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Adverse Drug Reaction

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1. Long-Term Drug Therapy and Drug Holidays for Osteoporosis Fracture Prevention: A Systematic Review

, Los Angeles Los Angeles, CA Nancy Lane, M.D. Director and Distinguished Professor Center for Musculoskeletal Health and Department of Internal Medicine University of California at Davis, School of Medicine Sacramento, California Jasvinder Singh, M.D., M.P.H. Division of Rheumatology University of Alabama Birmingham, AL vii Long-Term Drug Therapy and Drug Holidays for Osteoporosis Fracture Prevention: A Systematic Review Structured Abstract Objective. To summarize the effects of long-term (...) Long-Term Drug Therapy and Drug Holidays for Osteoporosis Fracture Prevention: A Systematic Review Long-Term Drug Therapy and Drug Holidays for Osteoporosis Fracture Prevention: A Systematic Review Comparative Effectiveness Review Number 218 RComparative Effectiveness Review Number 218 Long-Term Drug Therapy and Drug Holidays for Osteoporosis Fracture Prevention: A Systematic Review Prepared for: Agency for Healthcare Research and Quality U.S. Department of Health and Human Services 5600

2019 Effective Health Care Program (AHRQ)

2. The effect of SENATOR (Software ENgine for the Assessment and optimisation of drug and non-drug Therapy in Older peRsons) on incident adverse drug reactions (ADRs) in an older hospital cohort - Trial Protocol. Full Text available with Trip Pro

The effect of SENATOR (Software ENgine for the Assessment and optimisation of drug and non-drug Therapy in Older peRsons) on incident adverse drug reactions (ADRs) in an older hospital cohort - Trial Protocol. The aim of this trial is to evaluate the effect of SENATOR software on incident, adverse drug reactions (ADRs) in older, multimorbid, hospitalized patients. The SENATOR software produces a report designed to optimize older patients' current prescriptions by applying the published STOPP (...) and START criteria, highlighting drug-drug and drug-disease interactions and providing non-pharmacological recommendations aimed at reducing the risk of incident delirium.We will conduct a multinational, pragmatic, parallel arm Prospective Randomized Open-label, Blinded Endpoint (PROBE) controlled trial. Patients with acute illnesses are screened for recruitment within 48 h of arrival to hospital and enrolled if they meet the relevant entry criteria. Participants' medical history, current prescriptions

2019 BMC Geriatrics Controlled trial quality: predicted high

3. Evaluation of Adverse Drug Reaction Profile of Drugs Used as First-Line Antiretroviral Therapy Full Text available with Trip Pro

Evaluation of Adverse Drug Reaction Profile of Drugs Used as First-Line Antiretroviral Therapy The objective was to study the adverse drug reaction (ADR) profile in HIV patients receiving first-line antiretroviral therapy.This was a prospective, observational study that included 171 HIV patients with a follow-up at six months. Demographic details, medical history, details of HIV infection including most recent CD4 count, details of antiretroviral therapy, and other concomitant medication were (...) recorded. Adverse drug reactions were elicited by reviewing patient records and also by interviewing the patient/attendants directly.171 patients completed the study out of which 88 (51.5%) were males and 83 (48.5%) were females. The study subjects included HIV-positive, treatment naïve patients who were started on treatment regimens recommended by the NACO guidelines. The ADRs observed were a fall in haemoglobin or absolute anaemia in response to zidovudine, nonspecific symptoms like headache

2018 Interdisciplinary perspectives on infectious diseases

4. Anticancer Drugs Induced Severe Adverse Cutaneous Drug Reactions: An Updated Review on the Risks Associated with Anticancer Targeted Therapy or Immunotherapies Full Text available with Trip Pro

Anticancer Drugs Induced Severe Adverse Cutaneous Drug Reactions: An Updated Review on the Risks Associated with Anticancer Targeted Therapy or Immunotherapies Cutaneous adverse drug reactions are commonly seen in patients with anticancer drug treatment. Anticancer drugs, including chemotherapy, target therapy, and recent immunotherapy causing skin reactions ranging from mild skin rash to life-threatening severe cutaneous adverse reactions (SCARs), such as Stevens-Johnson syndrome (SJS (...) ) and toxic epidermal necrosis (TEN) with increase morbidity and mortality while they are receiving cancer treatments, have been proposed to be a result of direct skin toxicity or drug hypersensitivity reactions (these are proposed mechanism, not definite). Differentiating SCARs from other more commonly seen reactions with a better outcome help prevent discontinuation of therapy and inappropriate use of systemic immunosuppressants for presumable allergic reactions, of which will affect the clinical

