Regulatory withdrawal of medicines marketed with uncertain benefits : the bevacizumab case study

Acknowledgements Professor Elizabeth Roughead is funded by a Future Fellowship from the Australian Research Council. The views expressed are those of the authors, the sponsor had no role in the preparation of the manuscript.Peer reviewedPublisher PD

The challenge of pharmaceutical promotion regulation in Malaysia.

Information on medicines provided to doctors should be of high quality to support the quality use of medicines. Pharmaceutical promotion is used by pharmaceutical companies to disseminate information about their medicines to doctors. Although the companies claim that promotion offers evidence-based information, research shows that pharmaceutical promotion often provide bias and poor quality of information that may negatively influence doctors' prescribing behaviour. In Malaysia, the pharmaceutical market is highly competitive. It appears that pharmaceutical companies actively promoting their medicines to Malaysian doctors. Given the absence of a comprehensive independent source of prescribing information in Malaysia, Malaysian doctors may be more likely to rely on medicines information provided by pharmaceutical companies. Clearly, pharmaceutical promotional activities in Malaysia need to be effectively regulated. This article will discuss the regulation of pharmaceutical promotion and current policy challenges in Malaysia

Quality and availability of consumer information on heart failure in Australia

<p>Abstract</p> <p>Background</p> <p>Provision of consumer information and patient education are considered an essential part of chronic disease management programmes developed for patients with heart failure. This study aimed to review the quality and availability of consumer information materials for people with heart failure in Australia.</p> <p>Methods</p> <p>The availability of consumer information was assessed through a questionnaire-based survey of the major organisations in Australia known, or thought, to be producing or using consumer materials on heart failure, including hospitals. The questionnaire was designed to explore issues around the use, production and dissemination of consumer materials. Only groups that had produced consumer information on heart failure were asked to complete the totality of the questionnaire.</p> <p>The quality of information booklets was assessed by using a standardised checklist.</p> <p>Results</p> <p>Of 101 organisations which were sent a questionnaire, 33 had produced 61 consumer resources on heart failure including 21 information booklets, 3 videos, 5 reminder fridge magnets, 7 websites, 15 self-management diaries and 10 self-management plans. Questionnaires were completed for 40 separate information resources. Most had been produced by hospitals or health services. Two information booklets had been translated into other languages. There were major gaps in the availability of these resources as more than half of the resources were developed in 2 of the 8 Australian states and territories, New South Wales and Victoria.</p> <p>Quality assessment of 19 information booklets showed that most had good presentation and language. Overall eight high quality booklets were identified. There were gaps in terms of topics covered, provision of references, quantitative information about treatment outcomes and quality and level of scientific evidence to support medical recommendations. In only one case was there evidence that consumers had been involved in the production of the booklets.</p> <p>Conclusion</p> <p>Key findings arising from the study included the need to develop a nationally coordinated approach for increasing the dissemination of information resources on heart failure. While the more recent publication of a booklet by the National Heart Foundation may have improved the situation, dissemination of written information materials may remain sub-optimal, especially among patients who are not enrolled in chronic heart failure management programmes.</p

Quality of Pharmaceutical Advertisements in Medical Journals: A Systematic Review

