Access to medicines and vaccines to prevent and treat non-communicable diseases (NCDs) is unaccep... more Access to medicines and vaccines to prevent and treat non-communicable diseases (NCDs) is unacceptably low worldwide. In the 2011 UN political declaration on the prevention and control of NCDs, heads of government made several commitments related to access to essential medicines, technologies, and vaccines for such diseases. 30 years of experience with policies for essential medicines and 10 years of scaling up of HIV treatment have provided the knowledge needed to address barriers to long-term eff ective treatment and prevention of NCDs. More medicines can be acquired within existing budgets with effi cient selection, procurement, and use of generic medicines. Furthermore, low-income and middle-income countries need to increase mobilisation of domestic resources to cater for the many patients with NCDs who do not have access to treatment. Existing initiatives for HIV treatment off er useful lessons that can enhance access to pharmaceutical management of NCDs and improve adherence to long-term treatment of chronic illness; policy makers should also address unacceptable inequities in access to controlled opioid analgesics. In addition to off -patent medicines, governments can promote access to new and future on-patent medicinal products through coherent and equitable health and trade policies, particularly those for intellectual property. Frequent confl icts of interest need to be identifi ed and managed, and indicators and targets for access to NCD medicines should be used to monitor progress. Only with these approaches can a diff erence be made to the lives of hundreds of millions of current and future patients with NCDs.
Previous theoretical and empirical work on health policy decisions about reimbursement focuses on... more Previous theoretical and empirical work on health policy decisions about reimbursement focuses on specific rationales such as effectiveness, economic considerations and equal access for equal needs. As reimbursement decisions take place in a social and political context we propose that the analysis of decision-making should incorporate factors, which go beyond those commonly discussed. As an example we chose three health technologies (sildenafil, rivastigmine and statins) to investigate how decisions about reimbursement of medicines are made in the United Kingdom National Health Service and what factors influence these decisions. From face-to-face, in-depth interviews with a purposive sample of 20 regional and national policy makers and stakeholders we identified two dimensions of decision-making, which extend beyond the rationales conventionally cited. The first dimension relates to the role of 'subjectivity' or 'the personal' in the decisions, including personal experiences of the condition and excitement about the novelty or potential benefit of the technology-these factors affect what counts as evidence, or how evidence is interpreted, in practice. The second dimension relates to the social and political function of decision-making and broadens what counts as the relevant ends of decision-making to include such things as maintaining relationships, avoiding organisational burden, generating politically and legally defensible decisions and demonstrating the willingness to care. More importantly, we will argue that these factors should not be treated as contaminants of an otherwise rational decision-making. On the contrary we suggest that they seem relevant, reasonable and also of substantial importance in considering in decisionmaking. Complementing the analysis of decision-making about reimbursement by incorporating these factors could increase our understanding and potentially improve decision-making.
Various mechanisms to ensure the protection of subjects in human research have been suggested, in... more Various mechanisms to ensure the protection of subjects in human research have been suggested, including the presence of witnesses during the informed consent process. For our commentary on the use of witnesses and their potential role and responsibility during the consent process, we start by addressing current guidelines for human subjects research in four Latin American countries. By using examples from public health research, we highlight some of the practical difficulties of using witnessed consent, from becoming a meaningless ritual at one end of the spectrum to the research subject feeling intimidated or coerced to participate at the other. Apart from these practical difficulties, it is unclear what responsibility the witness could and should have. We argue that there are important ethical questions about the role of witnesses that have not been adequately addressed in national and international regulations. This work addresses these gaps and argues that more debate is required to define the role and responsibilities of witnesses in the consent process, their training requirements and whether a universal legal requirement for witnessed consent, regardless of the type of research, is desirable.
To investigate the incidence and the severity of intravenous (i.v.) drug preparation and administ... more To investigate the incidence and the severity of intravenous (i.v.) drug preparation and administration errors in two countries and three pharmacy services. A disguised observational method was used to record details of the preparation and administration of prescribed i.v. drugs on two wards in each of three teaching hospitals: one with a traditional British ward pharmacy service (TBP) and two hospitals in Germany, one with a traditional ward stock supply (TGP) and one with a satellite pharmacy service (GSP) with unit dose system. Errors in i.v. drug preparation and administration and their potential significance. The number of observed preparations/administrations were: TBP 77/63, TGP 126/109 and GSP 134/106. The preparation error rates were: TBP 22% (95% confidence interval: 13-31%), TGP 23% (16-30%) and GSP 31% (23-39%). The administration error rates were TBP 27% (16-38%), TGP 49% (39-58%) and GSP 22% (14-30%). The percentage of administration errors on the wards with TGP was st...
