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Australia Proposes Mandatory Reporting Major Failings Medicines Shortages PubMed articles on BioPortfolio. Our PubMed references draw on over 21 million records from the medical literature. Here you can see the latest Australia Proposes Mandatory Reporting Major Failings Medicines Shortages articles that have been published worldwide.
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In Australia, the Home Medicines Review (HMR) is a nationally-funded program, led by pharmacists to optimize medication use for older people. A Medicines Conversation Guide was developed for pharmacists to use in the context of a HMR. The Guide aims to increase patient involvement and support discussions about: general health understanding, decision-making and information preferences, health priorities related to medicines, patient goals and fears, views on important activities and trade-offs.
Public reporting of hospital performance data is a developing area that is gaining increased attention. This is the first study to explore a range of stakeholder opinions on how such public reporting could be strengthened in Australia. Thirty-four semi-structured interviews were conducted with a purposive sample of expert healthcare consumer, provider and purchaser informants who worked in a variety of senior roles and had knowledge of or involvement in public reporting of hospital data within the public or...
Background Under-reporting of adverse drug reactions (ADRs) by healthcare professionals is prevalent worldwide. Community pharmacists are the most frequently visited healthcare professional and are well placed to document ADRs as a part of their routine practice. Objective To measure community pharmacists' knowledge and perspectives towards ADR reporting and their reporting practices. Setting Community pharmacists in the New South Wales, Queensland, Victoria and Tasmania, Australia. Method A survey tool con...
Spontaneous reporting system is the most widely used method by pharmacovigilance centers. Its "voluntary nature" represents the main cause of adverse drug reaction (ADR) under-reporting phenomena. The aim of this study was to point out the issue of ADR under-reporting from doctors, particularly serious ADRs and adverse reactions caused by medicinal products subject to additional monitoring, such as novel oral anticoagulants (NOACs).
Few medicines have been approved for children, leading to rates of off-label prescribing reported to be as high as 90%. In 2007, the European Union adopted the Paediatric Regulation, which mandates that pharmaceutical companies conduct paediatric studies for all new medicines, unless granted a waiver. We aimed to evaluate the availability of paediatric trial results from studies required under the Paediatric Regulation for new medicines authorised in the EU.
Consumers have questions about their medication but the nature of these concerns and how they reflect medication use is unknown.
John Tingle, Associate Professor (Teaching and Scholarship), Nottingham Trent University, discusses some recent reports highlighting major failings in healthcare provision for people with learning disabilities.
Pharmacovigilance is a practice aimed to monitor drug safety in real life conditions and capture adverse drug events during the post marketing phase of drug's life cycle. But under reporting of adverse reactions is a major cause of concern and a threat to the pharmacovigilance systems. The present article looks into the major obstacles affecting the spontaneous reporting of adverse drug reactions (ADRs) in India and the possible solutions. As per available scientific literature, the major impediments to ADR...
Older adults with multimorbidity, polypharmacy, and complex health needs are the major consumer of health care. Ensuring that medicines are used safely, effectively, and delivered efficiently in this population is challenging. In this context, the approach to medicines delivery should seek to overcome some of the difficulties of delivering medicines to older people, and ensure each medication is delivered by the optimal and most convenient route for the patient in question. However, this poses significant o...
The aim of this study was to describe the prevalence of adverse drug events (ADEs) and associated factors reported by users of medicines in Brazil. This was a cross-sectional population-based study conducted from September 2013 to February 2014 with data from the Brazilian National Survey on Access, Use, and Promotion of Rational Use of Medicines (PNAUM). The study included all individuals that reported the use of medicines and identified, among them, all those reporting at least one problem with the medici...
Small and medium-sized enterprises (SMEs) are an important source of innovative medicines. Compared with their larger counterparts, they experience challenges as a result of insufficient human and financial resources that can hamper drug development and regulatory compliance. This analysis reviews the profile of major objections raised in applications for medicines for human use submitted by SMEs to the European Medicines Agency between 2011 and 2015 and their impact on the outcome of applications. It showe...
To identify uses of WHO Model list of essential medicines (EM) and summarize studies examining essential medicines (EM) and national EM lists (NEMLs).
Adolescents often start to use medicines independently without having sufficient knowledge or previous experience, which can lead to the inappropriate use of the medicines.
The Health Star Rating (HSR) system is a voluntary front-of-pack labelling (FoPL) initiative endorsed by the Australian government in 2014. This study examines the impact of the HSR system on pre-packaged food reformulation measured by changes in energy density between products with and without HSR. The cost-effectiveness of the HSR system was modelled using a proportional multi-state life table Markov model for the 2010 Australian population. We evaluated scenarios in which the HSR system was implemented o...
It is widely understood that the 1962 Kefauver-Harris Amendment to the Food, Drug and Cosmetics Act ushered in the modern regulation of medicines requiring a combination of safety and efficacy. However, fewer appreciate the amendment was applied retroactively to virtually all medicines sold in the USA. For various reasons, many medicines faded into history. Here, we identify and analyze >1600 medicines (including over-the-counter drugs) and their innovators prior to the enactment of Kefauver-Harris. We repo...
This article examines pharmaceutical services and access to essential medicines in Brazil during the 30 years since the advent of Brazil's Unified Health System from a comprehensiveness perspective. The following topics are addressed: the "realignment" of pharmaceutical services; human resources in pharmaceutical services; the essential medicines concept; the rational use of medicines; technological advances and drug manufacturing; and ethical regulation. With a strong regulatory focus and a structural fram...
In an effort to relieve the pressure of drug shortages, the Chinese government implemented Low-price Medicines (LPM) policy to raise the price cap in July 2014. The purpose of this study is to examine the effect of the implementation of this policy on drug price in China. Price data of 491 LPM, including 218 low-price chemical medicines (LPCM) and 273 low-price traditional Chinese medicines (LPTCM), were collected from 699 hospitals. We used interrupted time series design to identify the variation of monthl...
The results of medical laboratory testing are only useful if they lead to appropriate actions by medical practitioners and/or patients. An underappreciated component of the medical testing process is the transfer of the information from the laboratory report into the reader's brain. The format of laboratory reports can be determined by the testing laboratory, which may issue a formatted report, or by electronic systems receiving information from laboratories and controlling the report format. As doctors can...
Access to medicines without prescription is a major contributing factor for self-medication practices. This study was designed to examine the ratio of non-prescribed medicines sales and self-medication practices in Punjab, Pakistan. This study also evaluates the reasons for self-medication within its communities.
To study trends in Bacillus Calmette-Guerin (BCG) utilization for non-muscle invasive bladder cancer (NMIBC) before and during national BCG shortages.
Occupational fatigue in anaesthetists is recognised as a patient safety risk. Better understanding of the issues surrounding their fatigue is needed. This study aimed to ascertain the sources and effects of occupational fatigue amongst anaesthetists in Australia and New Zealand. An anonymous online survey was sent to 979 anaesthetists. The response rate was 38.0%. Most participants reported regularly working over 40 hours per week; men reported five more hours per week than women. Stated contributors to fat...
Adverse drug events (ADEs) impose a major clinical and cost burden on acute hospital services. It has been reported that medicines reconciliation provided by pharmacists is effective in minimizing the chances of hospital admissions related to adverse drug events.
National mandatory public performance reporting (PPR) for Australian public hospitals, including measures of cancer surgery waiting times, was introduced in 2011. PPR is voluntary for private hospitals. The aims of this study were to assess whether PPR of hospital data is used by patients with breast, bowel or lung cancer when selecting a hospital for elective surgery and how PPR could be improved to meet their information needs.