Australian access to FDA-approved breakthrough therapy designation medicines: a 10-year review.

Background: Regulatory pathways adopted by the United States Food Drug and Administration (FDA) and Australian Therapeutic Goods Administration (TGA) enable expedited approval of medicines that are thought to offer significant clinical advantage over existing options for severe diseases. Objectives: To review Australian accessibility to medicines approved through the FDA breakthrough therapy designation (BTD) process including timelines and approvals by the TGA and Pharmaceutical Benefits Advisory Committee (PBAC) for listing on the Pharmaceutical Benefits Scheme (PBS). Methods: Retrospective review of published reports from the FDA, TGA, PBAC and PBS for BTDs from 1 January 2013-31 August 2023. Uniform data about BTD and milestone dates were collected. Analysis included all BTDs approved by FDA until 31-August-2022. Main outcome measures: Rates of approval by TGA and PBAC, and PBS-listing; and median (interquartile range, IQR) time from FDA submission to FDA approval, and FDA approval to TGA approval, PBAC approval and PBS listing for cancer and non-cancer medicines. Results: Of 237 BTDs across 156 medicines, 68% were approved by the TGA, and 37% were listed on the PBS. Median (IQR) time from FDA submission to FDA approval was shorter for cancer compared to non-cancer; 179 days (140-210) vs 232 days (181-245), p < 0.02. Time from FDA approval to PBS listing was similar for cancer and non-cancer; median 744 days (IQR, 549-1136) and 733 days (IQR 440-960) respectively, with improvements for cancer BTDs noted for 2018-2022 compared to 2013-2017; 566 days (IQR 319-831) vs 880 days (IQR 620-1362), p < 0.02 but not for non-cancer BTDs. Conclusion: BTD medicines are accessible in Australia approximately 2 years after FDA approval. Since 2018, time to PBS listing for cancer therapies improved, mirroring shorter FDA approval times for this category. Further understanding of clinical studies and context by therapeutic area may improve timely and safe access to life-saving medicines.

Interventions to Expand Community Pharmacists' Scope of Practice.

BACKGROUND: The role of community pharmacists has evolved beyond the dispensing of medicines. The aim of this scoping review was to describe the interventions that expand the pharmacist's scope of practice within a community pharmacy setting and assess their effectiveness. METHODS: We performed a scoping review to identify randomised controlled trials (RCTs), published worldwide from 2013 to 2024, which focused on interventions designed to expand pharmacists' scope of practice in the community. The review was undertaken in accordance with the Joanna Briggs Institute methodology for scoping reviews. To address the aim of this scoping review, the included RCTs were mapped to themes influenced by the Professional Practice Standards 2023 as developed by the Pharmaceutical Society of Australia: medication management, collaborative care and medication adherence. RESULTS: Twelve studies demonstrated the potential to expand community pharmacists' scope of practice. Two RCTs resulted in no effect of the intervention. One RCT (conducted in Italy) led to an actual change to community pharmacists' scope of practice, with a statistically significant improvement in the proportion of patients with controlled asthma. CONCLUSIONS: On the whole, this scoping review synthesised the findings of peer-reviewed RCT studies that revealed expanding community pharmacists' scope of practice may result in improved patient outcomes, a reduced burden for the healthcare system, and greater productivity.

Expanding community pharmacists' scope of practice in relation to contraceptive counselling and referral: a protocol for a pragmatic, stepped-wedge, cluster randomised trial (ALLIANCE).

INTRODUCTION: Improving access to effective contraception has the potential to reduce unintended pregnancy and abortion rates. Community pharmacists could play an expanded role in contraceptive counselling and referral to contraceptive prescribers particularly when women are already attending community pharmacy to obtain emergency contraceptive pills (ECPs) or to have medical abortion (MA) medicines dispensed. The ALLIANCE trial aims to compare the subsequent uptake of effective contraception (hormonal or intrauterine) in women seeking ECP or MA medicines, who receive the ALLIANCE community pharmacy-based intervention with those who do not receive the intervention. METHODS AND ANALYSIS: ALLIANCE is a stepped-wedge pragmatic cluster randomised trial in Australian community pharmacies. The ALLIANCE intervention involves community pharmacists delivering structured, patient-centred, effectiveness-based contraceptive counselling (and a referral to a contraceptive prescriber where appropriate) to women seeking either ECPs or to have MA medicines dispensed. Women participants will be recruited by participating pharmacists. A total of 37 pharmacies and 1554 participants will be recruited. Pharmacies commence in the control phase and are randomised to transition to the intervention phase at different time points (steps). The primary outcome is the self-reported use of effective contraception at 4 months; secondary outcomes include use of effective contraception and the rate of pregnancies or induced abortions at 12 months. A process and economic evaluation of the trial will also be undertaken. ETHICS AND DISSEMINATION: Ethical approval has been obtained from the Monash University Human Research Ethics Committee (#34563). An explanatory statement will be provided and written consent will be obtained from all participants (pharmacy owner, pharmacist and women) before their commencement in the trial. Dissemination will occur through a knowledge exchange workshop, peer-reviewed journal publications, presentations, social media and conferences. TRIAL REGISTRATION NUMBER: ACTRN12622001024730.

