scholarly journals Adverse drug reactions in hospitalized cardiac patients: Characteristics and risk factors

2015 ◽  
Vol 72 (11) ◽  
pp. 975-981 ◽  
Author(s):  
Snezana Mugosa ◽  
Zoran Bukumiric ◽  
Aleksandra Kovacevic ◽  
Aneta Boskovic ◽  
Dragana Protic ◽  
...  
Keyword(s):  
Risk Factors ◽  
Adverse Drug Reactions ◽  
Health Care Professionals ◽  
Cardiac Patients ◽  
World Health ◽  
Drug Reactions ◽  
Probability Scale ◽  
Clinical Centre ◽  
Health Organization ◽  
Symptoms And Signs

Background/Aim: Adverse drug reactions (ADRs) appear more frequently than actually reported and registered. The main goal of our work was to analyze risk factors, incidence and characteristics of ADRs in hospitalized cardiac patients. Methods. This prospective study included 200 patients, hospitalized at Cardiology Center of the Clinical Centre of Montenegro. ADRs were collected using specially designed questionnaire, based on the list of symptoms and signs that could point out to potential ADRs. Data from medical charts of patients, lab tests and other available parameters were observed and combined with the data from questionnaire. Severity of ADRs were assessed as serious or nonserious according to the World Health Organization criteria. Causality was assessed using the Naranjo probability scale. Results. A total of 34% of all the patients experienced at least one ADR. The most common ADRs occurred as nervous system disorders, less frequent were cardiovascular disorders, while the immune system disorders were the rarest. Sixteen percent of all ADRs were characterized as serious, most often caused by carvedilol and amiodarone. The majority of patients (97.3%) recovered without consequences. The multivariate analysis showed independent significant associations between ADRs and age, gender, comorbidities and polypragmasia. Conclusion. ADRs represent a significant issue in hospitalized cardiac patients population. The most significant predictors for ADRs in observed population were age, comorbidity, number of medications used during hospitalization and patients? gender. Preventive measures such as pharmacotherapy rationalization and continual education of health care professionals could reduce the frequency of ADRs appearance in patients with detected risk factors.

Diuretic Drug Utilization Study

1996 ◽  
Vol 12 (4) ◽  
pp. 169-176
Author(s):  
Jaime Torelló ◽  
José A Durán ◽  
María I Serrano
Keyword(s):  
Adverse Drug Reactions ◽  
Diuretic Therapy ◽  
University Hospital ◽  
World Health ◽  
Drug Reactions ◽  
Cardiac Symptoms ◽  
Medicine Service ◽  
Combined Use ◽  
Health Organization ◽  
The University

Objective: To evaluate the present use of diuretics in our institution, and determine the appropriateness of that use and the incidence of adverse reactions and interactions. Design: This retrospective study describes the indications for use of an identified drug or combination of drugs. By the time the data were collected, some patients had been discharged or had died. Setting: The study was carried out in a referral center, the University Hospital “Virgen Macarena,” Seville, Spain. Patients: All patients receiving diuretic therapy. Those undergoing hemodialysis or receiving home care were excluded from the study. Intervention: A therapeutic audit was performed using specific standards of reference. Two models were used — one for each of the most frequent indications, ascites and congestive heart failure (CHF). Main Outcome Measures: A structured protocol gathered data on (1) demographic characteristics, (2) causes of admission and pathologic antecedents, (3) diuretic treatment, (4) basic controls (24-h diuresis and daily basal weight), (5) clinical evolution, and (6) concurrent complementary studies. The protocol included a checklist of the most frequent adverse drug reactions and interactions whose degree of causality was determined by applying the modified algorithm of Karch-Lasagna, used in the World Health Organization voluntary reporting system of adverse drug reactions. Results: One hundred twenty-six patients (16% of total admissions) received diuretic therapy. Of these, 71% were analyzed; information in the medical records was incomplete for the rest (29%). Fifty-one percent of the patients were more than 60 years old. The most frequent admission diagnoses were cardiovascular (51.5%), followed by digestive (16.7%) diseases. A total of 134 cardiac symptoms was seen in 50 patients. The most notable were acute pulmonary edema (26%), ischemic cardiopathy (12%), and cardiogenic shock (8%). Most patients receiving diuretic therapy (47.3%) were admitted to the internal medicine service. The most-prescribed diuretic was furosemide (59%), followed by spironolactone (27%). The combined use of furosemide and spironolactone occurred in all but 1 of the patients with hepatic ascites (92%), whereas in those with CHF the figure for the combined use of furosemide and spironolactone fell to 38% (p = 0.001). In 63% of the patients with ascites, the spironolactone dosage was changed in the first 48 hours of treatment. There was a high percentage of deaths (21%) in the study patients. Conclusions: Therapeutic strategy often does not follow the guidelines laid down in the standards of reference on diuretic use in serious CHF and/or ascites in this institution.

