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AIMS: The Framework Convention on Tobacco Control (FCTC) requires nations that have ratified the convention to ban all tobacco advertising and promotion. In the face of these restrictions, tobacco packaging has become the key promotional vehicle for the tobacco industry to interest smokers and potential smokers in tobacco products. This paper reviews available research into the probable impact of mandatory plain packaging and internal tobacco industry statements about the importance of packs as promotional vehicles. It critiques legal objections raised by the industry about plain packaging violating laws and international trade agreements. METHODS: Searches for available evidence were conducted within the internal tobacco industry documents through the online document archives; tobacco industry trade publications; research literature through the Medline and Business Source Premier databases; and grey literature including government documents, research reports and non-governmental organization papers via the Google internet search engine. RESULTS: Plain packaging of all tobacco products would remove a key remaining means for the industry to promote its products to billions of the world’s smokers and future smokers. Governments have required large surface areas of tobacco packs to be used exclusively for health warnings without legal impediment or need to compensate tobacco companies. CONCLUSIONS: Requiring plain packaging is consistent with the intention to ban all tobacco promotions. There is no impediment in the FCTC to interpreting tobacco advertising and promotion to include tobacco packs.
Freeman,B Chapman,S Rimmer,M
School of Public Health, University of Sydney, NSW, Australia.
OBJECTIVE: To examine changes in age of tobacco experimentation and progression to daily smoking in men and women between birth cohorts that differ in exposure to public health programmes that aim to discourage smoking. DESIGN: Analysis of national cross-sectional household surveys of smoking patterns, conducted in Australia in 2001 and 2004. SETTING AND PARTICIPANTS Australian adults aged 22 years and over in 2001 and 2004 who responded to the National Drug Strategy Household Survey. MAIN OUTCOME MEASURES: Prevalence of tobacco experimentation and progression to daily smoking by age 21, estimated by sex and birth cohort. Odds of tobacco experimentation and progression to daily smoking by age 21 estimated by sex for each birth cohort, with corrections for the effects of ‘forward telescoping’ in recalling age of use. RESULTS: Sex differences in smoking prevalence are smaller in younger birth cohorts. Tobacco experimentation has increased among women, while progression to daily smoking has decreased among men. CONCLUSIONS: Sex differences in smoking experimentation and progression to daily smoking have decreased in younger birth cohorts. However, a significant proportion of younger males and females continue to experiment with tobacco and become daily smokers despite strong public health efforts to discourage smoking. More research is needed to determine why sex differences in smoking behaviour are not evident in younger birth cohorts.
Morley,KI Hall,WD
Centre for Molecular, Environmental, Genetic, and Analytic Epidemiology, The University of Melbourne, Australia.
AIMS: To (i) examine the predictors of mortality in a randomized study of methadone versus buprenorphine maintenance treatment; (ii) compare the survival experience of the randomized subject groups; and (iii) describe the causes of death. DESIGN: Ten-year longitudinal follow-up of mortality among participants in a randomized trial of methadone versus buprenorphine maintenance treatment. SETTING: Recruitment through three clinics for a randomized trial of buprenorphine versus methadone maintenance. PARTICIPANTS: A total of 405 heroin-dependent (DSM-IV) participants aged 18 years and above who consented to participate in original study. MEASUREMENTS: Baseline data from original randomized study; dates and causes of death through data linkage with Births, Deaths and Marriages registries; and longitudinal treatment exposure via State health departments. Predictors of mortality examined through survival analysis. FINDINGS: There was an overall mortality rate of 8.84 deaths per 1000 person-years of follow-upand causes of death were comparable with the literature. Increased exposure to episodes of opioid treatment longer than 7 days reduced the risk of mortality; there was no differential mortality among methadone versus buprenorphine participants. More dependent, heavier users of heroin at baseline had a lower risk of death, and also higher exposure to opioid treatment. Older participants randomized to buprenorphine treatment had significantly improved survival. Aboriginal or Torres Strait Islander participants had a higher risk of death. CONCLUSIONS: Increased exposure to opioid maintenance treatment reduces the risk of death in opioid-dependent people. There was no differential reduction between buprenorphine and methadone. Previous studies suggesting differential effects may have been affected by biases in patient selection.
