scholarly journals A prospective observational pharmacovigilance study of adverse drug reaction monitoring in patients of MDR-TB at tertiary care hospital

2018 ◽  
Vol 7 (7) ◽  
pp. 1291
Author(s):  
Mirza Shiraz Baig ◽  
Monali Raghunath Kale ◽  
Avinash Lamb
Keyword(s):  
Adverse Drug Reactions ◽  
Health Care Professionals ◽  
Tertiary Care Hospital ◽  
Tertiary Care ◽  
Public Health Problem ◽  
Treatment Withdrawal ◽  
Care Hospital ◽  
Drug Reactions ◽  
Medical College ◽  
Mdr Tb

Background: The emergence of drug resistant mycobacteria has become a significant public health problem world over creating an obstacle to effective TB control. ADRs are common in patients of MDR-TB on DOTs-Plus drug regimen. Present study was carried out in tertiary care hospital. Identification of types and frequency of adverse drug reactions in Intensive and continuation phase of MDR-TB Patients.Methods: It was a prospective observational study conducted in Department of TB- Chest and Medicine, Govt. Medical College, Aurangabad, Maharashtra, India. All the MDR-TB patients admitted at the directly observed treatment, short course plus (DOTS plus) Center at Medical College Hospital were enrolled and were monitored for ADRs. The causality and severity of the reactions were determined using Naranjo algorithm and Hartwig questionnaire, respectively.Results: A total of 121 tuberculosis patients of MDR-TB on DOTS therapy were enrolled for the study. Out of 121 patients, 13 were dropouts, 6 died, 7 defaulted so 108 patients assessed for ADRs, 48 patients developed 61 (56.48%) adverse drug reactions. The higher numbers of ADRs were observed in age group 31-40yrs followed by 21-30yrs which were more common in men. Majority of adverse drug reactions were Gastrointestinal (GI) problems 32 (52.45%), followed by Ototoxicity 7 (11.48%) and Psychiatric Manifestations 6 (9.84%) and skin problems 3 (4.92%). On evaluation of the causality of ADRs, majority were found to be Possible (59.02%). The severity assessment showed that most of the patients ADRs were of moderate level (50.82%).Some patients required treatment withdrawal and replacement with other drug and most of the patients were managed with supportive medication without removing anti-tubercular drug from their treatment regimen.Conclusions: ADRs are major factor limiting completion of drug therapy under RNTCP and occurrence of drug resistance which requires attention of all health care professionals.

scholarly journals To monitor the adverse drug reactions and safety of medicines commonly prescribed at obstetrics and gynaecology unit in a tertiary care hospital

2014 ◽  
Vol 2 (03) ◽  
pp. 112-119
Author(s):  
Kavita Dhar ◽  
Shalu Chauhan ◽  
Jyotsna Sharma ◽  
Preeti Gaur ◽  
V. S. Chopra ◽  
...  
Keyword(s):  
Adverse Drug Reactions ◽  
Health Care Professionals ◽  
Vascular System ◽  
Tertiary Care Hospital ◽  
Safety Issue ◽  
Tertiary Care ◽  
Care Hospital ◽  
Drug Reactions ◽  
Obstetrics And Gynaecology ◽  
Organ Systems

