Journal of Pharmaceutical Policy and Practice最新文献

{"title":"'Piloting a framework for analysing the public contributions to R&D: new antibiotics in focus'.","authors":"Louise Schmidt, Ozren Sehic, Ursula Theuretzbacher, Daniel Fabian, Claudia Wild","doi":"10.1080/20523211.2024.2449045","DOIUrl":"10.1080/20523211.2024.2449045","url":null,"abstract":"<p><strong>Background: </strong>Within the context of increasing transparency around public contributions, a framework for reporting and analysing public contributions to research and development (R&D) was previously developed and is piloted here using the example of antibiotics. The aim of this work is to check whether the category system is feasible, to revise and adjust the granularity of the category system where necessary, and to expand the range of sources for detailed analyses.</p><p><strong>Methods: </strong>All antimicrobial medicinal products in development, discontinued and approved in the last 10 years were identified in the literature. Thereafter clinical trials and company information was searched generating a list of 56 compounds where primarily small to medium-sized enterprises (SMEs) were involved in antibiotics development. Information on clinical trials, university spinouts and public funding for SMEs was then gathered from various sources. The framework for classifying public contributions was then applied.</p><p><strong>Results: </strong>We found that around one-third of antibiotics are developed by SMEs. We identified numerous public funding sources for SMEs that develop antibiotics. At both early-stage and late-stage development, public research funding is the most common public funding reported by SMEs, ahead of other public sources like public equity funds, private-public partnerships and philanthropic sources. A deep-dive into one antibiotic drug, Venatorx, revealed public funds investment of approximately $655 million, dwarfing private investment funds. We found the classification framework generally practicable and we suggest recommendations to improve its granularity and applicability.</p><p><strong>Conclusion: </strong>In this paper we piloted and revised a framework that has been developed to classify types of public contributions to pharmaceutical products at different stages of development. The framework, together with work we have done on identifying sources for funding, can be applied to support pharmaceutical price negotiations that reflect the level of public contribution to product development.<b>Trial registration:</b> EU Clinical Trials Register identifier: 0004-2083-2207.<b>Trial registration:</b> EU Clinical Trials Register identifier: 0003-1754-9422.</p>","PeriodicalId":16740,"journal":{"name":"Journal of Pharmaceutical Policy and Practice","volume":"18 1","pages":"2449045"},"PeriodicalIF":3.3,"publicationDate":"2025-01-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11753009/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143023728","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}

{"title":"Supervision, performance assessment, and recognition strategy (SPARS) - a multipronged strategy to strengthen medicines management in Nepal: pilot study methods and baseline results.","authors":"Nirajan Bhusal, Anup Bastola, Reekesh Shrestha, Narendra Kumar Khanal, Birna Trap","doi":"10.1080/20523211.2024.2449043","DOIUrl":"10.1080/20523211.2024.2449043","url":null,"abstract":"<p><strong>Background: </strong>Nepal piloted a multipronged supervision, performance assessment, and recognition strategy (SPARS), to improve medicines management (MM) in public health facilities. This paper describes the SPARS pilot intervention and reports on MM performance at baseline.</p><p><strong>Methods: </strong>To build MM capacity at public sector health facilities, health workers were trained as MM supervisors to visit and supervise government health facilities, assess MM performance, and use the findings to provide support in MM practices. Performance was assessed using a SPARS indicator-based tool containing 25 indicators covering five MM domains: dispensing quality, prescribing quality, stock management, storage management, and ordering and reporting. From the middle of 2022, we trained 60 MM supervisors who began conducting supervisory visits at 284 health facilities in 12 randomly selected pilot districts located in three provinces. The intent, pending funding, is to continue supervision and expand SPARS to achieve national coverage.