Gibson,A Degenhardt,L Mattick,RP Ali,R White,J O’Brien,S
National Drug and Alcohol Research Centre, UNSW, Australia. amy.gibson@med.unsw.edu.au
AIMS: To assess the prospective association between alcohol consumption and self-rated health: in particular whether there is a relationship between stable alcohol intake and health; whether health is affected by changes in alcohol consumption; whether having a chronic condition alters the relationships between stable and changing alcohol intake and health; and whether the health of longer-term abstainers is different from more recent and intermittent abstainers. DESIGN: Longitudinal analysis of a prospective, population-based study. SETTING: Australia. PARTICIPANTS: A total of 13 585 randomly selected 45-50-year-old women surveyed in 1996, of whom 9396 (69%) were resurveyed in 1998, 2001 and 2004. MEASUREMENTS: Estimates for the General Health subscale of the SF-36 for different levels of alcohol intake adjusted for having a chronic condition, depression, smoking and other factors. FINDINGS: Longitudinal models of consistent alcohol intake showed mean scores for general health of moderate drinkers were significantly better than that of non-drinkers [mean difference = 4.3, standard error (SE) = 0.61], occasional drinkers (mean difference = 3.1, SE 0.52) and heavy drinkers (mean difference drinkers, a decrease or variation in alcohol consumption was associated with a significant decline of three to four points in general health. Similar results were obtained when women with an existing chronic condition were excluded from these models. The health of recent abstainers and intermittent drinkers was the same as longer-term abstainers. CONCLUSIONS: Consistent moderate drinkers had the best health even after adjustment for having a chronic condition, depression and life-style factors. Poorer health was associated with decreased alcohol intake among occasional and moderate drinkers.
Powers,JR Young,AF
Research Centre for Gender, Health and Ageing, University of Newcastle, Callaghan, Australia. jenny.powers@newcastle.edu.au
After oral administration, the majority of drug molecules are absorbed across the small intestine and enter the systemic circulation via the portal vein and the liver. For some highly lipophilic drugs (typically log P > 5, lipid solubility > 50 mg/g), however, association with lymph lipoproteins in the enterocyte leads to transport to the systemic circulation via the intestinal lymph. The attendant delivery benefits associated with lymphatic drug transport include a reduction in first-pass metabolism and lymphatic exposure to drug concentrations orders of magnitude higher than that attained in systemic blood. In the current review we briefly describe the mechanisms by which drug molecules access the lymph and the formulation strategies that may be utilised to enhance lymphatic drug transport. Specific focus is directed toward recent advances in understanding regarding the impact of lipid source (both endogenous and exogenous) and intracellular lipid trafficking pathways on lymphatic drug transport and enterocyte-based first-pass metabolism.
Natalie L. Trevaskisa William N. Charmana Christopher J.H. PorteraEmail:chris.porter@vcp.monash.edu.au
[a]Department of Pharmaceutics, Victorian College of Pharmacy, Monash University, 381 Royal Parade, Parkville, Victoria, 3052 Australia
Lipid-based delivery systems are finding increasing application in the oral delivery of poorly water-soluble, lipophilic drugs. Whilst lipidic dose forms may improve oral bioavailability via several mechanisms, enhancement of gastrointestinal solubilisation remains argueably the most important method of absorption enhancement. This review firstly describes the mechanistic rationale which underpins the use of lipid-based delivery systems to enhance drug solubilisation and briefly reviews the available literature describing increases in oral bioavailability after the administration of lipid solution, suspension and self-emulsifying formulations. The use of in vitro methods including dispersion tests and more complex models of in vitro lipolysis as indicators of potential in vivo performace are subsequently described, with particular focus on recent data which suggests that the digestion of surfactants present in lipid-based formulations may impact on formulation performance. Finally, a series of seven guiding principles for formulation design of lipid-based delivery systems are suggested based on an analysis of recent data generated in our laboratories and elsewhere.
Christopher J.H. PorteraEmail:Chris.Porter@vcp.monash.edu.au Colin W. Poutonb Jean F. Cuinea William N. Charmana
[a]Department of Pharmaceutics, Victorian College of Pharmacy, Monash University (Parkville campus), Parkville, Victoria 3052, Australia;[b]Department of Pharmaceutical Biology, Victorian College of Pharmacy, Monash University (Parkville campus), Parkville, Victoria 3052, Australia
AIMS: This paper reviews available literature regarding the effectiveness, safety and utility of intranasal (i.n.) naloxone for the treatment of heroin overdose. METHODS: Scientific literature in the form of published articles during the period January 1984 to August 2007 were identified by searching several databases including Medline, Cinahl and Embase for the following terms: naloxone, narcan, intranasal, nose. The data extracted included study design, patient selection, numbers, outcomes and adverse events. RESULTS: Reports of the pharmacological investigation and administration of i.n. naloxone for heroin overdose are included in this review. Treatment of heroin overdose by administration of i.n. naloxone has been introduced as first-line treatment in some jurisdictions in North America, and is currently under investigation in Australia. CONCLUSION: Currently there is not enough evidence to support i.n. naloxone as first-line intervention by paramedics for treatment of heroin overdose in the pre-hospital setting. Further research is required to confirm its clinical effectiveness, safety and utility. If proved effective, the i.n. route may be useful for drug administration in community settings (including peer-based administration), as it reduces risk of needlestick injury in a population at higher risk of blood-borne viruses. Problematically, naloxone is not manufactured currently in an ideal form for i.n. administration.
