Journal of Pharmaceutical Policy and Practice最新文献

{"title":"Assessment of self-medication practices and safety profile of medicines utilisation among pregnant women attending antenatal clinics in Freetown, Sierra Leone: a multicentre cross-sectional study.","authors":"Onome Thomas Abiri, Shakiratu Lawal, Joshua Coker, James Baligeh Walter Russell, Ibrahim Franklyn Kamara, N'falie Ibrahim Sesay, Joseph Sam Kanu, Foday Umaro Turay, Michael Lahai, Henry Edward Clarence Carter, Mohamed Bawoh, Mohamed Samai","doi":"10.1080/20523211.2024.2380874","DOIUrl":"10.1080/20523211.2024.2380874","url":null,"abstract":"<p><strong>Background: </strong>Despite the potential foetal and maternal risks of self-medication, studies on self-medication practice and the safety profile of medicines used during pregnancy are scarce in our setting. This study determined the self-medication practice and safety profile of medicines used among pregnant women.</p><p><strong>Methods: </strong>This cross-sectional study was conducted in face-to-face interviews among 345 pregnant women at three hospitals in Sierra Leone. Data were analysed using descriptive statistics and binary logistic regression to determine the prevalence and associated factors of self-medication.</p><p><strong>Results: </strong>A total of 345 pregnant women participated in the study. The prevalence of self-medication prevalence among pregnant women with conventional and/or herbal medicine was 132 (38.3%). Also, 93 (75%) of the conventional medicines (CMs) were categorised as probably safe, of which paracetamol 36 (29.0%) was commonly used, followed by amoxicillin 23 (18.5%) and antimalarials 22 (17.7%) for common illnesses such as headache 30 (25.4%), urinary tract infection 23 (19.4%) and malaria 22 (18.6%). The most common reason for self-medication was previous experience with the disease 24 (27.3%). <i>Luffa acutangula</i> 19 (30.2%) was the most used herbal medicine (HM), and Oedema 30 (47.6%) was the most reported ailment. Among the HM users, 34 (54.0%) believe they are more effective than CMs. Secondary school education (AOR = 2.128, 95%CI = 1.191-3.804, <i>p</i> = 0.011), tertiary education (AOR = 2.915, 95%CI = 1.104-7.693, <i>p</i> = 0.031), monthly income of greater than NLe 1,000 (AOR = 4.084, 95% CI = 1.269-13.144, <i>p</i> = 0.018), and perceived maternal illness (AOR = 0.367, CI = 0.213-0.632, <i>p</i> = <0.001) were predictors of self-medication.</p><p><strong>Conclusion: </strong>Self-medication practice was highly prevalent and was associated with educational status, monthly income, and perceived maternal illness during pregnancy. Therefore, intervention programmes should be designed and implemented to minimise the practice and risk associated with self-medication among pregnant women.</p>","PeriodicalId":16740,"journal":{"name":"Journal of Pharmaceutical Policy and Practice","volume":null,"pages":null},"PeriodicalIF":3.3,"publicationDate":"2024-07-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11271070/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141759346","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":"A retrospective analysis of the pharmacovigilance data registry in a tertiary teaching hospital in Jordan.","authors":"Khawla Abu Hammour, Faris El-Dahiyat, Rund Hyari, Sara Salameh, Qusai Manaseer, Rana Abu Farha, Adnan Abu Hammour, Mohammed Zawiah","doi":"10.1080/20523211.2024.2378461","DOIUrl":"https://doi.org/10.1080/20523211.2024.2378461","url":null,"abstract":"<p><strong>Objectives: </strong>The study aims to analyse adverse drug reaction (ADR) reporting patterns at Jordan University Hospital to enhance pharmacovigilance practices.</p><p><strong>Methods: </strong>Retrospective analysis of ADR data from February to August 2023 was conducted. Data included patient demographics, drugs implicated, seriousness criteria, and system organ classes affected.</p><p><strong>Results: </strong>Among 1340 ADR reports analysed, females accounted for 67.4% of cases, with adults aged 18 to less than 65 years comprising 95.3% of reports. The majority of ADRs were non-serious, with only 2.1% resulting in hospitalisation or prolonged hospital stay. The most frequently reported ADRs included abdominal pain (8.3%), nausea (6.9%), headache (4.7%), and dizziness (4.7%). Notably, cardiovascular system drugs (16.4%) and alimentary tract and metabolism drugs (16.2%) were commonly associated with ADRs, followed by musculoskeletal system drugs (9.0%). Additionally, among all reported drugs, 99.9% were considered suspects, (suspected ADR cases include patient treatment cases for which a likelihood of being related to a drug therapy was scored as 'possible', 'probable', or 'certain' after causality assessment (by the WHO-UMC system in 2017), with oral administration being the predominant route (89.5%).</p><p><strong>Conclusion: </strong>The study highlights a notable increase in ADR reporting during the study period compared to historical data, indicating heightened awareness and understanding among healthcare providers. Enhanced pharmacovigilance practices, particularly involving pharmacists, are essential for detecting and reporting ADRs effectively. Further investigation into factors contributing to prevalent serious ADRs is warranted to improve patient safety and health outcomes.