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Therapeutic Advances in Drug Safety

Almasa Bass, Lynn R Webster, Kyle T Matschke, Bimal K Malhotra, Gernot Wolfram
Background: Abuse of prescription opioids, particularly by intravenous (IV) administration, can cause respiratory depression and death. ALO-02, an abuse-deterrent opioid formulation, is designed to release sequestered naltrexone upon manipulation by crushing, thereby antagonizing the pharmacologic effects of oxycodone. This exploratory post-hoc analysis examined the effects of IV administration of simulated crushed ALO-02 on end-tidal carbon dioxide (EtCO2 ), a surrogate marker of respiratory depression...
2019: Therapeutic Advances in Drug Safety
Muhammad Junaid Farrukh, Muhammad Haseeb Tariq, Obaidullah Malik, Tahir Mehmood Khan
No abstract text is available yet for this article.
2019: Therapeutic Advances in Drug Safety
Paul Misasi, Joseph R Keebler
Lack of verification is often cited as a root cause of medication errors; however, medication errors occur in spite of conventional verification practices and it appears that human factors engineering (HFE) can inform the design of a more effective method. To this end, an HFE-driven process was designed and implemented in an urban, Midwestern emergency medical service agency. Medication error data were collected over a 54-month period, 27 months before and after implementation. A decrease in the average monthly error rate was realized for all medications administered (49...
2019: Therapeutic Advances in Drug Safety
Thananan Rattanachotphanit, Chulaporn Limwattananon, Onanong Waleekhachonloet
Background: The aim of this study was to assess trends and variations in coprescribing of simvastatin or atorvastatin with interacting drugs in Thailand. Methods: Outpatient prescriptions between 2013 and 2015 in 26 tertiary care hospitals were analyzed for statin coprescribing. The proportion of patients exposed to coprescribing was estimated for semi-annual changes, using a time-series analysis and for hospital variations, using an interquartile range (IQR). Results: The coprescribing of simvastatin with all contraindicated drugs in 10 university and 16 general hospitals, respectively, was 3...
2019: Therapeutic Advances in Drug Safety
Danijela Gnjidic, Hui Min Magdalene Ong, Celeste Leung, Jesse Jansen, Emily Reeve
Background: Long-term benzodiazepine use in the older population is common and is associated with significant harm. The provision of a patient-educational booklet during hospitalization may encourage patients to discuss review and possible deprescribing of benzodiazepine therapy with their health professionals. The aim of this study was to assess the feasibility and effect of a patient empowerment intervention in hospital inpatients on patient initiation of a discussion about deprescribing benzodiazepines versus usual care...
2019: Therapeutic Advances in Drug Safety
Abimbola O Opadeyi, Annie Fourrier-Réglat, Ambrose O Isah
Background: Our aim in this study was to evaluate the effect of a combined educational intervention and year-long monthly text message reinforcements via the Short Messaging System (SMS) on the knowledge, attitude and practice (KAP) of healthcare professionals (HCPs) towards pharmacovigilance. Methods: Six randomly selected teaching hospitals in the South-South zone of Nigeria were randomized in 1:1 ratio into intervention and control groups. The educational intervention consisted of delivering a seminar followed by sending monthly texts message reinforcements via SMS over 12 months...
2019: Therapeutic Advances in Drug Safety
Kristina M Niehoff, Marcia C Mecca, Terri R Fried
Polypharmacy is common among older adults and is associated with adverse outcomes. Polypharmacy increases the likelihood of receiving a potentially inappropriate medication (PIM). PIMs have traditionally been defined as medications that have either no benefit (e.g. therapeutic duplication) or increased risk (e.g. altered pharmacodynamics/kinetics with aging). A growing literature supports the notion that these represent only a subset of the potential risks of medications prescribed to older adults. Different authors have proposed new sets of criteria for evaluating medication appropriateness...
2019: Therapeutic Advances in Drug Safety
Chirn-Bin Chang, Hsiu-Yun Lai, Shinn-Jang Hwang, Shu-Yu Yang, Ru-Shu Wu, Hsing-Cheng Liu, Ding-Cheng Chan
Background: PIM-Taiwan criteria were first established in 2010 for potentially inappropriate medications (PIMs). Currently, updating of PIM criteria is mandatory because of newly established evidence and newly developed medications. This study aims to evaluate the prevalence of PIM based on country-specific PIM criteria and factors associated with PIM use by applying 2010 version and newly updating PIM-Taiwan criteria in a cohort with polypharmacy. Methods: The baseline data of Medication Safety Review Clinic Taiwan (MSRC-Taiwan) study were used to investigate the prevalence of PIMs...
