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

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

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. Follow-up occurred in February 2021. RESULTS: A search of the TGA advertising complaints database found 'no result' for 84% of the 140 cases submitted. Despite the TGA delisting three products and sponsors delisting ten others, all products complained about were still being advertised. Some products had minor changes in imagery but not claims. The sponsor (Cat Media, Naturopathica) had listed three new FatBlaster weight loss products. CONCLUSIONS: The TGA failed to protect consumers from ineffective weight loss medicines. Implications for public health: Weight loss medicines with misleading and deceptive claims are likely to divert users from evidence-based weight loss activities. The TGA should ask for the evidence supporting promotional claims for these products and, if this is lacking, delist the entire class of products. For recalcitrant sponsors who repeatedly make egregious claims, civil and criminal penalties should be applied.

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. Determinations of the Panel were ineffective at reducing code breaches. When the Panel referred problems to the TGA, usually no action resulted. Over 2014-18, on average there were 763 breaches of the Therapeutic Goods Advertising Code per year, most commonly because claims were misleading, unverifiable or exaggerated efficacy. Over the same period, TGA post-marketing surveillance reviewed, on average, 289 listed products each year; 77% were found to be non-compliant, primarily because of an inability to substantiate the claims made. Only 15% of 684 knowledgeable consumers surveyed agreed that complementary medicines were appropriately regulated. Conclusions Numerous complementary medicines (and medical devices) that were extensively advertised failed to meet real health needs, diverted consumers from more evidence-based treatment and wasted their money. The laws to protect consumers were adequate: the problem was lack of enforcement. What is known about the topic? The previous co-regulatory system for complementary medicines has been the subject of long-standing criticism; however, definitive data about the problems were largely unanalysed or disregarded. What does this paper add? This is the first analysis of the Complaints Resolution Panel's determinations over its entire life (1999-June 2018). The paper provides a baseline from which the outcomes of the new complaint system (after July 2018) can be assessed. At that time, the Panel was abolished and the TGA took over the complaint system, with enhanced investigative and enforcement powers. The analysis shows that most complaints received were upheld by the Panel and a small number of sponsors repeatedly breached the Code. TGA post-marketing data from 2014 to 2018 revealed a high level of regulatory non-compliance by listed products, and a 2018 consumer survey showed low levels of trust in the regulatory system. What are the implications for practitioners? The failure of the TGA to ensure regulatory compliance by advertisers of complementary medicines (and medical devices) meant that health practitioners and consumers were unlikely to recognise the extent of misleading and deceptive claims in the marketplace. Practitioners rarely have the time or resources to investigate claims themselves. The consequence is that consumers will waste their money on useless products and be diverted from seeking more evidence-based remedies. It remains to be seen whether the new regulatory system will address these problems.

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. Results Of 1821 complaint records analysed, 92% were classified as low priority and closed by sending the advertiser a Regulatory Obligation letter. For low priority complaints, no details of the product, advertiser or alleged Code violation were published, and no follow-up was undertaken. Of 121 higher priority complaints, 79% failed to meet their key performance indicator (KPI) time to closure (60-90 days). These included complaints about dangerous sports supplements and ineffective weight loss and hangover products, some of which had been submitted in July 2018. Conclusions Complaint classification and actions taken by the TGA were inconsistent. The TGA's new compliance powers were rarely applied. The new complaint system is less transparent than the one it replaced. There is a high rate of advertising complaints and a low rate of effective regulatory response. Time-based KPIs should be based on outcome measures, not when a case is closed by a process measure. An urgent review of the new system is required. Comment on Australia's 2018 Royal Commission into Misconduct in Banking is equally applicable to the TGA: 'Essentially a failure to enforce the law undermines the authority of the regulator whose fundamental responsibility is to do just that.' It also encourages others to break the law, leading to a race to the bottom and consumer detriment. What is known about the topic? The previous co-regulatory system for complementary medicines was the subject of long-standing criticism and high levels of regulatory non-compliance. The new system, operated solely by the TGA, was meant to overcome these problems. What does this paper add? High levels of advertising complaints persist. The TGA was unable to close many higher-priority complaints within the time frame set by its KPIs. These complaints involved serious breaches of the Therapeutic Goods Act 1989 (Cwlth), which can attract both civil and (strict liability) criminal penalties. However, in most cases compliance was achieved by negotiation. The TGA met its KPIs for virtually all complaints it classified as low priority because these were closed by merely sending an obligations letter with no follow-up. What are the implications for practitioners? The persisting high levels of regulatory violation mean that practitioners cannot trust the claims made for complementary medicines or give good advice. In addition, consumers are wasting their money on useless products and are diverted from seeking more evidence-based remedies.

