Abstract
The aim of the research is the comparison of professional activity of pharmacists of pharmaceutical institution in Ukraine with different education level in relation to their responsibilities in detection and prevention of adverse reactions (AR) or lack of efficacy of pharmaceutical products (PP), set out in the regulatory documentation on this matter. Materials and methods. The questionnaire was developed and used for pharmacists of pharmaceutical institution, taken training on cycles of postgraduate education during 2016–2018. 70 higher education pharmacists (HEPs) and 80 specialized secondary education pharmacists (SSEP) were inquired. The integrity was evaluated by Fisher's ratio test (F). For convenience of calculation the corresponding functions of MS Excel were used. Results. The majority of SSEPs and HEPs of Ukrainian pharmaceutical institutions are aware of their duty to provide information on AR or lack of efficacy of pharmaceutical products to the Department of Post-authorization Supervision of the State Expert Center of the Ministry of Health of Ukraine and are aware of the regulatory legal documentation on this issue, however they are not active enough to take necessary action filling in the “Adverse drug reaction reporting form” and sending it to the national department. One of the reasons for the underactivity of pharmacy workers, irrespective of their level of education, is the low organization of this process in pharmacy institutions, in particular the absence of the “Adverse drug reaction reporting forms”. Conclusion. Higher education pharmacist are more self-acting in completing “Adverse drug reaction reporting forms” and are less likely to shift their responsibilities to the pharmacy manager. It is critical to resolve the issue on enhancement of efficiency of detecting AR and/or lack of efficacy of PP in pharmacy institutions of Ukraine is to improve the quality of organizational work of pharmacy managers.
Highlights
The sixties of the XX century are considered the beginning of the history of pharmacovigilance
On the first question: «Do you know about the responsibility of the pharmacist to provide information to the Post-authorisation Supervision Department of the “State Expert Center of the Ministry of Health of Ukraine” about the adverse reactions (AR)/lack of efficacy of drugs obtained from pharmacy shoppers?», out of 80 specialized secondary education pharmacists (SSEP), 66 (82.5 %) respondents gave positive answer on awareness of their responsibilities and 14 (17.5 %) responded negatively (Fig. 1, a)
When analyzing the answer to the second poll question: «Specify the correct regulatory framework that determines the duty of the pharmaceutical sales representative to provide information about the AR/lack of efficacy of drugs obtained from pharmacy shoppers in the PaSD of the SEC of the Ministry of Health» it was found that the correct answer was given by 60 (75 %) SSEPs (Fig. 2, a)
Summary
The sixties of the XX century are considered the beginning of the history of pharmacovigilance. It was during the XX World Health Assembly that a decision was made on the need to establish an international control system of adverse reactions (AR) to pharmaceutical products (PP) [1]. Spontaneous reports are (2020), «EUREKA: Health Sciences» Number 5 the main sources of information about AR on drug products [3]. Spontaneous reports of AR or lack of efficacy of PP coming from pharmacy practitioners are extremely necessary for future creation of recommendations on safety of drugs [4]. According to WHO recommendations [5], a modern pharmacist, regardless of his or her level of education (higher or specialized secondary), should be able to advise patients and their representatives on problems of healthy lifestyle, as well as on the conditions for safe and effective usage of PP that help prevent AR [6]
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