Pub Date : 2019-05-01DOI: 10.1177/2399202619847639
J. Fudin, Amelia L Persico, J. Bettinger, Erica L Wegrzyn
Over the past decade, opioid use has been at the forefront of a public health crisis throughout the United States. In response to the tremendous negative societal, personal, and economic impacts that the growing opioid crisis has caused, several governmental agencies began to respond. These efforts include declaration of a nationwide public health emergency, increased public health surveillance of the epidemic, research support for pain and addiction, and increased access to overdose-reversing drugs such as naloxone. Naloxone access, in particular, has become a priority. In the United States, pharmacists have had the opportunity to play a crucial role in promoting access to naloxone. Since initial approval by the Food and Drug Administration (FDA) in 1971 as an antidote to opioid agonist overdose, naloxone access has evolved significantly. Today many states have authorized standing orders for naloxone, allowing it to be dispensed by pharmacists without a patient-specific prescription, and all 50 states and the District of Columbia allow medical providers to prescribe take-home naloxone to at-risk patients. While the opioid epidemic itself remains a contentious topic of political, ethical, and medical debate, it is widely acknowledged that mitigation strategies that could lessen morbidity and mortality are essential. Improved access to naloxone is one such strategy which remains at the forefront during this public health crisis.
{"title":"The state of naloxone: Access amid a public health crisis","authors":"J. Fudin, Amelia L Persico, J. Bettinger, Erica L Wegrzyn","doi":"10.1177/2399202619847639","DOIUrl":"https://doi.org/10.1177/2399202619847639","url":null,"abstract":"Over the past decade, opioid use has been at the forefront of a public health crisis throughout the United States. In response to the tremendous negative societal, personal, and economic impacts that the growing opioid crisis has caused, several governmental agencies began to respond. These efforts include declaration of a nationwide public health emergency, increased public health surveillance of the epidemic, research support for pain and addiction, and increased access to overdose-reversing drugs such as naloxone. Naloxone access, in particular, has become a priority. In the United States, pharmacists have had the opportunity to play a crucial role in promoting access to naloxone. Since initial approval by the Food and Drug Administration (FDA) in 1971 as an antidote to opioid agonist overdose, naloxone access has evolved significantly. Today many states have authorized standing orders for naloxone, allowing it to be dispensed by pharmacists without a patient-specific prescription, and all 50 states and the District of Columbia allow medical providers to prescribe take-home naloxone to at-risk patients. While the opioid epidemic itself remains a contentious topic of political, ethical, and medical debate, it is widely acknowledged that mitigation strategies that could lessen morbidity and mortality are essential. Improved access to naloxone is one such strategy which remains at the forefront during this public health crisis.","PeriodicalId":74158,"journal":{"name":"Medicine access @ point of care","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2019-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1177/2399202619847639","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"47126597","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 : 2019-01-01DOI: 10.1177/2399202619834246
H. Castro, Tanya Malpica-Llanos, R. Musila, N. Konduri, Ana Amaris, Jennifer Sullivan, C. Gilmartin
Managed entry agreements (MEAs)—a type of formal institutional arrangement between pharmaceutical companies and payers for sharing the risk with respect to the introduction of new pharmaceutical technologies—may expand access to new pharmaceutical technologies for non-communicable diseases (NCDs). Although common in highincome countries (HICs), there is limited evidence of their use in low- and middle-income countries (LMICs). This article aims to document international experiences of countries implementing MEAs and potential barriers and facilitators for their use in LMICs. We reviewed published literature sources on MEAs over the past 10 years considering peer-reviewed publications and gray literature data. We took into consideration the MEAs taxonomy presented by Kanavos and Ferrario et al. to categorize our findings, and extract information on factors for their implementation. We retrieved 285 MEAs documented in the literature, mostly from HICs and for a broad spectrum of NCDs. Financial schemes were slightly more prominent than performance-based agreements. Identified factors that could potentially facilitate or hinder the implementation of MEAs included the presence of quality administrative and information systems to track their implementation; availability of quality data and evidence of positive outcomes; uncertainty of drug efficacy/effectiveness, safety, and financial impact; and cultural factors, namely country’s preference for certain type of agreement and trust among payers and manufacturers. The increased availability of publications in recent years suggests a growing interest among policy-makers and researchers in the implementation of MEAs. While the use of MEAs in LMICs is very limited, this could be the result of limited empirical evidence on its use and possibly due to the use of a different taxonomy for describing MEAs in these settings. As any other policy option, the implementation and use of MEAs come with advantages and challenges. Since there is limited evidence on their use in LMICs, the identified cases of implementation in HICs may serve to inform the interest on MEAs in resource limited settings. Therefore, further research in this field especially in the context of LMICs may be of value for the global community as all countries are embarking into fairer and sustainable Universal Health Coverage (UHC).
