scholarly journals Reporting Adverse Drug Reactions Among Hospitalized Medical Patients: A Prospective Study From Tertiary Care Hospital in Western Nepal

2014 ◽  
Vol 4 (1) ◽  
pp. 330-336 ◽  
Author(s):  
Kadir Alam ◽  
R Shakya ◽  
P Ojha
Keyword(s):  
Adverse Drug Reaction ◽  
Drug Reaction ◽  
Adverse Drug Reactions ◽  
Tertiary Care ◽  
Uppsala Monitoring Centre ◽  
Care Hospital ◽  
Medical Patients ◽  
Drug Reactions ◽  
Online Data ◽  
General Medical Ward

Background    The risk of adverse drug reaction ranges nearly from zero to high level depending upon the drug itself and the patient factor. The process of detection, assessment, monitoring and reporting of adverse drug reaction is necessary to prevent its occurrence in future. Materials and Methods Information related to suspected Adverse Drug Reactions(ADRs) were collected by pharmacists from general medical ward using ADRs reporting form from Manipal Teaching Hospital (MTH)during ward rounds. The details of suspected drug, drug reaction and all related data were documented. Naranjo Algorithm, modified Hartwig and Siegel and modified Shumock and Thornton scale were used for assessment of causality, severity and preventability respectively. All suspected ADRs were reported to National Pharmacovigilance Center and then to Uppsala Monitoring centre through the electronic online data base named Vigiflow.  Results Among 1,105 patients, 51 patients experienced ADR (4.61%). Incidents of ADRs were higher with antibiotics (47.06%) and Ceftriaxone was at top of list (15.69 %). Dermatological system (25.49%) and gastrointestinal system (19.61%) were affected more. About 33.33% of suspected drugs were discontinued. About 41.18% of ADRs required medical treatment where antihistaminic (24.32%) and antipruritic (21.62%) were most commonly used to treat ADRs. To sum up, 64.71% of ADRs were probable, 62.75% were mild in nature and 60.78% were probably preventable. Conclusion Finding of the study suggests that ADRs still pose serious health threat among hospitalized patients and as a matter of fact over 60% of them are preventable. Reporting of ADR scan provide effective measures to prevent the occurrence in the future in which the role of pharmacist is vital.DOI: http://dx.doi.org/10.3126/nje.v4i1.10135 Nepal Journal of Epidemiology 2014;4 (1): 330-336

scholarly journals Prescribing pattern and adverse drug effects monitoring of anti-rheumatoid drugs in rheumatoid arthritis patients in a tertiary care hospital

2019 ◽  
Vol 8 (3) ◽  
pp. 462
Author(s):  
M. Venkateswaran ◽  
M. Dhanasekaran ◽  
S. Rajavelu
Keyword(s):  
Rheumatoid Arthritis ◽  
Adverse Drug Reaction ◽  
Drug Reaction ◽  
Adverse Drug Reactions ◽  
Tertiary Care ◽  
Common Disease ◽  
Care Hospital ◽  
Drug Reactions ◽  
Prescribing Pattern ◽  
Elevated Liver Enzymes

Background: Rheumatoid arthritis (RA) is a common disease that causes substantial morbidity in most patients and premature mortality in many. All the drugs used in the treatment of rheumatoid arthritis show significant toxicity and hence it is important to monitor the drugs for adverse drug reaction. This study will estimate the prescribing pattern and bring out the possible adverse drug reactions in patients with rheumatoid arthritis.Methods: This study included 200 patients with rheumatoid arthritis who fulfilled the study criteria were observed for three months. Their prescriptions were collected and analysed. The symptoms of adverse drug reaction were documented through questionnaire. The causality assessment was done by WHO-UMC assessment scale and severity by using modified Hartwig-Seigel severity assessment scale.Results: This study showed most of the patients were female (86%). Majority of them were in age group of 51-60 years. Average number of drugs per prescription was 10.57. Out of 200 patients, 2% were on single DMARD and 50.5% were on two DMARDs. 40% and 7.5% were taking three and four DMARDs respectively. A total of 450 adverse drug reactions were reported, out of which 68.4% due to steroid,12.5% due to DMARDs and 19.1 due to use of NSAIDs, DMARDs and glucocortisteroids. Chloroquine maculopathy occurred in 3 patients and elevated liver enzymes due to methotrexate in 3 patients, which necessitated DMARD withdrawal. Most patients had 1-3 ADRs. 6% of ADRs were severe and 54% belongs to probable category of causality assessment.Conclusions: Treatment of rheumatoid arthritis is mainly based on DMARDs, glucocorticosteroids and NSAIDs. So, occurrence of ADR is much common. Proper monitoring of therapy and timely modification of drugs and lifestyle can reduce the ADR occurrence.

