Pub Date : 2018-08-28DOI: 10.1177/2399202618795431
K. Lewis
The rising cost of clinical development, coupled with the ethical obligation to ensure that patients exiting a clinical trial are able to remain on active treatment if necessary, has led some pharmaceutical and bio-pharmaceutical companies to review their trial protocols and consider alternative options. The traditional open-label extension or phase IV trial is appropriate in some instances, as is a post-trial supply program using the legislation available for unlicensed medicines in the many countries around the world. This article looks at some of the key considerations and how many companies are adopting different supply models.
{"title":"Post-trial access to treatment: How managed access programs could be a solution","authors":"K. Lewis","doi":"10.1177/2399202618795431","DOIUrl":"https://doi.org/10.1177/2399202618795431","url":null,"abstract":"The rising cost of clinical development, coupled with the ethical obligation to ensure that patients exiting a clinical trial are able to remain on active treatment if necessary, has led some pharmaceutical and bio-pharmaceutical companies to review their trial protocols and consider alternative options. The traditional open-label extension or phase IV trial is appropriate in some instances, as is a post-trial supply program using the legislation available for unlicensed medicines in the many countries around the world. This article looks at some of the key considerations and how many companies are adopting different supply models.","PeriodicalId":74158,"journal":{"name":"Medicine access @ point of care","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2018-08-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1177/2399202618795431","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"48247118","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2018-07-13DOI: 10.1177/2399202618786932
C. Lewis
Introduction: Aggressive cancers such as mantle cell lymphoma are life-changing diseases, affecting all aspects in the life of a patient. Not only affecting a patient physically due to the disease itself and potential treatments but also mentally, socially and economically as well. The aim of this article is to describe the journey of a patient from a clinical and personal perspective, highlighting the importance of a collaborative approach to patients’ post-treatment care from clinicians, allied health professionals and patient advocacy groups/charities. Case presentation: The case presented the journey of a 51-year-old male with stage IV mantle cell lymphoma presented from his own perspective. The clinical case highlights a number of key issues on post-treatment support and the need for improvement to ensure cancer survivors have the best quality of life once treatment has ended. Conclusions: It is essential that cancer survivors receive the support and information they require to adjust to lifestyle changes arising from their disease and treatment. Improving communication and access to care and providing additional emotional support may assist survivors in adapting to these changes. Increased collaboration among physicians, researchers, allied health professionals, patient groups and charities and patients will continue to improve quality of life for cancer patients after treatment has ceased.
{"title":"Improving access to post-treatment support for patients with cancer – thinking outside the box: A patient perspective","authors":"C. Lewis","doi":"10.1177/2399202618786932","DOIUrl":"https://doi.org/10.1177/2399202618786932","url":null,"abstract":"Introduction: Aggressive cancers such as mantle cell lymphoma are life-changing diseases, affecting all aspects in the life of a patient. Not only affecting a patient physically due to the disease itself and potential treatments but also mentally, socially and economically as well. The aim of this article is to describe the journey of a patient from a clinical and personal perspective, highlighting the importance of a collaborative approach to patients’ post-treatment care from clinicians, allied health professionals and patient advocacy groups/charities. Case presentation: The case presented the journey of a 51-year-old male with stage IV mantle cell lymphoma presented from his own perspective. The clinical case highlights a number of key issues on post-treatment support and the need for improvement to ensure cancer survivors have the best quality of life once treatment has ended. Conclusions: It is essential that cancer survivors receive the support and information they require to adjust to lifestyle changes arising from their disease and treatment. Improving communication and access to care and providing additional emotional support may assist survivors in adapting to these changes. Increased collaboration among physicians, researchers, allied health professionals, patient groups and charities and patients will continue to improve quality of life for cancer patients after treatment has ceased.","PeriodicalId":74158,"journal":{"name":"Medicine access @ point of care","volume":"2 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2018-07-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1177/2399202618786932","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"41942140","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2018-05-29DOI: 10.1177/2399202618774510
Yannis Natsis
The present analysis looks at the key issues which dominate the EU medicines policy agenda during 2018 namely the proposed regulation on European collaboration on Health Technology Assessment (HTA), the ongoing discussion around the role of intellectual property related incentives in biomedical R&D, the future of initiatives such as BeNeLuxA, the role of the European Medicines Agency and the reaction of the pharmaceutical companies to the unprecedented debate around access to medicines in Europe.