The American journal of tropical medicine and hygiene, Jan 18, 2015
There are 300,000 estimated cases of Chagas disease in the United States but limited data on acce... more There are 300,000 estimated cases of Chagas disease in the United States but limited data on access to care. This study analyzed trends in access to care for Chagas disease in the United States and assessed the national and state barriers to access. Data on cases in blood donors and drug releases were obtained from the AABB (formerly American Association of Blood Banks) and U.S. Centers for Disease Control and Prevention (CDC), respectively. Semi-structured in-depth interviews were conducted with 30 key informants at the national level and in six states where treatment had been released. Interview responses were analyzed according to the health systems dimensions of regulation, financing, payment, organization, and persuasion. Data indicate that 1,908 cases were identified in the blood donation system from 2007 to 2013 and that CDC released 422 courses of benznidazole or nifurtimox during this period. The barriers to access at the national level include limited diagnostic and instit...
Journal of pharmaceutical policy and practice, 2014
Promoting generic medicines to increase access to essential medicines is relevant to achieve the ... more Promoting generic medicines to increase access to essential medicines is relevant to achieve the Millennium Development Goal (MDGs) and post 2015 goals. There are several barriers to encouraging wider use of generic medicines in health systems, e.g. the widely-held perception that low price equals low quality and misalignment of provider and consumer incentives. Overcoming the complex barriers and other challenges can be re-formulated as a 'generic medicine evidence-based policy agenda': (1) What policy and strategies can increase consumer trust in the quality of all medicines granted market authority including generic products? (2) Are there differences in prices between branded and unbranded generics? (3) What are synergies between policies that can enhance promoting of generic medicines effectively? Evaluating the policies promoting generic medicines will be critical to create evidence that countries can use to implement policies in their local settings.
To analyze medicine utilization and expenditure and associated factors in Mexico, as well as to d... more To analyze medicine utilization and expenditure and associated factors in Mexico, as well as to discuss their implications for pharmaceutical policy. Analysis of a sample of 193,228 individuals from the Mexican National Health and Nutrition Survey 2012. Probability and amount of expenditure were estimated using logit, probit and quantile regression models, evaluating three dimensions of access to medicines: (1) likelihood of utilization of medicines in the event of a health problem, (2) probability of incurring expenses and (3) amount spent on medicines. Individuals affiliated to IMSS were more likely to use medicines (OR=1.2, p<0.05). Being affiliated to the IMSS, ISSSTE or SP reduced the likelihood of spending compared to those without health insurance (about RM 0.7, p<0.01). Median expenditures varied between 195.3 and 274.2 pesos. Factors associated with the use and expenditure on medicines indicate that inequities in the access to medicines persist.
Unlike many other Latin American countries Mexico has no coherent and explicit national pharmaceu... more Unlike many other Latin American countries Mexico has no coherent and explicit national pharmaceutical policy (NPP). Other national challenges are: high out-of-pocket expenditure on medicines despite the implementation of universal health care coverage through Seguro Popular, high prices of medicines in the private sector in comparison to other countries when adjusted for income level, and the lack of clear strategies to improve safety and efficiency in the use of medicines, in particular interventions aimed at private physicians, pharmacies and consumers. The aim of this paper is to describe the challenges and opportunities to (1) consolidate the processes of formulating, implementing and evaluating NPP, and (2) define the policy content with regard to access and use of medicines.
To analyse the medicines prescription, prescription filling, payment expenditure for medicines by... more To analyse the medicines prescription, prescription filling, payment expenditure for medicines by ambulatory health service users (HSU) in 2006, and to evaluate its evolution in the last 12 years. Using data from the National Health Surveys in 2006 three binary logistic regression models were constructed to identify the variables associated with the prescription rate, prescription filling and payment for medicines in 2006. The results of access to medicines were compared to the ones from previous National Health Services from 1994 and 2000. The type of health service provider was found to be the most important predictors of access to medicines. Although the proportion of HSU obtaining a prescription and paying for drugs has broadly stayed the same as in 1994, the percentage of HSU paying for their prescribed medicines decreased from 70% in 1994 to 42% at Ministry of Health institutions in 2006. The progress in prescription and population access to medicines has been uneven across he...
