scholarly journals Surveillance of adverse drug reactions at an adverse drug reaction monitoring centre in Central India: a 7-year surveillance study

BMJ Open ◽  
2021 ◽  
Vol 11 (10) ◽  
pp. e052737
Author(s):  
Megha Sharma ◽  
Ruchi Baghel ◽  
Sunil Thakur ◽  
Sandeep Adwal
Keyword(s):  
Adverse Drug Reaction ◽  
Drug Reaction ◽  
Subcutaneous Tissue ◽  
Central India ◽  
Adverse Drug Reaction Monitoring ◽  
Monitoring Centre ◽  
Adr Reporting ◽  
Spontaneous Adverse Drug Reaction ◽  
Male Patients ◽  
The Relationship

ObjectivesTo analyse and present the occurrence and severity of spontaneous adverse drug reaction (ADR) reports prospectively registered at an ADR monitoring centre (AMC) in Central India.Setting and dataThe survey was conducted between 2013 and 2019 at an ADR Monitoring Centre in Central India. ADRs were recorded using the standard ‘Suspected ADR Reporting form’.Outcome measuresThe causality of the ADRs were categorised using the WHO causality assessment scale to assess the relationship between a drug and the occurrence of an ADR.ResultsTotally 1980 spontaneous ADRs were reported involving 960 patients and 1316 drugs prescriptions. The occurrence of ADRs was common among male patients (64%) and patients of age between 19 and 65 years (81%). Antimicrobials caused 29% ADRs, followed by drugs of antiretroviral therapy (19%). Zidovudine caused most ADRs (88%) followed by ethambutol and ciprofloxacin. The ADRs of skin and subcutaneous tissue disorders (28%) were most common among all system organ classes followed by gastrointestinal systems (18%). Four per cent of all reported ADRs were severe. A peak of ADR reports was attained in 2016 with 224 reports, which decreased to 127 in 2019.ConclusionA high number of ADRs caused by antimicrobials is an alarming situation, which adds up to antimicrobial resistance. Judicious use of antimicrobials is yet again proven as need of the hour. Under-reporting of ADRs is evident in our study and is a major factor for the delay in the withdrawal of drugs responsible for causing ADRs. Interventions in terms of training and feedback are suggested to encourage and improve ADR reporting.

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

2017 ◽  
Vol 6 (4) ◽  
pp. 845
Author(s):  
Toshan L. Todar ◽  
Manju Agrawal ◽  
Rajesh Hishikar ◽  
Anuja Jha ◽  
Basant Maheshwari ◽  
...  
Keyword(s):  
Adverse Drug Reaction ◽  
Drug Reaction ◽  
Tertiary Care ◽  
Reaction Monitoring ◽  
Adverse Drug Reaction Monitoring ◽  
Medical College ◽  
Monitoring Centre ◽  
Adr Reporting ◽  
Attitude And Practice ◽  
Knowledge Attitude And Practice

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.  

Spontaneous adverse drug reaction monitoring in oncology: Our experience

2015 ◽  
Vol 52 (3) ◽  
pp. 467
Author(s):  
K Kaur ◽  
M Sood ◽  
S Bhagat ◽  
T Singh ◽  
M Jain ◽  
...  
Keyword(s):  
Adverse Drug Reaction ◽  
Drug Reaction ◽  
Reaction Monitoring ◽  
Adverse Drug Reaction Monitoring ◽  
Spontaneous Adverse Drug Reaction

scholarly journals A study on pattern of adverse drug reaction in an adverse drug reaction monitoring centre of a tertiary care hospital in South Kerala, India

2019 ◽  
Vol 8 (8) ◽  
pp. 1813
Author(s):  
Ajay Rajan ◽  
Ramani P. T. ◽  
Sabitha Raj
Keyword(s):  
Adverse Drug Reaction ◽  
Drug Reaction ◽  
Adverse Drug Reactions ◽  
Care Hospital ◽  
Reaction Monitoring ◽  
Government Medical College ◽  
Drug Reactions ◽  
Adverse Drug Reaction Monitoring ◽  
Medical College ◽  
Monitoring Centre

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.

scholarly journals Adverse drug reaction reporting in a large tertiary hospital in Saudi Arabia: results of an incentive strategy

2018 ◽  
Vol 9 (10) ◽  
pp. 585-590 ◽  
Author(s):  
Sheraz Ali ◽  
Oluwaseun Egunsola ◽  
Dalal Salem Al-Dossari ◽  
Ibrahim Abdulaziz Al-Zaagi
Keyword(s):  
Adverse Drug Reaction ◽  
Drug Reaction ◽  
Health Care Providers ◽  
Healthcare Professionals ◽  
Adverse Drug Reaction Reporting ◽  
Tertiary Hospital ◽  
Care Providers ◽  
Adr Reporting ◽  
Spontaneous Adverse Drug Reaction ◽  
Incentive Strategy

