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https://www.readbyqxmd.com/read/29777799/title-studies-on-drug-switchability-showed-heterogeneity-in-methodological-approaches-a-scoping-review
#1
REVIEW
Valeria Belleudi, Francesco Trotta, Simona Vecchi, Laura Amato, Antonio Addis, Marina Davoli
BACKGROUND: Several drugs share the same therapeutic indication, including those undergoing patent expiration. Concerns on the interchangeability are frequent in clinical practice, challenging the evaluation of switchability through observational research. AIM: To conduct a scoping review of observational studies on drug switchability to identify methodological strategies adopted to deal with bias and confounding. METHODS: We searched PubMed, EMBASE, and Web of Science (updated 1/31/2017) to identify studies evaluating switchability in terms of effectiveness/safety outcomes or compliance...
May 16, 2018: Journal of Clinical Epidemiology
https://www.readbyqxmd.com/read/29772071/to-test-or-not-to-test-the-value-of-toxicology-in-a-delayed-overdose-death
#2
Erin E Walsh, Elisa N Shoff, Mary Elizabeth Zaney, George W Hime, Fintan Garavan, Diane M Boland
A case demonstrating the necessity of thorough death investigation processes where toxicology plays an active role is presented. A 33-year-old white man presented to the emergency room in respiratory distress after an overdose episode where he was revived on the scene by fire rescue. His condition continued to deteriorate and he expired 6 days after the initial incident. No admission specimens were available for testing; however, there were specimens drawn 4 and 5 days after the incident. Drug paraphernalia from the scene was obtained by the laboratory through collaboration with local law enforcement...
May 17, 2018: Journal of Forensic Sciences
https://www.readbyqxmd.com/read/29748254/national-trends-in-prescription-drug-expenditures-and-projections-for-2018
#3
Glen T Schumock, JoAnn Stubbings, Michelle D Wiest, Edward C Li, Katie J Suda, Linda M Matusiak, Robert J Hunkler, Lee C Vermeulen
PURPOSE: Historical trends and factors likely to influence future pharmaceutical expenditures are discussed, and projections are made for drug spending in 2018 in nonfederal hospitals, clinics, and overall (all sectors). METHODS: Drug expenditure data through calendar year 2017 were obtained from the IQVIA (formerly QuintilesIMS) National Sales Perspectives database and analyzed. New drug approvals, patent expirations, and other factors that may influence drug spending in hospitals and clinics in 2018 were also reviewed...
May 10, 2018: American Journal of Health-system Pharmacy: AJHP
https://www.readbyqxmd.com/read/29733729/evaluating-the-impact-of-the-orphan-drug-act-s-seven-year-market-exclusivity-period
#4
Ameet Sarpatwari, Reed F Beall, Abdurrahman Abdurrob, Mengdong He, Aaron S Kesselheim
For thirty-five years the Orphan Drug Act of 1983 has provided incentives for pharmaceutical manufacturers to develop drugs to treat rare diseases-conditions that affect fewer than 200,000 people in the US. One key statutory incentive is an exclusive seven-year marketing right for the rare disease indication, which has been heralded as driving a dramatic increase in the number of rare disease treatments. However, most new drugs are also protected by patents. In this study we assessed all new small-molecule drugs approved in the period 1985-2014 that had at least one indication for an orphan-designated disease as of January 1, 2017...
May 2018: Health Affairs
https://www.readbyqxmd.com/read/29715257/evaluation-of-richmond-agitation-sedation-scale-rass-in-mechanically-ventilated-in-the-emergency-department
#5
Marianne K Pop, Katelyn R Dervay, Mary Dansby, Carolina Jones
The purpose of this study was to assess Richmond Agitation Sedation Scale (RASS) goal implementation in mechanically ventilated patients sedated in the emergency department (ED), compliance with RASS, and goal achievement. This study was a retrospective chart review at a large Level I trauma academic medical center. Patients who were intubated in the ED or en route to the ED between October 1, 2013, and October 1, 2014, were eligible for inclusion if they met the following criteria: aged 18 years or older, 24 hr or more on mechanically ventilated support receiving continuous sedation and/or analgesia during the first 48 hr of admission, and a hospital stay of 6 days or more...