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. METHODS: Software features were identified by a literature review, key informants and an expert group. A modified Delphi process was used with a 12-member multidisciplinary expert group to reach consensus on the expected impact of the features in four domains: patient safety, quality of care, usefulness to the clinician and usefulness to the patient. The setting was electronic prescribing in general practice in Australia. RESULTS: A list of 114 software features was developed. Most of the features relate to the recording and use of patient data, the medication selection process, prescribing decision support, monitoring drug therapy and clinical reports. The expert group rated 78 of the features (68%) as likely to have a high positive impact in at least one domain, 36 features (32%) as medium impact, and none as low or negative impact. Twenty seven features were rated as high positive impact across 3 or 4 domains including patient safety and quality of care. Ten features were considered "aspirational" because of a lack of agreed standards and/or suitable knowledge bases. CONCLUSIONS: This study defines features of e-prescribing software systems that are expected to support safety and quality, especially in relation to prescribing and use of medicines in general practice. The features could be used to develop software standards, and could be adapted if necessary for use in other settings and countries.

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. There was widespread and increasing use of complementary medicines yet consumers were often unaware that, unlike conventional medicines, these medicines were not evaluated for efficacy. The justification of this two-tiered regulatory system was that complementary medicines are relatively low-risk products. However low risk does not mean no risk. A number of consumers have been shown to use these products for conditions where there is no evidence of effect, potentially placing them at risk. In addition, promotion often overstates their benefits while minimising and sometimes denying known adverse effects and drug interactions. Complaint procedures are overloaded and the "sanctions" available do not deter repeat offenders. A number of regulatory reforms have been suggested to overcome these problems; they are reviewed in this paper.

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. METHODS: Australian and international guideline materials were amalgamated with the help of Chinese experts. Antibiotics prescribed for surgical prophylaxis in 60 consecutive patients undergoing clean or clean-contaminated surgery (120 total) were then compared with guideline recommendations in three phases; a pre-intervention period from June to August, 2002, an intervention period from June to August 2003 and post-intervention period from September to November 2003. During the intervention phase, feedback about prescriptions not in accord with the guideline was discussed with around 25 prescribers every two weeks. In addition, local factors influencing antibiotic use were explored with 13 junior surgeons and 8 high level informants. RESULTS: While agreement was reached on the principles of antibiotic surgical prophylaxis there was no consensus on detail. Of 180 patients undergoing clean surgery throughout all phases of the study, antibiotic prophylaxis was administered to 78% compared to 98% of the 180 patients undergoing clean-contaminated surgery. Second and third generation cephalosporin antibiotics predominated in both low-risk clean and clean-contaminated operations. The timing of prophylaxis was correct in virtually all patients. The duration of prophylaxis was less than 24 hours in 96% of patients undergoing clean surgery compared to only 62% of patients undergoing clean-contaminated surgery. The intervention produced no improvement in the duration of prophylaxis nor the overuse and inappropriate choice of unnecessary broad-spectrum and expensive drugs. Interviews and focus groups revealed that an important explanation for the latter problem was Chinese government policy which expected hospitals to support themselves largely through the sale of drugs. CONCLUSION: Improving antibiotic use in China will require hospital funding reform, more authoritative best-practice guidelines, and hospital authorities embracing quality improvement.

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. There was also concern that the Australia-United States Free Trade Agreement could place further pressure on the Scheme. In 2003, as in 2002, the government proposed a 27% increase in PBS patient co-payments and safety-net thresholds in order to transfer more of the cost of the PBS from the government to consumers. While this measure was initially blocked by the Senate, the forthcoming election resulted in the Labor Party eventually supporting this policy. Recommendations of the Pharmaceutical Benefits Advisory Committee to list, not list or defer a decision to list a medicine on the PBS were made publicly available for the first time and the full cost of PBS medicines appeared on medicine labels if the price was greater than the co-payment. Pharmaceutical reform in Victorian public hospitals designed to minimise PBS cost-shifting was evaluated and extended to other States and Territories. Programs promoting the quality use of medicines were further developed coordinated by the National Prescribing Service, Australian Divisions of General Practice and the Pharmacy Guild of Australia. The extensive uptake of computerised prescribing software by GPs produced benefits but also problems. The latter included pharmaceutical promotion occurring at the time of prescribing, failure to incorporate key sources of objective therapeutic information in the software and gross variation in the ability of various programs to detect important drug-drug interactions. These issues remain to be tackled.

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.

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. Physicians were provided with individualized performance profiles along with diabetes management education. The pilot data were well received, and the program was expanded to 67 primary providers in 23 clinics in northeastern Mississippi and northwestern Alabama. RESULTS: A 12-month review of annual screening demonstrated statistically significant improvement in HgbA1c screening from 83% to 97% (p < or = 0.001); microalbumin screening increased from 12% to 33% (p < or = 0.001); and foot exams increased from a baseline of 24% to 31% (p < or = 0.001). CONCLUSION: Providing individualized data on ambulatory care management engaged physicians in improving annual diabetes screening.

