The Australian obesity epidemic and the regulation of complementary medicine weight loss products.

Objective: Investigate the response of the Therapeutic Goods Administration's (TGA) new advertising complaint system to resubmitted complaints about complementary medicine weight loss products previously upheld by the Complaint Resolution Panel.

Methods: Between July 2018 and July 2019, complaints about a convenience sample of 22 complementary medicines by eight sponsors, advertised on 140 different internet sites (cases), were resubmitted to the TGA. FatBlaster products featured.

Complementary medicines advertising policy Part I: unethical conduct in the Australian market before July 2018.

Objective This study assessed the effects of complementary medicines advertising policy before major changes in 2018. Methods The study consisted of an analysis of Complaints Resolution Panel determinations from 1999 to 2018, Therapeutic Goods Administration (TGA) post-marketing surveillance data of listed products from 2014 to 2018 and a 2018 consumer survey. Results Over 1999-2018, one company, Pharmacare Laboratories (with its acquisition, Cat Media), repeatedly breached the Therapeutic Goods Advertising Code at a level threefold higher than that of any other company.

Complementary medicines advertising policy Part II: unethical conduct in the Australian market after July 2018.

Objective To assess the effects of Australian complementary medicines advertising policy after major changes in 2018. These included a legally enforceable advertising code, stronger investigative and compliance powers for the Therapeutic Goods Administration (TGA) and enhanced educational resources for industry. Methods Analysis of the TGA complaint outcome database from 1 July 2018 to 30 June 2019 and the new regulatory measures.

Saving money on the PBS: ranibizumab or bevacizumab for neovascular macular degeneration?

The cost differential between these two drugs is no longer defensible.

Identification of features of electronic prescribing systems to support quality and safety in primary care using a modified Delphi process.

Background: Electronic prescribing is increasingly being used in primary care and in hospitals. Studies on the effects of e-prescribing systems have found evidence for both benefit and harm. The aim of this study was to identify features of e-prescribing software systems that support patient safety and quality of care and that are useful to the clinician and the patient, with a focus on improving the quality use of medicines.

A review of proposals to reform the regulation of complementary medicines.

In 2003, the Therapeutic Goods Administration instituted a major recall of products made by Pan Pharmaceuticals Limited. Later that year, an expert committee produced 49 recommendations for complementary medicines reform, many of which were to be implemented by the proposed Australia New Zealand Therapeutic Products Authority (ANZTPA). In 2008, the Pan Pharmaceuticals affair reached some conclusion in the courts, the ANZTPA had been abandoned and the case for reform had intensified.

Commercialism, choice and consumer protection: regulation of complementary medicines in Australia.

Controls on the supply and promotion of complementary medicines in Australia are weak. We used weight-loss products as an example to compare the regulation in Australia of listed complementary medicines and registered pharmaceutical products. Complementary medicines are listed without evaluation for efficacy, while conventional pharmaceutical products are registered after evaluation for quality, safety and efficacy.

Rational antibiotic use in China: lessons learnt through introducing surgeons to Australian guidelines.

Background: World-wide concern about increasing antibiotic resistance has focused attention on strategies to improve antibiotic use. This research adapted Australian best-practice guidelines on the prophylactic use of antibiotics in surgery to a Beijing teaching hospital and then used them as a quality assessment and improvement tool, supplemented by educational interventions. Qualitative data about factors influencing antibiotic use was also obtained.

Pharmaceutical advertisements in prescribing software: an analysis.

Objective: To assess pharmaceutical advertisements in prescribing software, their adherence to code standards, and the opinions of general practitioners regarding the advertisements.

Design, Setting And Participants: Content analysis of advertisements displayed by Medical Director version 2.81 (Health Communication Network, Sydney, NSW) in early 2005; thematic analysis of a debate on this topic held on the General Practice Computer Group email forum (GPCG_talk) during December 2004.