{"title":"The top 5 issues in EU medicines policy for 2018","authors":"Yannis Natsis","doi":"10.1177/2399202618774510","DOIUrl":"https://doi.org/10.1177/2399202618774510","url":null,"abstract":"The present analysis looks at the key issues which dominate the EU medicines policy agenda during 2018 namely the proposed regulation on European collaboration on Health Technology Assessment (HTA), the ongoing discussion around the role of intellectual property related incentives in biomedical R&D, the future of initiatives such as BeNeLuxA, the role of the European Medicines Agency and the reaction of the pharmaceutical companies to the unprecedented debate around access to medicines in Europe.","PeriodicalId":74158,"journal":{"name":"Medicine access @ point of care","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2018-05-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1177/2399202618774510","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"45690998","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2018-04-17DOI: 10.1177/2399202618768676
Lidio Brasola, Domenico Di Giorgio, Fulvio La Bella, M. Pani, G. Turchetti
In recent years, medicine thefts have become a European challenge. In Italy, the number of thefts, from hospitals, has increased exponentially since 2011. The major drivers were the introduction of life-saving expensive medicines, the price differentials between countries and the different reimbursement regimes adopted in the European Union. This situation resulted in the AIFA (Italian Medicines Agency) Counterfeiting Prevention Unit setting up a number of preventive strategies that have minimized and in some cases eradicated the problem. In this review, we briefly describe trends and impacts of medicine thefts in Italy, the ‘Herceptin Case’, a major criminal effort that has been dismantled, and some of the preliminary results of PADLOck (Progetto di Adeguamento Dei Livelli di sicurezza delle farmacie Ospedaliere contro il rischio di furti e definizione di standard tecnici), a study aimed at evaluating the safety of hospital pharmacists and made sure that preventive and corrective measures against medicine thefts are put in place. The implementation of some of the tools developed by AIFA is under evaluation and/or implementation by other European Authorities, leading to a more effective approach in tackling one of the most relevant challenges in access to medicines in the European Union.
近年来，药品盗窃已成为欧洲面临的一大挑战。在意大利，自2011年以来，医院的盗窃数量呈指数级增长。主要的驱动因素是采用挽救生命的昂贵药物、各国之间的价格差异以及欧洲联盟采用的不同报销制度。这种情况导致AIFA(意大利药品管理局)防伪股制定了一些预防战略，尽量减少并在某些情况下根除了这个问题。在这篇综述中，我们简要地描述了意大利药品盗窃的趋势和影响，“赫赛汀案”，一个已经被破获的主要犯罪活动，以及PADLOck的一些初步结果(Progetto di Adeguamento Dei livellidi sicurezza delle pharmacy Ospedaliere控制il rischio di进一步定义标准技术)。一项研究旨在评估医院药剂师的安全，并确保对药品盗窃的预防和纠正措施到位。AIFA开发的一些工具的实施情况正在由其他欧洲主管部门进行评估和/或实施，从而采用更有效的方法来应对欧盟药品可及性方面最相关的挑战之一。
{"title":"Medicine Thefts And Their Prevention: Current Approach In Italy And Future Perspectives","authors":"Lidio Brasola, Domenico Di Giorgio, Fulvio La Bella, M. Pani, G. Turchetti","doi":"10.1177/2399202618768676","DOIUrl":"https://doi.org/10.1177/2399202618768676","url":null,"abstract":"In recent years, medicine thefts have become a European challenge. In Italy, the number of thefts, from hospitals, has increased exponentially since 2011. The major drivers were the introduction of life-saving expensive medicines, the price differentials between countries and the different reimbursement regimes adopted in the European Union. This situation resulted in the AIFA (Italian Medicines Agency) Counterfeiting Prevention Unit setting up a number of preventive strategies that have minimized and in some cases eradicated the problem. In this review, we briefly describe trends and impacts of medicine thefts in Italy, the ‘Herceptin Case’, a major criminal effort that has been dismantled, and some of the preliminary results of PADLOck (Progetto di Adeguamento Dei Livelli di sicurezza delle farmacie Ospedaliere contro il rischio di furti e definizione di standard tecnici), a study aimed at evaluating the safety of hospital pharmacists and made sure that preventive and corrective measures against medicine thefts are put in place. The implementation of some of the tools developed by AIFA is under evaluation and/or implementation by other European Authorities, leading to a more effective approach in tackling one of the most relevant challenges in access to medicines in the European Union.","PeriodicalId":74158,"journal":{"name":"Medicine access @ point of care","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2018-04-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1177/2399202618768676","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"45871996","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2018-03-14DOI: 10.1177/2399202618761854
Mia Gannedahl, A. Udechuku, M. Bending
