Analysis of cutaneous adverse drug reactions in a tertiary care teaching hospital

Background: Cutaneous Adverse Drug Reaction (CADR) is considered as one of the reasons for discontinuation of drug as well as medication non-adherence. This study analyses the common drugs causing CADR, clinical spectrum of different types of CADR, causality and drugs causing severe CADR.Methods: This was a retrospective cross-sectional observational study conducted by the Department of Pharmacology, Coimbatore Medical College, Coimbatore, Tamil Nadu, India. The study was conducted using data collected in CDSCO’s ADR reporting forms with CADR from June 2015 to July 2017. Patient’s information, details related to adverse drug reaction, suspected medication details, concomitant medication history, causality and seriousness were recorded.Results: A total of 102 CADR were evaluated in this study. The mean age of sample was 37.21±20.33 years. Maximum number of cases was in the age group of 40-49 years. Male to female ratio was 0.96:1. The commonly incriminated drugs causing CADR were antimicrobial agents. Ciprofloxacin (21.57%), phenytoin (9.8%), diclofenac sodium (6.86%), anti-snake venom (6.86%) and vancomycin (3.92%) were the common drugs implicated in CADR. Maculopapular rash and itching were the most common CADR. Anticonvulsants especially phenytoin was commonly associated with severe CADR.Conclusions: The present study has made an impact on all departments of this institution and awareness has been created about spontaneous reporting of all adverse drug reactions in CDSCO ADR reporting forms to the pharmacovigilance centres. Thus, sound knowledge about the adverse drug reactions may decrease the occurrence of drug induced morbidity and mortality.

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

International Journal of Basic & Clinical Pharmacology ◽

10.18203/2319-2003.ijbcp20193177 ◽

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.

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

Nepal Journal of Epidemiology ◽

10.3126/nje.v4i1.10135 ◽

2014 ◽

Vol 4 (1) ◽

pp. 330-336 ◽

Cited By ~ 1

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

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

International Journal of Research in Dermatology ◽

10.18203/issn.2455-4529.intjresdermatol20164248 ◽

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

Background: 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 & pattern of cutaneous adverse drug reactions reported to department of dermatology at MediCiti Institute of Medical Sciences, Hyderabad, India.Methods: 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 & 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.Results: 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). Conclusions: 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.

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Analysis of spontaneously reported cutaneous adverse drug reactions in a tertiary care teaching hospital in South India

International Journal of Basic & Clinical Pharmacology ◽

10.18203/2319-2003.ijbcp20185085 ◽

2018 ◽

Vol 8 (1) ◽

pp. 27

Author(s):

Vijaya Chandra Reddy Konda ◽

Sree Surya Durga Devi Pilla ◽

A. Surekha ◽

K. R. Subash ◽

K. Umamaheswara Rao

Keyword(s):

Adverse Drug Reactions ◽

Continuous Monitoring ◽

Antimicrobial Agents ◽

Tertiary Care ◽

Maculopapular Rash ◽

Drug Reactions ◽

Drug Eruptions ◽

Fixed Drug ◽

The Common ◽

Clinical Patterns

Background: Skin is the most common organ involved in adverse reactions due to drugs. With newer drugs released into market every year, there is changing pattern of the reported cutaneous adverse drug reactions (ADRs). In order to ensure safer use of medicines in patients, there is need for continuous monitoring of ADRs. This is a retrospective study to analyse spontaneously reported cutaneous ADRs.Methods: All the cutaneous ADRs reported between January 2017 and September 2018 were analysed for clinical patterns, suspected medications, causality, severity and preventability.Results: Of the 1035 reports received during the study period, 232 (22.41%) included cutaneous reactions. 113 (48.7%) were male and 119 (51.29%) were female. Maculopapular rash 70 (30.17%), pruritus 31 (13.36%), palmar plantar erythrodysesthesia 30 (12.93%), acne 19 (8.19%), urticaria 16 (6.89%) and fixed drug eruptions (FDE) 13 (5.6%) were the common clinical patterns. Antimicrobial agents followed by anticancer drugs, nonsteroidal anti-inflammatory drugs (NSAIDs), hormones and related drugs, and antiepileptic drugs were the common suspected group of drugs. Causality assessment as done by WHO-UMC scale showed that 3 (1.29%) were certainly related, 174 (75%) were probably related and 55 (23.7%) were possibly related to the suspected medication.Conclusions: Cutaneous ADRs are most frequently reported ADRs in the present study. With newer drugs released into market, there is a need for continuous monitoring of use of drugs to promote safer use of medicines in patients.