{"title":"Sharing knowledge for policy action in low- and middle-income countries: A literature review of managed entry agreements","authors":"H. Castro, Tanya Malpica-Llanos, R. Musila, N. Konduri, Ana Amaris, Jennifer Sullivan, C. Gilmartin","doi":"10.1177/2399202619834246","DOIUrl":"https://doi.org/10.1177/2399202619834246","url":null,"abstract":"Managed entry agreements (MEAs)—a type of formal institutional arrangement between pharmaceutical companies and payers for sharing the risk with respect to the introduction of new pharmaceutical technologies—may expand access to new pharmaceutical technologies for non-communicable diseases (NCDs). Although common in highincome countries (HICs), there is limited evidence of their use in low- and middle-income countries (LMICs). This article aims to document international experiences of countries implementing MEAs and potential barriers and facilitators for their use in LMICs. We reviewed published literature sources on MEAs over the past 10 years considering peer-reviewed publications and gray literature data. We took into consideration the MEAs taxonomy presented by Kanavos and Ferrario et al. to categorize our findings, and extract information on factors for their implementation. We retrieved 285 MEAs documented in the literature, mostly from HICs and for a broad spectrum of NCDs. Financial schemes were slightly more prominent than performance-based agreements. Identified factors that could potentially facilitate or hinder the implementation of MEAs included the presence of quality administrative and information systems to track their implementation; availability of quality data and evidence of positive outcomes; uncertainty of drug efficacy/effectiveness, safety, and financial impact; and cultural factors, namely country’s preference for certain type of agreement and trust among payers and manufacturers. The increased availability of publications in recent years suggests a growing interest among policy-makers and researchers in the implementation of MEAs. While the use of MEAs in LMICs is very limited, this could be the result of limited empirical evidence on its use and possibly due to the use of a different taxonomy for describing MEAs in these settings. As any other policy option, the implementation and use of MEAs come with advantages and challenges. Since there is limited evidence on their use in LMICs, the identified cases of implementation in HICs may serve to inform the interest on MEAs in resource limited settings. Therefore, further research in this field especially in the context of LMICs may be of value for the global community as all countries are embarking into fairer and sustainable Universal Health Coverage (UHC).","PeriodicalId":74158,"journal":{"name":"Medicine access @ point of care","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2019-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1177/2399202619834246","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"49185846","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 : 2019-01-01DOI: 10.1177/2399202619846847
G. Khalid, A. Jatau, U. Ibrahim, Fatima Mustapha Dungus, Zayyanu Shitu, A. Sha’aban, Sai’du Lawal Burji
Introduction: The burden of antibiotic self-medication (ASM) is increasing and becoming a global health threat due to antibiotics resistance. However, little is known about ASM among undergraduate pharmacy students who are the future custodians of medicines including antibiotics. Therefore, this study aims to develop, validate and utilize an online survey tool to investigate the prevalence of ASM among undergraduate pharmacy students in Northern Nigeria. Methods: A cross-sectional online survey form was developed, validated by face validity, content validity, and pilot study. The hyperlink to the online survey form was shared with undergraduate pharmacy students in northern Nigeria via WhatsApp, Facebook, and Twitter. Data were collected from eligible participants and analyzed using descriptive statistic. Results: A total of 217 students responded to the online survey, with a completion rate of 100%. Of the total number of respondents, 200 (92.2%) reported practicing ASM at least once in their lifetime. The major reasons for ASM were previous knowledge (40.4%) and having no time to see a doctor or pharmacist (27.5%). Amoxicillin (32.6%), Amoxicillin/Clavulanic