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Therapeutic Advances in Drug Safety

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https://www.readbyqxmd.com/read/30283628/the-surge-in-biosimilars-considerations-for-effective-pharmacovigilance-and-eu-regulation
#1
REVIEW
Begoña Calvo, Javier Martinez-Gorostiaga, Enrique Echevarria
The development of biosimilars is growing rapidly, especially in Europe. They are a cost-effective alternative to original biological medicines and can help improve patient access to these therapies. The European Medicines Agency (EMA) has been the first to issue scientific guidelines related to regulatory requirements for the approval of biosimilars. These guidelines have been being updated in line with advances in analytical techniques and growing experience in the clinical use of these drugs. Given the complex nature of biological medicines, they pose a greater potential risk of immunogenicity than nonbiological medicines, and hence warrant special consideration...
October 2018: Therapeutic Advances in Drug Safety
https://www.readbyqxmd.com/read/30283627/using-social-media-in-safety-signal-management-is-it-reliable
#2
REVIEW
Sue Rees, Sadiqa Mian, Neal Grabowski
Social media use is growing globally, with a reported 3 billion active users in 2017. This medium is used increasingly in a health setting by patients (and to a limited extent, healthcare professionals) to share experiences and ask advice on medical conditions as well as pharmaceutical products. In recent years, attention has turned to this huge, generally untapped, source of potential health information as a possible tool for pharmacovigilance, and in particular signal detection. In this article we explore some of the challenges of utilizing social media for safety signal detection and look at some of the pilot studies conducted to date in order to weigh the evidence for and against the utility of social media data in safety signal detection...
October 2018: Therapeutic Advances in Drug Safety
https://www.readbyqxmd.com/read/30283626/adverse-drug-reaction-reporting-in-a-large-tertiary-hospital-in-saudi-arabia-results-of-an-incentive-strategy
#3
Sheraz Ali, Oluwaseun Egunsola, Dalal Salem Al-Dossari, Ibrahim Abdulaziz Al-Zaagi
Background: Underreporting is a common problem with spontaneous adverse drug reaction (ADR) reporting. In this study, we aim to describe the reporting of ADRs in a tertiary hospital and determine the effect of incentives to healthcare professionals on ADR reporting. Methods: In this interventional study, a time series analysis was used to determine the effect of incentives on ADR reporting in a tertiary hospital between 2015 and 2016. The incentive strategy included public commendation of health care providers and nomination for a monthly award...
October 2018: Therapeutic Advances in Drug Safety
https://www.readbyqxmd.com/read/30283625/real-world-incidence-of-patient-reported-dyspnoea-with-ticagrelor
#4
Adaire E Prosser, Jessica L Dawson, KethLyn Koo, Karen M O'Kane, Michael B Ward, Richard J Woodman, Arduino A Mangoni, Cameron J Phillips
Dyspnoea, a common and multifactorial symptom in patients with acute coronary syndrome, has been associated with lower quality of life and hospital readmission. Prescriber preference for antiplatelet therapy, the standard of care in this patient group, is shifting to ticagrelor due to mortality benefits demonstrated in trials compared with clopidogrel. In these trials, dyspnoea was more commonly reported in patients prescribed ticagrelor but the aetiology is still debated. An observational cohort study was conducted to quantify the rates and severity of dyspnoea reported in patients with acute coronary syndrome and newly prescribed ticagrelor compared with those prescribed clopidogrel...
October 2018: Therapeutic Advances in Drug Safety
https://www.readbyqxmd.com/read/30283624/scientific-evidence-rather-than-uncontrolled-case-studies-should-be-the-basis-for-patient-management
#5
Dennis Savaiano
No abstract text is available yet for this article.
October 2018: Therapeutic Advances in Drug Safety
https://www.readbyqxmd.com/read/30181862/using-emr-enabled-computerized-decision-support-systems-to-reduce-prescribing-of-potentially-inappropriate-medications-a-narrative-review
#6
REVIEW
Ian A Scott, Peter I Pillans, Michael Barras, Christopher Morris
Prescribing of potentially inappropriate medications (PIMs) that pose more risk than benefit in older patients is a common occurrence across all healthcare settings. Reducing such prescribing has been challenging despite multiple interventions, including educational campaigns, audits and feedback, geriatrician assessment and formulary restrictions. With the increasing uptake of electronic medical records (EMRs) across hospitals, clinics and residential aged care facilities (RACFs), integrated with computerized physician order entry (CPOE) and e-prescribing, opportunities exist for incorporating clinical decision support systems (CDSS) into EMR at the point of care...
September 2018: Therapeutic Advances in Drug Safety
https://www.readbyqxmd.com/read/30181861/medication-use-and-potentially-inappropriate-prescribing-in-older-adults-with-intellectual-disabilities-a-neglected-area-of-research
#7
REVIEW
Maire O'Dwyer, Philip McCallion, Mary McCarron, Martin Henman
It is known that for all adults, prevalence of potentially inappropriate prescribing (PIP) and polypharmacy increases with advancing age and morbidity. This has been associated with adverse drug reactions and poor outcomes. As a result, screening tools have been developed to identify PIP and to improve prescribing and health outcomes. A growing body of evidence supports the fact that there are even greater concerns among older adults with intellectual disability (ID) who are living longer than before but still have premature mortality and poorer health outcomes compared with the general population...
