scholarly journals Knowledge, attitude and practice towards adverse drug reactions reporting in post graduate students of a tertiary care hospital

Author(s):  
Aparna S. Chincholkar ◽  
Alisha Naik

Background: Adverse Drug Reactions (ADRs) are a major cause of morbidity and mortality. Under reporting of ADRs by health care professionals is a very common problem worldwide. So, the present study was planned to assess the knowledge, attitude and practices of postgraduate (PG) students towards ADR reporting and suggest possible ways for improvement.Methods: It was a cross sectional questionnaire-based study conducted among 44 PG students using a questionnaire with questions on knowledge (21), attitude (13) and practices (15) of ADR reporting. The questionnaire was analyzed question wise and the percentage was calculated using Microsoft Excel spreadsheet in Microsoft Office 2010 software.Results: Most of them were aware of the term pharmacovigilance (PV) (95.45%). 54.55% agreed to be trained on how to report an ADR. 88.63% knew about the existence of pharmacovigilance committee in the institute.93% of participants knew that Central Drug Standard Control Organization (CDSCO) is responsible for monitoring of ADRs. 56.82% were aware about VIGIBASE an online software to report ADR. 81.82% of participants had agreed to witness ADRs in patients but only 38.64% reported them. The main reason behind it was non – availability of ADR forms. 42.55% opine that mobile based app would be the most preferred method to send ADR information to an ADR reporting center.Conclusions: There exists a huge gap between ADR experienced and ADR reported by PG students. Participants agreed upon necessity of reporting ADR and periodic briefing about PV.

Author(s):  
Leeyasid Shaik ◽  
Vasundhara Krishnaiah ◽  
Girish K.

Background: Adverse drug reactions (ADRs) are the main leading causes of hospitalization which leads to morbidity and mortality worldwide. Reporting of ADRs to national databases is necessary. To strengthen this system, consumers apart from health-care professionals have also been empowered to report any ADRs directly to the regulatory agencies. Direct and spontaneous patient or consumer reporting offers various benefits beyond pharmacovigilance (PV). Consumer reporting of ADRs has existed in several countries for decades, but in India, with the inclusion of consumer reporting of ADR, the data on the same is valuable and limited. Hence the present study is taken up. The aim of this study was to explore the knowledge, perceptions and practice of ADR reporting among consumers in KIMS hospital and research center, Bangalore.Methods: The data was collected from Patients attending OPD’s, admitted in wards and at pharmacy in KIMS Hospital and Research Center, Bangalore. It is a cross sectional descriptive study. Study period is for six months from 1st April to 31st September 2018 and sample size is 200. A structured questionnaire in English and Kannada was used as a tool.Results: Of the 200 patients from the surveyed, in males the knowledge scores were better when compared to females and attitude, perception scores were same (statistically not significant). Most of the patients opined for the establishment of consumer pharmacovigilance system at hospitals and local pharmacies.Conclusions: Knowledge about ADR reporting and pharmacovigilance is less in consumers. So that there is a need to increase awareness in consumers.


Author(s):  
Kaksha J. Patel ◽  
Ashwin K. Panchasara ◽  
Manish J. Barvaliya ◽  
C. B. Tripathi

Background: The objective of the study was to study the clinical patterns, causality and severity of adverse drug reactions in a tertiary care hospital.Methods: Total 131 ADR forms were collected from January 2012 to December 2012 and evaluated. Patient’s characteristics, ADR and drug characteristics, causality, severity and preventability of collected ADR were analyzed.Results: Total 131 ADR forms were evaluated. Male patient experiencing ADR were more (73, 55.7%) than female (58, 44.2%). Adult patients (12-60 years) experienced 110 (84%) ADR followed by pediatric patients (< 12 years) 11 (8.4%) and geriatric patients (>60 years) 10 (7.63%). Antimicrobial were the most common group of drugs responsible for ADR followed by NSAIDs and antipsychotic group.Conclusions: Present study shows lack of awareness among health care professionals for reporting of an ADR. Training and collaboration of health care professionals are needed for improvement in ADR reporting. Appropriate feedback from ADR reporting will help in selection of drug and promotes safer use of drugs.


Author(s):  
Priyanka S. Survase ◽  
Amit P. Date ◽  
Archana S. Borkar ◽  
Rupesh T. Badwaik ◽  
Riaz A. Siddiqui ◽  
...  

