scholarly journals ADVERSE DRUG REACTIONS: AN OVERVIEW OF THE OLD AND CONTINUOUS CHALLENGE TO DRUG THERAPY AND DEVELOPMENT

2012 ◽  
Vol 1 ◽  
Author(s):  
Abdelbaset A Elzagallaai
Keyword(s):  
Drug Therapy ◽  
Drug Development ◽  
Adverse Drug Reactions ◽  
Hospital Admissions ◽  
Current Knowledge ◽  
The United States ◽  
World Health ◽  
Drug Reactions ◽  
Major Health Problem ◽  
Health Organization

Adverse drug reactions (ADRs) represent a major health problem worldwide and constitute a big challengeto drug therapy and the drug development process. ADRs are responsible for 3% of total hospital admissions and occur in 10 to 20% of hospitalized patients. It has been estimated that ADRs account for at least 100,000 deaths annually in the United States alone ranking them as the fifth leading cause of death. According to the World Health Organization definition an ADR is a noxious and unintended response to a drug that occurs at a dose normally used in man for prophylaxis, diagnosis or therapy. This commonly used definition, however, excludes other drug therapy consequences such as drug abuse, accidental and inadvertent drug overdose and therapeutic failure. ADRs are classified into two main groups: Type A, which are predictable from the drugs’ normal pharmacological actions and are dose dependent and Type B, which are unpredictable, unrelated to the drugs’ pharmacology and do not have clear dose dependency. This is an overview of the currently used definitions and classifications of ADRs in clinical pharmacology and toxicology. Specific relevant examples are cited and some important points are discussed in the light of current knowledge. A special emphasis is made on the importance of ADRs in clinical drug therapy and drug development, which are the areas where ADRs play the most significant role.

Pediatric Infectious Diarrhea and Dehydration

2018 ◽  
Author(s):  
John W. Martel ◽  
Scott McCorvey
Keyword(s):  
Hospital Admissions ◽  
The United States ◽  
World Health ◽  
Volume Depletion ◽  
Clinical Criteria ◽  
American Academy Of Pediatrics ◽  
Outpatient Visits ◽  
Control And Prevention ◽  
Uremic Syndrome ◽  
Health Organization

Diarrhea is a common emergency department (ED) complaint, leading to more than 1.5 million outpatient visits and 200,000 hospital admissions in the United States alone. Although concomitant dehydration also exists in some cases, there are no standard clinical criteria to aid in identifying those children who merit intravenous resuscitation. Current pediatric volume repletion guidelines are based primarily on the estimated degree of volume depletion per the World Health Organization, Centers for Disease Control and Prevention, and American Academy of Pediatrics criteria. These practice guidelines stratify patients into mild (3 to 5% volume depletion), moderate (5 to 10% volume depletion), and severe (> 10% volume depletion).  This review contains 5 figures, 9 tables, and 64 references. Key Words: Clostridium difficile, dehydration, diarrhea, gastroenteritis, hemolytic-uremic syndrome, pediatrics

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 An opportunity for clinical pharmacology trained physicians to improve patient drug safety: A retrospective analysis of adverse drug reactions in teenagers

F1000Research ◽  
2018 ◽  
Vol 7 ◽  
pp. 677 ◽  
Author(s):  
Andy R. Eugene ◽  
Beata Eugene
Keyword(s):  
Clinical Pharmacology ◽  
Drug Interactions ◽  
Adverse Drug Reactions ◽  
Hospital Admissions ◽  
The United States ◽  
Drug Reactions ◽  
The Third ◽  
Data Limitations ◽  
Ondansetron Hydrochloride ◽  
Improve Patient

Background: Adverse drug reactions (ADRs) are a major cause of hospital admissions, prolonged hospital stays, morbidity, and drug-related mortality. In this study, we sought to identify the most frequently reported medications and associated side effects in adolescent-aged patients in an effort to prioritize clinical pharmacology consultation efforts for hospitals seeking to improve patient safety.   Methods: Quarterly reported data were obtained from the United States Food and Drug Administration Adverse Events Reporting System (FAERS) from the third quarter of 2014 and ending in the third quarter of 2017. We then used the GeneCards database to map the pharmacogenomic biomarkers associated with the most reported FAERS drugs. Data homogenization and statistics analysis were all conducted in R for statistical programming. Results: We identified risperidone (10.64%) as the compound with the most reported ADRs from all reported cases. Males represented 90.1% of reported risperidone cases with gynecomastia being the most reported ADR. Ibuprofen OR=188 (95% CI, 105.00 – 335.00) and quetiapine fumarate OR=116 (95% CI, 48.40 – 278.00) were associated with the highest odds of completed suicide in teenagers. Ondansetron hydrochloride OR=7.12 (95% CI, 1.59 – 31.9) resulted in the highest odds of pneumothorax. Lastly, olanzapine (8.96%) represented the compound with the most reported drug-drug interactions cases, while valproic acid OR=221 (95% CI, 93.900 – 522.00) was associated with the highest odds of drug-drug interactions. Conclusion: Despite any data limitations, physicians prescribing risperidone in males should be aware of the high rates of adverse drug events and an alternative psychotropic should be considered in male patients. Further, patients with a history of pneumothorax or genetically predisposed to pneumothorax should be considered for an alternative antiemetic to ondansetron hydrochloride, due to increased odds associated with the drug and adverse event.

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.

Sign in / Sign up

Export Citation Format

Share Document