ABSTRACT
Background: Pharmacovigilance is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other possible drug-related problems. An “adverse drug reaction” is any noxious, unintended and undesired effect of a drug, which occurs at a dose used in humans for prophylaxis, diagnosis, therapy or modification of physiological functions. Reporting of adverse events and adverse drug reactions is the commonest method utilized for generating safety data. Lack of awareness about Pharmacovigilance is one of the most important causes of such under-reporting. Spontaneous reporting system is considered the main mechanism of pharmacovigilance study for gathering information about ADRs. Hence this study was undertaken to assess the knowledge, attitude and practice regarding Pharmacovigilance among junior residents and interns in a tertiary care hospital.Methods: A cross-sectional study was carried out in 134 doctors using pre-validated 20 item questionnaire with details of participant’s information followed by questions regarding knowledge, attitude and prescribing practice of pharmacovigilance was used as a tool, administrated to all the resident doctors and the collected data was analysed.Results: Our study revealed that knowledge about pharmacovigilance was not adequate to JRs and INTs. Survey results revealed that the knowledge of pharmacovigilance among doctors 63 (88.73%) JR and 49 (77.78%) INTs had a knowledge score of less than 50%. This shows that only few doctors are aware about the pharmacovigilance programme. The assessment of questionnaire based on attitude regarding pharmacovigilance shows that 21 (29.58%) JR and 17 (26.98%) of INTs had attitude score of 70% and above. The attitude score was less compared to the knowledge score of JRs and INTs. 52 JR and 58 INTs stated that they have not been trained on how to report ADRs and basic orientation about pharmacovigilance which hinders the process of practicing pharmacovigilance. Conclusions: For the success of Pharmacovigilance programmes only knowledge and attitude regarding Pharmacovigilance is not enough as is evident from our study. Success of Pharmacovigilance programmes depend also upon the effective practice of Pharmacovigilance by healthcare professionals.
ABSTRACT
Background: Fixed Dose Combinations (FDCs) are defined by the World Health Organization (WHO) as combination of two or more active ingredients in a fixed ratio of doses. According to the FDA, “two or more drugs may be combined in a single dose when each component makes a contribution to the claimed effects, and the dosage of each component (i.e., amount, frequency, and duration) is such that the combination is safe and effective for significant patient population requiring such concurrent therapy. However, certain disadvantages like incompatible pharmacokinetics, inflexible dose ratio, increased toxicity and cost, contraindication of one component of the FDC decreased their utility. Adverse effect of any one component also limits their use. The aim of the study is to compare and evaluate the knowledge, attitude and practices about prescribing fixed dose combinations among junior resident doctors (JRs) and interns (INTs) at SDM College of Medical Sciences and Hospital Dharwad.Methods: A cross-sectional study was carried out in 134 doctors using pre-validated 10 item questionnaire with details of participant’s information followed by questions regarding knowledge, attitude and prescribing practice of fixed dose combinations was used as a tool, administrated to all the resident doctors and the collected data was analysed.Results: Our study revealed that knowledge about FDCs was lacking in JRs and INTs. They were not able to point out the actual advantages and disadvantages of FDCs. Knowledge about rational/irrational, banned FDCs and availability of WHO EML was also lacking.Conclusions: There is need to improve knowledge about rationality, essential medicine list, usage and banned FDCs in undergraduate medical students to promote the rational use of drugs.