The Rules of Good Pharmacovigilance Practice of the Eurasian Economic Union oblige developers and marketing authorisation holders to implement a pharmacovigilance system that has to be described in the pharmacovigilance system master file (PSMF). Analysis of public sources revealed lack of data describing the creation of a PSMF. Therefore, the creation of a PSMF and keeping it up to date may prove challenging for pharmacovigilance specialists. The aim of the study was to identify information needs of pharmacovigilance specialists by carrying out a sociological survey. Materials and methods : the authors used information analysis methods (review and analysis of regulatory documents and scientific literature) and sociological methods (a questionnaire for pharmacovigilance specialists). Results : the analysis helped to identify the following master file sections that present problems for specialists: sources of safety data; annexes to the master file; quality system; changes in the pharmacovigilance system that may result in an additional request from the competent authorities, etc. Conclusions : the authors identified the most relevant topics for additional training: “Pharmacovigilance system documents” and “Pharmacovigilance system master file”. The results of the study are helpful for elaboration and updating of additional training programmes for pharmacovigilance specialists.
The Rules of Good Pharmacovigilance Practice of the Eurasian Economic Union oblige developers and marketing authorisation holders to implement a pharmacovigilance system that has to be described in the pharmacovigilance system master file (PSMF). Analysis of public sources revealed lack of data describing the creation of a PSMF. Therefore, the creation of a PSMF and keeping it up to date may prove challenging for pharmacovigilance specialists.The aim of the study was to identify information needs of pharmacovigilance specialists by carrying out a sociological survey.Materials and methods: the authors used information analysis methods (review and analysis of regulatory documents and scientific literature) and sociological methods (a questionnaire for pharmacovigilance specialists).Results: the analysis helped to identify the following master file sections that present problems for specialists: sources of safety data; annexes to the master file; quality system; changes in the pharmacovigilance system that may result in an additional request from the competent authorities, etc.Conclusions: the authors identified the most relevant topics for additional training: “Pharmacovigilance system documents” and “Pharmacovigilance system master file”. The results of the study are helpful for elaboration and updating of additional training programmes for pharmacovigilance specialists.
Eurasian Economic Union claims single rules for pharmaceutical circulation it will the ground for organizing the single pharmaceutical market. Because of such changes all the specialist from pharmaceutical market have to know all the new legislations. For the purpose of raise the organization responsibilities for quality and safety pharmaceuticals. Market autorotation holder have to create pharmacovigilance system. In connection with it the framework of the social survey was to find out the educational needs in pharmacovigilance among the health experts. The results of polling showed that experts had diffi culties in preparing pharmacovigilance documents. Major of the pollees expressed a wish to complete educational training which will be dedicated to the system of pharmacovigilance. The social survey results shows: converts educational needs among the pollees from 23 to 65 %, it points that experts want to get more additional information and some practical cases for understanding some issues in pharmacovigilance system through workshops, educational programs.
Early determination of educational needs of specialists is one of the most important tools of improving teaching and learning activities within the system of continuing professional education. For this purpose the Center of Educational Programmes of the FSBI «SCEEMP» has surveyed about 350 specialists engaged in the sphere of medicines circulation. The survey respondents participated in seminars and professional development programmes, which were provided by the Center of Educational Programmes in 2014. This article presents the results of this opinion poll.
The article discusses the results of an opinion poll among healthcare professionals and pharmacists devoted to finding out their attitude to the main problems associated with instructions for medicinal products. It was discovered that there was a lack of consensus on what could be regarded as official and unofficial sources of information about medicinal products. The poll elicited the attitude towards instructions for medicinal products among specialists and, indirectly, the general public, and helped establish a need for introducing changes into the instruction form.
The article presents a first attempt of implementation of the methodology multicriteriale analysis of decision making in the organization of the system of drug provision in the Russia. In this paper, the reasons to update the activity aimed to implement the described methodology, as well as a dedicated area of drug supply, which multicriterial analysis of decision-making is most in demand - namely, for the organization of drug provision of patients with orphan diseases.
The article summarises the results of a 2015 survey of healthcare professionals and pharmacists that was aimed to reveal their educational needs on the subject of interchangeable medicines. It was discovered that the respondents were not sufficiently informed about interchangeability of medicines, because independent exploration of regulatory framework does not help to get to know this topic well enough. The survey helped to identify a group of specialists who needed training in «interchangeability of medicines» more than others.
The article summarises the results of a 2015 survey of healthcare professionals and pharmacists that was aimed to reveal their educational needs on the subject of interchangeable medicines. It was discovered that the respondents were not sufficiently informed about interchangeability of medicines, because independent exploration of regulatory framework does not help to get to know this topic well enough. The survey helped to identify a group of specialists who needed training in «interchangeability of medicines» more than others.
The article presents a first attempt of implementation of the methodology multicriteriale analysis of decision making in the organization of the system of drug provision in the Russia. In this paper, the reasons to update the activity aimed to implement the described methodology, as well as a dedicated area of drug supply, which multicriterial analysis of decision-making is most in demand - namely, for the organization of drug provision of patients with orphan diseases.
The article discusses the results of an opinion poll among healthcare professionals and pharmacists devoted to finding out their attitude to the main problems associated with instructions for medicinal products. It was discovered that there was a lack of consensus on what could be regarded as official and unofficial sources of information about medicinal products. The poll elicited the attitude towards instructions for medicinal products among specialists and, indirectly, the general public, and helped establish a need for introducing changes into the instruction form.
Early determination of educational needs of specialists is one of the most important tools of improving teaching and learning activities within the system of continuing professional education. For this purpose the Center of Educational Programmes of the FSBI «SCEEMP» has surveyed about 350 specialists engaged in the sphere of medicines circulation. The survey respondents participated in seminars and professional development programmes, which were provided by the Center of Educational Programmes in 2014. This article presents the results of this opinion poll.