scholarly journals An evaluation of knowledge, attitude and perception about adverse drug reactions and pharmacovigilance among intern doctors in a medical college teaching hospital of Sangli

Author(s):  
Santoshkumar A. Shetti ◽  
R. P. Limaye

Background: Underreporting of various adverse drug reactions (ADRs) by consultants is a common incurable problem. National pharmacovigilance program is one of the ongoing programs to monitor the adverse drug reactions & reporting at the earliest to the nearby AMCs. As medical interns are budding doctors, the focus of this study was to evaluate the knowledge, attitude and perception about ADRs and pharmacovigilance in them.Methods: A cross section questionnaire-based study was conducted after approval by our institutional ethics committee pretested and validated questions consisting of 20 questions (knowledge, attitude, perception) were administrated to medical interns. The filled questionnaires were collected and analysed.Results: In our study, medical interns have fair enough idea about ADR and pharmacovigilance. In knowledge domain they were aware of term ADRs (100%), pharmacovigilance (72.6%). In attitude domain majority of interns (80.6%) known availability of ADR forms, compulsory of pharmacovigilance unit (90.3%). In perception domain very poor response from interns, not even a single intern had reported any ADR filled form and they don’t know meaning of re-challenge and de-challenge, very few interns (9.7%) know how to manage the ADRs in emergency conditions.Conclusions: Under reporting problem can be improved by doing more teaching activities at undergraduate level and intern’s level including various workshops, CMEs, problem-based teaching of adverse reactions in their curriculum. These exercises will improve their reporting frequency and sensitize the interns from the undergraduate days itself in their upcoming clinical practice in community.

2018 ◽  
Vol 10 (2) ◽  
pp. 21-26 ◽  
Author(s):  
S Neupane ◽  
B Basnet

Background: Cutaneous adverse drug reactions (CADRs) range from minor reactions to several life threatening complications. Objectives: To study the clinical spectrum of cutaneous adverse drug reactions, determine the causative drugs responsible for the reactions and to assess the preventability.Methods: The study was carried out in the Department of Dermatology of Gandaki Medical College Teaching Hospital from June 2011 to June 2015. All the patients attending the Dermatology Outpatient Department and the patients admitted in the wards with suspected cutaneous adverse drug reactions to systemic drugs were included in the study. A detailed clinical history, including the history of drug intake was noted. Each case was assessed for its causality by using the WHO definitions. Data analysis was done using SPSS software.Results: There were 102 patients in total. The mean age of the patient was 32 ±15.7 years. Maximum patients belonged to the 21 to 30 years age group. There were 59 female patients and 43 male patients. Severe type of cutaneous adverse drug reactions was noted in 7.8% of patients. Antibiotics were responsible for most of the cutaneous adverse drug reactions. Cefixime was the most commonly incriminated drug. Exanthematous drug reaction was the most common type seen in 45%. Stevens-Johnson syndrome was the commonest type noted among the serious adverse drug reactions. Drug preventability was noted in 6% of patients.Conclusions: The commonest type of CADR noted was exanthematous type. Antibiotics were the commonest drug group involved in CADR. Six percent of CADR were preventable. J-GMC-N | Volume 11 | Issue 01 | January-June 2018, Page: 21-26


2011 ◽  
Vol 57 (3) ◽  
pp. 189 ◽  
Author(s):  
G Parthasarathi ◽  
S Guido ◽  
A Harugeri ◽  
M Ramesh ◽  
H Basavanagowdappa

Author(s):  
Mirza Shiraz Baig ◽  
Monali Raghunath Kale ◽  
Avinash Lamb

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.


