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Infection prevention and control (IPC) measures are critical in preventing the risk of acquiring and transmitting nosocomial infections. In Zambia, there is little information concerning IPC practices among pharmacy students who are exposed to potentially infectious areas both in public and private healthcare settings. Therefore, this study assessed the knowledge, attitude, and practices of undergraduate pharmacy students toward infection prevention and control at the University of Zambia.
Materials and methods:
This cross-sectional study was conducted among 290 undergraduate pharmacy students at the University of Zambia using a structured questionnaire from August 2022 to October 2022. Data analysis was performed using SPSS version 25.0, and statistical significance was set at a 95% confidence level.
Results:
Of the 290 participants, 166(57.2%) were female and the majority were aged between 18 and 23 years. Overall, 252(86.9%) had good knowledge, 167(57.6%) had positive attitudes, and 248(85.5%) had good practices toward IPC measures. These results indicate lower attitude scores compared to knowledge and practices. Having good knowledge of IPC was associated with being a Christian by religion compared to other religions (OR = 5.314, 95% CI: 1.141–24.745). There was no association between sociodemographics and attitude and practice concerning IPC.
Conclusion:
This study found that pharmacy students had good knowledge, positive attitudes, and good practices toward IPC measures. Consequently, more emphasis is needed to improve the student’s knowledge, attitudes, and practices toward IPC, especially in areas where gaps were identified. Additionally, there is a need to improve curricula on IPC measures in the training of pharmacy programs.
Infection prevention and control (IPC) measures are easily adoptable activities to prevent the spread of infection to patients as well as among health-care workers (HCWs).
Methods:
This cross-sectional study evaluated the adherence to IPC measures among HCWs working at coronavirus disease 2019 (COVID-19) treatment centers in Punjab, Pakistan. HCWs were recruited by means of convenient sampling through Google Form® using the World Health Organization risk assessment tool. All data were analyzed using SPSS 20.
Results:
A total of 414 HCWs completed the survey (response rate = 67.8%), and majority of them were males (56.3%). Most of the HCWs were nurses (39.6%) followed by medical doctors (27.3%). Approximately 53% reported insufficiency of personal protective equipment (PPE), 58.2% did not receive IPC training and 40.8% did not have functional IPC team at their health facilities. The majority of HCWs (90%) used disposable gloves and N95 facemasks while interacting with COVID-19 patients. Nearly 45% used protective face shields and gowns before providing care to their patients. Hand hygiene practices while touching, and performing any aseptic procedure was adopted by 70.5% and 74.1% of HCWs, respectively.
Conclusions:
In conclusion, the adherence to IPC measures among Pakistani HCWs working in COVID-19 treatment centers is good despite the limited availability of PPEs. Their practices can be optimized by establishing institutional IPC teams, periodic provision of IPC training, and necessary PPE.
The principle of pragmatism in clinical trials has been broadly recognised as a way to close the gap between research and practice. In this contribution, we argue that the conduct of pragmatic clinical trials in Europe may be hampered by poor implementation of current European Union's Clinical Trial Regulation No. 536/2014.
The growing prevalence of non-communicable diseases, combined with greater recognition of the effectiveness of lipid lowering agents (LLAs), has fuelled their increasing use in recent years. Similarly, increasing recognition of mental health and, arguably, societal expectations and pressures, has driven appreciable growth in antidepressant prescribing in recent years. Concurrent with this, growing resource pressures enhanced by the continual launch of new premium priced medicines necessitates reforms and initiatives within finite budgets. Scotland has introduced multiple measures in recent years to improve both the quality and efficiency of prescribing. There is a need to document these initiatives and outcomes to provide future direction.
Methods
Assessment of the utilization (items dispensed) and expenditure of key LLAs (mainly statins) and SSRIs between 2001 and 2017 in Scotland alongside initiatives.
Results
Multiple interventions have increased international non-proprietary name (INN) prescribing (99% for statins and up to 99.9% for SSRIs). They have also increased preferential prescribing of generic versus patented statins with low costs for generics, reduced inappropriate prescribing of ezetimibe due to effectiveness concerns, and increased the prescribing of higher dose statins (71% in 2015). These measures have resulted in a 50% reduction in LLA expenditure between 2001 and 2015 despite a 412% increase in utilization. Initiatives to reduce the prescribing of escitalopram as lack of evidence demonstrating cost-benefits over generic citalopram, along with high INN prescribing, achieved a 73.7% reduction in SSRI expenditure between 2001 and 2017 despite a 2.34-fold increase in utilisation. Concerns with paroxetine, and more recently citalopram and escitalopram following safety warnings, resulted in a considerable reduction in their use alongside a significant increase in sertraline.
