scholarly journals Statin-Associated Adverse Events

2015 ◽  
Vol 7 ◽  
pp. CMT.S18865
Author(s):  
Wei Cheng Yuet ◽  
Htet Khine ◽  
Zahid Ahmad
Keyword(s):  
Cognitive Impairment ◽  
Adverse Effects ◽  
Adverse Events ◽  
Health Care Providers ◽  
Hemorrhagic Stroke ◽  
Case Reports ◽  
The United States ◽  
Incident Diabetes ◽  
Care Providers ◽  
United States Food

Although statins are well tolerated, their widespread use has raised awareness of rare adverse events. For example, the United States Food and Drug Administration (FDA) has issued product label warnings about statin-associated myopathy, incident diabetes, and cognitive impairment. Additional statin-associated adverse effects include proteinuria, transaminitis, and hemorrhagic stroke. The underlying pathophysiology of these adverse events remains unclear, and thus little guidance exists on addressing these issues at the bedside. Although statin-associated myopathy is common, many patients eventually tolerate a statin – albeit at less than ideal doses. Incident diabetes remains difficult to predict, but high statin potency, increasing age, and preexisting diabetes risk factors may predispose patients. Cognitive impairment – described mostly in case reports – may resolve after discontinuation of the offending statin. Rosuvastatin is linked to dose-dependent proteinuria. Elevated transaminases are reversible and unlikely to cause severe consequences. History of cerebrovascular disease increases the risk of hemorrhagic stroke on statin therapy. Overall, a thorough understanding of statin-associated adverse events will help health care providers manage patients who develop these complications. Here, we review the evidence for several statin-associated adverse effects and the implications for clinical practice.

Real-world risk of anosmia with cancer directed systemic therapy: A pharmacovigilance assessment using FDA Adverse Events Reporting System (FAERS) database.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e18790-e18790
Author(s):  
Anahat Kaur ◽  
Shuai Wang ◽  
Arlene Yu ◽  
Tarek N. Elrafei ◽  
Lewis Steinberg ◽  
...  
Keyword(s):  
Adverse Events ◽  
Reporting System ◽  
Case Reports ◽  
Descriptive Analysis ◽  
Package Insert ◽  
Case Series ◽  
The United States ◽  
Chemotherapeutic Agents ◽  
United States Food ◽  
Pharmacovigilance Database

e18790 Background: Anosmia is a rare and under-reported adverse event associated with the use of several oncologic drugs. Instances of olfactory disturbances following administration of chemotherapeutic agents have been sporadically documented in case reports and case series. We aimed to conduct a more comprehensive study to generate signal for anosmia as adverse effect of drugs used for oncologic indications. Methods: The United States Food and Drug Administration (FDA) Adverse Events Reporting System (FAERS) database, a pharmacovigilance database, was used to extract data. All reported cases of anosmia in the database were filtered for an indication of cancer. Descriptive analysis was conducted using SPSS 26. Results: Total 10250 cases of anosmia were extracted from FAERS database. Out of these, cancer as an indication for medication use was noted in 139 cases. Some of the most common suspect medications exclusively associated with more than one case of anosmia were palbociclib (n=16), enzalutamide (13), pazopanib (8), cabozantinib (8), letrozole (6), leuprolide (5), niraparib (5), rucaparib (4), tamoxifen (4), capecitabine (3), everolimus (3), anastrazole (2), exemestane (2), zoledronic acid (2), vandetanib (2) and vismodegib (2). Detailed description of medications with highest number of reported cases is listed in Table. Median age at diagnosis was 66 years (interquartile range 58-71). Anosmia was reported more commonly in females (64% ) as compared to males (33.8%). Reactions were reported to the FDA more commonly by consumers (56.8%) as compared to healthcare professionals (40.3% cases). Out of 139 patients with anosmia, 93 (66.9%) had concomitant ageusia, 8 (5.7 %) had dysgeusia and 6 (4.3%) patients had neuropathy. Conclusions: This study demonstrates a signal for anosmia as side effect in patients receiving select oncologic medications based on the FAERS database. It is worth noting that none of the suspect medications identified in this study have anosmia listed as known adverse reaction on accompanying package insert. Further studies need to be conducted to confirm if causal relationship exists between use of these drugs and olfactory function compromise. [Table: see text]

scholarly journals LO20: Naloxone dosing for suspected opioid and ultra-potent opioid overdoses: A systematic review