Background: Adverse drug reactions are one of the major medicine related problem related to pharmacotherapy which may lead to increased morbidity and mortality causing increased hospital stay and financial burden on the society. Spontaneous voluntary reporting of adverse drug reaction can play a vital role in generating safety signals in which nurses can play important role, hence this study was undertaken to evaluate the knowledge attitude and practice of ADR reporting along with factors affecting reporting among nurses.Methods: The present study was a cross sectional questionnaire based study, which included nurses of a tertiary care hospital in central India. We tried to find out the possible ways to perk up spontaneous reporting of ADR and factors responsible for scarce reporting of ADRs.Results: After analyzing the data, we observed few of responders were aware of the ADR reporting system and the most encouraging finding was that majority of the responders were of the view that this reporting system is necessary. However, response to practice related questions was below average. Main factors which discouraged ADR reporting by nurses was thinking that reporting would lead to extra work and non availability of forms.Conclusions: The deficiencies in ADR reporting require awareness so as to perquisite spontaneous reporting and improve safety of patients. Training to nurses will lead to improvement in reporting of ADR.


Author(s):  
Anuran Bhadury ◽  
Olivia Mukhopadhyay ◽  
Saswati Sarkar

Background: Pharmacovigilance programs have been introduced to keep an eye on adverse drug reactions and safe use of drugs. All Healthcare professionals (HCPs) should report each and every adverse events which they come across. Pharmacovigilance programme of India is running actively since 2010 but India contributes only 2% of Adverse drug reactions (ADR’s) reported worldwide. There is need to monitor awareness of HCP’s about pharmacovigilance to achieve the goals. Such studies from peripheries of Eastern India are lacking. The aim of the study was to assess the knowledge, attitude and practice and overall awareness among HCP’s about pharmacovigilance and to understand actual barriers of ADR reporting.Methods: A cross-sectional questionnaire-based study was done in Burdwan Medical College and Hospital. Ninety-nine HCP’s completed the pre-designed questionnaire. There were 15 questions to assess the awareness and cause(s) of underreporting. Data were analysed using appropriate statistical software.Results: We analysed data of 67 doctors and 32 nurses. We found, 67.2% doctors and 59.4% nurses knew definition of pharmacovigilance. About half HCP’s had knowledge about existing pharmacovigilance committee in our hospital. Almost all HCP’s felt ADR reporting is necessary. Surprisingly 88.1% doctors and 46.9% nurses experienced ADR at least once but 25.4% and 3.1% reported them respectively. For knowledge and practice related questions, correct responses were significantly higher for doctors. Most common discouraging factors regarding ADR reporting were, didn’t know how to report (52.5%) where to report (41.4%).Conclusions: Attitude of HCP’s towards pharmacovigilance activities was appreciable and combining it with periodic sensitizing programs, and training sessions will increase the knowledge, clear doubts about ADR reporting and improve the awareness about pharmacovigilance.


Author(s):  
Prasad R. Shivarudraiah ◽  
Ravi H. Kudthni ◽  
Santhosh Ramakrishna ◽  
S. S. Koushik ◽  
Prajna V. Karki ◽  
...  

Background: Adverse drug reactions (ADRs) represent a serious health problem. Effective generation of ADR related data helps in practicing evidence-based medicine and thus prevents many adverse drug reactions. Spontaneous reporting of ADRs has remained the major sources of information of pharmacovigilance. Underreporting of ADRs is a common problem. In order to improve the reporting rate, it is important to improve the Knowledge, Attitude and Practices (KAP) of the prescribers regarding ADR reporting and Pharmacovigilance. Hence this study was undertaken to assess the knowledge, attitude and practice regarding Pharmacovigilance among doctors of Shridevi Institute of Medical Sciences and Research Hospital, Tumkur, Karnataka.Methods: This was a cross sectional, observational, questionnaire based study conducted using a predesigned Knowledge Attitude Practice (KAP) questionnaire among 110 doctors. The completed KAP questionnaire was collected and data analyzed.Results: Most of the doctors (98.15%) accepted that reporting ADR is necessary. 67.31% agreed that ADR reporting is necessary for identifying safety of the drug and 94.44% agreed that pharmacovigilance should be taught in detail to health-care professionals. But there was a huge gap between the ADR experienced (80%), and ADR reported (25.45%) by the prescribers. Only 29.09% medical professionals have ever seen the ADR reporting form and only 16.36% respondents have been trained on reporting on ADR.Conclusions: Study revealed that the majority of the doctors had a good knowledge but poor attitude and practice of pharmacovigilance. They should be trained properly on ADR reporting to improve the current scenario in the pharmacovigilance program of the country.


