scholarly journals A prospective study of adverse drug reactions in a tertiary care teaching hospital

Author(s):  
More Pankaj Daulat ◽  
Ambika Abhishake V. J. ◽  
Prabhakar Singh ◽  
Bhupendra Raj

Background: Adverse drug reactions (ADRs) have become frequent cause for hospitalization and are coming up as an economic burden on health systems. Identification of ADRs and their reporting pattern can provide useful information for their management.Methods: This was an observational and prospective study. ADR reports of 130 patients were collected of the inpatient department of various clinical departments of Sanjay Gandhi Memorial Hospital, Rewa, Madhya Pradesh (M.P.) The ADRs were collected during October 2014-September 2015, with ADR reporting form of Central Drugs Standard Control Organization (CDSCO), New Delhi. ADRs were assessed for their causality, severity, and preventability as per the standard scales. Data was analysed using descriptive statistics and expresses in percentages.Results: Overall occurrence of ADRs was slightly more in males (55%). Maximum (26%) suspected ADR reported during study period was skin rash. Skin (44%) was the most commonly affected organ system. Antimicrobials (68%) were the drug group most commonly involved in ADRs. Most of the suspected ADRs were probable in causality assessment, moderate in severity and probably preventable.Conclusions: The study results revealed opportunities for interventions in ADR management to ensure safer drug use.

Author(s):  
Gajanan P. Kulkarni ◽  
Lokesh V. Patil

Objective: To assess ADRs with reference to causative drugs, organ systems involved and seriousness of reactions.Methods: A prospective study conducted over a period of 1 y. The spontaneous adverse drug reactions reported between July 2016 and July 2017 at AMC centre BRIMS, Bidar were analyzed using Naranjo’s scale. Causality assessment of suspected drugs involved, system affected, and seriousness of reactions was assessed.Results: GIT system was most commonly involved, followed by generalized features, skin and appendages, CNS i. e, extrapyramidal system and dizziness, hearing and vestibular systems.Conclusion: Majority of the ADRs reported were mild to moderate severity and 20% can be categorized as severe reactions, which needed to treat under hospitalization


Author(s):  
Kabilan K. ◽  
Sathyanarayanan V. ◽  
R. Jammuna Rani

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.


Author(s):  
Sujatha Sowmyanarayan ◽  
Rajeshwari K. A. ◽  
Swati Banerjee

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.


2014 ◽  
Vol 22 (4) ◽  
pp. 303-308 ◽  
Author(s):  
M. Shamna ◽  
C. Dilip ◽  
M. Ajmal ◽  
P. Linu Mohan ◽  
C. Shinu ◽  
...  

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