scholarly journals The pattern of reported adverse drug reactions with reference to specific drug class and organ system

Author(s):  
Margaret Viola Jillapegu ◽  
Dhishan Sai Kumboju Srinivasulu ◽  
Umamaheswara Raju Sarikonda ◽  
Raghunatha Rao Ponnaluri ◽  
Jahnavi Tiruveedhula

Background: Adverse drug reactions (ADRs) represent a major public health problem. The overall ADR rate is estimated to be 6.5 and 28% of these are preventable.ADR incidence in Indian population ranges between 1.8-25% with 8% resulting in hospitalization. Hence, the present study was undertaken to study the pattern of reported adverse drug reactions with reference to specific drug class and organ system in a tertiary care hospital.Methods: A cross-sectional retrospective study was carried to analyse the ADRs reported over a period of one year (January-December 2019). Individual case safety reports (ICSRs) of all patients of suspected adverse drug reactions seen in various out-patient departments and admitted in the wards of the hospital were included in the study. The ICSRs were analysed for patient demography, causality, severity and with reference to specific drug class and organ system.Results: Among 382 reported ADRs, 27.2% of the ADRs were reported as serious. The most common therapeutic class of drugs causing ADRs where Antimicrobial agents (36.07%). The skin is the most common affected organ system (25.39%).Conclusions: A coordinated system of identifying the ADRs early in the course of treatment and recognizing the preventable ADRs is required by the health care system. The coordination of prescribing physicians and pharmacovigilance personnel can produce better trend of reporting the ADRs.

Author(s):  
Sangeetha Raja ◽  
Jamuna Rani R ◽  
Kala P

ABSTRACTObjective: The aim of this study was to carry out adverse drug reactions (ADRs) monitoring in various departments of a tertiary care teaching hospital.Methods: A cross-sectional study was conducted on ADRs reported in the hospital from December 2012 to May 2013 after obtaining InstitutionalEthics Committee approval.Results: A total of 40 ADRs were reported, 47.50% were males and 52.50% were females. The female adult population was 45%. The majority of ADRswere due to antimicrobial agents especially beta-lactam antibiotics (42.5%) followed by NSAIDs (7.50%). A maximum number of patients (75%)were reported with dermatological manifestations. The department of medicine reported the highest number of ADRs (37.5%). As per Naranjo’sprobability scale, 62.5% reports were assessed as probable. 62.5% reports were documented as mild according to Modified Hartwig’s criteria forseverity assessment.Conclusion: This study was done to sensitize the practicing physicians on the importance of adverse drug monitoring and reporting.Keywords: Pharmacovigilance, Adverse drug reactions, Tertiary care teaching hospital, Antimicrobial agents.


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):  
Anand M Ingale ◽  
Pratibha Nadig ◽  
Ananya Chakraborty

Objectives: The objectives of the study were to analyze the various adverse drug reactions (ADRs) collected in the Pharmacovigilance Unit of Vydehi Institute of Medical Sciences and Research Centre with respect to their causality, severity, and preventability and also to identify the various risk factors, concomitant medications, and comorbid conditions with the occurrence of these events.Methods: A prospective, non-interventional, observational, and cross-sectional study was carried out in the various clinical departments of Vydehi Institute of Medical Sciences and Research Centre from June 2014 to May 2015. The Classes of drugs, Organ system involved, Comorbid conditions associated and Concomitant drugs involved in causing ADRs were looked into. The assessment for causality and severity was determined by Naranjo and Modified Hartwig and Siegel scales, respectively. The data were compiled and subjected to descriptive statistical analysis.Results: A total of 433 patients developing ADR reports were analyzed during our study period. Of these, 53.59% were females. 75% of them were of adult age group. Antimicrobials and chemotherapy group showed the maximum ADRs. The skin and appendages (27.6%) were the most affected organ system followed by the gastrointestinal system (22.8%). Comorbid conditions were found in 76 (20.1%) reports; of which diabetes (28.9%) and hypertension (26.3%) were maximum. 74 were serious reports. Maximum reports were probable and of mild severity.Conclusion: Through active surveillance of the ADRs helps in early detection and prevention of all the possible adverse events associated with the usage of drugs and thereby provides a better health-care treatment to the patients. 