scholarly journals An overview of the worldwide master key for pharmacovigilance and its role in India

2021 ◽  
Vol 2 (2) ◽  
pp. 19-26
Author(s):  
Janmejay Pant ◽  
Harneet Marwah ◽  
Ripudaman M Singh ◽  
Subhajit Hazra
Keyword(s):  
World Health Organization ◽  
Adverse Drug Reactions ◽  
Marketing Authorisation ◽  
World Health ◽  
Drug Reactions ◽  
Regulatory Authorities ◽  
The World ◽  
Health Organization ◽  
Positive Results ◽  
Uppsala Monitoring

Introduction: Pharmacovigilance (PV) is defined as the science and activities related to the detection, assessment, understanding, and prevention of Adverse Drug Reactions (ADRs) and related conditions. Methods: In the 1970s, several significant cases of ADR aided the advancement of the discipline. Between 1989 and 2004, several attempts were made to implement such a program in India, but the scheme was eventually launched in 2010 and is now operating successfully and producing positive results. Results: The pharmacovigilance Program of India (PvPI) contributed different data to the World Health Organization (WHO) Uppsala Monitoring Center (UMC) based on the data gathered from this process. Indian regulatory have sent several alerts to stakeholders and provided the Central Drugs Standard Control Organization (CDSCO) with several recommendations. CDSCO has since advised Marketing Authorisation Holders (MAHs) to follow the same guidelines and has amended the Drugs and Cosmetics Act and Regulations to reflect this. Conclusions: The time has come for Indian regulatory authorities to take the required action based on data generated in our country rather than data generated in several other countries.

scholarly journals Pharmacovigilance programme of India: revival of the renaissance

2018 ◽  
Vol 7 (11) ◽  
pp. 2281
Author(s):  
Jyoti B. Gadhade ◽  
Rajesh S. Hiray ◽  
Rekha Y. Aherkar ◽  
Kalpana U. Shah
Keyword(s):  
Adverse Drug Reactions ◽  
Adverse Drug Reaction Reporting ◽  
World Health ◽  
Uppsala Monitoring Centre ◽  
Family Welfare ◽  
Drug Reactions ◽  
Monitoring Centre ◽  
The World ◽  
Health Organization

Adverse drug reactions (ADRs) are the fourth leading cause of morbidity in the world. In order to safeguard the health of the community, Pharmacovigilance Programme of India (PvPI) is implemented as the monitoring body by Indian Pharmacopoeia Commission (IPC). It is leading national authority. National Coordinating Centre (NCC) PvPI works as the World Health Organization (WHO) collaborating centre for pharmacovigilance. Adverse drug reactions are reported to NCC PvPI which are then directed towards WHO Uppsala Monitoring Centre (UMC) Sweden which is the global monitoring centre for worldwide data. Central Drugs Standard Control Organization (CDSCO) is the regulatory authority of India under the Ministry of Health and Family Welfare (MOHFW), Government of India. This article focusses on the various strands of pharmacovigilance at the healthcare professional and consumer level. It also discusses the pitfalls in the journey of pharmacovigilance thus helping in enhancing the quality of health safety. Even a minuscule contribution by a health care professional or a consumer can voluminously help in promotion of drug safety. Therefore, there is a need of inculcating the culture of adverse drug reaction reporting for the welfare of the vulnerable masses.

The Characteristics of Adverse Drug Reactions in Cancer Patients: An Analysis of Spontaneously Reported Cases

2020 ◽  
Vol 95 (2) ◽  
pp. 104-113
Author(s):  
Hae-Soo Jeon ◽  
Hee-Kyoo Kim ◽  
Gil-Soon Choi
Keyword(s):  
Cancer Patients ◽  
Clinical Features ◽  
Adverse Drug Reactions ◽  
Antineoplastic Agents ◽  
Medical Information ◽  
University Hospital ◽  
World Health ◽  
Drug Reactions ◽  
Iodinated Contrast ◽  
Health Organization