2018 Journal of immunology research

5. Using Clinical Laboratory Tests to Monitor Drug Therapy in Pain Management Patients

by the treating clinicians. These could include patients with a known history of abuse for medications in this category. However, it may also include drugs where the prevalence of use/abuse is endemic to local region. In addition, it applies to patients who have poly- pharmacy that puts them at an increased risk of adverse drug reactions, or to detect patients with multiple providers. Further- more, it may also apply to patients who experience a lack of effi- cacy for one of these drugs or who may (...) Using Clinical Laboratory Tests to Monitor Drug Therapy in Pain Management Patients LABORATORY MEDICINE PRACTICE GUIDELINES EDITED BY LORALIE J. LANGMAN AND PAUL J. JANNETTO Using Clinical Laboratory Tests to Monitor Drug Therapy in Pain Management Patients Co-Sponsored byLABORATORY MEDICINE PRACTICE GUIDELINES Using Clinical Laboratory Tests to Monitor Drug Therapy in Pain Management Patients Loralie J. Langman Committee Chair Department of Laboratory Medicine and Pathology Mayo Clinic

2018 American Academy of Pain Medicine

6. Drug Therapy for Early Rheumatoid Arthritis: A Systematic Review Update

-analysis: Discontinuations due to adverse events, non-TNF versus non-TNF 113 Appendixes Appendix A. Search Strings Appendix B. Excluded Articles Appendix C. Detailed Evidence Table Appendix D. Risk of Bias Ratings and Rationales for Included Studies Appendix E. Strength of Evidence for Key Questions 1-4 Outcomes Appendix F. Eligible Clinical and Self-Reported Scales and Instruments Commonly Used in Eligible Studies of Drug Therapy for Rheumatoid Arthritis Appendix G. Tests of Consistency for Main (...) therapies including reducing disease activity, slowing or limiting the progression of joint damage, or inducing remission Clinical tools including: • ACR 20/50/70 • DAS • Sharp Score b 2. Benefits of drug therapies including improving patient-reported symptoms, functional capacity, or quality of life Clinical tools including: • HAQ • SF-36 3. Harms of drug therapies including tolerability, patient adherence, and adverse effects Harms including: • Overall discontinuations • Discontinuations attributable

2018 Effective Health Care Program (AHRQ)

7. The economic impact of pharmacogenomics test-guided drug therapy for the prevention of adverse drug reactions (ADRs) with clinical evidence and recommendations from CPIC guideline: a systematic review

The economic impact of pharmacogenomics test-guided drug therapy for the prevention of adverse drug reactions (ADRs) with clinical evidence and recommendations from CPIC guideline: a systematic review Print | PDF PROSPERO This information has been provided by the named contact for this review. CRD has accepted this information in good faith and registered the review in PROSPERO. The registrant confirms that the information supplied for this submission is accurate and complete. CRD bears (...) research paper (e.g. review, editorial) 2. Not an in vivo animal study 3. No metastases/ only primary tumor 4. No control group 5. Combination therapy or contamination 6. Not about analgesics used in the clinic Full text-screening: As above, with the addition of: 7. No relevant outcome measure reported ">Prioritise the exclusion criteria Example: Two reviewers will independently extract data from each article. We first try to extract numerical data from tables, text or figures

2019 PROSPERO

8. Adverse Drug Reactions Among Patients Initiating Second-Line Antiretroviral Therapy in South Africa Full Text available with Trip Pro

Adverse Drug Reactions Among Patients Initiating Second-Line Antiretroviral Therapy in South Africa Understanding the occurrence of antiretroviral (ARV)-related adverse events (AEs) among patients receiving second-line antiretroviral therapy (ART) is important in preventing switches to more limited and expensive third-line regimens.This study aimed to estimate the rates and examine predictors of AEs among adult HIV-1-infected patients receiving second-line ART in the Right to Care (RTC (...) ) clinical cohort in South Africa.This was a cohort study of HIV-1-infected adult patients (≥ 18 years of age) initiating standard second-line ART in South Africa from 1 April 2004 to 10 January 2016. Our primary outcome was the development of an AE within 24 months of initiating second-line therapy. We used Kaplan-Meier survival analysis to determine AE incidence in the first 24 months of second-line ART. Predictors of AEs were modelled using a Cox proportional hazards model.A total of 7708 patients