Author(s):  
Smita Y. Wankhede ◽  
Milind L. Pardeshi ◽  
Vishal V. Ghorpade ◽  
Balasaheb B. Ghongane

Background: Cardiovascular disease is very prevalent in India. So, use of cardiovascular drugs is also more. So, it is very important to keep watch on adverse drug reactions. Aim of this study was to assess the pattern of adverse drug reactions (ADRs) reported with cardiovascular drugs in a tertiary care institute.Methods: The study was carried out in medicine department of a tertiary care hospital over a period of one year. Each ADR was analysed for demographic data, causality, relationship between frequency of ADRs and the number of drugs used etc. In statistical analysis Microsoft excel 2013, SPSS software was used.Results: A total of 136 patients, 58 (43%) men and 78 (57%) women, using cardiovascular medications reported ADRs during the entire study period. Total 168 ADRs were reported out of which, Amlodipine (causing headache and edema feet) was the most common drug with 51 (30.3%) ADR’s followed by Enalapril, Aspirin and Isosorbide Dinitrate with 37 (22%), 24 (14.2%), 23 (13.6%) ADRs respectively. Most common ADR was headache (due to amlodipine and Isosorbide di nitrate) affecting 38 (22.62%) cases followed by dry cough 37 (22.02%) cases, edema feet 36 (21.43%), gastritis 24 (14.29%) and 10 (5.95%) of nausea.Conclusions: Monitoring ADRs in patients using cardiovascular drugs is a matter of importance since this class of medicines are mostly used as multidrug therapy and always prone for ADRs.


Author(s):  
Mirza Shiraz Baig ◽  
Monali Raghunath Kale ◽  
Avinash Lamb

Background: The emergence of drug resistant mycobacteria has become a significant public health problem world over creating an obstacle to effective TB control. ADRs are common in patients of MDR-TB on DOTs-Plus drug regimen. Present study was carried out in tertiary care hospital. Identification of types and frequency of adverse drug reactions in Intensive and continuation phase of MDR-TB Patients.Methods: It was a prospective observational study conducted in Department of TB- Chest and Medicine, Govt. Medical College, Aurangabad, Maharashtra, India. All the MDR-TB patients admitted at the directly observed treatment, short course plus (DOTS plus) Center at Medical College Hospital were enrolled and were monitored for ADRs. The causality and severity of the reactions were determined using Naranjo algorithm and Hartwig questionnaire, respectively.Results: A total of 121 tuberculosis patients of MDR-TB on DOTS therapy were enrolled for the study. Out of 121 patients, 13 were dropouts, 6 died, 7 defaulted so 108 patients assessed for ADRs, 48 patients developed 61 (56.48%) adverse drug reactions. The higher numbers of ADRs were observed in age group 31-40yrs followed by 21-30yrs which were more common in men. Majority of adverse drug reactions were Gastrointestinal (GI) problems 32 (52.45%), followed by Ototoxicity 7 (11.48%) and Psychiatric Manifestations 6 (9.84%) and skin problems 3 (4.92%). On evaluation of the causality of ADRs, majority were found to be Possible (59.02%). The severity assessment showed that most of the patients ADRs were of moderate level (50.82%).Some patients required treatment withdrawal and replacement with other drug and most of the patients were managed with supportive medication without removing anti-tubercular drug from their treatment regimen.Conclusions: ADRs are major factor limiting completion of drug therapy under RNTCP and occurrence of drug resistance which requires attention of all health care professionals.


Author(s):  
Ravi D. Mala ◽  
D. M. Ravichand ◽  
B. V. Patil ◽  
B. S. Payghan ◽  
Anurag Yadav

Background: Adverse drug reactions (ADRs) are noxious and unintended effects of a drug that occurs at doses normally used in humans. ADRs may also result in diminished quality of life, increased physician visits, hospitalizations, and even death. The objectives of this study are to analyze and assess the causality and severity of reported ADRs.Methods: A cross sectional study of ADRs reported to Pharmacovigilance cell of MNR Medical College and Hospital Sangareddy in a year. The details of the various ADRs were statistically analyzed to find out pattern of ADRs. The WHO-UMC causality category and Hartwig-Seigel Scale were used to assess causality and severity of ADRs respectively.Results: The study shows, out of 60 suspected ADRs, the majority of ADRs were adults (68.3%) and out of whom 56% were females. According to the WHO-UMC Causality categories, 43.3% of the ADRs were categorized under Probable/likely, followed by possible (35%). The Hartwig-Siegel severity assessment scale shows that the majority (90%) of suspected ADRs were of mild category.Conclusions: The pattern of ADRs reported in our study is comparable to other studies. The commonest organ system affected was gastrointestinal tract, nervous and cutaneous system. Antimicrobial agents were causing maximum ADRs and medicine and allied departments have more number of ADRs. This study provides a valuable database for ADRs due to all commonly used drugs at hospitals and also helps in creating awareness regarding safe & judicious use of drugs to prevent ADRs.


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