2020 ◽  
pp. 1-3
Author(s):  
Anup Latne ◽  
Prabhakar Jirvankar

Hypertension is a major public health problem all over the world. The incidence of hypertension is increasing year after year and the prevalence of hypertension is increasing day by day due to increased life expectancy and aging population and their sedentary lifestyle. Hypertension is known to cause microvascular changes and increased cardiovascular risk from it. Microalbuminuria possibly reflects a state of increased renal endothelial permeability and is an easily measured marker of rather diffuse endothelial dysfunction, low grade inflammation and vascular disease burden2. Microalbuminuria has been determined as an important prognostic indicator and has been reported to be associated with increased cardiovascular risk and progressive renal damage. Reliable data on the prevalence of microalbuminuria in the general population and its association with cardiovascular risk factors is limited. Till now, there is little data available regarding screening and early treatment of hypertensive patients with microalbuminuria, as in the case of microalbuminuric non diabetic subjects. With these perspective this cross sectional study of microalbuminuria in non-diabetic hypertensive patients was undertaken to study prevalence of microalbuminuria in Non Diabetic hypertensive patients. Objectives: To determine the prevalence of microalbuminuria in non-diabetic hypertensive patients and to correlate the presence of microalbuminuria with the patients of different clinical profiles. Materials and Methods: This was observational, cross sectional study of Patients diagnosed with hypertension either admitted in ward or attending OPD of Medical College and Tertiary Care Centre. Urine microalbumin creatinine ratio was used for estimation of microalbuminuria. Conclusion: It was proved that microalbuminuria prevalence was directly proportional to the duration of hypertension, the stage of hypertension. Prevalence of microalbuminria was low in ACE inhibitor and ARB treated hypertensive patients.


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.


Author(s):  
Abdul Aslam P. ◽  
Sangeetha Purushothaman ◽  
Jihana Shajahan

Background: Adverse drug reactions (ADRs) are an important concern in modern therapeutics. Due to limitations in identifying ADRs during research phase, organized post marketing studies are essential. However, there are only few recent studies on this subject available in India. Hence this study was done in a tertiary care hospital in South Kerala to evaluate the profile and causality of ADRs.Methods: The details of patients who developed ADRs during the period from October 2016 to November 2017 were collected. Data collection was done using the suspected drug reactions monitoring form by CDSCO used under PvPI and a retrospective observational cross-sectional analysis was done. The profile and causality of ADRs were evaluated.Results: The total number of ADR events reported was 300. 179 ADRs were hypersensitivity reactions (Aronson Type B) and the remaining 121 reactions were Type A reactions. The individual drug class causing majority of the ADRs was antibiotics (36%). Commonest significant dose related ADR was bleeding (7%) caused by combined use of antiplatelets and anticoagulants. The organ system most affected as per SOC classification was skin and appendages (56%). Causality assessment revealed that majority (76%) belonged to “probable” category, whereas 23.6% were of “possible” type.Conclusions: The development of ADRs can significantly affect treatment course – interruption of drug therapy, use of additional drugs and prolonged hospital stay. Employing monitors dedicated to ADR detection and education of prescribers to closely monitor patients can help manage ADRs effectively.


Author(s):  
Aparna S. Chincholkar ◽  
Alisha Naik

Background: Adverse Drug Reactions (ADRs) are a major cause of morbidity and mortality. Under reporting of ADRs by health care professionals is a very common problem worldwide. So, the present study was planned to assess the knowledge, attitude and practices of postgraduate (PG) students towards ADR reporting and suggest possible ways for improvement.Methods: It was a cross sectional questionnaire-based study conducted among 44 PG students using a questionnaire with questions on knowledge (21), attitude (13) and practices (15) of ADR reporting. The questionnaire was analyzed question wise and the percentage was calculated using Microsoft Excel spreadsheet in Microsoft Office 2010 software.Results: Most of them were aware of the term pharmacovigilance (PV) (95.45%). 54.55% agreed to be trained on how to report an ADR. 88.63% knew about the existence of pharmacovigilance committee in the institute.93% of participants knew that Central Drug Standard Control Organization (CDSCO) is responsible for monitoring of ADRs. 56.82% were aware about VIGIBASE an online software to report ADR. 81.82% of participants had agreed to witness ADRs in patients but only 38.64% reported them. The main reason behind it was non – availability of ADR forms. 42.55% opine that mobile based app would be the most preferred method to send ADR information to an ADR reporting center.Conclusions: There exists a huge gap between ADR experienced and ADR reported by PG students. Participants agreed upon necessity of reporting ADR and periodic briefing about PV.


Author(s):  
Krishnakanth K. ◽  
Jagadeesh A. ◽  
Swetha T. D.

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.


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