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. From 1996 to 2006, over 1000 "weight-loss" products were listed on the Australian Register of Therapeutic Goods; most contained multiple unevaluated ingredients (herbs, vitamins, minerals) of dubious efficacy. Over the same period, 10 conventional medicines were registered; each contained one evaluated ingredient of proven efficacy. The number of listed weight-loss products (and complaints about their promotion) is increasing. These appear to be a direct consequence of the decision not to evaluate listed products for efficacy and the lower fees for listing a product, compared with registration. Complaint procedures (now overloaded) are no substitute for adequate regulation at the time of market entry. Regulatory reform of listed and homoeopathic products is required.

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. OUTCOME MEASURES: Placement, frequency and type of advertisements; their compliance with the Medicines Australia Code of Conduct, and the views of GPs. RESULTS: 24 clinical functions in Medical Director contained advertisements. These included 79 different advertisements for 41 prescription products marketed by 17 companies, including one generic manufacturer. 57 of 60 (95%) advertisements making a promotional claim appeared noncompliant with one or more requirements of the Code. 29 contributors, primarily GPs, posted 174 emails to GPCG_talk; there was little support for these advertisements, but some concern that the price of software would increase if they were removed. CONCLUSIONS: We suggest that pharmaceutical promotion in prescribing software should be banned, and inclusion of independent therapeutic information be mandated.

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. The Australian Health Insurance Commission won the contract for the pharmaceutical reform project. Australian experts were matched with Croatian experts in order to share knowledge, learn from each other, and provide the best advice. The project had two main components. The first addressed supply side issues and provided advice about savings that could be made by incorporating pharmacoeconomic principles into the selection and purchase of drugs on the Croatian positive list. The second component addressed demand side issues and provided advice aimed at evaluating and improving the quality and effectiveness of drug prescribing by Croatian physicians. This paper describes the second project component. We quantitatively and qualitatively evaluated the prescribing practice of Croatian physicians and ascertain how these might be improved. Croatian general practitioners are required to enter an International Classification of Diseases, 10th Revision (ICD10) diagnostic code on their prescription in order to indicate the clinical problem being treated. Quantitative research involved sorting CIHI prescription data for 2002 into ICD10 diagnostic categories and comparing the drugs prescribed for particular conditions with the recommendations in local and international best-practice guidelines. The results showed a number of areas where the prescribing of Croatian general practitioners and specialists could be improved, such as the use of antibiotics in upper respiratory tract infections and the treatment of hypertension. Qualitative research involved a series of workshops with local pharmacological experts and general practitioners during which the collected prescribing data was discussed, local factors which influenced prescribing were explored, and suggestions for improvement were collated. Many general practitioners felt pressured by increasingly assertive consumers, relentless pharmaceutical promotion, and strident government (CIHI) demands to restrain escalating health care costs. In addition, there was a lack of information about what constituted cost-effective treatment appropriate to the Croatian economic situation. There was support for the production of concise Croatian therapeutic guidelines that provided a limited number of best-practice treatment options for common conditions. A pilot set of such guidelines was devised and incorporated into a clinical software trialed in a Primary Health Care Information Technology Project in Koprivnica. This initiative received support from the general practitioners involved. It was recommended that a unit for the quality use of medicines should be set up to sustain the production of therapeutic guidelines and coordinate this activity with related initiatives. In addition, a quality assurance system (including performance indicators linked to financial incentives) was recommended that would encourage general practitioners to practice in accord with guidelines. We understand that the Croatian government has accepted a number of these recommendations and, in particular, performance indicators (and financial incentives) are written into new contracts for Croatian general practitioners in 2004.

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. Mere distribution of the guidelines had little impact on prescribing habits. However, targeted education campaigns have helped to improve antibiotic prescribing. The Antibiotic title remains the flagship of Therapeutic Guidelines Limited with sales, surveys and endorsements over 11 editions attesting to its wide acceptance and use. Therapeutic Guidelines: Antibiotic is one of many initiatives that have contributed to improving antibiotic use and it serves as a valuable foundation on which to build other strategies. There is demand for a consumer friendly version of the guidelines. In addition, the increasing use of computerised prescribing programs has highlighted the need for electronic guidelines to be closely integrated with decision support software.

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. The TG data model was integrated with the prototype MCCA data model for drug products. This integration indicates that the representation of drugs, while not ideal, is an appropriate means of linking clinical drug reference information to drug product information.

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. Intellectual property provisions of AUSFTA are likely to delay the entry of PBS cost-reducing generic products when pharmaceutical patents expire. We support the many concerned health and consumer organisations who have asked the Senate either not to pass the enabling legislation, or to delay its passage until a fairer deal in terms of public health can be obtained.