Pub Date : 2021-07-09eCollection Date: 2021-01-01DOI: 10.1177/23992026211027692
Biljana Tubic, Vanda Marković-Peković, Saša Jungić, Eleonora Allocati, Brian Godman
Background: Monoclonal antibodies (mAbs) represent the most numerous and significant group of biotherapeutics. While mAbs have undoubtedly improved treatment for many chronic diseases, including inflammatory diseases, they are typically expensive for health care systems and patients. Consequently, access to mAbs has been a problem for many patients especially among Central and Eastern European (CEE) countries. However, biosimilars can potentially help with costs, although there are concerns with their effectiveness and safety. This includes biosimilars for long-acting insulin analogues.
Aim: Assess the availability and use of biological medicines, including biosimilars within Bosnia and Herzegovina (B&H).
Methods: Assess the availability of mAbs via the current lists of approved and accessed mAbs versus those licenced in Europe and the United States and their utilisation, as well as specifically insulin glargine and its biosimilars, within B&H.
Results: The availability of the mAbs in B&H appears satisfactory, which is encouraging. However, current usage is limited to a few mAbs which is a concern for subsequent patient care especially with limited use of biosimilars to address issues of affordability. We also see limited use of biosimilar insulin glargine.
Conclusion: The limited use of mAbs including biosimilars needs to be addressed in B&H to improve the future care of patients within finite resources. We will monitor these developments.
{"title":"Availability and accessibility of monoclonal antibodies in Bosnia and Herzegovina: Findings and implications.","authors":"Biljana Tubic, Vanda Marković-Peković, Saša Jungić, Eleonora Allocati, Brian Godman","doi":"10.1177/23992026211027692","DOIUrl":"https://doi.org/10.1177/23992026211027692","url":null,"abstract":"<p><strong>Background: </strong>Monoclonal antibodies (mAbs) represent the most numerous and significant group of biotherapeutics. While mAbs have undoubtedly improved treatment for many chronic diseases, including inflammatory diseases, they are typically expensive for health care systems and patients. Consequently, access to mAbs has been a problem for many patients especially among Central and Eastern European (CEE) countries. However, biosimilars can potentially help with costs, although there are concerns with their effectiveness and safety. This includes biosimilars for long-acting insulin analogues.</p><p><strong>Aim: </strong>Assess the availability and use of biological medicines, including biosimilars within Bosnia and Herzegovina (B&H).</p><p><strong>Methods: </strong>Assess the availability of mAbs via the current lists of approved and accessed mAbs versus those licenced in Europe and the United States and their utilisation, as well as specifically insulin glargine and its biosimilars, within B&H.</p><p><strong>Results: </strong>The availability of the mAbs in B&H appears satisfactory, which is encouraging. However, current usage is limited to a few mAbs which is a concern for subsequent patient care especially with limited use of biosimilars to address issues of affordability. We also see limited use of biosimilar insulin glargine.</p><p><strong>Conclusion: </strong>The limited use of mAbs including biosimilars needs to be addressed in B&H to improve the future care of patients within finite resources. We will monitor these developments.</p>","PeriodicalId":74158,"journal":{"name":"Medicine access @ point of care","volume":" ","pages":"23992026211027692"},"PeriodicalIF":0.0,"publicationDate":"2021-07-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1177/23992026211027692","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"33491215","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}
Pub Date : 2021-06-27eCollection Date: 2021-01-01DOI: 10.1177/23992026211018087
Matthew J Wood, Hannah Mn Wilson, Sarah L Parry
Objective: Amid COVID-19 disruptions, e-therapy has become even more essential and has rapidly expanded across statutory, private and third sectors to meet growing demands for digital mental health support. A challenge in digital therapeutic care is how to develop and maintain a supportive, collaborative therapeutic relationship, built upon mutual trust and respect; intrinsic values of relationships that are often implied through complex non-verbal cues. Online practitioners are eager to learn how to adapt to online delivery, although platform-specific training is limited. The aim of the current study was to focus upon the therapist experience of online therapeutic relationships with young people, exploring a range of factors through their perspectives, including the impact of anonymity.
Methods: Eight e-therapy practitioners were recruited from Kooth, an online mental health service. Narrative interviews undertaken via Skype facilitated reflective conversational one-to-one discussions, based upon the practitioners' individual experiences, led by the interviewee. Following transcription and anonymisation, a narrative analysis was undertaken to explore participants' experiences, perspectives and reflections.
Results: Four analytic layers arose from the narratives, which explored the challenging learning experience of translating existing therapeutic skills to online working, rapidly building therapeutic relationships, managing risk in the online therapeutic relationship, and techniques for maintaining a digital therapeutic relationship.
Conclusion: The study provides novel insights into the flexibility and adjustments therapists can make to improve online interventions and delivery through the development and maintenance of positive therapeutic relationships. Recommendations are also made in relation to platform-specific training, communicative adaptations, risk management and practitioner support.
