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generics drugs AND quality

Miran Brvar, Ming Yin Chan, Andrew H Dawson, Richard R Ribchester, Michael Eddleston
INTRODUCTION: Treatment of acute organophosphorus or carbamate insecticide self-poisoning is often ineffective, with tens of thousands of deaths occurring every year. Researchers have recommended the addition of magnesium sulfate or calcium channel blocking drugs to standard care to reduce acetylcholine release at cholinergic synapses. OBJECTIVE: We aimed to review systematically the evidence from preclinical studies in animals exposed to organophosphorus or carbamate insecticides concerning the efficacy of magnesium sulfate and calcium channel blocking drugs as therapy compared with placebo in reducing mortality or clinical features of poisoning...
March 20, 2018: Clinical Toxicology
Muhammad Atif, Muhammad Azeem, Muhammad Rehan Sarwar, Iram Malik, Wajiha Ahmad, Fariha Hassan, Ayesha Rehman, Mahjabeen Rana
BACKGROUND: Appropriate use of medicines is important to provide quality health. The aim of this study was to assess the prescribing practices and prescription errors in the private clinic practices of Bahawalpur, Pakistan. METHODS: A cross-sectional observational study was performed in March 2015 to assess the prescribing practices and prescription errors in the private clinical practices of Bahawalpur, Pakistan. We used the standard World Health Organization (WHO) methodology to achieve the study objectives...
March 13, 2018: Journal of the Chinese Medical Association: JCMA
Fauzia A Khan, Alan F Merry
The safety of anesthesia characteristic of high-income countries today is not matched in low-resource settings with poor infrastructure, shortages of anesthesia providers, essential drugs, equipment, and supplies. Health care is delivered through complex systems. Achieving sustainable widespread improvement globally will require an understanding of how to influence such systems. Health outcomes depend not only on a country's income, but also on how resources are allocated, and both vary substantially, between and within countries...
April 2018: Anesthesia and Analgesia
Xinyi Wang, Sharadrao M Patil, David A Keire, Xiaoming Xu, Kang Chen
Generic drug products are expected to have the same active pharmaceutical ingredient (API) (Q1) with the same content (Q2) and microstructure arrangement (Q3) as the innovator product. In complex oil-in-water emulsion drugs, the hydrophobic API is mainly formulated in oil droplets stabilized by surfactant and micelles composed of extra surfactant molecules. The API phase partition in oil and water (mainly micelle) is a critical quality attribute (CQA) of emulsion product in demonstrating physicochemical equivalence using difluprednate (DFPN) emulsion product Durezol® as a model, we developed a novel low-field benchtop NMR method to demonstrate its applicability in measuring DFPN phase partition for ophthalmic oil-in-water emulsion products...
March 2, 2018: AAPS PharmSciTech
Salman Hussain, Ambrish Singh, Syed Obaidur Rahman, Anwar Habib, Abul Kalam Najmi
Calcium channel blockers (CCBs) are an established class of drug for the management of hypertension. Observational studies have found that CCB use is associated with a reduction in the risk of developing dementia; however, studies have variably linked the CCBs use with the risk of dementia. This meta-analysis aims to assess whether, in elderly hypertensive patients, the use of CCBs alters the risk of developing dementia. We searched PubMed, Embase and Cochrane from August 2013 to 21st August 2017. Studies were screened on the basis of title and abstract...
February 13, 2018: Neuroscience Letters
Richard Croker, Alex J Walker, Seb Bacon, Helen J Curtis, Lisa French, Ben Goldacre
BACKGROUND: Minimising prescription costs while maintaining quality is a core element of delivering high-value healthcare. There are various strategies to achieve savings, but almost no research to date on determining the most effective approach. We describe a new method of identifying potential savings due to large national variations in drug cost, including variation in generic drug cost, and compare these with potential savings from an established method (generic prescribing). METHODS: We used English National Health Service (NHS) Digital prescribing data, from October 2015 to September 2016...
February 8, 2018: BMJ Open
A Broe, A Pottegård, J Hallas, T P Ahern, J Fedder, P Damkier
STUDY QUESTION: Does phthalate exposure from prescription drugs affect semen quality? SUMMARY ANSWER: Exposure to phthalate-containing drugs is associated with poor semen quality. WHAT IS KNOWN ALREADY: Phthalates and their metabolites have been shown to disrupt the hormone signalling in animal studies. One study has shown associations between medicinal phthalate exposure and poor semen quality, suggesting similar effects in humans. STUDY DESIGN, SIZE, DURATION: We included 18 515 males with poor semen quality (cases) and 31 063 males with normal semen quality (controls) registered in the Danish IVF Registry from 2006 to 2016...