Journal advertising is one of the main sources of medicines information to doctors. Despite the availability of regulations and controls of drug promotion worldwide, information on medicines provided in journal advertising has been criticized in several studies for being of poor quality. However, no attempt has been made to systematically summarise this body of research. We designed this systematic review to assess all studies that have examined the quality of pharmaceutical advertisements for prescription products in medical and pharmacy journals.Studies were identified via searching electronic databases, web library, search engine and reviewing citations (1950 - February 2006). Only articles published in English and examined the quality of information included in pharmaceutical advertisements for prescription products in medical or pharmacy journals were included. For each eligible article, a researcher independently extracted the data on the study methodology and outcomes. The data were then reviewed by a second researcher. Any disagreements were resolved by consensus. The data were analysed descriptively. The final analysis included 24 articles. The studies reviewed advertisements from 26 countries. The number of journals surveyed in each study ranged from four to 24 journals. Several outcome measures were examined including references and claims provided in advertisements, availability of product information, adherence to codes or guidelines and presentation of risk results. The majority of studies employed a convenience-sampling method. Brand name, generic name and indications were usually provided. Journal articles were commonly cited to support pharmaceutical claims. Less than 67% of the claims were supported by a systematic review, a meta-analysis or a randomised control trial. Studies that assessed misleading claims had at least one advertisement with a misleading claim. Two studies found that less than 28% of claims were unambiguous clinical claims. Most advertisements with quantitative information provided risk results as relative risk reduction. Studies were conducted in 26 countries only and then the generalizability of the results is limited.Evidence from this review indicates that low quality of journal advertising is a global issue. As information provided in journal advertising has the potential to change doctors' prescribing behaviour, ongoing efforts to increase education about drug promotion are crucial. The results from our review suggest the need for a global pro-active and effective regulatory system to ensure that information provided in medical journal advertising is supporting the quality use of medicines

Medicines information provided by pharmaceutical representatives: a comparative study in Australia and Malaysia

Background: Pharmaceutical representatives provide medicines information on their promoted products to doctors. However, studies have shown that the quality of this information is often low. No study has assessed the medicines information provided by pharmaceutical representatives to doctors in Malaysia and no recent evidence in Australia is present. We aimed to compare the provision of medicines information by pharmaceutical representatives to doctors in Australia and Malaysia. Methods: Following a pharmaceutical representative’s visit, general practitioners in Australia and Malaysia who had agreed to participate, were asked to fill out a questionnaire on the main product and claims discussed during the encounter. The questionnaire focused on provision of product information including indications, adverse effects,precautions, contraindications and the provision of information on the Pharmaceutical Benefit Scheme (PBS) listings and restrictions (in Australia only). Descriptive statistics were produced. Chi-square analysis and clustered linear regression were used to assess differences in Australia and Malaysia. Results: Significantly more approved product information sheets were provided in Malaysia (78%) than in Australia(53%) (P < 0.001). In both countries, general practitioners reported that indications (Australia, 90%, Malaysia, 93%) and dosages (Australia, 76%, Malaysia, 82%) were frequently provided by pharmaceutical representatives. Contraindications, precautions, drug interactions and adverse effects were often omitted in the presentations (range 25% - 41%). General practitioners in Australia and Malaysia indicated that in more than 90% of presentations, pharmaceutical representatives partly or fully answered their questions on contraindications, precautions, drug interactions and adverse effects. More general practitioners in Malaysia (85%) than in Australia (60%) reported that pharmaceutical representatives should have mentioned contraindications, precautions for use, drug interaction or adverse effects spontaneously (P < 0.001). In 48% of the Australian presentations, general practitioners reported the pharmaceutical representatives failed to mention information on PBS listings to general practitioners. Conclusions: Information on indications and dosages were usually provided by pharmaceutical representatives in Australia and Malaysia. However, risk and harmful effects of medicines were often missing in their presentations. Effective control of medicines information provided by pharmaceutical representatives is needed

Pharmaceutical promotion : the theoretical framework of regulation.

Pharmaceutical promotion IS persuaSIve communication (World Health Organization, 2010) which often creates the impression of superior efficacy of a medicine, \vithout a\vareness of the health professionals (Mansfield & Henry, 2004). Doctors often use pharmaceutical promotion as a source of medicines information (Fischer et a1., 2009~ McKinney et aI., 1990~ National Survey ofPhysicians (2002), Poirier et aI., 1994; Prosser et a!., 2003 ~ Strang et aI., 1996; Uchenna et aI., 2010) and it may influence their prescribing pattern (Andersen et aI., 2006~ Muijrers et aI., 2005). For this reason, it is essential that the medicines information provided in pharmaceutical promotion should be effectively regulate

