Aplenc, R, Fisher, BT, Huang, YS, Li, Y, Alonzo, TA, Gerbing, RB, Hall, M, Bertoch, D, Keren, R, Seif, AE, Sung, L, Adamson, PC & Gamis, A 2012, 'Merging of the National Cancer Institute–funded cooperative oncology group data with an administrative data source to develop a more effective platform for clinical trial analysis and comparative effectiveness research: a report from the Children's Oncology Group', Pharmacoepidemiology and Drug Safety, vol. 21, no. S2, pp. 37-43.
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ABSTRACTPurposeThe National Cancer Institute–funded cooperative oncology group trials have improved overall survival for children with cancer from 10% to 85% and have set standards of care for adults with malignancies. Despite these successes, cooperative oncology groups currently face substantial challenges. We are working to develop methods to improve the efficiency and effectiveness of these trials. Specifically, we merged data from the Children's Oncology Group (COG) and the Pediatric Health Information Systems (PHIS) to improve toxicity monitoring, to estimate treatment‐associated resource utilization and costs, and to address important clinical epidemiology questions.MethodsCOG and PHIS data on patients enrolled on a phase III COG trial for de novo acute myeloid leukemia at 43 PHIS hospitals were merged using a probabilistic algorithm. Resource utilization summary statistics were then tabulated for the first chemotherapy course based on PHIS data.ResultsOf 416 patients enrolled on the phase III COG trial at PHIS centers, 392 (94%) were successfully matched. Of these, 378 (96%) had inpatient PHIS data available beginning at the date of study enrollment. For these, daily blood product usage and anti‐infective exposures were tabulated and standardized costs were described.ConclusionsThese data demonstrate that patients enrolled in a cooperative group oncology trial can be successfully identified in an administrative data set and that supportive care resource utilization can be described. Further work is required to optimize the merging algorithm, map resource utilization metrics to the National Cancer Institute Common Toxicity Criteria for monitoring toxicity, to perform ...
Ball, P & Pont, L 2012, 'Home grown or imported?', Australian Journal of Pharmacy, vol. 93, no. 1110, p. 34.
Ball, P & Pont, L 2012, 'Let he who is without sin...', Australian Journal of Pharmacy, vol. 93, no. 1106, p. 33.
Ball, P & Pont, L 2012, 'Moving on from the Olympics', Australian Journal of Pharmacy, vol. 93, no. 1108, p. 39.
Ball, P & Pont, L 2012, 'Mushrooming practice', Australian Journal of Pharmacy, vol. 93, no. 1102, p. 32.
Ball, P & Pont, L 2012, 'Student placement support', Australian Journal of Pharmacy, vol. 93, no. 1100, p. 23.
Ball, P & Pont, L 2012, 'Will the circle be unbroken?', Australian Journal of Pharmacy, vol. 93, no. 1104, p. 38.
Dolton, MJ, Pont, L, Stevens, G & McLachlan, AJ 2012, 'Prevalence of Potentially Harmful Drug Interactions in Older People in Australian Aged‐Care Facilities', Journal of Pharmacy Practice and Research, vol. 42, no. 1, pp. 33-36.
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ABSTRACTBackgroundOlder people living in aged‐care facilities are prescribed more medications than those living in their own homes. Thus, increasing their risk of potentially harmful drug interactions. Few studies have investigated potential drug interactions in residents of aged‐care facilities.AimTo determine the prevalence of potentially harmful drug interactions in long‐term residents of aged‐care facilities.MethodPotentially harmful drug interactions were investigated using dispensing data from residents of 26 aged‐care facilities who received one or more medications from July 2008 to June 2010. Drug interactions analysed were chosen based on their inclusion at the highest severity rating in at least 3 of 4 international drug information resources. Data were compared to findings from a cohort of Australian veterans.ResultsPotentially harmful drug interactions were identified for 6.1% of the 3876 residents included in the study. A substantially higher incidence than previously reported in Australian veterans (1.5%) and certain overseas populations. Interactions involving warfarin, amiodarone, verapamil, lithium and methotrexate had the highest prevalence in aged‐care residents, and generally a higher prevalence than in the Australian veteran population.ConclusionPotentially harmful drug interactions were more prevalent in aged‐care residents than in an Australian veteran population.
