inappropriate or incomplete use of antidepressants: many people discontinue treatment before achieving an effective therapeutic response or take subtherapeutic doses.

This makes it impossible to determine whether it is a case of refractory depression or simply poor adherence. For this reason, health regulations require not only formal prescription but also continuous medical follow-up, with an emphasis on adherence and pharmacovigilance.

Augmentation strategies and controlled medications

When a patient does not respond to two appropriate antidepressants in monotherapy, augmentation strategies are considered. These include the use of atypical antipsychotics (such as aripiprazole, quetiapine, or olanzapine), lithium, thyroid hormone, or stimulants such as modafinil.

All of these drugs have specific indications and restrictions, and their use requires in-depth knowledge of their interactions, metabolic risks, side effects, and legal considerations.

For example, drugs such as ketamine, initially an anesthetic, have recently been incorporated in some countries into therapeutic protocols for resistant depression, always in controlled hospital settings.

Regulation versus self-medication and market control

Although many psychotropic drugs are protected by prescription regulations, there are situations where they are accessed through informal means or their use is perpetuated without professional supervision.

Of particular concern are “Z” hypnotics (such as zolpidem) and some anxiolytics (such as benzodiazepines), whose indiscriminate prescription or chronic us