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Expired drugs

Paresh Zanzmera, Ramshekhar N Menon, Kalyani Karkare, Himanshu Soni, Sujit Jagtap, Ashalatha Radhakrishnan
PURPOSE: The purpose of this article was to study the electroclinical characteristics and seizure outcome of children with epilepsy with myoclonic absences (EMA). METHOD: In this descriptive cohort study, we reviewed clinical records of patients who met the criteria for EMA. Each patient's demographic data, birth/developmental history, seizure semiology/pattern, antiepileptic drugs (AED), clinical examination, video-electroencephalography (VEEG), and neuroimaging data were reviewed...
October 19, 2016: Epilepsy & Behavior: E&B
Zohar Barnett-Itzhaki, Tamar Berman, Itamar Grotto, Eyal Schwartzberg
BACKGROUND: Large amounts of expired and unused medications accumulate in households. This potentially exposes the public to hazards due to uncontrolled use of medications. Most of the expired or unused medications that accumulate in households (household medical waste) is thrown to the garbage or flushed down to the sewage, potentially contaminating waste-water, water resources and even drinking water. There is evidence that pharmaceutical active ingredients reach the environment, including food, however the risk to public health from low level exposure to pharmaceuticals in the environment is currently unknown...
2016: Israel Journal of Health Policy Research
Joseph Zaia, Kshitij Khatri, Joshua A Klein, Chun Shao, Yuewei Sheng, Rosa Viner
Low molecular weight heparins (LMWH) prepared by partial depolymerization of unfractionated heparin are used globally to treat coagulation disorders on an outpatient basis. Patent protection for several LMWH has expired and abbreviated new drug applications have been approved by the Food and Drug Administration. As a result, reverse engineering of LMWH for biosimilar LMWH has become an active global endeavor. Traditionally, the molecular weight distributions of LMWH preparations have been determined using size exclusion chromatography (SEC) with optical detection...
October 6, 2016: Analytical Chemistry
Heberto Arboleya Casanova, Héctor Marino Zavala Sánchez, Angélica María Hernández Fernández, Dulce Janeth González Herrera
In 2009, with the implementation of the National Hospital Pharmacy Model, Mexico began regulating single-dose drugs. The repackaging of oral drugs is fundamental and critical and should be standardized by Mexican health legislation to enable quality drugs to be dispensed. Data is required on stability, compatibility, drug interactions, containers, and repackaging methods, in order to establish a new expiration date. The literature on health regulations applicable to repackaging was analyzed, revealing major conceptual imprecisions since there is no legislation in Mexico that regulates repackaging; rather, everything is carried out according to pharmacists' recommendations and criteria...
June 2016: Revista Panamericana de Salud Pública, Pan American Journal of Public Health
Daniel L Moellentin, Dale Stewart, James Barbour
A 39-year-old man presented with new onset right hemiparesis and aphasia within an hour of using approximately 120 mL lidocaine 4% topical solution intranasally. Lidocaine had been prescribed over a 3-week period for pain due to multiple debridements of the nasal septum. A total of 650 mL of 4% lidocaine (26 g) had been dispensed to the patient during this time. The patient had a significant history of drug abuse, including snorting crushed tablets. Otherwise he was a healthy man with no chronic diseases or conditions...
September 2016: Hospital Pharmacy
H Q Wang, T Li
Objective: To review the clinical research on the main drugs which are used to treat pneumoconiosis in China, evaluate and analyze the efficacy, and give the suggestions on the study of pneumoconiosis treatment. Methods: The data of researches on the therapeutic effects of eight main drugs on patients with pneumoconiosis in China were retrieved from CNKI and Wanfang database before Jan. 1, 2016 including polyvinylpyridine, tetrandrine, piperaquine phosphate, hydroxypiperaquine phosphate, aluminium citrate, Xinin, Xifeining and N-acetyl cysteine (NAC) after consulting the related project files on the clinical treatment on the patients with pneumoconiosis, and a systematic analysis was made on the random control test (RCT) which conformed to the quality criteria in terms of five indices such as the improvement rate of respiratory system symptoms such as cough, expectoration, chest pain and dyspnea, the decrease of the respiratory system infection rate, the changes in FEV1...
July 20, 2016: Chinese Journal of Industrial Hygiene and Occupational Diseases
Murray Aitken, Ernst R Berndt, David Cutler, Michael Kleinrock, Luca Maini
In the period 2005-13 the US prescription drug market grew at an average annual pace of only 1.8 percent in real terms on an invoice price basis (that is, in constant dollars and before manufacturers' rebates and discounts). But the growth rate increased dramatically in 2014, when the market expanded by 11.5 percent-which raised questions about future trends. We determined the impact of manufacturers' rebates and discounts on prices and identified the underlying factors likely to influence prescription spending over the next decade...