Dolton, MJ, Ray, JE, Chen, SC-A, Ng, K, Pont, L & McLachlan, AJ 2012, 'Multicenter Study of Posaconazole Therapeutic Drug Monitoring: Exposure-Response Relationship and Factors Affecting Concentration', Antimicrobial Agents and Chemotherapy, vol. 56, no. 11, pp. 5503-5510.
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ABSTRACT Posaconazole has an important role in the prophylaxis and salvage treatment of invasive fungal infections (IFIs), although poor and variable bioavailability remains an important clinical concern. Therapeutic drug monitoring of posaconazole concentrations has remained contentious, with the use of relatively small patient cohorts in previous studies hindering the assessment of exposure-response relationships. This multicenter retrospective study aimed to investigate relationships between posaconazole concentration and clinical outcomes and adverse events and to assess clinical factors and drug interactions that may affect posaconazole concentrations. Medical records were reviewed for patients who received posaconazole and had ≥1 concentration measured at six hospitals in Australia. Data from 86 patients with 541 posaconazole concentrations were included in the study. Among 72 patients taking posaconazole for prophylaxis against IFIs, 12 patients (17%) developed a breakthrough fungal infection; median posaconazole concentrations were significantly lower than in those who did not develop fungal infection (median [range], 289 [50 to 471] ng/ml versus 485 [0 to 2,035] ng/ml; P < 0.01). The median posaconazole concentration was a significant predictor of breakthrough fungal infection via binary logistic regression ( P < 0.05). A multiple linear regression analysis identified a number of significant drug interactions associated with reduced posaconazole exposure, including coadministration with proton pump inhibitors, metoclopramide, phenytoin or rifampin, and the H 2 antagonist ranitidine ( P < 0.01). Clinical factors such as mucositis, diarrhea, and the early posttransplant period in hematopo...
Dolton, MJ, Ray, JE, Chen, SC-A, Ng, K, Pont, LG & McLachlan, AJ 2012, 'Multicenter Study of Voriconazole Pharmacokinetics and Therapeutic Drug Monitoring', Antimicrobial Agents and Chemotherapy, vol. 56, no. 9, pp. 4793-4799.
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ABSTRACT Voriconazole is a first-line agent in the treatment of many invasive fungal infections and is known to display highly variable pharmacokinetics. Previous studies of voriconazole therapeutic drug monitoring (TDM) have suggested concentration monitoring to be clinically useful but have been limited by small patient samples at a single institution. This multicenter retrospective study aimed to investigate relationships between voriconazole concentration and clinical outcomes and adverse events and to assess clinical factors and drug interactions that may affect voriconazole concentration. Medical records were reviewed for patients who received voriconazole and had at least 1 concentration measured at seven hospitals in Australia. The study included 201 patients with 783 voriconazole trough concentrations. Voriconazole concentrations of <1.7 mg/liter were associated with a significantly greater incidence of treatment failure (19/74 patients [26%]) than concentrations of ≥1.7 mg/liter (6/89 patients [7%]) ( P < 0.01). Neurotoxic adverse events (visual and auditory hallucinations) occurred more frequently at voriconazole concentrations of >5 mg/liter (10/31 patients [32%]) than at concentrations of ≤5 mg/liter (2/170 patients [1.2%]) ( P < 0.01). Multiple regression analysis of voriconazole concentration identified associations between increasing patient weight, oral administration of voriconazole, and coadministration of phenytoin or rifampin and significantly reduced concentrations, and associations between increasing patient age and coadministration of proton pump inhibitors and increased concentrations. Coadministration of glucocorticoids was found to significantly reduce voriconazole concentrations, inferring a previously unreported drug interaction between glucocorticoids and v...
Dua, K, Kok Leong, N, Kaur, M, Wen Bin, L, Azman, K & Gorajana, A 2012, 'Preparation, Physicochemical Evaluation and Antimicrobial Potential of Topical Dosage Forms Containing Natural Anti-inflammatory Agent, Curcuma longa', Anti-Inflammatory & Anti-Allergy Agents in Medicinal Chemistry, vol. 10, no. 6, pp. 452-462.