Improving timely patient access to new medicines, particularly in areas with high unmet need, has been a healthcare priority during the past 5–10 years, with several new regulatory initiatives from the European Medicines Agency, as well as on national level within the European Union. Nevertheless, evidence suggests that medicines going through these regulatory initiatives experience variable reimbursement outcomes due to uncertainties in the clinical or economic evidence base. New initiatives, including the adaptive pathways concept, have therefore been introduced that embrace a holistic view of a medicine’s route to patient access. These involve expanded clusters of stakeholders working together to prospectively influence and design evidence generation strategies, including use of real-world evidence, to ensure that development plans meet the needs of multiple stakeholders including regulatory agencies and health technology assessment bodies. Multi-stakeholder dialogues, provided through scientific advice, are already available for medicines in Europe in various forms and are important tools for regulators, health technology assessment bodies and pharmaceutical companies to develop evidence generation plans optimised to support decision-making on marketing authorisation and reimbursement of new medicines. Multiple stakeholder groups have been actively engaged in advancing developments of initiatives driving timely access and it is likely to continue due to the need to balance this with affordability. The aim of this article is to provide a review of the latest, as well as a future perspective on, developments with respect to accelerated access of medicines in the European Union with a particular focus on procedures for formal scientific advice.
{"title":"Initiatives driving accelerated access to medicines in Europe: Review of recent concepts and developments","authors":"Mia Gannedahl, A. Udechuku, M. Bending","doi":"10.1177/2399202618761854","DOIUrl":"https://doi.org/10.1177/2399202618761854","url":null,"abstract":"Improving timely patient access to new medicines, particularly in areas with high unmet need, has been a healthcare priority during the past 5–10 years, with several new regulatory initiatives from the European Medicines Agency, as well as on national level within the European Union. Nevertheless, evidence suggests that medicines going through these regulatory initiatives experience variable reimbursement outcomes due to uncertainties in the clinical or economic evidence base. New initiatives, including the adaptive pathways concept, have therefore been introduced that embrace a holistic view of a medicine’s route to patient access. These involve expanded clusters of stakeholders working together to prospectively influence and design evidence generation strategies, including use of real-world evidence, to ensure that development plans meet the needs of multiple stakeholders including regulatory agencies and health technology assessment bodies. Multi-stakeholder dialogues, provided through scientific advice, are already available for medicines in Europe in various forms and are important tools for regulators, health technology assessment bodies and pharmaceutical companies to develop evidence generation plans optimised to support decision-making on marketing authorisation and reimbursement of new medicines. Multiple stakeholder groups have been actively engaged in advancing developments of initiatives driving timely access and it is likely to continue due to the need to balance this with affordability. The aim of this article is to provide a review of the latest, as well as a future perspective on, developments with respect to accelerated access of medicines in the European Union with a particular focus on procedures for formal scientific advice.","PeriodicalId":74158,"journal":{"name":"Medicine access @ point of care","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2018-03-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1177/2399202618761854","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"48048717","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2018-02-14DOI: 10.1177/2399202617753101
P. Galván, Miguel Velázquez, Ronald Rivas, G. Benítez, Antonio Barrios, E. Hilario
