Introduction
In the previous study, a pharmacoeconomic analysis of codeine medicines was conducted using the ABC
and VED methods [1]. Antitussive drugs play an important role in the treatment of respiratory diseases accompanied by cough. A special niche among such drugs is occupied by codeine medicines. Codeine is a semisynthetic opioid that has been used in medicine for more than a century. Codeine has a unique mechanism of action: it affects the cough center in the medulla oblongata, suppressing the cough reflex, which makes it indispensable in the treatment of dry, debilitating cough. However, along with proven effectiveness, codeine
medicines have several features that affect their use in clinical practice [2-7]. Globally, codeine medicines are the subject of significant attention from regulatory authorities due to the risk of addiction, abuse, and side effects. In many countries, their circulation is strictly controlled, including restrictions on access to non-prescription drugs and the establishment of quotas for production and sales. In Ukraine, this problem is also relevant, as codeine abuse among the population leads to social and medical complications, in particular the development of addiction and side effects. At the same time, such drugs remain
important in pharmacotherapy due to their high effectiveness [8-10]. Regulatory aspects of the use of codeine medicines in Ukraine deserve special attention. On the one hand, there is a need to ensure the availability of these drugs for patients who really need them. On the other hand, it is important to minimize the risks of uncontrolled use. As of today, Ukraine has introduced strict restrictions on the dispensing of codeine medicines - they are available only by prescription. In addition, work is ongoing to improve the regulatory framework for their circulation, which meets international standards [11-13]. The epidemiological situation also affects the use of codeine medicines. The increase in the number of diseases accompanied by cough, such as influenza, COVID-19 and other acute respiratory infections, increases the demand for antitussives. At the same time, the pandemic has highlighted weaknesses in the supply chain of medicines, including codeine medicines, in particular problems with organization, storage, and availability for end users [14, 15].
Codeine abuse is a significant problem, especially among young people. Cases of using codeine medicines for
non-medical purposes, such as achieving a euphoric effect, pose serious health risks and require active action by the state and the medical community. In this context, preventive measures aimed at raising public awareness of the dangers of abuse and strengthening control over the circulation of such medicines are important [16, 17]. From a marketing point of view, codeine medicines have a stable demand on the pharmaceutical
market of Ukraine. However, competition between manufacturers forces them to look for new ways to attract
consumers, through the introduction of new forms of release, increasing the availability of information about medicines and ensuring high product quality. At the same time, pharmaceutical companies face challenges related to regulatory restrictions and the need for transparency of the entire production and sales process [18, 19]. No less important are the forecasts for the further use of codeine medicines in Ukraine. It is expected that
regulatory policy will become stricter, especially regarding circulation control and prescription dispensing. At the same time, there is a trend in the world to search for alternatives to codeine, synthetic or herbal remedies that provide similar efficacy, but have a lower risk of addiction [20]. The study utilized the following registries: European Convention on Drug Control, 1986. Council of Europe, International Convention on Narcotic Drugs and Psychotropic Substances, 1988. UN, WHO Drug Control System, World Health Organization, 2019, and Convention on Narcotic Drugs, 1961. UN. Thus, antitussive codeine medicines remain an
important component of pharmacotherapy, but their use is accompanied by several challenges. The relevance of this issue is due not only to medical aspects, but also to social, economic, and regulatory factors. Further study of these medicines will contribute to improving their use, increasing the safety and effectiveness of treatment.
Purpose of the study
The purpose of this article is to study the features of codeine medicines and analyze their role in modern medicine. The article aims to:
1. Describe the clinical and pharmacological properties of codeine – to reveal the mechanism of its action, antitussive, analgesic effects, and explain how these properties contribute to the treatment of various diseases.
2. Consider the features of the composition and forms of release of codeine medicines – to demonstrate the diversity of medicines, their combinations with other active substances, as well as the advantages of each form in different clinical situations.
3. Analyze the codeine medicines market in Ukraine – to provide an idea of the main manufacturers, and to study the development trends of this segment of the pharmaceutical market.
4. Assess the regulatory aspects of the circulation of codeine medicines – to study the rules of registration, release and control that operate on the Ukrainian market, and to compare them with international standards.
