Dataset Information

Transformation of Australian Community Pharmacies Into Good Clinical Practice Compliant Trial Pharmacies for HIV Pre-Exposure Prophylaxis.

ABSTRACT: Background: In Australia, clinical trial drugs are conventionally dispensed through clinical trial pharmacies only, while community pharmacies dispense drugs approved by Australia's regulatory body. A large HIV pre-exposure prophylaxis study aimed to deliver clinical trial drug through community pharmacies to improve convenience and mimic real world prescribing. This paper describes the process of making community trials compliant with good clinical practice and reports outcomes of delivering clinical trial drug through community pharmacies. Methods: Eight community and four clinical trial pharmacies across three Australian states were approached to participate. A good clinical practice checklist was generated and pharmacies underwent a number of changes to meet clinical trial pharmacy requirements prior to study opening. Changes were made to community pharmacies to make them compliant with good clinical trial practice including; staff training, structural changes, and implementing monitoring of study drug and prescribing practices. Study drug was ordered through standard clinical trial processes and dispensed from study pharmacies by accredited pharmacists. Throughout the trial, record logs for training, prescriber signature and delegation, temperature, participant, and drug accountability were maintained at each pharmacy. The study team monitored each log and delivered on-site training to correct protocol variations. Results: Each pharmacy that was approached agreed to participate. All community pharmacies achieved good clinical practice compliance prior to dispensing study drug. Over the course of the study, 20,152 dispensations of study drug occurred, 83% of these occurred at community pharmacies. Only 2.0% of dispensations had an error, and errors were predominantly minor. On five occasions a pharmacist who was not accredited dispensed study drug. Conclusions: Community based pharmacies can undergo training and modifications to achieve good clinical practice compliance and dispense clinical trial study drug. Community based pharmacies recorded few variations from study protocol. Community based pharmacies offer a useful alternative to clinical trial pharmacies to increase convenience for study participants and expanded use of these pharmacies should be considered for large clinical trials, including HIV prevention trials.

SUBMITTER: Lal L

PROVIDER: S-EPMC6854879 | biostudies-literature | 2019

REPOSITORIES: biostudies-literature

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Transformation of Australian Community Pharmacies Into Good Clinical Practice Compliant Trial Pharmacies for HIV Pre-Exposure Prophylaxis.

Lal Luxi L Ryan Kathleen K Liu Iris Yi IY Price Brian B Lockwood Timmy T Aguirre Ivette I Slobodian Peter P Lam Ada A Vassan Manoj M Lim Kie K Silverii John J Tesoriero Joseph J Phu Johnny J Lim Wan W Naidoo Bharathy B Russell Nick N Rundle Matthew M Sewell Rowan R Cooper Craig C Hardman Alexander A Quinn Martin M Mak Anne A Wright Edwina J EJ

Frontiers in pharmacology 20191107

<b>Background:</b> In Australia, clinical trial drugs are conventionally dispensed through clinical trial pharmacies only, while community pharmacies dispense drugs approved by Australia's regulatory body. A large HIV pre-exposure prophylaxis study aimed to deliver clinical trial drug through community pharmacies to improve convenience and mimic real world prescribing. This paper describes the process of making community trials compliant with good clinical practice and reports outcomes of delive ...[more]

