A pharmacovigilance study in the department of medicine of a university teaching hospital

Sharma, Himanshu; Aqil, Mohammad; Imam, Faisal; Alam, Mohammad Mahboob; Kapur, Prem; Pillai, K. K.

doi:10.4321/s1886-36552007000100008

Cited by 25 publications

(23 citation statements)

References 14 publications

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“…The demographic details of our study showed a female gender predominance over males for ADRs, (F-54%, M-46%) which was similar to that which was found in other studies which have been reported in the literature [17,18], though on the other hand, some studies have been published, where males were implicated more as compared to females [19,20].…”

Section: Discussionsupporting

confidence: 89%

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The Profile of Voluntary Reported Adverse Drug Reactions at a Tertiary Care Hospital: A Fifteen Month Prospective Study

Dang

Bhandare²

2012

JCDR

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Objectives: The present study was undertaken to provide the health professionals who were working at a tertiary care hospital, with a simple method to report Adverse Drug Reactions (ADRs) and to monitor, document and to evaluate them according to the set criteria.Method and Materials: This study was conducted over a period of 15 months from 1st Jan' 2008 to 31st March 2009 at Goa Medical College and Hospital (Goa, India). The evaluation of the data was done for various parameters, which included patient demographics and drug and reaction characteristics. An assessment was also done for the outcome, causality and the severity of the drug reactions.Results: A total of 265 ADRs were reported. Among the drugs, the ß-lactam antibiotics were implicated the maximum number of times (54, 20.37%), followed by fluoroquinolones (35, 13.20%), antiretrovirals (33, 12.45%) and antiepileptics (31, 11.69%). Females showed more ADRs (142, 54%) than males (123, 46%). The skin was involved in about 57.73% (153) of the ADRs, while the CNS and the vascular system were involved in 8.67% (23) and 8.30% (22) of the ADRs. Most of the ADRs were categorized as "Type II" (203, 77%) against "Type I" (62, 23%) by Rawlins and Thompson's classification. The causality assessment was done by the Naranjo Algorithm and 62.26% (165) were seen to fall in the "probable category" as compared to 29.05% (77) in the "highly probable" one. Out of all the ADRs which were reported, 34.71% (148) were "severe", in accordance with the Modified Hartwig and Siegel's scale. Conclusion:The present work was a humble attempt to set up a well organized ADR reporting system at our government hospital. The systematic tracking and monitoring of ADRs can shed light on their extensiveness and their patterns of occurrence.

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Section: Discussionsupporting

confidence: 89%

“…This was at par with the findings of a study which was done by Sharma et al, [20] Not many studies took this point into consideration as one of the drug characteristics in ADR monitoring. The more common intake of oral drugs as compared to parenteral ones could be one of the reasons for this particular finding.…”

Section: Discussionsupporting

confidence: 69%

The Profile of Voluntary Reported Adverse Drug Reactions at a Tertiary Care Hospital: A Fifteen Month Prospective Study

Dang

Bhandare²

2012

JCDR

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“…The demographic details of our study population showed female gender predominance over males, which was similar to that reported in other studies found in the literature [10,11,14-18]. This might be due to higher emotion quotient in females, which makes them more sensitive to the pharmacological actions of medicines, thus enhancing the probability of ADRs.…”

Section: Discussionsupporting

confidence: 88%

Monitoring of adverse drug reactions associated with antihypertensive medicines at a university teaching hospital in New Delhi

et al. 2012

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AimTo monitor the adverse drug reactions (ADRs) caused by antihypertensive medicines prescribed in a university teaching hospital.MethodsThe present work was an open, non-comparative, observational study conducted on hypertensive patients attending the Medicine OPD of Majeedia Hospital, Jamia Hamdard, New Delhi, India by conducting patient interviews and recording the data on ADR monitoring form as recommended by Central Drugs Standard Control Organization (CDSCO), Government of India.ResultsA total of 21 adverse drug reactions were observed in 192 hypertensive patients. Incidence of adverse drug reactions was found to be higher in patients more than 40 years in age, and females experienced more ADRs (n = 14, 7.29%) than males, 7 (3.64%). Combination therapy was associated with more number of adverse drug reactions (66.7%) as against monotherapy (33.3%). Calcium channel blockers were found to be the most frequently associated drugs with adverse drug reactions (n = 7), followed by diuretics (n = 5), and β-blockers (n = 4). Among individual drugs, amlodipine was found to be the commonest drug associated with adverse drug reactions (n = 7), followed by torasemide (n = 3). Adverse drug reactions associated with central nervous system were found to be the most frequent (42.8%) followed by musculo-skeletal complaints (23.8%) and gastro-intestinal disorders (14.3%).ConclusionsThe present pharmacovigilance study represents the adverse drug reaction profile of the antihypertensive medicines prescribed in our university teaching hospital. The above findings would be useful for physicians in rational prescribing. Calcium channel blockers were found to be the most frequently associated drugs with adverse drug reactions.

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“…As expected, combination therapy was associated with higher number of ADRs as compared to monotherapy. Amlodipine and atenolol combination therapy leads to greater risk of ADRs than the monotherapy as reported earlier[61819]. In this study we found that CCBs were the commonest group of drugs prescribed, though beta-blockers and ACE inhibitors were associated with higher incidences of ADRs.…”

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confidence: 77%

A pharmacovigilance study of antihypertensive medicines at a South Delhi hospital

et al. 2009

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The aim of the present study was to monitor adverse drug reactions associated with antihypertensive drugs. The study was conducted in medicine out patient department of 150-bed Majeedia Hospital at Hamdard University Campus in New Delhi. The study was conducted by way of one to one patient interview by a registered pharmacist using a questionnaire-based Adverse Drug Reaction Monitoring Form drafted according to the World Health Organisation Monitoring Guidelines. A total of 34 adverse drug reactions were observed in 250 hypertensive patients during the four month study. A high percentage of adverse drug reactions occurred in middle aged and female patients. Of the 34 adverse drug reactions, 18 (52.9%) were mild, 14 (41.2%) moderate and only 2 (5.8%) were classified as severe. Combination therapy was associated with significantly high occurrence (P < 0.05) of adverse drug reactions, with a total of 21 (61.8%) as compared to monotherapy (n=13, 38.2%). Cardiovascular adverse drug reactions constituted a major component, followed by gastrointestinal and respiratory complaints. Beta-blockers were the drug category associated with majority of adverse drug reactions, followed by angiotensin-converting enzyme inhibitors and calcium channel blockers. The above pharmacovigilance study presents the adverse drug reaction profile of antihypertensive medicines prescribed in our University Teaching Hospital. It was concluded that calcium channel blockers were the most frequently prescribed drug category but beta blockers were associated with higher frequency of adverse drug reactions.

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A pharmacovigilance study in the department of medicine of a university teaching hospital

Abstract: promotion of rational prescribing and drug use in the hospital.

Cited by 25 publications

References 14 publications

The Profile of Voluntary Reported Adverse Drug Reactions at a Tertiary Care Hospital: A Fifteen Month Prospective Study

The Profile of Voluntary Reported Adverse Drug Reactions at a Tertiary Care Hospital: A Fifteen Month Prospective Study

Monitoring of adverse drug reactions associated with antihypertensive medicines at a university teaching hospital in New Delhi

A pharmacovigilance study of antihypertensive medicines at a South Delhi hospital

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