2018 Drug Safety

9. Targeted therapies and adverse drug reactions in oncology: the role of clinical pharmacist in pharmacovigilance Full Text available with Trip Pro

Targeted therapies and adverse drug reactions in oncology: the role of clinical pharmacist in pharmacovigilance Background The majority of adverse drug reactions (ADRs) reported in the summary of product characteristics (SPCs) are based on pivotal clinical trials, performed under controlled conditions and with selected patients. Objectives (1) to observe ADRs in the real-world setting and to evaluate if the supervision of the pharmacist impacts on the management of ADRs and on the satisfaction (...) of patients; (2) to sensitise health professionals and patients on the need to increase the reporting of ADRs, in compliance with Pharmacovigilance. Setting CRO Aviano, Italian National Cancer Institute. Method From February 2013 to April 2015, we conducted an observational study enrolling 154 patients (≥ 18 years) undergoing treatment with at least one of ten targeted-therapies included in the study. Main outcome ADR reporting in the real-world setting. Patient satisfaction with clinical pharmacist

2018 International journal of clinical pharmacy

10. Adverse events in patients with high platelet reactivity following successful chronic total occlusion PCI: The Assessment of Dual AntiPlatelet Therapy with Drug-Eluting Stents (ADAPT-DES) study. (Abstract)

Adverse events in patients with high platelet reactivity following successful chronic total occlusion PCI: The Assessment of Dual AntiPlatelet Therapy with Drug-Eluting Stents (ADAPT-DES) study. Chronic total occlusion (CTO) percutaneous coronary intervention (PCI) typically requires a greater number of stents and longer stent length than non-CTO PCI, placing these patients at greater risk for adverse ischemic events. We sought to determine whether the association between high platelet (...) reactivity (HPR) and the risk of ischemic events is stronger after CTO than non-CTO PCI.Patients undergoing successful PCI in the multicenter ADAPT-DES study were stratified according to whether they underwent PCI of a CTO. HPR was defined as VerifyNow platelet reaction units >208. The study primary endpoint was the 2-year risk target vessel failure ([TVF] defined as cardiac death, myocardial infarction, or target lesion revascularization).CTO PCI was performed in 400 of 8448 patients. HPR was present

2019 American Heart Journal

11. Prescribing medicines in renal impairment: using the appropriate estimate of renal function to avoid the risk of adverse drug reactions

Prescribing medicines in renal impairment: using the appropriate estimate of renal function to avoid the risk of adverse drug reactions Prescribing medicines in renal impairment: using the appropriate estimate of renal function to avoid the risk of adverse drug reactions - GOV.UK GOV.UK uses cookies which are essential for the site to work. We also use non-essential cookies to help us improve government digital services. Any data collected is anonymised. By continuing to use this site, you (...) agree to our use of cookies. Accept cookies You’ve accepted all cookies. You can at any time. Hide Search Register by 26 November to vote in the General Election on 12 December. Prescribing medicines in renal impairment: using the appropriate estimate of renal function to avoid the risk of adverse drug reactions For most patients and most medicines, estimated Glomerular Filtration Rate (eGFR) is an appropriate measure of renal function for determining dosage adjustments in renal impairment; however

2019 MHRA Drug Safety Update

12. Assessment of the expectancy, seriousness and severity of adverse drug reactions reported for chronic obstructive pulmonary disease therapy Full Text available with Trip Pro

obstructive pulmonary disease therapy based on their reporting in the national pharmacovigilance system.This was a prospective, observational, 1-year, real-life study about the pharmacotherapy of a sample of 390 chronic obstructive pulmonary disease patients. Prescribed medicines were systematized and national pharmacovigilance databases were searched for reported adverse drug reactions. The expectedness was evaluated through the review of the summary of product characteristics, the seriousness (...) Assessment of the expectancy, seriousness and severity of adverse drug reactions reported for chronic obstructive pulmonary disease therapy Adverse drug reactions can cause increased morbidity and mortality, and therefore information needs to be studied systematically. Little is known about the adverse drug reactions for chronic obstructive pulmonary disease therapy. The goal of this study is to assess the expectedness, seriousness and severity of adverse drug reactions during chronic

