Journal of Pharmaceutical Policy and Practice最新文献

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International comparison of availability for orphan drugs: focused on approved orphan drugs in South Korea. 孤儿药供应情况的国际比较:重点关注韩国已获批准的孤儿药。
IF 4.2
Journal of Pharmaceutical Policy and Practice Pub Date : 2024-06-05 eCollection Date: 2024-01-01 DOI: 10.1080/20523211.2024.2354299
Eun Young Shin, Young Jun Hong, Kyung Min Lim, Tae Hyang Kim, Jong Hyuk Lee
{"title":"International comparison of availability for orphan drugs: focused on approved orphan drugs in South Korea.","authors":"Eun Young Shin, Young Jun Hong, Kyung Min Lim, Tae Hyang Kim, Jong Hyuk Lee","doi":"10.1080/20523211.2024.2354299","DOIUrl":"10.1080/20523211.2024.2354299","url":null,"abstract":"<p><strong>Introduction: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusion: </strong>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.</p>","PeriodicalId":16740,"journal":{"name":"Journal of Pharmaceutical Policy and Practice","volume":null,"pages":null},"PeriodicalIF":4.2,"publicationDate":"2024-06-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11155423/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141283955","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Advancing opioid stewardship in low-middle-income countries: challenges and opportunities. 在中低收入国家推进阿片类药物管理:挑战与机遇。
IF 4.2
Journal of Pharmaceutical Policy and Practice Pub Date : 2024-06-05 eCollection Date: 2024-01-01 DOI: 10.1080/20523211.2024.2345219
Rojita Jadhari, Nabin Pathak, Rajeev Shrestha, Sunil Shrestha, Bhuvan Kc, Siew Hua Gan, Vibhu Paudyal
{"title":"Advancing opioid stewardship in low-middle-income countries: challenges and opportunities.","authors":"Rojita Jadhari, Nabin Pathak, Rajeev Shrestha, Sunil Shrestha, Bhuvan Kc, Siew Hua Gan, Vibhu Paudyal","doi":"10.1080/20523211.2024.2345219","DOIUrl":"10.1080/20523211.2024.2345219","url":null,"abstract":"<p><p>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.</p>","PeriodicalId":16740,"journal":{"name":"Journal of Pharmaceutical Policy and Practice","volume":null,"pages":null},"PeriodicalIF":4.2,"publicationDate":"2024-06-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11155429/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141283952","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Regulatory histories of recently withdrawn ovarian cancer treatment indications of 3 PARP inhibitors in the US and Europe: lessons for the accelerated approval pathway. 美国和欧洲最近撤销 3 种 PARP 抑制剂卵巢癌治疗适应症的监管历史:加速审批途径的经验教训。
IF 4.2
Journal of Pharmaceutical Policy and Practice Pub Date : 2024-06-04 eCollection Date: 2024-01-01 DOI: 10.1080/20523211.2024.2351003
Mahnum Shahzad, Huseyin Naci, Katharine M Esselen, Joseph A Dottino, Anita K Wagner
{"title":"Regulatory histories of recently withdrawn ovarian cancer treatment indications of 3 PARP inhibitors in the US and Europe: lessons for the accelerated approval pathway.","authors":"Mahnum Shahzad, Huseyin Naci, Katharine M Esselen, Joseph A Dottino, Anita K Wagner","doi":"10.1080/20523211.2024.2351003","DOIUrl":"10.1080/20523211.2024.2351003","url":null,"abstract":"<p><strong>Background: </strong>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.</p><p><strong>Methods: </strong>We use a comparative case study approach to evaluate the regulatory histories of these drug indications in the US and Europe.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusion: </strong>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.</p>","PeriodicalId":16740,"journal":{"name":"Journal of Pharmaceutical Policy and Practice","volume":null,"pages":null},"PeriodicalIF":4.2,"publicationDate":"2024-06-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11151792/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141261372","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Evaluating Greek pharmacists’ attitudes and barriers regarding medicines adherence 评估希腊药剂师对坚持用药的态度和障碍