2012 ◽  
Vol 26 (1) ◽  
pp. 54-61 ◽  
Author(s):  
Durga Bista ◽  
Bal Ram Shrestha ◽  
Prakash Rai ◽  
Akhilesh Chandra Jauhari ◽  
Vishnu Kant Kulshrestha

The Pharmacovigilance program in Nepal is at very preliminary stage. Present study analyzed the pattern, causality, severity and preventability of the reported adverse drug reactions (ADRs) to the Pharmacovigilance center at Nepal Medical College and Teaching Hospital (NMCTH), from June 2007 to July 2011. A total of 40 ADR cases were reported, among which 23 (57.5%) were in males and 17 (42.5%) in females. Nineteen (47.5%) ADRs were reported in the age group between 21-40 years. Department of Medicine reported 12(30%) ADRs. Among the total ADRs, antibiotics [n=17, (42.5%)] were responsible for most of the reactions followed by non steroidal anti-inflammatory drugs [n=5, (12.5%)]. Most of the drugs were found to affect dermatological system [n=14, (35%)]. Carbamazepine accounted for 5 (12.5%) ADRs. The causality assessment showed 34 (85%) of the ADRs to have a ‘probable’ relationship with the suspected reaction.DOI: http://dx.doi.org/10.3126/jnpa.v26i1.6633JNPA. XXVI(1) 2012 54-61


1970 ◽  
Vol 8 (1) ◽  
pp. 11-16 ◽  
Author(s):  
Sneegdha Poddar ◽  
Razia Sultana ◽  
Rebeka Sultana ◽  
Maruf Mohammad Akbor ◽  
Mohammad Abul Kalam Azad ◽  
...  

The objective of the present study was to evaluate the pattern of adverse drug reactions (ADRs)occurring in cancer patients treated with chemotherapy in tertiary care hospitals in Bangladesh. A prospectivehospital based study over a period of six month was carried out in the Department of oncology, Bangabandhu SheikhMujib Medical University and Dhaka Medical College Hospital. The data were subjected to descriptive analysis. Atotal of 50 patients having ADRs due to cancer chemotherapy were randomly selected. Adverse drug reactions weremostly occurred in the age group between 41-50 years (26%). Considering socio-economic status of cancer patientsmarried persons (82%) have significantly higher risk than unmarried (18%). Prevalence of breast cancer (20%),cervical cancer (14%) and leukemia (16%) were higher and they were treated mostly by adjuvant chemotherapy(46%) and secondly by chemotherapy (38%) alone. In most cases ADRs were developed in patients receivingalkylating agents (40%) and antimetabolites (40%) as anticancer therapy. The five certain ADRs observed in thecurrent study were nausea, stomatitis, alopecia, myelosuppression and increased ESR level in both male and femalepatients. Moreover, hematological system was affected severely by alkylating agents and antimetabolites. Similarstudies covering more patients from different regions are needed to validate our findings.Key words: ADRs; Cancer; Chemotherapy; Tertiary hospital; Bangladesh.DOI: 10.3329/dujps.v8i1.5330Dhaka Univ. J. Pharm. Sci. 8(1): 11-16, 2009 (June)


Author(s):  
Ravi D. Mala ◽  
D. M. Ravichand ◽  
B. V. Patil ◽  
B. S. Payghan ◽  
Anurag Yadav

Background: Adverse drug reactions (ADRs) are noxious and unintended effects of a drug that occurs at doses normally used in humans. ADRs may also result in diminished quality of life, increased physician visits, hospitalizations, and even death. The objectives of this study are to analyze and assess the causality and severity of reported ADRs.Methods: A cross sectional study of ADRs reported to Pharmacovigilance cell of MNR Medical College and Hospital Sangareddy in a year. The details of the various ADRs were statistically analyzed to find out pattern of ADRs. The WHO-UMC causality category and Hartwig-Seigel Scale were used to assess causality and severity of ADRs respectively.Results: The study shows, out of 60 suspected ADRs, the majority of ADRs were adults (68.3%) and out of whom 56% were females. According to the WHO-UMC Causality categories, 43.3% of the ADRs were categorized under Probable/likely, followed by possible (35%). The Hartwig-Siegel severity assessment scale shows that the majority (90%) of suspected ADRs were of mild category.Conclusions: The pattern of ADRs reported in our study is comparable to other studies. The commonest organ system affected was gastrointestinal tract, nervous and cutaneous system. Antimicrobial agents were causing maximum ADRs and medicine and allied departments have more number of ADRs. This study provides a valuable database for ADRs due to all commonly used drugs at hospitals and also helps in creating awareness regarding safe & judicious use of drugs to prevent ADRs.