Introduction: Information and communication technologies (ICTs) applied to the healthcare offer multiple advantages for diagnostic services and remote consultations. However, evidence on the diagnosis improvement in rural communities is limited. The usability of telemedicine to improve the coverage of diagnostic services in Paraguay was investigated. Methods: The goal of this descriptive study was to evaluate whether a telemedicine system implemented in remote public regional and district hospitals in Paraguay over a period of 3 years from 2014 to 2016 could facilitate the universal coverage of diagnostic services in rural communities. Results: In the study period, 182,406 remote diagnoses from 54 hospitals through a telemedicine system were performed. Of the total, 37.31% (68,085) corresponded to tomography, 62.00% (113,059) to electrocardiogram (ECG), 0.68% (1243) to electroencephalogram (EEG), and 0.01% (19) to ultrasound (US). Tomography was performed in 12 hospitals: 54.4% corresponded to head injuries, 13.8% to chest, and the rest to other anatomical regions. ECG was carried out in 52 hospitals; and in 62.1% of the cases, the results were normal; 12.5% unspecified arrhythmias; and 10.4% sinus bradycardia among the most frequent pathologies. EEG diagnosis showed history of seizure (54.3%), evolutionary control (14.0%), and headache (11.5%) among the most frequent diagnoses. All 19 US studies corresponded to prenatal control. Conclusion: These results showed that telemedicine may enhance the diagnostic services in rural communities, thus reducing the number of referrals and optimizing human and financial resources.
{"title":"Health diagnosis improvement in remote community health centers through telemedicine","authors":"P. Galván, Miguel Velázquez, Ronald Rivas, G. Benítez, Antonio Barrios, E. Hilario","doi":"10.1177/2399202617753101","DOIUrl":"https://doi.org/10.1177/2399202617753101","url":null,"abstract":"Introduction: Information and communication technologies (ICTs) applied to the healthcare offer multiple advantages for diagnostic services and remote consultations. However, evidence on the diagnosis improvement in rural communities is limited. The usability of telemedicine to improve the coverage of diagnostic services in Paraguay was investigated. Methods: The goal of this descriptive study was to evaluate whether a telemedicine system implemented in remote public regional and district hospitals in Paraguay over a period of 3 years from 2014 to 2016 could facilitate the universal coverage of diagnostic services in rural communities. Results: In the study period, 182,406 remote diagnoses from 54 hospitals through a telemedicine system were performed. Of the total, 37.31% (68,085) corresponded to tomography, 62.00% (113,059) to electrocardiogram (ECG), 0.68% (1243) to electroencephalogram (EEG), and 0.01% (19) to ultrasound (US). Tomography was performed in 12 hospitals: 54.4% corresponded to head injuries, 13.8% to chest, and the rest to other anatomical regions. ECG was carried out in 52 hospitals; and in 62.1% of the cases, the results were normal; 12.5% unspecified arrhythmias; and 10.4% sinus bradycardia among the most frequent pathologies. EEG diagnosis showed history of seizure (54.3%), evolutionary control (14.0%), and headache (11.5%) among the most frequent diagnoses. All 19 US studies corresponded to prenatal control. Conclusion: These results showed that telemedicine may enhance the diagnostic services in rural communities, thus reducing the number of referrals and optimizing human and financial resources.","PeriodicalId":74158,"journal":{"name":"Medicine access @ point of care","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2018-02-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1177/2399202617753101","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"47491474","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2018-01-01DOI: 10.1177/2399202618813463
Diarmuid De Faoite
The patient’s perspective is increasingly being sought out in measuring the success of a medical procedure. Patientreported outcome measures (PROMs) are the tools used to elicit patient options. Despite increased popularity, issues still remain around their use. Electronic PROMs have been suggested as an improvement on paper-based collection of data. Begun in 2004, the US-initiated Patient-Reported Outcome Measurement Information System (PROMIS®) aims to improve the standards for the assessment of self-reported health status. The PROMIS initiative has generated a reliable and sensitive system, customised to the patient, which poses as few questions as possible. This is achieved through the use of computer-adaptive tests (CATs), which are individually tailored electronic questionnaires. Smith & Nephew collaborated with Wellframe Inc., a US-based patented health management solution, to adapt their platform for total knee arthroplasty patients and PROMIS CAT data collection. The platform’s app can be used outside of scheduled clinic visits to collect data from patients. This enables orthopaedic surgeons, for the first time, to remotely track their patients’ real-time healing progress and satisfaction levels. Smith & Nephew is currently investigating the use of this application for clinical research purposes. If electronic PROMs deliver on their promise, there is great potential to introduce them to the many clinical studies that the company runs and/or funds.