Conclusions
Generic availability coupled with multiple measures has resulted in appreciable shifts in statin and SSRI prescribing behavior and reduced ezetimibe prescribing, resulting in improvements in both the quality and efficiency of prescribing to provide future direction.
The Zika virus is a newly emerging infection associated with increasingly large outbreaks especially in countries such as Brazil where an estimated 326,224 cases were confirmed between 2015 and 2018. Common symptoms associated with Zika include headache, conjunctivitis, fever, erythema, myalgia, vomiting, diarrhea, and abdominal pain. However, the symptoms are usually self-limiting and last on average for 4 to 7 days, with patients typically not accessing the public healthcare system (SUS). In severe cases, symptoms include neurological disorders and neonatal malformations. A future Zika vaccine can contribute to decreasing the number of cases and associated complications. However, this has to be balanced against continuing costs to control this and other vector borne diseases. Consequently, information about consumers’ willingness to pay (WTP) for a hypothetical Zika vaccine can help with price setting discussions in Brazil starting with the private market before being considered within SUS.
Methods
A cross-sectional study was conducted among residents in one of the main provinces of Brazil (Minas Gerais) regarding their WTP for a hypothetical Zika vaccine with agreed characteristics. This included a mean effective protection of 80 percent, with the possibility of some local and systemic side-effects. The discussed price was USD 56.41 (BRL 180.00) per vaccination as this figure was utilized in a previous WTP study for a dengue vaccine.
Results
Five hundred and seventeen people were interviewed. However, thirty would not be vaccinated even if the vaccine was free. Most of the resultant interviewees (489) were female (58.2 percent), were employed (71.2 percent), had private health insurance (52.7 percent), had household incomes above twice the minimum wage (69.8 percent) and did not have Zika (96.9 percent). The median individual maximum WTP for this hypothetical Zika vaccine was USD 31.34 (BRL 100.00).
Conclusions
WTP research can contribute to decision-making about possible prices alongside other economic criteria once a Zika vaccine becomes available in Brazil alongside other programmes to control the virus.
Hemodialysis (HD) and peritoneal dialysis (PD) are commonly used to treat patients with end-stage renal disease (ESRD). However, their costs have grown considerably in recent years as the rates of non-communicable diseases including diabetes and hypertension have grown. This will adversely impact on national health budgets especially in low- and middle-income countries (LMICs). Currently, there is limited knowledge about the costs of ESRD and the different components within the public healthcare system in South Africa. Consequently, our objective was to examine the direct medical costs of both approaches from a public provider perspective to provide future guidance.
Methods
A prospective observational study undertaken at a leading public hospital in South Africa based principally on patients’ notes and costs from nationally procured lists. A micro-costing approach was used to estimate health care costs among adult patients with ESRD who had received either HD and PD for at least 3 months.
Results
The majority of patients (35 percent) were aged 40 to 50 years. Patients aged 29-39 years were mostly on HD (28 percent) while those between 51-59 years mostly on PD (29 percent), with HD typically managed in the private sector with limited facilities in the public sector. The average age of patients on HD and PD was 41 and 42 years respectively. Variable costs (USD 20, 488.79) were the highest cost component for PD patients with fixed costs the highest component for HD patients ((USD 16,231.45). The annual cost of HD (USD 31,993.12) was higher than PD (USD 25,282 per patient) but not statistically significant (p = 0.816). The overall burden if appreciably more patients with ESRD are managed appropriately within the public system (covering 80 percent of the population) would be considerable and become unaffordable.
Conclusions
HD costs more than PD. These cost estimates are useful for carrying out future health economic analyses and for allocating greater resources to prevent progress to ESRD.
To synthetize the state of the art of methods for identifying candidate technologies for disinvestment and propose an evidence-based framework for executing this task.
Methods
An interpretative review was conducted. A systematic literature search was performed to identify secondary or tertiary research related to disinvestment initiatives and/or any type of research that specifically described one or more methods for identifying potential candidates technologies, services, or practices for disinvestment. An iterative and critical analysis of the methods described alongside the disinvestment initiatives was performed.
Results
Seventeen systematic reviews on disinvestment or related terms (health technology reassessment or medical reversal) were retrieved and methods of 45 disinvestment initiatives were compared. On the basis of this evidence, we proposed a new framework for identifying these technologies based on the wide definition of evidence provided by Lomas et al. The framework comprises seven basic approaches, eleven triggers and thirteen methods for applying these triggers, which were grouped in embedded and ad hoc methods.