PMID: 31787893

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Project description:Objective:This study aims to assess good pharmacy practice (GPP) aspects and compare GPP scores among community pharmacies in Lebanon, using a tool developed jointly by the International Pharmaceutical Federation (FIP) and the World Health Organization (WHO) to improve and maintain standards of pharmacy practice. Methods:Data collection was carried out between July and October 2018 by a team of 10 licensed inspectors who work at the Lebanese Order of Pharmacists (OPL) and visited community pharmacies across Lebanon. The questionnaire was adapted to the Lebanese context and included 109 questions organized under five sections: socio-demographics, Indicator A (data management and data recording), Indicator B (services and health promotion), Indicator C (dispensing, preparation and administration of medicines), and Indicator D (storage and facilities). The value of 75% was considered as the cutoff point for adherence to indicators. Results:Out of 276 pharmacies visited, a total of 250 (90.58%) pharmacists participated in the study with one pharmacist being interviewed in every pharmacy. Results showed that 18.8% of pharmacists were generally adherents to GPP guidelines (scores above the 75% cutoff): 23.3% were adherent to indicator A, 21.6% to indicator B, 14.8% to indicator C and 13.2% to indicator D. Moreover, comparison of GPP scores across geographical regions revealed a higher adherence among community pharmacists working in the Beirut region compared to the North region, the South region, Mount Lebanon, and the Bekaa. Conclusions:Our study shows that community pharmacists in Lebanon do not fulfill GPP criteria set by FIP/WHO, and that this poor adherence is a trend across the country's geographical regions. Therefore, efforts should be made to raise awareness among pharmacists about the necessity to adhere to GPP guidelines and standards, and train them and support them appropriately to reach that goal. This is the first indicator-based comprehensive pilot assessment to evaluate GPP adherence in community pharmacies across Lebanon. Working on the optimization of this assessment tool is also warranted.

Project description:Pre-exposure prophylaxis (PrEP) has emerged as a promising strategy for preventing the transmission of HIV. Although only one formulation is currently approved for PrEP, research into both new compounds and new delivery systems for PrEP regimens offer intriguing challenges from the perspective of pharmacokinetic and pharmacodynamic modeling. This review aims to provide an overview the current modeling landscape for HIV PrEP, focused on PK/PD and QSP models relating to antiretroviral agents. Both current PrEP treatments and new compounds that show promise as PrEP agents are highlighted, as well as models of uncommon administration routes, predictions based on models of mechanism of action and viral dynamics, and issues related to adherence to therapy. The spread of human immunodeficiency virus (HIV) remains one of the foremost global health concerns. In the absence of a vaccine, other prophylactic strategies have been developed to prevent HIV transmission. One approach, known as pre-exposure prophylaxis (PrEP), allows HIV-negative individuals who are at high risk of exposure to the virus, be it through an HIV-positive sexual partner or through the shared use of drug injection equipment, to substantially reduce the risk of developing an HIV infection. PrEP is a relatively recent approach to combating the HIV epidemic, with the only currently approved treatment being Truvada, a daily oral antiretroviral (ARV) therapy initially indicated in the treatment of active HIV-1 infections, but approved for HIV PrEP in 2012. Although PrEP therapy has consistently demonstrated high efficacy in preventing HIV infection, this efficacy is dependent on patient adherence to the prescribed treatment regimen. This can present a significant problem in low- and middle-income countries, which may lack the infrastructure to provide sufficient access to PrEP medication to maintain daily dosing regimens. Furthermore, while the conventional approach has generally been to advocate for continuous administration akin to regimens used for viral suppression in infected patients, there has been some discussion of whether a better treatment paradigm might be to push for PrEP therapy primarily during those known periods of heightened exposure risk, while relying on post-exposure prophylaxis regimens to prevent infection after unanticipated exposures during low-risk periods. These considerations have led to a push for the development of long-duration and on-demand PrEP formulations, including subdermal and subcutaneous implants, slow-release intramuscular depot injections, vaginal and rectal antimicrobial gels, and intravaginal rings and dissolving films. PrEP therapy is a quickly evolving field, with a variety of antiretroviral compounds and formulations under investigation. This review aims to report on notable drugs and formulations from a pharmacokinetic/pharmacodynamic (PK/PD) modeling perspective. Given the nature of PrEP as a preventive therapy designed for long-term use, clinical trials for PrEP therapies can last for months or even years, particularly in the case of long-duration formulations. Furthermore, in contrast to antiretroviral trials in infected patients, pharmacodynamic endpoints in PrEP therapies are difficult to quantify, as the primary endpoint for efficacy is generally the rate of seroconversion. Computational modeling approaches offer flexible and powerful tools to provide insight into drug behavior in clinical settings, and can ultimately reduce the time, expense, and patient burden incurred in the development of PrEP therapies.