Author(s):  
Supriya K. H. ◽  
Shashikumar N. S. ◽  
Prakash G. M. ◽  
Rajeshwari N.

Background: Medication errors are one of the most common types of medical error that is seen in hospitalised patients. Since medication error is one of the growing concerns of healthcare issue and have implications on patient safety, the purpose of this study was to identify medication error and in turn would help to create awareness among healthcare professionals and provide safety to the patients.Methods: Study was initiated after obtaining approval from the Institutional Ethics Committee. The study was done for a period of 1 year between June 2016 and May 2017. Clinical data and data regarding the medication that was prescribed, transcribed, dispensed, administered was collected and was analysed for various types of medication errors during the different stages of medication use process.Results: A total of 351 subjects were recruited in the study for assessing medication error. About 2,283 drugs were prescribed among 351 patients. Maximum number of drugs was administered through parenteral route (50.3%). Medication error was most common during the prescribing stage (51.4%) followed by transcribing stage (39.1%), administration stage (6.9%), and dispensing stage (2.6%). On an average 6 drugs were prescribed per patient. Total of about 5411 errors have occurred out of which 98.8% of errors were preventable, 1.2% of errors were non-preventable. Cardiovascular system (21.9%) and endocrine and renal system (21.9%) was commonly affected due to the medication errors.Conclusions: Medication errors are one of the commonest problems of the healthcare system should be identified and documented and their causes should be studied in order to develop systems that minimize the recurrence.


2016 ◽  
Vol 12 (2) ◽  
pp. 71-75
Author(s):  
Md Niamul Gani Chowdhury ◽  
Mohammad Enamul Hoque ◽  
Md Abdul Latif Khan ◽  
Md Shirajul Islam Khan

Introduction: The Severe Cutaneous Adverse Drug Reactions (SCADRs) are rare but life-threatening as these encompass drug reaction with eosinophilia and systemic symptoms (DRESS), Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN) and acute generalized exanthematous pustulosis (AGEP). Objective: To estimate the incidence of SCADRs and to find out the cause in Bangladesh. Materials and Methods: 50 patients with SCADRs were studied over a period of 1 year from January 2015 to December 2015 in the Department of Dermatology, Combined Military Hospital, Dhaka. Data were collected from the informant and recorded in structured Case Report Form. Quantitative data were expressed as mean and standard deviation and qualitative data as frequency and percentage. Results: Clinical diagnosis of the study subjects recognized 46.0% cases as SJS, 28(19.0%) as TEN, 16.0% as DRESS and 10.0% as AGEP. The maximum incidence (46%) was seen in the age group of 31-50 years; mean age of the patient was 37.42+5.3 years. Male and female ratio was 2.84:1. Anticonvulsant group of drugs could give rise to maximum incidence of SCADRs. Carbamazepine was responsible in 22.0% cases of SCADRs, followed by Phenytoin in 16.0% patients and Phenobarbital in 14.0% cases. Conclusion: SCADRs were seen mostly with the anticonvulsant drugs belonging to Carbamazepine and Phenytoin group. SCADRs deserve continuous monitoring to plan preventive strategies. Journal of Armed Forces Medical College Bangladesh Vol.12(2) 2016: 71-75


2021 ◽  
Vol 2 (2) ◽  
pp. 33-38
Author(s):  
Rajalakshmi Rukmangathen ◽  
Vasundara Devi Brahmanapalli

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.


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