</p><p><strong>Results: </strong>The overall MM baseline median score was 8.5 (34%) (maximum 25) with an inter-quartile range (IQR) of 6.4-10.7. Median facility domain scores (maximum 5) were: storage management, 2.0 (IQR 1.4-2.6); stock management 0.3 (IQR 0.0-1.0); ordering and reporting 2.5 (IQR 1.7-3.5); dispensing quality 1.3 (IQR 0.9-1.6); and prescribing quality 2.3 (IQR 1.3-3.3). The overall score did not differ significantly by level of care; however, hospitals had the lowest overall baseline score and individual domain scores.</p><p><strong>Conclusion: </strong>The baseline assessment using the SPARS tool provides valuable information on the current state of MM in Nepal, which was poor, assessed by the 25 SPARS indicators covering stock and storage management, ordering and reporting, prescribing, and dispensing. Assessing and building national capacity in MM is needed at health facilities at all levels of care.</p>","PeriodicalId":16740,"journal":{"name":"Journal of Pharmaceutical Policy and Practice","volume":"18 1","pages":"2449043"},"PeriodicalIF":3.3,"publicationDate":"2025-01-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11749287/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143007273","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}

{"title":"Pharmacist-led antibiotic interventions in infectious disease patients: a Pakistani tertiary care antimicrobial stewardship study.","authors":"Ali Hassan, Naeem Ur Rehman, Sumeira Maqbool, Mehreen Arif","doi":"10.1080/20523211.2025.2450017","DOIUrl":"10.1080/20523211.2025.2450017","url":null,"abstract":"<p><strong>Background: </strong>Antibiotics are widely used medications among infectious disease patients; therefore, proper monitoring and assessment are critical for ensuring rational use. Antimicrobial stewardship addresses the rational and appropriate use of antibiotics, which reinforces overall health outcomes. Ongoing antimicrobial resistance scenarios are an alarming condition for healthcare, necessitating continued practice of such assessments.</p><p><strong>Objectives: </strong>To evaluate the use of antibiotics in patients with infectious diseases, implement and evaluate clinical pharmacy interventions that adhere to antimicrobial stewardship protocols.</p><p><strong>Methods: </strong>A before and after study was designed to evaluate clinical pharmacy and antimicrobial stewardship interventions for infectious disease patients at a tertiary care hospital in Lahore. A Performa was designed for manual data collection. Study first identified the signal of error, implemented intervention and noted post-interventional followups.</p><p><strong>Results: </strong>102 infectious disease cases were analyzed in total and proposed 136 interventions. Physicians accepted 66% of the interventions (90) and rejected the remaining ones as unjustified. The most accepted intervention was the spectrum-based choice (<i>n</i> = 30), followed by de-escalation of dose (<i>n</i> = 17). Use of ceftriaxone was very high (54 Pt.), followed by vancomycin (30 Pt.).</p><p><strong>Conclusion: </strong>Antimicrobial stewardship programmes are critical for any institution's proper health care system. It ensures proper antibiotic outflow to patients, thereby improving their health status. The role of pharmacists in establishing an AMS in a hospital setting is a highly commendable activity that enhances healthcare collaboration and outcomes. Clinical pharmacists should implement such activities to improve patient care.</p>","PeriodicalId":16740,"journal":{"name":"Journal of Pharmaceutical Policy and Practice","volume":"18 1","pages":"2450017"},"PeriodicalIF":3.3,"publicationDate":"2025-01-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11740292/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143007266","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}

{"title":"Reforming the innovation system to deliver affordable medicines: a conceptual framework of pharmaceutical innovation as a complex adaptive system (forest) and theory of change.","authors":"Suerie Moon, Adrian Alonso Ruiz, Marcela C F Vieira, Kaitlin E Large, Iulia Slovenski","doi":"10.1080/20523211.2024.2436899","DOIUrl":"10.1080/20523211.2024.2436899","url":null,"abstract":"<p><strong>Background: </strong>The current mainstream pharmaceutical innovation system (PIS) is driven by the market-based logic of charging the highest prices societies will bear. Outcomes include unaffordable medicines, restricted access and pressure on health budgets. How can the innovation system change to deliver fairly-priced medicines?