Previous theoretical and empirical work on health policy decisions about reimbursement focuses on... more Previous theoretical and empirical work on health policy decisions about reimbursement focuses on specific rationales such as effectiveness, economic considerations and equal access for equal needs. As reimbursement decisions take place in a social and political context we propose that the analysis of decision-making should incorporate factors, which go beyond those commonly discussed. As an example we chose three health technologies (sildenafil, rivastigmine and statins) to investigate how decisions about reimbursement of medicines are made in the United Kingdom National Health Service and what factors influence these decisions. From face-to-face, in-depth interviews with a purposive sample of 20 regional and national policy makers and stakeholders we identified two dimensions of decision-making, which extend beyond the rationales conventionally cited. The first dimension relates to the role of 'subjectivity' or 'the personal' in the decisions, including personal experiences of the condition and excitement about the novelty or potential benefit of the technology-these factors affect what counts as evidence, or how evidence is interpreted, in practice. The second dimension relates to the social and political function of decision-making and broadens what counts as the relevant ends of decision-making to include such things as maintaining relationships, avoiding organisational burden, generating politically and legally defensible decisions and demonstrating the willingness to care. More importantly, we will argue that these factors should not be treated as contaminants of an otherwise rational decision-making. On the contrary we suggest that they seem relevant, reasonable and also of substantial importance in considering in decisionmaking. Complementing the analysis of decision-making about reimbursement by incorporating these factors could increase our understanding and potentially improve decision-making.
This paper highlights some of the limitations of models of patient involvement in decision-making... more This paper highlights some of the limitations of models of patient involvement in decision-making and explores the reasons for, and implications of, these limitations. Taking the three models of interpretative, shared and informed decision-making as examples, we focus on two limitations of the models: (1) neglect of which decisions the patient should be involved in (the framing problem) and how the patient should be involved in decision-making (the nature of reasoning problem). Although there will inevitably be a gap between models and practice-this much is in the nature of the models-we suggest that these two issues are substantially neglected by the models and yet are fundamental to understanding patient-doctor decision-making. We also suggest that the fundamental problem that lies behind these limitations is insufficient attention to, and explicitness about, the dilemmas of professional ethics, which are played out in the professional-patient relationships that the models are supposed to represent, particularly with respect to the issue of expert and lay accountability. r
To identify users' perception about ambulatory healthcare services quality and associated fac... more To identify users' perception about ambulatory healthcare services quality and associated factors in Mexico. Analysis of the 2006 and 2012 National Surveys of Health and Nutrition that included users' perception of healthcare services and improvement in health status. A multivariate regression analysis allowed identifying the associated factors with the perception of improved health status. Between 2006 and 2012, users' positive perception of healthcare services increased from 82 to 85%, and user report of improvement in health status increased from 79 to 81%. Health status improvement, explanations about the disease and treatment, being attended without appointment, freedom to choose the provider and short waiting time were associated with a perception of better quality of care. Users' perception about the quality of care in ambulatory healthcare settings has improved, yet it is still neccessary to strengthen organizational strategies to provide healthcare when need...
The American journal of tropical medicine and hygiene, 2014
Chagas disease is a neglected vector-borne disease with an estimated prevalence of 1.1 million ca... more Chagas disease is a neglected vector-borne disease with an estimated prevalence of 1.1 million cases in Mexico. Recent research showed that access to treatment of Chagas disease is limited in Mexico, with < 0.5% of infected cases treated. This brief report used quantitative data from the Morelos Program on Chagas disease and qualitative analysis of key informant interviews to examine strategies to increase treatment access for infected patients in Morelos, Mexico. From 2007 to 2011, 263 (9.2%) of the registered cases of Chagas disease in Mexico occurred in Morelos. Among these, 152 (57.8%) were treated and 97.3% of those treated received benznidazole. The assessment finds that state officials decided to directly purchase benznidazole from the distributor to increase access and improve clinical quality of treatment of patients in their state. They also faced significant barriers, especially in regulation and health system organization, which limited efforts to make high quality tr...