Adverse drug reactions are the recognized hazards of drug therapy and they can occur with any class of drugs. Any substance that is capable of producing a therapeutic effect can also produce unwanted or adverse effects. Adverse Drug Reactions result in increased healthcare cost due to the need of some interventions and increased hospital stay. The study was undertaken to monitor the adverse drug reactions to medicines commonly prescribed at obstetrics and gynaecology unit in a tertiary care hospital, to establish ten most commonly prescribed medicines in this unit that gave maximum adverse drug reactions and to determine the list of commonly affected organ systems and assess their causality. In this Retrospective, non-interventional study a total of 63 adverse drug reaction reports were collected from 249 patients. The most common medicine that caused maximum ADRs was Oxytocin 10 (15.87%). Other frequently used drugs were Amikacin, Methylergometrine, Mifepristone+Misoprostol,Levonorgestrel+Ethinylestradiol, Cefotaxim+sulbactam, Cefixime+Ofloxacin, Mifepristone alone,Clomifene citrate, Tramadol. The most commonly affected organ system was cardio-vascular system 12 (19.04%).The assessment by Naranjo’s scale showed that out of 63 ADRs, 41 (65.07%) ADRs were probably related to drugs, 21 (33.33%) ADRs were possibly related to drugs and 1 (1.58%) ADR was doubtful. WHO causality assessment scale revealed that out of 63 ADRs, 51(80.95%) ADRs were probable or likely, 12(19.04%) ADRs were possible. It was observed that safe medicines were prescribed in obstetrics and gynaecology department as per FDA category A with no banned drugs .However, there is a need to sensitize the doctors to prescribe rationally and emphasize this aspect in under and post graduate medical teaching as well. The health system needs to promote spontaneous reporting of Adverse Drug Reactions from all health care professionals and the public at large in a well structured programme to build synergies for monitoring ADR in the country. Also proper documentation and periodic reporting to regional pharmacovigilance centres should be encouraged to arrive at meaningful conclusion on safety issue of medicines and thereby reduce considerably social and economic consequences of ADRs.

scholarly journals Pharmacovigilance study in geriatric patients of a tertiary care hospital

2021 ◽  
Vol 2 (2) ◽  
pp. 33-38
Author(s):  
Rajalakshmi Rukmangathen ◽  
Vasundara Devi Brahmanapalli
Keyword(s):  
Adverse Drug Reactions ◽  
Geriatric Patients ◽  
Causality Assessment ◽  
Tertiary Care Hospital ◽  
Tertiary Care ◽  
Care Hospital ◽  
Drug Reactions ◽  
Adverse Drug Reaction Monitoring ◽  
Medical College ◽  
Organ Systems

Introduction: The aim was to assess, categorize and analyze the adverse drug reactions among geriatric patients in a tertiary care hospital.  Methods: All adverse drug reactions of geriatric patients reported at the Adverse Drug Reaction Monitoring Center, Sri Venkateswara Medical College, Tirupati, under the Pharmacovigilance programme of India, during September 2016 and January 2018 were identified and evaluated. A retrospective analysis was carried out for ADR pattern, drug groups, organ systems implicated in suspect ADR, demographic profile, causality (as per the WHO–UMC scale), severity (Hartwig and Seigel scale), and preventability (Schumock and Thornton criteria) of a said drug. Results: A total of 120 ADRs were received among geriatric patients. Most of the ADRs occurred in male geriatrics (55.83 %) and (34.2 %) occurred in the age group of 60- 64 years. Antibiotics comprised the major group of drugs causing ADRs (18.3 %). ADRs related to gastrointestinal systems were most common with 31.7 % followed by skin disorders (15 %) and central nervous system disorders (13.3 %). As per the causality assessment scale, the majority of adverse drug reactions were found to be possible (51.7 %). Conclusions: There were 60.8 % of reactions being mild and 39.2 % were moderate reactions as per severity scale. The majority of the adverse drug reactions were non-serious (33 %) and in the serious category, 27.5 % of ADRs required intervention to prevent permanent damage.

scholarly journals A PROSPECTIVE STUDY OF ADVERSE DRUG REACTIONS DUE TO PLATINUM ANALOGS - CHEMOTHERAPY IN A TERTIARY CARE HOSPITAL

2018 ◽  
Vol 11 (6) ◽  
pp. 215
Author(s):  
Sumit Kumar ◽  
Badruddeen Badruddeen ◽  
Singh S P ◽  
Mohammad Irfan Khan
Keyword(s):  
Adverse Drug Reactions ◽  
Tertiary Care Hospital ◽  
Tertiary Care ◽  
World Health ◽  
Care Hospital ◽  
Drug Reactions ◽  
Medical College ◽  
Health Organization ◽  
A Prospective Study ◽  
Platinum Analogs

