scholarly journals ANTIMICROBIAL-RELATED ADVERSE DRUG REACTION IN A TERTIARY CARE HOSPITAL

Author(s):  
Jindal M ◽  
Sharma Rk

  Objective: The objective of the study was to evaluate the adverse drug reaction (ADR) related to commonly used antimicrobials in a tertiary care hospital.Methods: A prospective spontaneous reporting study involving, active methods (pharmacist actively looking for suspected ADRs) and passive methods (stimulating prescribers to report suspected ADRs) was carried out in all departments of a tertiary care hospital, for 1 year. Patients of all age groups were included in the study. The data for the study were taken from case sheets, investigation reports of patients who had experienced an ADR, personal interviews with reporting persons or clinicians, personal interviews with patient or patient’s attendant, past history of medication use, which were generally obtained from, prescriptions from the past, reports of medical and surgical interventions, referral letters, ADR reporting forms. Collected data were then analyze for causality assessment by Naranjo’s scale and severity assessment by Hartwig and Siegel’s scale.Result: During 1 year of study period, 75 ADRs related to antimicrobial were reported among 1354 patients who were given antibiotic for the treatment. The incidence rate of antibiotic was found to be 5.53%. The department that reported ADR was medicine (10.16%), ENT (4.6%), pediatric (8.12%), orthopedics (06.9%), surgery (06.9%), chest and tuberculosis (04.6%), obstetrics and gynecology (06.9%), dentistry (02.3%), and skin (10.16%). The most common ADRs were related to gastrointestinal tract; dermatological reactions were second in the list of antimicrobial drugs causing ADR. In this study, among antimicrobials, fluoroquinolones, and beta-lactam antibiotics were the most common drugs causing gastrointestinal and dermatological ADRs. There was no unknown ADR reported that may need to be further investigated through active monitoring. All patients recovered from ADRs without any complications. The causality was assessed by Naranjo’s scale and it revealed that out of 75 antibiotics related ADR 48 (64%) were possible, 27 (36%) were probable, 3 (4.00%) were definate, and 0% were unlikely. According to the Hartwig and Siegel’s scale, most of ADR were mild 45 (60%) and moderate 30 (40%) in nature.Conclusion: ADRs related to antimicrobials occurs frequently. Among antimicrobials, fluoroquinolones, and beta-lactam antibiotics were the most common drugs causing gastrointestinal and dermatological ADRs. The health-care system can promote the spontaneous reporting of antimicrobial ADR to pharmacovigilance center for ensuring safe drug use and patient care.

Author(s):  
SUPRIYA SONOWAL ◽  
CHETNA K DESAI ◽  
JIGAR R PANCHAL

Objectives: The objectives of the study were to evaluate the impact of certain educational interventions on adverse drug reaction (ADR) reporting by nursing health professionals at a tertiary care hospital. Methods: Knowledge, attitude, and practice (KAP) of the nurses regarding ADR reporting were evaluated before and after interventions using a KAP questionnaire. Educational interventions carried out among the nurses were workshops, booklets, SMSes, personal briefings, and posters. Number and quality of ADR reported by nurses in pre-intervention (3 months), intervention (10 months), and post-intervention (3 months) phase were compared. Results: There was a significant increase in response rate to questionnaires in the post-intervention phase (post-IP) (97.74%) as compared to pre-intervention (91.28%) phase (pre-IP). The knowledge score of the nurses increased significantly in post-IP (11.65 ± 2.14) as compared to the pre-intervention (6.98 ± 2.46) phase. No ADR was reported by nurses in pre-IP. Thirty nurses reported 30 ADRs in the intervention phase and six nurses reported six ADRs in the post-IP. The mean score of completeness of ADR notification forms decreased significantly in post-IP. Maximum ADRs (10) were reported after the workshops. Conclusion: Educational interventions improved the KAP of ADR reporting by nurses, albeit temporary. This suggests the need of continuous educational interventions.


Author(s):  
V Aggarwal ◽  
Shakti Kumar Gupta ◽  
DK Sharma ◽  
S Arya ◽  
S Singh

ABSTRACT Adverse drug reactions (ADRs) are a significant cause of morbidity and mortality and contribute to the incidence of adverse events, resulting in increased healthcare costs. Healthcare providers need to understand their role and responsibility in the detection, management, documentation, and reporting of ADRs. The purpose of this study is to provide guidelines regarding the procedure of reporting ADRs to hospital authority. It was a descriptive cross-sectional study carried out between April and August 2013. The study population included doctors, nursing personnel, paramedical staff and quality managers of tertiary care hospital from one public and two private hospitals. Interaction was done with study population against the back drop of the checklist and ADR policy was formulated. How to cite this article Singh S, Gupta SK, Arya S, Sharma DK, Aggarwal V. Adverse Drug Reaction Policy in a Tertiary Care Hospital. Int J Res Foundation Hosp Healthc Adm 2015; 3(1):41-47.


