Pharmacovigilance in Kazakhstan

19-11-2024
Posted by: Eldaniz Hasanov
Category: Uncategorized

Pharmacovigilance in Kazakhstan: Progress, and Future Directions

Pharmacovigilance, which involves monitoring the safety of drugs on the market and identifying adverse drug reactions (ADRs), plays a crucial role in protecting public health. In Kazakhstan, the pharmacovigilance system has evolved over the past decade, driven by regulatory reforms, improved healthcare infrastructure, and international collaboration. As the country continues to modernize its healthcare sector, the landscape of pharmacovigilance is becoming increasingly sophisticated. This article explores the current state of pharmacovigilance in Kazakhstan, focusing on recent developments, and opportunities for strengthening the system.

Regulatory Framework and Oversight

Kazakhstan’s pharmacovigilance system is primarily governed by national laws and regulations, which have undergone significant updates in recent years to align with international standards.

Key Regulatory Bodies

Ministry of Health of the Republic of Kazakhstan (MoH): The Ministry is the principal regulatory authority overseeing healthcare policies, including pharmacovigilance. It is responsible for the approval of medicinal products, monitoring drug safety, and ensuring compliance with regulations.
Committee for Medical and Pharmaceutical Control (CMPC): This body is responsible for regulating pharmaceutical products, including the safety and efficacy of medicines, and plays a central role in pharmacovigilance activities.
National Center for Expertise of Medicines and Medical Devices (NCE): This authority serves as the national pharmacovigilance center, handling ADR reports, assessing drug safety, and facilitating regulatory updates (Kazakhstan Ministry of Health, 2024).

Kazakhstan’s legal framework for pharmacovigilance has been aligned with European Medicines Agency (EMA) standards and World Health Organization (WHO) guidelines. The country’s adherence to international standards has been facilitated by its participation in the Eurasian Economic Union (EAEU), where pharmacovigilance practices are harmonized among member states. Kazakhstan’s regulatory framework also benefits from the influence of the Good Pharmacovigilance Practices (GVP) guidelines, which emphasize systematic and transparent drug safety monitoring.

Adverse Drug Reaction Reporting

One of the key components of pharmacovigilance in Kazakhstan is the reporting and monitoring of adverse drug reactions (ADRs). The CMPC and NCE coordinate the collection and analysis of ADR data, relying on reports from healthcare professionals, patients, and pharmaceutical companies.

ADR Reporting System

Kazakhstan has a national ADR reporting system that allows healthcare professionals, patients, and pharmaceutical companies to report adverse events through both paper-based and electronic platforms. The Unified State Information System of Healthcare (USIS), launched in 2020, provides an electronic interface for ADR reporting. The system facilitates the collection of ADR reports in a more streamlined and efficient manner, improving both the speed and quality of safety data collection (Sultanov et al., 2024).

Reports submitted through this system are analyzed by the CMPC, which compiles the data and provides updates on new safety information and potential risks associated with medicinal products. The system is also connected to the EAEU’s Centralized Pharmacovigilance System, which ensures that adverse reactions are shared across member states, enhancing regional drug safety surveillance.

Pharmacovigilance in Kazakhstan: Progress, and Future Directions

Challenges in ADR Reporting

Despite these advancements, there are still significant barriers to effective ADR reporting in Kazakhstan. Underreporting remains a significant challenge, a common issue in many countries. According to a recent study, only around 15-20% of ADRs are reported to the national system, which is lower than expected for a country of Kazakhstan’s size and healthcare complexity (Shakirov et al., 2024). This underreporting is attributed to several factors:

Lack of awareness: Many healthcare professionals are still unfamiliar with the reporting system, or they perceive ADRs as not severe enough to warrant formal documentation.
Resource limitations: Limited time and resources, particularly in rural and underserved areas, hinder healthcare providers from consistently reporting ADRs.
Cultural factors: Patients may not always report ADRs either due to a lack of knowledge or fear of potential consequences for their treatment.

International Collaboration and Integration

Kazakhstan’s pharmacovigilance system benefits from increasing integration with international organizations and regulatory bodies. As a member of the Eurasian Economic Union (EAEU), Kazakhstan has access to a shared pharmacovigilance network that connects it with other member countries, including Russia, Belarus, Armenia, and Kyrgyzstan. This regional cooperation has helped streamline pharmacovigilance practices and improve drug safety monitoring across the region.

Kazakhstan also collaborates closely with the World Health Organization (WHO), contributing to the WHO Global Individual Case Safety Reports (ICSRs) database. This partnership provides Kazakhstan with valuable data for detecting global safety signals and improving local pharmacovigilance practices (Uppsala Monitoring Centre, 2024).

In addition to its work with WHO and the EAEU, Kazakhstan maintains a working relationship with the European Medicines Agency (EMA), particularly in areas related to the harmonization of pharmacovigilance regulations and the exchange of safety information. The alignment of Kazakhstan’s pharmacovigilance practices with EMA standards has helped improve the country’s capacity to monitor drug safety and manage risk more effectively.