Surveillance of adverse drug reactions and drug–drug interactions with pediatric oncology patients in a south Indian tertiary care hospital

2019 ◽  
Vol 26 (5) ◽  
pp. 1103-1109
Author(s):  
Bency Joseph ◽  
Julius X Scott ◽  
M G Rajanandh
Keyword(s):  
Adverse Drug Reaction ◽  
Drug Reaction ◽  
Drug Interaction ◽  
Adverse Drug Reactions ◽  
Pediatric Oncology ◽  
Tertiary Care Hospital ◽  
Tertiary Care ◽  
Care Hospital ◽  
Drug Reactions ◽  
Drug Drug Interaction

Objective The present study was conducted to evaluate the pattern of occurrence of adverse drug reactions and drug–drug interaction in a pediatric oncology unit of a tertiary care hospital. Methods A prospective, observational study was conducted in the Department of Pediatric Oncology, Sri Ramachandra Medical College and Hospital, India. Patients were monitored actively for the occurrences of any adverse drug reaction during the study period. Patient's demographic details, clinical, and treatment data were collected for drug–drug interaction analysis. The detected adverse drug reaction was assessed for causality, severity, and preventability. Drug–drug interaction identified was rated based on their level of urgency and the nature of actions necessary to respond to an interaction. Results Of 176 patients, 118 were detected for the occurrence of various adverse drug reaction. The majority of the cases were suffering with acute lymphocytic leukemia (67.9%). Vincristine was noted for a maximum number of adverse drug reaction in cytotoxic drugs. Rash is the most frequently occurred reaction. Assessment of causality showed that the majority of cases are “probable” (60.16%). In evaluating the severity of adverse drug reactions, 57.6% reactions were moderately severe and 74.5% of the reactions were preventable. Upon assessing the drug–drug interaction, 38.13% of the prescription needs to be monitored and 10 drug–drug interactions were under the risk category of “X.” The majority of the adverse drug reaction was moderately severe in nature and those were preventable. Conclusion Since pediatrics are vulnerable population, they must have a thorough surveillance system for adverse drug reaction and drug–drug interaction; thereby, a positive impact on the medication-use system and improved patient care can be achieved.

Adverse Drug Reaction Profile of Anticancer Agents in a Tertiary Care Hospital: An Observational Study

2021 ◽  
Vol 16 ◽  
Author(s):  
Sana Parveen Shaikh ◽  
Rajan Nerurkar
Keyword(s):  
Adverse Drug Reaction ◽  
Drug Reaction ◽  
Adverse Drug Reactions ◽  
Anticancer Agents ◽  
Financial Burden ◽  
Tertiary Care ◽  
Moderate Intensity ◽  
Future Research ◽  
Care Hospital ◽  
Drug Reactions

Background: Anti-cancer agents are known to be toxic, leading to a number of adverse drug reactions (ADRs). ADRs not only increase the financial burden on patient/healthcare system but also decrease quality of life. Understanding the burden of ADR will help strengthen the knowledge on patient safety and thereby in implementing intervention strategies to reduce it. Objectives: 1. To study the pattern of Adverse drug reaction of anticancer agents of patients admitted in the oncology ward. 2. To assess the causality, severity, and preventability of the adverse drug reactions observed. Results: Out of the total 732 ADRs encountered, alopecia was the most common ADR. The average number of ADRs observed per patient was 3.66 + 1.59(mean + SD). The maximum number of ADRs were seen in Paclitaxel-carboplatin 3 weekly regimen. Nausea and alopecia were the most common ADRs reported with most regimens. On causality assessment, 95(12.97%) were definitely related according to Naranjo’s Causality scale, while 15.71% were certainly related according to WHO scale. Of all the ADRs recorded,47.81% were of moderate-intensity while 52.18% were of mild intensity. The majority of ADRs were not preventable, 87.59%. Conclusion: Alopecia was the most common ADR reported. Most of the ADRs could be causally related to drugs. These ADRs were mild to moderate in severity and were not preventable. There is need to identify the underlying factors that predispose patients to these ADRs and target them in future research.

