scholarly journals Knowledge, attitude and practice toward adverse drug reaction reporting among practicing clinicians at a tertiary care hospital

Author(s):  
Toshan L. Todar ◽  
Manju Agrawal ◽  
Rajesh Hishikar ◽  
Anuja Jha ◽  
Basant Maheshwari ◽  
...  

Background: Pharmacovigilance has evolved as an important tool for dealing with Adverse Drug Reactions (ADRs) both in pre-marketing and post-marketing scenario. Underreporting of ADRs at our Adverse drug reaction Monitoring Centre (AMC) led us to conduct this study to assess Knowledge, Attitude and Practice (KAP) of the practicing clinicians at our tertiary care Pt. J.N.M. Medical College associated Dr. B.R.A.M. Hospital, Raipur, Chhattisgarh, India, towards ADRs reporting.Methods: This was a cross-sectional study using pretested questionnaires consisting of 29 questions related to KAP of the practicing clinicians at Pt. J.N.M. Medical College associated Dr. B.R.A.M.  Hospital, Raipur towards ADRs reporting. The percentage of responders for each question was calculated. All statistical analysis was performed in Microsoft Office Excel 2007.Results: Out of 135 questionnaires distributed only 100 were considered for analysis, so the overall response rate was 74.07%. We calculated the result from the 100 responders. Overall 77% responders were aware of existence of ADR monitoring system in India, while only 40% were aware of its existence at their hospital. Only 8% responders had reported ADRs to the National Pharmacovigilance Centre and 10% to the Adverse drug reaction Monitoring Centre (AMC) at their hospital. Lack of knowledge about where, how and whom to report ADRs, lack of time, inability to decide what to report (known or unknown ADRs) and unavailability of ADR reporting form were the important factors discouraging them reporting ADRs.Conclusions: Creating awareness regarding ADR reporting through CMEs among practicing clinicians and early sensitization at medical undergraduate level for medical students may improve the current ADR reporting rate.  

Author(s):  
Jeet J. Patel ◽  
Megha K. Shah ◽  
Prakruti P. Patel ◽  
A. M. Gandhi ◽  
Mira K. Desai

Background: Background: Adverse Drug Reaction (ADR) reporting by consumers is quite low in India. Assessing knowledge and attitude of consumers regarding ADR reporting and observing practice of ADR reporting among them can help explore probable causes for underreporting of ADRs by consumers.Methods: This was a cross-sectional study conducted in a tertiary care teaching hospital using investigator-administered questionnaire and interviewing indoor patients of Surgery, Medicine, Obstetrics & Gynaecology and Dermatology departments. The questionnaire was prepared to assess knowledge, attitude and practice of consumers about ADR reporting. Data was analysed using mean, standard deviation and percentages.Result: A total of 820 consumers of medicines were included. It was found that 32.2% consumers were not aware that a drug can produce adverse effects. After being explained about adverse drug reactions, 94.6% consumers felt that adverse drug reactions should be reported. However, 98.8% consumers were not aware of Pharmacovigilance Programme of India. After consulting about consumer reporting programme, majority of respondents (96.1%) felt that the direct consumer reporting programme helps reporting of ADRs. Moreover, 93.7% of consumers were willing to use it to report ADRs in future. Consumers preferred the Telephonic method with a Toll free number for ADR reporting followed by informing a health care professional.Conclusion: Poor knowledge and awareness about ADR reporting is the major factor for low to nearly absent ADR reporting by consumers in India.