</p><p><strong>Methods: </strong>We inductively developed a novel conceptual framework of the PIS as a complex adaptive system (CAS) analogous to a forest. We constructed a database of 140 pharmaceutical innovation initiatives that sought to address global public interest objectives such as fair pricing or missing innovation. We found a critical mass of initiatives clustered around four areas: pandemic preparedness, neglected diseases, rare diseases and antibiotics, which we conceptualised as <i>niches</i> within the ecosystem. We reviewed the literature on how each niche had emerged and evolved, conducted interviews, and organised workshops with experts on each niche. Finally, we identified from the literature an initial list of 'levers' of change in the PIS, supplemented them with additional levers found in each niche, then compared across niches.</p><p><strong>Results: </strong>We found that actors created niches in the broader system by purposefully problematising an issue, then pulling on one or more of three levers: mobilising new resources, changing the roles of or creating new actors, and/or changing societal norms or legal rules. A wide range of actors - including governments, funders, R&D practitioners, or civil society groups - could pull these levers, and the order in which they were pulled was not fixed, consistent with a CAS.</p><p><strong>Conclusions: </strong>Parts of the vast pharmaceutical innovation system have changed to deliver more affordable medicines by design. Such change has occurred largely within specialised niches, responding to evolving societal norms about the purpose of pharmaceutical innovation. Actors can achieve larger-scale change by further expanding and/or solidifying these niches through changes to resources, actor roles, norms and rules.</p>","PeriodicalId":16740,"journal":{"name":"Journal of Pharmaceutical Policy and Practice","volume":"18 1","pages":"2436899"},"PeriodicalIF":3.3,"publicationDate":"2025-01-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11740976/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143007269","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}

{"title":"Quality of life for patients on oncology treatments in the Kingdom of Saudi Arabia: a systematic review.","authors":"Abdullah U Althemery, Rawan Alzahrani, Nura Alajlan, Abdullah M Alrajhi","doi":"10.1080/20523211.2024.2449036","DOIUrl":"10.1080/20523211.2024.2449036","url":null,"abstract":"<p><strong>Background: </strong>Cancer cases in the Kingdom of Saudi Arabia (KSA) have tripled in recent years. Quality of Life (QoL) measurements are crucial for healthcare professionals because they reveal important information about how patients respond to drugs and their general health. This study aimed to collect and summarise articles exploring the QoL of patients undergoing oncology treatments in KSA.</p><p><strong>Methods: </strong>This systematic review captured articles on the Quality of Life of patients undergoing oncology treatments living in the KSA from 2000-2023. A query was established by adapting (PICOS) guidelines for systematic research. A systematic review accelerator (SRA) was used to organise the search and enable multiple reviewers to conduct and validate the process.</p><p><strong>Results: </strong>Twelve articles met the inclusion criteria. Riyadh and Jeddah contributed to all publications. A total of 2,430 patients with cancer were surveyed; 1,377 patients were female (56.67%) with an average age of 51.23 years. Six articles mentioned pharmacological interventions, whereas the remaining articles did not mention which pharmacology had been utilised.</p><p><strong>Conclusion: </strong>This systematic review highlights the recent attention given to the patient's reported outcomes of cancer patients. Further research on rare cancer types is required, particularly for generic instruments.</p>","PeriodicalId":16740,"journal":{"name":"Journal of Pharmaceutical Policy and Practice","volume":"18 1","pages":"2449036"},"PeriodicalIF":3.3,"publicationDate":"2025-01-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11731331/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142983720","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}