April 2018: Advanced Emergency Nursing Journal
https://www.readbyqxmd.com/read/29688797/progress-with-infliximab-biosimilars-for-inflammatory-bowel-disease
#6
Zsuzsanna Kurti, Lorant Gonczi, Peter L Lakatos
Biological therapies have revolutionized the treatment of inflammatory bowel diseases (IBD) in the last two decades. Though biological drugs are effective, their use is associated with high costs and access to biological agents varies among countries. As the patent for the reference products expired, the advent of biosimilar monoclonal antibodies has been expected. Biosimilars represent less expensive alternatives compared to the reference product. Areas covered: In this review, authors will review the literature on the clinical efficacy, safety and immunogenicity of current and future biosimilar infliximabs...
April 29, 2018: Expert Opinion on Biological Therapy
https://www.readbyqxmd.com/read/29675070/frequency-and-outcome-of-acute-neurologic-complications-after-congenital-heart-disease-surgery
#7
Sidra Kaleem Jafri, Lubaina Ehsan, Qalab Abbas, Fatima Ali, Prem Chand, Anwar Ul Haque
Objectives: To determine the frequency and immediate outcome of acute neurologic complications (ANCs) in children undergoing congenital heart surgery (CHS). Materials and Methods: In this retrospective study, all patients undergoing CHS at our hospital from January 2007 to June 2016 were included. Patients were followed up for the development of seizures, altered level of consciousness (ALOC), abnormal movements, and stroke. Results are presented as mean with standard deviation and frequency with percentages...
October 2017: Journal of Pediatric Neurosciences
https://www.readbyqxmd.com/read/29667118/acmt-position-statement-alternative-or-contingency-countermeasures-for-acetylcholinesterase-inhibiting-agents
#8
Andrew Stolbach, Vikhyat Bebarta, Michael Beuhler, Shaun Carstairs, Lewis Nelson, Michael Wahl, Paul M Wax, Charles McKay
First responders and health care providers must prepare to provide care for patients poisoned by acetylcholinesterase (AchE) inhibitor chemical warfare agents or pesticides. However, pre-deployed medical countermeasures (MCMs) may not be sufficient due to production and delivery interruption, rapid depletion of contents during a response, expiration of MCM components, or lack of local availability of approved MCMs. To augment supplies of community-based and forward-deployed nerve agent countermeasures, the American College of Medical Toxicology (ACMT) supports several strategies: (1) The use of expired atropine, diazepam, and pralidoxime auto-injectors and vials if non-expired drugs are unavailable; and (2) Investigation, development, and identification of alternative countermeasures-commonly stocked drugs that are not approved for nerve agent poisoning but are in the same therapeutic class as approved drugs...
April 17, 2018: Journal of Medical Toxicology: Official Journal of the American College of Medical Toxicology
https://www.readbyqxmd.com/read/29653328/a-pragmatic-study-on-efficacy-tolerability-and-long-term-acceptance-of-ketogenic-diet-therapy-in-74-south-indian-children-with-pharmacoresistant-epilepsy
#9
Neena Baby, Kollencheri Puthenveettil Vinayan, Nivedita Pavithran, Arun Grace Roy
PURPOSE: Significant challenges exist for Ketogenic Diet (KD) programs in many populations, mainly due to the variations in local dietary preferences. Here we report a single center experience of KD therapy in a cohort of South Indian children with pharmaco-resistant epilepsies. METHODS: Children aged 0-18 years, enrolled in the KD program for pharmacoresistant epilepsies of Amrita institute of Medical Sciences, Kochi, Kerala, India (2010 - 2015) were included in this pragmatic study...
March 21, 2018: Seizure: the Journal of the British Epilepsy Association
https://www.readbyqxmd.com/read/29557727/absorption-metabolism-and-excretion-of-14-c-evogliptin-tartrate-in-male-rats-and-dogs
#10
Dae Young Lee, Ju-Hyun Kim, Hyun Joo Shim, Hyeon-Uk Jeong, Hye Suk Lee
The objective of this study was to determine the absorption, excretion, and metabolism of a novel, oral antihyperglycemic drug, evogliptin, in male rats and dogs. Plasma, urine, feces, and expired air samples were collected after a single oral dose administration of [14 C]evogliptin, samples were analyzed by measuring overall radioactivity levels using high-performance liquid chromatography (HPLC), and radioactivity levels were measured by utilizing LC-tandem mass spectrometry (LC-MS/MS). The total amounts of radioactivity excreted in urine, feces, and expired air up to 168 h after administration of [14 C]evogliptin tartrate to rats (30 mg evogliptin/kg) and dogs (10 mg evogliptin/kg) were 96...
