Pharmacovigilance and Adverse Drug Reactions (Adrs) Practice of Healthcare Professionals

Aim: To assess pharmacovigilance and adverse drug reactions practice of healthcare professionals in Ribat University Hospital, Khartoum, Sudan. Methods: This was a cross-sectional study to evaluate pharmacovigilance and ADRs practice among physicians, pharmacist and nurses working in the National Ribat University, Khartoum, Sudan. The sample size was calculated as 100. Data were collected by a pre-tested questionnaire after obtaining ethics approval. Data analysis was performed by SPSS software. Results: The HCPs who acquired good and poor pharmacovigilance practice were 16 (16%) and 84 (84%) respectively. Ninety-eight (98%) of the healthcare professionals have ever experienced ADR in their patients during professional practice. Ninety-four (94%) have ever seen ADR reporting form. Forty (40%) have ever reported ADR to the pharmacovigilance center. Pharmacists, Physicians and nurses with good practice were30.8%, 18.4% and 7.9% respectively. Conclusion: Most healthcare professionals acquire good pharmacovigilance practice. The pharmacist acquires higher level of pharmacovigilance practice followed by physicians and nurses. Healthcare professionals with shorter years of experience have significantly higher pharmacovigilance practice. Keywords: Pharmacovigilance, Adverse Drug Reactions, Healthcare Professionals

Results of a Sociological Survey on the Needs of Drug Safety Monitoring Specialists for Information on the Creation of the Pharmacovigilance System Master File

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.

A questionnaire based study on the knowledge, attitude and the practices of pharmacovigilance among the postgraduate students at a tertiary care hospital in south India

Background: Adverse drug reactions (ADRs) are common cause of morbidity in the practice of medicine. Pharmacovigilance is the science of detection, assessment and understanding and prevention of adverse effects or any drug related problems. Post graduates are perhaps the first to notice ADRs in outpatient/inpatient setup as they spend most of the time bedside. Thus, this study was conducted to assess the knowledge, attitude and practices (KAP) of postgraduates about Pharmacovigilance.Methods: A prevalidated and pretested questionnaire with 20 questions related to KAP of pharmacovigilance is administered to postgraduate students after obtaining their consent. All the completed and returned questionnaires were analysed for results using appropriate statistics.Results: 180 pretested questionnaires were distributed among postgraduates out of which, 122 were returned from postgraduates of all major medical and surgical allied departments. 90.2 % defined pharmacovigilance correctly, 83.6% thought reporting ADRs is a professional obligation, while only 65.6% knew regarding the existence of national pharmacovigilance program. 58.4% have experienced ADRs, of which only 24.6% reported ADR to pharmacovigilance centre. Major reasons for under reporting are lack of time to report and difficulty to decide whether ADR has occurred or not.Conclusions: In this study, the knowledge and attitude related to Pharmacovigilance is good amongst postgraduates, but practical implementation in reporting of ADRs is poor. Sensitization programs on pharmacovigilance practice in tertiary care hospitals and regular review meetings to ensure ADR reporting to pharmacovigilance centre will strengthen the health care setup.

Review on Pharmacovigilance Practice for Safety of Medication System in Bangladesh

Pharmacovigilance is a system that provides safety to the patients in case of medication. It mainly deals with adverse drug reactions. With the outbreak of new diseases new medicines are developing worldwide. So to ensure the safety of drug, pharmacovigilance is very necessary. National pharmacovigilance center of a country coordinates the overall activity of pharmacovigilance in collaboration with international regulatory authorities like WHO, the Uppsala Monitoring Centre etc. Integration of pharmacovigilance system in public health has positive impact on improvement of health care system. In Bangladesh Directorate General of Drug Administration (DGDA) is playing an active role to ensure the safety of medication system.Bangladesh Pharmaceutical Journal 20(1): 105-114, 2017