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Expired pharmaceutical

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
W D Ludwig, S Dicheva
Biosimilar medicinal products (biosimilars) have been available in Europe for 10 years, allowing a wide use particularly in oncology. Biosimilars are being developed and approved by means of scientifically sound principles to assure close similarity with the reference products with regard to quality, efficacy, and safety. The scientific principles for establishing biosimilarity are the same as those for demonstrating comparability after a change in the manufacturing process of an already licensed biological...
October 10, 2016: Zeitschrift Für Gastroenterologie
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
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
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
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
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
Kunal Roy, Supratik Kar
Pharmaceuticals and their active metabolites are one of the significantly emerging environmental toxicants. The major routes of entry of pharmaceuticals into the environment are industries, hospitals, or direct disposal of unwanted or expired drugs made by the patient. The most important and distinct features of pharmaceuticals are that they are deliberately designed to have an explicit mode of action and designed to exert an effect on humans and other living systems. This distinctive feature makes pharmaceuticals and their metabolites different from other chemicals, and this necessitates the evaluation of the direct effects of pharmaceuticals in various environmental compartments as well as to living systems...
2016: Methods in Molecular Biology
Tomas Gabriel Bas, Carolina Oliu Castillo
The development of biological products has experienced continuous growth over the past three decades. The expiration of patent protection for many biological medicines has led to the development of biosimilars in many countries around the world. This paper reviews the literature on biosimilar drugs and covers their therapeutic status, clinical trials, approved biosimilars, and regulatory guidelines in Japan, South Korea, and Malaysia. The literature suggests that biosimilars are comparable but not identical to the reference product...
2016: BioMed Research International
Glen T Schumock, Edward C Li, Katie J Suda, Michelle D Wiest, JoAnn Stubbings, 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 2016 in nonfederal hospitals, clinics, and overall (all sectors). METHODS: Drug expenditure data through calendar year 2015 were obtained from the IMS Health National Sales Perspectives database and analyzed. Other factors that may influence drug spending in hospitals and clinics in 2016, including new drug approvals and patent expirations, were also reviewed...
July 15, 2016: American Journal of Health-system Pharmacy: AJHP
Leandro de Moura França, Maria Fernanda Pimentel, Simone da Silva Simões, Severino Grangeiro, José M Prats-Montalbán, Alberto Ferrer
Pharmaceutical quality control is important for improving the effectiveness, purity and safety of drugs, as well as for the prevention or control of drug degradation. In the present work, near infrared hyperspectral images (HSI-NIR) of tablets with different expiration dates were employed to evaluate the degradation of captopril into captopril disulfide in different layers, on the top and on the bottom surfaces of the tablets. Multivariate curve resolution (MCR) models were used to extract the concentration distribution maps from the hyperspectral images...
July 2016: European Journal of Pharmaceutics and Biopharmaceutics
Cory Soto, Jamie Stiner, Daniel O Noji, Jeffrey M Rusheen, Yue Ming Huang
INTRODUCTION: The acquisition and use of pharmaceuticals in simulation is a common challenge for many institutions and simulation centers. There are 2 major avenues of obtaining medications, namely, via expired drugs donated by manufacturers or via purchasing simulated medication vials filled with inactive ingredients. Neither option is ideal to keep pace with busy simulation centers or to meet the specialized requirements of many educational programs. We describe an alternative solution through internal production of simulated drugs using readily available materials from laboratory suppliers...
June 2016: Simulation in Healthcare: Journal of the Society for Simulation in Healthcare
Hye-Young Kwon, Brian Godman
BACKGROUND: There have been concerns in Korea that the availability of cheaper generics can appreciably increase prescribed volumes thereby negating their beneficial effects on overall pharmaceutical expenditure. Consequently, this study aimed to explore market changes after newly entered generics including market expansion and substitution effects, and to examine factors contributing to the prescribing of newly entered generics using atorvastatin as an exemplar. This is because previous studies have shown market expansion had occurred following generic atorvastatin...
2016: BMC Health Services Research
Celia Dias-Ferreira, Susana Valente, João Vaz
This work is the first nationwide study in Portugal on pharmaceutical waste generated at households, exploring people's attitudes and risk perception. The waste audit was carried out from September to November 2014, targeting pharmaceutical products kept by a sample of families (n = 244). This campaign was an assignment of VALORMED, the non-profit association that manages waste and packaging from expired and unused pharmaceutical products collected by the pharmacies. On average, each household kept at home 1097 g of pharmaceutical products, of which 20% were in use, 72% were not in use, and 8% were mostly expired products ready to discard...
March 29, 2016: Waste Management & Research
Mu-Chen Lu, Yao Yin Chen, Mei-Rung Chiou, Men Yu Chen, Huan-Jung Fan
Landfill leachates might contain pharmaceuticals due to the expired or unwanted drugs were disposed of at landfills. These pharmaceuticals might pose a threat to soil and groundwater. Therefore, this study investigated the distributions of pharmaceutical residues and toxicities among four typical municipal landfill leachates. Twenty six pharmaceuticals were investigated in this study and fifteen of them were found in all samples from four leachates. In addition, ampicillin and methylenedioxymethamphetamine (MDMA) were detected in urban landfills (A1 and A2) but were not in rural and suburb landfills (B and C)...
September 2016: Waste Management
Fatma Al-Shareef, Sarah Abu El-Asrar, Lamyaa Al-Bakr, Maisam Al-Amro, Fulwah Alqahtani, Fadilah Aleanizy, Sarah Al-Rashood
Background Improper disposal of medication has several possible consequences such as childhood poisoning, environmental pollution, a negative impact on wildlife, and antibiotic resistance. The number of studies conducted to characterize pharmaceutical disposal practices is limited, particularly in the Middle East. Objective The aim of this cross-sectional study was to examine the behaviour of individuals with respect to the disposal of expired and unused medications. Furthermore, we aimed to identify the best methods of education regarding appropriate, safe disposal of medication...
August 2016: International Journal of Clinical Pharmacy
M Ben Yahya
The department of pharmacy of the Regional Hospital of Dapaong is responsible for delivery of health products. We sought to assess the department's avoidable costs to optimize the hospital's drug policies and thereby improve patient care. This cost-forecasting study is intended to convince the hospital staff of the utility of setting up a drug and therapeutics committee and more particularly of developing a drug handbook for use within the public health institutions of the Savanna region. This prospective study seeks to improve the efficiency, quality, and availability of medicines by listing the references currently available at the Regional Hospital to demonstrate the percentage of duplicates and to show the references currently unavailable via "lost" sales...
May 1, 2016: Médecine et Santé Tropicales
Carl Rudolf Blankart, Tom Stargardt
In recent years, the expiration of patents for large drug classes has increased the importance of post-patent drug markets. However, previous research has focused solely on patent drug markets. In this study, the authors evaluate the influence of preferred supplier contracts, the German approach to tendering, in post-patent drug markets using a hierarchical market share attraction model. The authors find that preferred supplier contracts are a powerful strategic instrument for generic manufacturers in a highly competitive environment...
February 22, 2016: Health Care Management Science
Eve Namisango, Chris Ntege, Emmanuel B K Luyirika, Fatia Kiyange, Matthew J Allsop
BACKGROUND: Medicine availability is improving in sub-Saharan Africa for palliative care services. There is a need to develop strong and sustainable pharmaceutical systems to enhance the proper management of palliative care medicines, some of which are controlled. One approach to addressing these needs is the use of mobile technology to support data capture, storage and retrieval. Utilizing mobile technology in healthcare (mHealth) has recently been highlighted as an approach to enhancing palliative care services but development is at an early stage...
2016: BMC Palliative Care
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