{"title":"Payment models and the sustainability of community pharmacy practice: a qualitative interview study with community pharmacists.","authors":"Kelly Ann Schmidtke, Terri Warholak","doi":"10.1080/20523211.2025.2450018","DOIUrl":"10.1080/20523211.2025.2450018","url":null,"abstract":"<p><strong>Background: </strong>The sustainability of community pharmacies in the United States depends, in large part, on policies enacted by the Centers for Medicare and Medicaid Services (CMS). In 2003, CMS policy allowed retrospective direct and indirect remuneration (DIR) fees to manage costs. From 2024, only prospective DIR fees are permitted. The current study explores how existing payment models have impacted practice and how the policy change might impact future practice.</p><p><strong>Methods and materials: </strong>Semi-structured qualitative interviews were conducted with community pharmacists knowledgeable about third-party payment and reimbursement practices in the state of Missouri. Interviews were recorded, transcribed, and reflectively analysed to identify broad themes. Final codes were applied to direct quotes. Participants checked transcripts and drafts of the manuscript for accuracy and completeness.</p><p><strong>Results: </strong>Twelve pharmacists (11 males) with self-expressed knowledge of fees impacting their practice(s) participated. The pharmacists owned or worked for community pharmacies. The median percentage of patients served on Medicare Part D was 35% (range 24% to 60%). Four main themes and one overarching theme were identified. Theme 1 describes a sense of being punished for the basic component of pharmacy practice, i.e. safely dispensing prescription medications. Theme 2 describes a diversification of the business model to subsidise losses on the basic component. Theme 3 describes anticipated challenges given the policy change. Theme 4 describes what may be needed to achieve payment reform. The overarching theme describes the purpose of community pharmacy, including who community pharmacists are and who they serve, i.e. their community.</p><p><strong>Conclusion: </strong>Community pharmacies require a financially viable and sustainable business model to deliver the legally required basic component of practice: safely dispensing prescription medications. Legislative action could help to ensure community pharmacies are appropriately compensated for work at the federal and state levels. Where services beyond the basics cost-effectively benefit public health, payment models could support them.</p>","PeriodicalId":16740,"journal":{"name":"Journal of Pharmaceutical Policy and Practice","volume":"18 1","pages":"2450018"},"PeriodicalIF":3.3,"publicationDate":"2025-01-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11730775/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142983642","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}

{"title":"Predictors of knowledge level and awareness towards the principles and methodology evaluation of pharmacoeconomics in Saudi Arabia.","authors":"Dhafer Mahdi Alshayban","doi":"10.1080/20523211.2024.2442496","DOIUrl":"10.1080/20523211.2024.2442496","url":null,"abstract":"<p><strong>Background: </strong>Pharmaceutical expenditure has been a major concern for decision-makers worldwide. One strategy to control medication costs involves applying pharmacoeconomic (PE) methods in the approval and listing of new medications. Pharmacists need to possess the knowledge, skill, and competence to analyse and implement PE study findings. This study aimed to evaluate the predictors of pharmacy professionals' knowledge and awareness towards PE and their ability to apply its concepts. Furthermore, this study sought to identify the barriers to the practical application of PE.</p><p><strong>Methods: </strong>A cross-sectional study was conducted between October 2022 and June 2023. A chi-square test was employed to examine the associations between dependent and independent variables while multiple binary logistic regression was performed to identify predictors of PE knowledge and awareness.</p><p><strong>Results: </strong>A total of 204 pharmacists were included. The mean age was 29.34 years (SD: 6.45) and 75.5%of participants were male. Of the participants, 46.6% held a bachelor's degree. A total of 81.4% were aware of PEs and 65.2% exhibited low knowledge levels. Around 60% of participants agreed to all the questions concerning the pharmacists' attitudes towards PE. Females were 2.6 times more likely than males to have good PE knowledge (AOR = 2.62, <i>p</i> < 0.01). Participants aged 26-35 and those over 36 were 2.6 times (AOR = 2.6, <i>p</i> < 0.05) and 2.8 times (AOR = 2.83, <i>p</i> < 0.01) more likely to have good knowledge than those under 25, respectively.</p><p><strong>Conclusion: </strong>This study highlighted a gap in the knowledge, and ability to apply PE concepts in practice. Key predictors such as being aged 30 or older, having longer years of work experience, and holding advanced pharmacy degrees were linked to higher levels of PE knowledge, positive attitudes, and awareness and enhanced the ability to apply PE concept. Future research should assess the effectiveness of PE courses offered in pharmacy colleges across Saudi Arabia.</p>","PeriodicalId":16740,"journal":{"name":"Journal of Pharmaceutical Policy and Practice","volume":"18 1","pages":"2442496"},"PeriodicalIF":3.3,"publicationDate":"2025-01-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11721936/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142971387","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}

