AZERBAIJAN IS A SMALL COUNTRY of around 10 million people bordered on the east by the Caspian Sea, neighbouring Iran, Turkey, Georgia, Russia and Armenia. Part of the WHO Euro region, it is an oil-rich nation with a strong artistic legacy, culture and national traditions. The capital, Baku, is one of the largest industrial, scientific and cultural centres in the region, and reflects the ethnic composition of the whole country.
In Azerbaijan, the national pharmacovigilance centre was established in 2017 within the Analytical Expertise Center (AEC) of the Ministry of Health (the national regulatory authority). It is responsible for formulating and implementing technical and operational guidelines, regulations and standards, setting up and coordinating pharmacovigilance systems at the national level, monitoring medicines safety, and identifying all changes affecting the benefit-risk balance.
The first pharmacovigilance activities in Azerbaijan were in 2010 when it joined the WHO Programme for International Drug Monitoring (WHO PIDM) as an associate member. The centre began submitting individual case safety reports (ICSRs) through VigiFlow to the WHO global database (VigiBase), and the current total number is 1,818. ICSRs are mainly received on medicines that are part of public health programmes, such as medicines for tuberculosis and AIDS. On 23 January 2018, the centre became the 130th full member of the WHO PIDM, further boosting pharmacovigilance activities in Azerbaijan.
ENSURING MEDICATION SAFETY IN AZERBAIJAN is one of the AEC’s primary responsibilities. UMC’s web-based tools make it possible to actively monitor the safety of medicines marketed in Azerbaijan and take timely decisions based on safety signals. VigiFlow, being a web-based pharmacovigilance management system compatible with the ICH E2B (R2 and R3) guidelines for ICSR reporting, eases data entry options for ADR and AEFI reports. It uses integrated standardised medical terminologies such as WHODrug Global and MedDRA, and also supports the use of different causality assessment methods (such as WHO-UMC causality, Naranjo, etc.), and provides access to VigiLyze, where it is possible to perform signal detection by using disproportionality analysis and signal management. This online reporting tool gives us the confidence to continuously strengthen our collaboration within the WHO PIDM and to use VigiBase services.
Integration of the online reporting interface to the VigiFlow database makes it easy for staff to collect ICSRs. Currently, we are working on a video guide for reporters who will use the interface.
INCREASING GLOBAL AWARENESS OF THE IMPORTANCE of pharmacovigilance systems led the Azerbaijan government to call for legal reforms, which accelerated the revision of the law of the Azerbaijan Republic on medicinal products, and following that, the preparation of a “Regulation of Pharmacovigilance for Medicinal Products” in 2019. The regulation, developed to implement state control on the effectiveness and safety of medicinal products, defines a set of measures to detect, evaluate, and prevent adverse reactions and other undesirable consequences when using medicinal products. It applies to medicinal products’ marketing authorisation holders (MAH) and all health institutions. Implementation has been supported by a set of guidelines for the conduct of pharmacovigilance in Azerbaijan, “Good pharmacovigilance practices (GVP)”.
In connection with the implementation of pharmacovigilance activities provided by the 2019 regulation, both MAHs and health institutions must assign a person with a medical or pharmacy background to be responsible for pharmacovigilance. Since March 2022, public health institutions (hospitals and polyclinics) have undertaken active recruitment to the positions of responsible person for pharmacovigilance. Their duties and responsibilities include reporting ICSRs to the AEC’s pharmacovigilance department, responding promptly in case of crises, and following up on ICSR reports.
THE NEXT STAGE WILL BE CRUCIAL: working with responsible persons for pharmacovigilance assigned by health institutions. We plan to organise workshops and training for them and give them access to VigiFlow for reporting ICSRs. As a result, we believe that we will see a significant increase in the number and quality of ICSRs sent to VigiBase.
Besides that, with the support of experts from UMC, AEC has implemented an online reporting system. The UMC-developed online system for reporting ICSRs provides easy access to a simple, native language e-reporting form. Integration of the online reporting interface to the VigiFlow database makes it easy for national pharmacovigilance staff to collect ICSRs. Currently, we are working on preparing a video guide for reporters who will use the interface.
To ensure timely identification of suspected safety problems in medicinal products, we aim to enhance pharmacovigilance activities in health institutions across Azerbaijan. The continuous education, communication with healthcare professionals and MAHs, and workshops and campaigns will promote a reporting culture and encourage healthcare professionals and patients to report ICSRs.