Objective: The objective of this study was to analyze the types of adverse drug reactions (ADRs) associated with platinum analogs (cisplatin, carboplatin and oxaliplatin) used for cancer chemotherapy in a tertiary care hospital and determine their causal relationship with the offending drug.Methods: This prospective, observational, non-interventional study was conducted in a tertiary care hospital at GSVM Medical College Kanpur, India, for 4 months. Patients of all age and either sex were included in the study. ADRs were reported by the physicians of oncology department of the hospital and ADRs were assessed for different parameters -causality, outcome, and seriousness of ADR as per the World Health Organization (WHO), type of ADRs as per expanded Rawlins and Thompson’s classification, predictability using council for international organization of medical sciences guidelines and severity using modified Hartwig’s scale. Descriptive statistics were used for data analysis.Results: A total of 140 ADRs were reported from platinum analogs following treatment of different types of cancer in hospital. The burden of ADRs in each patient was 2.41. Most of the ADRs were observed in the age group of 40–60 years. Vomiting (27 ADRs) was commonly reported reaction. Among platinum analogs, cisplatin leads to 82 ADRs (58.57%) followed by carboplatin with 53 ADRs (37.86%) and least with oxaliplatin 5 ADRs (3.57%). Most of the ADRs on causality assessment were possible (104, 74.29%) and probable (36, 25.71%) in nature. Type -A ADRs account for 4/5th of the total reported ADRs, followed by Type-B and C. Severity of 90.71% ADRs was found to be mild followed by moderate, with no case of severe and serious nature. Nearly, most of the ADRs were of predictable type (97.14%).Conclusion: The potential of platinum analogs to cause ADRs is high; thus, the need of effective ADRs monitoring is highly emphasized.

scholarly journals A pattern of serious adverse drug reactions reported in a tertiary care hospital, Rangaraya Medical College, Kakinada, Andhra Pradesh

2020 ◽  
Vol 9 (4) ◽  
pp. 566
Author(s):  
Sweta Bindu Mendu ◽  
K. V. Siva Prasad
Keyword(s):  
Adverse Drug Reactions ◽  
Andhra Pradesh ◽  
Tertiary Care Hospital ◽  
Tertiary Care ◽  
Kidney Injury ◽  
Close Monitoring ◽  
Care Hospital ◽  
Social Inhibition ◽  
Drug Reactions ◽  
Medical College

Background: Serious adverse drug reactions (ADRs) constitute a major limitation in clinical development of a drug thus necessitating close monitoring. Studies regarding the pattern of serious ADRs are limited in southern India. The present study was conducted in tertiary care hospital in Andhra Pradesh with an objective to evaluate the pattern of severe cutaneous and non-cutaneous ADRs in our hospital and to assess the causality, severity, and preventability of these reactions.Methods: A retrospective observational study was conducted over two years, from January 2016 till January 2018 in our ADR monitoring center. The pattern of serious adverse drug reactions, the nature of ADR, suspected drug, the outcome and preventability were analyzed using Modified Hartwig and Siegel scale, and modified Schumock and Thorton scale.Results: Out of 734 ADRs reported, 42 were serious, while 692 were non-serious. Out of 42, 22 were dermatological in origin while the others were acute kidney injury, acute psychosis, febrile neutropenia, gynecomastia, and lipodystrophy. According to WHO causality assessment scale, 27 were probable while 15 were possible. The majority were reported in the age group of 16 to 65 years with female (34) preponderance. The most common drug category responsible was antimicrobials, followed by antiretrovirals, anti-epileptics, and analgesics.Conclusions: Antimicrobial, anti-epileptics, and analgesics contributed to serious ADRs. Although non-cutaneous ADRs did not result in hospitalization, they caused social inhibition and mental stress in the patient.

scholarly journals A Retrospective Study on Adverse Drug Reaction Monitoring in A Tertiary Care Hospital

2021 ◽  
Vol 70 (1) ◽  
Author(s):  
Adiba Nousheen ◽  
Asra Asra ◽  
Hasnat Fatima ◽  
Nashra Nizami ◽  
Sarah Noureen ◽  
...  
Keyword(s):  
Health Care ◽  
Adverse Drug Reactions ◽  
Health Care Professionals ◽  
Tertiary Care Hospital ◽  
Tertiary Care ◽  
Age Groups ◽  
General Medicine ◽  
Care Hospital ◽  
Age Group ◽  
Drug Reactions