September 2018: Therapeutic Advances in Drug Safety
https://www.readbyqxmd.com/read/30181860/shed-meds-pilot-of-a-patient-centered-deprescribing-framework-reduces-medications-in-hospitalized-older-adults-being-transferred-to-inpatient-postacute-care
#8
Alec W Petersen, Avantika S Shah, Sandra F Simmons, Matthew S Shotwell, J Mary Lou Jacobsen, Amy P Myers, Amanda S Mixon, Susan P Bell, Sunil Kripalani, John F Schnelle, Eduard E Vasilevskis
Background: Polypharmacy is common in hospitalized older adults. Deprescribing interventions are not well described in the acute-care setting. The objective of this study was to describe a hospital-based, patient-centered deprescribing protocol (Shed-MEDS) and report pilot results. Methods: This was a pilot study set in one academic medical center in the United States. Participants consisted of a convenience sample of 40 Medicare-eligible, hospitalized patients with at least five prescribed medications...
September 2018: Therapeutic Advances in Drug Safety
https://www.readbyqxmd.com/read/30181859/identifying-and-assessing-potential-harm-of-medication-errors-and-potentially-unsafe-medication-practices-in-paediatric-hospital-settings-a-field-study
#9
Rikke Mie Rishoej, Anna Birna Almarsdóttir, Henrik Thybo Christesen, Jesper Hallas, Lene Juel Kjeldsen
Background: Hospitalized children are prone to experience harm from medication errors (MEs). Strategies to prevent MEs can be developed from identified malfunctioning practices and conditions in the medication use process. In this study, we aimed to identify MEs and potentially unsafe medication practices (PUMPs) in hospitalized children, and to assess the potential harm of these, using raters of different professions. Methods: A 1-week observation using an undisguised technique was conducted on four paediatric hospital wards...
September 2018: Therapeutic Advances in Drug Safety
https://www.readbyqxmd.com/read/30181858/effect-of-a-voice-recognition-system-on-pediatric-outpatient-medication-errors-at-a-tertiary-healthcare-facility-in-kenya
#10
Angela N Migowa, William M Macharia, Pauline Samia, John Tole, Alfred K Keter
Background: Medication-related errors account for one out of every 131 outpatient deaths, and one out of 854 inpatient deaths. The risk is threefold greater in the pediatric population. In sub-Saharan Africa, research on medication-related errors has been obscured by other health priorities and poor recognition of harm attributable to such errors.Our primary objective was to assess the effect of introduction of a voice recognition system (VRS) on the prevalence of medication errors. The secondary objective was to describe characteristics of observed medication errors and determine acceptability of VRS by clinical service providers...
September 2018: Therapeutic Advances in Drug Safety
https://www.readbyqxmd.com/read/30364909/antidepressant-use-in-older-inpatients-current-situation-and-application-of-the-revised-stopp-criteria
#11
Lynn Gers, Mirko Petrovic, Stany Perkisas, Maurits Vandewoude
Objectives: Antidepressant use increases as age rises. Moreover, older patients are more sensitive to side effects and drug interactions. This descriptive study aims to map antidepressant use among patients at the geriatrics department of a university hospital and to evaluate whether prescribing happens in an evidence-based manner. Methods: Patients aged 75 years and over, admitted to the geriatrics department of the Middelheim Hospital in Antwerp between February and July 2017 were included...
August 2018: Therapeutic Advances in Drug Safety
https://www.readbyqxmd.com/read/30364900/withdrawal-of-prenylamine-perspectives-on-pharmacological-clinical-and-regulatory-outcomes-following-the-first-qt-related-casualty
#12
REVIEW
Rashmi R Shah, Peter D Stonier
Prenylamine, an antianginal agent marketed since early 1960, became the first casualty of QT interval related proarrhythmias in 1988 when it was withdrawn from the market. The period of its synthesis and marketing is of particular interest since it antedated, first, any serious clinical safety concern regarding drug-induced prolongation of the QT interval which was, in fact, believed to be an efficient antiarrhythmic mechanism; second, the first description of torsade de pointes as a unique proarrhythmia, typically associated with prolonged QT interval; and third, the discovery and recognition of calcium antagonism as an important cardiovascular therapeutic strategy...
August 2018: Therapeutic Advances in Drug Safety
https://www.readbyqxmd.com/read/30364888/what-does-the-research-say-about-androgen-use-and-cerebrovascular-events
#13
REVIEW
M Reza Sadaie, Mehdi Farhoudi, Masumeh Zamanlu, Nasser Aghamohammadzadeh, Atieh Amouzegar, Robert E Rosenbaum, Gary A Thomas
Many studies have investigated the benefits of androgen therapy and neurosteroids in aging men, while concerns remain about the potential associations of exogenous steroids and incidents of cerebrovascular events and ischemic stroke (IS). Testosterone is neuroprotective, neurotrophic and a potent stimulator of neuroplasticity. These benefits are mediated primarily through conversion of a small amount of testosterone to estradiol by the catalytic activity of estrogen synthetase (aromatase cytochrome P450 enzyme)...