acid (32.1%), Ampicillin/Cloxacillin (21.7%) and Ciprofloxacin (22.6%) were the most commonly implicated antibiotics in ASM. Cough, diarrhea, typhoid, and wound were the most frequently involved conditions. Patent medicine vendors (75.4%) and community pharmacies (29.4%) were the common source of antibiotics subjected to ASM. Conclusion: A research tool to assess ASM among undergraduate pharmacy students has been developed, validated and utilized. The prevalence of ASM is high among undergraduate pharmacy students in Northern Nigeria. Interventions to improve knowledge and awareness on ASM are needed among undergraduate pharmacy students to ensure antibiotic stewardship.
{"title":"Antibiotics self-medication among undergraduate pharmacy students in Northern Nigeria","authors":"G. Khalid, A. Jatau, U. Ibrahim, Fatima Mustapha Dungus, Zayyanu Shitu, A. Sha’aban, Sai’du Lawal Burji","doi":"10.1177/2399202619846847","DOIUrl":"https://doi.org/10.1177/2399202619846847","url":null,"abstract":"Introduction: The burden of antibiotic self-medication (ASM) is increasing and becoming a global health threat due to antibiotics resistance. However, little is known about ASM among undergraduate pharmacy students who are the future custodians of medicines including antibiotics. Therefore, this study aims to develop, validate and utilize an online survey tool to investigate the prevalence of ASM among undergraduate pharmacy students in Northern Nigeria. Methods: A cross-sectional online survey form was developed, validated by face validity, content validity, and pilot study. The hyperlink to the online survey form was shared with undergraduate pharmacy students in northern Nigeria via WhatsApp, Facebook, and Twitter. Data were collected from eligible participants and analyzed using descriptive statistic. Results: A total of 217 students responded to the online survey, with a completion rate of 100%. Of the total number of respondents, 200 (92.2%) reported practicing ASM at least once in their lifetime. The major reasons for ASM were previous knowledge (40.4%) and having no time to see a doctor or pharmacist (27.5%). Amoxicillin (32.6%), Amoxicillin/Clavulanic acid (32.1%), Ampicillin/Cloxacillin (21.7%) and Ciprofloxacin (22.6%) were the most commonly implicated antibiotics in ASM. Cough, diarrhea, typhoid, and wound were the most frequently involved conditions. Patent medicine vendors (75.4%) and community pharmacies (29.4%) were the common source of antibiotics subjected to ASM. Conclusion: A research tool to assess ASM among undergraduate pharmacy students has been developed, validated and utilized. The prevalence of ASM is high among undergraduate pharmacy students in Northern Nigeria. Interventions to improve knowledge and awareness on ASM are needed among undergraduate pharmacy students to ensure antibiotic stewardship.","PeriodicalId":74158,"journal":{"name":"Medicine access @ point of care","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2019-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1177/2399202619846847","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"45009746","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 : 2019-01-01DOI: 10.1177/2399202619840627
P. Galván, Ronald Rivas, J. Portillo, J. Mazzoleni, E. Hilario, J. Ortellado
Introduction: Telemedicine tools offer multiple advantages to achieve an epidemiological screening of communities in rural settings countrywide. However, evidence on the cardiological pathology surveillance in these communities is limited. The feasibility of telemedicine as an electrocardiographic (EKG) mapping tool for the diagnosis and prevention of cardiological pathologies in Paraguay was investigated. Methods: A descriptive study was conducted in 60 telediagnostic centers countrywide in Paraguay to evaluate the feasibility of telemedicine as an EKG mapping tool for the diagnosis and prevention of cardiological pathologies over a period of 5 years from 2014 to 2018. The adherence rate was determined comparing yearly scheduled visits versus fulfilled visits at the telemedicine platform. Results: During the study, 246,217 remote EKG diagnoses were performed in 60 hospitals using telemedicine. The patients were 19.4% children/adolescents and 80.6% adults. The results of EKG tests in the children/adolescent group were 79.4% normal and 20.6% abnormal. The