</p>","PeriodicalId":16740,"journal":{"name":"Journal of Pharmaceutical Policy and Practice","volume":null,"pages":null},"PeriodicalIF":3.3,"publicationDate":"2024-07-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11268214/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141759345","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":"Awareness, perspectives and practices of antibiotics deprescribing among physicians in Jordan: a cross-sectional study.","authors":"Rana Abu-Farha, Lobna Gharaibeh, Karem H Alzoubi, Rawand Nazal, Mohammed Zawiah, Ammena Y Binsaleh, Sireen Abdul Rahim Shilbayeh","doi":"10.1080/20523211.2024.2378484","DOIUrl":"10.1080/20523211.2024.2378484","url":null,"abstract":"<p><strong>Background: </strong>Antibiotics have significantly reduced mortality and improved outcomes across various medical fields; however, the rise of antibiotic resistance poses a major challenge, causing millions of deaths annually. Deprescribing, a process that involves discontinuing unnecessary antibiotics, is crucial for combating this threat. This study was designed to assess the knowledge, perceptions, and practices of physicians regarding antibiotic deprescribing in Jordan.</p><p><strong>Methods: </strong>A cross-sectional survey was conducted between January-February 2024 to assess the knowledge, perceptions, and practices of physicians regarding antibiotic deprescribing in Jordan. An electronic questionnaire served as the data collection tool. Descriptive analysis was performed using SPSS software version 26. Additionally, logistic regression analysis was carried out to identify independent factors associated with physicians' willingness to deprescribe antibiotics.</p><p><strong>Results: </strong>The study involved 252 physicians, primarily male (n = 168, 67.7%), with a median age of 33 years. Regarding antibiotics deprescribing, 21.8% (n = 55) expressed willingness to deprescribe inappropriate antibiotics.High awareness of deprescribing was evident, with 92.9% (n = 234) familiar with the concept, 94% (n = 237) knowledgeable about appropriate situations, and 96.8% (n = 244) recognising its potential benefits. Furthermore, 81.8% (n = 205) reported having received formal training in antibiotics deprescribing, and 85.3% (n = 215) were informed about the availability of deprescribing tools.Physicians highlighted challenges including insufficient time (44.4%, n = 112) and resistance from patients (41.3%, n = 104) and colleagues (42.1%, n = 106). Despite challenges, a significant proportion regularly assessed antibiotic necessity (46.9%, n = 117) and educated patients about antibiotic-related harms (40.5%, n = 102). Logistic regression analysis revealed no significant demographic factors influencing physicians' willingness to deprescribe antibiotics (<i>p</i> > 0.05).</p><p><strong>Conclusion: </strong>Physicians in Jordan exhibit high awareness of antibiotics deprescribing and recognise its benefits. Challenges such as time constraints and communication barriers need to be addressed to facilitate effective deprescribing practices. Comprehensive guidelines and interdisciplinary collaboration are essential for promoting judicious antibiotic use and combating antimicrobial resistance.</p>","PeriodicalId":16740,"journal":{"name":"Journal of Pharmaceutical Policy and Practice","volume":null,"pages":null},"PeriodicalIF":3.3,"publicationDate":"2024-07-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11262212/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141748379","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 methotrexate adherence and patient's awareness of it in rheumatoid arthritis and its effect on quality of life.","authors":"Marwa Mohamed, Abd El-Maboud, Heba F Salem, Mohamed N Salem, Mahmoud Abo Elmaaty, Nermin Eissa, Amira S A Said, Raghda R S Hussein","doi":"10.1080/20523211.2024.2365933","DOIUrl":"10.1080/20523211.2024.2365933","url":null,"abstract":"<p><strong>Introduction: </strong>Adherence studies among rheumatoid arthritis (RA) patients, in Egypt and throughout the Middle East region, are lacking. This study aimed to evaluate methotrexate (MTX) adherence in Rheumatoid arthritis (RA) patients and to identify specific non-adherence predictors.</p><p><strong>Methods: </strong>A cross-sectional observational study included 300 RA patients who were administered MTX for at least one year. The survey was completed through direct interviews. The demographic patient data were collected (age, education, sex, work status, disease duration, duration of MTX administration and current dose). Patients' adherence to MTX predictors for non-adherence, MTX side effects and functional disability were assessed in the study.</p><p><strong>Results: </strong>Majority of respondents showed good MTX adherence, and more than 50% of patient's experienced MTX side effects. A large percentage of participants showed low knowledge about MTX nature and side effects. Most participants reported no or some difficulty in quality of life-related activities and functional disability.