Scoping review of pharmacy-based initiatives for preventing unintended pregnancy: protocol.

INTRODUCTION: Due to a high global incidence of unintended pregnancy, finding novel ways to increase the accessibility of contraceptive products and information is critical. One proposed strategy is to use the accessibility of community pharmacies and expand the role of pharmacists to deliver these services. This protocol reports the methods of a proposed scoping review of pharmacy-based initiatives for preventing unintended pregnancy. We intend to identify the range of interventions employed by pharmacists worldwide and their outcomes and aim to infer the value of task sharing for reducing certain access and equity barriers to contraception. METHODS AND ANALYSIS: This protocol was developed with guidance from the Joanna Briggs Institute Methodology for Scoping Reviews. Reporting is compliant with the Preferred Reporting Items for Systematic Reviews and Meta-analysis (PRISMA) protocols. The scoping review will be reported according to the PRISMA Extension for Scoping Reviews. Seven electronic databases (PubMed, Ovid Medline, Embase, Cochrane Library, Scopus and Cumulative Index to Nursing and Allied Health Literature) were systematically searched for relevant literature published in English from 2000, on 22 August 2019. Two authors will individually screen articles for eligibility in Covidence and data will be charted and reported using a tool developed for the purpose of this review. ETHICS AND DISSEMINATION: Findings will be disseminated in publications and presentations with relevant stakeholders. Ethical approval is not required as we will be using data from publicly available literature sources. We will map available evidence across the breadth of studies that have been conducted and identify the effectiveness and acceptability of interventions.

Improving Australian care home medicine supply services: Evaluation of a quality improvement intervention.

AIM: The study aims to determine the impact of a quality improvement intervention on how accurately and suitably medicines are supplied to residents of residential aged-care facilities (RACFs). METHODS: Between September 2012 and January 2013, pharmacy-supplied dose administration aids (DAAs) were audited at 45 Victorian RACFs (Australia). RACFs had previously received an intervention (education session/toolkit) and were involved in an earlier DAA audit. Recently supplied DAAs containing regular medicines were compared to prescriber-prepared medicine charts to identify, and classify risks of, inaccurate or unsuitable packing incidents. RESULTS: Of 2389 DAAs audited for 983 residents, 770 incidents in 502 DAAs were identified. The overall DAA incident rate increased significantly from 11.5% pre-intervention to 21.0% post-intervention (P < 0.001). The proportion of DAAs affected by incidents classified as 'insignificant' or 'minor' risk increased post-intervention (P < 0.001). CONCLUSIONS: Further wide-scale evaluation of RACF medicine supply services is needed. Interventions that are effective in reducing DAA incidents should be explored.

Protocol for ACCESS: a qualitative study exploring barriers and facilitators to accessing the emergency contraceptive pill from community pharmacies in Australia.

INTRODUCTION: The rate of unplanned pregnancy in Australia remains high, which has contributed to Australia having one of the highest abortion rates of developed countries with an estimated 1 in 5 women having an abortion. The emergency contraceptive pill (ECP) offers a safe way of preventing unintended pregnancy after unprotected sex has occurred. While the ECP has been available over-the-counter in Australian pharmacies for over a decade, its use has not significantly increased. This paper presents a protocol for a qualitative study that aims to identify the barriers and facilitators to accessing the ECP from community pharmacies in Australia. METHODS AND ANALYSIS: Data will be collected through one-on-one interviews that are semistructured and in-depth. Partnerships have been established with 2 pharmacy groups and 2 women's health organisations to aid with the recruitment of women and pharmacists for data collection purposes. Interview questions explore domains from the Theoretical Domains Framework in order to assess the factors aiding and/or hindering access to ECP from community pharmacies. Data collected will be analysed using deductive content analysis. The expected benefits of this study are that it will help develop evidence-based workforce interventions to strengthen the capacity and performance of community pharmacists as key ECP providers. ETHICS AND DISSEMINATION: The findings will be disseminated to the research team and study partners, who will brainstorm ideas for interventions that would address barriers and facilitators to access identified from the interviews. Dissemination will also occur through presentations and peer-reviewed publications and the study participants will receive an executive summary of the findings. The study has been evaluated and approved by the Monash Human Research Ethics Committee.

Towards improving dose administration aid supply: a quality improvement intervention aimed at reducing dispensing errors.

