Journal of Pharmaceutical Policy and Practice最新文献

Background: Advances in targeted therapies have expanded the treatment options for colorectal cancer (CRC), allowing for more tailored and effective approaches to managing the disease. In targeted therapy, Bevacizumab is a commonly prescribed anti-VEGF monoclonal antibody that has a direct anti-vascular impact in cancer patients. Vascular Endothelial Growth Factors (VEGFs), especially VEGF-A, are significant agents in promoting tumour angiogenesis.

Objective: To assess the impact of adding Bevacizumab to chemotherapy on progression-free survival (PFS) and overall survival (OS) in patients with metastatic colorectal cancer.

Methodology: Comprehensive searches have been performed on electronic databases such as PubMed, and Google Scholar using the following terms: colorectal cancer, adenocarcinoma, Bevacizumab, chemotherapy, and monoclonal antibody.

Results: In the meta-analysis, 16 out of the 24 included studies were analysed. In the final analysis, incorporating Bevacizumab with chеmothеrapy demonstrated favourable outcomes for OS with a hazard ratio (HR = 0.689,95%CI: 0.51-0.83, I² = 39%, p <0.01) and for PFS with a hazard ratio (HR = 0.77 95% CI: 0.60-0.96, I² = 54%, p < 0.01). The subgroup analysis of PFS, categorised by study dеsign (prospеctivе vs rеtrospеctivе), reveals that the Hazard Ratio (HR = 0.82, 95% CI: 0.62-0.97, I² = 21%, p < 0.01) and for OS with a hazard ratio (HR = 0.73, 95% CI: 0.52-0.86, I² = 17%, p < 0.01).

Conclusion: Our findings indicate that combining Bevacizumab with chemotherapy enhances clinical outcomes and results in a significant increase in PFS and OS in patients with metastatic colorectal cancer. Positive outcomes are demonstrated by a substantial 23% increase in PFS and 31% increase in OS in patients with metastatic colorectal cancer who undergo Bevacizumab in conjunction with chemotherapy.

Introduction: In this study, we aimed to comparatively analyse the indicators of availability to orphan drugs in South Korea, the United States of America, Europe Union, and Japan.

Methods: For 169 drugs designated as orphan drugs in South Korea between 2012 and 2021, information on the drugs designated as orphan drugs from each jurisdiction was extracted by country. Then, the availability indicators (approval time, drug lag time, and designation gap) were analysed for the drugs approved in each jurisdiction.

Results: The approval rate of drugs designated as orphan drugs were 11.22% and 6.31% in the USA and EU, respectively, which was lower than that of orphan drugs in South Korea and Japan. The highest number of approved drugs was in the USA (87 drugs), EU 27 drugs, Japan 22 drugs and Korea 21 drugs. Furthermore, the approval time significantly differed between South Korea and the other countries. South Korea had a significantly different drug lag time and designation gap compared with the USA and EU.

Conclusion: Our findings show that to fundamentally improve the access to treatments for rare disease, a policy of regulatory science that can comprehensively support the early stages of research and development and commercialisation is needed.

The increased utilization of opioids in low- and middle-income countries (LMICs) presents a growing threat of opioid-related abuse, misuse and diversion. Pharmacists, as integral members of healthcare teams, are responsible for dispensing and monitoring opioid use and hold a pivotal role in opioid stewardship within LMICs. This commentary describes the potential and multifaceted roles of pharmacists in opioid stewardship in resource-constrained settings and highlights appropriate strategies for promoting responsible opioid utilization. Opioid stewardship involves prioritising evidence-based prescribing, management and practices for pain management. It includes measures such as incorporating prescription drug monitoring programmes for appropriate opioid prescription, implementing safe disposal through drug take-back programmes, promoting non-opioid pain management, addressing the opioid addiction stigma, tapering opioid dose, educating patients and caregivers, establishing drug information centers, providing rehabilitative services and integrating collaboration with communities and experts. The combined difficulties of restricted access to healthcare resources and services coupled with low levels of literacy worsen the susceptibility to opioid abuse, misuse, and diversion in LMICs. Early detection, assessment and implementation of interventions to optimise opioid use are imperative for ensuring safe and effective opioid utilization, thereby mitigating the risks of overdose and addiction. The involvement of pharmacists in promoting safe and effective opioid utilization through education, monitoring, collaboration, and policy advocacy serves as a critical component in bridging existing gaps in opioid stewardship within LMICs.