Various mechanisms to ensure the protection of subjects in human research have been suggested, in... more Various mechanisms to ensure the protection of subjects in human research have been suggested, including the presence of witnesses during the informed consent process. For our commentary on the use of witnesses and their potential role and responsibility during the consent process, we start by addressing current guidelines for human subjects research in four Latin American countries. By using examples from public health research, we highlight some of the practical difficulties of using witnessed consent, from becoming a meaningless ritual at one end of the spectrum to the research subject feeling intimidated or coerced to participate at the other. Apart from these practical difficulties, it is unclear what responsibility the witness could and should have. We argue that there are important ethical questions about the role of witnesses that have not been adequately addressed in national and international regulations. This work addresses these gaps and argues that more debate is requir...
To describe and evaluate policies implemented in Chile, Colombia, Venezuela and Mexico (1995-2009... more To describe and evaluate policies implemented in Chile, Colombia, Venezuela and Mexico (1995-2009) to prohibit antibiotic OTC sales and explore limitations in available data. We searched and analysed legislation, grey literature and peer-reviewed publications on regulatory interventions and implementation strategies to enforce prohibition of OTC antibiotic sales. We also assessed the impact using private sector retail sales data of antibiotics studying changes in level and consumption trends before and after the policy change using segmented time series analysis. Finally, we assessed the completeness and data quality through an established checklist to test the suitability of the data for analysis of the interventions. Whereas Chile implemented a comprehensive package of interventions to accompany regulation changes, Colombia&#39;s reform was limited to the capital district and Venezuela&#39;s limited to only some antibiotics and without awareness campaigns. In Mexico, no enforcement was enacted. The data showed a differential effect of the intervention among the countries studied with a significant change in level of consumption in Chile (-5.56 DID) and in Colombia (-1.00DID). In Venezuela and Mexico, no significant change in level and slope was found. Changes in population coverage were identified as principal limitations of using sales data for evaluating the reform impact. Retail sales data can be useful when assessing policy impact but should be supplemented by other data sources such as public sector sales and prescription data. Implementing regulatory enforcement has shown some impact, but a sustainable, concerted approach will be needed to address OTC sales in the future.
To compare the sociodemographic characteristics, reasons for attending, perception of quality and... more To compare the sociodemographic characteristics, reasons for attending, perception of quality and associated out-of-pocket (OOP) expenditures of doctors' offices adjacent to private pharmacies (DAPPs) users with users of Social Security (SS), Ministry of Health (MoH), private doctor's offices independent from pharmacies and non-users. Secondary data analysis of the 2012 National Survey of Health and Nutrition of Mexico. The study population comprised 25 852 individuals identified as having had a health problem 15 days before the survey, and a random sample of 12 799 ambulatory health service users. Sociodemographic characteristics, reasons for attending healthcare services, perception of quality and associated OOP expenditures. The distribution of users was as follows: DAPPs (9.2%), SS (16.1%), MoH (20.9%), private providers (15.4%) and non-users (38.5%); 65% of DAPP users were affiliated with a public institution (MoH 35%, SS 30%) and 35% reported not having health coverage...
To identify the current clinical, socio-demographic and obstetric factors associated with the var... more To identify the current clinical, socio-demographic and obstetric factors associated with the various types of delivery strategies in Mexico. This is a cross-sectional study based on the 2012 National Health and Nutrition Survey (ENSANUT) of 6,736 women aged 12 to 49 years. Delivery types discussed in this paper include vaginal delivery, emergency cesarean section and planned cesarean section. Using bivariate analyses, sub-population group differences were identified. Logistic regression models were applied, including both binary and multinomial outcome variables from the survey. The logistic regression results identify those covariates associated with the type of delivery. 53.1% of institutional births in the period 2006 through 2012 were vaginal deliveries, 46.9% were either a planned or emergency cesarean sections. The highest rates of this procedure were among women who reported a complication during delivery (OR: 4.21; 95%CI: 3.66-4.84), between the ages of 35 and 49 at the tim...