{"title":"Exploring the development and maintenance of therapeutic relationships through e-Health support: A narrative analysis of therapist experiences.","authors":"Matthew J Wood, Hannah Mn Wilson, Sarah L Parry","doi":"10.1177/23992026211018087","DOIUrl":"10.1177/23992026211018087","url":null,"abstract":"<p><strong>Objective: </strong>Amid COVID-19 disruptions, e-therapy has become even more essential and has rapidly expanded across statutory, private and third sectors to meet growing demands for digital mental health support. A challenge in digital therapeutic care is how to develop and maintain a supportive, collaborative therapeutic relationship, built upon mutual trust and respect; intrinsic values of relationships that are often implied through complex non-verbal cues. Online practitioners are eager to learn how to adapt to online delivery, although platform-specific training is limited. The aim of the current study was to focus upon the therapist experience of online therapeutic relationships with young people, exploring a range of factors through their perspectives, including the impact of anonymity.</p><p><strong>Methods: </strong>Eight e-therapy practitioners were recruited from Kooth, an online mental health service. Narrative interviews undertaken via Skype facilitated reflective conversational one-to-one discussions, based upon the practitioners' individual experiences, led by the interviewee. Following transcription and anonymisation, a narrative analysis was undertaken to explore participants' experiences, perspectives and reflections.</p><p><strong>Results: </strong>Four analytic layers arose from the narratives, which explored the challenging learning experience of translating existing therapeutic skills to online working, rapidly building therapeutic relationships, managing risk in the online therapeutic relationship, and techniques for maintaining a digital therapeutic relationship.</p><p><strong>Conclusion: </strong>The study provides novel insights into the flexibility and adjustments therapists can make to improve online interventions and delivery through the development and maintenance of positive therapeutic relationships. Recommendations are also made in relation to platform-specific training, communicative adaptations, risk management and practitioner support.</p>","PeriodicalId":74158,"journal":{"name":"Medicine access @ point of care","volume":" ","pages":"23992026211018087"},"PeriodicalIF":0.0,"publicationDate":"2021-06-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9413613/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"33492226","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}
Pub Date : 2021-05-16eCollection Date: 2021-01-01DOI: 10.1177/23992026211013644
Pedro Galván, José Fusillo, Felipe González, Oraldo Vukujevic, Luciano Recalde, Ronald Rivas, José Ortellado, Juan Portillo, Julio Mazzoleni, Enrique Hilario
Aim: The aim of the study was to present the results and impact of the application of artificial intelligence (AI) in the rapid diagnosis of COVID-19 by telemedicine in public health in Paraguay.
Methods: This is a descriptive, multi-centered, observational design feasibility study based on an AI tool for the rapid detection of COVID-19 in chest computed tomography (CT) images of patients with respiratory difficulties attending the country's public hospitals. The patients' digital CT images were transmitted to the AI diagnostic platform, and after a few minutes, radiologists and pneumologists specialized in COVID-19 downloaded the images for evaluation, confirmation of diagnosis, and comparison with the genetic diagnosis (reverse transcription polymerase chain reaction (RT-PCR)). It was also determined the percentage of agreement between two similar AI systems applied in parallel to study the viability of using it as an alternative method of screening patients with COVID-19 through telemedicine.
Results: Between March and August 2020, 911 rapid diagnostic tests were carried out on patients with respiratory disorders to rule out COVID-19 in 14 hospitals nationwide. The average age of patients was 50.7 years, 62.6% were male and 37.4% female. Most of the diagnosed respiratory conditions corresponded to the age group of 27-59 years (252 studies), the second most frequent corresponded to the group over 60 years, and the third to the group of 19-26 years. The most frequent findings of the radiologists/pneumologists were severe pneumonia, bilateral pneumonia with pleural effusion, bilateral pulmonary emphysema, diffuse ground glass opacity, hemidiaphragmatic paresis, calcified granuloma in the lower right lobe, bilateral pleural effusion, sequelae of tuberculosis, bilateral emphysema, and fibrotic changes, among others. Overall, an average of 86% agreement and 14% diagnostic discordance was determined between the two AI systems. The sensitivity of the AI system was 93% and the specificity 80% compared with RT-PCR.
Conclusion: Paraguay has an AI-based telemedicine screening system for the rapid stratified detection of COVID-19 from chest CT images of patients with respiratory conditions. This application strengthens the integrated network of health services, rationalizing the use of specialized human resources, equipment, and inputs for laboratory diagnosis.
