ORCID Profile
0000-0002-5310-1994
Current Organisations
Bond University
,
Royal College of Pathologists of Australasia
,
University of Melbourne
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Publications
Commercial detailing techniques used by pharmaceutical representatives to influence prescribing
Publisher: Wiley
Date: 06-1998
DOI: 10.1111/J.1445-5994.1998.TB01953.X
Abstract: To determine the use of influence techniques by pharmaceutical representatives in their encounters with medical practitioners. We identified six influence techniques from the marketing literature which are thought to be commonly used by sales people. These have been termed the principles of reciprocity, friendship/liking, commitment/consistency, social validation, authority, and scarcity. We examined the use of these techniques by analysing audio-recordings of pharmaceutical representatives' presentations to medical practitioners. Sixteen recordings, detailing 64 medicines, were obtained from seven medical practitioners. Reciprocation was the most commonly observed method of influence. S les, gifts, printed material, patient information leaflets or invitations were offered in all encounters. Appeals to authority figures, where promotional claims were supported by reference to professors or specialists, specialist groups and specialist hospitals, were recorded. Social validation acts, where reference was made to the peer group were also common. Commitment acts were observed to occur in two ways the first was as a direct request to use the product detailed and the second was as a series of questions or statements which gradually moved from pre-agreed areas to solicitation of a commitment to prescribe the drug. Influence techniques were found to be commonly used by pharmaceutical representatives when they detailed products to medical practitioners. Medical practitioners may not be aware of the potential effect these techniques can have on their prescribing practices. Knowledge of these techniques must be incorporated into educational programmes designed to provide health professionals with critical appraisal skills.
Modelling and Encoding Therapeutic Guidelines: Applying ICD-10-AM and European Article Number Codes
Publisher: SAGE Publications
Date: 03-2004
DOI: 10.1177/183335830403200205
Abstract: 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.
Complementary medicines advertising policy Part I: unethical conduct in the Australian market before July 2018
Publisher: CSIRO Publishing
Date: 2021
DOI: 10.1071/AH19267
Abstract: ObjectiveThis study assessed the effects of complementary medicines advertising policy before major changes in 2018. MethodsThe 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. ResultsOver 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. ConclusionsNumerous complementary medicines (and medical devices) that were extensively advertised failed to meet real health needs, erted 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 erted from seeking more evidence-based remedies. It remains to be seen whether the new regulatory system will address these problems.
Regulation of complementary medicines
Publisher: Wiley
Date: 09-2017
DOI: 10.1111/IMJ.13548
A review of proposals to reform the regulation of complementary medicines
Publisher: CSIRO Publishing
Date: 2009
DOI: 10.1071/AH090279
Abstract: 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.
The value of food fortification as a public health intervention
Publisher: AMPCo
Date: 02-2018
DOI: 10.5694/MJA17.01095
Patents, pills and politics: the Australia–United States Free Trade Agreement and the Pharmaceutical Benefits Scheme
Publisher: CSIRO Publishing
Date: 2004
DOI: 10.1071/AH040218
Abstract: 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.
Editorial: Retail genetics
Publisher: Therapeutic Guidelines Limited
Date: 06-2017
Enteric bacteria of reptiles on java and the krakatau islands
Publisher: The Royal Society
Date: 19-12-1988
Abstract: A small survey of faecal bacteria from six species of reptile on West Java and the Krakatau Islands showed that species of Citrobacter were present in 17 out of 19 in idual reptiles s led. Species of Enterobacter, Klebsiella and Pseudomonas were also common but Escherichia coli was rare (present in only 2 out of 19 in idual reptiles). Streptococcus faecalis was not detected in any reptile. Species of Pseudomonas were not detected in the faeces of any of the three gecko species s led ( Gekko gecko, Gekko monarchus and Hemidactylus frenatus ), although they were detected in s les from the other three reptile species ( Mabuia multifasciata, Chrysopelea paradisi and Varanus salvtor ). Species of Citrobacter and Pseudomonas were more common and E. coli less common in reptiles than in mammals (rats and bats) living in the same area. The antibiotic-resistance patterns of the Citrobacter species were not significantly different between islands of the Krakatau group. Citrobacter species from reptiles were more resistant to chlor henicol (43 % resistant) than those from mammals (8 % resistant). None of the isolates of Klebsiella and E. coli from reptiles was resistant to tetracycline.
“I want to consume this product; should public health experts stop me?” — Yes
Publisher: AMPCo
Date: 10-2011
DOI: 10.5694/MJA11.11074
Identification of features of electronic prescribing systems to support quality and safety in primary care using a modified Delphi process
Publisher: Springer Science and Business Media LLC
Date: 15-04-2010
The Pharmaceutical Benefits Scheme 2003-2004
Publisher: Springer Science and Business Media LLC
Date: 2005
Rational antibiotic use in China: lessons learnt through introducing surgeons to Australian guidelines
Publisher: Springer Science and Business Media LLC
Date: 30-05-2006
Abstract: 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. 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. 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. Improving antibiotic use in China will require hospital funding reform, more authoritative best-practice guidelines, and hospital authorities embracing quality improvement.
