Pharmacy最新文献

{"title":"Examining the Impact of the World Health Organization 2022 Guidelines on Evaluation of Biosimilars for Non-Local Comparators in Biosimilar Studies on Middle East and North Africa Member States.","authors":"Michael W Strand, Jonathan H Watanabe","doi":"10.3390/pharmacy12030094","DOIUrl":"10.3390/pharmacy12030094","url":null,"abstract":"<p><p>Global support and standardization of regulation for biosimilars approval owes much of its legacy to the World Health Organization (WHO), since the first guidance by the organization on the matter was released in 2009. Since then, and with over a decade of research, the 2022 revision provides opportunities for time and financial savings to pharmaceutical manufacturers aiming to prove similarity of a potential biosimilar product to some reference product, particularly by clarifying that the use of a non-local reference product as a comparator in certain studies is permissible. This declaration has important implications, particularly in the emerging biological markets of the Middle East and North Africa region, where WHO guidelines have been integral to the regulatory framework of over a dozen countries for more than a decade. This article aims to review the impact of this revision on these countries and relevant policies on non-local comparator usage. Since 2022, this revision has been adopted only in Egypt. Many North African countries are yet to adopt a first draft of the formalized guidance. This analysis revealed that, although many of these countries reference the WHO guidelines, hesitation remains in terms of sourcing comparator products outside the US or European countries. This likely translates to slow regional development and cooperation of functioning, sustainable biosimilars markets. Future studies will be necessary to evaluate the continued development of guidance within these countries and changes in comparator sourcing norms as more time is allowed for their policies to mature and adapt to new standards.</p>","PeriodicalId":30544,"journal":{"name":"Pharmacy","volume":"12 3","pages":""},"PeriodicalIF":2.0,"publicationDate":"2024-06-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11207457/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141451664","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":"The Association between Academic Performance and Entry-to-Practice Milestones within a Co-Operative Education PharmD Program.","authors":"Ali Syed, Yuying Huang, Joslin Goh, Sarah Moroz, John Pugsley, Nancy M Waite, Sherilyn K D Houle","doi":"10.3390/pharmacy12030090","DOIUrl":"10.3390/pharmacy12030090","url":null,"abstract":"<p><p>Research on associations between student performance in pharmacy programs and entry-to-practice milestones has been limited in Canada and in programs using a co-operative (co-op) education model. Co-op exposes students to a variety of opportunities both within direct patient care roles and in non-traditional roles for pharmacists, such as policy, advocacy, insurance, research, and the pharmaceutical industry. The purpose of this research is to analyze associations between student grades and evaluations achieved in the University of Waterloo (UW) Doctor of Pharmacy (PharmD) co-op program and success rates on entry-to-practice milestones, including the Pharmacy Examining Board of Canada (PEBC) Pharmacist Qualifying Examination and performance on final-year clinical rotations. Grades and evaluations from courses, co-op work terms, clinical rotations, and PEBC exam data from three graduating cohorts were obtained. A multiple regression analysis was performed to explore associations between student evaluations and PEBC Pharmacist Qualifying Examination and clinical rotation performance. Holding all other variables constant, grades in anatomy/physiology were negatively correlated with scores on the PEBC Pharmacist Qualifying Examination, while grades in one of the professional practice courses showed a positive relationship with the same examination. Students with higher grades in a problem-based learning capstone therapeutics course, in their first co-op work term, and in the direct patient care co-op work term tended to score higher on clinical rotations. Co-op performance was not significant in predicting PEBC performance. However, complimentary descriptive analysis underscored that students with a co-op rating of good or below were more likely to fail courses, midpoint evaluations, Objective Structured Clinical Examinations (OSCEs), and PEBC measures. Multiple predictors of performance on final-year clinical rotations and the PEBC Pharmacist Qualifying Examination were identified. This predictive model may be utilized to identify students at risk of underperforming and to facilitate early intervention and remediation programs, while also informing curricular revision.