Adverse drug reactions (ADRs) are a major concern in clinical practice. Reporting of ADRs either through health care professionals or the patients themselves is of utmost importance to give an accurate estimate of the prevalence, severity and preventability of ADRs. Present study was conducted to evaluate the prevalence of adverse drug reactions in a tertiary care hospital in Hyderabad, Telangana, India. This was a retrospective observational study, extending over 3 months (December 2020 to February 2021). A total of 41 cases comprising patients of either sex or age group were studied. The data was collected using CDSCO ADR reporting form. A total of 41 ADRs were reported during the three months period of study. During the study period a total of 41 ADR reports were received from various departments of the hospital. We observed 25 ADRs in females and 16 ADRs in males from our study. Among the age groups, 3 ADRs in age group 0 – 19 Yrs., 28 ADRs were seen in age group 20 – 59 Yrs., and 10 ADRs were seen in age group >60 Yrs. Maximum number of ADRs came from General Medicine department 17 (41.46%). Drug therapy 41 (100%) and diseases 19 (46.34%) were the most prominent predisposing factors of ADRs seen in our hospital. Causality assessment of suspected drugs was assessed using Naranjo scale. According to Naranjo scale most of the reported ADRs were found to be probable 23 (56.9%) followed by possible 16 (39.02%) and definite 2 (4.8%). The severities of the reactions were done using Hart Wig Scale. Majority of the reactions were mild 25 (60.97%). Withdrawal of the drug 5 (12.19%) was the main line of the management of the adverse drug reactions in the present study. Majority of serious ADRs were preventable in our study. ADRs are a major cause of morbidity worldwide. Frequency of ADRs can be reduced by careful follow up and a robust hospital-based pharmacovigilance setup. A measure to improve detection and reporting of adverse drug reactions by all health care professi

scholarly journals A prospective observational pharmacovigilance study of adverse drug reaction monitoring in patients of tuberculosis receiving category I and II treatment regimens at tertiary care hospital

2019 ◽  
Vol 8 (5) ◽  
pp. 875
Author(s):  
Monali Raghunath Kale ◽  
Mirza Shiraz Baig ◽  
Avinash Lamb
Keyword(s):  
Adverse Drug Reactions ◽  
Health Care Professionals ◽  
Tertiary Care Hospital ◽  
Tertiary Care ◽  
Treatment Interruption ◽  
Limiting Factor ◽  
Care Hospital ◽  
Drug Reactions ◽  
Total N ◽  
Pulmonary Tb

Background: First line Anti-TB therapy with rifampicin, isoniazid, pyrazinamide, and ethambutol / streptomycin is very effective. However, major adverse reactions to antituberculous drugs can cause significant morbidity and mortality. One of the main reasons for non‑adherence to anti‑TB therapy (ATT) is ADRs, even under DOTS. Present study was carried out in tertiary care hospital. The objective of the study was to evaluate types and frequency of ADRs in intensive and continuation phase of category I and II Anti-TB medication.Methods: A prospective observational study conducted in Department of TB- Chest and Medicine, Govt. Medical College, Aurangabad, Maharashtra, India.  All the TB patients reporting at DOTS Center of institute were enrolled and monitored for ADRs. The causality and severity of the reactions were determined using Naranjo algorithm and Hartwig questionnaire.Results: Total, n = 241 tuberculosis patients on DOTS therapy were enrolled for the study. Out of 241 patients, 17 were dropouts so 224 patients assessed for ADRs. 127 (56.69%) developed adverse drug reactions. The higher numbers of ADRs were observed in age group 31-40 yrs followed by 21-30 yrs, ADRs were more common in men.  Pulmonary TB (73.66%) cases were more common than extra pulmonary TB. Majority of adverse drug reactions were Gastrointestinal (GI) problems (30.92%), followed by Liver dysfunction and Hepatotoxicity (20.39%) and skin problems (17.10%). The causality of ADRs, in majority cases were found to be Probable (56.57%). Around 19 patients require treatment interruption and most of the patients were managed with supportive medication without removing anti tubercular drug from regimen.Conclusions: ADRs are major limiting factor for completion of drug therapy under RNTCP and occurrence of drug resistance which requires attention of all health care professionals.