Evaluating Australia's National Medicines Policy using geographical mapping.
Publisher: Wiley
Date: 03-2002
Caution with complementaries for cognitive impairment
Publisher: Therapeutic Guidelines Limited
Date: 02-2011
The Australian obesity epidemic and the regulation of complementary medicine weight loss products
Publisher: Elsevier BV
Date: 12-2021
Abstract: 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. Between July 2018 and July 2019, complaints about a convenience s le 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. 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. 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 ert 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.
Antibiotic-resistance patterns of enteric bacteria of wild mammals on the Krakatau Islands and West Java, Indonesia
Publisher: The Royal Society
Date: 19-12-1988
Abstract: Apart from feral pigs on Panjang, rats ( Rattus rattus and Rattus tiomanicus ) and bats (various families, genera and species) are the only mammals resident on the Krakatau Islands. The two species of rat occur on separate islands, R. rattus on Rakata and R. tiomanicus on Panjang and Sertung. Both occur on Java. Of the two genera of bats examined, species of Cynopterus were found on Java and all the Krakatau islands, whereas Myotis muricola muricola was detected only on Java and Rakata. The main faecal bacteria of these mammals were shown to be Escherichia coli and species of Klebsiella , Enterobacter and Citrobacter , with other bacteria (e.g. Proteus sp., Pseudomonas sp., Aeromonas sp., Serratia sp., Proteus/ Providenca sp., Morganella sp. and Streptococcus faecalis ) being present in only a minority of in iduals Significant differences were noted between the faecal floras of the two rat species. E. coli was always present in R. rattus , but was less frequent in R. tiomanicus (p 0.05), whereas species of Klebsiella and Citrobacter were less frequent in R. rattus than in R. tiomanicus (p 0.05). Differences between the faecal floras of the two bat genera were less significant, with the four main faecal bacteria being present in each genus. However, some in idual M. muricola muricola yielded S. faeclis, Morganella sp. and Proteus/Providencia sp. whereas species of Cynopterus did not ( p 0.05). S. faecalis was detected in rats and the bat M. muricola muricola on Java, but not in mammals on the Krakataus. This may be related to the absence of humans and their domesticated animals on the Krakatau islands. Only on Java did rats carry tetracycline-resistant E. coli or tetracycline-resistant species of Klebsiella . This may be related to the widespread use of tetracycline by humans on Java, where tetracycline is available without medical supervision. Isolates of E. coli from rats on Panjang were more resistant to chlor henicol than were E. coli isolated from rats on the other islands of the Krakatau group, and isolates of Klebsiella from bats on Panjang were more resistant to sulphamethoxazole than were Klebsiella species isolated from bats on Rakata. The reason for faecal bacteria from Panjang mammals being more antibiotic resistant than those from mammals on other islands of the group is unclear, but may be related to differences in diet and vegetation, or the presence of feral pigs on Panjang only.
Complementary medicines advertising policy Part II: unethical conduct in the Australian market after July 2018
Publisher: CSIRO Publishing
Date: 2021
DOI: 10.1071/AH20047
Abstract: ObjectiveTo 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. MethodsAnalysis of the TGA complaint outcome database from 1 July 2018 to 30 June 2019 and the new regulatory measures. ResultsOf 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. ConclusionsComplaint 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 erted from seeking more evidence-based remedies.
Anibiotic-resistance patterns and relative concentrations of bacteria (gram-negative rods) from ash deposits of various ages on the Krakatau Islands
Publisher: The Royal Society
Date: 19-12-1988
Abstract: The Krakatau islands Rakata, Sertung and Panjang, have been colonized by plants, animals and microorganisms over about a century, since the area was probably sterilized by the eruptions of August 1883. In 1930 the island of Anak Krakatau appeared and has since grown subaerially by periodic volcanic eruptions. Parts of this island may have been sterilized by ash eruptions in 1952 and 1953, and since 1962 lava flows have added new land surfaces to the island, the most recent being in 1980. At the northern end of Sertung Island, a long, narrow, sand spit built of eroded volcanic debris provides a land surface that is only a few decades old. These very new land habitats on Anak Krakatau and the Sertung spit, when examined for antibiotic-resistance patterns (resistotypes) of soil bacteria (Gramnegative rods, GNR), were shown to contain GNR much less antibiotic-resistant than those from the older habitats of Sertung on which over 100 years of post-eruptive colonization and succession has been possible. The concentration of soil microorganisms was also considerably less in these very young land habitats only where vegetation had become established were soil GNR significantly resistant to antibiotics and soil microbial concentrations similar to those in the older habitats of the archipelago.
Does admission to a hospital geriatric psychiatry programme improve benzodiazepine and other drug use?