</p>","PeriodicalId":30544,"journal":{"name":"Pharmacy","volume":"12 3","pages":""},"PeriodicalIF":2.0,"publicationDate":"2024-06-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11207931/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141451706","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":"Challenges and the Way Forward in Demand-Forecasting Practices within the Ethiopian Public Pharmaceutical Supply Chain.","authors":"Arebu Issa Bilal, Umit Sezer Bititci, Teferi Gedif Fenta","doi":"10.3390/pharmacy12030086","DOIUrl":"10.3390/pharmacy12030086","url":null,"abstract":"<p><p>This study delves into the challenges of pharmaceutical forecasting within the Ethiopian public pharmaceutical supply chain, which is vital for ensuring medicine availability and optimizing healthcare delivery. t It aims to identify and analyze key hindrances to pharmaceutical forecasting in Ethiopia, employing qualitative analysis through semi-structured interviews with stakeholders. Thematic analysis using NVIVO 14 software reveals challenges including finance-related constraints, workforce shortages, and data quality issues. Financial challenges arise from funding uncertainties, causing delayed procurement and stockouts. Workforce shortages hinder accurate forecasting, while data quality issues result from incomplete and untimely reporting. Recommendations include prioritizing healthcare financing, investing in workforce development, and improving data quality through technological advancements and enhanced coordination among stakeholders.</p>","PeriodicalId":30544,"journal":{"name":"Pharmacy","volume":"12 3","pages":""},"PeriodicalIF":2.0,"publicationDate":"2024-05-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11207870/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141451662","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":"COVID-19 Vaccine Hesitancy among Parents of Children Younger than 12 Years: Experience from a Tertiary Outpatient Clinic.","authors":"Moataz Mohamed Hassan, Laila Al Yazidi, Nagi Elsidig, Mohamed Al Falahi, Najah Salmi, Yahya Al-Jaffari, Labiba Al-Amri, Huyam Zeiidan, Ibrahim Al-Zakwani","doi":"10.3390/pharmacy12030085","DOIUrl":"10.3390/pharmacy12030085","url":null,"abstract":"<p><p>This study explored parents' attitudes towards vaccinating their children against COVID-19 and the rate of vaccine hesitancy in Oman. A cross-sectional, online, self-administered questionnaire, previously validated and administered between June 2021 and May 2022, was used. The questionnaire consisted of nine items. Parents of children younger than 12 years were eligible for participation. A total of 384 participants, including 207 males (54%), completed the questionnaire, resulting in an 86% response rate (384/447). The results showed that 69% of participants were hesitant to vaccinate their children aged 1-11 years. In parents of children aged 1-4 years, vaccination status was significantly associated with vaccine hesitancy (odds ratio [OR], 0.116; 95% confidence interval [CI], 0.044-0.306; <i>p</i> = 0.001). Furthermore, after multivariable analysis, compared to the fathers, mothers were significantly less likely to be associated with vaccine hesitancy (OR, 0.451; 95% CI, 0.240-0.848; <i>p</i> = 0.013).</p>","PeriodicalId":30544,"journal":{"name":"Pharmacy","volume":"12 3","pages":""},"PeriodicalIF":2.0,"publicationDate":"2024-05-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11207560/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141451663","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":"The Role of a Clinical Pharmacist in the Identification of Potentially Inadequate Drugs Prescribed to the Geriatric Population in Low-Resource Settings Using the Beers Criteria: A Pilot Study.","authors":"Tijana Kovačević, Maja Savić Davidović, Vedrana Barišić, Emir Fazlić, Siniša Miljković, Vlado Djajić, Branislava Miljković, Peđa Kovačević","doi":"10.3390/pharmacy12030084","DOIUrl":"10.3390/pharmacy12030084","url":null,"abstract":"<p><p>Population aging is a global phenomenon. Each country in the world faces an increased number of older persons in the total population. With aging, a high prevalence of multiple chronic diseases occurs, leading to the use of complex therapeutic regimens and often to polypharmacy. Potentially inappropriate medication (PIM) is a medicine prescribed to a patient for whom the risks outweigh the benefits. Today, several tools are used to evaluate the use of pharmacotherapy in older adults, one of them is the 2019 AGS Beers Criteria. In this prospective, pilot study, we aimed to investigate if the number of PIMs in elderly patients would be significantly reduced if a clinical pharmacist performed a pharmacotherapy review. The study included 66 patients over 65 years of age who were hospitalized at the 1200-bed university hospital. The intervention was conducted by a clinical pharmacist who reviewed the patients' pharmacotherapy and provided written suggestions to physicians. The pharmacotherapy was again reviewed at the patients' discharge from the hospital. A total number of 204 PIMs were identified in the pharmacotherapy of the study population. At discharge, the number of PIMs decreased to 67. A total of 67% of the pharmacist's suggestions were accepted by the physicians. The pharmacist's intervention led to significant decrease in the number of PIMs on patients' discharge letters.