February 7, 2018: Human Reproduction
Wen Chin Foo, Yuet Mei Khong, Rajeev Gokhale, Sui Yung Chan
Orodispersible films (ODF) have clinical potential as extemporaneous pharmacy preparations for individualized pharmacotherapy. However, the conventional method of ODF preparation using a film applicator may limit its application, due to content uniformity challenges arising from viscosity changes of the casting solution and varied operator manipulation. This study proposes the unit-dose (UD) plate as an alternative to the film applicator for compounding individual ODFs. Using a design-of-experiments approach, we developed an extemporaneous ODF formulation for an antiemetic drug, ondansetron hydrochloride dihydrate (OND), at a clinically relevant dose...
January 31, 2018: International Journal of Pharmaceutics
Chrisanne Wilks, Erik Krisle, Kimberly Westrich, Kristina Lunner, David Muhlestein, Robert Dubois
BACKGROUND: Optimized medication use involves the effective use of medications for better outcomes, improved patient experience, and lower costs. Few studies systematically gather data on the actions accountable care organizations (ACOs) have taken to optimize medication use. OBJECTIVES: To (a) assess how ACOs optimize medication use; (b) establish an association between efforts to optimize medication use and achievement on financial and quality metrics; (c) identify organizational factors that correlate with optimized medication use; and (d) identify barriers to optimized medication use...
May 30, 2017: Journal of Managed Care & Specialty Pharmacy
Luis Enrique Tierrablanca, Jessica Ochalek, Deborah Ford, Ab Babiker, Diana Gibb, Karina Butler, Anna Turkova, Susan Griffin, Paul Revill
OBJECTIVES: To analyze the cost effectiveness of short-cycle therapy (SCT), where patients take antiretroviral (ARV) drugs 5 consecutive days a week and have 2 days off, as an alternative to continuous ARV therapy for young people infected with human immunodeficiency virus (HIV) and taking efavirenz-based first-line ARV drugs. METHODS: We conduct a hierarchical cost-effectiveness analysis based on data on clinical outcomes and resource use from the BREATHER trial...
February 2018: Medicine (Baltimore)
Meredith L Tate, Sydney Hopper, Sean Paul Bergeron
BACKGROUND: The primary goals of an accountable care organization (ACO) are to reduce health care spending and increase quality of care. Within an ACO, pharmacists have a unique opportunity to help carry out these goals within patient-centered medical homes (PCMHs). Pharmacy presence is increasing in these integrated care models, but the pharmacist's role and benefit is still being defined. OBJECTIVE: To exhibit the clinical and economic benefit of pharmacist involvement in ACOs and PCMHs as documented by clinical interventions (CIs) and drug cost reductions...
February 2018: Journal of Managed Care & Specialty Pharmacy
Qian Jiang, Lu Yu, Robert Peter Gale
PURPOSE: To explore patients' and hematologists' concerns regarding tyrosine kinaseinhibitor (TKI)-therapy and identify variables associated these concerns. Methods A cross-sectional questionnaire including 16 common issues related to TKI-therapy was distributed to adults with chronic myeloid leukemia (CML) receiving TKIs and hematologists treating CML patients and answered anonymously. RESULTS: Data from 1518 patient respondents receiving TKI-therapy ≥ 3 months were analyzed...
January 29, 2018: Journal of Cancer Research and Clinical Oncology
Sofia-Sotiria Xanthopoulou, Korina Katsaliaki
The increase in the consumption of generic drugs to reduce pharmaceutical expenditure is a challenge for many countries, especially during the economic crisis. The purpose of the present study is to review the Greek market of generic drugs and the decisions that shape it, to determine the factors that affect Greek patients' and doctors' attitudes about generic substitution and present a set of measures for all stakeholders based on the findings of the secondary and primary analysis. The study includes (a) an analysis of international and national reports and legislation on drugs policies and (b) a questionnaire survey of 242 hospital patients and 85 doctors regarding their perceptions on generics...