{"title":"The advantages of electronic patient-reported measures and an example digital platform to collect ePROs after total knee arthroplasty","authors":"Diarmuid De Faoite","doi":"10.1177/2399202618813463","DOIUrl":"https://doi.org/10.1177/2399202618813463","url":null,"abstract":"The patient’s perspective is increasingly being sought out in measuring the success of a medical procedure. Patientreported outcome measures (PROMs) are the tools used to elicit patient options. Despite increased popularity, issues still remain around their use. Electronic PROMs have been suggested as an improvement on paper-based collection of data. Begun in 2004, the US-initiated Patient-Reported Outcome Measurement Information System (PROMIS®) aims to improve the standards for the assessment of self-reported health status. The PROMIS initiative has generated a reliable and sensitive system, customised to the patient, which poses as few questions as possible. This is achieved through the use of computer-adaptive tests (CATs), which are individually tailored electronic questionnaires. Smith & Nephew collaborated with Wellframe Inc., a US-based patented health management solution, to adapt their platform for total knee arthroplasty patients and PROMIS CAT data collection. The platform’s app can be used outside of scheduled clinic visits to collect data from patients. This enables orthopaedic surgeons, for the first time, to remotely track their patients’ real-time healing progress and satisfaction levels. Smith & Nephew is currently investigating the use of this application for clinical research purposes. If electronic PROMs deliver on their promise, there is great potential to introduce them to the many clinical studies that the company runs and/or funds.","PeriodicalId":74158,"journal":{"name":"Medicine access @ point of care","volume":"2 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2018-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1177/2399202618813463","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"65969679","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
The EU Falsified Medicines Directive (FMD) mandates the serialisation of prescription-only medicines using a two-dimensional (2D) barcode by pharmaceutical companies and the systematic verification of this 2D barcode in pharmacies. This European directive has ramifications for many stakeholders, including market authorization holders, wholesalers, parallel importers, and dispensers. Focusing primarily on the impact on UK dispensers, the following questions are addressed in this article: Where should the affected medicines be scanned? and who will pay for the incoming changes to practice? The role of the EU FMD in terms of drug recalls, the preparation required for EU FMD compliance, and the potential for added healthcare value are also discussed. Dispensers must prepare for the February 2019 EU FMD deadline date by choosing a point within their dispensing processes to scan medicines. Dispensers must also budget appropriately for the incoming costs associated with new hardware and processes.
{"title":"The EU Falsified Medicines Directive: Key Implications for Dispensers","authors":"B. Naughton","doi":"10.5301/maapoc.0000024","DOIUrl":"https://doi.org/10.5301/maapoc.0000024","url":null,"abstract":"The EU Falsified Medicines Directive (FMD) mandates the serialisation of prescription-only medicines using a two-dimensional (2D) barcode by pharmaceutical companies and the systematic verification of this 2D barcode in pharmacies. This European directive has ramifications for many stakeholders, including market authorization holders, wholesalers, parallel importers, and dispensers. Focusing primarily on the impact on UK dispensers, the following questions are addressed in this article: Where should the affected medicines be scanned? and who will pay for the incoming changes to practice? The role of the EU FMD in terms of drug recalls, the preparation required for EU FMD compliance, and the potential for added healthcare value are also discussed. Dispensers must prepare for the February 2019 EU FMD deadline date by choosing a point within their dispensing processes to scan medicines. Dispensers must also budget appropriately for the incoming costs associated with new hardware and processes.","PeriodicalId":74158,"journal":{"name":"Medicine access @ point of care","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2017-12-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.5301/maapoc.0000024","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"49534665","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
The peril of substandard and falsified medicines (SFM) risk complete failure of the United Nations Sustainable Development Goals on access to safe, effective, quality, and affordable essential medicines in African countries. The global market volume of SFM could be up to US$200 billion, and up to 70% of the total medicines in circulation could be SFM in some parts of Africa. This dominance in the region is a clear sign of SFM proliferation, which continues to cause avoidable health hazards leading to severe adverse effects and devastating loss of human lives, by compromising treatment of chronic, infectious, and life-threatening diseases, such as malaria, cancer, pneumonia, tuberculosis, and diabetes. Besides these consequences to public health and safety, the economic and societal detriments are also grave. Although the recent advancement in detection technology coupled with increased collaborative efforts among some African drug regulatory agencies has led to a considerable success in countering the SFM pandemic, there is need to amplify and intensify such efforts in order to curb or totally eradicate the menace. Here, we provide an overview of the detrimental impact of SFM on the healthcare system in African countries and highlight various strategies for curbing the menace in order to arrest its hazardous consequence to the public.
