R.S. Safiullin, A.E. Krasheninnikov

In various national systems of the global global pharmacovigilance architecture, pharmaceutical workers have traditionally been one of the leading links in the collection and upstream channel of information on adverse events associated with drug use. The organization of pharmacovigilance determines the procedure for collecting spontaneous reactions about adverse drug events, as required by good pharmacovigilance practice.

The Russian Federation, being a member country of the World Health Organization (hereinafter referred to as WHO), has fully accepted the global WHO principles on the priority of the safety regime for drug circulation on its territory and has introduced the concept of pharmacovigilance into the national legislative system. Pharmacovigilance as a function overseeing the effectiveness and safety of the drug circulation regime is fixed, in particular, by Article 64 of the Federal Law “On Circulation of Medicines”, and is implemented on the basis of the obligation of pharmaceutical employees to inform the authorized official of the organization information about incidents, the list of which is determined by law, but not limited by it, related to the use of medicinal products. The pharmaceutical organization sends the information received from pharmaceutical workers to the Federal Service for Surveillance in Healthcare (hereinafter – Roszdravnadzor) as an executive body authorized to perform a supervisory function in the field of pharmacovigilance. Thus, pharmaceutical workers are one of the key components of the national pharmacovigilance system, directly interacting with consumers of medicines, as well as the primary link in collecting information on violations of the safety regime of medicines circulation, including adverse reactions (AD). It is the pharmaceutical industry who should make a significant contribution to the collection of spontaneous reactions to adverse drug events, as required by good pharmacovigilance practice.

In addition, the effectiveness of monitoring the safety regime of the circulation of OTC drugs depends mainly on the pharmaceutical workers. However, under the conditions of the functioning of the Russian pharmacovigilance system, the practice of extremely low activity of pharmaceutical workers has developed, which has been repeatedly pointed out in the scientific discourse by the authors of numerous publications. Based on the identified problem, the aim of the undertaken study was to study the current role of pharmaceutical workers in pharmacovigilance in terms of their effectiveness as its primary link. The opinion of 100 pharmaceutical workers in the Republic of Tatarstan on the specifics of the organization of pharmacovigilance as part of their professional activities was collected and summarized by the method of a questionnaire survey. The study led to the following conclusions.

CONCLUSIONS

  1. The role of pharmaceutical workers in the Russian pharmacovigilance system is one of the leading, which is legally enshrined in the legal norms of federal laws. A survey study of the experience of pharmaceutical workers shows that the leading role of pharmaceutical workers remains in the area of ​​pharmacovigilance practice: on average, 52.5% of pharmaceutical workers are faced with cases of adverse reactions in a patient or with facts of lack of therapeutic effect of drugs; the vast majority of pharmaceutical workers (on average 65.5%) report this. The organization of pharmacovigilance, which determines the procedure for collecting spontaneous reactions to adverse drug events, requires a significant increase in the activity of pharmaceutical workers in this regard, as required by good pharmacovigilance practice.
  2. An indirect mechanism for notifying Roszdravnadzor about incidents with medicinal products within the framework of good pharmacovigilance practice, which implies the existing obligation for pharmaceutical workers to notify the organization’s authorized person for pharmacovigilance, as well as the right, but not the obligation to report directly to Roszdravnadzor, determines the prevailing desire of pharmacy workers to confine themselves to oral communication to the immediate supervisor (on average 83.94% of pharmaceutical workers according to the survey results), although the organization of pharmacovigilance determines a different procedure for collecting spontaneous reactions about adverse drug events.
  3. The professional competence of pharmaceutical workers in the field of pharmacovigilance is insufficient for their independent (including online) reporting of incidents with medicinal products to Roszdravnadzor through the “Notice of an adverse reaction or lack of therapeutic effect of a medicinal product”, the form of which is established by the Order of Roszdravnadzor from 02/15/2017 No. 1071 “On approval of the Procedure for the implementation of pharmacovigilance.” Additional development is required for such professional competencies of pharmaceutical workers as: the ability and willingness to identify an incident caused by a drug; the ability and willingness to fill out the “Notice of an adverse reaction or lack of a therapeutic effect of a medicinal product”, the form of which is established by the Order of Roszdravnadzor dated 15.02.2017 No. 1071 “On approval of the Procedure for the implementation of pharmacovigilance.”
  4. Increasing the professional competence of pharmaceutical workers in the field of pharmacovigilance in two professional competencies should be carried out through the development and implementation of additional measures to organize intra-pharmacy pharmacovigilance training for workers based on the principles of scientific nature, accessibility, visibility, modernity, high technology, interactivity. The listed principles are fully consistent with the interactive teaching technology in the form of a master class.