September 1, 2016: Health Affairs
Joanna Sieczkowska, Dorota Jarzębicka, Monika Meglicka, Grzegorz Oracz, Jaroslaw Kierkus
Infliximab was the first monoclonal antibody used in the treatment of inflammatory bowel disease (IBD). Over several years, this antitumour necrosis factor (TNF) treatment proved its efficacy in both induction and maintenance therapy. In many cases this biological treatment stopped the progression of the disease, probably also decreasing morbidity and hospitalization rates, and improving patients' comfort. When the patent on infliximab started to expire, the first biosimilar of a monoclonal antibody was introduced onto the pharmacological market...
September 2016: Therapeutic Advances in Gastroenterology
Maria Josep Cabañas Poy, Carme Cañete Ramírez, Sabina X González di Lauro, Virginia Rodríguez Garrido, Gloria Roig Carbajosa, Aurora Fernández-Polo, Susana Clemente Bautista
The oral administration of drugs to the pediatric population involves the extemporaneous preparation of liquid formulations. These formulations have studies on their physicochemical stability, but they often lack microbiological studies. The objective of this study is to check the microbiological quality of five oral liquid formulations prepared with different excipients, which represent five major combinations, in two conditions: kept unopened until the day of the test, and in a multi-dose vial opened daily...
September 2016: Farmacia Hospitalaria
Andrew Hill, Dzintars Gotham, Graham Cooke, Sanjay Bhagani, Isabelle Andrieux-Meyer, Jennifer Cohn, Joseph Fortunak
BACKGROUND: In 2013, an estimated 686,000 people died from hepatitis B virus (HBV) infection worldwide. Mass treatment programmes for hepatitis B will require very low drug costs. International treatment guidelines recommend first-line monotherapy with either entecavir or tenofovir disoproxil fumarate (TDF). While the basic patent on TDF expires in 2017/8, entecavir is already generic in several countries, including the US. The chemical structure of entecavir is related to abacavir, which costs <$200 per person-year in low-income countries...
2015: Journal of Virus Eradication
Paolo Dapavo, Igor Vujic, Maria Teresa Fierro, Pietro Quaglino, Martina Sanlorenzo
BACKGROUND: The infliximab originator's patent recently expired, leading to the production of biosimilar versions of the drug. The biosimilars' efficacy was not tested on patients with psoriasis but most regulatory authorities approved their use in psoriasis because of an extrapolation of data from studies conducted in other diseases. OBJECTIVE: We sought to describe the use of the infliximab biosimilar (Remsima; CT-P13) in patients with psoriasis. METHODS: Objective (Psoriasis Area and Severity Index) and subjective (visual analog pain scale) measurements of disease activity were collected in 2 cohorts of patients with moderate to severe plaque psoriasis: cohort 1 patients switched from the infliximab originator to the infliximab biosimilar; and cohort 2 patients were infliximab-naïve and started on the infliximab biosimilar...
October 2016: Journal of the American Academy of Dermatology
Barry A Borlaug, Vojtech Melenovsky, Katlyn E Koepp
RATIONALE: Abnormalities in nitric oxide signaling play a pivotal role in heart failure with preserved ejection fraction (HFpEF). Intravenous sodium nitrite, which is converted to nitric oxide in vivo, improves hemodynamics in HFpEF, but its use is limited by the need for parenteral administration. Nitrite can also be administered using a novel, portable micronebulizer system suitable for chronic use. OBJECTIVE: Determine whether inhaled nitrite improves hemodynamics in HFpEF...
September 16, 2016: Circulation Research
Warren A Kaplan, Reed F Beall
BACKGROUND: Lack of access to insulin and poor health outcomes are issues for both low and high income countries. This has been accompanied by a shift from relatively inexpensive human insulin to its more expensive analogs, marketed by three to four main global players. Nonetheless, patent-based market exclusivities are beginning to expire there for the first generation insulin analogs. This paper adds a global dimension to information on the U.S. patent landscape for insulin by reviewing the patent status of insulins with emphasis on the situation outside the US and Europe...