Project description:As pre-exposure prophylaxis (PrEP) effectiveness is strongly linked to adherence, we sought to determine if certain self-report measures could be used to inform objective PrEP adherence. We studied participants from the TAPIR study (a multicenter randomized study of daily text messages to support adherence to PrEP In At-Risk), a 48-week randomized controlled trial of HIV-uninfected men who have sex with men (MSM) randomized to receive text message to support adherence versus standard of care. Self-reported medication adherence was assessed using several validated measures modified for PrEP. Objective PrEP adherence was determined through dried blood spot (DBS) measurement of intracellular tenofovir diphosphate (TFV-DP) and emtricitabine triphosphate (FTC-TP). A summary of adherence was estimated using responses to the seven adherence items at weeks 12 and 48 using confirmatory factor analysis. Correlations between self-report questions and drug concentrations were estimated with Pearson's correlations for continuous outcomes and point-biserial correlations for dichotomous outcomes. Receiver operating characteristic (ROC) analyses were conducted to assess the performance of self-report measures in predicting protective or perfect TFV-DP concentrations. Of the 369 participants who completed week 12 or 48 visits, the mean age was 35 (standard deviation 9 years), with 79% White, 12% Black, and 29% Hispanic. Correlations between self-report measures of adherence (both individual items and the adherence factor) and quantifiable FTC-TP and continuous TFV-DP concentrations showed that all self-report measures were significantly associated with these objective measures. Compared to a summary measure of self-reported adherence, the 4-week percent taken question medication recall was the only self-report item similarly or more strongly associated with recent adherence and long-term protective and perfect adherence at weeks 12 and 48. ROC analysis also showed that 4-week percent taken question had a reasonable AUC (0.798 at week 12 and 0.758 at week 48) in predicting protective TFV-DP concentrations. All single-item self-report questions assessing PrEP adherence were significantly associated with biomarker quantification, with the 4-week percent taken question performing best. Therefore, in the absence of drug concentration measurements, a 4-week self-report percent taken question may be a good single-item measure of PrEP adherence.

Project description:OBJECTIVES:This study investigated pharmacists' and pharmacy assistants' current practices and perspectives with regard to oral healthcare provision across Australian community pharmacies. DESIGN:Cross-sectional study. A questionnaire for each pharmacist and pharmacy assistant cohort was developed and administered by online or postal means. Pearson's ?2 test was used to examine relationships between categorical variables. PARTICIPANTS:Pharmacists and pharmacy assistants working within 2100 randomly selected Australian community pharmacies. RESULTS:The overall response rate was 58.5% (644/1100) for the pharmacist cohort and 28% (280/1000) for the pharmacy assistant cohort. This represents pharmacy staff responses from 803 community pharmacies across Australia (approximately 14.6%, 803/5500 of community pharmacies nationally). Overall, the majority of pharmacists (80.2%; 516/644) and pharmacy assistants (83.6%; 234/280) reported providing oral health advice/consultations to health consumers up to five times each week. More than half of community pharmacists and pharmacy assistants were involved in identifying signs and symptoms for oral health problems; and the majority believed health consumers were receptive to receiving oral health advice. Additionally, more than 80% of pharmacists and 60% of pharmacy assistants viewed extended oral healthcare roles positively and supported integrating them within their workplace; extended roles include provision of prevention, early intervention and referral to oral healthcare services. The most commonly reported barriers to enhance pharmacy staff involvement in oral healthcare within Australian community pharmacies include lack of knowledge, ongoing training and resources to assist practice. CONCLUSION:This study highlights that Australian pharmacists have an important role in oral health and provides evidence supporting the need for growing partnerships/collaborations between pharmacy and dental healthcare professionals and organisations to develop, implement and evaluate evidence-based resources, interventions and services to deliver improved and responsive oral healthcare within Australian communities.

Dataset Information

Transformation of Australian Community Pharmacies Into Good Clinical Practice Compliant Trial Pharmacies for HIV Pre-Exposure Prophylaxis.

Publications

Transformation of Australian Community Pharmacies Into Good Clinical Practice Compliant Trial Pharmacies for HIV Pre-Exposure Prophylaxis.

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