Internal medicine journal
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As patents expire on biological agents for the treatment of rheumatic diseases, we have the opportunity to develop non-proprietary biologic agents, biosimilars. The development and approval of these agents present novel challenges to both pharma and regulatory agencies although there is great promise of high quality, less expensive biologic agents for the treatment of rheumatic diseases. Here, we review the definitions of biosimilars, the regulatory challenges to approval of these agents and the record of approvals of biosimilars to date.
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Internal medicine journal · Mar 2014
Method for improving the quality of discharge summaries written by a general medical team.
We developed a writing rubric that assessed the quality of four common errors found in the synopsis of a discharge summary: relevance, accuracy, clarity and presentation (R-A-C-P). We assessed the effect of an intervention that taught the essentials of discharge summary preparation. The intervention reduced the number of inadequate discharge summaries written by medical staff on a busy medical service. Writing the clinical synopsis of a discharge summary is a skill that can be taught quickly.
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Internal medicine journal · Feb 2014
Prescribing for comorbid disease in a palliative population: focus on the use of lipid-lowering medications.
The balance of benefit versus burden of ongoing treatments for comorbid disease in palliative populations as death approaches needs careful consideration given their particular susceptibility to adverse drug effects. ⋯ Polypharmacy is prevalent for this group of patients, placing them at high risk of drug-drug and drug-host interactions. Prescribing may be driven by risk factors and disease guidelines rather than a rational, patient-centred approach.
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Ejaculatory dysfunction is a common complaint and is often associated with a reduced quality of life for sufferer and partner. The spectrum of ejaculatory dysfunction extends from premature ejaculation (PE) to delayed ejaculation (DE) and anejaculation. Over the past 20-30 years, the PE treatment paradigm, previously limited to behavioural psychotherapy, has expanded to include drug treatment. ⋯ Although some appear to be effective, none has been properly evaluated in large-scale samples. Treatment of DE or anejaculation with pharmacotherapy has met with limited success. No drugs have been approved by regulatory agencies for this purpose, and most drugs that have been identified for potential use have limited efficacy, impart significant side-effects or are yet considered experimental in nature.
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Internal medicine journal · Feb 2014
Multicenter StudyThe Australia and New Zealand Fontan Registry: description and initial results from the first population-based Fontan registry.
The Fontan procedure is the final in a series of staged palliations for single-ventricle congenital heart disease, which encompasses rare and heterogeneous cardiac lesions. It represents an unusual and novel physiological state characterised by absence of a subpulmonary ventricle. ⋯ The population surviving after the Fontan procedure has been growing in recent decades, especially since survival with hypoplastic left heart syndrome has improved. The Australia and New Zealand Fontan Registry provides population-based data, and only large databases like this will give opportunities for understanding the population and performing prospective trials.