{"title":"Rapid screening for COVID-19 by applying artificial intelligence to chest computed tomography images: A feasibility study.","authors":"Pedro Galván, José Fusillo, Felipe González, Oraldo Vukujevic, Luciano Recalde, Ronald Rivas, José Ortellado, Juan Portillo, Julio Mazzoleni, Enrique Hilario","doi":"10.1177/23992026211013644","DOIUrl":"10.1177/23992026211013644","url":null,"abstract":"<p><strong>Aim: </strong>The aim of the study was to present the results and impact of the application of artificial intelligence (AI) in the rapid diagnosis of COVID-19 by telemedicine in public health in Paraguay.</p><p><strong>Methods: </strong>This is a descriptive, multi-centered, observational design feasibility study based on an AI tool for the rapid detection of COVID-19 in chest computed tomography (CT) images of patients with respiratory difficulties attending the country's public hospitals. The patients' digital CT images were transmitted to the AI diagnostic platform, and after a few minutes, radiologists and pneumologists specialized in COVID-19 downloaded the images for evaluation, confirmation of diagnosis, and comparison with the genetic diagnosis (reverse transcription polymerase chain reaction (RT-PCR)). It was also determined the percentage of agreement between two similar AI systems applied in parallel to study the viability of using it as an alternative method of screening patients with COVID-19 through telemedicine.</p><p><strong>Results: </strong>Between March and August 2020, 911 rapid diagnostic tests were carried out on patients with respiratory disorders to rule out COVID-19 in 14 hospitals nationwide. The average age of patients was 50.7 years, 62.6% were male and 37.4% female. Most of the diagnosed respiratory conditions corresponded to the age group of 27-59 years (252 studies), the second most frequent corresponded to the group over 60 years, and the third to the group of 19-26 years. The most frequent findings of the radiologists/pneumologists were severe pneumonia, bilateral pneumonia with pleural effusion, bilateral pulmonary emphysema, diffuse ground glass opacity, hemidiaphragmatic paresis, calcified granuloma in the lower right lobe, bilateral pleural effusion, sequelae of tuberculosis, bilateral emphysema, and fibrotic changes, among others. Overall, an average of 86% agreement and 14% diagnostic discordance was determined between the two AI systems. The sensitivity of the AI system was 93% and the specificity 80% compared with RT-PCR.</p><p><strong>Conclusion: </strong>Paraguay has an AI-based telemedicine screening system for the rapid stratified detection of COVID-19 from chest CT images of patients with respiratory conditions. This application strengthens the integrated network of health services, rationalizing the use of specialized human resources, equipment, and inputs for laboratory diagnosis.</p>","PeriodicalId":74158,"journal":{"name":"Medicine access @ point of care","volume":" ","pages":"23992026211013644"},"PeriodicalIF":0.0,"publicationDate":"2021-05-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/31/43/10.1177_23992026211013644.PMC9413752.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"33492225","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}
Pub Date : 2021-04-27eCollection Date: 2021-01-01DOI: 10.1177/23992026211011314
Aneeta Pasha, Hasha Siddiqui, Shiza Ali, Meredith B Brooks, Naveen R Maqbool, Aamir J Khan
Introduction: Depression and anxiety among tuberculosis (TB) patients can adversely affect TB treatment adherence and completion.
Aim: We studied whether integrating mental health services into existing TB treatment programs would reduce symptoms of depression and anxiety and improve treatment completion among patients with drug-susceptible TB.
Methods: Integrated practice units (IPUs) for TB and mental health were established within six existing TB treatment facilities in Karachi, Pakistan. Patients were screened for depression and anxiety and, if symptomatic, offered a mental health intervention consisting of at least four counseling sessions. We measured changes in reported levels of depression and anxiety symptoms from baseline following completion of counseling sessions, and rates of TB treatment completion.
Results: Between February 2017 and June 2018, 3500 TB patients were screened for depression and anxiety. 1057 (30.2%) symptomatic patients received a baseline adherence session. 1012 enrolled for a mental health intervention received at least 1 counseling session. 522 (51.5%) reported no symptoms after four to six sessions. Symptomatic patients who completed at least four counseling sessions had higher rates of TB treatment completion than those who did not (92.9% vs 75.1%; p < 0.0001).
Conclusion: Mental health interventions integrated within TB programs can help reduce symptoms of depression and anxiety and improve TB treatment completion.
结核病(TB)患者的抑郁和焦虑会对结核病治疗的依从性和完成产生不利影响。目的:我们研究将心理健康服务纳入现有结核病治疗方案是否会减少药物敏感结核病患者的抑郁和焦虑症状,并提高治疗完成度。方法:在巴基斯坦卡拉奇的6个现有结核病治疗机构内建立结核病和精神卫生综合实践单位(ipu)。对患者进行抑郁和焦虑筛查,如果出现症状,则提供至少四次咨询会议的心理健康干预。我们测量了咨询会议结束后抑郁和焦虑症状报告水平的基线变化,以及结核病治疗完成率。结果:2017年2月至2018年6月,对3500名结核病患者进行了抑郁和焦虑筛查。1057例(30.2%)有症状的患者接受了基线依从性治疗。参加心理健康干预的1012人至少接受了一次咨询。522人(51.5%)在4到6次治疗后没有出现症状。完成至少4次咨询的有症状患者的结核病治疗完成率高于未完成咨询的患者(92.9% vs 75.1%;P < 0.0001)。结论:将心理健康干预纳入结核病规划有助于减少抑郁和焦虑症状,提高结核病治疗的完成率。
{"title":"Impact of integrating mental health services within existing tuberculosis treatment facilities.","authors":"Aneeta Pasha, Hasha Siddiqui, Shiza Ali, Meredith B Brooks, Naveen R Maqbool, Aamir J Khan","doi":"10.1177/23992026211011314","DOIUrl":"https://doi.org/10.1177/23992026211011314","url":null,"abstract":"<p><strong>Introduction: </strong>Depression and anxiety among tuberculosis (TB) patients can adversely affect TB treatment adherence and completion.</p><p><strong>Aim: </strong>We studied whether integrating mental health services into existing TB treatment programs would reduce symptoms of depression and anxiety and improve treatment completion among patients with drug-susceptible TB.</p><p><strong>Methods: </strong>Integrated practice units (IPUs) for TB and mental health were established within six existing TB treatment facilities in Karachi, Pakistan. Patients were screened for depression and anxiety and, if symptomatic, offered a mental health intervention consisting of at least four counseling sessions. We measured changes in reported levels of depression and anxiety symptoms from baseline following completion of counseling sessions, and rates of TB treatment completion.