most frequent abnormal heart rhythms observed were sinusal bradicardia (10.6%), sinusal tachycardia (3.2%), and unspecified arrhythmia (2.8%). In the adult group, the results were 66.3% normal and 33.7% abnormal. The most frequent abnormal heart rhythms in this group were sinusal bradicardia (11.2%), blockade of the right branch (4.8%), and left ventricular hypertrophy (4.7%). The most frequent cardiovascular risk factors observed were the association of hypertension and obesity (40%), hypertension and diabetes (20%), and hypertension and dyslipidemia (19%). During the test period (2014–2018), the average rate of patient adherence to the prevention program was 2.26 for each 1000 diagnosis. Conclusion: These results demonstrate the feasibility of telemedicine as an EKG mapping tool for the diagnosis and prevention of cardiological pathologies in low-resource countries, thus enhancing cardiovascular disease surveillance and optimizing human and financial resources.
{"title":"National electrocardiographic mapping by telemedicine for diagnosis and prevention of cardiological pathologies in Paraguay","authors":"P. Galván, Ronald Rivas, J. Portillo, J. Mazzoleni, E. Hilario, J. Ortellado","doi":"10.1177/2399202619840627","DOIUrl":"https://doi.org/10.1177/2399202619840627","url":null,"abstract":"Introduction: Telemedicine tools offer multiple advantages to achieve an epidemiological screening of communities in rural settings countrywide. However, evidence on the cardiological pathology surveillance in these communities is limited. The feasibility of telemedicine as an electrocardiographic (EKG) mapping tool for the diagnosis and prevention of cardiological pathologies in Paraguay was investigated. Methods: A descriptive study was conducted in 60 telediagnostic centers countrywide in Paraguay to evaluate the feasibility of telemedicine as an EKG mapping tool for the diagnosis and prevention of cardiological pathologies over a period of 5 years from 2014 to 2018. The adherence rate was determined comparing yearly scheduled visits versus fulfilled visits at the telemedicine platform. Results: During the study, 246,217 remote EKG diagnoses were performed in 60 hospitals using telemedicine. The patients were 19.4% children/adolescents and 80.6% adults. The results of EKG tests in the children/adolescent group were 79.4% normal and 20.6% abnormal. The most frequent abnormal heart rhythms observed were sinusal bradicardia (10.6%), sinusal tachycardia (3.2%), and unspecified arrhythmia (2.8%). In the adult group, the results were 66.3% normal and 33.7% abnormal. The most frequent abnormal heart rhythms in this group were sinusal bradicardia (11.2%), blockade of the right branch (4.8%), and left ventricular hypertrophy (4.7%). The most frequent cardiovascular risk factors observed were the association of hypertension and obesity (40%), hypertension and diabetes (20%), and hypertension and dyslipidemia (19%). During the test period (2014–2018), the average rate of patient adherence to the prevention program was 2.26 for each 1000 diagnosis. Conclusion: These results demonstrate the feasibility of telemedicine as an EKG mapping tool for the diagnosis and prevention of cardiological pathologies in low-resource countries, thus enhancing cardiovascular disease surveillance and optimizing human and financial resources.","PeriodicalId":74158,"journal":{"name":"Medicine access @ point of care","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2019-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1177/2399202619840627","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"47174125","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 : 2019-01-01DOI: 10.1177/2399202619865167
J. Barman-Aksözen