Access to medicines and vaccines to prevent and treat non-communicable diseases (NCDs) is unaccep... more Access to medicines and vaccines to prevent and treat non-communicable diseases (NCDs) is unacceptably low worldwide. In the 2011 UN political declaration on the prevention and control of NCDs, heads of government made several commitments related to access to essential medicines, technologies, and vaccines for such diseases. 30 years of experience with policies for essential medicines and 10 years of scaling up of HIV treatment have provided the knowledge needed to address barriers to long-term eff ective treatment and prevention of NCDs. More medicines can be acquired within existing budgets with effi cient selection, procurement, and use of generic medicines. Furthermore, low-income and middle-income countries need to increase mobilisation of domestic resources to cater for the many patients with NCDs who do not have access to treatment. Existing initiatives for HIV treatment off er useful lessons that can enhance access to pharmaceutical management of NCDs and improve adherence to long-term treatment of chronic illness; policy makers should also address unacceptable inequities in access to controlled opioid analgesics. In addition to off -patent medicines, governments can promote access to new and future on-patent medicinal products through coherent and equitable health and trade policies, particularly those for intellectual property. Frequent confl icts of interest need to be identifi ed and managed, and indicators and targets for access to NCD medicines should be used to monitor progress. Only with these approaches can a diff erence be made to the lives of hundreds of millions of current and future patients with NCDs.
Previous theoretical and empirical work on health policy decisions about reimbursement focuses on... more Previous theoretical and empirical work on health policy decisions about reimbursement focuses on specific rationales such as effectiveness, economic considerations and equal access for equal needs. As reimbursement decisions take place in a social and political context we propose that the analysis of decision-making should incorporate factors, which go beyond those commonly discussed. As an example we chose three health technologies (sildenafil, rivastigmine and statins) to investigate how decisions about reimbursement of medicines are made in the United Kingdom National Health Service and what factors influence these decisions. From face-to-face, in-depth interviews with a purposive sample of 20 regional and national policy makers and stakeholders we identified two dimensions of decision-making, which extend beyond the rationales conventionally cited. The first dimension relates to the role of 'subjectivity' or 'the personal' in the decisions, including personal experiences of the condition and excitement about the novelty or potential benefit of the technology-these factors affect what counts as evidence, or how evidence is interpreted, in practice. The second dimension relates to the social and political function of decision-making and broadens what counts as the relevant ends of decision-making to include such things as maintaining relationships, avoiding organisational burden, generating politically and legally defensible decisions and demonstrating the willingness to care. More importantly, we will argue that these factors should not be treated as contaminants of an otherwise rational decision-making. On the contrary we suggest that they seem relevant, reasonable and also of substantial importance in considering in decisionmaking. Complementing the analysis of decision-making about reimbursement by incorporating these factors could increase our understanding and potentially improve decision-making.
Various mechanisms to ensure the protection of subjects in human research have been suggested, in... more Various mechanisms to ensure the protection of subjects in human research have been suggested, including the presence of witnesses during the informed consent process. For our commentary on the use of witnesses and their potential role and responsibility during the consent process, we start by addressing current guidelines for human subjects research in four Latin American countries. By using examples from public health research, we highlight some of the practical difficulties of using witnessed consent, from becoming a meaningless ritual at one end of the spectrum to the research subject feeling intimidated or coerced to participate at the other. Apart from these practical difficulties, it is unclear what responsibility the witness could and should have. We argue that there are important ethical questions about the role of witnesses that have not been adequately addressed in national and international regulations. This work addresses these gaps and argues that more debate is required to define the role and responsibilities of witnesses in the consent process, their training requirements and whether a universal legal requirement for witnessed consent, regardless of the type of research, is desirable.
To investigate the incidence and the severity of intravenous (i.v.) drug preparation and administ... more To investigate the incidence and the severity of intravenous (i.v.) drug preparation and administration errors in two countries and three pharmacy services. A disguised observational method was used to record details of the preparation and administration of prescribed i.v. drugs on two wards in each of three teaching hospitals: one with a traditional British ward pharmacy service (TBP) and two hospitals in Germany, one with a traditional ward stock supply (TGP) and one with a satellite pharmacy service (GSP) with unit dose system. Errors in i.v. drug preparation and administration and their potential significance. The number of observed preparations/administrations were: TBP 77/63, TGP 126/109 and GSP 134/106. The preparation error rates were: TBP 22% (95% confidence interval: 13-31%), TGP 23% (16-30%) and GSP 31% (23-39%). The administration error rates were TBP 27% (16-38%), TGP 49% (39-58%) and GSP 22% (14-30%). The percentage of administration errors on the wards with TGP was st...
