A prospective study on adverse drug reactions in outpatients and inpatients of medicine department in a tertiary care hospital

Background: To study cutaneous adverse drug reactions with regard to their clinical pattern. etiology, causality and severity.Methods: It was a prospective study undertaken in a 300 bedded tertiary care hospital. Patients with cutaneous ADRs presenting in Dermatology OPD were studied. Causality and severity of the adverse drug reactions were analysed and other parameters such as gender wise distribution of the ADRs and types of ADR were studied.Results: 35 cases of ADRs were enrolled for the study in the duration of Sept.2016 to May 2017. The majority of the patients were in the age group of 21-30 years (37.14%). The most common CADRs were Acne vulgaris (22.86%), followed by Fixed Drug eruption (11.43%) and Tinea cruris (8.57%). The most common class of drugs causing ADRs were topical steroids (64%), followed by non-steroidal anti-inflammatory drugs (14.29%).Conclusions: Female preponderance was seen. Topical steroids were the most offending drug followed by Diclofenac Sodium, the analgesic. Causality assessment showed a high score of Certain category. These variations may be explained by variations in drug usage patterns. The knowledge of the adverse drug reactions and the drugs causing them is essential for the clinician so that the choice of drug therapy can be made keeping these adverse drug reactions in mind.

supporting

confidence: 89%

Adverse drug reactions in the department of dermatology at a tertiary care hospital: a prospective study

Sowmyanarayan¹,

Rajeshwari²,

Banerjee³

2017

“…This result was in contradiction to various studies which showed increased incidence of ADR among 40-60 yrs. 4,7 This may be due to the fact this population is attending hospital more frequently and is a major population to receive drug therapy. Male patients were more predisposed to ADRs and a similar pattern of gender distribution was evident in the present study.…”

Section: Resultsmentioning

confidence: 99%

“…It affects patient's recovery and is an important cause of mortality and morbidity in both hospitalized and ambulatory patients. 4 Therefore, early detection and evaluation of ADR is essential to reduce harm to the patients. Also introduction of newer drugs in the market has been increased in the last two to three decades.…”

mentioning

confidence: 99%

“…6 The main drawback of this system by health care professionals (HCP) is under-reporting and selective reporting, which leads to a false conclusion about drug risk. 4 ADR reporting and monitoring activities are of vital importance for patient safety, which can generate valid data regarding causality association, preventability and severity of ADRs in the human population. This study was therefore designed to evaluate incidence and the patterns of ADRs from the reports collected from various clinical departments of this hospital and to establish the causal link between the suspected drug and the reaction by using the causality definitions.…”

mentioning

confidence: 99%

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Spectrum of adverse drug reactions and implicated drugs in a tertiary care centre: a prospective study

Kabilan¹,

Sathyanarayanan²,

Rani³

2018

Background: Adverse Drug Reaction(ADR) is the major limitation in providing health care to patients at a global level. It affects patient’s recovery and is an important cause of mortality and morbidity in both hospitalized and ambulatory patients. ADR can occur with any class of drugs. Early detection and evaluation of ADR is essential to reduce harm to the patients. Thus, the present study was aimed to estimate the number of ADR’s reported, analyze its spectrum and the drugs attributed to it.Methods: This was a prospective study conducted in a tertiary care teaching hospital for a period of 3 months from March 2016 to May 2016 in SRM Medical College and Hospital, Potheri. Adverse drug reactions were collected by spontaneous reporting by active and passive methods. The causality assessment of the reported ADR’s was done using Naranjo causality assessment scale.Results: A total of 38 ADR’s were reported during the study period with male predominance (58%). Most of the ADR’s (42%) were common in patients in the age group 19-39 years. More number of ADR’s were from Medicine (29%) followed by Surgery (16%) and OG (16%) departments. Most commonly affected organ systems were skin (45%) followed by GIT (24%). The drugs mostly accounted were antibiotics (55%) especially Cephalosporins (33%). Most of the reactions were type A (68%) rather than type B (32%) and thus predictable. According to Naranjo’s causality assessment, 63% of reactions were probable, 26% were possible and 11% were definite. No reactions were unlikely. Severity assessment by Modified Hartwig and Seigel scale revealed 45% ADRs to be moderate, 42% were mild and 13% were severe and life threatening.Conclusions: The study concluded that Adverse Drug Reactions are common and some of them resulted in increased healthcare cost due to need of some interventions and increased length of hospital stay. As majority of ADR is predictable (Type A), so preventable. The health system should promote the spontaneous reporting of Adverse Drug Reactions (May be done mandatory). The proper documentation and periodic reporting to regional pharmacovigilance centres to ensure drug safety.

“…This finding is similar to other studies conducted. 17,18 Among the antibiotics Intravenous Ceftriaxone was the most common offending agent. There were reactions caused by intravenous fluids such as Normal saline.…”

Section: Discussionmentioning

confidence: 99%

Monitoring of adverse drug reactions in medicine, paediatric and surgical departments of a tertiary care hospital: a prospective observational study

Sowmyanarayan¹,

Banerjee²

2018

Background: the aim of the study was to monitor all adverse drug reactions in the departments of Medicine, Paediatrics and Surgery in a Tertiary Care Hospital.Methods: It was a prospective study undertaken in a 300 bedded tertiary care hospital. Patients presenting with adverse drug reactions in Medicine, Paediatrics and Surgery Departments were studied. Causality and severity of the adverse drug reactions were analysed Other parameters such as age wise and gender wise distribution of the ADRs, types of ADRs and drugs causing ADRs were studied.Results: There were 33 cases of ADRs were enrolled for the study in the duration of Sept. 2016 to Aug. 2017. Female preponderance was seen. The largest number of ADRs were seen in the age group of 21-30 years (30.3%). The most common ADR was skin rash (30.3%) followed by periorbital edema (12%). There were two SAEs namely Anaphylaxis and Steven Johnson syndrome. The most offending class of drug was antibiotics (30.3%) followed by intravenous fluids (12.1%).Conclusions: The maximum number of cases were reported from the Medicine Department which was 11 (33.33%). The highest number of ADRs fell in the probable category (63.6%). The number of cases of mild and moderate severity were equal (42.4%). The knowledge of these adverse drug reactions is necessary while prescribing drugs to patients as patient safety is absolutely essential. Also the healthcare provided by the institution will improve. This data has been collected with a view to establish an ADR monitoring centre at our hospital.