Patient representation during the evaluation of medicines by key decision makers such as regulatory agencies, Health Technology Assessment bodies, and healthcare payers is increasingly considered to add value to the appraisals and empowers patients, which means that they gain a more powerful voice over decisions and actions affecting their own health. As I myself suffer from the ultra-rare condition erythropoietic protoporphyria (EPP), I have participated as a patient expert in several discussions on access to afamelanotide, which currently is the only treatment for EPP and was approved in the European Union (EU) in 2014. As a molecular biologist with a PhD in EPP research, I consider myself having the necessary requirements to meaningfully contribute to such assessments. In this article, I share my personal experiences with regard to the discussions on access in Germany and England at the respective national competent authorities, the Federal Joint Committee, and the National Institute for Health and Care Excellence, respectively. In addition, I discuss the insights of the International Porphyria Patient Network, a group of highly empowered EPP patients effectively supporting national patient communities in their efforts to enable access to the afamelanotide treatment in their countries.
{"title":"Patient empowerment and access to medicines: Insights from a scientist-patient suffering from erythropoietic protoporphyria","authors":"J. Barman-Aksözen","doi":"10.1177/2399202619865167","DOIUrl":"https://doi.org/10.1177/2399202619865167","url":null,"abstract":"Patient representation during the evaluation of medicines by key decision makers such as regulatory agencies, Health Technology Assessment bodies, and healthcare payers is increasingly considered to add value to the appraisals and empowers patients, which means that they gain a more powerful voice over decisions and actions affecting their own health. As I myself suffer from the ultra-rare condition erythropoietic protoporphyria (EPP), I have participated as a patient expert in several discussions on access to afamelanotide, which currently is the only treatment for EPP and was approved in the European Union (EU) in 2014. As a molecular biologist with a PhD in EPP research, I consider myself having the necessary requirements to meaningfully contribute to such assessments. In this article, I share my personal experiences with regard to the discussions on access in Germany and England at the respective national competent authorities, the Federal Joint Committee, and the National Institute for Health and Care Excellence, respectively. In addition, I discuss the insights of the International Porphyria Patient Network, a group of highly empowered EPP patients effectively supporting national patient communities in their efforts to enable access to the afamelanotide treatment in their countries.","PeriodicalId":74158,"journal":{"name":"Medicine access @ point of care","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2019-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1177/2399202619865167","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"42780226","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 : 2019-01-01DOI: 10.1177/2399202619873228
B. Fernandopulle, N. Gunawardena, S. De Silva, Chinta Abayawardana, L. Hirimuthugoda
Introduction: In Sri Lanka in 2013, 16 medicines were identified as priority to manage non-communicable disease (NCD), and in 2017, 48 NCD medicines were price-regulated. Objective: The aim of the present study was to describe the experiences on availability of drugs and out-of-pocket expenditure (OOPE) for drugs among patients with NCDs in Sri Lanka. Methods: This community-based, household survey was conducted in nine districts of the country. The survey included 1100 adults (aged 50 years and above) with a diagnosis of NCD for 5 years. They were interviewed by trained pharmacy students. Results: Approximately 66%, 49% and 21.6% suffering from hypertension, diabetes and ischaemic heart disease, respectively, with a majority having more than one NCD. The evidence showed that prescribers align to drugs that have been recognized to be made more available and more affordable. Of all, 14% had prescriptions with all NCD medicines classified in the list, while 40% had only one or two of the drugs prescribed which are not in the list. Most of the prescribed drugs were also included in the price regulation – with 29% having all medicines included, while 31.6% having only one or two drugs prescribed out of the list. Approximately, two-thirds (64.2%) had exclusively used government hospitals for NCD care during the past 5 years. A majority (58.3%) had all prescribed drugs available at the last visit to the state sector clinic, while almost all of the others (35.7%) had some of the drugs available. Conclusion: The study concluded that patient experiences in Sri Lanka showed good availability and access to NCD medicines in Sri Lanka.