</p><p><strong>Results: </strong>Between February 2017 and June 2018, 3500 TB patients were screened for depression and anxiety. 1057 (30.2%) symptomatic patients received a baseline adherence session. 1012 enrolled for a mental health intervention received at least 1 counseling session. 522 (51.5%) reported no symptoms after four to six sessions. Symptomatic patients who completed at least four counseling sessions had higher rates of TB treatment completion than those who did not (92.9% vs 75.1%; <i>p</i> < 0.0001).</p><p><strong>Conclusion: </strong>Mental health interventions integrated within TB programs can help reduce symptoms of depression and anxiety and improve TB treatment completion.</p>","PeriodicalId":74158,"journal":{"name":"Medicine access @ point of care","volume":" ","pages":"23992026211011314"},"PeriodicalIF":0.0,"publicationDate":"2021-04-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1177/23992026211011314","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"33492228","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}
Pub Date : 2021-04-26eCollection Date: 2021-01-01DOI: 10.1177/23992026211008805
Tizalegn Tesfaye Mamo, Eden Ashenafi, Addisu Alemayehu Gube, Tesfanew Bekele
Background: During pregnancy, due to the physiological and hormonal change, the requirement of iron-folic acid is enhanced. Therefore, the occurrence of iron/folic acid deficiency is relatively high and it is responsible for 95% of anemia during pregnancy.
Objectives: The aim of this study was to assess adherence to prenatal iron-folic acid supplementation (IFAS) and associated factors among pregnant women attending antenatal care services at public health facilities of Dilla town.
Methods: Facility-based cross-sectional study design was employed selecting 403 pregnant women attending antenatal care services in three public health institutions of Dilla town. The women were included in the study by simple random sampling. Data were collected by interview and document review. Then it was entered into EPI Data version 3.1 and exported to SPSS version 20 for analysis. Bivariate and multivariate binary logistic regression techniques were used to identify independent predictors. A p-value <0.05 was taken as indication of statistical significance.
Results: From the total of planned 403 pregnant women, 396 participated in the study, with a response rate of 98.2%. Of these, 172 (43.4%) pregnant women were adhered to IFAS. The study also revealed that history of previous anemia (adjusted odds ratio (AOR) = 1.87; 95% confidence interval (CI): (1.01-3.47); p = 0.04), frequency of antenatal care center (ANC) visits (AOR = 2.51; 95% CI: (1.17-5.37); p = 0.01), knowledge of IFA supplement (AOR = 2.28; 95% CI: (1.36-3.82); p = 0.002), and knowledge of anemia (AOR = 2.30; 95% CI: (1.40-3.77); p = 0.001) were independent predictors of adherence to IFAS.
Conclusion: The finding of this study showed that less than half of the pregnant women were adhered to IFAS. History of previous anemia, frequency of ANC visits, knowledge of IFA supplement, and knowledge of anemia were the factors associated with adherence to IFA supplement.
{"title":"Adherence to prenatal iron-folic acid supplementation and associated factors among pregnant women attending antenatal care services in Dilla town, South Ethiopia.","authors":"Tizalegn Tesfaye Mamo, Eden Ashenafi, Addisu Alemayehu Gube, Tesfanew Bekele","doi":"10.1177/23992026211008805","DOIUrl":"https://doi.org/10.1177/23992026211008805","url":null,"abstract":"<p><strong>Background: </strong>During pregnancy, due to the physiological and hormonal change, the requirement of iron-folic acid is enhanced. Therefore, the occurrence of iron/folic acid deficiency is relatively high and it is responsible for 95% of anemia during pregnancy.</p><p><strong>Objectives: </strong>The aim of this study was to assess adherence to prenatal iron-folic acid supplementation (IFAS) and associated factors among pregnant women attending antenatal care services at public health facilities of Dilla town.</p><p><strong>Methods: </strong>Facility-based cross-sectional study design was employed selecting 403 pregnant women attending antenatal care services in three public health institutions of Dilla town. The women were included in the study by simple random sampling. Data were collected by interview and document review. Then it was entered into EPI Data version 3.1 and exported to SPSS version 20 for analysis. Bivariate and multivariate binary logistic regression techniques were used to identify independent predictors. A <i>p</i>-value <0.05 was taken as indication of statistical significance.</p><p><strong>Results: </strong>From the total of planned 403 pregnant women, 396 participated in the study, with a response rate of 98.2%. Of these, 172 (43.4%) pregnant women were adhered to IFAS. The study also revealed that history of previous anemia (adjusted odds ratio (AOR) = 1.87; 95% confidence interval (CI): (1.01-3.47); <i>p</i> = 0.04), frequency of antenatal care center (ANC) visits (AOR = 2.51; 95% CI: (1.17-5.37); <i>p</i> = 0.01), knowledge of IFA supplement (AOR = 2.28; 95% CI: (1.36-3.82); <i>p</i> = 0.002), and knowledge of anemia (AOR = 2.30; 95% CI: (1.40-3.77); <i>p</i> = 0.001) were independent predictors of adherence to IFAS.</p><p><strong>Conclusion: </strong>The finding of this study showed that less than half of the pregnant women were adhered to IFAS. History of previous anemia, frequency of ANC visits, knowledge of IFA supplement, and knowledge of anemia were the factors associated with adherence to IFA supplement.</p>","PeriodicalId":74158,"journal":{"name":"Medicine access @ point of care","volume":" ","pages":"23992026211008805"},"PeriodicalIF":0.0,"publicationDate":"2021-04-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1177/23992026211008805","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"33493280","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}
Pub Date : 2021-04-19eCollection Date: 2021-01-01DOI: 10.1177/23992026211005991
Carolyn Riley Chapman, Hayley M Belli, Danielle Leach, Lesha D Shah, Alison Bateman-House
Introduction: Physicians in the United States play an essential role guiding patients through single patient pre-approval access (PAA) to investigational medical products via either the Food and Drug Administration (FDA)'s Expanded Access (EA) or the federal Right To Try (RTT) pathways. In this study, we sought to better understand pediatric hematologist/oncologists' attitudes about seeking PAA, on behalf of single patients, to investigational drugs outside of clinical trials.
