scholarly journals Adverse drug reactions in hospitalized patients in a tertiary care teaching hospital: analysis of the reported cases

Author(s):  
Althab Begum M. ◽  
Satyajit Mohapatra ◽  
R. Jamuna Rani

Background: Adverse Drug Reactions (ADR’s) contributes to the burden of drug-related morbidity and mortality. ADRs are seen frequently in hospitals due to a variety of factors like complexity of diseases, drug interactions, polypharmacy, and possible negligence. The purpose of the study was to identify and assess ADR in various departments of a tertiary care teaching hospital.Methods: A prospective spontaneous reporting was carried out in a tertiary care teaching hospital during a period of four months from November 2016 to February 2017. All suspected spontaneous ADRs were assessed and the information was collected and analyzed by the pharmacologists for causality assessment using the Naranjo’s causality assessment scale.Results: A total of 30 ADRs were reported with female preponderance (70%). Majority of ADRs were from General Medicine and Oncology departments. The most affected organ systems were skin (80%) followed by the gastrointestinal system (13.3%). The most frequent drugs causing ADRs were antibiotics (56.3%) in which type B reactions were more compared to type A and followed by anticancer drugs (10%). The severity assessment showed that most of them were mild reactions (76.6%). Causality assessment revealed that 90% of the reactions were probable, 10% were possible and no reactions were unlikely.Conclusions: The study accomplished that ADRs are widespread and a few of them raised the healthcare expenditure due to increased hospital stay. The reporting of the ADRs to regional Pharmacovigilance centers should be encouraged to ensure drug safety.

Author(s):  
Raja Vikram Prasad ◽  
M. A. Mushtaq Pasha ◽  
Afsar Fatima ◽  
C. Deepalatha

Background: As a part of pharmacovigilance program of India (PvPI) adverse drug reactions (ADRs) are cause of mortality and morbidity in patients unnoticed, which is a part of WHO program for International Drug Safety Monitoring across world. ADRs are considered to be among top 10 causes for mortality. The reason for sex difference in medication response is multi factorial with wide range of aspects like steroid hormones, organ physiology to psychology and socio-cultural factors. The aim was to study on gender related differences in adverse drug reactions in patients attending tertiary care teaching hospital at Nandyal.Methods: ADR cases were collected from multicenter health care units from tertiary care teaching hospital. ADRs were reported in ADR notification forms or yellow form, CDSCO forms are used to report ADR to Regional pharmacovigilance center. Causality assessment of the ADRs was done based on WHO-UMC causality assessment scale using modified Hartwig and Seigel scale.Results: In the 30 ADR reports collected 21 reports (70%) are of female patients and 9 reports (30%) are of male patients. According to WHO-UMC scale 20 (70%) of Adverse drug reactions were falling into PROBABLE, while 10 (30%) ADR’s are CERTAIN. In 21 females, ADR reports were due to 15(76.43%) Antibiotics, 2 (9.52%) NSAID’s, 2 (9.52%) proton pump inhibitors, 2 (9.52%) anti-convulsants. In 9 males, ADR reports were due to 5 (55.5%) Antibiotics, 2 (22.22%) NSAID’s, 2 (22.22%) anti-convulsants.Conclusions: ADRs are the common occurrences but ADR monitoring helps in prevention of morbidity and mortality in patients. The most commonly affected gender is among female patients, as they are more exposed to drugs starting their journey right from the childhood, pregnancy till their adult menopausal stage. 


Author(s):  
Sangeetha Raja ◽  
Jamuna Rani R ◽  
Kala P

ABSTRACTObjective: The aim of this study was to carry out adverse drug reactions (ADRs) monitoring in various departments of a tertiary care teaching hospital.Methods: A cross-sectional study was conducted on ADRs reported in the hospital from December 2012 to May 2013 after obtaining InstitutionalEthics Committee approval.Results: A total of 40 ADRs were reported, 47.50% were males and 52.50% were females. The female adult population was 45%. The majority of ADRswere due to antimicrobial agents especially beta-lactam antibiotics (42.5%) followed by NSAIDs (7.50%). A maximum number of patients (75%)were reported with dermatological manifestations. The department of medicine reported the highest number of ADRs (37.5%). As per Naranjo’sprobability scale, 62.5% reports were assessed as probable. 62.5% reports were documented as mild according to Modified Hartwig’s criteria forseverity assessment.Conclusion: This study was done to sensitize the practicing physicians on the importance of adverse drug monitoring and reporting.Keywords: Pharmacovigilance, Adverse drug reactions, Tertiary care teaching hospital, Antimicrobial agents.


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):  
A. R. Malahat ◽  
C. Deepa Latha ◽  
Sudhakar K. ◽  
Deepika Baloju ◽  
G. Vijayalakshmi

Objective: This study attempts to analyze the severe ADRs in a tertiary care centre and assess their seriousness, outcome, causality and severity. We emphasize on the need for reporting of ADRs by all healthcare professionals as it will reduce the burden of morbidity due to drugs and ensure better and more efficient healthcare. To analyse and evaluate the severe ADVERSE DRUG REACTIONs reported from various departments in a Tertiary care Teaching hospital.Methods: It is a prospective observational study that was carried out over a period of 6 mo (from July 2016 to December 2016) to assess the percentage of severe adverse drug reactions reported to the Pharmacovigilance cell of a tertiary care teaching hospital. The data collected included patient’s demographic details, presenting complaints, clinical diagnosis and details of the drug(s) prescribed. The data was analysed for causality (as per the WHO-UMC scale) and severity (as per Hartwig and Siegel scale).Results: Out of 64 ADRs reported, 17 were serious. The majority of serious ADRs were categorized as probable (82.35%), whilst 1(5.8%) was categorized as possible and 2(11.76%) as certain in nature. The criteria for the majority of serious ADRs were hospitalization (%) followed by intervention to prevent permanent impairment or damage (%).Conclusion: The highest percentage of severe cases was reported with Antitubercular therapy (23.5%) followed by analgesics (23%) and anti epileptic agents (17.6%).


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