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Adverse drug reactions reporting by undergraduate medical students in a tertiary care teaching hospital of India: Content and quality analysis in comparison to physician reporting.

ABSTRACT: An important challenge to spontaneous reporting system is underreporting. The sensitization and involvement of undergraduate medical students can reduce underreporting in pharmacovigilance program.To analyze the clinical characteristics and reporting quality of adverse drug reactions (ADRs) by undergraduate medical students in comparison with physicians' reporting.We sensitized the second professional year undergraduate medical students about pharmacovigilance and asked them to submit reports of ADR observed during their clinical posting from January to December 2015. We compared students' reports with those sent by physicians (Department of Medicine and Allied Branches, Paediatric, Obstetrics and Gynaecology) of our institute during the same time period. We included ADRs of "certain," "probable," or "possible" categories as per the World Health Organization causality definitions in analysis of both groups. We excluded "unlikely," "unclassified," and "unclassifiable" causality ADRs from the analysis due to questionable association of reactions with suspected drugs. We collected data of demographics, pattern of ADRs, causative drugs, seriousness, other clinical characteristics, and quality of reporting.We analyzed a total number of 176 students' reports having 269 ADRs and 143 physicians' reports covering 180 ADRs. The students predominantly reported ADRs of single drug suspect (84.09% vs. 43.35%), "probable" causality (63.94% vs. 21.11), and augmented type reactions (67.29% vs. 55%) than physicians. Both groups did not differ in reporting of serious reactions (6.25% vs. 9.09%). Students most frequently suspected gastrointestinal disorders (35.68%), whereas physicians most frequently reported skin and appendages disorders (41.11%). Students and physicians more commonly suspected ADRs due to systemic anti-infective (33.64%) and nervous system (42.07%) class of drugs, respectively. The quality analysis suggested no substantial difference in most domains of ADR reporting among both groups.Students' reported valuable and clinically relevant ADRs. Medical students should be exposed to ADR reporting during their clinical teaching posting and should be actively involved in pharmacovigilance program to improve detection rate.

SUBMITTER: Patel PB

PROVIDER: S-EPMC5543765 | biostudies-other | 2017 Jul-Sep

REPOSITORIES: biostudies-other

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Project description:AIMS:To develop a systematic generic method of enabling patients to report symptoms which they believe to be due to a particular prescribed drug. METHODS:A piloted body system-based questionnaire was distributed to patients registered with 79 medical practices in Grampian prescribed one of nine recently marketed 'black triangle' drugs. These comprised four antidepressants, three antiepileptics and two analgesics. This requested respondents to identify any symptoms experienced over the previous year which they thought could be due to the 'black triangle' drug they had used. A sample of medical records was examined to compare symptoms recorded with those reported by patients. A classification system was developed for the study to enable the assessment of symptoms reported for their potential relationship to patients' drug therapy. All symptoms reported were classified, taking into account information provided by patients on their concomitant drugs and diseases. A specialist pharmacist independently re-classified a sample of the symptoms to validate the process. RESULTS:A 36.3% response rate was obtained (837/2307) with 742 respondents (88.6%) reporting at least one symptom. The median per patient was 6.0 (range 0--71), with almost half (406, 48.5%) reporting fewer than five symptoms. Most symptoms (71.0%) were classified as being probably or possibly related to the drugs studied. Agreement between researcher and specialist on the classification of 75.3% of 716 symptoms was obtained (Kappa=0.563). Responses from patients prescribed antidepressant drugs were more likely to include symptoms potentially caused by these drugs (74.5% of all symptoms reported) than those from patients prescribed analgesics (67.4%) or antiepileptics (65.1%, chi2 = 23.858, d.f. = 2, P < 0.001). Patients reporting large numbers of symptoms were more likely to report some which were classed as unlikely to be an ADR or unattributable (chi2 = 80.587, d.f. = 3, P < 0.001). Of the 742 reporting symptoms in questionnaires, 402 (54.2%) claimed to have reported some or all of these to their doctor. Only 162 (22.6%) of 716 patient-reported symptoms were documented in the primary care medical records of 103 patients prescribed tramadol or venlafaxine. CONCLUSIONS:Respondents were clearly willing to report symptoms, the majority of which were classed as possibly/probably related to the drugs studied. The results suggest that patients do not report all symptoms they suspect to be ADRs to their GP and that GPs do not record all symptoms which may be reported to them. The method could help to identify problems which patients perceive as being related to their drug therapy and contribute to increased ADR reporting.

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Adverse drug reactions reporting by undergraduate medical students in a tertiary care teaching hospital of India: Content and quality analysis in comparison to physician reporting.

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