{"title":"Understanding the regulatory-procurement interface for medicines in Africa via publicly available information on standards, implementation, and enforcement in five countries.","authors":"Jillian C Kohler, Mariangela Castro-Arteaga, Saher Panjwani, David Mukanga, Murray M Lumpkin, Bonface Fundafunda, Anthony B Kapeta, Chimwemwe Chamdimba, Anna S Y Wong, Kristin N Harper, Charles Preston","doi":"10.1080/20523211.2024.2436898","DOIUrl":"10.1080/20523211.2024.2436898","url":null,"abstract":"<p><strong>Background: </strong>Substandard and falsified medicines in Africa are a major public health concern. Access to quality medical products in African countries is governed in large part by two major entities at the national level: the regulatory authority and the procurement agency. The importance of national regulators in ensuring quality medical products is well known. The interplay between the national regulator and the national procurement agency also has a significant impact on access to quality medicines but is less understood. This study's aim was to characterise the regulatory-procurement interface - the intersection of decision-making in these two spheres - using publicly available data from five African countries.</p><p><strong>Methods: </strong>For the five target countries, we adapted criteria from WHO's 2018 <i>Pharmaceutical System Transparency and Accountability Assessment Tool</i> to identify key national policies and practices around the nexus of medicines regulation and procurement.</p><p><strong>Results: </strong>Though legal and policy frameworks enabling best practices in procurement were often in place, implementation and enforcement of these practices appear to be key areas for strengthening. In addition, we documented a lack of publicly available information related to the role that quality plays in selecting medical products. Finally, none of the five countries have publicly published the results of their selection decisions with key product details, making it difficult to assess whether basic quality standards are being met.</p><p><strong>Conclusion: </strong>Based on these findings, one of the most important next steps for improving the effectiveness and transparency of national procurement is for procurement agencies to publish detailed quality selection criteria and an up-to-date list of the medical products they have purchased, with key product information. We hope these findings can help inform the conversation about implementing and enforcing best practices at the regulatory-procurement interface, with the goal of improving access to quality versions of medical products in Africa and globally.</p>","PeriodicalId":16740,"journal":{"name":"Journal of Pharmaceutical Policy and Practice","volume":"18 1","pages":"2436898"},"PeriodicalIF":3.3,"publicationDate":"2025-01-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11721952/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142971391","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}

{"title":"Professional self-actualisation of pharmacist in the United Arab Emirates: a pilot study.","authors":"A Abd Al Magied, K Beyene, E Arafa, A Elnour, N Kheir","doi":"10.1080/20523211.2024.2443524","DOIUrl":"10.1080/20523211.2024.2443524","url":null,"abstract":"<p><strong>Objective: </strong>This pilot study evaluated the professional self-actualisation (PSA) of pharmacists in the United Arab Emirates (UAE) across various practice settings.</p><p><strong>Methods: </strong>Our study was conducted in the UAE from February to May 2024 and targeted pharmacists in hospitals, community pharmacies, industry, and academia. A PSA questionnaire was developed using validated instruments and expert input, and included items on professional fulfilment (PF), societal acceptance (SA), work environment (WE), autonomy and professional opportunities (APO), involvement in professional advocacy (IPA), and the impact of work on personal relationships (IWPR).