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In an attempt for better treatment of bacterial infections and burn wounds various topical formulations containing 1%w/w of Curcuma longa were prepared and evaluated for physical appearance, pH, rheological properties and stability studies. Antimicrobial activity of prepared formulations was found to be more effective against various strains of bacteria. Carbopol gel base is the most suitable dermatological base for Curcuma longa in comparison to various other dermatological bases. It also has aesthetic appeal, which other bases lack, an important aspect from patient compliance and consumer point of view. The therapeutic potential of such topical formulations may motivate researchers for its further exploitation so that it may be commercially viable. This innovative mode of formulation of Curcuma longa can be employed for enhancing the anti-microbial effect. © 2011 Bentham Science Publishers.
Dua, K, Pabreja, K & Gorajana, A 2012, 'Dissolution behaviour of aceclofenac-PVP coprecipitates', Ars Pharmaceutica, vol. 53, no. 3, pp. 7-12.
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Aim: The objective of the present investigation was to study the effect of PVP on in vitro dissolution of aceclofenac from coprecipitates. Materials and Methods: Aceclofenac coprecipitates (CP) with different drug loadings were prepared and in vitro dissolution studies of pure drug, physical mixtures and coprecipitates were carried out. Results: Coprecipitates of aceclofenac with PVP showed considerable increase in the dissolution rate in comparison with physical mixture and pure drug in 0.1 N HCl, pH1.2 and phosphate buffer, pH, 7.4. Coprecipitates in 1:2 ratio showed maximum dissolution rate in comparison to other ratios. Amorphous nature of the drug in coprecipitates was confirmed by scanning electron microscopy and a decrease in enthalpy of drug melting in coprecipitates compared to the pure drug. FT- IR spectroscopy and differential scanning calorimetry studies indicated no interaction between aceclofenac and PVP in coprecipitates in solid state. Dissolution enhancement was attributed to decreased crystallinity of the drug and to the wetting, eutectic formation and solubilizing effect of the carrier from the coprecipitates of aceclofenac. Conclusion: dissolution of aceclofenac can be enhanced by the use of hydrophilic carriers like PVP.
Gorajana, A, Rajendran, A, Dua, K, Pabreja, K & Hoon, TP 2012, 'Preparation, Characterization, and In Vitro Evaluation of Nitrendipine Solid Dispersions', Journal of Dispersion Science and Technology, vol. 33, no. 5, pp. 676-684.
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Hammill, BG, Curtis, LH & Setoguchi, S 2012, 'Performance of propensity score methods when comparison groups originate from different data sources', Pharmacoepidemiology and Drug Safety, vol. 21, no. S2, pp. 81-89.
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ABSTRACTPurposeTo examine the performance of propensity score‐based methods for estimating relative risks when exposed and comparison subjects are selected from different data sources.MethodsWe conducted Monte Carlo simulations to assess the performance of propensity score methods under various scenarios in which exposed and comparison subjects were selected from different data sources for a comparative effectiveness study of a medical device.ResultsThe use of propensity score methods in our simulated data scenarios often yielded estimates of relative risk that were close to the true effect, unless the comparison group differed from the exposed group systematically on a factor associated with the outcome. This situation caused severe bias regardless of which method was used but could be overcome if the exposed group could be restricted similarly to the comparison group. Mean square error of relative risk estimates was lowest for similarly restricted study groups and when the comparison group could be considered a random sample of the source population that generated the exposed group.ConclusionsWhen exposed and comparison groups originated from different data sources, all propensity score methods yielded relatively unbiased and consistent estimates of relative risk in most situations reflected in our simulation study. Copyright © 2012 John Wiley & Sons, Ltd.
McLachlan, AJ & Pont, LG 2012, 'Drug Metabolism in Older People--A Key Consideration in Achieving Optimal Outcomes With Medicines', The Journals of Gerontology Series A: Biological Sciences and Medical Sciences, vol. 67A, no. 2, pp. 175-180.
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Pabreja, K, Dua, K & Gorajana, A 2012, 'Evaluation of Topical Gels Containing Ketorolac Tromethamine on Inflammation and Hyperalgesia in Rats', Anti-Inflammatory & Anti-Allergy Agents in Medicinal Chemistry, vol. 10, no. 5, pp. 323-326.