</p>","PeriodicalId":30544,"journal":{"name":"Pharmacy","volume":"12 3","pages":""},"PeriodicalIF":2.0,"publicationDate":"2024-05-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11207722/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141451707","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":"Associations between Diabetes-Specific Medication Regimen Complexity and Cardiometabolic Outcomes among Underserved Non-Hispanic Black Adults Living with Type 2 Diabetes Mellitus.","authors":"Cheryl Wisseh, Edward Adinkrah, Linda Opara, Sheila Melone, Emem Udott, Mohsen Bazargan, Magda Shaheen","doi":"10.3390/pharmacy12030083","DOIUrl":"10.3390/pharmacy12030083","url":null,"abstract":"<p><p>Type 2 diabetes mellitus (T2DM) management and glycemic control in underserved non-Hispanic Black adults presents with multifaceted challenges: balancing the optimal complexity of antihyperglycemic medications prescribed, limited medication access due to socioeconomic status, medication nonadherence, and high prevalence of cardiometabolic comorbidities. This single-center, cross-sectional, retrospective chart analysis evaluated the association of Medication Regimen Complexity (MRC) with cardiometabolic outcomes (glycemic, atherogenic cholesterol, and blood pressure control) among non-Hispanic Black adults with type 2 diabetes. Utilizing 470 independent patient electronic health records, MRC and other covariates were examined to determine their associations with cardiometabolic outcomes. Chi-square tests of independence and multiple logistic regression were performed to identify associations between MRC and cardiometabolic outcomes. Our findings indicate significant negative and positive associations between MRC and glycemic control and atherogenic cholesterol control, respectively. However, there were no associations between MRC and blood pressure control. As diabetes MRC was shown to be associated with poor glycemic control and improved atherogenic cholesterol control, there is a critical need to standardize interdisciplinary diabetes care to include pharmacists and to develop more insurance policy interventions that increase access to newer, efficacious diabetes medications for historically marginalized populations.</p>","PeriodicalId":30544,"journal":{"name":"Pharmacy","volume":"12 3","pages":""},"PeriodicalIF":2.0,"publicationDate":"2024-05-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11207877/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141451661","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":"Development and Implementation of an Ultraviolet-Dye-Based Qualification Procedure for Hand Washing and Disinfection to Improve Quality Assurance of Pharmacy Preparations and Compounding, Especially in Cleanrooms: A Pilot Study.","authors":"Catharina W J Knol, Paul H Stob, Herman J Woerdenbag","doi":"10.3390/pharmacy12030073","DOIUrl":"10.3390/pharmacy12030073","url":null,"abstract":"<p><p>Even though, nowadays, most medicines are manufactured industrially, patients may have medical needs that can only be met by a tailor-made approach. This requires the availability of pharmacy preparations made under Good Manufacturing Practice (GMP) conditions. An efficient hand hygiene practice is essential herewith, especially if sterile products that are prepared in a cleanroom are concerned. The effectiveness of hand washing and hand disinfection procedures greatly relies on adequate training. We carried out an observational cross-sectional pilot study aimed at optimizing hand hygiene training with objective and measurable quality assessments using an ultraviolet (UV) dye. Practical acceptance criteria for qualifying personnel through this method were set and evaluated. In total, 25 GMP-qualified cleanroom operators washed and disinfected their hands with UV dye hand wash lotion and UV dye hand alcohol, respectively. To obtain a proof-of-concept, the results were judged based on adherence to the WHO six-step protocol and associated acceptance criteria. Commonly missed areas were brought to light, and the influence of procedure duration was investigated. UV-dye-based assessments appeared to be more valuable in hand disinfection than in hand washing. In both procedures, the back of the hands and the thumbs were frequently missed. This underpins the need for enhanced and repeated education on hand washing and disinfection. Additionally, a dry skin gave rise to extra cleaning challenges. From this pharmacy practice pilot study with a focus on pharmaceutical product care, it may be concluded that the application of UV-dye-based assessments offers valuable insights for pharmacists to optimize hand hygiene, thereby increasing the safety of tailor-made medicines and on-site preparations.</p>","PeriodicalId":30544,"journal":{"name":"Pharmacy","volume":"12 3","pages":""},"PeriodicalIF":2.2,"publicationDate":"2024-04-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11130823/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141158414","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":"Leveraging Large Data, Statistics, and Machine Learning to Predict the Emergence of Resistant <i>E. coli</i> Infections.","authors":"Rim Hur, Stephine Golik, Yifan She","doi":"10.3390/pharmacy12020053","DOIUrl":"10.3390/pharmacy12020053","url":null,"abstract":"<p><p>Drug-resistant Gram-negative bacterial infections, on average, increase the length of stay (LOS) in U.S. hospitals by 5 days, translating to approximately $15,000 per patient. We used statistical and machine-learning models to explore the relationship between antibiotic usage and antibiotic resistance over time and to predict the clinical and financial costs associated with resistant <i>E. coli</i> infections. We acquired data on antibiotic utilization and the resistance/sensitivity of 4776 microbial cultures at a Kaiser Permanente facility from April 2013 to December 2019. The ARIMA (autoregressive integrated moving average), neural networks, and random forest time series algorithms were employed to model antibiotic resistance trends. The models' performance was evaluated using mean absolute error (MAE) and root mean squared error (RMSE). The best performing model was then used to predict antibiotic resistance rates for the year 2020. The ARIMA model with cefazolin, followed by the one with cephalexin, provided the lowest RMSE and MAE values without signs of overfitting across training and test datasets. The study showed that reducing cefazolin usage could decrease the rate of resistant <i>E. coli</i> infections. Although piperacillin/tazobactam did not perform as well as cefazolin in our time series models, it performed reasonably well and, due to its broad spectrum, might be a practical target for interventions in antimicrobial stewardship programs (ASPs), at least for this particular facility. While a more generalized model could be developed with data from multiple facilities, this study acts as a framework for ASP clinicians to adopt statistical and machine-learning approaches, using region-specific data to make effective interventions.