Background: Withdrawals of drug indications may reveal potential inadequacies in the regulatory approval processes of new drugs. Understanding potential weaknesses of the regulatory approval process is paramount given the increasing use of expedited pathways. In this paper, we focus on three poly-ADP-ribose polymerase inhibitors (olaparib, rucaparib and niraparib) for the treatment of women with heavily pretreated, recurrent ovarian cancer, which were eventually withdrawn.

Methods: We use a comparative case study approach to evaluate the regulatory histories of these drug indications in the US and Europe.

Results: Two drug indications benefited from the FDA's accelerated approval pathway, which explicitly lowers the bar for evidence of efficacy at the time of approval. Following accelerated approval, manufacturers are mandated to conduct post-marketing studies to confirm clinical benefit. The FDA granted accelerated approval to olaparib and rucaparib based on data on surrogate endpoints and converted the approval to regular approval after the submission of additional data on surrogate endpoints from one of two required confirmatory trials, that is, without data on clinical benefit. Niraparib directly received regular approval based only on data on a surrogate endpoint. By contrast, the EMA granted conditional marketing authorisation to rucaparib and was quicker to restrict usage than the FDA.

Conclusion: The regulatory histories of these drug indications highlight the need to reform the accelerated approval pathway by ensuring that post-marketing requirements are followed, and that regular approval is only based on evidence of clinical benefit.

Introduction: Poisoning is a major public health issue and a leading cause of admission to the emergency department (ED). There is a paucity of data describing the epidemiology and cost of acute poisoning. Therefore, this study investigated the epidemiology, patterns, and associated costs of acute poisoning in emergency department of the largest tertiary care healthcare centre in Qatar.

Method: This study was a retrospective review of the health records of patients admitted to the ED due to poisoning between January 2015 and December 2019. Incidence, clinical characteristics, and costs associated with acute poisoning were assessed. Frequency and percentages were calculated for categorical variables and mean and SD for continuous variables. The relationship between sociodemographic characteristics and poisoning profile was assessed using the chi-square test. A micro-costing approach using the cost of each resource was applied for cost calculations.

Result: The incidence of acute poisoning was 178 cases per 100,000 patients. Females (56%) and children below 14 years (44.3%) accounted for the largest proportion. Most of the exposures were accidental involving therapeutic agents (64.2%). The mean length of hospital stay was found to be 1.84 ± 0.81 days, and most patients (76.6%) were discharged within the first 8 h. A statistically significant difference was found between age groups and type of toxin (χ2 = 23.3, p < 0.001), cause and route of exposure (χ2 = 42.2, p < 0.001), and length of hospital stay (χ2 = 113.16, p < 0.001). Admission to intensive care units had the highest cost expenditure (USD 326,008), while general wards accounted for the least (USD 57,709).

Conclusion: Unintentional poisoning by pharmacological agents is common in infants and children. This study will assist in the development of educational and preventive programmes to minimise exposure to toxic agents. Further studies are required to explore the impact of medical toxicology services, and post discharge monitoring of poisoning.

Aim: Cannabis-based medication has recently been made available in the NHS for reducing pain and spasticity in patients with multiple sclerosis (MS). The currently available preparation of Sativex (nabiximols) contains a combination of botanical cannabis extracts with cannabidiol (CBD) and tetrahydrocannabinol (THC) with almost equal amounts in addition to minor cannabinoids and terpenoids and is delivered via an oro-mucosal spray. The present study aims to examine the use and trends in prescribing cannabinoid-based Sativex to control pain in patients diagnosed with MS.

Methods: Primary care prescribing data for cannabinoid-based Sativex (2013-2022) from the Prescription Cost Analysis were extracted and analysed. Linear regression analyses were performed to examine prescription trends and prescription costs (average change per year).

Results: There was a general increasing trend in the number of prescriptions each year, from 4.42 items dispensed per 100,000 people in 2013 to 5.15 in 2022. Overall, prescription items for cannabinoid-based Sativex increased by 0.34% per year (95% CI:-3.98, 4.67, p = 0.860) on average between 2013 and 2022. On average, a 2.43% (95% CI: -5.78, 0.92, p = 0.133) increase per year was observed for the costs of cannabinoid-based Sativex from 2013 to 2022.

Conclusion: The results suggested that cannabinoid-based Sativex should be considered an option due to its effectiveness, acceptable tolerance, and safety profile in the prescribing of Sativex.