The Pharmaceutical Benefits Scheme 2003-2004.

The Pharmaceutical Benefits Scheme (PBS) grew by 8% in 2003-04; a slower rate than the 12.0% pa average growth over the last decade. Nevertheless, the sustainability of the Scheme remained an ongoing concern given an aging population and the continued introduction of useful (but increasingly expensive) new medicines.

Patents, pills and politics: the Australia-United States Free Trade Agreement and the Pharmaceutical Benefits Scheme.

There is tension between the need of the pharmaceutical innovator for intellectual property protection and the need of society for equitable and affordable access to innovative drugs. The recent Australia-United States Free Trade Agreement provides a nice illustration of this interplay between patents, pills and politics. This article provides a brief history of patent law as applied to pharmaceuticals, describes how the Pharmaceutical Benefits Scheme got caught up in AUSFTA negotiations, analyses the clauses that are likely to impact upon the PBS and describes the political process that reviewed and ultimately amended the AUSFTA.

Croatian pharmaceutical sector reform project: rational drug use.

The Croatian Pharmaceutical Sector Reform Project was one component of a larger Health Reform Project financed by the World Bank. The Croatian government was concerned that Croatia appeared to spend more money on medicinal drugs than most other countries in the region; that the price of drugs purchased in Croatia was higher than in some other countries, and that the prescribing habits of some Croatian physicians were perceived to be unnecessarily expensive. In addition, the Croatian Institute for Health Insurance (CIHI), which pays for most health care, had come under considerable financial pressure due to increasing health expenditure and a decreasing proportion of the population contributing to insurance.

Will the Australia-United States Free Trade Agreement undermine the Pharmaceutical Benefits Scheme?

The Australia-United States Free Trade Agreement (AUSFTA) contains major concessions to the US pharmaceutical industry that may undermine the egalitarian principles and operation of the Pharmaceutical Benefits Scheme (PBS) and substantially increase the costs of medicinal drugs to Australian consumers. AUSFTA's approach to the PBS excessively emphasises the need to reward manufacturers of "innovative" new pharmaceuticals, instead of emphasising consumers' need for equitable and affordable access to necessary medicines (the first principle of our National Medicines Policy). Several features of AUSFTA may bring pressure to bear on the Pharmaceutical Benefits Advisory Committee (PBAC) to list "innovative" drugs that the committee initially rejected because the evidence for cost-effectiveness was not compelling.

Outcomes management of an ambulatory clinic system population: experience with patients with diabetes.

Purpose: North Mississippi Medical Center (NMMC) applied well-established in-patient outcomes management techniques to patients in its ambulatory care clinics. Diabetes was targeted for the initial outcomes management project because screening and treatment guidelines are clear and non-controversial.

Project: Eleven providers in five clinics were initial participants in the pilot program that recorded annual screening of HgbA1c, lipids, microalbumin, foot exams, and eye exams.

Modelling and encoding Therapeutic Guidelines: applying ICD-10-AM and European Article Number codes.

This article reports on the assignment of ICD-10-AM and EAN codes to 2500 topics in Therapeutic Guidelines (TG). The analysis of the assignment of ICD-10-AM codes in this project has revealed that ICD-10-AM is not capable of describing the complete clinical information in the guidelines series. It is not likely that any existing single classification scheme will be capable of this and that a combination of schemes will be necessary.

Improving antibiotic use: 25 years of antibiotic guidelines and related initiatives.

In the late 1970s concern in Melbourne teaching hospitals over the increasing incidence of antibiotic-resistant microorganisms and inappropriate antibiotic prescribing, led to the establishment of a working party to produce guidelines on appropriate antimicrobial therapy. Therapeutic Guidelines: Antibiotic is now produced, marketed and sold by Therapeutic Guidelines Limited, an independent, not-for-profit enterprise that distils best-practice prescribing guidelines for Australian health professionals. Therapeutic Guidelines now cover all major therapeutic areas.