IF 4.2
Journal of Pharmaceutical Policy and Practice Pub Date : 2024-05-22 DOI: 10.1080/20523211.2024.2319746
P. Petrou, Panagiota Kelepouri, Christos Petrou
{"title":"Evaluating Greek pharmacists’ attitudes and barriers regarding medicines adherence","authors":"P. Petrou, Panagiota Kelepouri, Christos Petrou","doi":"10.1080/20523211.2024.2319746","DOIUrl":"https://doi.org/10.1080/20523211.2024.2319746","url":null,"abstract":"ABSTRACT Adherence constitutes an integral aspect of achieving consistently good clinical results. Understanding pharmacists’ perceptions and attitudes, along with existing barriers is essential on the roadmap of enhancing patient adherence. This constitutes the goal of this study. Methodology A validated questionnaire was sent to a sample of 280 community pharmacists. Pharmacists were notified both by email and telephone. A response rate of 55% was achieved. Results Most pharmacists agree that the identification of patients’ suboptimal adherence falls under their professional responsibility and they engage in activities to promote it. There is evidence to support that the most popular interventions were self-management and indirect methods. Specific tools were used to a lesser degree. Finally, the current study illustrated that the most commonly identified barriers were the preference of patients for physicians regarding adherence, lack of information from patients and lack of time. Conclusion Although the important role of pharmacists in adherence is ascertained, significant discrepancies in the tools used to control and promote adherence among pharmacists were identified, and also in obstacles faced by themselves and their patients. The interventions should be more consistent and the notion of cooperation among health care professionals should be nurtured.","PeriodicalId":16740,"journal":{"name":"Journal of Pharmaceutical Policy and Practice","volume":null,"pages":null},"PeriodicalIF":4.2,"publicationDate":"2024-05-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141109153","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
A cost-effectiveness analysis for high versus standard (low) dose caffeine for the treatment of apnea in neonatal intensive care unit 新生儿重症监护室治疗呼吸暂停的高剂量咖啡因与标准(低)剂量咖啡因的成本效益分析
IF 4.2
Journal of Pharmaceutical Policy and Practice Pub Date : 2024-05-22 DOI: 10.1080/20523211.2024.2345218
Eilan Al-Hersh, D. Abushanab, Fouad F. Abounahia, Daniel Rainkie, M. Al Hail, P. Abdulrouf, Wessam El-Kassem, D. Al-Badriyeh
{"title":"A cost-effectiveness analysis for high versus standard (low) dose caffeine for the treatment of apnea in neonatal intensive care unit","authors":"Eilan Al-Hersh, D. Abushanab, Fouad F. Abounahia, Daniel Rainkie, M. Al Hail, P. Abdulrouf, Wessam El-Kassem, D. Al-Badriyeh","doi":"10.1080/20523211.2024.2345218","DOIUrl":"https://doi.org/10.1080/20523211.2024.2345218","url":null,"abstract":"ABSTRACT Objective: Preterm babies are prone to experiencing apnea of prematurity (AOP), mostly characterised by a pause in breathing lasting a minimum of 20 seconds. Recent literature supported higher maintenance doses of caffeine, indicating benefits. This study evaluated the cost-effectiveness of high maintenance dose (HD) versus low maintenance dose (LD) caffeine for AOP in neonates. Methods: From the hospital perspective of Hamad Medical Corporation (HMC), Qatar, a cost-effectiveness decision-analytic model was constructed to follow the use of a HD maintenance caffeine of 20 mg/kg/dose versus a LD maintenance caffeine of 10 mg/kg/dose, in a simulated cohort of AOP neonates, over a therapy follow-up duration of six weeks, until neonatal intensive care (NICU) discharge. The clinical inputs were primarily literature-based, while the resource cost and utilisation were locally extracted in HMC. The cost-effectiveness outcome measure was calculated per therapy success, defined as survival with no apnea and successful extubation