scholarly journals An observational study to find out incidence and pattern of adverse drug reactions among multidrug resistant tuberculosis patients treated under revised national TB control program of India

2019 ◽  
Vol 8 (2) ◽  
pp. 320
Author(s):  
Preet Lakhani ◽  
Shireen Barua ◽  
Divya Singh ◽  
Suchi Jain ◽  
Surya Kant ◽  
...  
Keyword(s):  
Adverse Drug Reaction ◽  
Drug Reaction ◽  
Observational Study ◽  
Adverse Drug Reactions ◽  
Tertiary Care ◽  
Care Hospital ◽  
Age Group ◽  
Impaired Hearing ◽  
Drug Reactions ◽  
Mdr Tb

Background: Between 2006 and 2015, the prevalence of MDR-TB has been found to be as high as 39.9% in some states. Approximately 35.8% of all previously treated patients developed MDR-TB. The objective of the present study was to identify demographic and health characteristics of patients as well as incidence and pattern of the adverse drug reactions caused by antitubercular drugs in MDR-TB patients in a tertiary care hospital of northern India.Methods: This 12 months study of observational study was conducted at a DOTS centre. MDR-TB diagnosed patients treated with DOTS Plus regimen were enrolled after getting informed consent. Patient information was recorded. Patient follow-up was conducted to identify the incidence and pattern of ADRs.Results: A total of 115 patients were enrolled. Maximum number of cases were in the 31-40 age group (25.21%) followed by the 41-50 age group (20.86%). 76 (66.08%) were males and 39 (33.91%) were females. 52 patients (45.21%) had concomitant diseases, out of which 15 (13.04%) were HIV positive and 21 (18.26%) were diabetic. 70 patients (60.86%) developed ADRs. The adverse drug reaction that were seen are -38 (38.76%) cases of gastrointestinal adverse drug reactions, 8 (8.16%) jaundice/hepatitis, 7 (7.14%) impaired hearing/vertigo, 21 (21.24%) central nervous system adverse drug reaction, 6 (6.12%) peripheral neuropathy, 6 (6.12%) rash and itching, 5 (5.10%) arthralgia, 3 (3.06%) renal impairment, 2 (2.04%) hypothyroidism and 2 (2.04%) blurred vision.Conclusions: Determining which population groups are affected most by ADRs can help physicians to better monitor and make an early diagnosis to reduce ADR-related morbidity and mortality.

scholarly journals Evaluation of adverse drug reactions of anti-tubercular drugs in the treatment of tuberculosis in tertiary care hospital

2020 ◽  
Vol 9 (9) ◽  
pp. 1430
Author(s):  
Krishnakanth K. ◽  
Jagadeesh A. ◽  
Swetha T. D.
Keyword(s):  
Adverse Drug Reaction ◽  
Adverse Drug Reactions ◽  
Adverse Drug Events ◽  
Tertiary Care Hospital ◽  
Tertiary Care ◽  
Care Hospital ◽  
Drug Reactions ◽  
Cross Sectional ◽  
Medicine Department ◽  
Study Results