</p><p><strong>Conclusion: </strong>MTX adherence and awareness were positively correlated to many variables, including, age, educational level and disease duration, which in turn has its positive impact on the patient's quality of life. Still, more research is needed to determine the impact of non-adherence on the patient's health outcomes.</p>","PeriodicalId":16740,"journal":{"name":"Journal of Pharmaceutical Policy and Practice","volume":null,"pages":null},"PeriodicalIF":3.3,"publicationDate":"2024-07-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11259066/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141734446","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":"Direct oral anticoagulants versus low-molecular-weight heparin in patients with cancer-associated venous thrombosis: a cost-effectiveness analysis.","authors":"Wei Kang, Kuan Peng, Vincent K C Yan, Daoud Al-Badriyeh, Shing Fung Lee, Hei Hang Edmund Yiu, Yue Wei, Silvia T H Li, Xuxiao Ye, Aya El Helali, Ka On Lam, Victor H F Lee, Ian C K Wong, Esther W Chan","doi":"10.1080/20523211.2024.2375269","DOIUrl":"10.1080/20523211.2024.2375269","url":null,"abstract":"<p><strong>Background: </strong>Direct oral anticoagulants (DOACs) have demonstrated clinical benefits and better patient adherence over low-molecular-weight heparin (LMWH) in treating patients with cancer-associated venous thrombosis (CAT). We aimed to compare the cost-effectiveness of DOACs against LMWH in patients with CAT from the perspective of the Hong Kong healthcare system.</p><p><strong>Methods: </strong>A Markov state-transition model was performed to estimate the incremental cost-effectiveness ratio (ICER) per quality-adjusted life years (QALYs) for DOACs and LMWH in a hypothetical cohort of 10,000 patients with CAT over a 5-year lifetime horizon. The model was primarily based on the health states of no event, recurrent venous thromboembolism, bleeding, and death. Transition probabilities, relative risks, and utilities were derived from the literature. Resource cost data were obtained from the Hong Kong Hospital Authority. Deterministic and probabilistic sensitivity analyses tested the robustness of the results.</p><p><strong>Results: </strong>Relative to LMWH, DOACs were associated with increased QALYs (1.52 versus 1.50) at a lower medical cost of USD 2,232 versus 8,224 in five years. The cost of LMWH was the main contributor to the outcome. Out of 10,000 simulated cases, DOACs were dominant in 15.8% and cost-effective in 42.1%, at the willingness-to-pay threshold of USD 148,392 per additional QALY.</p><p><strong>Conclusions: </strong>DOACs were associated with greater QALY improvements and lower overall costs compared to LMWH. Accounting for uncertainty, DOACs were between cost-effective and dominant in 57.9% of cases. DOACs are a cost-effective alternative to LMWH in the management of CAT in Hong Kong.</p>","PeriodicalId":16740,"journal":{"name":"Journal of Pharmaceutical Policy and Practice","volume":null,"pages":null},"PeriodicalIF":3.3,"publicationDate":"2024-07-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11257015/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141723757","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":"Unpacking the process of developing South Africa's national drug policy - lessons for universal health coverage.","authors":"Andrew L Gray, Fatima Suleman","doi":"10.1080/20523211.2024.2376349","DOIUrl":"10.1080/20523211.2024.2376349","url":null,"abstract":"<p><strong>Background: </strong>South Africa's National Drug Policy (NDP) was first issued in 1996, at a time of considerable political change.</p><p><strong>Objectives: </strong>To revisit the lessons learned from the process of development and initial implementation of the NDP.</p><p><strong>Methods: </strong>Six in-depth face-to-face interviews were held with purposively-selected key actors. Interviews, which followed pre-determined semi-structured questions, but were allowed to explore additional areas, were recorded and transcribed, and then subjected to abductive thematic analysis, informed by the Walt and Gilson model.</p><p><strong>Results: </strong>Three key themes emerged, described as 'evidence', 'trust' and 'looking forward'. A paucity of evidence backed some of the key concepts in the NDP, and these have not been addressed as evidence has matured. The lack of trust which characterised the policy process impacted on the ways in which actors were able to or not able to engage, and therefore on the resultant content and the choices exercised. The coherence of the policy, its articulation with other health reforms, and its contribution to subsequent efforts to ensure universal health coverage in South Africa have all been weakened by the failure to revise the document over time.</p><p><strong>Conclusion: </strong>As South Africa advances its plans for universal health coverage, there is an urgent need to revisit key components of the NDP which are no longer fit for purpose.