</p>","PeriodicalId":30544,"journal":{"name":"Pharmacy","volume":"12 2","pages":""},"PeriodicalIF":2.2,"publicationDate":"2024-03-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10961794/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140207733","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":"Adverse Childhood Experiences and Prescription Stimulant Use in Adults: A Systematic Review.","authors":"Avery Beatty, Emily Shepard, Erek Bickford, Lisa Weyandt","doi":"10.3390/pharmacy12020052","DOIUrl":"10.3390/pharmacy12020052","url":null,"abstract":"<p><p>Nonmedical prescription stimulant use (NPSU) is an ongoing public health crisis in the United States. There exists, however, a dearth of research investigating specific childhood risk factors that may contribute to this illicit use. Adverse childhood experiences (ACEs) may be a significant risk factor to address in the prevention and treatment of NPSU, as research has provided evidence for increased substance use, potentially including prescription stimulant misuse, among individuals who have experienced trauma. A systematic review of the literature was conducted to gather and synthesize research articles specifically examining the relationship between nonmedical prescription stimulant use in adults and the experience of adverse childhood experiences (ACEs). Four studies met all inclusion criteria and were included in the review. The results demonstrated that the nonmedical use of prescription stimulants in adults is significantly associated with ACEs, with a higher numerical count of ACEs associated with a greater likelihood of nonmedical prescription stimulant use. Gaps in the literature were identified, specifically noting a lack of information available regarding the relationship between ACEs and NPSU within gender- and racially diverse populations. The findings have implications for informing interventions related to ACEs and the misuse of prescription stimulant medication in adults.</p>","PeriodicalId":30544,"journal":{"name":"Pharmacy","volume":"12 2","pages":""},"PeriodicalIF":2.2,"publicationDate":"2024-03-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10961765/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140207729","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":"Pharmacy Students' Perceived Ability to Implement the Pharmacist's Patient Care Process before and after a Redesigned Case Study Series in the United States.","authors":"Amy Henneman, Samantha Axtell","doi":"10.3390/pharmacy12020051","DOIUrl":"10.3390/pharmacy12020051","url":null,"abstract":"<p><p>Since the incorporation of the Pharmacist's Patient Care Process (PPCP) into the American Association of Colleges of Pharmacy standards, the process has been integrated in a variety of ways across curriculums. A two-semester case-based course was redesigned as a four-semester case-based course formally integrating the PPCP. Pharmacy students completing the original, two-semester course series and those completing the first two semesters of the redesigned course were given a voluntary survey to assess their perceived ability to integrate the PPCP into practice after the completion of each course. A total of 107 pharmacy students, 61 students completing the original series and 46 students completing two semesters of the redesigned series, completed the survey. The pharmacy students completing the redesigned, four-semester course series had a significantly higher perception of their ability to integrate the PPCP into patient care compared to the students completing the original series. This included the perceived ability to ask appropriate questions, identify medication-related problems (MRPs), document MRPs, and develop a plan for addressing MRPs. A significant difference was found in the students' perceived ability to ask pertinent questions in an appropriate manner, identifying and documenting MRPs, managing and solving MRPs, and documenting patient interactions. No significant difference was identified regarding the students' perceived ability to document the interaction or ensure that treatment-related plans were implemented. The students' perception regarding the importance of asking pertinent questions, identifying MRPs, and documentation in patient care did not differ between the cohorts. The case-based course series redesigned from two to four semesters with formal integration of the PPCP resulted in an increase in the students' perceptions of their ability to integrate the PPCP into patient care.</p>","PeriodicalId":30544,"journal":{"name":"Pharmacy","volume":"12 2","pages":""},"PeriodicalIF":2.2,"publicationDate":"2024-03-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10961795/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140207734","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}