Pharmacovigilance in Russia

Current State of Affairs, Challenges, and Prospects

Abstract
Pharmacovigilance (PV) refers to the science and activities related to the detection, assessment, understanding, and prevention of adverse events or any other drug-related problems. In Russia, pharmacovigilance has evolved significantly since the country’s integration into the global healthcare landscape. This article reviews the current state of pharmacovigilance in Russia, identifies key challenges, and discusses future prospects for strengthening this essential public health function.

Introduction

Pharmacovigilance plays a crucial role in ensuring drug safety in the post-marketing phase of pharmaceuticals. In Russia, the regulatory framework for PV has undergone substantial changes since the early 2000s, evolving from a fragmented system into a more organized and systematic approach. This article presents an overview of the current state of pharmacovigilance in Russia, highlights major challenges facing the system, and outlines potential pathways for its enhancement.

Pharmacovigilance in Russia: Current State of Affairs

Legal Framework and Regulatory Bodies

The core legislative framework for pharmacovigilance in Russia is governed by the Federal Law No. 61-FZ “On Circulation of Medicines” enacted in 2010, which was further amended to align with international standards (Russian Government, 2010). The Federal Service for Surveillance in Healthcare (Roszdravnadzor) serves as the main regulatory authority overseeing pharmacovigilance activities, including the collection, analysis, and reporting of adverse drug reactions (ADRs) (Kudinov et al., 2021).

In recent years, Russia has made significant strides in establishing a national pharmacovigilance system that includes mandatory ADR reporting from healthcare professionals and pharmaceutical companies, as well as the implementation of electronic reporting systems. Although the legal framework is robust, the enforcement of regulations and the actual practices of reporting still exhibit variability across different regions and institutions (Zhelnov et al., 2019).

Russia Pharmacovigilance Guidelines

PV Normative Documents:

1. Federal Law No. 61 of 12.04.2010 -FZ “On the Circulation of Medicines”
2. Order of Roszdravnadzor No. 1071 of 15.02.2017 “On approval of the procedure for implementing pharmacovigilance”
3. The rules of Good Pharmacovigilance Practice (GVP), approved by the Decision of the Council of the Eurasian Economic Commission of 03.11. 2016 No. 87 (GVP EAEU)
4. Order of the Ministry of Health of Russia dated 07.09.2015 No. 5539 “On approval of the procedure for implementing selective quality control of medicines for medical use”
5. Agreement on uniform principles and rules for the circulation of medicines within the Eurasian Economic Union.

Pharmacovigilance Requirements

MAH responsibility in Russia	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

Data Management and Reporting Systems

The Good Pharmacovigilance Practice (GVP) guidelines, adapted by Russia, emphasizes the importance of data quality and risk management (European Medicines Agency, 2012). The Russian drug safety monitoring system involves several databases for ADR reports, including the State Register of Medicines and national databases maintained by the Ministry of Health. However, issues with data accessibility and transparency remain (Zaslavskaya et al., 2020).

Pharmacovigilance in Russia: Challenges

Underreporting of Adverse Drug Reactions

One of the primary challenges in pharmacovigilance in Russia is the underreporting of ADRs. Studies indicate that the reporting rate is significantly lower than expected, with estimates suggesting that less than 10% of ADRs are reported to authorities (Olivier et al., 2021). Factors contributing to underreporting include a lack of awareness among healthcare professionals, inadequate training, and the perception that ADRs are not sufficiently serious to warrant reporting (Sukhorukov et al., 2020).

Limited Public Awareness

Public understanding of pharmacovigilance is also limited, which affects patient engagement and reporting of ADRs. Educational initiatives aimed at both healthcare providers and patients are essential for improving the pharmacovigilance landscape in Russia (Borisova et al., 2021).

Insufficient Funding and Resources

Budget constraints have hindered the expansion and effective functioning of pharmacovigilance systems. There is an urgent need for increased funding to improve infrastructure, training, and technology that can facilitate effective ADR reporting and analysis (Zhelnov et al., 2019).

Prospects for Improvement

Strengthening Training and Education

Enhancing education and training programs for healthcare professionals is critical to address the underreporting issue. Continuous medical education programs that include pharmacovigilance topics can help equip healthcare providers with the necessary knowledge and skills to recognize and report ADRs effectively (Kudinov et al., 2021).

Leveraging Technology

The use of digital technologies, such as mobile applications and electronic health records, can streamline the reporting process and enhance data collection. Innovations in data analytics and machine learning could assist in identifying potential safety signals from large datasets (Olivier et al., 2021).

International Collaboration

Collaboration with international pharmacovigilance organizations and sharing data with global databases can enhance Russia’s pharmacovigilance capabilities. Engaging with the World Health Organization and other international bodies can facilitate best practices and harmonization of standards (European Medicines Agency, 2012).

Conclusion

While Russia has made notable advancements in its pharmacovigilance system, significant challenges remain. Addressing these issues through improved training, public awareness, technological integration, and international cooperation is essential for enhancing drug safety. By reinforcing its pharmacovigilance framework, Russia can better protect public health and ensure the safe use of medications.

References

• Borisova, E. A., et al. (2021). “Awareness of pharmacovigilance among healthcare professionals: A Russian survey.” Journal of Drug Safety, 44(5), 205-213.
• European Medicines Agency. (2012). “Guideline on good pharmacovigilance practices (GVP).” Retrieved from EMA website.
• Kudinov, S. A., et al. (2021). “Training healthcare professionals for better pharmacovigilance outcomes in Russia.” Therapeutic Advances in Drug Safety, 12, 1-10.
• Olivier, S., et al. (2021). “Pharmacovigilance in emerging markets: Lessons from Russia.” International Journal of Drug Safety, 5(3), 121-130.
• Russian Government. (2010). “Federal Law No. 61-FZ ‘On Circulation of Medicines’.” Retrieved from Official website.
• Sukhorukov, A., et al. (2020). “Barriers to adverse drug reaction reporting in Russia: A qualitative study.” Pharmaceutical Medicine, 34(2), 81-88.
• Zaslavskaya, S., et al. (2020). “Data quality in Russian pharmacovigilance: Challenges and solutions.” Pharmacovigilance Reports, 14(2), 55-62.
• Zhelnov, I., et al. (2019). “Assessing the state of pharmacovigilance in Russia: Current challenges and possible solutions.” Russian Journal of Pharmacology, 16(3), 123-130.