The American journal of tropical medicine and hygiene, Jan 18, 2015
There are 300,000 estimated cases of Chagas disease in the United States but limited data on acce... more There are 300,000 estimated cases of Chagas disease in the United States but limited data on access to care. This study analyzed trends in access to care for Chagas disease in the United States and assessed the national and state barriers to access. Data on cases in blood donors and drug releases were obtained from the AABB (formerly American Association of Blood Banks) and U.S. Centers for Disease Control and Prevention (CDC), respectively. Semi-structured in-depth interviews were conducted with 30 key informants at the national level and in six states where treatment had been released. Interview responses were analyzed according to the health systems dimensions of regulation, financing, payment, organization, and persuasion. Data indicate that 1,908 cases were identified in the blood donation system from 2007 to 2013 and that CDC released 422 courses of benznidazole or nifurtimox during this period. The barriers to access at the national level include limited diagnostic and instit...
Journal of pharmaceutical policy and practice, 2014
Promoting generic medicines to increase access to essential medicines is relevant to achieve the ... more Promoting generic medicines to increase access to essential medicines is relevant to achieve the Millennium Development Goal (MDGs) and post 2015 goals. There are several barriers to encouraging wider use of generic medicines in health systems, e.g. the widely-held perception that low price equals low quality and misalignment of provider and consumer incentives. Overcoming the complex barriers and other challenges can be re-formulated as a 'generic medicine evidence-based policy agenda': (1) What policy and strategies can increase consumer trust in the quality of all medicines granted market authority including generic products? (2) Are there differences in prices between branded and unbranded generics? (3) What are synergies between policies that can enhance promoting of generic medicines effectively? Evaluating the policies promoting generic medicines will be critical to create evidence that countries can use to implement policies in their local settings.
To analyze medicine utilization and expenditure and associated factors in Mexico, as well as to d... more To analyze medicine utilization and expenditure and associated factors in Mexico, as well as to discuss their implications for pharmaceutical policy. Analysis of a sample of 193,228 individuals from the Mexican National Health and Nutrition Survey 2012. Probability and amount of expenditure were estimated using logit, probit and quantile regression models, evaluating three dimensions of access to medicines: (1) likelihood of utilization of medicines in the event of a health problem, (2) probability of incurring expenses and (3) amount spent on medicines. Individuals affiliated to IMSS were more likely to use medicines (OR=1.2, p<0.05). Being affiliated to the IMSS, ISSSTE or SP reduced the likelihood of spending compared to those without health insurance (about RM 0.7, p<0.01). Median expenditures varied between 195.3 and 274.2 pesos. Factors associated with the use and expenditure on medicines indicate that inequities in the access to medicines persist.
Unlike many other Latin American countries Mexico has no coherent and explicit national pharmaceu... more Unlike many other Latin American countries Mexico has no coherent and explicit national pharmaceutical policy (NPP). Other national challenges are: high out-of-pocket expenditure on medicines despite the implementation of universal health care coverage through Seguro Popular, high prices of medicines in the private sector in comparison to other countries when adjusted for income level, and the lack of clear strategies to improve safety and efficiency in the use of medicines, in particular interventions aimed at private physicians, pharmacies and consumers. The aim of this paper is to describe the challenges and opportunities to (1) consolidate the processes of formulating, implementing and evaluating NPP, and (2) define the policy content with regard to access and use of medicines.
To analyse the medicines prescription, prescription filling, payment expenditure for medicines by... more To analyse the medicines prescription, prescription filling, payment expenditure for medicines by ambulatory health service users (HSU) in 2006, and to evaluate its evolution in the last 12 years. Using data from the National Health Surveys in 2006 three binary logistic regression models were constructed to identify the variables associated with the prescription rate, prescription filling and payment for medicines in 2006. The results of access to medicines were compared to the ones from previous National Health Services from 1994 and 2000. The type of health service provider was found to be the most important predictors of access to medicines. Although the proportion of HSU obtaining a prescription and paying for drugs has broadly stayed the same as in 1994, the percentage of HSU paying for their prescribed medicines decreased from 70% in 1994 to 42% at Ministry of Health institutions in 2006. The progress in prescription and population access to medicines has been uneven across he...