Conclusions
Although identification methods have been described in the literature and tested in different contexts, the proliferation of terms and concepts used to describe this process creates considerable confusion. The proposed framework is a rigorous and flexible tool that could guide the implementation of strategies for identifying potential candidates for disinvestment.
There is continuing controversy surrounding the funding of insulin glargine versus neutral protamine Hagedorn (NPH) insulin in Brazil, due to substantial differences in their prices, and recent meta-analyses of randomized controlled trials and independent observational studies that show no difference in effectiveness; however, sponsored observational studies show greater effectiveness of insulin glargine. Overall, the cost-effectiveness of insulin glargine in Brazil is controversial. In view of the continuing controversy, there is a need to address this using patient level data within the public health system in Brazil.
Methods:
We conducted a retrospective historical cohort study of type 1diabetes patients receiving insulin glargine from January 2011 to January 2015, including patients in the public health system in Minas Gerais. Variables included (i) demographic variables, (ii) clinical variables e.g. time with a diagnosis of type 1 diabetes, (iii) treatment characteristics, and (iv) laboratory results of HbA1c. Individuals were compared with themselves in an analysis of HbA1c values before and after six months of using insulin glargine, with each patient acting as their own control.
Results:
Five hundred and eighty patients were included in the study. HbA1c varied from 8.80±1.98 percent in NPH insulin users to 8.54±1.88 percent after insulin glargine for six months, which is not clinically significant. The frequency of glycemic control varied from 22.6 percent with NPH insulin to 26.2 percent with insulin glargine. No statistically significant difference was observed between groups for all analyzed factors, including type and frequency of insulin use and carbohydrate counting.
Conclusions:
There were limited differences between NPH insulins and insulin analogues in this real world study. As a result, the continued appreciable cost difference in between insulin glargine and NPH insulin in Brazil cannot be justified.
Candidate health technologies identified for disinvestment will require prioritization depending on the system's capacity for dealing with the assessments or for further considerations. Compilations of low value lists, such as the National Institutes for Health and Clinical Excellence's, “Do not do recommendations”, can serve as databases for prioritization topics. Prioritization processes can also be triggered by experience or event-based regional requests and decisions; new evidence on safety, effectiveness and cost-effectiveness, variations in clinical practice, patient or consumer voicing, discrepancies between practice and guidelines; and or time-based mechanisms, such as approval of new health technologies and reassessment five years after introduction.
Methods:
A search of the published and grey literature was conducted to identify the current methods or tools used to prioritize potential health technologies and services for disinvestment. The description of the methods and tools identified, the prioritization criteria, and the stakeholders involved in the process were reviewed and summarized.
Results:
The methods and tools used for prioritization that were identified in the literature include the PriTec Prioritization tool, nominal group technique, Program Budgeting and Marginal Analysis, consensus building, and online surveys. Further, common criteria for prioritization centered on the disease burden, possible risks and benefits, costs and cost-effectiveness, utilization, and time-based criteria. Prioritization can be conducted by health care professionals, decision makers, patients or patient groups and representative community members.
Conclusions:
The prioritization process for disinvestment candidates should be transparent and guided largely by evidence. It is highly recommended that the list of predefined criteria be developed with input from all relevant stakeholders to meet the objectives of the specific health care setting. The commonly cited basic requirements include clinical parameters, economic measures, and social, ethical or legal considerations.
The use of long-acting insulin analogues have been reported in patients with type 1 diabetes mellitus who exhibit important oscillations of their daily blood glucose, although the therapeutic benefits are lacking. The aim of this study was to evaluate the effectiveness and safety of the insulin analogue glargine compared detemir to support health decision-making.
Methods:
We performed a systematic review with meta-analysis of observational studies (cohort and registry), available in the MEDLINE (Pubmed), Latin American and Caribbean Health Sciences (LILACS), EMBASE and Cochrane Library databases (accessed August 2017), including research in the electronic journal Diabetes Care and gray literature. Several combinations of terms were used, including disease terms, interventions and type of study. The results evaluated were: glycated hemoglobin; weight gain; occurrence of severe hypoglycemia; total insulin dose; and, fasting capillary glycemia. Methodological quality was assessed using the Newcastle scale. The meta-analyses were performed in Review Manager® 5.2 software using a random effects model. Protocol number CRD42017054925 (International Prospective Register of Ongoing Systematic Reviews).