2020 ◽  
Vol 3 (2) ◽  
pp. 54-58
Author(s):  
Ajay K Gupta

ABSTRACT Introduction An adverse drug reaction (ADR) is any undesirable effect of a drug to the patient beyond its anticipated therapeutic effects while used clinically. Aims and objective To analyze the incidence of ADRs in a tertiary care hospital reported from April 2015 till December 2017. Materials and methods Two hundred ADR forms were included in the study and analyzed. These were codified into various drug classes according to anatomical therapeutic chemical (ATC) classification based on WHO–ATC Index 2019 besides categorized into preventable or not modified Schumock and Thornton scale. Severity was assessed based on a scale by Hartwig et al. Also, the ADRs were classified based on MedDRA 13.01 to system organ class (SOC) and preferred terms (PT) falling under respective SOC. Results Maximum ADRs were reported by dermatology. Most commonly, it involved gastrointestinal system (GIT) followed by skin. Antibiotics and anti-cancer drugs caused maximum ADRs. About two-thirds were classifiable as moderate to severe, whereas about one-third were preventable. About 10% of cases were such that left deep impact of sequelae or were not recovered and one case was fatal. Conclusion Extreme vigilance by clinicians is of utmost crucial virtue in detecting, diagnosing, and reporting such ADR for continued drug safety monitoring. How to cite this article Gupta AK. A Retrospective Descriptive Study of Adverse Drug Reaction Monitoring in Tertiary Care Hospital. J Med Acad 2020;3(2):54–58.


Author(s):  
Madhuri Kulkarni ◽  
Anant Patil

Objective: The objective of this study was to analyze the pattern of drug utilization in outpatients of orthopedics department from a tertiary care hospital.Material and Methods: In this retrospective study, prescriptions of randomly selected patients attending orthopedics clinic were screened to analyze a number of medicines per prescription. Number and percentages of prescribed medicines were calculated.Results: In this study, 512 patients (male 260 [50.8%] and females 252 [49.2%]) were included in the study. The total number of prescribed medicines was 1562, accounting for 3.1 medicines per patient. A total number of oral, parenteral, and topical medicines were 1375 (88%), 176 (11.3%), and 11 (0.7%), respectively. Nonsteroidal anti-inflammatory agents (NSAIDs), antacid/anti-ulcerants, and antimicrobial agents were 641 (41%), 371 (23.8%), and 102 (6.5%), respectively. A total of 54 (52.9%), 29 (28.4%), 9 (8.8%), 6 (5.9%), 3 (2.9%), and 1 (1%) patients were prescribed fluoroquinolones, beta-lactam antibiotics, metronidazole, trimethoprim plus sulfamethoxazole, macrolides, and doxycycline, respectively. For 371 (23.8%) patients, anti-ulcerant and antiulcer were prescribed, among which ranitidine was the most common prescription [353 (95.1%)]Conclusion: Number of medicines prescribed per patient in orthopedic clinic was 3.1. NSAIDs and antacid/anti-ulcerants were the most commonly prescribed medicines.


Author(s):  
Amruta Pasgonda Patil ◽  
Prashant A. Shirure ◽  
Rasika S. Khobragade

Background: Early detection of adverse drug reaction is one step towards the prevention of ADRs. Foundation of Pharmacovigilance is spontaneous reporting which is minimal in India. Among the all health care professionals, nurses are caregivers at bedside. Improvement in knowledge and practice of adverse drug reaction reporting among nurses will definitely increases spontaneous reporting. In this study, knowledge, attitude and practice of nursing staff about pharmacovigilance was evaluated.Methods: It was prospective, cross-sectional, observational, questionnaire-based study among the nurses of the tertiary care hospital Solapur. A questionnaire evaluating knowledge, attitude and practice was distributed among nursing staff and filled questionnaire were collected back and analyzed by microsoft excel 2013.Results: Response rate of our study was 44.88%.  38.61% doctors were knowing meaning of pharmacovigilance while 61.38% participants knew that all drugs available in market are not safe. Taking proper medication history before prescribing drugs was considered important by 92.57% participants. 79.70% participants were aware about Pharmacovigilance program of India. 64.35% doctors answered correctly to elements which are mandatory to record. Only 24.75% participants were knowing the basis that pharmcovigilance provides for.Conclusions: Nursing staff of tertiary care hospital, Solapur had very appreciable and positive attitude towards pharmacovigilance but there is a need for improvement in knowledge and practice of ADR reporting.


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