January 1, 2018: Health Services Management Research
James C Ulchaker, Melissa S Martinson
Objective: To conduct a cost-effectiveness analysis from payers' perspectives of six treatments for lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH) and to examine positioning of these modalities in the marketplace for the best use of health care funds and quality-of-life benefits for patients. Methods: The economic analysis was conducted with a Markov model to compare combination prescription drug therapy (ComboRx), minimally invasive therapies (MITs) including convective radiofrequency (RF) water vapor thermal therapy (Rezūm®), conductive RF thermal therapy (Prostiva®), and prostatic urethral lift (UroLift®), and invasive surgical procedures including photovaporization of the prostate (Greenlight® PVP) and transurethral resection of the prostate (TURP)...
2018: ClinicoEconomics and Outcomes Research: CEOR
Yin Chen, Jing Zhao, Yanlei Yu, Xinyue Liu, Lei Lin, Fuming Zhang, Robert J Linhardt
Low molecular weight heparins (LMWHs) are widely used as clinical anticoagulant drugs. LMWHs are heterogeneous and highly negatively charged glycans prepared by chemical or enzymatic depolymerization of unfractionated heparin. The detailed structural analysis of a LMWH is essential for the drug quality control. In this study, a LMWH, enoxaparin sodium (a generic version of Lovenox) was separated to different molecular weights fractions by a Superdex peptide column. The disaccharide compositions, 3-O-sulfo group containing tetrasaccharides composition, and antithrombin III binding affinity of the fractions from this LMWH were analyzed...
January 12, 2018: Journal of Pharmaceutical Sciences
Jia-Li Ma, Nan Sheng, Wen-Wen Ding, Ying Zhang
OBJECTIVE: To investigate the current quality of life in children with chronic diseases, and to explore the impact of transition readiness on quality of life. METHODS: A total of 332 children with chronic diseases from two children's hospitals in Shanghai, China were enrolled. A self-designed demographic questionnaire, Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQLTM 4.0), and Self-Management and Transition to Adulthood with Rx=Treatment (STARx) Questionnaire were used to evaluate transition readiness and quality of life...
January 2018: Zhongguo Dang Dai Er Ke za Zhi, Chinese Journal of Contemporary Pediatrics
I-Chen Sun, Churn-Shiouh Gau
Generic drugs are accounted for majority of medicinal products. To reduce the unnecessary review for incomplete dossiers of generic drugs, Taiwanese government launched a refuse-to-file (RTF) procedure since 2017. The present study aimed to examine the outcome of RTF procedure by analyzing application characteristic, RTF rate and deficiencies found in the submitted dossiers. Descriptions of administrative information, chemistry, manufacturing and controls, bioequivalence study, and comparative dissolution testing were presented during the first 6 months after the implementation of RTF policy...
January 9, 2018: Regulatory Toxicology and Pharmacology: RTP
Stephanie L Harrison, Lisa Kouladjian O'Donnell, Clare E Bradley, Rachel Milte, Suzanne M Dyer, Emmanuel S Gnanamanickam, Enwu Liu, Sarah N Hilmer, Maria Crotty
BACKGROUND: Inappropriate polypharmacy may negatively impact the quality of life of residents in aged care facilities, but it remains unclear which medications may influence this reduced quality of life. OBJECTIVE: The objective of this study was to examine whether the Drug Burden Index and potentially inappropriate medications were associated with quality of life in older adults living in residential care with a high prevalence of cognitive impairment and dementia...
January 2018: Drugs & Aging
Peter Bai James, Abdulai Jawo Bah, Emmanuel Kamanda Margao, Christian Hanson, John Alimamy Kabba, Shazia Qasim Jamshed
Most low-income nations have national medicine policy that emphasized the use of generic medicines in the public health sector. However, the use of generics is often debatable as there are concerns over its efficacy, quality, and safety compared to their branded counterparts. This study was conducted to compare the knowledge and perception of generic medicines among final year undergraduate medical, pharmacy, and nursing students in Sierra Leone. We conducted a questionnaire-based cross-sectional study among these students at the College of Medicine and Allied Health Sciences University of Sierra Leone...
January 4, 2018: Pharmacy (Basel, Switzerland)
Naser Y Shraim, Tasneem A Al Taha, Rawan F Qawasmeh, Hiba N Jarrar, Maram A N Shtaya, Lama A Shayeb, Waleed M Sweileh
BACKGROUND: Generic substitution in several countries has become a common practice. Besides, it is considered as a major cost minimizing strategy meant to contain pharmaceutical expenditure without compromising healthcare quality. However, the safety and quality issues of generic products are of top concerns of general practitioners and health work professionals. This study aimed to investigate community pharmacist's knowledge, attitudes and practices toward generic medicines in Palestine...
December 28, 2017: BMC Health Services Research
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