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4561. Analgesia in Neurocritical Care: An International Survey and Practice Audit. (Abstract)

scarce across sites and neuropathologies. Few national or regional differences were found. The analgesic preference rankings noted by the 95 international physicians who completed the survey matched the audits. However, self-reported analgesic prescription rates were much higher than pharmacy records indicate, with self-reported prescribing of both acetaminophen/paracetamol and opiates in 97% of patients and gabapentin in 45% of patients. Third-line analgesic variability appeared to be driven (...) Analgesia in Neurocritical Care: An International Survey and Practice Audit. To characterize analgesic administration in neurocritical care.ICU pharmacy database analgesic delivery audits from five countries. A 31-question analgesic agent survey was constructed, validated, and e-distributed in four countries.International multicenter neuro-ICU database audit and electronic survey.Six ICUs provided individual, anonymized analgesic delivery data in primary neurological diagnosis patients

2016 Critical Care Medicine

4562. Medication discrepancies associated with a medication reconciliation program and clinical outcomes after hospital discharge. (Abstract)

) was prepared for all patients. Patients were called 30 days postdischarge to determine the medication discrepancy rate from the BPMDP and whether this was intentional or unintentional; three clinicians used standardized criteria to determine if the discrepancy was inconsequential. Electronic health records and patient contact were used to ascertain death, hospital readmissions, and emergency department (ED) visits at 90 days.Of 433 patients (mean age 64 yrs, 52% female, median discharge prescriptions 6

2016 Pharmacotherapy

4563. Estimating the extent and economic impact of under and overdiagnosis of chronic obstructive pulmonary disease in primary care. Full Text available with Trip Pro

) during a 3-year period. All participants gave detailed medical history, underwent spirometry, and their current and past inhaled medications were registered through the national electronic prescription system. We diagnosed 342 subjects (10.7%) with COPD of whom 180 (52.6%) had no prior medical diagnosis. Overdiagnosis was the case for 306 subjects (9.6%) of whom 35.1% were treated with inhaled drugs during the last year. We calculated that 55.4% of the current cost for inhaled drugs is wasted

2016 Chronic respiratory disease

4564. Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics

, by electron microscopy, X-ray crystallography amino acid sequencing and gene sequencing. The concentrations of potentially contaminant substances (formaldehyde, barium sulphate, sodium citrate, and CTAB) are controlled during the process or in the MPH. Limits are applied. Polysorbate 80 is also used as an excipient of MF59C.1 adjuvant and is not considered as a residual of production but is nevertheless tested on the MPH. It is concluded that the impurities in the Active Substance are sufficiently

2010 European Medicines Agency - EPARs

4567. Hydrocodone and pseudoephedrine (Rezira)

, Rezira TM (hydrocodone bitartrate and pseudoephedrine hydrochloride) Oral Solution, Cypress Pharmaceuticals, Inc. 12/08/2010, Xu Wang, M.D., Ph.D. lower than that of analgesics, hydrocodone-containing medications should be prescribed and ant. It can be mphetamine Act, doephedrine by ounter, limiting a tification and signature for each pseudoephedrine in the proposed drug to make seudoephedrine) Oral Solution is a prescription drug, acological study. exposure during eling indicates that controlled (...) The proposed drug produc hydrochloride per 5 mL. It is proposed as a prescription drug combination of antituss nasal decongestant. The indication is for relief of cough and nasal congestion common cold. The proposed dosage is (5 mL) every 4 to 6 hour exceed (NTE) 4 doses (20 mL) in 24 hours for adults 18 years of age and olde 1.3.5 Drug-Drug Interactions There is no drug-drug interaction study conducted in this NDA submission. T clinical pharmacology study S08-0179 in the original NDA submission (NDA 2 442