Background: Adverse drug reactions are very common among patients on anti-tubercular treatment. Hence, the current study was done to evaluate the adverse drug reaction (ADR) profile in patients receiving anti-tubercular treatment (ATT).Methods: A 6 months prospective, cross-sectional observational study was performed in collaboration with Pulmonology Medicine department. WHO-UMC scale and Naranjo scale was used to evaluate the ADRs.Results: Ninety-two patients receiving ATT presented with 113 adverse drug events (ADE). Males were more affected than females. DOTS category-1 regimen was mostly responsible for ADE. Addition of drugs for the management of ADR events was done.Conclusions: The study results show more ADRs related to ATT demanding increased collaboration between NTEP 2020 and Pharmacovigilance Programme of India to enhance drug safety in this field.

scholarly journals Prevalence and pattern of adverse cutaneous drug reactions presenting to a tertiary care hospital

2017 ◽  
Vol 3 (1) ◽  
pp. 74
Author(s):  
B. Janardhan ◽  
D. Shailendra
Keyword(s):  
Drug Reaction ◽  
Adverse Drug Reactions ◽  
Tertiary Care ◽  
Clinical Manifestations ◽  
Care Hospital ◽  
Drug Reactions ◽  
Medical Sciences ◽  
Female Ratio ◽  
The Mean ◽  
Cutaneous Drug Reactions

<p class="abstract"><strong>Background:</strong> An adverse cutaneous drug reaction (ACDR) is defined as an undesirable clinical manifestation resulting from administration of a particular drug. With an ever increasing number of drugs and varied formulations being continuously made available it is important that a close watch on the risks of adverse drug reactions is looked for, to ensure safe use of medicines in the interest of the patient. In the present study our aim is to study the prevalence &amp; pattern of cutaneous adverse drug reactions reported to department of dermatology at MediCiti Institute of Medical Sciences, Hyderabad, India<span lang="EN-IN">.</span></p><p class="abstract"><strong>Methods:</strong> All suspected cutaneous adverse drug reactions reported to the department of dermatology at MediCiti Institute of Medical Sciences during the two year period from January 2013 to December 2014 were included in this study. A thorough clinical examination of all these cases &amp; details related to the drug use and clinical manifestations of the cutaneous adverse drug reaction were documented using a structured proforma. Naranjo scale was used to assess causality in all the causes of cutaneous adverse drug reactions.<strong></strong></p><p class="abstract"><strong>Results:</strong> The mean age of the patients was 42 years (age range: 1-64 years). Most of them were in the age group of 30-39 years. The male to female ratio was 1.78:1. The most common type of skin eruptions observed were maculopapular rash (35.55%), urticaria (26.19%) and fixed drug eruption (17.87%). The mean duration between drug intake and appearance of rash was 4 days (range: 1-120 days)<span lang="EN-IN">. </span></p><p class="abstract"><strong>Conclusions:</strong> The pattern of ACDRs and the drugs causing them in this study were similar to that reported in other studies both in terms of disease burden and clinical pattern. Knowledge of adverse cutaneous drug reactions will help to identify common medications contributing to dermatological reactions, so as to anticipate, prevent and limit their undue consequences<span lang="EN-IN">.</span></p>

scholarly journals Knowledge, attitude and practice among consumers about adverse drug reaction reporting

2019 ◽  
Vol 8 (8) ◽  
pp. 1776
Author(s):  
Jeet J. Patel ◽  
Megha K. Shah ◽  
Prakruti P. Patel ◽  
A. M. Gandhi ◽  
Mira K. Desai
Keyword(s):  
Adverse Drug Reaction ◽  
Drug Reaction ◽  
Adverse Drug Reactions ◽  
Tertiary Care ◽  
Drug Reactions ◽  
Adr Reporting ◽  
Attitude And Practice ◽  
Reporting Programme ◽  
Consumer Reporting ◽  
Knowledge Attitude And Practice