March 20, 2018: Journal of Toxicology and Environmental Health. Part A
https://www.readbyqxmd.com/read/29557204/next-generation-fixed-dose-combination-pharmacotherapies-for-treating-hiv
#11
Margaret R Caplan, Eric S Daar, Katya C Corado
Treatment options for patients with HIV-1 infection have grown over the past two decades to include multiple fixed-dose combination pharmacotherapies that have greatly simplified administration of antiretroviral therapy (ART) for both patients and providers. Effective virologic control can often be achieved with once-daily use of a single-tablet regimen. Over the past three years, ART drug development has focused on the next generation of fixed-dose combinations for initial and maintenance therapy with improved efficacy, safety and tolerability...
March 20, 2018: Expert Opinion on Pharmacotherapy
https://www.readbyqxmd.com/read/29549597/biosimilar-drugs-for-psoriasis-principles-present-and-near-future
#12
REVIEW
Jose-Manuel Carrascosa, Ira Jacobs, Danielle Petersel, Robert Strohal
Psoriasis is a chronic, inflammatory, lifelong disease with a high prevalence (afflicting approximately 1-5% of the population worldwide) and is associated with significant morbidity. The introduction of biologic therapies has improved the management of this disease. Multiple biologic medicines that block cytokine signaling, including tumor necrosis factor (TNF) antagonists (adalimumab, etanercept, and infliximab) and inhibitors of interleukin (IL)-17 (brodalumab, ixekizumab, and secukinumab), IL-23 (guselkumab), or IL-12/23 (ustekinumab), are approved for the treatment of psoriasis...
March 16, 2018: Dermatology and Therapy
https://www.readbyqxmd.com/read/29501057/impact-of-the-implementation-of-vasoactive-drug-protocols-on-costs-in-the-treatment-of-critically-ill-patients
#13
Isabel Cuesta-López, Marina Sánchez-Cuervo, Ángel Candela-Toha, Juana Benedí-González, Teresa Bermejo-Vicedo
OBJECTIVE: To evaluate the efficiency of the protocolization and centralization of  the preparation of intravenous vasoactive drug mixtures in the treatment of  critically ill patients. METHOD: A prospective interventional study (July 2012-December 2014) was  conducted to measure the impact of different vasoactive drug protocols on costs  in the treatment of critically ill patients. The economic impact was measured by  comparing the direct costs (fixed and variable) of the preparation of intravenous  vasoactive drug mixtures in the Pharmacy Department with their traditional  preparation in hospital care units...
March 1, 2018: Farmacia Hospitalaria
https://www.readbyqxmd.com/read/29480848/exenatide-once-weekly-for-smoking-cessation-study-protocol-for-a-randomized-clinical-trial
#14
RANDOMIZED CONTROLLED TRIAL
Luba Yammine, Thomas R Kosten, Paul M Cinciripini, Charles E Green, Janet C Meininger, Jennifer A Minnix, Thomas F Newton
BACKGROUND: Cigarette smoking is the greatest preventable cause of morbidity and premature mortality in the United States. Approved pharmacological treatments for smoking cessation are marginally effective, underscoring the need for improved pharmacotherapies. A novel approach might use glucagon-like peptide-1 (GLP-1) agonists, which reduce alcohol and drug use in preclinical studies. GLP-1 is produced in the intestinal L-cells and in the hindbrain. The peptide maintains glucose homeostasis and reduces food intake...
January 2018: Medicine (Baltimore)
https://www.readbyqxmd.com/read/29464665/generic-substitution-of-orphan-drugs-for-the-treatment-of-rare-diseases-exploring-the-potential-challenges
#15
Antonello Di Paolo, Elena Arrigoni
Generic drugs are important components of measures introduced by healthcare regulatory authorities to reduce treatment costs. In most patients and conditions the switch from a branded drug to its generic counterpart is performed with no major complications. However, evidence from complex diseases suggests that generic substitution requires careful evaluation in some settings and that current bioequivalence criteria may not always be adequate for establishing the interchangeability of branded and generic products...