Previous theoretical and empirical work on health policy decisions about reimbursement focuses on... more Previous theoretical and empirical work on health policy decisions about reimbursement focuses on specific rationales such as effectiveness, economic considerations and equal access for equal needs. As reimbursement decisions take place in a social and political context we propose that the analysis of decision-making should incorporate factors, which go beyond those commonly discussed. As an example we chose three health technologies (sildenafil, rivastigmine and statins) to investigate how decisions about reimbursement of medicines are made in the United Kingdom National Health Service and what factors influence these decisions. From face-to-face, in-depth interviews with a purposive sample of 20 regional and national policy makers and stakeholders we identified two dimensions of decision-making, which extend beyond the rationales conventionally cited. The first dimension relates to the role of 'subjectivity' or 'the personal' in the decisions, including personal experiences of the condition and excitement about the novelty or potential benefit of the technology-these factors affect what counts as evidence, or how evidence is interpreted, in practice. The second dimension relates to the social and political function of decision-making and broadens what counts as the relevant ends of decision-making to include such things as maintaining relationships, avoiding organisational burden, generating politically and legally defensible decisions and demonstrating the willingness to care. More importantly, we will argue that these factors should not be treated as contaminants of an otherwise rational decision-making. On the contrary we suggest that they seem relevant, reasonable and also of substantial importance in considering in decisionmaking. Complementing the analysis of decision-making about reimbursement by incorporating these factors could increase our understanding and potentially improve decision-making.
This paper highlights some of the limitations of models of patient involvement in decision-making... more This paper highlights some of the limitations of models of patient involvement in decision-making and explores the reasons for, and implications of, these limitations. Taking the three models of interpretative, shared and informed decision-making as examples, we focus on two limitations of the models: (1) neglect of which decisions the patient should be involved in (the framing problem) and how the patient should be involved in decision-making (the nature of reasoning problem). Although there will inevitably be a gap between models and practice-this much is in the nature of the models-we suggest that these two issues are substantially neglected by the models and yet are fundamental to understanding patient-doctor decision-making. We also suggest that the fundamental problem that lies behind these limitations is insufficient attention to, and explicitness about, the dilemmas of professional ethics, which are played out in the professional-patient relationships that the models are supposed to represent, particularly with respect to the issue of expert and lay accountability. r
To identify users' perception about ambulatory healthcare services quality and associated fac... more To identify users' perception about ambulatory healthcare services quality and associated factors in Mexico. Analysis of the 2006 and 2012 National Surveys of Health and Nutrition that included users' perception of healthcare services and improvement in health status. A multivariate regression analysis allowed identifying the associated factors with the perception of improved health status. Between 2006 and 2012, users' positive perception of healthcare services increased from 82 to 85%, and user report of improvement in health status increased from 79 to 81%. Health status improvement, explanations about the disease and treatment, being attended without appointment, freedom to choose the provider and short waiting time were associated with a perception of better quality of care. Users' perception about the quality of care in ambulatory healthcare settings has improved, yet it is still neccessary to strengthen organizational strategies to provide healthcare when need...
The American journal of tropical medicine and hygiene, 2014
Chagas disease is a neglected vector-borne disease with an estimated prevalence of 1.1 million ca... more Chagas disease is a neglected vector-borne disease with an estimated prevalence of 1.1 million cases in Mexico. Recent research showed that access to treatment of Chagas disease is limited in Mexico, with < 0.5% of infected cases treated. This brief report used quantitative data from the Morelos Program on Chagas disease and qualitative analysis of key informant interviews to examine strategies to increase treatment access for infected patients in Morelos, Mexico. From 2007 to 2011, 263 (9.2%) of the registered cases of Chagas disease in Mexico occurred in Morelos. Among these, 152 (57.8%) were treated and 97.3% of those treated received benznidazole. The assessment finds that state officials decided to directly purchase benznidazole from the distributor to increase access and improve clinical quality of treatment of patients in their state. They also faced significant barriers, especially in regulation and health system organization, which limited efforts to make high quality tr...