2010 FDA - Drug Approval Package

4568. Hydrocodone, chlorpheniramine, and pseudoephedrine (Zutripro)

per 5 proposed as a prescription drug combination of antitussive, antihistamine, and de The proposed indications are: “Relief of cough and nasal congestion associated cold; Relief of symptoms including nasal congestion associated with uppe The sponsor’s proposed nam (5 mL) every 4 to 6 hours as needed, not to exceed (NTE) 4 doses (20 for adults 18 years of age and older. This is a 505(b)(2) application and the Ap provided an electronic submission. As a basis for the 505(b)(2) submission route (...) published in peer ingredients. The literature survey revealed no new safety signals for hydrocodone, itted a 120-day safety 2-439, SN026). There are no animal studies and clinical safety studies conducted for the proposed drug and the proposed drug has not been manufactured heniramine e hydrochloride per 5 mL. It is proposed as a prescription ine and decongestant. The proposed indications are: l congestion associated with common cold; Relief of symptoms proposed dosage is es (20 mL) in 24 The result

2010 FDA - Drug Approval Package

4569. Carglumic acid (Carbaglu)

sources: z Electronic and paper submission of NDA 22-562 z Data from ongoing study IND 68,185 by Mendel Tuchman, MD z Interactions with the applicant via e-mail for clarification and additional data z Original NDA 20-645 Ammonul (sodium phenylacetate and sodium benzoate) injection clinical review dated February 10, 2005 z Current approved label for Buphenyl (sodium phenylbutyrate) tablets and powder z Current approved label for Ammonul (sodium phenylacetate and sodium benzoate) injection z Independent (...) literature review z Proposed labeling for carglumic acid z Submitted electronic datasets z Consultative meetings regarding data findings and clinical issues The Applicant submitted a retrospective case series consisting of 23 patients with NAGS deficiency summarizing their clinical course during treatment with carglumic acid. The Applicant also obtained a right of reference to the ongoing study under IND 68,185. The Applicant did not provide any data from prospective, controlled trials to support

2010 FDA - Drug Approval Package

4570. Buprenorphine Transdermal System (Butrans)

of an electronic record that was signed electronically and this page is the manifestation of the electronic signature. --------------------------------------------------------------------------------------------------------- /s/ ---------------------------------------------------- ROBERT A LEVIN 05/20/2010 ROBERT B SHIBUYA 05/20/2010 I concur with Dr. Levin's review.CLINICAL REVIEW Application Type NDA Application Number(s) 21-306 Priority or Standard Standard Submit Date(s) 25 September 2009 Received Date(s (...) electronic ECG data was to have been transmitted to for cardiologist interpretation. A copy of these and all subsequent ECGs were to have been saved in the subject’s file • Blood, urine and pregnancy testing If and when subjects met all eligibility criteria (with exception of the daily pain scores), the Investigator or site staff were to have immediately contacted the subjects by telephone and instructed them to discontinue all analgesic medications and other medications used for chronic pain. Subjects

2010 FDA - Drug Approval Package

4571. Daxas - roflumilast (medical review)

Important Safety Issues with Consideration to Related Drugs Theophylline is a non selective phosphodiesterase inhibitor with significant toxicities in the gastrointestinal and neurologic systems (nausea, vomiting, headache, insomnia). It can produce cardiac arrhythmias and seizure activity at high levels of exposure. It has significant drug-drug interaction with commonly prescribed drugs such as H-2 blockers, macrolide antibiotics and benzodiazepines. Therefore, its use generally requires monitoring

2010 FDA - Drug Approval Package

4572. Glycopyrrolate oral solution

-------------------- -------------------- -------------------- ------------------------------------------ NDA-22571 ORIG-1 SHIONOGI PHARMA INC GLYCOPYRROLATE ORAL SOLUTION --------------------------------------------------------------------------------------------------------- This is a representation of an electronic record that was signed electronically and this page is the manifestation of the electronic signature. --------------------------------------------------------------------------------------------------------- /s/ ---------------------------------------------------- TATIANA OUSSOVA 07/29 (...) to the past drug use. Drug use data has determined that Robinul tablets are frequently used off label to treat drooling in CP children. The most recent data show that approximately prescriptions are filled annually in the United States for Robinul tablets and its generic equivalents for children between the ages of 3 and 16. Although the information regarding the diagnoses of the patients using glycopyrrolate tablets is limited, it appears as though approximately 50% of the current glycopyrrolate usage