</p><p><strong>Results: </strong>Sixty-eight responses were received from pharmacists working in the community, hospital, industry and academic sectors. No significant differences in self-actualisation were observed between genders. PF scores were consistent across age groups, and education level significantly impacted IPA scores, with MSc/PhD holders (mean = 3.6, SD = 0.7) scoring higher than Bachelor's degree holders (mean = 2.9, SD = 0.9; <i>p</i> = 0.008). Years of experience were significantly associated with SA scores (<i>p</i> = 0.046), with pharmacists having 5-10 years of experience (mean = 3.5, SD = 0.8) scoring higher than those with less than 5 years (mean = 3.1, SD = 0.9) or more than 10 years (mean = 2.9, SD = 0.7). PF showed a strong correlation with a supportive WE (<i>r</i> = 0.744), highlighting the crucial role of a positive work setting in professional self-actualisation.</p><p><strong>Conclusion: </strong>This study identified key factors affecting pharmacists' self-actualisation in the UAE, emphasising the importance of a supportive work environment, recognition, and professional development for job satisfaction. Despite limitations such as low sample size and underrepresentation of certain sectors, the findings provide a basis for future research and inform strategies to enhance work environments, policies, and pharmacists' professional satisfaction.</p>","PeriodicalId":16740,"journal":{"name":"Journal of Pharmaceutical Policy and Practice","volume":"18 1","pages":"2443524"},"PeriodicalIF":3.3,"publicationDate":"2025-01-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11721847/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142971389","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}

{"title":"Pharmacovigilance systems for safety monitoring of herbal medicines: assessment of the national regulatory authority, manufacturers and marketing authorisation holders in Tanzania.","authors":"Alambo K Mssusa, Lone Holst, Sheila Maregesi, Godeliver Kagashe","doi":"10.1080/20523211.2024.2438223","DOIUrl":"https://doi.org/10.1080/20523211.2024.2438223","url":null,"abstract":"<p><strong>Background: </strong>The increase in the consumption of herbal medicines and their documented adverse reactions (ARs) necessitate countries to have good pharmacovigilance (PV) systems at all levels. PV systems should be frequently assessed in a systematic manner with available harmonised tools to monitor the implementation of efforts, strengthen the systems and identify areas for improvement.</p><p><strong>Objectives: </strong>This study aimed to assess the performance of pharmacovigilance and its quality systems for monitoring herbal medicine safety at the National PV Centre at the Tanzania Medicines and Medical Devices Authority (TMDA), manufacturers and herbal medicine marketing authorisation holders (MAHs) to identify gaps, challenges and opportunities for improvement.</p><p><strong>Methods: </strong>A descriptive cross-sectional study was conducted using structured interviews with key informants, questionnaires administered by the researchers and document analysis. A retrospective study of suspected ARs to herbal medicines received via the TMDA was also performed.</p><p><strong>Results: </strong>Policies and a legal framework for regulatory control and safety monitoring of herbal medicines were in place with a well-established and functional PV system at the TMDA. However, some gaps and challenges in the safety monitoring of herbal medicines, such as underreporting, lack of training, and dissemination of PV information, have been identified. A total of 18 reports containing 40 suspected herbal medicine ARs were received at the TMDA. Among the MAHs, only 64% had PV systems, with only 29% having mechanisms for the collection of ARs from their products. Only a few MAHs (39%) had a qualified person in the PV. The majority of the MAHs (64%) had established a quality system for PV; however, the systems were inadequate.</p><p><strong>Conclusion: </strong>Deliberate efforts need to be made to strengthen herbal medicine safety monitoring at the regulatory level. MAHs need to develop efficient PV systems and recruit qualified persons to identify safety issues related to herbal medicines.</p>","PeriodicalId":16740,"journal":{"name":"Journal of Pharmaceutical Policy and Practice","volume":"18 1","pages":"2438223"},"PeriodicalIF":3.3,"publicationDate":"2024-12-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11703424/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142950558","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}