Methods: A cross-sectional survey was developed and sent to pediatric hematologist/oncologists via St. Baldrick's Foundation's email distribution list.
Results: Of 73 respondents (10.1% of those who received the survey), 56 met eligibility criteria and are included in the analysis. Over 80% (n = 46) had prior experience with single patient PAA. Respondents were most concerned about the unknown risks and benefits of investigational drugs and financial implications of PAA for patients. One hundred percent and 91.1% of respondents indicated a willingness to support patients through EA and RTT pathways, respectively. When asked about their most recent experience with PAA, 40 out of 46 indicated that they used the FDA's EA pathway to seek PAA and 4 out of 46 indicated that they used the RTT pathway. Of 44 respondents who had used the EA or RTT pathway, 43 indicated that the biotechnology or pharmaceutical company they solicited granted access to the requested product.
Conclusion: Survey results support other findings suggesting a need for additional physician support and education about PAA and that physicians may have unequal access to information about investigational drugs and concerns about financial implications of PAA for their patients.
{"title":"A survey of pediatric hematologists/oncologists' perspectives on single patient Expanded Access and Right to Try.","authors":"Carolyn Riley Chapman, Hayley M Belli, Danielle Leach, Lesha D Shah, Alison Bateman-House","doi":"10.1177/23992026211005991","DOIUrl":"10.1177/23992026211005991","url":null,"abstract":"<p><strong>Introduction: </strong>Physicians in the United States play an essential role guiding patients through single patient pre-approval access (PAA) to investigational medical products via either the Food and Drug Administration (FDA)'s Expanded Access (EA) or the federal Right To Try (RTT) pathways. In this study, we sought to better understand pediatric hematologist/oncologists' attitudes about seeking PAA, on behalf of single patients, to investigational drugs outside of clinical trials.</p><p><strong>Methods: </strong>A cross-sectional survey was developed and sent to pediatric hematologist/oncologists via St. Baldrick's Foundation's email distribution list.</p><p><strong>Results: </strong>Of 73 respondents (10.1% of those who received the survey), 56 met eligibility criteria and are included in the analysis. Over 80% (<i>n</i> = 46) had prior experience with single patient PAA. Respondents were most concerned about the unknown risks and benefits of investigational drugs and financial implications of PAA for patients. One hundred percent and 91.1% of respondents indicated a willingness to support patients through EA and RTT pathways, respectively. When asked about their most recent experience with PAA, 40 out of 46 indicated that they used the FDA's EA pathway to seek PAA and 4 out of 46 indicated that they used the RTT pathway. Of 44 respondents who had used the EA or RTT pathway, 43 indicated that the biotechnology or pharmaceutical company they solicited granted access to the requested product.</p><p><strong>Conclusion: </strong>Survey results support other findings suggesting a need for additional physician support and education about PAA and that physicians may have unequal access to information about investigational drugs and concerns about financial implications of PAA for their patients.</p>","PeriodicalId":74158,"journal":{"name":"Medicine access @ point of care","volume":" ","pages":"23992026211005991"},"PeriodicalIF":0.0,"publicationDate":"2021-04-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/76/62/10.1177_23992026211005991.PMC9413614.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"33491212","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}
Pub Date : 2021-04-18eCollection Date: 2021-01-01DOI: 10.1177/23992026211005642
John B Hertig, Shannon M James, Connor J Hummel, Matthew J Rubin
Background: An estimated 95% of all online pharmacies operate unlawfully. Illegal online pharmacies distribute substandard and falsified medical products that may result in patient harm and suboptimal treatment, leading to an overall mistrust of medications, healthcare providers, and health systems. As medication experts, pharmacists are trusted to guide patients in selection of safe and effective medication therapy.
Objective: The objective of this study was to determine gaps in knowledge and recognition of the negative clinical and safety impacts associated with illegal Internet pharmacies by licensed pharmacists.
Methods: A 37-question electronic survey was developed and distributed to pharmacists across the United States by email via a database from the American Pharmacists Association. Descriptive statistics was utilized to analyze data.