CJEM ◽  
2019 ◽  
Vol 21 (S1) ◽  
pp. S14
Author(s):  
J. Moe ◽  
J. Godwin ◽  
R. Purssell ◽  
F. O'Sullivan ◽  
J. Hau ◽  
...  
Keyword(s):  
Systematic Review ◽  
Adverse Events ◽  
Clinical Response ◽  
Health Care Providers ◽  
Case Reports ◽  
Data Extraction ◽  
Cochrane Central Register ◽  
Care Providers ◽  
Number Of Patients ◽  
Study Characteristics

Introduction: Optimizing naloxone dosing in the context of increasing fentanyl and ultra-potent opioid (UPO) prevalence is an important consideration for emergency health care providers. The goal of this systematic review was to evaluate the association between initial and cumulative naloxone doses on effective reversal and adverse events in undifferentiated and fentanyl/UPO overdoses. Methods: We searched Embase, MEDLINE, Cochrane Central Register of Controlled Trials, DARE, CINAHL, Science Citation Index, reference lists, toxicology websites, and conference proceedings from July to October 2018 and back to 1972. Our search included pertinent indexing terms for UPOs. We included interventional and observational studies reporting on naloxone administration for opioid toxicity reversal in people ≥12 years old. Additionally, we accessed non-traditional evidence sources (case reports and series) given this rapidly changing field. We conducted inclusion screens, data extraction and quality assessments in duplicate. We summarized study characteristics and where reported, analyzed number of patients with clinical response. Response was defined as not receiving further naloxone doses and remaining alive. Results: We included 174 studies (108 case reports and series, 55 observational, 9 interventional) with 26,660 subjects (median age 35.1; 74.2% male). We observed lower response among patients exposed to fentanyl/UPO versus heroin for initial naloxone doses ≤0.4mg (56.8% versus 80.2%) and > 0.4mg (27.0% versus 82.1%). Mean cumulative doses were higher for fentanyl/UPO (2.10 mg, SD 1.80 mg) versus heroin (1.48 mg, SD 1.68 mg) overdoses. In North American studies the median cumulative dose used was higher for fentanyl/UPO versus heroin overdoses. A dose-response curve for fentanyl/UPO studies showed marked variability in doses among responders, indicating heterogeneity. Adverse events reporting was inconsistent; 10% of subjects experienced withdrawal based on studies in which they were reported. Conclusion: This is the first systematic review to summarize proportion of patients with clinical response by naloxone dose provided. While variable reporting, study quality, heterogeneity, and our outcome definitions limit the conclusions we can draw, it appears that higher initial doses and in some cases, higher cumulative naloxone doses were used and may be necessary to reverse toxicity due to fentanyl/UPO compared to other opioids. High-quality prospective studies assessing effectiveness and safety are needed.

The Special Perils of Being Old and Sick in Prison

2020 ◽  
Vol 32 (5) ◽  
pp. 276-284
Author(s):  
William J. Jefferson
Keyword(s):  
United States ◽  
Health Care ◽  
Medical Care ◽  
Health Care Providers ◽  
The United States ◽  
United States Constitution ◽  
Care Providers ◽  
Medical Practitioners ◽  
Medical Needs ◽  
Access To Medical Care

The United States Supreme Court declared in 1976 that deliberate indifference to the serious medical needs of prisoners constitutes the unnecessary and wanton infliction of pain…proscribed by the Eighth Amendment. It matters not whether the indifference is manifested by prison doctors in their response to the prisoner’s needs or by prison guards intentionally denying or delaying access to medical care or intentionally interfering with treatment once prescribed—adequate prisoner medical care is required by the United States Constitution. My incarceration for four years at the Oakdale Satellite Prison Camp, a chronic health care level camp, gives me the perspective to challenge the generally promoted claim of the Bureau of Federal Prisons that it provides decent medical care by competent and caring medical practitioners to chronically unhealthy elderly prisoners. The same observation, to a slightly lesser extent, could be made with respect to deficiencies in the delivery of health care to prisoners of all ages, as it is all significantly deficient in access, competencies, courtesies and treatments extended by prison health care providers at every level of care, without regard to age. However, the frailer the prisoner, the more dangerous these health care deficiencies are to his health and, therefore, I believe, warrant separate attention. This paper uses first-hand experiences of elderly prisoners to dismantle the tale that prisoner healthcare meets constitutional standards.

