Pharmacovigilance in Kazakhstan
- 19-11-2024
- Posted by: Araz Suleymanov
- 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.
Kazakhstan Pharmacovigilance Guideline
PV Normative Documents:
1.Code of the Republic Of Kazakhstan On Public Health And The Healthcare System (with amendments and additions as of 07.07.2020)
2.Decision No. 87 of November 3, 2016 “On approval of the Rules of good pharmacovigilance practice of the Eurasian Economic Union”
3.Order of the Minister of Health of the Republic of Kazakhstan dated December 23, 2020 No. KR DSM-320/2020. “On approval of the rules for conducting pharmacovigilance and monitoring the safety, quality and efficacy of medical devices”
4.Order of the Minister of Health of the Republic of Kazakhstan dated January 27, 2021 No. KR DSM-10 “On approval of the rules for conducting examination of medicines and medical devices”
5.Order of the Acting Minister of Health of the Republic of Kazakhstan dated February 4, 2021 No. KR DSM-15 “On approval of good pharmaceutical practices”
6.Order of the Minister of Health of the Republic of Kazakhstan dated September 10, 2020 No. KR DSM-101/2020 “On approval of the Rules for drafting and formalizing instructions for medical use of medicines and medical devices and general characteristics of the medicine”
7.Order of the Minister of Health of the Republic of Kazakhstan dated January 27, 2021 No. KR DSM-9 “On approval of the rules for conducting pharmaceutical inspections for good pharmaceutical practices”
Pharmacovigilance Requirements
MAH responsibility in Kazakhstan | Requirement |
Pharmacovigilance System Master File (PSMF) | Yes |
Qualified Person for Pharmacovigilance (QPPV) | Yes |
Local QPPV/Local Contact Person for Pharmacovigilance (LCPPV) | Yes |
Adverse Event reporting | Yes |
Weekly local/global literature surveillance | Yes |
Weekly local/global Regulatory intelligence monitoring | Yes |
Routine PSUR/PBRER/DSUR submission | Yes |
RMP submission | Yes |
Local/global Signal detection | Yes |
Risk Minimization Measures (RMM) | Yes |
Additional Risk Minimization Measures (aRMM) | Yes |
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.
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.
Pharmacovigilance in Kazakhstan: Opportunities and Future Directions
Kazakhstan has several opportunities to strengthen its pharmacovigilance system, particularly in the following areas:
- Digitalization and AI Integration: The continued development of digital health tools and the use of artificial intelligence (AI) in signal detection and ADR analysis could significantly improve the efficiency of pharmacovigilance in Kazakhstan. Integrating big data analytics could allow for faster identification of safety signals and more effective post-market surveillance (Liu et al., 2024).
- Public-Private Partnerships: Strengthening collaboration between the government, pharmaceutical companies, healthcare providers, and academic institutions will help improve pharmacovigilance practices. Pharmaceutical companies can play a proactive role in educating healthcare professionals and the public about ADR reporting and safety monitoring (Sultanov et al., 2024).
- Training and Education: More extensive pharmacovigilance training programs for healthcare professionals are essential. This should include not only physicians and pharmacists but also nurses and medical students, who play a critical role in identifying and reporting ADRs.
- Public Awareness Campaigns: Increasing public awareness of ADR reporting systems will be crucial to improving the volume and quality of ADR reports. Public health campaigns can help educate patients about the importance of reporting adverse events and how to do so effectively.
Conclusion
Kazakhstan’s pharmacovigilance system has made significant progress in aligning with international standards and improving drug safety monitoring. By leveraging digital tools, strengthening public-private partnerships, improving education, and enhancing international collaboration, Kazakhstan can address the challenges and build a more comprehensive and efficient pharmacovigilance system that ensures the safety and efficacy of medicines for its population.
References
- Demeuov, S., Sarybaev, R., & Zhanbatai, A. (2024). Post-market Surveillance and Pharmacovigilance in Kazakhstan: A Review of Current Practices. Kazakh Journal of Pharmaceutical Sciences, 14(1), 22-30.
- Kazakhstan Ministry of Health. (2024). Annual Report on Pharmacovigilance Activities. Ministry of Health of Kazakhstan.
- Liu, Y., Chen, L., & Zhang, Z. (2024). Digitalization and AI in Pharmacovigilance: Global Trends and Opportunities. Journal of Drug Safety, 47(2), 145-152.
- Shakirov, D., Kazybayev, T., & Toktarova, A. (2024). ADR Reporting and Underreporting in Kazakhstan: A Survey of Healthcare Professionals. Central Asian Journal of Public Health, 5(1), 18-27.
- Sultanov, A., Bektur, R., & Yeldesbayev, E. (2024). Pharmacovigilance in Kazakhstan: Challenges and Strategic Directions. Journal of Pharmaceutical Policy and Law, 29(2), 87-94.
- Uppsala Monitoring Centre. (2024). Global Individual Case Safety Reports (ICSRs). World Health Organization.
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