Kerr,D Dietze,P Kelly,AM
Joseph Epstein Centre for Emergency Medicine Research, The University of Melbourne, Australia. debbie.kerr@wh.org.au
AIMS: To critique the methodological adequacy of evaluations of emergency department (ED)-based interventions for alcohol problems and to conduct a meta-analysis to examine the extent to which interventions in this setting are effective in reducing alcohol consumption and related harm. METHODS: An electronic search of 11 databases and a manual search of reference lists were conducted to identify studies published in peer-review journals between January 1996 and July 2007 (inclusive). Studies evaluating the outcome of an intervention designed to reduce alcohol problems in patients presenting to the ED were eligible for inclusion. Methodological data were extracted using review criteria adapted from the both the Center for Disease Control (CDC) Guide to Community Preventive Services Data Collection Instrument and the Cochrane Effective Practice and Organization of Care Review Group Data Collection Checklist. Continuous outcomes were pooled using a fixed effect inverse variance approach while binary outcomes were pooled in a generic inverse variance meta-analysis. RESULTS: Thirteen studies were identified for inclusion in the review. Methodological quality was found to be reasonable, with the exception of poor reporting of effect-size information and inconsistent selection of outcome measures. Meta-analyses revealed that interventions did not significantly reduce subsequent alcohol consumption, but were associated with approximately half the odds of experiencing an alcohol-related injury (odds ratio = 0.59, 95% confidence interval 0.42-0.84). CONCLUSIONS: There are few evaluations of emergency department-based interventions for alcohol problems. Future evaluations should use consistent outcome measures and report effect sizes. The existing evidence suggests that interventions are effective in reducing subsequent alcohol-related injuries.
Havard,A Shakeshaft,A Sanson-Fisher,R
National Drug and Alcohol Research Centre, University of New South Wales, Sydney, Australia. a.harvard@unsw.edu.au
Oral lipid-based drug delivery systems may include a broad range of oils, surfactants, and cosolvents. This diversity makes comparison of lipid-based formulations difficult. Although the relationship between formulation and drug absorption is understood at a conceptual level, performance in vivo cannot be predicted with confidence at present. The Lipid Formulation Classification System (LFCS) identifies the factors which are likely to affect performance in vivo. There is now a need to establish performance criteria which will facilitate in vitro–in vivo correlation studies. In this review we discuss the properties of excipients, and identify criteria for selection of excipients for lipid-based formulations. Excipients are discussed in the context of the LFCS, our existing knowledge of the fate of these materials during dispersion and digestion, and the likely consequences of their use in formulations. We outline the formulation strategies that can be used for each type of lipid formulation, and suggest a framework for the in vitro testing of each type. Finally we address the choice of lipid formulations in relation to the physicochemical properties of the drug.
Colin W. PoutonaEmail:colin.pouton@vcp.monash.edu.au Christopher J.H. Porterb
[a]Department of Pharmaceutical Biology, Victorian College of Pharmacy, Monash University (Parkville Campus), 381 Royal Parade Parkville, Victoria 3052, Australia;[b]Department of Pharmaceutics, Victorian College of Pharmacy, Monash University (Parkville Campus), 381 Royal Parade Parkville, Victoria 3052, Australia
AIM: To assess the promise and risks of technological applications of genetic research on liability to develop nicotine dependence. METHODS: We reviewed (i) the evidence on the genetics of nicotine dependence; (ii) the technical feasibility of using genetic information to reduce smoking uptake and increase cessation; and (iii) policy and ethical issues raised by the uses of genetic information on addiction liability. RESULTS: (i) Despite evidence from twin studies that genes contribute to addiction susceptibility, research to date has not identified commonly occurring alleles that are strongly predictive of developing nicotine addiction. Nicotine addiction is likely to involve multiple alleles of small effect that interact with each other and with the environment. (ii) Population screening for susceptibility alleles is unlikely to be effective or cost-effective. Tailoring of smoking cessation treatments with genetic information is more plausible but results to date have been disappointing. Population health strategies such as increased taxation and reduced opportunities to smoke are more efficient in reducing cigarette smoking. Tobacco harm reduction policies applied to populations may also play a role in reducing tobacco-related harm. (iii) Future uses of genomic information on addiction risk will need to assess the risks of medicalising addiction (e.g. pessimism about capacity to quit) and community concerns about genetic privacy. CONCLUSIONS: Nicotine genomics is a very new and underdeveloped field. On the evidence to date, its advocates would be wise to avoid extravagant claims about its preventive applications.
Hall,WD Gartner,CE Carter,A
School of Population Health, The University of Queensland, Queensland, Australia. w.hall@sph.uq.edu.au