December 2018: Therapeutic Advances in Drug Safety
Justin P Turner, Claude Richard, Marie-Thérèse Lussier, Marie-Eve Lavoie, Barbara Farrell, Denis Roberge, Cara Tannenbaum
Background: Little is known about the initiation, style and content of patient and healthcare provider communication around deprescribing. We report the findings from a content analysis of audio-recorded discussions of proton pump inhibitor (PPI) and benzodiazepine deprescribing in primary care. Methods: Participants were healthcare providers ( n = 13) from primary care practices ( n = 3) and patients aged ⩾65 ( n = 24) who were chronic users of PPIs or benzodiazepines...
December 2018: Therapeutic Advances in Drug Safety
Ricky Hsu, Jennifer Fusco, Cassidy Henegar, Karam Mounzer, Michael Wohlfeiler, Vani Vannappagari, Michael Aboud, Lloyd Curtis, Gregory Fusco
Background: Psychiatric outcomes are common among people living with HIV and may be associated with specific antiretroviral use. We evaluated the occurrence of psychiatric outcomes in patients taking dolutegravir (DTG)-containing regimens compared with five other core agents. Methods: Patients in the OPERA database prescribed regimens based on DTG, efavirenz (EFV), raltegravir (RAL), darunavir (DRV), rilpivirine (RPV), or elvitegravir (EVG) for the first time between 1 January 2013 and 31 December 2015 were analyzed...
December 2018: Therapeutic Advances in Drug Safety
Keyhan Mohammadi, Mona Kargar
No abstract text is available yet for this article.
December 2018: Therapeutic Advances in Drug Safety
Cynthia A King, Kathleen M Babcock, Rhianna J Godios, Benjamin S King
Nafcillin, a beta-lactam semisynthetic penicillin, is highly resistant to penicillinase and is similar to other penicillins except that it is primarily metabolized in the liver. It is believed that nafcillin causes CYP3A4 enzyme induction which decreases warfarin's half-life. The onset of CYP3A4 induction by nafcillin occurs within the first 7 days, but maximal effects may take up to 2 weeks. Once nafcillin is discontinued, the effects persist for several weeks. A 79-year-old male with a history of atrial fibrillation and a 53-year-old male with a history of recurrent venous thromboembolism required significantly higher weekly warfarin doses during courses of nafcillin therapy...
November 2018: Therapeutic Advances in Drug Safety
Justin P Turner, Janet Currie, Johanna Trimble, Cara Tannenbaum
Many seniors remain unaware that certain medications may be harmful, despite high rates of polypharmacy and inappropriate medication use among community-dwelling older adults. Patient education is an effective method for reducing the use of inappropriate medications. Increasing public awareness and engagement is essential for promoting shared decision-making to deprescribe. The Canadian Deprescribing Network was created to address the lack of a systematic pan-Canadian initiative to implement deprescribing among older Canadians...
November 2018: Therapeutic Advances in Drug Safety
Gregory M Ouellet, Jennifer A Ouellet, Mary E Tinetti
Although the majority of older adults in the developed world live with multiple chronic conditions (MCCs), the task of selecting optimal treatment regimens is still fraught with difficulty. Older adults with MCCs may derive less benefit from prescribed medications than healthier patients as a result of the competing risk of several possible outcomes including, but not limited to, death before a benefit can be accrued. In addition, these patients may be at increased risk of medication-related harms in the form of adverse effects and significant burdens of treatment...
November 2018: Therapeutic Advances in Drug Safety
Marco Sardella, Glyn Belcher
The assessment of the safety of medicines for rare diseases during the development phase is often limited by the few data available from small numbers of patients. This also applies to a lesser extent during the postmarketing phase of the lifecycle of a medicine. By using all available sources of data for rare diseases drugs, and by carefully assessing these data, the most informed safety profile can be obtained. This should also allow a clear view of data that are not available at any given time point and facilitates planning of strategies to obtain data through appropriate postmarketing risk management...
November 2018: Therapeutic Advances in Drug Safety
Daniel Okeowo, Alastair Patterson, Cynthia Boyd, Emily Reeve, Danijela Gnjidic, Adam Todd
Background: The aim of this study was (1) to apply the current United Kingdom (UK) National Institute for Health and Care Excellence (NICE) clinical practice guidelines to a hypothetical older patient with multimorbidity and life-limiting illness; (2) consider how treatment choices could be influenced by NICE guidance specifically related to multimorbidity; and, (3) ascertain if such clinical practice guidelines describe how and when medication should be reviewed, reduced and stopped...
November 2018: Therapeutic Advances in Drug Safety
Nadine Matti, Minh-Nha R Nguyen, Cassandra Mosel, Luke E Grzeskowiak
Background: Medication errors are common in neonatal care and can lead to significant harm. We sought to explore utilization of various medication error prevention strategies across Australian and New Zealand neonatal units (NNUs) through a clinical practice survey. Methods: An electronic survey was distributed in October 2016 to relevant staff at each of the 29 level III NNUs identified as members of the Australian and New Zealand Neonatal Network (ANZNN). The survey contained questions relating to a range of medication error prevention strategies identified from a previous systematic review on the topic...
November 2018: Therapeutic Advances in Drug Safety
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
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
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
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