2010 FDA - Drug Approval Package

4573. Roflumilast tablets (statistical review)

)--------------------------------------------------------------------------------------------------------- This is a representation of an electronic record that was signed electronically and this page is the manifestation of the electronic signature. --------------------------------------------------------------------------------------------------------- /s/ ---------------------------------------------------- ROBERT ABUGOV 01/14/2011 JOAN K BUENCONSEJO 01/14/2011 I concur with Dr. Abugov's statistical review of NDA 22-522 SN29 and SN35. Reference ID: 2891761 U.S. Department of Health and Human Services Food and Drug (...) Prescribed Year 36 Table 18: Mean Exacerbation Days Per Treatment Year 37 Table 19: Moderate or Severe Adverse Events Per Prescribed Year, by Symptom 38 Table 20: Moderate or Severe Adverse Events Per Treatment Year, by Symptom 38 Table 21: Moderate or Severe Adverse Event Days Per Prescribed Year, by Symptom, Not Including Weight Loss. 39 Table 22: Moderate or Severe Adverse Event Days Per Treatment Year, Not Including Weight Loss. 39 Table 23: Exacerbation Rates by Gender 40 Table 24: Exacerbation

2010 FDA - Drug Approval Package

4574. Poor Adherence to Statin and Antihypertensive Therapies as Risk Factors for Fatal Stroke. Full Text available with Trip Pro

Poor Adherence to Statin and Antihypertensive Therapies as Risk Factors for Fatal Stroke. Poor adherence to medication regimens is common, potentially contributing to the occurrence of related disease.The authors sought to assess the risk of fatal stroke associated with nonadherence to statin and/or antihypertensive therapy.We conducted a population-based study using electronic medical and prescription records from Finnish national registers in 1995 to 2007. Of the 58,266 hypercholesterolemia (...) to antihypertensive therapy, and 1.30 (95% CI: 0.53 to 3.20) for those adherent to statin, but nonadherent to antihypertensive, therapy.Individuals with hypercholesterolemia and hypertension who fail to take their prescribed statin and antihypertensive medication experience a substantially increased risk of fatal stroke. The risk is lower if the patient is adherent to either one of these therapies.Copyright © 2016 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

2016 Journal of the American College of Cardiology

4575. Predicting the Unpredictable: Drug-Induced QT Prolongation and Torsades de Pointes. Full Text available with Trip Pro

and clinical risk factors for diLQTS and TdP are well known and raise the possibility of TdP prevention. Clinical decision support systems (CDSS) can scan the patient's electronic health records for clinical risk factors predictive of diLQTS and warn when a drug that can cause TdP is prescribed. CDSS have reduced prescriptions of QT-prolonging drugs, but these relatively small changes lack the power to reduce TdP. The growing genetic evidence linking diLQTS to cLQTS suggests that prevention of TdP

2016 Journal of the American College of Cardiology

4576. Cardiovascular disease treatment among patients with severe mental illness: a data linkage study between primary and secondary care. Full Text available with Trip Pro

Cardiovascular disease treatment among patients with severe mental illness: a data linkage study between primary and secondary care. Suboptimal treatment of cardiovascular diseases (CVD) among patients with severe mental illness (SMI) may contribute to physical health disparities.To identify SMI characteristics associated with meeting CVD treatment and prevention guidelines.Population-based electronic health record database linkage between primary care and the sole provider of secondary mental (...) characteristics associated with QOF clinical target achievement.Patients with SMI and with coronary heart disease and heart failure experienced reduced prescribing of beta blockers and angiotensin-converting enzyme inhibitor/angiotensin receptor blockers (ACEI/ARB). A diagnosis of schizophrenia, being identified with any indicator of risk or illness severity, and being prescribed with depot injectable antipsychotic medication was associated with the lowest likelihood of prescribing.Linking primary