</p>","PeriodicalId":16740,"journal":{"name":"Journal of Pharmaceutical Policy and Practice","volume":null,"pages":null},"PeriodicalIF":3.3,"publicationDate":"2024-07-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11256999/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141723758","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":"Patient-pharmacist relationship dynamics: a mediation analysis of patient characteristics and reported outcomes.","authors":"Hala Sacre, Chadia Haddad, Fouad Sakr, Jihan Safwan, Aline Hajj, Rony M Zeenny, Marwan Akel, Pascale Salameh","doi":"10.1080/20523211.2024.2371409","DOIUrl":"10.1080/20523211.2024.2371409","url":null,"abstract":"<p><strong>Background: </strong>While previous research underscores the independent effect of the pharmacist-patient relationship on patient outcomes, it did not delve further into the patient-pharmacist relationship dynamics and their effects on reported outcomes. Therefore, this study aimed to assess whether patient-pharmacist relationship aspects mediate the association between patient personal and health characteristics, on the one hand, and adherence to medication and quality of life, on the other hand (QOL).</p><p><strong>Methods: </strong>An online cross-sectional study was conducted between April 11 and 27, 2023. It enrolled 865 adults from all Lebanese governorates and used validated scales to measure the various concepts.</p><p><strong>Results: </strong>The mean age was 32.52 ± 14.56 years, and 68.8% were female. Also, 79.3% reported having no chronic disease, and 57.7% indicated that getting nonprescription medications was the main reason for visiting a community pharmacy. The average routine intake of medications per day was 0.87 ± 1.78. Our key findings reveal a compelling association between worse health status and both increased medication non-adherence and reduced QOL. Sociodemographic factors were found to be correlated with QOL. Despite the considerable impact of demographic factors on patient expectations, our study challenges the expected mediation role of the pharmacist-patient relationship and counseling time on medication adherence. Nevertheless, patient expectations partially mediated the relationship between sociodemographic characteristics and QOL.</p><p><strong>Conclusion: </strong>This study sheds light on the intricate dynamics between patient characteristics, health status, medication adherence, and QOL within the context of the patient-pharmacist relationships.</p>","PeriodicalId":16740,"journal":{"name":"Journal of Pharmaceutical Policy and Practice","volume":null,"pages":null},"PeriodicalIF":3.3,"publicationDate":"2024-07-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11251441/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141626951","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":"Availability and pricing of insulin and related diagnostics in South Africa.","authors":"Samirah Bayat, Velisha Ann Perumal-Pillay, Fatima Suleman","doi":"10.1080/20523211.2024.2372467","DOIUrl":"10.1080/20523211.2024.2372467","url":null,"abstract":"<p><strong>Background: </strong>In South Africa (SA), most patients rely on the government for free healthcare. Some choose to subscribe to a medical insurance scheme. If insulin is unavailable in government or otherwise unaffordable, non-adherence may occur, which can increase complications of the disease.</p><p><strong>Methods: </strong>Data on availability and pricing of insulin and related diagnostics was collected from SA pharmacies via an online survey. Co-payments levied on insulin by the biggest medical aids were extracted from formularies. Affordability of these items was then assessed. An adapted methodology from the World Health Organization/Health Action International tool was used.</p><p><strong>Results: </strong>There was fairly high availability of insulin in the public sector, with the exception of long-acting insulin which respondents claimed was difficult to find; however, long-acting insulin glargine was available in most private sector pharmacies. Point-of-care (POC) blood glucose testing was free in the public sector but offered in only 31.25% of pharmacies. Patients pay a minimum of USD 40.4 (over 3 days' wages for the lowest paid government worker (LPGW)) for a months' supply of the cheapest insulin, needles and test strips. Insulin in SA was cheaper than 5 other countries, except Australia.</p><p><strong>Conclusion: </strong>Overall, there is a good availability of insulin and related diagnostics in SA. Even though insulin is cheaper than other countries, it is unaffordable to the LPGW. This highlights the importance of ensuring a constant availability of insulin in the free public sector. Whilst human insulins are cheaper than newer analogue insulins and SA faces cost constraints, important variables in favour of newer insulins, such as ease-of-use, long term outcomes and value should be considered when treatment guidelines are updated. Annual POC testing should be available and offered free to all patients to detect diabetes early.