A survey of Instagram users with asthma to evaluate the acceptability of a planned clinical trial intervention (Preprint)

2020 ◽  
Author(s):  
Kerry Spitzer ◽  
Brent Heineman ◽  
Marcella Jewell ◽  
Michael Moran ◽  
Peter Lindenauer
Keyword(s):  
United States ◽  
Social Media ◽  
Health Care Providers ◽  
College Education ◽  
The United States ◽  
Survey Study ◽  
Care Providers ◽  
Healthy Behaviors ◽  
Social Media Platforms ◽  
Hispanic White

BACKGROUND Asthma is a chronic lung disease that affects nearly 25 million individuals in the United States. There is a need for more research into the potential for health care providers to leverage existing social media platforms to improve healthy behaviors and support individuals living with chronic health conditions. OBJECTIVE In this study, we assess the willingness of Instagram users with poorly controlled asthma to participate in a pilot study that uses Instagram as a means of providing social and informational support. In addition, we explore the potential for adapting photovoice and digital storytelling to social media. METHODS A survey study of Instagram users living with asthma in the United States, between the ages of 18 to 40. RESULTS Over 3 weeks of recruitment, 457 individuals completed the pre-survey screener; 347 were excluded. Of the 110 people who were eligible and agreed to participate in the study, 82 completed the study survey. Respondents mean age was 21(SD = 5.3). Respondents were 56% female (n=46), 65% (n=53) non-Hispanic white, and 72% (n=59) had at least some college education. The majority of respondents (n = 66, 81%) indicated that they would be willing to participate in the study. CONCLUSIONS Among young-adult Instagram users with asthma there is substantial interest in participating in a study that uses Instagram to connect participants with peers and a health coach in order to share information about self-management of asthma and build social connection.

Effects of Cardiovascular Disease and Related Risk Factors on Neurocognition

2019 ◽  
pp. 83-116
Author(s):  
Spencer W. Liebel ◽  
Lawrence H. Sweet
Keyword(s):  
Cardiovascular Disease ◽  
Older Adults ◽  
Cognitive Processing ◽  
Health Care Providers ◽  
The United States ◽  
Research Literature ◽  
Neurocognitive Functioning ◽  
Care Providers ◽  
Cardiac Events ◽  
Related Risk

Cardiovascular disease (CVD) affects approximately 44 million American adults older than age 60 years and remains the leading cause of death in the United States, with approximately 610,000 each year. With improved survival from acute cardiac events, older adults are often faced with the prospect of living with CVD, which causes significant psychological, social, and economic hardship. The various disease processes that constitute CVD also exert a deleterious effect on neurocognitive functioning. Although existing knowledge of neurocognitive functioning in CVD and its subtypes is substantial, a review of these findings by CVD type and neurocognitive domain does not exist, despite the potential impact of this information for patients, health care providers, and clinical researchers. This chapter provides a resource for clinicians and researchers on the epidemiology, mechanisms, and neurocognitive effects of CVDs. This chapter includes a discussion of neurocognitive consequences of CVD subtypes by neuropsychological domain and recommendations for assessment. Overall, the CVD subtypes that have the most findings available on specific neurocognitive domains are heart failure, hypertension, and atrial fibrillation. Despite a large discrepancy between the number of available studies across CVD subtypes, existing literature on neurocognitive effects by domain is consistent with the literature on the neurocognitive sequelae of unspecified CVD. Specifically, the research literature suggests that cognitive processing speed, attention, executive functioning, and memory are the domains most frequently affected. Given the prevalence of CVDs, neuropsychological assessment of older adults should include instruments that allow consideration of these potential neurocognitive consequences of CVD.

scholarly journals Neurocognitive effects associated with proprotein convertase subtilisin-kexin type 9 inhibitor use: a narrative review

2021 ◽  
Vol 12 ◽  
pp. 204209862095927
Author(s):  
Wei C. Yuet ◽  
Didi Ebert ◽  
Michael Jann
Keyword(s):  
Cognitive Impairment ◽  
Adverse Events ◽  
The United States ◽  
Narrative Review ◽  
Lipid Lowering ◽  
Patient Specific ◽  
Proprotein Convertase ◽  
Pcsk9 Inhibitors ◽  
Pcsk9 Inhibitor ◽  
Receptor Modulation