removal within 72 hours, with or without adverse events. One-way and multivariate sensitivity analyses were performed to confirm the robustness of the results. Results: With 0.23 (95% CI, 0.23–0.23) enhancement in success rate, at United States dollar (US$) 3869 (95% CI, US$ 3823–3915) added infant cost, the HD caffeine was between dominant (34.8%) and cost-effective (63.7%), with an average incremental cost-effectiveness ratio of US $16,895 (95% CI, US$ 15,242–18,549) relative to LD caffeine per additional case of success. The hospitalisation contributed the most to the total infant cost, and the probability of patent ductus arteriosus was the model input that influenced the results most. Conclusion: This is the first literature economic evaluation of caffeine for AOP. Despite increasing the cost of therapy, HD maintenance caffeine seems to be a cost-effective alternative to LD caffeine in Qatar. Our results support the recent global trends of increased use of HD caffeine for AOP in NICU.","PeriodicalId":16740,"journal":{"name":"Journal of Pharmaceutical Policy and Practice","volume":null,"pages":null},"PeriodicalIF":4.2,"publicationDate":"2024-05-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141108979","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Navigating nephrology: unveiling pharmacist perspectives on renal dose adjustment in Saudi Arabia – a comprehensive cross-sectional analysis 肾病学导航:揭示沙特阿拉伯药剂师对肾病剂量调整的看法--综合横断面分析
IF 4.2
Journal of Pharmaceutical Policy and Practice Pub Date : 2024-05-22 DOI: 10.1080/20523211.2024.2344223
Hind M. Alosaimi, Rshed A. Alwatban, Haifa M. Alshammari, Ahmed H. Alshammari, S. S. Alanazi, M. Alreshidi, A. A. Alreshidi, Abrar S. Alsayed, Furat A. Alfaraj, Kawther A. Alzayer, Aymen A. Alzaher, Khawla M. Almutairi, Manar S. Almutairi, Reema H. Aljasir, Mohammed K. Alshammari
{"title":"Navigating nephrology: unveiling pharmacist perspectives on renal dose adjustment in Saudi Arabia – a comprehensive cross-sectional analysis","authors":"Hind M. Alosaimi, Rshed A. Alwatban, Haifa M. Alshammari, Ahmed H. Alshammari, S. S. Alanazi, M. Alreshidi, A. A. Alreshidi, Abrar S. Alsayed, Furat A. Alfaraj, Kawther A. Alzayer, Aymen A. Alzaher, Khawla M. Almutairi, Manar S. Almutairi, Reema H. Aljasir, Mohammed K. Alshammari","doi":"10.1080/20523211.2024.2344223","DOIUrl":"https://doi.org/10.1080/20523211.2024.2344223","url":null,"abstract":"ABSTRACT\u0000 Introduction Chronic kidney disease (CKD) is a major public health concern in Saudi Arabia. it is pertinent to mention that in the Southwestern region of Saudi Arabia. Hypertension and diabetes mellites are considered the major drivers of CKD. Research has documented worldwide the inappropriate dose adjustments in patients, ranging from 25% to 77%, of drugs requiring dose modifications. Pharmacists are pivotal members of the healthcare team, tasked with addressing issues pertaining to medications. This study aims to unveil pharmacist perspectives on renal dose adjustment in Saudi Arabia an important step in gauging their involvement in promoting healthy behaviours. Method A cross-sectional study design was conducted from December 2023 to January 2024 among pharmacists working in diverse healthcare settings, including clinical and hospital pharmacies, retail, and community pharmacies who had direct encounters with patients diagnosed with CKD. A validated questionnaire, the Renal Dose Adjustment-13 (RDQ-13) was used for this study. For comparing the knowledge, attitude, and perception scores of pharmacists statistical tests like One-Way ANOVA, and independent t-test; while for factors influencing the knowledge, attitude, and perception scores a multivariate linear regression was performed. The statistical significance level was set at 0.05. Results A total of 379 pharmacists completed the questionnaire, the knowledge score of pharmacists was 22.06 ± 2.81, while the attitude score was 8.56 ± 2.62 and the practice