Background: Underreporting is a common problem with spontaneous adverse drug reaction (ADR) reporting. In this study, we aim to describe the reporting of ADRs in a tertiary hospital and determine the effect of incentives to healthcare professionals on ADR reporting. Methods: In this interventional study, a time series analysis was used to determine the effect of incentives on ADR reporting in a tertiary hospital between 2015 and 2016. The incentive strategy included public commendation of health care providers and nomination for a monthly award. Results: A total of 967 ADRs were reported over a 2-year period. After the introduction of incentives in January 2016, the number of ADR reports per month increased by 40.6 (95% confidence interval: 26.1–55.1). The proportion of serious ADRs reported was significantly higher in 2016 (39/800) than 2015 (0/167) ( p < 0.001). In 2016, there was a significant association between profession and serious ADR reporting ( p < 0.001). A total of 14/21 ADRs (66.7%) reported by physicians in 2016 were serious compared with 20/700 (2.9%) reported by clinical pharmacists and 5/72 (6.9%) by nurses. Conclusions: ADR reporting was improved by providing incentives, including commendation and reward, to healthcare professionals.

scholarly journals Legislation and current developments in adverse drug reaction reporting in Mongolia: how far are we?

2021 ◽  
Vol 14 (1) ◽  
Author(s):  
Zuzaan Zulzaga ◽  
Erdenetuya Myagmarsuren ◽  
Herman J. Woerdenbag ◽  
Eugene P. van Puijenbroek
Keyword(s):  
Adverse Drug Reaction ◽  
Drug Reaction ◽  
Drug Safety ◽  
Reporting System ◽  
Adverse Drug Reaction Reporting ◽  
Safety Data ◽  
Regulatory System ◽  
Basic Structure ◽  
Reaction Reporting ◽  
Adr Reporting

AbstractMonitoring adverse drug reactions is a vital issue to ensure drug safety and to protect the general public from medication-related harmful effects. In order to properly monitor drug safety, a regulatory system needs to be in place as well as an infrastructure that allows for analyzing national and international safety data. In Mongolia, adverse drug reaction (ADR) reporting activities have been implemented in the past decade. During this period, the basic structure and legal basis of an adverse drug reaction monitoring system was established. Because of the fragmented but growing healthcare system and the complexity of pharmaceutical issues in Mongolia, a sustainable process for the development of the adverse drug reaction reporting system is a key issue. The aim of this article is to disclose the Mongolian situation for the rest of the world and to share experiences on how an ADR reporting system can be developed towards a higher and more advanced level to contribute to both national and international drug safety issues. In this article, we review the features of the Mongolian health care and pharmaceutical systems, as well as the current development of the adverse drug reaction reporting system.

scholarly journals A Qualitative Evaluation of Adverse Drug Reaction Reporting System in Pakistan: Findings from the Nurses’ Perspective

2020 ◽  
Vol 17 (9) ◽  
pp. 3039
Author(s):  
Rabia Hussain ◽  
Mohamed Azmi Hassali ◽  
Anees ur Rehman ◽  
Jaya Muneswarao ◽  
Muhammad Atif ◽  
...  
Keyword(s):  
Adverse Drug Reaction ◽  
Drug Reaction ◽  
Healthcare Professionals ◽  
Reporting System ◽  
Adverse Drug Reaction Reporting ◽  
Qualitative Interviews ◽  
Qualitative Evaluation ◽  
Adr Reporting ◽  
Willingness To Report ◽  
And Training

The contribution of all key healthcare professionals is vital to promote an efficient adverse drug reaction (ADR) reporting system. In this context, nurses are important as they are in a better position to observe a patient’s response regarding the drug therapy and to report an ADR. The aim of the study was to explore the perspectives of nurses about ADR reporting system in Lahore, Pakistan. A total of 21 nurses were interviewed. The thematic content analysis of the qualitative interviews yielded six major themes and eight subthemes. Major themes included: (1) Knowledge about the concept of the medication safety & the ADR; (2) Knowledge regarding pharmacovigilance activities; (3) Willingness to report; (4) Practices related to the ADR reporting; (5) Barriers to the ADR reporting; (6) Facilitators to the ADR reporting. The majority of the nurses were aware of medicine safety and ADRs, but in many cases, they were unable to report these ADRs. The study pointed out considerable concerns regarding the knowledge and practices of nurses about pharmacovigilance activities in their workplace, mainly due to increased workload, due to the absence of a reporting system and legal liability. The main challenges turned out to be the lack of knowledge and training, as well as the implementation of guidelines. Based on the findings, it is suggested that outcome of this study can serve as a guide to design policies that support ADR reporting by nurses in Pakistan.

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