{"title":"Patient experiences of access to NCD medicines in Sri Lanka: Evidence of the success story towards universal coverage","authors":"B. Fernandopulle, N. Gunawardena, S. De Silva, Chinta Abayawardana, L. Hirimuthugoda","doi":"10.1177/2399202619873228","DOIUrl":"https://doi.org/10.1177/2399202619873228","url":null,"abstract":"Introduction: In Sri Lanka in 2013, 16 medicines were identified as priority to manage non-communicable disease (NCD), and in 2017, 48 NCD medicines were price-regulated. Objective: The aim of the present study was to describe the experiences on availability of drugs and out-of-pocket expenditure (OOPE) for drugs among patients with NCDs in Sri Lanka. Methods: This community-based, household survey was conducted in nine districts of the country. The survey included 1100 adults (aged 50 years and above) with a diagnosis of NCD for 5 years. They were interviewed by trained pharmacy students. Results: Approximately 66%, 49% and 21.6% suffering from hypertension, diabetes and ischaemic heart disease, respectively, with a majority having more than one NCD. The evidence showed that prescribers align to drugs that have been recognized to be made more available and more affordable. Of all, 14% had prescriptions with all NCD medicines classified in the list, while 40% had only one or two of the drugs prescribed which are not in the list. Most of the prescribed drugs were also included in the price regulation – with 29% having all medicines included, while 31.6% having only one or two drugs prescribed out of the list. Approximately, two-thirds (64.2%) had exclusively used government hospitals for NCD care during the past 5 years. A majority (58.3%) had all prescribed drugs available at the last visit to the state sector clinic, while almost all of the others (35.7%) had some of the drugs available. Conclusion: The study concluded that patient experiences in Sri Lanka showed good availability and access to NCD medicines in Sri Lanka.","PeriodicalId":74158,"journal":{"name":"Medicine access @ point of care","volume":"3 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2019-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1177/2399202619873228","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"42732556","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 : 2019-01-01DOI: 10.1177/2399202619852317
Emma Eatwell, Anna Swierczyna
Voluntary cooperation between European healthcare systems in medicines can bring concrete benefits for those healthcare systems and for patients. Although cooperation between countries in the form of clusters has been in place for some years now, there is still relatively little information on their objectives, scope, structures, procedures and activities – partly due to confidentiality, partly due to an ever-changing environment. By interviewing people who are directly leading the voluntary cooperation in countries, this article brings more clarity on the current state of play in voluntary cooperation and unpacks the challenges that countries and companies are facing in moving the joint process forward. In particular, we have anticipated the potential short- and long-term outcomes and consequences for medicine assessment in participating countries.