score was 5.75 ± 2.25. The findings of multivariate linear regression analysis indicated a statistically significant positive association between knowledge score and pharmacist’s age while for practice score the findings revealed a statistically negative association between working setting and designation of pharmacists. Conclusion The pharmacist in Saudi Arabia exhibited a proficient knowledge score of drug dosage adjustment pertinent to renal function while the attitude and practice score was less as compared to the knowledge score.","PeriodicalId":16740,"journal":{"name":"Journal of Pharmaceutical Policy and Practice","volume":null,"pages":null},"PeriodicalIF":4.2,"publicationDate":"2024-05-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141108292","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Epidemiology, clinical characteristics, and associated cost of acute poisoning: a retrospective study. 急性中毒的流行病学、临床特征和相关费用:一项回顾性研究。
IF 4.2
Journal of Pharmaceutical Policy and Practice Pub Date : 2024-05-10 eCollection Date: 2024-01-01 DOI: 10.1080/20523211.2024.2325513
Waleed Salem, Pallivalappila Abdulrouf, Binny Thomas, Wessam Elkassem, Dina Abushanab, Haseebur Rahman Khan, Yolande Hanssens, Rajvir Singh, Hany A Zaki, Aftab Mohammed Azad, Moza Al Hail, Shaban Mohammed
{"title":"Epidemiology, clinical characteristics, and associated cost of acute poisoning: a retrospective study.","authors":"Waleed Salem, Pallivalappila Abdulrouf, Binny Thomas, Wessam Elkassem, Dina Abushanab, Haseebur Rahman Khan, Yolande Hanssens, Rajvir Singh, Hany A Zaki, Aftab Mohammed Azad, Moza Al Hail, Shaban Mohammed","doi":"10.1080/20523211.2024.2325513","DOIUrl":"10.1080/20523211.2024.2325513","url":null,"abstract":"<p><strong>Introduction: </strong>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.</p><p><strong>Method: </strong>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.</p><p><strong>Result: </strong>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, <i>p</i> < 0.001), cause and route of exposure (χ2 = 42.2, <i>p</i> < 0.001), and length of hospital stay (χ2 = 113.16, <i>p</i> < 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).</p><p><strong>Conclusion: </strong>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.</p>","PeriodicalId":16740,"journal":{"name":"Journal of Pharmaceutical Policy and Practice","volume":null,"pages":null},"PeriodicalIF":4.2,"publicationDate":"2024-05-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11089918/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140916058","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Trends in prescription and cost of Sativex, a cannabinoid-based medicine, in treating patients with multiple sclerosis in England. 英国治疗多发性硬化症患者的大麻类药物 Sativex 的处方和成本趋势。
IF 4.2
Journal of Pharmaceutical Policy and Practice Pub Date : 2024-05-08 eCollection Date: 2024-01-01 DOI: 10.1080/20523211.2024.2342318
Farideh A Javid, Anam Alam, Emily Williams, Sidhra Sajid Malik, Usama Mohayuddin, Syed Shahzad Hasan
{"title":"Trends in prescription and cost of Sativex, a cannabinoid-based medicine, in treating patients with multiple sclerosis in England.","authors":"Farideh A Javid, Anam Alam, Emily Williams, Sidhra Sajid Malik, Usama Mohayuddin, Syed Shahzad Hasan","doi":"10.1080/20523211.2024.2342318","DOIUrl":"10.1080/20523211.2024.2342318","url":null,"abstract":"<p><strong>Aim: </strong>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.</p><p><strong>Methods: </strong>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).</p><p><strong>Results: </strong>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, <i>p</i> = 0.860) on average between 2013 and 2022. On average, a 2.43% (95% CI: -5.78, 0.92, <i>p</i> = 0.133) increase per year was observed for the costs of cannabinoid-based Sativex from 2013 to 2022.</p><p><strong>Conclusion: </strong>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.</p>","PeriodicalId":16740,"journal":{"name":"Journal of Pharmaceutical Policy and Practice","volume":null,"pages":null},"PeriodicalIF":4.2,"publicationDate":"2024-05-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11080669/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140897973","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Developing Nepal's medicines pricing policy: evidence synthesis and stakeholders' consultation. 制定尼泊尔药品定价政策:证据综述和利益相关者咨询。