Results: A total of 347 pharmacists from across the United States responded to at least one question in the survey. In all, 58% of pharmacists reported a lack of confidence in their ability to counsel patients on the identification of illegal pharmacy websites. Fewer than 60% of pharmacists were able to accurately identify the legitimacy of a webpage based on visual characteristics. In addition, 75% of pharmacists reported being unfamiliar with resources available to help consumers identify safe and legitimate online pharmacies.
Conclusion: Integration of the topic into pharmacy education curricula, training on available resources, and additional research into the prevalence and impact of illegal pharmacy websites are necessary to ensure that pharmacists and other healthcare professionals are adequately prepared to protect their communities from the threat of illegal online pharmacies.
{"title":"Evaluation of pharmacists' awareness of illegal online pharmacies and perceived impact on safe access to medicines.","authors":"John B Hertig, Shannon M James, Connor J Hummel, Matthew J Rubin","doi":"10.1177/23992026211005642","DOIUrl":"https://doi.org/10.1177/23992026211005642","url":null,"abstract":"<p><strong>Background: </strong>An estimated 95% of all online pharmacies operate unlawfully. Illegal online pharmacies distribute substandard and falsified medical products that may result in patient harm and suboptimal treatment, leading to an overall mistrust of medications, healthcare providers, and health systems. As medication experts, pharmacists are trusted to guide patients in selection of safe and effective medication therapy.</p><p><strong>Objective: </strong>The objective of this study was to determine gaps in knowledge and recognition of the negative clinical and safety impacts associated with illegal Internet pharmacies by licensed pharmacists.</p><p><strong>Methods: </strong>A 37-question electronic survey was developed and distributed to pharmacists across the United States by email via a database from the American Pharmacists Association. Descriptive statistics was utilized to analyze data.</p><p><strong>Results: </strong>A total of 347 pharmacists from across the United States responded to at least one question in the survey. In all, 58% of pharmacists reported a lack of confidence in their ability to counsel patients on the identification of illegal pharmacy websites. Fewer than 60% of pharmacists were able to accurately identify the legitimacy of a webpage based on visual characteristics. In addition, 75% of pharmacists reported being unfamiliar with resources available to help consumers identify safe and legitimate online pharmacies.</p><p><strong>Conclusion: </strong>Integration of the topic into pharmacy education curricula, training on available resources, and additional research into the prevalence and impact of illegal pharmacy websites are necessary to ensure that pharmacists and other healthcare professionals are adequately prepared to protect their communities from the threat of illegal online pharmacies.</p>","PeriodicalId":74158,"journal":{"name":"Medicine access @ point of care","volume":" ","pages":"23992026211005642"},"PeriodicalIF":0.0,"publicationDate":"2021-04-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1177/23992026211005642","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"33491219","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}
Pub Date : 2021-03-30eCollection Date: 2021-01-01DOI: 10.1177/23992026211003499
Beth Sundstrom, Andrea L DeMaria, Merissa Ferrara, Stephanie Meier, Kerri Vyge, Deborah Billings, Dee DiBona, Bridget M McLernon Sykes
Background: Up to two-thirds of pregnancies among young, unmarried women in the United States are unintended, despite increased access to highly effective contraceptive options.
Aim: This study implemented and evaluated a social marketing campaign designed to increase access to a full range of contraceptive methods among women aged 18-24 years on a southeastern university campus.
Methods: Researchers partnered with Choose Well and Student Health Services to design, implement, and evaluate You Have Options, a 10-week multi-media social marketing campaign. The campaign aimed to raise awareness, increase knowledge, and improve access to contraceptive options, including long-acting reversible contraception (LARC) methods among college women. A pretest-posttest web-based survey design measured campaign awareness and recognition, as well as attitudes, subjective norms, and behavior.
Results: Participants demonstrated a significant increase in knowledge about intrauterine devices (IUDs) between pretest (M = 2.66, SD = 1.30) and posttest (M = 3.06; SD = 1.96); t(671) = -2.60, p < .01). Analysis revealed that frequent exposure to the campaign prompted participants to engage in discussions about LARC with friends (p < .05). In addition, 20- to 24-year-olds who reported seeing the campaign messages were more likely to seek out information (p < .01) and adopt a LARC method (p = .001) than 18- or 19-year-olds who saw the campaign messages.
Conclusion: Findings from the study offer practical recommendations for implementing social marketing campaigns aimed at increasing access to LARC and reducing unintended pregnancy.