{"title":"Emerging voluntary cooperation between European healthcare systems: Are we facing a new future?","authors":"Emma Eatwell, Anna Swierczyna","doi":"10.1177/2399202619852317","DOIUrl":"https://doi.org/10.1177/2399202619852317","url":null,"abstract":"Voluntary cooperation between European healthcare systems in medicines can bring concrete benefits for those healthcare systems and for patients. Although cooperation between countries in the form of clusters has been in place for some years now, there is still relatively little information on their objectives, scope, structures, procedures and activities – partly due to confidentiality, partly due to an ever-changing environment. By interviewing people who are directly leading the voluntary cooperation in countries, this article brings more clarity on the current state of play in voluntary cooperation and unpacks the challenges that countries and companies are facing in moving the joint process forward. In particular, we have anticipated the potential short- and long-term outcomes and consequences for medicine assessment in participating countries.","PeriodicalId":74158,"journal":{"name":"Medicine access @ point of care","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2019-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1177/2399202619852317","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"45194357","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 : 2018-12-04DOI: 10.1177/2399202618816900
Pelden Chejor, Kinga Jamphel, Tsheten, Zimba Letho, Guru, U. Tshering
Introduction: Compliance of community pharmacies with the national medicines law for proper storage and dispensing of medicines is crucial for ensuring the quality and safety of medicines. Community pharmacies in Bhutan are of two types: retail pharmacies and wholesale pharmacies. Objective: This study was aimed to assess the compliance of community pharmacies with the Medicines Act of the Kingdom of Bhutan 2003 and Bhutan Medicines Rules and Regulation 2012. Methods: This is a retrospective cross-sectional study from the inspection reports of community pharmacies inspected from January 2015 to December 2017. Descriptive statistics in frequency and percentage was used to report the results. Results: The overall compliance level for the regulatory provisions under critical and minor categories was 90.4% followed by 86.74% for major category. Around 32.99% of community pharmacies were found without standard operating procedures for storing and dispensing of medicines while 100% of community pharmacies had technical authorization from the Drug Regulatory Authority. Conclusion: Although the compliance level of community pharmacies in Bhutan for storing and dispensing of medicines was found to be above 80%, there are several areas that need to be corrected to ensure full compliance. This study will serve as a baseline for policymakers, managers, and researchers in developing designs for future interventions.
{"title":"Compliance to current national medicines law for proper storage and dispensing of medicines at community pharmacies in Bhutan","authors":"Pelden Chejor, Kinga Jamphel, Tsheten, Zimba Letho, Guru, U. Tshering","doi":"10.1177/2399202618816900","DOIUrl":"https://doi.org/10.1177/2399202618816900","url":null,"abstract":"Introduction: Compliance of community pharmacies with the national medicines law for proper storage and dispensing of medicines is crucial for ensuring the quality and safety of medicines. Community pharmacies in Bhutan are of two types: retail pharmacies and wholesale pharmacies. Objective: This study was aimed to assess the compliance of community pharmacies with the Medicines Act of the Kingdom of Bhutan 2003 and Bhutan Medicines Rules and Regulation 2012. Methods: This is a retrospective cross-sectional study from the inspection reports of community pharmacies inspected from January 2015 to December 2017. Descriptive statistics in frequency and percentage was used to report the results. Results: The overall compliance level for the regulatory provisions under critical and minor categories was 90.4% followed by 86.74% for major category. Around 32.99% of community pharmacies were found without standard operating procedures for storing and dispensing of medicines while 100% of community pharmacies had technical authorization from the Drug Regulatory Authority. Conclusion: Although the compliance level of community pharmacies in Bhutan for storing and dispensing of medicines was found to be above 80%, there are several areas that need to be corrected to ensure full compliance. This study will serve as a baseline for policymakers, managers, and researchers in developing designs for future interventions.","PeriodicalId":74158,"journal":{"name":"Medicine access @ point of care","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2018-12-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1177/2399202618816900","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"46985165","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 : 2018-11-02DOI: 10.1177/2399202618810121
F. Lucas
Success in launching new therapies for rare diseases (RDs) implies the ability for the manufacturer to achieve a level of reimbursed price and a level of market access that are commercially viable on the global market. Access to RD therapies is challenging in many countries because the legal and policy frameworks may be absent, funding may be insufficient and/or payers do not see the justification with the prices for these therapies. The industry has, however, a real opportunity to partner with healthcare systems to address these issues, for example, through education towards payers, responsible and evidence-based pricing, and innovative contracting. Such support is particularly needed in middle-income and emerging markets, where it will contribute to growth in RD therapy coverage.