5. Warn about the risks of abuse – emphasize the danger of developing addiction if recommendations are not followed and consider measures that help minimize such risks. This article is aimed at comprehensively highlighting the role of codeine medicines in pharmacotherapy, as well as providing recommendations for their rational and safe use.
Materials and methods
The following materials and methods were used to conduct this study:
Research materials
1. Codeine medicines registration data Information from the State Register of Medicines of Ukraine, containing information about codeine medicines, their composition, release forms, manufacturers, and
registration dates.
Current pharmacopoeial and regulatory documents related to the production, circulation, and control of codeine medicines.
2. Scientific literature Publications on pharmacology, toxicology and clinical medicine related to the use of codeine. Analytical reviews and studies devoted to the medicines market in Ukraine and the world.
The following databases were used in the study:
State Register of Medicines State Formulary of Medicines ATC/DDD Index 2024, WHO Collaborating Centre for Drug Statistics Methodology ATC/DDD Index 2023, WHO Collaborating Centre for Drug Statistics Methodology ATC classification, Compendium Review of the pharmaceutical market of Ukraine Analytical reviews of the market – Weekly APTEKA Analysis of the pharmaceutical market in Ukraine, 2023 – Pro-Consulting Pharmaceutical market of Ukraine – analytical review Pharmacies of the world – 2023: digital initiatives and their impact on the pharmaceutical market Global pharmaceutical industry outlook, 2023 and beyond Global use of medicines: status and trends Pharmaceutical market – Pharmaceutical Encyclopedia World forecasts and trends – Weekly APTEKA
Research methods
1. Analytical method. The composition of codeine medicines, their release forms and compliance with
modern pharmacopoeial requirements were analyzed. The features of combinations of codeine with other active substances were studied.
2. Statistical method. Data processing was carried out on the number of registered codeine medicines in Ukraine, the dynamics of their sales and popularity among patients and doctors.
3. Comparative analysis. Regulatory requirements for the circulation of codeine medicines in Ukraine were
compared with international standards. Differences in release forms and dosages of medicines in different markets were studied.
4. Documentary analysis of scientific sources. A critical analysis of scientific works was conducted that consider the effectiveness, safety, and risks of the use of codeine medicines.
5. Expert assessment. The conclusions of practicing physicians, pharmacologists and regulatory specialists
were involved to assess the safety of use and prospects for the development of the codeine medicines market.
Research limitations The study is based on available public sources and statistical data. Limitations may include incomplete data on unofficial consumption of codeine medicines or unavailability of information on clinical trials in private companies. The use of the above methods allowed to provide a comprehensive approach to the analysis of codeine medicines, their role in medicine and the pharmaceutical market of Ukraine. The research of the article is a fragment of research works of Private Scientific Institution "Scientific and Research University of Medical and Pharmaceutical Law" and Danylo Halytsky Lviv National Medical University on the topic "Diagnosis, treatment, pharmacotherapy of inflammatory, traumatic and onco-thoracic pathology using instrumental methods" (state registration number 0125U000071, implementation period 2025-2031); Lviv Medical Institute on the topic of "Improving the system of circulation of drugs during pharmacotherapy on the basis of evidentiary and forensic pharmacy, organization, technology, biopharmacy and pharmaceutical law" (state registration number 0120U105348, implementation period 2021-2026); Private Scientific Institution "Scientific and Research University of Medical and Pharmaceutical Law" on the topic “Multidisciplinary research of post-traumatic stress disorders during war among patients (primarily
combatants)” (state registration number 0124U002540, implementation period 2024-2028).
Results and discussion
1. Description of the pharmacological properties of codeine Codeine is an alkaloid of the opium poppy, which belongs to the group of semi-synthetic opioids. It is widely used in medicine as an analgesic, antitussive and weak sedative. The main pharmacological properties of codeine include: Anesthetic action Codeine interacts with μ-opioid receptors in the central nervous system, which reduces the transmission of pain impulses. Its analgesic effect is weaker than that of morphine, but sufficient to relieve moderate pain. Antitussive effect
Codeine suppresses the cough reflex by acting on the cough centers in the medulla oblongata. Due to this, it is used in the treatment of unproductive cough, especially in cases where the symptom is debilitating for the patient. Weak sedative effect Codeine has a sedative effect, which is due to its effect on the central nervous system. In small doses, it rarely causes severe drowsiness, which allows its use in outpatient practice.