: Géoprospective territoriale à l'île de La Réunion

16 p.National audienceThe objective of this paper is to present an approach for experimenting territorial prospective analysis based on spatial modelling. This approach is carried out in the framework of the DESCARTES project which aims at developing a spatial simulation tool to support the design and analysis of different scenarios for land-use allocation in Reunion Island in terms of environmental services. The spatial modelling tool is composed of two complementary applications: (i) the Ocelet modelling language and its land dynamics simulation environment, and (ii) the Margouill@ platform. The first demonstrator, a model of farm land consumption by urbanization, was developed and presented during workshops in order to test the role of the spatial simulation tool in support of a collaborative innovation process among stakeholders, and to foster new research on social learning, spatial simulation of environmental services, and scale change issues.L'objectif de cet article est de présenter une démarche de construction d'un exercice de prospective territoriale basé sur un outil de modélisation spatiale. Cette démarche est mise en œuvre dans le cadre du projet ANR DESCARTES dont l'objectif est de construire un outil de simulation cartographique pour analyser différents scénarios d'affectation de l'usage des sols à l'Ile de La Réunion, en termes de services environnementaux. La plateforme de simulation cartographique est composée de deux applications complémentaires (i) le langage de modélisation Ocelet et son environnement de simulation de paysages dynamiques, et (ii) la plateforme Margouill@. Le développement puis la présentation, en atelier, d'un premier démonstrateur sur la consommation des terres agricoles par l'urbanisation a permis de tester l'outil cartographique comme support d'un processus d'innovation collective entre les parties prenantes, et d'ouvrir de nouveaux champs de recherche sur l'analyse de la démarche par les apprentissages, la spatialisation et la simulation prospective des services écosystémiques, et la prise en compte du changement d'échelle

Influence of Comorbidities on Therapeutic Progression of Diabetes Treatment in Australian Veterans: A Cohort Study

BACKGROUND: This study assessed whether the number of comorbid conditions unrelated to diabetes was associated with a delay in therapeutic progression of diabetes treatment in Australian veterans. METHODOLOGY/PRINCIPAL FINDINGS: A retrospective cohort study was undertaken using data from the Australian Department of Veterans' Affairs (DVA) claims database between July 2000 and June 2008. The study included new users of metformin or sulfonylurea medicines. The outcome was the time to addition or switch to another antidiabetic treatment. The total number of comorbid conditions unrelated to diabetes was identified using the pharmaceutical-based comorbidity index, Rx-Risk-V. Competing risk regression analyses were conducted, with adjustments for a number of covariates that included age, gender, residential status, use of endocrinology service, number of hospitalisation episodes and adherence to diabetes medicines. Overall, 20134 veterans were included in the study. At one year, 23.5% of patients with diabetes had a second medicine added or had switched to another medicine, with 41.4% progressing by 4 years. The number of unrelated comorbidities was significantly associated with the time to addition of an antidiabetic medicine or switch to insulin (subhazard ratio [SHR] 0.87 [95% CI 0.84–0.91], P<0.001). Depression, cancer, chronic obstructive pulmonary disease, dementia, and Parkinson's disease were individually associated with a decreased likelihood of therapeutic progression. Age, residential status, number of hospitalisations and adherence to anti-diabetic medicines delayed therapeutic progression. CONCLUSIONS / SIGNIFICANCE: Increasing numbers of unrelated conditions decreased the likelihood of therapeutic progression in veterans with diabetes. These results have implications for the development of quality measures, clinical guidelines and the construction of models of care for management of diabetes in elderly people with comorbidities.Agnes I. Vitry, Elizabeth E. Roughead, Adrian K. Preiss, Philip Ryan, Emmae N. Ramsay, Andrew L. Gilbert, Gillian E. Caughey, Sepehr Shakib, Adrian Esterman, Ying Zhang and Robyn A. McDermot