Various mechanisms to ensure the protection of subjects in human research have been suggested, in... more Various mechanisms to ensure the protection of subjects in human research have been suggested, including the presence of witnesses during the informed consent process. For our commentary on the use of witnesses and their potential role and responsibility during the consent process, we start by addressing current guidelines for human subjects research in four Latin American countries. By using examples from public health research, we highlight some of the practical difficulties of using witnessed consent, from becoming a meaningless ritual at one end of the spectrum to the research subject feeling intimidated or coerced to participate at the other. Apart from these practical difficulties, it is unclear what responsibility the witness could and should have. We argue that there are important ethical questions about the role of witnesses that have not been adequately addressed in national and international regulations. This work addresses these gaps and argues that more debate is requir...
To describe and evaluate policies implemented in Chile, Colombia, Venezuela and Mexico (1995-2009... more To describe and evaluate policies implemented in Chile, Colombia, Venezuela and Mexico (1995-2009) to prohibit antibiotic OTC sales and explore limitations in available data. We searched and analysed legislation, grey literature and peer-reviewed publications on regulatory interventions and implementation strategies to enforce prohibition of OTC antibiotic sales. We also assessed the impact using private sector retail sales data of antibiotics studying changes in level and consumption trends before and after the policy change using segmented time series analysis. Finally, we assessed the completeness and data quality through an established checklist to test the suitability of the data for analysis of the interventions. Whereas Chile implemented a comprehensive package of interventions to accompany regulation changes, Colombia&#39;s reform was limited to the capital district and Venezuela&#39;s limited to only some antibiotics and without awareness campaigns. In Mexico, no enforcement was enacted. The data showed a differential effect of the intervention among the countries studied with a significant change in level of consumption in Chile (-5.56 DID) and in Colombia (-1.00DID). In Venezuela and Mexico, no significant change in level and slope was found. Changes in population coverage were identified as principal limitations of using sales data for evaluating the reform impact. Retail sales data can be useful when assessing policy impact but should be supplemented by other data sources such as public sector sales and prescription data. Implementing regulatory enforcement has shown some impact, but a sustainable, concerted approach will be needed to address OTC sales in the future.
To compare the sociodemographic characteristics, reasons for attending, perception of quality and... more To compare the sociodemographic characteristics, reasons for attending, perception of quality and associated out-of-pocket (OOP) expenditures of doctors' offices adjacent to private pharmacies (DAPPs) users with users of Social Security (SS), Ministry of Health (MoH), private doctor's offices independent from pharmacies and non-users. Secondary data analysis of the 2012 National Survey of Health and Nutrition of Mexico. The study population comprised 25 852 individuals identified as having had a health problem 15 days before the survey, and a random sample of 12 799 ambulatory health service users. Sociodemographic characteristics, reasons for attending healthcare services, perception of quality and associated OOP expenditures. The distribution of users was as follows: DAPPs (9.2%), SS (16.1%), MoH (20.9%), private providers (15.4%) and non-users (38.5%); 65% of DAPP users were affiliated with a public institution (MoH 35%, SS 30%) and 35% reported not having health coverage...
To identify the current clinical, socio-demographic and obstetric factors associated with the var... more To identify the current clinical, socio-demographic and obstetric factors associated with the various types of delivery strategies in Mexico. This is a cross-sectional study based on the 2012 National Health and Nutrition Survey (ENSANUT) of 6,736 women aged 12 to 49 years. Delivery types discussed in this paper include vaginal delivery, emergency cesarean section and planned cesarean section. Using bivariate analyses, sub-population group differences were identified. Logistic regression models were applied, including both binary and multinomial outcome variables from the survey. The logistic regression results identify those covariates associated with the type of delivery. 53.1% of institutional births in the period 2006 through 2012 were vaginal deliveries, 46.9% were either a planned or emergency cesarean sections. The highest rates of this procedure were among women who reported a complication during delivery (OR: 4.21; 95%CI: 3.66-4.84), between the ages of 35 and 49 at the tim...
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Papers by Veronika Wirtz