Publisher: Wiley
Date: 06-1994
Controlling complementary medicine claims
Publisher: Therapeutic Guidelines Limited
Date: 12-2008
Editorial: Initiatives to improve antibiotic use
Publisher: Therapeutic Guidelines Limited
Date: 04-1999
Transparency and the Therapeutic Goods Administration
Publisher: Therapeutic Guidelines Limited
Date: 08-2013
Renal Infection with Mycobacterium Chelonei
Publisher: Wiley
Date: 02-1980
DOI: 10.1111/J.1445-5994.1980.TB03417.X
Abstract: A case of renal infection with Mycobacterium chelonei is described. The infection probably occurred via haematogenous spread from an infected arteriovenous shunt in a uraemic woman. Prolonged treatment with intravenous cefoxitin combined with oral erythromycin and rif icin eradicated the organism from the urine. Although renal function stabilised for one year, gradual deterioration to end-stage renal failure occurred.
CLINICAL TRIAL OF PROPHYLAXIS OF WOUND SEPSIS IN ELECTIVE COLORECTAL SURGERY COMPARING TICARCILLIN WITH INIDAZOLE
Publisher: Wiley
Date: 03-1986
ANTIBACTERIAL ACTIVITY OF HYDROLYSED LINSEED OIL AND LINOLENIC ACID AGAINST METHICILLIN-RESISTANT STAPHYLOCOCCUS AUREUS
Publisher: Elsevier BV
Date: 11-1981
DOI: 10.1016/S0140-6736(81)91261-7
Abstract: Droplet-based printing methods are widely used in applications ranging from biological microarrays to additive manufacturing. However, common approaches, such as inkjet or electrohydrodynamic printing, are well suited only for materials with low viscosity or specific electromagnetic properties, respectively. While in-air acoustophoretic forces are material-independent, they are typically weak and have yet to be harnessed for printing materials. We introduce an acoustophoretic printing method that enables drop-on-demand patterning of a broad range of soft materials, including Newtonian fluids, whose viscosities span more than four orders of magnitude (0.5 to 25,000 mPa·s) and yield stress fluids (τ
Antibiotic-resistance patterns of soil bacteria (Gram-negative rods) from the Krakatau Islands (Rakata) and West Java, Indonesia, in 1984
Publisher: The Royal Society
Date: 19-12-1988
Abstract: The explosive eruption of the Indonesian island of Krakatau (Krakatoa) in 1883 almost certainly led to the total destruction of the fauna, flora and microorganisms of the three remaining islands, Rakata (Rakata Besar), Sertung and Panjang (Rakata Kecil). The Ujung Kulon peninsula of Java, 100 km to the south, was much less affected by the volcanic activity. Soil bacteria (Gram-negative rods, GNR) from Rakata (the post-1883 remnant of Krakatau) and the Ujung Kulon peninsula of Java were examined for their antibiotic-resistance patterns. A total of 27 patterns (‘resistotypes’) was detected, based on resistance to the antibiotics icillin, chlor henicol, sulphamethoxazole, trimethoprim, gentamicin, cephalothin and tetracycline. Nine resistotypes were common to Rakata and Java, eleven exclusive to Rakata, and seven exclusive to Java. Two of the common resistotypes (f and z) were widely distributed but most were limited in their distribution and detected at only one site. On both Java and Rakata different resistotypes were detected at different altitudes. Effective colonization of Rakata by GNR has occurred in the 101 years since its sterilization. Seeding of the upper slopes and summit of Rakata with biotypes from mountain areas in Java appears to have occurred. In addition, apparently independent evolution of GNR has occurred on Rakata. Overall, the GNR detected on the uninhabited and previously sterilized island of Rakata were resistant to as wide a range of antibiotics as were those from nearby Java.
Evaluation of features to support safety and quality in general practice clinical software
Publisher: Springer Science and Business Media LLC
Date: 03-05-2011
Self-Regulatory Codes of Conduct: Are They Effective in Controlling Pharmaceutical Representatives' Presentations to General Medical Practitioners?
Publisher: SAGE Publications
Date: 04-1998
DOI: 10.2190/B81X-4A53-TY5M-C2HR
Abstract: Self-regulatory codes of conduct are used to control the promotional practices of the pharmaceutical industry, but the effectiveness of these codes in controlling pharmaceutical representatives' presentations has not been examined. This is a matter of concern because pharmaceutical representatives have more influence than any other promotional media on prescribing practices. The authors developed a method for monitoring the oral presentations of pharmaceutical representatives when promoting products to medical practitioners. Sixteen audio-recordings, detailing 64 medicines, were obtained 38 of the 64 products were prescription-only medicines. Information on indications and on dosage and administration was commonly provided, but information on other areas of drug knowledge, particularly product risk, was minimal. Thirteen presentations contained at least one inaccuracy when compared with Australian Approved Product Information. Presentations did not always comply with current guidelines in the Code of Conduct. The Code provides only limited standards for pharmaceutical representatives' presentations, and no active monitoring system is in place to ensure adherence to the code. There is an urgent need for policy development on the role of pharmaceutical representatives, their standards of practice, and regulation of their activities to ensure they contribute to the appropriate use of medicines.
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No related grants have been discovered for Ken Harvey.