METHODS: This is a cross-sectional study from 4 primary care clinics where 240 patients aged >60 years and their caregivers were enrolled. Patients were assigned to a nurse or a health care assistant (HCA) for 2 separate PFFS-M assessments administered by HCPs of the same profession, as well as by a doctor during the first visit (inter-rater reliability). Patients were also administered the Self-Assessed Report of Personal Capacity & Healthy Ageing (SEARCH) tool, a 40-item frailty index, by a research officer. The correlation between patients' PFFS-M scores and SEARCH tool scores determined convergent validity. Patients returned 1 week later for PFFS-M reassessment by the same HCPs (test-retest reliability). Caregivers completed the PFFS-M for the patient at both clinic visits. Classification cut-points for the PFFS-M were derived against frailty categories defined through the SEARCH tool.
RESULTS: The inter-rater (intraclass correlation coefficient [ICC] = 0.92 [95% CI, 0.90-0.93)] and test-retest (ICC = 0.94 [95% CI, 0.92-0.95]) reliability between all raters was excellent, including by patients' education levels. The convergent validity was moderate (r = 0.637, p < 0.001), including for varying educational background. PFFS-M categories were identified as: 0-3, no frailty; 4-5, at risk of frailty; 6-8, mild frailty; 9-12, moderate frailty; and >13, severe frailty.
CONCLUSION: PFFS-M is a reliable and valid tool with frailty severity scores now established for use of this tool in primary care clinics.
MATERIALS AND METHODS: An online, anonymous, voluntary survey was conducted to assess the level of knowledge and understanding about EAPs among Malaysian oncologists using SurveyMonkey® between April 2020 and June 2020. Oncologists who had enquired about EAP in the past, were invited at random to participate in the survey. Participants who did not provide consent or failed to complete the survey were excluded.
RESULTS: A total of 15 oncologists participated in the survey, from both public (46.6%) and private (46.6%) practices. Most respondents (80%) had filed between 1 to 10 EAP applications in the past 12 months. For 73.3% respondents, resources or training were not provided for EAPs from institutions. Around 53% of the respondents reported that their knowledge of EAPs and application processes including country regulations is 'good'. The majority of respondents (73.3%) reported that the educational modules on an overview of EAPs, country regulations and the EAP application process will be beneficial. Most participants received information about the existing EAPs either by reaching out to a pharmaceutical sponsor or through another health care provider and some received information about the existing EAPs through their institutions or patients/caregivers. Most of the respondents recommended that pharmaceutical companies should have readily available information related to the availability and application of EAPs for all pipeline products on their websites.
DISCUSSION: EAPs are crucial treatment access pathways to provide investigational drugs to patients who have exhausted their treatment options and are not eligible for participation in clinical trials. Malaysian oncologists have a fair understanding about the EAPs and the application processes.
CONCLUSION: Additional training and awareness are needed for Malaysian oncologists to upscale the utilisation of EAPs.
METHODS: All new pharmaceutical products approved between January 2015 and March 2021 were examined (n = 136) using publicly available information. Factors associated with drug approval lag were determined using multiple linear regression.
RESULTS: The median drug approval lag was 855 days. Drug approval lag was associated with drug characteristics and regulatory factors. Median submission lag and median review time for products which fulfilled the requirement for the new regulations (Conditional Registration/ Facilitated Registration Pathway) were shorter compared to products which did not fulfil the requirement.
CONCLUSION: Drug approval lag may delay the access of innovative medicine to patients, and this may lead to an increase in morbidity, mortality and healthcare costs. Good Regulatory Practices ensure efficient and transparent regulatory system which support the public health policy objectives in the most efficient way. The new regulations in Malaysia reduced the median submission lag and review time. The findings may be useful for regulators to consider for future policy development for medication access.