2017 SAGE open medicine

13. Adverse drug reaction monitoring during antimicrobial therapy for septicemia patients at a university hospital in New Delhi Full Text available with Trip Pro

Adverse drug reaction monitoring during antimicrobial therapy for septicemia patients at a university hospital in New Delhi Adverse drug reaction (ADR) is an appreciably harmful or unpleasant reaction, resulting from an intervention related to the use of a medicinal product. The present study was conducted in order to monitor the frequency and severity of ADR during antimicrobial therapy of septicemia.A prospective, observational, and noncomparative study was conducted over a period of 6 months (...) the antimicrobial therapy of septicemia.

2017 The Korean journal of internal medicine

14. Impact of comorbidity on adverse drug reaction profile in a cohort of patients treated with Artemisinin combination therapies for uncomplicated malaria in Nigeria Full Text available with Trip Pro

Impact of comorbidity on adverse drug reaction profile in a cohort of patients treated with Artemisinin combination therapies for uncomplicated malaria in Nigeria Artemisinin-based combination antimalarial therapy (ACTs), is still highly effective in uncomplicated falciparum malaria, however, there remain some concerns in relation to its safety and tolerability. Comorbid disease conditions may influence susceptibility to adverse drug reactions (ADRs) as the presence of multiple disease (...) adverse drug reactions in all, of which 66.2% were recorded in patients with comorbidity, and 34% are patients without comorbidity. The mean age of patients with comorbidities was 38.3 ± 17.5 years and 23.8 ± 17.2 for those without comorbidity. Out of the 979 patients with comorbidity, 36% were hypertensive, 2.2% hypertensive-diabetes, 16.4% peptic ulcer disease, 10.4% HIV/AIDS, 4.4% diabetes and 4.3% were asthmatic. Patients with comorbidity were three times more likely to have adverse drug reaction

2017 Pharmacology research & perspectives

15. Real-world Incidence Proportion of Hepatic Toxicity and All Adverse Drug Reactions (ADRs) in Japanese Patients Receiving Daclatasvir (DCV) Trio Therapy

Real-world Incidence Proportion of Hepatic Toxicity and All Adverse Drug Reactions (ADRs) in Japanese Patients Receiving Daclatasvir (DCV) Trio Therapy Real-world Incidence Proportion of Hepatic Toxicity and All Adverse Drug Reactions (ADRs) in Japanese Patients Receiving Daclatasvir (DCV) Trio Therapy - Full Text View - ClinicalTrials.gov Hide glossary Glossary Study record managers: refer to the if submitting registration or results information. Search for terms x × Study Record Detail Saved (...) Studies Save this study Warning You have reached the maximum number of saved studies (100). Please remove one or more studies before adding more. Real-world Incidence Proportion of Hepatic Toxicity and All Adverse Drug Reactions (ADRs) in Japanese Patients Receiving Daclatasvir (DCV) Trio Therapy The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our

2017 Clinical Trials

16. Drug-induced oral lichenoid reaction during nivolumab therapy. (Abstract)

Drug-induced oral lichenoid reaction during nivolumab therapy. Oral lichenoid reaction, an immune-related adverse event of immunotherapy, has been reported in very few patients receiving anti-programmed cell death receptor-1 (anti-PD-1) therapy. Here, we describe a case of severe stomatitis (grade ≥3 by the Common Terminology Criteria for Adverse Events, version 4.0) accompanied by pharyngolaryngitis that was observed in a patient receiving nivolumab therapy. The stomatitis was diagnosed (...) as drug-induced lichenoid reaction. Nivolumab therapy was discontinued, and the patient was administered systemic prednisolone (1mg/kg). Most of the patient's mucosal changes in the oral cavity and pharyngolarynx resolved within approximately 3 weeks after starting the prednisolone. Clinicians should be aware that severe oral lichenoid reactions can occur in patients receiving anti-PD-1 therapy.Copyright © 2018 International Association of Oral and Maxillofacial Surgeons. Published by Elsevier Ltd