Background/Aims: Although the number of domestic adverse drug reactions (ADRs) reported in Korea is rapidly increasing, the analysis of ADRs in cancer patients remains limited. We sought to investigate the clinical features of ADRs in cancer patients.Methods: ADR data were collected from a spontaneous reporting system at single university hospital, between July 2010 and June 2015. ADR cases assessed to be “unlikely” or “unclassifiable” as per the criteria of the World Health Organization-Uppsala Monitoring Center were excluded. Additional medical information was retrospectively collected from chart reviews, and clinical features of ADRs were analyzed.Results: In total, 1,455 cases were reported. Of these, 822 ADRs (52.1%) were observed in cancer patients. The mean age of cancer patients was 60.8 years (range, 17–90 years), and 45.9% were male. The most prevalent clinical features were gastrointestinal abnormalities (32.6%), such as nausea and vomiting, followed by skin (28.5%) and neurologic manifestations (26.0%). Fifty-one (6.2%) and 296 cases (36.0%) were classified as severe and moderate, respectively. The most common causative agents were parenteral nutrition (PN) supplements (40.4%), followed by antibiotics (17.8%), analgesics (16.7%), iodinated contrast media (ICM, 10.6%), and vitamins (3.9%). Antineoplastic agents were responsible for 2.9% of cases. PN supplements were commonly associated with severe reactions.Conclusion: Although it is well known that antibiotics, ICM, and analgesics induce ADRs, PN supplements, vitamins, and antineoplastic agents should also be considered as common causes of ADRs in cancer patients. Further investigation and monitoring to determine the causality associated with these agents is required.

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 Dramatyping: A generic algorithm for detecting reasonable temporal correlations between drug administration and lab value alterations

2016 ◽  
Author(s):  
Axel Newe
Keyword(s):  
Adverse Drug Reactions ◽  
Temporal Correlation ◽  
World Health ◽  
Drug Reactions ◽  
Health Records ◽  
Temporal Correlations ◽  
Reference Implementation ◽  
Health Organization ◽  
Python Programming ◽  
Laboratory Test Abnormality

According to the World Health Organization, one of the criteria for the standardized assessment of case causality in adverse drug reactions is the temporal relationship between the intake of a drug and the occurrence of a reaction or a laboratory test abnormality. This article presents and describes an algorithm for the detection of a reasonable temporal correlation between the administration of a drug and the alteration of a laboratory value course. The algorithm is designed to process normalized lab values and is therefore universally applicable. It has a sensitivity of 0.932 for the detection of lab value courses that show changes in temporal correlation with the administration of a drug and it has a specificity of 0.967 for the detection of lab value courses that show no changes. Therefore the algorithm is appropriate to screen the data of electronic health records and to support human experts in revealing adverse drug reactions. A reference implementation in Python programming language is available.

scholarly journals Glucocorticoids: Boon or Bane-An assessment of safety proϐiling of steroids in a tertiary care hospital

2021 ◽  
Vol 12 (2) ◽  
pp. 1611-1619
Author(s):  
Sadhana N Holla
Keyword(s):  
Adverse Drug Reactions ◽  
Tertiary Care Hospital ◽  
Adverse Drug Reaction Reporting ◽  
Tertiary Care ◽  
Careful Consideration ◽  
World Health ◽  
Care Hospital ◽  
Drug Reactions ◽  
Relative Risks ◽  
Health Organization

Glucocorticoids are used in therapy empirically, but undesirable effects occur with large doses or prolonged administration. The aim of the study is to assess the pattern of adverse drug reactions of glucocorticoids in a tertiary care hospital. A retrospective analysis of adverse drug reactions (ADRs) following administration of glucocorticoids was conducted in the ADR monitoring center, Department of Pharmacology, Kasturba Medical College, Manipal. Clinical and treatment data were collected from the patient case records in the suspected adverse drug reaction reporting form as per the World Health Organization guidelines.  ADRs were assessed for Causality, Preventability and Severity using WHO causality assessment scale, Modified Schumock and Thornton’s scale and Hartwig’s severity scale, respectively. 100 ADRs were observed in 85 patients, with 51% males and 49% females. Prednisolone (53%) was the most common drug responsible for ADRs, followed by betamethasone (9%) and dexamethasone (8%). Hyperglycemia (34%) was the most common ADR, followed by cutaneous adverse reactions (32%). Acne (20%) was common among them. Over 86% reactions were categorized "possible". Among ADRs (91%) treated, only 16 % recovered. About 39% of cases were "probably preventable". The majority of ADRs (72%) were moderate in “severity”. Given the number and severity of side effects, the institution of glucocorticoids requires careful consideration of the relative risks and benefits in each patient.

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