Background: Background: Adverse Drug Reaction (ADR) reporting by consumers is quite low in India. Assessing knowledge and attitude of consumers regarding ADR reporting and observing practice of ADR reporting among them can help explore probable causes for underreporting of ADRs by consumers.Methods: This was a cross-sectional study conducted in a tertiary care teaching hospital using investigator-administered questionnaire and interviewing indoor patients of Surgery, Medicine, Obstetrics & Gynaecology and Dermatology departments. The questionnaire was prepared to assess knowledge, attitude and practice of consumers about ADR reporting. Data was analysed using mean, standard deviation and percentages.Result: A total of 820 consumers of medicines were included. It was found that 32.2% consumers were not aware that a drug can produce adverse effects. After being explained about adverse drug reactions, 94.6% consumers felt that adverse drug reactions should be reported. However, 98.8% consumers were not aware of Pharmacovigilance Programme of India. After consulting about consumer reporting programme, majority of respondents (96.1%) felt that the direct consumer reporting programme helps reporting of ADRs. Moreover, 93.7% of consumers were willing to use it to report ADRs in future. Consumers preferred the Telephonic method with a Toll free number for ADR reporting followed by informing a health care professional.Conclusion: Poor knowledge and awareness about ADR reporting is the major factor for low to nearly absent ADR reporting by consumers in India.

Cutaneous Drug Reactions in Children Attending a Tertiary Care Hospital

2020 ◽  
Vol 33 (2) ◽  
pp. 56-62
Author(s):  
Md Mostafizur Rahman ◽  
Md Azraf Hossain Khan ◽  
Pampa Chandra ◽  
Laila Shamima Sharmin ◽  
Fazlur Rahman ◽  
...  
Keyword(s):  
Drug Reaction ◽  
Adverse Drug Reactions ◽  
Tertiary Care Hospital ◽  
Tertiary Care ◽  
Stevens Johnson Syndrome ◽  
Care Hospital ◽  
Drug Reactions ◽  
Johnson Syndrome ◽  
Cutaneous Drug Reactions ◽  
Cutaneous Drug Reaction

Background: Cutaneous drug reaction (CDR) is a growing health hazard in the world. Adverse drug reactions are common complications in drug therapy. About 3-8% of all hospital admissions are the results of adverse drug reactions, among them 2-3% are children and these can cause significant disability to patients. Early identification and management of adverse cutaneous drug reaction has both short term and long term prognostic significance.  Objective: To know the cutaneous reaction to drugs in children in a tertiary care hospital.  Study design: Hospital based descriptive, observational study. Subjects: 50 children with cutaneous drug reactions were studied in the department of Dermatology and Pediatric respectively in Rajshahi Medical College Hospital, Rajshahi. Methods: Data were collected by detailed history taking, physical examination and laboratory investigations in a prefixed data collection sheet and with the help of GOLD guideline after taken informed consent of the patient. Results: This study showed a significant male predominance. Male: female ratio was 1.08:1 .In this study prevalence was highest among 1-5 years age group. Cotrimoxazole, NSAIDs, anticonvulsant and quinolone were most offending medications. Maculopapular eruption, Stevens Johnson Syndrome, fixed drug eruption and urticaria were most common morphological types. Majority of CDRs were noted with oral route of administration. It was observed that almost all the CDRs that were reported involved mainly the skin. Majority of adverse cutaneous drug reactions reported were moderate in severity. Conclusion: Frequency distribution of the offending drugs and the adverse reactions revealed that adverse cutaneous drug reactions occurred mostly by cotrimoxazole, NSAIDs and quinolones. Maculopapular rash and Stevens Johnson Syndrome were the most common morphological types. A better understanding of the mechanisms underlying CRDs is important in drug development and in patient care. TAJ 2020; 33(2): 56-62

scholarly journals Signals of adverse drug reactions communicated by pharmacovigilance stakeholders: protocol for a scoping review of the global literature

2020 ◽  
Author(s):  
Daniele Sartori ◽  
Jeffrey Aronson ◽  
Igho Onakpoya
Keyword(s):  
Adverse Drug Reaction ◽  
Drug Reaction ◽  
Adverse Drug Reactions ◽  
Scoping Review ◽  
Suspected Adverse Drug Reaction ◽  
World Health ◽  
Uppsala Monitoring Centre ◽  
Risk Minimization ◽  
Drug Reactions ◽  
Medicinal Products