IF 4.2
Journal of Pharmaceutical Policy and Practice Pub Date : 2024-04-29 eCollection Date: 2024-01-01 DOI: 10.1080/20523211.2024.2346222
Zaheer-Ud-Din Babar, Santosh Dulal, Narayan Prasad Dhakal, Madan Kumar Upadhyaya, Birna Trap
{"title":"Developing Nepal's medicines pricing policy: evidence synthesis and stakeholders' consultation.","authors":"Zaheer-Ud-Din Babar, Santosh Dulal, Narayan Prasad Dhakal, Madan Kumar Upadhyaya, Birna Trap","doi":"10.1080/20523211.2024.2346222","DOIUrl":"https://doi.org/10.1080/20523211.2024.2346222","url":null,"abstract":"<p><strong>Objectives: </strong>The objectives of this paper are to (a) explore stakeholders' opinions regarding Nepal's existing medicines pricing practices/situation and (b) build and present a set of medicines pricing policies for Nepal.</p><p><strong>Methods: </strong>A review of the literature and field visits to community retail pharmacies, hospital pharmacies, wholesalers, and distributor outlets in Kathmandu were conducted to assess the medicines pricing situation. Following the literature review, preliminary meetings with stakeholders and field visits were held and a draft interview guide was prepared. Consultative sessions subsequently were undertaken in Kathmandu, Nepal, in January 2023 with representatives from the Department of Drug Administration, Ministry of Health and Population, Association of Pharmaceutical Producers of Nepal, consumer groups, Transparency International, Medicines Importers Association of Nepal/ Pharmaceutical Distributors Association of Nepal, Nepal Chemist and Druggist Association, and Nepal Pharmaceutical Association. Notes were taken during these meetings regarding issues and concerns raised as well as experiences and recommendations for the future, as outlined in the interview guide.</p><p><strong>Results: </strong>The stakeholders in general stated that they do not have any objection to price regulation; however, they believe such regulation should be subject to periodic review. Both the importers and the Ministry of Health and Population have the view that an independent body/authority should be charged with regulating the prices of medicines. A set of policy options to be considered for use in Nepal include cost-plus pricing, external price referencing, internal reference pricing, and mark-up regulations.</p><p><strong>Conclusion: </strong>Key issues related to pricing were identified and suggest that a set of pricing policies and updated regulations need to be considered to establish changes that are transparent, rational, and acceptable to the related stakeholders. Hence, suggestions made in this paper could be useful to inform a rational and fair pricing structure and to improve access to medicines.</p>","PeriodicalId":16740,"journal":{"name":"Journal of Pharmaceutical Policy and Practice","volume":null,"pages":null},"PeriodicalIF":4.2,"publicationDate":"2024-04-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11060005/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140861495","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Innovations in pharmaceutical policies and learnings for sustainable access to affordable medicines 医药政策的创新和可持续获得负担得起的药品的经验教训
IF 4.2
Journal of Pharmaceutical Policy and Practice Pub Date : 2024-04-24 DOI: 10.1080/20523211.2024.2335492
S. Vogler, N. Zimmermann, M. Haasis, Verena Knoll, Jaime Espin, A. Mantel-Teeuwisse, Dimitra Panteli, F. Suleman, Veronika J Wirtz, Zaheer Babar
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