Neurocognitive adverse events have been observed with the widespread use of 3-hydroxy-3-methylglutaryl-CoA reductase inhibitors or “statins,” which reduce low-density lipoprotein cholesterol (LDL-C) levels and subsequently cardiovascular risk. The United States Food and Drug Association directed manufacturers of proprotein convertase subtilisin-kexin type 9 (PCSK9) inhibitors to monitor for neurocognitive adverse events due to their potent effects on LDL-C reduction, which is a proposed mechanism for neuronal cell dysfunction. Other proposed mechanisms for PCSK9 inhibitor-associated neurocognitive adverse events include N-methyl-d-aspartate receptor modulation, dysregulation of lipid and glucose metabolism, and patient-specific risk factors for cognitive impairment. The purpose of this narrative review article is to describe the proposed mechanisms, incidence of neurocognitive adverse events from phase II and III trials for PCSK9 inhibitors, neurocognitive assessments utilized in clinical trials, and clinical implications. Given the increasing prevalence of PCSK9 inhibitor use and the neurocognitive adverse events observed with prior lipid-lowering therapies, clinicians should be aware of the risks associated with PCSK9 inhibitors, especially when therapy is indicated for patients at high risk for cardiovascular events. Overall, the incidence of PCSK9 inhibitor-associated neurocognitive appears to be uncommon. However, additional prospective studies evaluating cognitive impairment may be beneficial to determine the long-term safety of these agents.

Nurse Practitioner Challenges to the Orthodox Structure of Health Care Delivery: Regulation and Restraints on Trade

1985 ◽  
Vol 11 (2) ◽  
pp. 195-225
Author(s):  
Karla Kelly
Keyword(s):  
Health Care ◽  
Health Care Providers ◽  
Health Care Delivery ◽  
Nurse Practitioners ◽  
Nurse Practitioner ◽  
Allied Health ◽  
Care Delivery ◽  
The United States ◽  
Care Providers ◽  
Allied Health Care

AbstractUntil recently, physicians have been the primary health care providers in the United States. In response to the rising health care costs and public demand of the past decade, allied health care providers have challenged this orthodox structure of health care delivery. Among these allied health care providers are nurse practitioners, who have attempted to expand traditional roles of the registered nurse.This article focuses on the legal issues raised by several major obstacles to the expansion of nurse practitioner services: licensing restrictions, third party reimbursement policies, and denial of access to medical facilities and physician back-up services. The successful judicial challenges to discriminatory practices against other allied health care providers will be explored as a solution to the nurse practitioners’ dilemma.

Patients' Perceptions of Different Information Exchange Mechanisms: An Exploratory Study in the United States

2020 ◽  
Vol 59 (04/05) ◽  
pp. 162-178
Author(s):  
Pouyan Esmaeilzadeh
Keyword(s):  
United States ◽  
Health Care ◽  
Health Information ◽  
Health Care Providers ◽  
Information Exchange ◽  
The United States ◽  
Exchange Mechanism ◽  
Care Providers ◽  
Security Risks ◽  
Direct Exchange

Abstract Background Patients may seek health care services from various providers during treatment. These providers could serve in a network (affiliated) or practice separately (unaffiliated). Thus, using secure and reliable health information exchange (HIE) mechanisms would be critical to transfer sensitive personal health information (PHI) across distances. Studying patients' perceptions and opinions about exchange mechanisms could help health care providers build more complete HIEs' databases and develop robust privacy policies, consent processes, and patient education programs. Objectives Due to the exploratory nature of this study, we aim to shed more light on public perspectives (benefits, concerns, and risks) associated with the four data exchange practices in the health care sector. Methods In this study, we compared public perceptions and expectations regarding four common types of exchange mechanisms used in the United States (i.e., traditional, direct, query-based, patient-mediated exchange mechanisms). Traditional is an exchange through fax, paper mailing, or phone calls, direct is a provider-to-provider exchange, query-based is sharing patient data with a central repository, and patient-mediated is an exchange mechanism in which patients can access data and monitor sharing. Data were collected from 1,624 subjects using an online survey to examine the benefits, risks, and concerns associated with the four exchange mechanisms from patients' perspectives. Results Findings indicate that several concerns and risks such as privacy concerns, security risks, trust issues, and psychological risks are raised. Besides, multiple benefits such as access to complete information, communication improvement, timely and convenient information sharing, cost-saving, and medical error reduction are highlighted by respondents. Through consideration of all risks and benefits associated with the four exchange mechanisms, the direct HIE mechanism was selected by respondents as the most preferred mechanism of information exchange among providers. More than half of the respondents (56.18%) stated that overall they favored direct exchange over the other mechanisms. 42.70% of respondents expected to be more likely to share their PHI with health care providers who implemented and utilized a direct exchange mechanism. 43.26% of respondents believed that they would support health care providers to leverage a direct HIE mechanism for sharing their PHI with other providers. The results exhibit that individuals expect greater benefits and fewer adverse effects from direct HIE among health care providers. Overall, the general public sentiment is more in favor of direct data transfer. Our results highlight that greater public trust in exchange mechanisms is required, and information privacy and security risks must be addressed before the widespread implementation of such mechanisms. Conclusion This exploratory study's findings could be interesting for health care providers and HIE policymakers to analyze how consumers perceive the current exchange mechanisms, what concerns should be addressed, and how the exchange mechanisms could be modified to meet consumers' needs.