August 2018: Therapeutic Advances in Drug Safety
https://www.readbyqxmd.com/read/30364883/case-series-of-docetaxel-induced-dorsal-hand-foot-syndrome
#14
Jolly Patel, J Tanner Ringley, Donald C Moore
Palmar-plantar erythrodysesthesia, also known as hand-foot syndrome (HFS), is a well-known dermatologic adverse event that can occur with a variety of cytotoxic chemotherapies including fluoropyrimidines, cytarabine, liposomal doxorubicin, and taxanes. HFS often presents as painful erythemas and desquamation of the skin involving the palms of the hands and the soles of the feet. Three cases are presented of patients with breast cancer who received multiagent chemotherapy regimens containing docetaxel that developed an atypical presentation of HFS on the dorsal aspect of the hands and feet...
August 2018: Therapeutic Advances in Drug Safety
https://www.readbyqxmd.com/read/30364869/dosing-challenges-with-direct-oral-anticoagulants-in-the-elderly-a-retrospective-analysis
#15
Joseph P Fava, Katelyn M Starr, David Ratz, Jennifer L Clemente
Background: Direct oral anticoagulants (DOACs) provide patients with attractive options for anticoagulation in atrial fibrillation (AF). However, dosing these agents in the elderly can be challenging due to factors such as drug interactions, reduced renal function, and less frequent monitoring. This study addressed this challenge by reviewing the dosing of three commonly used DOACs (i.e. apixaban, dabigatran, and rivaroxaban) in elderly patients managed at a pharmacist-run anticoagulation clinic...
August 2018: Therapeutic Advances in Drug Safety
https://www.readbyqxmd.com/read/30364852/medication-errors-involving-intravenous-patient-controlled-analgesia-results-from-the-2005-2015-medmarx-database
#16
Maitreyee Mohanty, Oluwadolapo D Lawal, Margie Skeer, Ryan Lanier, Nathalie Erpelding, Nathaniel Katz
Background: The aim of this study was to determine the current magnitude and characteristics of intravenous patient-controlled analgesia (IV-PCA) errors, and to identify opportunities for improving the PCA modality. Methods: We conducted a descriptive analysis of IV-PCA medication errors submitted to the MEDMARX database. Events were restricted to those occurring in inpatient hospital settings between 1 January 2005 and 31 December 2015. IV-PCA errors were classified by error category, cause of error, error type, level of care rendered, and actions taken...
August 2018: Therapeutic Advances in Drug Safety
https://www.readbyqxmd.com/read/30364850/smoking-cessation-in-pregnancy-a-continuing-challenge-in-the-united-states
#17
REVIEW
Ashley Scherman, Jorge E Tolosa, Cindy McEvoy
Despite significant population level declines, smoking during pregnancy remains a major public health issue in the United States (US). Approximately 360,000-500,000 smoke-exposed infants are born yearly, and prenatal smoking remains a leading modifiable cause of poor birth outcomes (e.g. birth < 37 gestational weeks, low birth weight, perinatal mortality). Women who smoke during pregnancy are more likely to be younger and from disadvantaged socioeconomic and racial and ethnic groups, with some US geographic regions reporting increased prenatal smoking rates since 2000...
August 2018: Therapeutic Advances in Drug Safety
https://www.readbyqxmd.com/read/30364834/validity-of-electronic-hospital-discharge-prescription-records-as-a-source-of-medication-data-for-pharmacoepidemiological-research
#18
Laura Fanning, Lilian Vo, Jenni Ilomäki, J Simon Bell, Rohan A Elliott, Pēteris Dārziņš
Background: The advent of hospital electronic medical records (EMRs) with electronic prescribing provides considerable opportunity for pharmacoepidemiological research. However, validity of EMR prescribing data for research purposes is not well established. Validity concerns the percentage of cases in which medications and characteristics (name, type, formulation, dose) are true when verified with an independent data source. This study evaluated the validity of EMR discharge prescription data within the Eastern Health hospital network in Melbourne, Australia...
August 2018: Therapeutic Advances in Drug Safety
https://www.readbyqxmd.com/read/30364758/accessing-social-media-information-for-pharmacovigilance-what-are-the-ethical-implications
#19
EDITORIAL
Robina Azam
No abstract text is available yet for this article.
August 2018: Therapeutic Advances in Drug Safety
https://www.readbyqxmd.com/read/30364757/identification-of-clinical-factors-predicting-warfarin-sensitivity-after-cardiac-surgery
#20
Karen Tyson, Nevil Hutchinson, Sian Williams, Greg Scutt
Background: Warfarin is commonly initiated post-cardiac surgery to reduce the risk of intracardiac thrombus formation. Studies have found that sensitivity is increased after cardiac surgery and anticoagulation is subsequently difficult to manage. This study set out to identify clinical markers of increased warfarin sensitivity in patients after cardiac surgery, and build a model that can predict warfarin sensitivity, and improve safety in this setting. Methods: The study was an observational, retrospective cohort design...
August 2018: Therapeutic Advances in Drug Safety
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