{"title":"Unveiling the Peril of Substandard and Falsified Medicines to Public Health and Safety in Africa: Need for All-Out War to End the Menace","authors":"N. Aminu, A. Sha’aban, A. Abubakar, M. Gwarzo","doi":"10.5301/maapoc.0000023","DOIUrl":"https://doi.org/10.5301/maapoc.0000023","url":null,"abstract":"The peril of substandard and falsified medicines (SFM) risk complete failure of the United Nations Sustainable Development Goals on access to safe, effective, quality, and affordable essential medicines in African countries. The global market volume of SFM could be up to US$200 billion, and up to 70% of the total medicines in circulation could be SFM in some parts of Africa. This dominance in the region is a clear sign of SFM proliferation, which continues to cause avoidable health hazards leading to severe adverse effects and devastating loss of human lives, by compromising treatment of chronic, infectious, and life-threatening diseases, such as malaria, cancer, pneumonia, tuberculosis, and diabetes. Besides these consequences to public health and safety, the economic and societal detriments are also grave. Although the recent advancement in detection technology coupled with increased collaborative efforts among some African drug regulatory agencies has led to a considerable success in countering the SFM pandemic, there is need to amplify and intensify such efforts in order to curb or totally eradicate the menace. Here, we provide an overview of the detrimental impact of SFM on the healthcare system in African countries and highlight various strategies for curbing the menace in order to arrest its hazardous consequence to the public.","PeriodicalId":74158,"journal":{"name":"Medicine access @ point of care","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2017-12-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.5301/maapoc.0000023","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"46882505","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
E. Bosone, G. Giuliani, Nicoletta Martone, A. Ponzianelli, Valeria Viola
Many tools have been developed in Europe to accelerate the access to and the availability of medicines. However, this is currently governed by the national Member State procedures for pricing and reimbursement. In many cases, this leads to procedures that often take many months or even years to be completed. This paper explores ways that would allow a more accelerated approach and thus enable a more efficient administrative procedure to be adopted. Therefore, this would favor the timely availability of medicines for severe diseases when an unmet medical need is present.
{"title":"Timely Access to Priority Medicines in Europe","authors":"E. Bosone, G. Giuliani, Nicoletta Martone, A. Ponzianelli, Valeria Viola","doi":"10.5301/MAAPOC.0000021","DOIUrl":"https://doi.org/10.5301/MAAPOC.0000021","url":null,"abstract":"Many tools have been developed in Europe to accelerate the access to and the availability of medicines. However, this is currently governed by the national Member State procedures for pricing and reimbursement. In many cases, this leads to procedures that often take many months or even years to be completed. This paper explores ways that would allow a more accelerated approach and thus enable a more efficient administrative procedure to be adopted. Therefore, this would favor the timely availability of medicines for severe diseases when an unmet medical need is present.","PeriodicalId":74158,"journal":{"name":"Medicine access @ point of care","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2017-12-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.5301/MAAPOC.0000021","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"46768695","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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