scholarly journals Patient Suffering in Chronic Digestive Diseases: Will Primary Care-Specialist Collaboration With Effective Interactive Communication and Integrative Medicine in the Plan of Care Improve Quality of Life?

2020 ◽  
Vol 7 (6) ◽  
pp. 989-993
Author(s):  
Andrew Thomas ◽  
Annie Thomas
Keyword(s):  
Quality Of Life ◽  
Primary Care ◽  
Health Care ◽  
Health Care Providers ◽  
The United States ◽  
Care Providers ◽  
Physician Visits ◽  
Digestive Diseases ◽  
Care Specialist

Acute and chronic digestive diseases are causing increased burden to patients and are increasing the United States health care spending. The purpose of this case report was to present how nonconfirmatory and conflicting diagnoses led to increased burden and suffering for a patient thus affecting quality of life. There were many physician visits and multiple tests performed on the patient. However, the primary care physician and specialists could not reach a confirmatory diagnosis. The treatment plans did not offer relief of symptoms, and the patient continues to experience digestive symptoms, enduring this burden for over 2 years. The central theme of this paper is to inform health care providers the importance of utilizing evidence-based primary care specialist collaboration models for better digestive disease outcomes. Consistent with patient’s experience, the authors propose to pilot/adopt the integrative health care approaches that are proven effective for treating digestive diseases.

Perceptions of Contexts of Intimate Partner Violence Among Young, Partnered Gay, Bisexual and Other Men Who Have Sex With Men in the United States

2021 ◽  
pp. 088626052110014
Author(s):  
Rob Stephenson ◽  
Lynae A. Darbes ◽  
Matthew T Rosso ◽  
Catherine Washington ◽  
Lisa Hightow-Weidman ◽  
...  
Keyword(s):  
Intimate Partner Violence ◽  
Health Care Providers ◽  
Partner Violence ◽  
The United States ◽  
Intimate Partner ◽  
Care Providers ◽  
Male Couples ◽  
Younger Men ◽  
Sex With Men ◽  
Controlling Behaviors

There has been a growth in research illustrating that gay, bisexual, and other men who have sex with men (GBMSM) experience intimate partner violence (IPV) at rates that are comparable to those among heterosexual women. However, the majority of research on IPV among same-sex male couples has focused on adults, and research on the experience of IPV among younger men (those aged under 18), remains at a nascent stage, despite knowledge that IPV is often common among younger men. This article adds to the growing body of literature on IPV among young GBMSM (YGBMSM) through of an analysis of qualitative data from in-depth interviews (IDI) with GBMSM aged 15–19 ( n = 30) in romantic relationships partnerships. The study sought to explore issues of relationship development, relationship contexts, and understandings of IPV. More than one-half of the sample reported experiencing some form of IPV in their current or past relationships. Participants described a range of experiences of IPV, including physical IPV, emotional IPV, sexual IPV, and controlling behaviors. Emotional IPV in the form of negative comments and controlling behaviors such as jealousy were the most commonly reported forms of violence behaviors. Although few participants reported experiencing physical or sexual IPV, several discussed concerns about giving, and partners’ acknowledging, sexual consent. Antecedents to IPV included wanting or feeling pressured to participate in normative development milestones, short-lived relationships, and societal stigma. Interventions that develop content on IPV and that reflect the lived realities of YGBMSM who are experiencing their first relationships are urgently needed. Study findings also support the need for training teachers, health care providers, and parents to identify signs of IPV and provide them with the knowledge and skills to talk to YGBMSM about relationships and violence to reduce IPV.

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