March 2018: Drugs
https://www.readbyqxmd.com/read/29455032/sevoflurane-for-procedural-sedation-in-critically-ill-patients-a-pharmacokinetic-comparative-study-between-burn-and-non-burn-patients
#16
Sebastien Perbet, Daniel Bourdeaux, Alexandre Lenoire, Claire Biboulet, Bruno Pereira, Malha Sadoune, Benoit Plaud, Jean-Marie Launay, Jean-Etienne Bazin, Valerie Sautou, Alexandre Mebazaa, Pascal Houze, Jean-Michel Constantin, Matthieu Legrand
BACKGROUND: Sevoflurane has anti-inflammatory proprieties and short lasting effects making it of interest for procedural sedation in critically ill patients. We evaluated the pharmacokinetics of sevoflurane and metabolites in severely ill burn patients and controls. The secondary objective was to assess potential kidney injury. METHODS: Prospective interventional study in a burn and a surgical intensive care unit; 24 mechanically ventilated critically ill patients (12 burns, 12 controls) were included...
February 15, 2018: Anaesthesia, Critical Care & Pain Medicine
https://www.readbyqxmd.com/read/29428205/biosimilars-concepts-and-controversies
#17
REVIEW
Reyes Gámez-Belmonte, Cristina Hernández-Chirlaque, María Arredondo-Amador, Carlos J Aranda, Raquel González, Olga Martínez-Augustin, Fermín Sánchez de Medina
Biosimilars are copies of reference biological drugs, developed as the patents for original biologicals expire. They are thus developed to replicate an original biological medicine just a generics are intended to replicate a chemically-synthesized medicine; however, there are important technical and regulatory differences between the two. Unlike chemical drugs, molecular identity cannot generally be established for any two biological drugs. Accordingly, their pharmacological properties cannot be assumed to be the same...
February 8, 2018: Pharmacological Research: the Official Journal of the Italian Pharmacological Society
https://www.readbyqxmd.com/read/29411318/policy-options-for-infliximab-biosimilars-in-inflammatory-bowel-disease-given-emerging-evidence-for-switching
#18
Don Husereau, Brian Feagan, Carl Selya-Hammer
Biosimilars are becoming increasingly available internationally as patents expire on the originator biologic drugs they are intended to copy. Although substitution policies seen with generic drugs are being considered as a means to reduce expenditures on biologics, some biosimilars pose particular challenges in that the act of substitution may eventually lead to increased rates of therapeutic failure. As evidence requirements from regulators do not directly address this challenge, switch trials of biosimilars have emerged that may provide further answers...
February 6, 2018: Applied Health Economics and Health Policy
https://www.readbyqxmd.com/read/29383440/-revised-version-of-the-statement-by-the-dgrh-on-biosimilars-update-2017
#19
J Braun, H M Lorenz, U Müller-Ladner, M Schneider, H Schulze-Koops, Ch Specker, A Strangfeld, U Wagner, T Dörner
The treatment of rheumatic diseases with bioloics has significantly improved the prognosis of patients. Currently, there are 13 preparations available in Germany for the treatment of patients with inflammatory rheumatic diseases. These original preparations generally have-depending on the individual country-15 years of patent protection. As soon as the patent has expired, approved biosimilars can be brought into use. For the approval of a biosimilar, authorities such as the European Medical Agency or the American Food and Drug Administration require proof of the best possible comparability with respect to efficacy and safety in comparison to the original or reference product...
February 2018: Zeitschrift Für Rheumatologie
https://www.readbyqxmd.com/read/29379327/assessment-of-the-association-between-drug-disposal-practices-and-drug-use-and-storage-behaviors
#20
Ahmet Akici, Volkan Aydin, Arzu Kiroglu
Objective: Keeping unnecessary drugs at home is a situation showing both causes and consequences of irrational use of medicine. This study aimed to evaluate the approaches of a company's employees regarding drug storage, use, and disposal. Method: This online-based descriptive study was held in a multi-centered private-sector company in a voluntary basis. The survey assessing participants' drug handling and storage behaviors was answered by 1121 employees from across eight provinces of Turkey in 2016...
January 2018: Saudi Pharmaceutical Journal: SPJ: the Official Publication of the Saudi Pharmaceutical Society
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