scholarly journals Pattern of adverse drug reactions occurring at department of neurology of a tertiary care hospital in India

2020 ◽  
Vol 9 (5) ◽  
pp. 772
Author(s):  
Virendra Kushwaha ◽  
Pooja Agrawal ◽  
Ruchi Srivastava ◽  
Alok Verma
Keyword(s):  
Adverse Drug Reactions ◽  
Joint Pain ◽  
Prospective Observational Study ◽  
Tertiary Care Hospital ◽  
Tertiary Care ◽  
Relevant Information ◽  
Care Hospital ◽  
Drug Reactions ◽  
Medical College ◽  
Antiparkinsonian Drugs

Background: The objective of the study was to study the pattern and trends of adverse effects of drugs used in department of neurology in a tertiary care hospital.Methods: A prospective, observational study was carried out for a duration of 12 months from November 2018 to October 2019 at Department of Neurology and Department of Pharmacology and Therapeutics, G.S.V.M. Medical College, Kanpur after getting an approval from institutional ethical committee. Data was collected by analyzing OPD prescription slip, treatment charts and investigation reports. All relevant information regarding adverse drug reactions (ADRs) were collected as per norms of Indian Pharmacopoeia commission (IPC).Results: During the study period, a total of 130 ADRs reported. Most of the ADRs were reported due to antiepileptic drugs followed by antiparkinsonian drugs. Dizziness was the most frequent ADR reported. Most of the ADRs were reported due to phenytoin. Other ADRs observed were drowsiness, nausea/vomiting, weakness, joint pain, dyskinesia.Conclusions: Most of the ADRs were due to anti-epileptic drugs. Most of the reactions were of mild severity.

scholarly journals Retrospective analysis of adverse drug reactions reported at ADR monitoring centre under PvPI in a tertiary care hospital

2018 ◽  
Vol 7 (2) ◽  
pp. 303
Author(s):  
Manodeep Sen ◽  
Arpita Singh ◽  
Mukul Misra
Keyword(s):  
Health Care ◽  
Retrospective Analysis ◽  
Adverse Drug Reactions ◽  
Health Care Professionals ◽  
Antimicrobial Agents ◽  
Tertiary Care Hospital ◽  
Tertiary Care ◽  
Care Hospital ◽  
Drug Reactions ◽  
Skin Reactions

Background: Adverse drug reactions (ADRs) are a major cause of morbidity and mortality in hospitals and pose great economic burden on the health care system. This study was conducted with the aim of creating awareness and developing a culture for proper communication and reporting of ADRs among health care professionals.Methods: This study is a retrospective analysis of total 60 reported ADRs from AMC at a tertiary care hospital during a period of 14 months from March 2015 to April 2016. These ADRs were analysed for the pattern and type of reactions, body systems involved, causative drugs, and severity of reaction, their outcome, management and causality assessment.Results: Patients in the age groups of 41-50 years were most commonly involved with slight male preponderance. Skin reactions like rashes and itching were the most commonly observed ADR. The most common causative drugs for ADR were antimicrobial agents; IV route was the most common route responsible. Majority of ADRs belonged to type B, were non serious and moderate in severity. Most of the patients recovered. On causality assessment scale, most of the ADRs were found to be probable with the causative drugs.Conclusions: Most of the ADRs were treatable by early and appropriate management. The major limitation was under-reporting of ADRs which can be overcome by creating awareness and enhancing the culture of ADR monitoring and reporting among health care professionals for safe use of drugs.

Adverse Drug Reactions: Trends in a Tertiary Care Hospital

2013 ◽  
Vol 7 (5) ◽  
pp. 384-388
Author(s):  
Harmeet S. Rehan ◽  
Deepti Chopra ◽  
Ravinder K. Sah ◽  
Ritu Mishra
Keyword(s):  
Adverse Drug Reactions ◽  
Tertiary Care Hospital ◽  
Tertiary Care ◽  
Care Hospital ◽  
Drug Reactions
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