</p>","PeriodicalId":16740,"journal":{"name":"Journal of Pharmaceutical Policy and Practice","volume":null,"pages":null},"PeriodicalIF":3.3,"publicationDate":"2024-07-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11251433/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141626950","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":"Prevalence of substandard, falsified, unlicensed and unregistered medicine and its associated factors in Africa: a systematic review.","authors":"Biset Asrade Mekonnen, Muluabay Getie Yizengaw, Minichil Chanie Worku","doi":"10.1080/20523211.2024.2375267","DOIUrl":"10.1080/20523211.2024.2375267","url":null,"abstract":"<p><strong>Background: </strong>Substandard, falsified, unlicensed, and unregistered medicines pose significant risks to public health in developed and developing countries. This systematic review provides an overview of the prevalence of substandard, falsified, unlicensed, and unregistered medicine and its associated factors in Africa.</p><p><strong>Methods: </strong>Articles published from April 2014 to March 2024 were searched in Google Scholar, Science Direct, PubMed, MEDLINE, and Embase. The search strategy focused on open-access articles published in peer-reviewed scientific journals and studies exclusively conducted in African countries. The quality of the studies was assessed according to the Medicine Quality Assessment Reporting Guidelines (MEDQUARG). This systematic review was reported according to the Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA).</p><p><strong>Results: </strong>Of the 27 studies, 26 had good methodological quality after a quality assessment. Of the 7508 medicine samples, 1639 failed at least one quality test and were confirmed to be substandard/falsified medicines. The overall estimated prevalence of substandard/falsified medicines in Africa was 22.6% (1718/7592). The average prevalence of unregistered medicines was 34.6% (108/312). Antibiotics, antimalarial, and antihypertensive medicines accounted for 44.6% (712/1596), 15.6% (530/3530), 16.3% (249/1530), and 16.3% (249/1530), respectively. Approximately 60.7% (91/150) were antihelmintic and antiprotozoal medicines. Poor market regulatory permission, Free trade zones, poor registration, high demand, and poor importation standards contribute to the prevalence of these problems.</p><p><strong>Conclusion/recommendations: </strong>Substandard, falsified, and unregistered medicines are highly prevalent in Africa, and attention has not been paid to the problem. Antibiotics, antimalarial, anthelmintic, and antiprotozoal are the most commonly reported substandard, falsified, and unregistered medicines. A consistent supply of high-quality products, enhancement of registration, market regulatory permission, and importation standards are essential to counter the problems in Africa. Preventing these problems is the primary duty of every responsible nation to save lives.</p>","PeriodicalId":16740,"journal":{"name":"Journal of Pharmaceutical Policy and Practice","volume":null,"pages":null},"PeriodicalIF":3.3,"publicationDate":"2024-07-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11251437/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141626952","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":"Advancing early access policies for innovative cancer drugs: a scoping review and explorative analysis in the Italian setting.","authors":"Margherita d'Errico, Diana Giannarelli, Daniela d'Angela, Carmine Pinto, Barbara Polistena, Federico Spandonaro","doi":"10.1080/20523211.2024.2377697","DOIUrl":"10.1080/20523211.2024.2377697","url":null,"abstract":"<p><strong>Introduction: </strong>Considering the clinical impact of innovative cancer therapies, policy makers strive to balance timely access and thorough value-assessment. While some European countries promoted early access schemes, Italy does not yet display a consolidated strategy for innovative drugs or for medicines targeting pathologies with a high unmet need.</p><p><strong>Methods: </strong>To better understand the risks and opportunities of early access strategies that could be applied in the Italian setting, we performed a scoping review, searching the PubMed and Web of Science databases and interviewing two field experts. The review results were complemented with an exemplificative quantitative analysis for a subset of innovative oncology drugs, to assess the clinical and economic impact of the price and reimbursement negotiation.</p><p><strong>Results: </strong>Our study suggests that early access schemes developed in Germany and France, combining a free-pricing period, pay-back mechanism, and arbitration, could serve as a basis for developing a feasible strategy in Italy. The quantitative analysis indicated that timely access to innovative drugs could have potentially prevented many cancer progressions, associated with a significant healthcare expenditure.</p><p><strong>Conclusion: </strong>Albeit not allowing to express a conclusive assessment, this study proposes a potential early access strategy for Italy and highlights the need for opening a debate on the opportunities and risks of such schemes.</p>","PeriodicalId":16740,"journal":{"name":"Journal of Pharmaceutical Policy and Practice","volume":null,"pages":null},"PeriodicalIF":3.3,"publicationDate":"2024-07-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11251434/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141626949","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}