BACKGROUND: There is a risk that medicines can be dispensed into dose administration aids (DAAs), inaccurately or unsuitably. Quality improvement interventions (QIIs) may target this pharmacy medicine supply service and reduce the occurrence of these dispensing errors. In turn, medicine administration can improve in nursing homes (NHs) that use these devices. OBJECTIVE: To develop, introduce and evaluate the potential of a QII to improve DAA medicine supply. SETTING: Fourteen Victorian community pharmacies and 45 NHs. METHODS: A QII was developed using findings from three focus groups with 13 participants involved with DAAs at community pharmacies and NHs. The intervention was introduced to community pharmacies and NHs via a pharmacist-facilitated education session; attendees completed an evaluation questionnaire. MAIN OUTCOME MEASURE: Potential usefulness and effectiveness of the QII at improving DAA supply and reducing dispensing errors. RESULTS: The QII was titled: 'Be alert and work together for medicine safety, DAA incident awareness toolkit'. Four-hundred and thirty-five questionnaires were returned (85.0 % response rate). Respondents believed the intervention had the potential to improve pharmacy medicine supply or NH medicine administration involving DAAs 'very' (47.3 % of responses) or 'extremely well' (23.4 %). The intervention had the potential to reduce the occurrence of DAA dispensing errors 'very' (49.6 %) or 'extremely well' (20.5 %). CONCLUSION: A stakeholder informed QII was perceived to have the potential to improve DAA medicine supply from community pharmacies to NHs and reduce the occurrence of dispensing errors found within them. Future quantitative evaluation of the intervention is required.

Medicines in Australian nursing homes: a cross-sectional observational study of the accuracy and suitability of re-packing medicines into pharmacy-supplied dose administration aids.

BACKGROUND: Though staff at Australian nursing homes (NHs) commonly administer medicines that have been re-packed into dose administration aids (DAAs) that organize medicines according to dose schedule, these pharmacy-supplied devices have not been extensively evaluated in the Australian setting. OBJECTIVE: To audit the accuracy and suitability of re-packing medicines into DAAs (blister packs or sachets) for NHs and identify the proportion of DAAs with inaccurate or unsuitable medicine re-packing. METHODS: Between January and June 2011, pharmacist researchers visited 49 randomly and purposively selected NHs from rural, regional, and metropolitan Victoria (Australia) to audit a sample of residents' newly prepared DAAs that contained all of their regularly re-packed medicines for 1 week. Over 1 or 2 days, the pharmacy-supplied DAAs were compared with the current prescriber-prepared NH medicine chart. Any occurrences of inaccurately re-packed medicines (discrepancies, with verification as necessary) or unsuitable medicine re-packing were recorded as DAA incidents and descriptive statistics was used to analyze the data. RESULTS: Six hundred and eighty-four incidents occurring in 457 DAAs were detected from a total of 3959 DAAs audited for 1757 residents (incident rate of 11.5% of DAAs) from 49 participating NHs. Incidents were detected in 10.5% of blister packs and 14.5% of sachets. The top five incidents were unsuitable re-packing according to pharmaceutical guidelines (50.1%); added medicine (9.8%); incorrect quantity re-packed (5.4%); omitted medicine (5.3%); and damaged medicine (5.1%). CONCLUSIONS: The incident rate of inaccurate or unsuitable medicine re-packing within DAAs supplied to NHs for use in medicine administration was higher than in previous research. Recommendations include using current findings in conjunction with further research to develop a quality improvement initiative to reduce DAA incident rates and improve NH standard of care.

A virtual practice environment to develop communication skills in pharmacy students.

OBJECTIVE: To develop communication skills in second-year pharmacy students using a virtual practice environment (VPE) and to assess students' and tutors' (instructors') experiences. DESIGN: A VPE capable of displaying life-sized photographic and video images and representing a pharmacy setting was constructed. Students viewed prescriptions and practiced role-playing with each other and explored the use of nonverbal communication in patient-pharmacist interactions. The VPE experiences were complemented with lectures, reflective journaling, language and learning support, and objective structured clinical examinations (OSCEs). ASSESSMENT: Most students believed the VPE was a useful teaching resource (87%) and agreed that the video component enabled them to contextualize patient problems (73%). While 45% of students questioned the usefulness of watching the role plays between students after they were video recorded, most (90%) identified improvement in their own communication as a result of participating in the tutorials. Most tutors felt comfortable using the technology. Focus group participants found the modified tutorials more engaging and aesthetically positive than in their previous experience. CONCLUSION: The VPE provided an effective context for communication skills development classes.

A palliative cancer care flexible education program for Australian community pharmacists.

OBJECTIVE: To implement and evaluate a flexible palliative care education program for Australian community pharmacists. DESIGN: After identifying pharmacists' education needs, the program content and format were developed. This included identifying expert writers to create modules, assigning education and palliative care specialists to review content, and designing Web hosting of materials. The program was comprised of 11 modules and 79 activities. ASSESSMENT: An average of 28 responses was posted for each of the 20 noticeboard activities. Of the 60 pharmacists who began the program, 15 contributed to the discussion group, with an average of 3 posts each. Participants' responses to an online questionnaire indicated the program addressed their education needs and improved their knowledge and confidence in providing palliative cancer care. CONCLUSION: A program that pharmacists could access at a time and place convenient to them via the Internet was developed. Pharmacists indicated the program positively impacted their practice.