背景:尽管越来越多的人可以获得高效的避孕方法,但在美国未婚年轻女性中,高达三分之二的怀孕是意外的。目的:本研究实施并评估了一项社会营销活动,旨在增加东南一所大学校园内18-24岁女性获得全方位避孕方法的机会。方法:研究人员与选择健康和学生健康服务合作,设计、实施和评估“你有选择”,这是一个为期10周的多媒体社会营销活动。该活动旨在提高认识,增加知识,并改善避孕选择,包括长效可逆避孕(LARC)方法。一项基于网络的前测后测调查设计测量了活动的知名度和认知度,以及态度、主观规范和行为。结果:在测试前(M = 2.66, SD = 1.30)和测试后(M = 3.06;sd = 1.96);T (671) = -2.60, p p p p = .001)比那些看到竞选信息的18岁或19岁的人要多。结论:研究结果为实施旨在增加LARC获取和减少意外怀孕的社会营销活动提供了实用建议。
{"title":"You Have Options: Implementing and evaluating a contraceptive choice social marketing campaign.","authors":"Beth Sundstrom, Andrea L DeMaria, Merissa Ferrara, Stephanie Meier, Kerri Vyge, Deborah Billings, Dee DiBona, Bridget M McLernon Sykes","doi":"10.1177/23992026211003499","DOIUrl":"https://doi.org/10.1177/23992026211003499","url":null,"abstract":"<p><strong>Background: </strong>Up to two-thirds of pregnancies among young, unmarried women in the United States are unintended, despite increased access to highly effective contraceptive options.</p><p><strong>Aim: </strong>This study implemented and evaluated a social marketing campaign designed to increase access to a full range of contraceptive methods among women aged 18-24 years on a southeastern university campus.</p><p><strong>Methods: </strong>Researchers partnered with Choose Well and Student Health Services to design, implement, and evaluate <i>You Have Options</i>, a 10-week multi-media social marketing campaign. The campaign aimed to raise awareness, increase knowledge, and improve access to contraceptive options, including long-acting reversible contraception (LARC) methods among college women. A pretest-posttest web-based survey design measured campaign awareness and recognition, as well as attitudes, subjective norms, and behavior.</p><p><strong>Results: </strong>Participants demonstrated a significant increase in knowledge about intrauterine devices (IUDs) between pretest (<i>M</i> = 2.66, <i>SD</i> = 1.30) and posttest (<i>M</i> = 3.06; <i>SD</i> = 1.96); <i>t</i>(671) = -2.60, <i>p</i> < .01). Analysis revealed that frequent exposure to the campaign prompted participants to engage in discussions about LARC with friends (<i>p</i> < .05). In addition, 20- to 24-year-olds who reported seeing the campaign messages were more likely to seek out information (<i>p</i> < .01) and adopt a LARC method (<i>p</i> = .001) than 18- or 19-year-olds who saw the campaign messages.</p><p><strong>Conclusion: </strong>Findings from the study offer practical recommendations for implementing social marketing campaigns aimed at increasing access to LARC and reducing unintended pregnancy.</p>","PeriodicalId":74158,"journal":{"name":"Medicine access @ point of care","volume":" ","pages":"23992026211003499"},"PeriodicalIF":0.0,"publicationDate":"2021-03-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1177/23992026211003499","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"33491211","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}
Background: Falsified medical products have been reported worldwide. Falsified medicines with poor quality are a potential health hazard. Some Internet sites advertise fluconazole (Diflucan®), an antifungal medicine used to treat deep mycoses, as "female Viagra®."
Aim: The aim of this study was to investigate the authenticity and quality of Diflucan® tablets distributed on the Internet.
Methods: We ordered Diflucan® tablets via the Internet and evaluated them by visual observation, authenticity investigation, quality evaluation (quantity of the active pharmaceutical ingredient, content uniformity, and dissolution), and near-infrared and Raman scattering spectroscopy.
Results: We obtained 11 samples of Diflucan® tablets from all 11 Japanese Internet sites identified in our search. Of 11 sites, 7 advertised fluconazole as having effects on female sexual function. Ten of the Diflucan® samples were confirmed as genuine and one sample was falsified. The genuine Diflucan® samples met the specifications of all quality evaluations. The packaging, size, and color of the falsified Diflucan® sample obtained in this study differed from the authentic Diflucan® tablet. The falsified Diflucan® sample obtained in this study did not contain fluconazole and instead contained what appeared to be sildenafil citrate. The spectra of the falsified Diflucan® tablet obtained in this study differed from the authentic Diflucan® tablet in near-infrared and Raman scattering spectroscopy.
Conclusion: We confirmed that one falsified Diflucan® tablet was distributed online. Thus, continued measures against falsified medicines are required.