2016 British Journal of General Practice

4577. Guideline adherence for mentally ill reproductive-aged women on treatment with valproic acid: a retrospective chart review. (Abstract)

are in place, when treating reproductive-aged women. Our study aimed to review and assess adherence to these guidelines.Using electronic medical record (EMR) and administrative claims data over a 19-month period (January 1, 2013-July 31, 2014), a retrospective chart review was conducted of all reproductive-aged female patients at a major medical center in the Midwest who were prescribed VPA as treatment for their psychiatric illness (n = 190; aged from 15 to 49 years). Psychiatric diagnoses were determined (...) via ICD-9 billing codes. We assessed 3 variables of interest as an index of adherence to guidelines: chart documentation of provider-patient discussion regarding potential teratogenicity associated with VPA use, prescription of contraceptives, and co-prescription of folic acid.EMR documentation of provider-patient discussions regarding possible teratogenicity of VPA was rare (13.2%), as was documentation of contraception use (30%) and co-prescription of folate (7.9%). Neither patient demographic

2016 Journal of Clinical Psychiatry

4578. Opioid-related Policies in New England Emergency Departments. (Abstract)

of a screening tool for patients with suspected prescription opioid abuse potential (n = 30, 18%), 2) access state prescription drug monitoring program (PDMP) before prescribing opioids (n = 132, 78%), 3) notify the primary opioid prescriber when prescribing opioids for ED patients with chronic pain (n = 69, 41%), 4) refer patients with opioid abuse to recovery resources (n = 117, 70%), and 5) prescribe naloxone to patients at risk of opioid overdose after ED discharge (n = 19, 12%). EDs located (...) in metropolitan areas and with at least one attending physician on duty 24/7 were less likely to implement opioid policies (incident rate ratio [IRR] = 0.65, 95% confidence interval [CI] = 0.48-0.89; and IRR = 0.78, 95% CI = 0.6-1.0, respectively) while EDs with ≥15% hospitalization rate that used electronic computerized medication ordering and those in Rhode Island were more likely to implement opioid policies (IRR = 1.23, 95% CI = 1.03-1.48; IRR = 1.95, 95% CI = 1.19-3.22; and IRR = 1.30, 95% CI = 1.08-1.56

2016 Academic Emergency Medicine

4579. Order Set to Improve the Care of Patients Hospitalized for COPD Exacerbations. (Abstract)

Order Set to Improve the Care of Patients Hospitalized for COPD Exacerbations. Physicians' adherence to prescribing evidence-based inpatient and outpatient therapies for chronic obstructive pulmonary disease (COPD) is low, and there is a paucity of information about the utility of admission order sets for patients with COPD exacerbations.To determine if implementation of a locally designed, evidence-based, multidisciplinary computer physician order entry set in the electronic health record (...) improves the quality of physician pharmacologic prescribing for patients hospitalized for COPD exacerbations.This study was performed before and after implementation of a computerized order set for patients hospitalized for COPD exacerbations. The primary outcome was the rate of zero prescribing errors by physicians for inpatient and discharge drugs for COPD over a 1-year period before implementation and for 6 months after implementation. Errors were defined as no therapy or inappropriate therapy

2016 Annals of the American Thoracic Society

4580. Practice patterns in endoscopic dacryocystorhinostomy: survey of the American Rhinologic Society. (Abstract)

Practice patterns in endoscopic dacryocystorhinostomy: survey of the American Rhinologic Society. The introduction of advanced endoscopic techniques has facilitated significant growth in endoscopic dacryocystorhinostomy (EnDCR). The purpose of this study is to evaluate clinical practice patterns of otolaryngologists performing EnDCR.A 25-item survey was electronically disseminated to the American Rhinologic Society (ARS) membership from November 17, 2014 to December 14, 2014. The target group (...) perform ophthalmologic workup. Lacrimal stents were used often or always in 80%, with 38% keeping stents in place for 6 to 8 weeks. The mucosal flap preservation technique was used often or always in 40%. Topical antimetabolites were used often or always in only 1%. Ophthalmology was present in most cases to perform lacrimal intubation. Postoperative antibiotics, topical ophthalmic steroids, and oral steroids were prescribed often or always in 62%, 47%, and 23%, respectively. Postoperative endoscopic

2016 International forum of allergy & rhinology

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