The role of the pharmacists in providing information on cases of adverse reactions (ARs) and/or lack of effectiveness of drugs in the Pharmacovigilance (PhV) Department of Ukraine is very important.
Objective: Assessment of the level of pharmacists' awareness about regulatory documents (RDs) regulating their duties to provide information about ARs and/or lack of effectiveness of drugs and their activity in this area.
The questionnaire for pharmacists was developed and used, the first seven questions of which were aimed at identifying pharmacists' awareness of their duties to provide information to the Department of PhV at the State Expert Center of the Ministry of Health of Ukraine about ARs and/or lack of effectiveness of drugs and their activity in filling the «Cards-message». Questioning of 70 pharmacists with different work experience (WE): 1‒5 years (12%), 5‒10 years (31%) and 10‒25 years (57%) was conducted.
50% of pharmacists with 1‒5 years WE, 64% of pharmacists with 5‒10 years WE and 75% of pharmacists with 10‒25 years WE know about obligation to provide information about ARs and/or lack of effectiveness of drugs. Only 9% of pharmacists with 5‒10 years WE independently filled and sent the «Card-message» to the department of PhV, in most cases pharmacists give the filled form to the head of the pharmacy.
Regardless of WE duration, the majority of pharmacists are aware the information about their responsibilities to provide reports about ARs and/or lack of drugs efficacy in the department of PhV and know the RDs that regulates this process. The inadequate activity of pharmacy workers to provide information about ARs and/or lack of effectiveness of drugs can be largely due to the low organization of this process at the pharmacy level and the conservatism of pharmacists with longer WE. It is advisable to increase the effectiveness of detection of ARs and/or lack of effectiveness of drugs due to activity of pharmacists in the conditions of pharmacy in Ukraine. Such professional activity of pharmacists helps to improve the quality of pharmaceutical care to the population of Ukraine.
Інститут підвищення кваліфікації спеціалістів фармації Національного фармацевтичного університету Національний фармацевтичний університет* Ключові слова: частотний аналіз; лікарські призначення; фармакотерапія; ішемічна хвороба серця
Інститут підвищення кваліфікації спеціалістів фармації Національного фармацевтичного університету 2 Вищий державний навчальний заклад України «Буковинський державний медичний університет»
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.
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