{"title":"Quality assessment of Diflucan<sup>®</sup> tablets distributed online: Diflucan<sup>®</sup> distributed online.","authors":"Tomoko Sanada, Myu Ohnishi, Naoko Yoshida, Kazuko Kimura, Hirohito Tsuboi","doi":"10.1177/23992026211002089","DOIUrl":"https://doi.org/10.1177/23992026211002089","url":null,"abstract":"<p><strong>Background: </strong>Falsified medical products have been reported worldwide. Falsified medicines with poor quality are a potential health hazard. Some Internet sites advertise fluconazole (Diflucan<sup>®</sup>), an antifungal medicine used to treat deep mycoses, as \"female Viagra<sup>®</sup>.\"</p><p><strong>Aim: </strong>The aim of this study was to investigate the authenticity and quality of Diflucan<sup>®</sup> tablets distributed on the Internet.</p><p><strong>Methods: </strong>We ordered Diflucan<sup>®</sup> tablets via the Internet and evaluated them by visual observation, authenticity investigation, quality evaluation (quantity of the active pharmaceutical ingredient, content uniformity, and dissolution), and near-infrared and Raman scattering spectroscopy.</p><p><strong>Results: </strong>We obtained 11 samples of Diflucan<sup>®</sup> tablets from all 11 Japanese Internet sites identified in our search. Of 11 sites, 7 advertised fluconazole as having effects on female sexual function. Ten of the Diflucan<sup>®</sup> samples were confirmed as genuine and one sample was falsified. The genuine Diflucan<sup>®</sup> samples met the specifications of all quality evaluations. The packaging, size, and color of the falsified Diflucan<sup>®</sup> sample obtained in this study differed from the authentic Diflucan<sup>®</sup> tablet. The falsified Diflucan<sup>®</sup> sample obtained in this study did not contain fluconazole and instead contained what appeared to be sildenafil citrate. The spectra of the falsified Diflucan<sup>®</sup> tablet obtained in this study differed from the authentic Diflucan<sup>®</sup> tablet in near-infrared and Raman scattering spectroscopy.</p><p><strong>Conclusion: </strong>We confirmed that one falsified Diflucan<sup>®</sup> tablet was distributed online. Thus, continued measures against falsified medicines are required.</p>","PeriodicalId":74158,"journal":{"name":"Medicine access @ point of care","volume":" ","pages":"23992026211002089"},"PeriodicalIF":0.0,"publicationDate":"2021-03-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1177/23992026211002089","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"33491220","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}
Pub Date : 2021-01-01Epub Date: 2021-03-08DOI: 10.1177/2399202620980303
Hui-Han Chen, Colleen Higgins, Sarah K Laing, Sarah L Bliese, Marya Lieberman, Sachiko Ozawa
Background: Over 10% of antibiotics in low- and middle-income countries (LMICs) are substandard or falsified. Detection of poor-quality antibiotics via the gold standard method, high-performance liquid chromatography (HPLC), is slow and costly. Paper analytical devices (PADs) and antibiotic paper analytical devices (aPADs) have been developed as an inexpensive way to estimate antibiotic quality in LMICs.
Aim: To model the impact of using a rapid screening tools, PADs/aPADs, to improve the quality of amoxicillin used for treatment of childhood pneumonia in Kenya.
Methods: We developed an agent-based model, ESTEEM (Examining Screening Technologies with Economic Evaluations for Medicines), to estimate the effectiveness and cost savings of incorporating PADs and aPADs in amoxicillin quality surveillance in Kenya. We compared the current testing scenario (batches of entire samples tested by HPLC) with an expedited HPLC scenario (testing smaller batches at a time), as well as a screening scenario using PADs/aPADs to identify poor-quality amoxicillin followed by confirmatory analysis with HPLC.
Results: Scenarios using PADs/aPADs or expedited HPLC yielded greater incremental benefits than the current testing scenario by annually averting 586 (90% uncertainty range (UR) 364-874) and 221 (90% UR 126-332) child pneumonia deaths, respectively. The PADs/aPADs screening scenario identified and removed poor-quality antibiotics faster than the expedited or regular HPLC scenarios, and reduced costs significantly. The PADs/aPADs scenario resulted in an incremental return of $14.9 million annually compared with the reference scenario of only using HPLC.
Conclusion: This analysis shows the significant value of PADs/aPADs as a medicine quality screening and testing tool in LMICs with limited resources.
{"title":"Cost savings of paper analytical devices (PADs) to detect substandard and falsified antibiotics: Kenya case study.","authors":"Hui-Han Chen, Colleen Higgins, Sarah K Laing, Sarah L Bliese, Marya Lieberman, Sachiko Ozawa","doi":"10.1177/2399202620980303","DOIUrl":"https://doi.org/10.1177/2399202620980303","url":null,"abstract":"<p><strong>Background: </strong>Over 10% of antibiotics in low- and middle-income countries (LMICs) are substandard or falsified. Detection of poor-quality antibiotics via the gold standard method, high-performance liquid chromatography (HPLC), is slow and costly. Paper analytical devices (PADs) and antibiotic paper analytical devices (aPADs) have been developed as an inexpensive way to estimate antibiotic quality in LMICs.</p><p><strong>Aim: </strong>To model the impact of using a rapid screening tools, PADs/aPADs, to improve the quality of amoxicillin used for treatment of childhood pneumonia in Kenya.</p><p><strong>Methods: </strong>We developed an agent-based model, ESTEEM (Examining Screening Technologies with Economic Evaluations for Medicines), to estimate the effectiveness and cost savings of incorporating PADs and aPADs in amoxicillin quality surveillance in Kenya. We compared the current testing scenario (batches of entire samples tested by HPLC) with an expedited HPLC scenario (testing smaller batches at a time), as well as a screening scenario using PADs/aPADs to identify poor-quality amoxicillin followed by confirmatory analysis with HPLC.</p><p><strong>Results: </strong>Scenarios using PADs/aPADs or expedited HPLC yielded greater incremental benefits than the current testing scenario by annually averting 586 (90% uncertainty range (UR) 364-874) and 221 (90% UR 126-332) child pneumonia deaths, respectively. The PADs/aPADs screening scenario identified and removed poor-quality antibiotics faster than the expedited or regular HPLC scenarios, and reduced costs significantly. The PADs/aPADs scenario resulted in an incremental return of $14.9 million annually compared with the reference scenario of only using HPLC.</p><p><strong>Conclusion: </strong>This analysis shows the significant value of PADs/aPADs as a medicine quality screening and testing tool in LMICs with limited resources.</p>","PeriodicalId":74158,"journal":{"name":"Medicine access @ point of care","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1177/2399202620980303","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"25574822","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}