{"title":"Improving market access to rare disease therapies: A worldwide perspective with recommendations to the industry","authors":"F. Lucas","doi":"10.1177/2399202618810121","DOIUrl":"https://doi.org/10.1177/2399202618810121","url":null,"abstract":"Success in launching new therapies for rare diseases (RDs) implies the ability for the manufacturer to achieve a level of reimbursed price and a level of market access that are commercially viable on the global market. Access to RD therapies is challenging in many countries because the legal and policy frameworks may be absent, funding may be insufficient and/or payers do not see the justification with the prices for these therapies. The industry has, however, a real opportunity to partner with healthcare systems to address these issues, for example, through education towards payers, responsible and evidence-based pricing, and innovative contracting. Such support is particularly needed in middle-income and emerging markets, where it will contribute to growth in RD therapy coverage.","PeriodicalId":74158,"journal":{"name":"Medicine access @ point of care","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2018-11-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1177/2399202618810121","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"45469905","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 : 2018-09-20DOI: 10.1177/2399202618799691
G. Prue, D. Grimes, P. Baker, M. Lawler
Human papillomavirus (HPV) is a common sexually transmitted infection. There is a well-established link between HPV and the development of cervical cancer, but HPV infection is also associated with vaginal and vulvar cancer, head and neck cancers as well as anal cancers in both sexes and penile cancer in men. Despite this, since its introduction in 2008, the United Kingdom has included only girls in its vaccination programme and, in 2017, suggested that it was not cost effective to extend the vaccine to adolescent boys. Men-who-have-sex-with-men (MSM) have been offered the HPV vaccine in the United Kingdom since 2016. A number of countries (21 to date) have implemented a universal HPV vaccination programme, with many countries arguing that female-only vaccination programmes protect males via herd immunity and that MSM will be protected via targeted vaccination programmes, although these may be limited in their effectiveness. Following an advocacy campaign to extend the HPV vaccination programme to boys in the United Kingdom, in July 2018 the Joint Commission for Vaccination and Immunisation recommended that boys should be included alongside 12/13-year-old girls in a school-based programme. Given that this decision has been delayed by many years, it is imperative that the UK Government and Department of Health implement this vaccine programme as quickly as possible and by September 2019 at the latest, that a catch-up programme for boys is introduced and, given the feminisation of HPV, that information materials on HPV vaccination that are targeted at boys, their parents and teachers are made widely available.
{"title":"Access to HPV vaccination for boys in the United Kingdom","authors":"G. Prue, D. Grimes, P. Baker, M. Lawler","doi":"10.1177/2399202618799691","DOIUrl":"https://doi.org/10.1177/2399202618799691","url":null,"abstract":"Human papillomavirus (HPV) is a common sexually transmitted infection. There is a well-established link between HPV and the development of cervical cancer, but HPV infection is also associated with vaginal and vulvar cancer, head and neck cancers as well as anal cancers in both sexes and penile cancer in men. Despite this, since its introduction in 2008, the United Kingdom has included only girls in its vaccination programme and, in 2017, suggested that it was not cost effective to extend the vaccine to adolescent boys. Men-who-have-sex-with-men (MSM) have been offered the HPV vaccine in the United Kingdom since 2016. A number of countries (21 to date) have implemented a universal HPV vaccination programme, with many countries arguing that female-only vaccination programmes protect males via herd immunity and that MSM will be protected via targeted vaccination programmes, although these may be limited in their effectiveness. Following an advocacy campaign to extend the HPV vaccination programme to boys in the United Kingdom, in July 2018 the Joint Commission for Vaccination and Immunisation recommended that boys should be included alongside 12/13-year-old girls in a school-based programme. Given that this decision has been delayed by many years, it is imperative that the UK Government and Department of Health implement this vaccine programme as quickly as possible and by September 2019 at the latest, that a catch-up programme for boys is introduced and, given the feminisation of HPV, that information materials on HPV vaccination that are targeted at boys, their parents and teachers are made widely available.","PeriodicalId":74158,"journal":{"name":"Medicine access @ point of care","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2018-09-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1177/2399202618799691","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"44160300","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}