Abstract Background: Signals of adverse drug reactions are the basis of some regulatory risk-minimization actions in pharmacovigilance, such as changes to the section of undesirable effects in Summaries of Products Characteristics (SmPCs). Reviews of the evidence of signals have highlighted that these are mostly supported by reports of adverse drug reactions or multiple types of evidence, but have so far been limited to specific medicinal products, time intervals, groups of adverse drug reactions and specific countries. The time that elapses between a report of a suspected adverse drug reaction and the communication of a signal has not been systematically investigated. Furthermore, difficulties in causally linking medicinal products to adverse events have been highlighted, but the elements of reports of suspected ADRs that authors used to support putative causal relationships have been rarely characterized.Methods: We plan a scoping review to chart the evidence underpinning signals in pharmacovigilance and the time that it takes to communicate a signal. We shall retrieve records from electronic databases, without language or publication restrictions; we shall apply backward and forward citation to adjust for variations in database indexing. We shall also hand-search the websites of 35 regulatory agencies/authorities, restricted publications from Uppsala Monitoring Centre, and drug bulletins in the list of International Society of Drug Bulletins. If websites do not report signals, signals will be requested from the competent stakeholder. We shall use the Oxford Centre for Evidence-Based Medicine Levels of Evidence to chart and summarize evidence. We shall use VigiBase, the World Health Organization’s Global Individual Case Safety Report database, to determine the date of reporting for reports of adverse drug reactions. Plots, or pictograms (if appropriate), will be used to represent the time from the first report of a suspected adverse drug reaction to a signal.Discussion: We expect that the findings from this exploratory investigation will be useful in better understanding global patterns of similarities or differences in regulatory decision-making in terms of evidence and timing of communications, and in identifying relevant research questions for future systematic reviews.Scoping review registration: osf.io/jtv38

scholarly journals An observational study to monitor cutaneous adverse drug reaction profile in Dermatology Department of tertiary care teaching hospital

2019 ◽  
Vol 8 (3) ◽  
pp. 442
Author(s):  
Janaki R. Torvi ◽  
S. G. S. Rajesh Reddy V.
Keyword(s):  
Adverse Drug Reaction ◽  
Drug Reaction ◽  
Adverse Drug Reactions ◽  
Tertiary Care ◽  
Maculopapular Rash ◽  
Drug Reactions ◽  
Dermatology Department ◽  
Care Teaching ◽  
Cutaneous Adverse Drug Reaction ◽  
Reaction Profile

Background: Incidence of cutaneous adverse drug reactions (CADRs) in developed countries is 1 to 3% and in developing countries, it is much higher i.e. 2 to 6%. 1 in 1000 hospitalized patients will develop severe cutaneous adverse reaction. Maculopapular rash represents majority of cutaneous drug reaction followed by urticaria. Most frequently elicited CADRs are associated with antimicrobials and NSAIDs. This study was designed to monitor Cutaneous adverse drug reaction profile of tertiary care teaching hospital.Methods: This is a prospective observational study of 6 months’ duration to monitor cutaneous adverse drug reactions in dermatology department of tertiary care teaching hospital. CADRs were analysed with respect to demographic details, suspected drugs and type of reaction. Causality assessment is by Naranjo algorithm. Data is represented in tables and graphs. Data is analyzed in Microsoft excel 2007.Results: Total 57 cases of cutaneous adverse drug reactions were reported. Among them, 57.9% were in males and 42.1% were in females. Majority of CADRs were due to antiretroviral drugs (38.5%) followed by antibacterial (28%) and antiepileptics (14%). Maculopapular rash is most common CADR (35%). Causality of 74% CADRs were probable according to Naranjo algorithm.Conclusions: CADRs are more commonly associated with antiretroviral therapy (ART), antibacterial drugs and antiepileptic drugs. In case of ART, antiepileptic drug and drugs used in chronic illness compliance plays a major role in the success of therapy. Adverse drug reactions lead to problem of non compliance and failure of therapy. Cutaneous adverse reactions like FDE heal with hyper pigmentation leads to cosmetic problem. Stevens Johnson syndrome (SJS) is life threatening that requires prompt withdrawal of drug and intensive medical management. Many drugs are available without prescription in India leading to problem of misdiagnosis of CADRs. So, data obtained from this study helps in proper diagnosis and treatment of CADRs.

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