2017: Journal of Pharmaceutical Policy and Practice
Aleksandra Grozdanova, Katerina Ancevska Netkovska, Zoran Sterjev, Zorica Naumovska, Rubin Zarevski, Aleksandar Dimovski, Ljubica Suturkova
The use of biological medicine has significantly increased in recent decades and has made substantial contributions to improving the effectiveness of therapies in many diseases. The expiration of patents of biological innovative medicines enables copies of those drugs called similar biological products (biosimilars) to be approved by regulatory authorities and to enter in clinical use. Biosimilars are comparable but not identical and are not a generic version of the innovator biological product. Although biosimilars undergo rigorous characterization as well as clinical studies to prove their safety and effectiveness, specific regulatory requirements for registration apply in the case of biosimilars...
2016: Prilozi (Makedonska Akademija Na Naukite i Umetnostite. Oddelenie za Medicinski Nauki)
Kazuki Tobita, Makoto Inada, Asuka Sato, Kimiyoshi Sudoh, Hitoshi Sato
BACKGROUND: The determination of gastric pH is important for the confirmation of efficacy of anti-secretory drugs. However, current methods for measurement of gastric pH provide significant stress to animals and humans. AIM: The objective of this study is to establish an easy and reliable gastric pH measurement method by determining (13)CO2 concentration in expired air of monkeys, dogs, and rats after oral administration of Ca(13)CO3. METHODS: A correlation of (13)CO2 concentration determined by a Ca(13)CO3 breath test with gastric pH just before Ca(13)CO3 administration was analyzed in the 3 animal species...
September 2016: Digestive and Liver Disease
João Gonçalves, Filipe Araújo, Maurizio Cutolo, João Eurico Fonseca
Biological drugs and their originated biosimilars are large, highly complex molecules derived from living cells or organisms. Traditional medicines, by contrast, are usually simple molecules of low molecular weight, synthesised by chemical means. The distinct complexities and methods of manufacture create an important difference between biosimilars and conventional generic drugs: while chemical generics can be fully characterised as identical to the originator product, biosimilars cannot. In addition, biological therapies are inherently variable, creating unavoidable differences between even subsequent batches of the same product...
July 2016: Clinical and Experimental Rheumatology
Sa'ed H Zyoud, Shaher H Zyoud, Samah W Al-Jabi, Waleed M Sweileh, Rahmat Awang
BACKGROUND: Recently, the pharmaceutical manufacturing industry has been growing rapidly in many countries in the world, including in Arab countries. Pharmaceuticals reach aquatic environments and are prevalent at small concentrations in wastewater from the drug manufacturing industry and hospitals. Such presence also occurs in domestic wastewater and results from the disposal of unused and expired medicines. Therefore, the objective of this study was to analyze and compare the quantity and quality of publications made by researchers in Arab countries on pharmaceutical wastewater...
2016: Annals of Occupational and Environmental Medicine
Misty G Eleryan, Sophia Akhiyat, Monica Rengifo-Pardo, Alison Ehrlich
With the expiration of patent protection for several biologics looming, the production of highly similar therapeutic agents has begun to emerge on the pharmaceutical market. These alternative drugs are referred to as biosimilars. Many anticipate that the introduction of these agents will result in a reduction in health care costs, which may create a more affordable biopharmaceutical market and also improve patient access. In contrast to generics, which are exact copies of their original products, biosimilars are not identical to their reference products...
2016: Clinical, Cosmetic and Investigational Dermatology
Jing Luo, John D Seeger, Macarius Donneyong, Joshua J Gagne, Jerry Avorn, Aaron S Kesselheim
IMPORTANCE: In November 2011, the cholesterol level-lowering medication atorvastatin calcium became available in the United States as a generic drug. However, only a single generic form (from a manufacturer that qualified for market exclusivity by challenging several of Pfizer's patents) and an authorized generic form (a brand-name drug sold as a generic) were available for the first 180 days. OBJECTIVE: To describe trends in the prescribing of generic atorvastatin after expiration of market exclusivity for the brand-name medication and the effect on patients' out-of-pocket spending...
September 1, 2016: JAMA Internal Medicine
Chie Hoon Song, Jeung-Whan Han
Extending the period of the market exclusivity and responding properly to the recent agglomeration of patent expiries are pivotal to the success of pharmaceutical companies. Declining R&D productivity, rising costs of commercialization, near-term patent expirations for many top-selling drugs are forcing companies to adopt new systems to introduce innovative products to market and to focus on strategies that increase the returns from the existing product portfolio. This systematic review explores various strategic and tactical management approaches by synthesizing the relevant literature and practical examples on patent expiration strategies...
2016: SpringerPlus
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