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Over recent years, non-steroidal anti-inflammatory drugs (NSAIDs) have been increasingly introduced as topical preparations as they are simple to apply and deliver high drug concentrations locally with limited side effects. Ketorolac trometamol (KT), a potent COX-2 inhibitor, produces typical side effects of NSAIDs when given orally and systemically. Hence the present investigation encompasses the development of topical formulations employing different dermatological bases and evaluated for its efficacy and safety. Standard procedures were followed to test the anti-inflammatory and antihyperalgesic effects in male Wistar albino rats. Amongst the various semisolid formulations, the formulation containing hydroalcoholic carbopol gel base (KT 1 ) was found to be significantly (p < 0.05) more effective in inhibiting hyperalgesia associated with inflammation (79.69±1.51 after 5 h of carrageenan administration) as compared to formulation containing plain carbopol gel base (68.75±2.76) and PEG base 73.44±1.23. This demonstrates the suitability of carbopol gel base as an ideal dermatological base for ketorolac trometamol topical formulation and thus providing an ample credence for better therapeutic efficacy. © 2011 Bentham Science Publishers.
Stupans, I, Owen, S, McKauge, L, Pont, L, Ryan, G & Woulfe, J 2012, 'Development and trialling of a graduated descriptors tool for Australian pharmacy students', Assessment & Evaluation in Higher Education, vol. 37, no. 7, pp. 829-845.
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Profession-derived competency standards are key determinants for curriculum and assessment in many professional university programmes. An Australian Learning and Teaching Council funded project used a participatory action research approach to enable the collaborative development of a graduated (or incremental) descriptors tool related to competencies, applicable to Australian pharmacy students at various stages within their university programmes. Consultations with pharmacy professional/registration organisations, students, preceptors and academics throughout Australia were undertaken. Recording of key themes of discussions and progressive development of the tool occurred. Initial trialling of the tool in pharmacy programmes at two different Australian universities has indicated that students were ambivalent regarding the tool and, for example, its usefulness for self-assessment against competencies and its role in supporting learning. Preceptors, supporting students on placements, were however very positive about the tool, its usefulness in supporting learning and in supporting discussions between preceptors and students. © 2012 Copyright Taylor and Francis Group, LLC.
V. Ramana, M, Dua, K, Himaja, M & Pabreja, K 2012, 'Preparation and Characterization of Solid Dispersions of Rofecoxib', Anti-Inflammatory & Anti-Allergy Agents in Medicinal Chemistry, vol. 10, no. 6, pp. 393-398.
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The present study is aimed at improving the dissolution of poorly soluble drug, rofecoxib, using solid dispersion technique. The solid dispersions were prepared in different proportions using hydrophilic carriers like mannitol, and urea. The dissolution rate studies were performed in both simulated gastric fluid and simulated intestinal fluid. It is observed that the dissolution was affected by the acidity of the medium. Solid dispersions gave faster dissolution rate when compared to corresponding physical mixture and pure drug. In vivo absorption and anti-inflammatory activity studies of solid dispersions also confirmed the above results. The DSC thermogram and IR spectra revealed that there is no interaction of Rofecoxib with additives and the drug, rofecoxib is stable in solid dispersions. © 2011 Bentham Science Publishers.
Denig, P, Andersen, M, Kildemoes, HW, Pont, L, Voorham, J & Gregoire, JP 1970, 'Advanced Methods and Measures for Studying Complex Drug Utilization Patterns with Patient-Level Databases', PHARMACOEPIDEMIOLOGY AND DRUG SAFETY, WILEY PERIODICALS, INC, pp. 37-37.
Pont, LG, Gilbert, AL, Truter, I, Wirtz, VJ, Yang, Y-HK, May, F & Anderson, M 1970, 'Globalisation of Utilisation Research: Current Challenges and Triumphs', PHARMACOEPIDEMIOLOGY AND DRUG SAFETY, WILEY PERIODICALS, INC, pp. 338-338.
Pont, LG, Postma, M, Stevens, G, Dolton, M & McLaclan, A 1970, 'Feasibility of a Novel Data Source for Drug Utilisation Research in Aged Care', PHARMACOEPIDEMIOLOGY AND DRUG SAFETY, WILEY PERIODICALS, INC, pp. 81-81.