2018 International Journal of Oral and Maxillofacial Surgery

17. Drug reaction with eosinophilia and systemic symptoms after daclizumab therapy. (Abstract)

Drug reaction with eosinophilia and systemic symptoms after daclizumab therapy. To report on 2 women with multiple sclerosis (MS) who developed severe neurologic deterioration and a drug reaction with eosinophilia and systemic symptoms (DRESS) after treatment with 2 and 4 subcutaneous injections of daclizumab, respectively.This report includes clinical, MRI, and histopathologic data.Daclizumab is a humanized monoclonal antibody that binds the interleukin-2 receptor. It was approved (...) for the treatment of relapsing MS. DRESS is an immunologic reaction to various medications that is characterized by eosinophilia as well as cutaneous and visceral manifestations. Following daclizumab treatment, both patients showed fulminant neurologic deterioration along with blood eosinophilia and skin changes, and both fulfilled the clinical criteria for the diagnosis of DRESS. They presented with multiple gadolinium-enhancing supra- and infratentorial lesions, with lesions in the basal ganglia

2018 Neurology

18. Biotechnologically produced drugs as second-line therapy for rheumatoid arthritis

of patients with therapy adaptation, in 4 studies the result is not classified as robust. ADR: adverse drug reactions, AE: adverse event, CI: confidence interval, DA: disease activity, DAS: Disease Activity Score, EQ-5D: EuroQol-5D, ESR: erythrocyte sedimentation rate, FACIT-F: Functional assessment of chronic illness therapy – Fatigue, HAQ-DI: Health Assessment Questionnaire-Disability Index, MTX: methotrexate, OR: Odds Ratio, Pat.: patients, RA: rheumatoid arthritis, RD: risk difference, SAE: serious (...) : Positive effect estimates mean better values under tocilizumab. e: Solely p-value taken into account in the present benefit assessment. ADR: adverse drug reactions, CI: confidence interval, DA: disease activity, DAS: Disease Activity Score, ESR: erythrocyte sedimentation rate, FACIT-F: Functional Assessment of Chronic Illness Therapy – Fatigue, HAQ: Health Assessment Questionnaire, MTX: methotrexate, OR: odds ratio, Pat.: patients, RA: rheumatoid arthritis, RD: risk difference, SMD: standardized mean

2013 Institute for Quality and Efficiency in Healthcare (IQWiG)

19. Assessing Adverse Drug Reactions from Psychotropic Medications Reported to the U.S. Food and Drug Administration in Older Adults. (Abstract)

Assessing Adverse Drug Reactions from Psychotropic Medications Reported to the U.S. Food and Drug Administration in Older Adults. Identify trends in adverse drug reactions (ADRs) reported to the U.S. Food and Drug Administration's Adverse Event Reporting System in three subpopulations of older adults (ages 55-64, 65-74, 75+) receiving psychotropic medications.Almost 12 years of ADR reports were compiled for adults over 55 years of age receiving psychotropic medications with known side effect (...) profiles. A comparison of the frequency of ADRs reported, odds ratios (ORs), and 95% confidence intervals (CIs) between subpopulations to the whole population of patients aged 55+ was conducted.ADRs reported in three subpopulations of older adults differed significantly when receiving the same psychotropic medications. For example, reports of increased blood glucose (OR, 1.8, CI, 1.4-2.2) were all significantly increased in the youngest population (55-64).Current classification of age greater than 65

2018 The American Journal of Geriatric Psychiatry

20. Preventable adverse drug reactions as percentage of total

Preventable adverse drug reactions as percentage of total DSEN Abstract: Preventable Adverse Drug Reactions as a Proportion of Adverse Drug Reactions - CIHR Language selection Search and menus Search Search website Search Topics menu You are here: DSEN Abstract Preventable Adverse Drug Reactions as a Proportion of Adverse Drug Reactions *This research was funded by the Drug Safety and Effectiveness Network (DSEN) and conducted by the following investigators: Dianna Wolfe, Fatemeh Yazdi, Salmaan (...) Kanji, Andrew Beck, Claire Butler, Leila Esmaeilisaraji, Candyce Hamel, Mona Hersi, Becky Skidmore, David Moher, Brian Hutton. The statements made herein are those of the stated authors, who are independent researchers. What is the issue? Preventable adverse drug reactions (PADRs) in inpatients are linked with harms, including increased length of stay and potential loss of life, and result in elevated costs of care. The incidence of inpatient PADRs in Canada and internationally is unclear. Summary

2018 Drug Safety and Effectiveness Network

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