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

International Journal of Basic & Clinical Pharmacology ◽

10.18203/2319-2003.ijbcp20190567 ◽

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.

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

Journal of Oncology Pharmacy Practice ◽

10.1177/1078155219882081 ◽

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.

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

International Journal of Basic & Clinical Pharmacology ◽

10.18203/2319-2003.ijbcp20190563 ◽

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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Clinical Profile of Cutaneous Adverse Drug Reactions in a Tertiary Care Centre

IRA-International Journal of Applied Sciences (ISSN 2455-4499) ◽

10.21013/jas.v3.n3.p12 ◽

2016 ◽

Vol 3 (3) ◽

Cited By ~ 1

Author(s):

Priya Prathap ◽

Elsy M.I ◽

Ajitha K. N ◽

Ajith Kumar ◽

Sandhya George

Keyword(s):

Adverse Drug Reactions ◽

Tertiary Care ◽

Maculopapular Rash ◽

Clinical Profile ◽

Drug Reactions ◽

Fixed Drug Eruption ◽

Tertiary Care Centre ◽

Dermatology Department ◽

Female Ratio ◽

The Common

<div>Context: Cutaneous adverse drug reactions (cADR) constitute 2-3% of all hospitalized patients. However there is paucity of data regarding occurrence of cADR among out patients. Hence we decided to do a study on clinical profile of cADR and to find out the common drugs resulting in cADR . Objective: To observe the clinical spectrum and the causative drugs of cADR among patients attending Dermatology Department in our hospital. Methods: Patients with cADR who attended Dermatology Out Patient Department (OPD) in our institution were studied for a period of one year.Results:71 patients were diagnosed to have cADR. Male to female ratio was 1.15 :1. Maculopapular rash (22/71 ; 31%) was the commonest presentation followed by generalised pruritus (16/71; 22.5%) , fixed drug eruption( FDE) ( 8/71 ;11.3%) and urticaria (5/71 ;7%). Antimicrobials (40.8%), NSAIDS (22.5%) and Antiepileptics (22.5 %) were the common drugs responsible for these eruptions. </div>

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Active surveillance of adverse drug reactions in patients with rheumatoid arthritis in a tertiary care teaching hospital

International Journal of Basic & Clinical Pharmacology ◽

10.18203/2319-2003.ijbcp20183934 ◽

2018 ◽

Vol 7 (10) ◽

pp. 1981

Author(s):

Nalini R. ◽

Keerthi D. ◽

Meenakshi B. ◽

Ezhil Ramya J. ◽

Vidhya .

Keyword(s):

Rheumatoid Arthritis ◽

Adverse Drug Reaction ◽

Drug Reaction ◽

Active Surveillance ◽

Adverse Drug Reactions ◽

Tertiary Care ◽

Severity Assessment ◽

Drug Reactions ◽

Rheumatic Drug ◽

Patient Department

Background: Drugs used in the treatment of rheumatoid arthritis show significant toxicity and morbidity. The objective of the study was to evaluate the nature and incidence of adverse drug reaction in patients with rheumatoid arthritis on anti-rheumatic drugs and to assess the causality and severity of the documented adverse drug reactions.Methods: The prospective observational study was done for two months in rheumatology outpatient department. All patients were interviewed for basic details, treatment history and adverse drug reactions and were recorded. Causality assessment and severity assessment of the recorded adverse drug reactions were done.Results: About 283 patients attended the rheumatology out-patient department during the two months period out of which 57 patients had one or more adverse drug reaction. The incidence of adverse drug reaction observed in rheumatology out-patient department to anti rheumatic drug was 20.14%. A total of 145 adverse drug reactions were noted in 57 patients. The most common adverse drug reaction reported was epigastric pain (6.89%) followed by headache and dyslipidemia (6.25%). The most common system associated with adverse drug reaction was gastrointestinal system (29.66%) followed by central nervous system and cardiovascular system (15.86%). Reported adverse drug reactions were assessed for causality and maximum belonged to probable (66.9%). Severity assessment revealed that most of the adverse drug reactions were mild (74.48%) in nature.Conclusions: Active surveillance for adverse drug reactions to anti rheumatic drug in patients with rheumatoid arthritis will allow early detection of adverse drug reactions and timely intervention to provide maximum benefit to the patients.

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

Current Drug Safety ◽

10.2174/1574886316666210825122152 ◽

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.

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