Author(s):  
Ajay Rajan ◽  
Ramani P. T. ◽  
Sabitha Raj

Background: Adverse drug reactions (ADR) are rated as fifth leading cause of death and accounts for approximately 5% of all hospital admissions. Under reporting of ADR from healthcare professional is considered as the contributing factor for increased morbidity and mortality. India has taken well appreciated step to launch Pharmacovigilance Programme of India (PvPI) to safeguard heath care of Indian population. This study looks into the detailed analysis of ADR reported to adverse drug reaction monitoring centre (AMC), Government Medical College, Trivandrum to assess its pattern, causality, severity and seriousness of ADR. Primary objectives of this study are the pattern of adverse drug reactions reported to ADR monitoring centre (AMC) and secondary objective is to assess causality, severity.Methods: A record based descriptive study was conducted in the ADR monitoring centre of government medical college, Trivandrum, Kerala from September 1st  2016 to February 2017(6 months). The data were collected from the all reported case records/ ADR report form of CDSCO. The details of the various adverse drug reactions were identified and analysed to find the pattern of adverse drug reactions including distribution of age, gender, causal drug group, system organ class. Also, an attempt is made to do causality assessment using WHO UMC scale and severity by using Heart wig Seigel Scale.Results: Out of 320 ADR cases, majority of reports were due to cutaneous manifestations. Most common ADRs were erythema, induration, and rash, itching. Females were 56% and males were 44%. Majority cases were of adult age group. Causality 91.88% were probably related, 75.6% were mild reaction. 25% of cases were serious. 77.5% were recovered. Antibacterial implicated 25(7.8%) followed by anti-epileptics 24 (7.5%) ADR.Conclusions: The pattern of adverse drug reactions reported to this AMC is comparable to the studies done in other parts of country. A strong need for streamlining of ADR monitoring system and reporting reemphasized by this study, which will promote the ADR reporting in healthcare professionals.


Author(s):  
Kaustav Saha ◽  
Bhabagrahi Rath ◽  
Ratna Agrawal

Background: Adverse drug reactions (ADRs) are the major cause of drug related morbidity and mortality. Pharmacovigilance is the science that plays an important role in the reduction of ADRs. Voluntary reporting of ADRs by healthcare professionals is an important tool in the success of pharmacovigilance program, but the same are scantly reported due to lack of awareness and knowledge among the physicians. So, the present study was conducted to evaluate the knowledge, attitude and practice (KAP) regarding ADR reporting among healthcare professionals at a tertiary care hospital.Methods: A questionnaire-based study containing 25 questions (knowledge- 18, attitude -2 and practice- 5) was conducted in 70 prescribers and time allotted to complete it was 1 week. Statistical analysis was done by using Graph Pad Prism version 6.01.Results: Out of 70 prescribers, only 50 (71.43%) responded. ADR reporting was considered very important by almost all of them, but actual practice was lacking as only 36% of consultants had reported any ADR. The higher grading was given to causes most important for reporting were patient safety, to identify safe drug and new ADRs. The main reasons for under-reporting were unavailability of reporting forms when needed, uncertain association and lack of knowledge about reporting procedure.Conclusions: The prescribers are aware of the importance of ADR reporting, but lack of awareness and knowledge are most common cause of under-reporting. So, there is need of pharmacovigilance awareness program to improve voluntary reporting of ADRs.


2020 ◽  
Vol 3 (2) ◽  
pp. 54-58
Author(s):  
Ajay K Gupta

ABSTRACT Introduction An adverse drug reaction (ADR) is any undesirable effect of a drug to the patient beyond its anticipated therapeutic effects while used clinically. Aims and objective To analyze the incidence of ADRs in a tertiary care hospital reported from April 2015 till December 2017. Materials and methods Two hundred ADR forms were included in the study and analyzed. These were codified into various drug classes according to anatomical therapeutic chemical (ATC) classification based on WHO–ATC Index 2019 besides categorized into preventable or not modified Schumock and Thornton scale. Severity was assessed based on a scale by Hartwig et al. Also, the ADRs were classified based on MedDRA 13.01 to system organ class (SOC) and preferred terms (PT) falling under respective SOC. Results Maximum ADRs were reported by dermatology. Most commonly, it involved gastrointestinal system (GIT) followed by skin. Antibiotics and anti-cancer drugs caused maximum ADRs. About two-thirds were classifiable as moderate to severe, whereas about one-third were preventable. About 10% of cases were such that left deep impact of sequelae or were not recovered and one case was fatal. Conclusion Extreme vigilance by clinicians is of utmost crucial virtue in detecting, diagnosing, and reporting such ADR for continued drug safety monitoring. How to cite this article Gupta AK. A Retrospective Descriptive Study of Adverse Drug Reaction Monitoring in Tertiary Care Hospital. J Med Acad 2020;3(2):54–58.


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