Results:
A total of 705 publications, eight cohort studies were included. The quality of included studies was classified as high. In the meta-analysis, the results for episodes of severe hypoglycemia (p = 0.002), measurements of fasting capillary glycemia (p = 0.01), and weight gain (p = 0.001) were favorable for detemir. The glycated hemoglobin endpoint (p = 0.49, heterogeneity = 89 percent) revealed high heterogeneity and no statistically significant difference between groups, showing no difference between the interventions for glycemic control.
Conclusions:
Although some results are favorable to detemir, it was not possible to identify significant differences in effectiveness and safety between the two analogues evaluated, requiring new long term studies and better quality of methodological studies.
Health technology has no or low added value when it is harmful and/or is deemed to deliver limited health gain relative to its cost, representing inefficient health resource allocation. A joint effort by the Health Technology Assessment International (HTAi) interest group (IG) on disinvestment and early awareness, the IG on ethics, the EuroScan network and the International Network of Agencies for Health Technology Assessment (INAHTA) is aiming to design a toolkit that could aid organizations and individuals considering disinvestment activities. We synthesized state of the art methods for identifying candidate technologies for disinvestment, and propose a framework for executing this task.
Methods:
We searched systematic reviews on disinvestment and compared the methods used for identifying potential candidates. A descriptive analysis was performed including sources of evidence used and methods for selection / filtration.
Results:
Ten systematic reviews were retrieved, and the methods of 29 disinvestment initiatives were compared. A new framework for identifying potential candidates was proposed which comprises seven basic approaches based on the wide definition of evidence provided by Lomas et al.; 11 triggers for disinvestment were adapted from Elshaug's proposal, and 13 methods for applying these triggers that were grouped in embedded and ad-hoc methods.
Conclusions:
Identification methods have been described in the literature, and have been tested in different contexts. Context is crucial in determining the ‘not to do’ practices as they are described in different sources.
Patients are the people who, with their informed consent, receive medical interventions. It is important, therefore, that patients have an understanding of interventions and their potential as a treatment for their condition. Patients are becoming more informed about their health care and the treatments that are available to them. At a population level, the potential benefits and harms of treatments need to be regularly assessed. This is part of healthcare decision making at a policy level about what treatments are publically available. As technology develops and old methods are replaced by new and evidence-based interventions and procedures, healthcare payers look to streamline their payment schedules and disinvest in old technologies and procedures. Some users of health care are reluctant to let go of outmoded methods, so disinvestment is best achieved through transparent processes. Successful engagement with key stakeholders of health care, engaging with payers, health service administrators, clinicians and patients, can facilitate implementation of disinvestment processes.
Methods:
To assist in this process, Health Technology Assessment International (HTAi) Interest Groups and EuroScan have come together to develop the following key points to consider in the involvement and engagement of clinicians, patients, and the public in the disinvestment of services and technologies.
Results:
The best time to involve clinicians and patient representatives is right at the beginning of the process. Clinicians and patients can make valuable contributions as advisory committee members. The disinvestment processes may be led by clinicians, payers, or independent organizations. This will likely influence commitment of clinicians to the process.
Conclusions:
Broader consultation with clinicians, patients and the public in the development and consideration of draft reports and recommendations can increase the transparency of the disinvestment process. Consultation is an important means of obtaining buy in. Feedback needs to be seen as taken seriously, and explanations given for any changes made or not made to the report and its recommendations.
Quality of life (QoL) is an important health measure and is widely used to assess the difference between treatments for Type 1 Diabetes Mellitus (T1DM) since the desirable glycemic control and the minimization of episodes of hypoglycemia are fundamental aspects for a better QoL. This study aims to identify the factors associated with QoL in patients with T1DM.
Methods:
A cross-sectional study (approved by ethics committee) was carried out in the state of Minas Gerais with 401 T1DM patients who used insulin glargine (GLA) selected in March 2017, and 179 patients who used insulin-neutral protamine (NPH) selected between January and February 2014, and both groups were treated by Brazilian National Health System (SUS). A questionnaire with three blocks was used: A) sociodemographic data; B) clinical data and access to the service; and C) QoL by Euroqol (EQ-5D-3L). We used multiple linear regression model by the forward stepwise method to access the correlation between the utilities of the EQ-5D-3L and all the explanatory variables (blocks A and B). We adopted the significance level and confidence interval of 95 percent (95% CI).
Results:
Of the 580 patients evaluated, 54 percent were women, 47 percent were in the age group between 18–40 years, 53 percent reported to be non-black. The EQ-5D-3L analysis showed patients treated with insulin analogue GLA had an average utility of 0.849 and those treated with NPH insulin 0.722 (p < 0.000). Individuals young, very good/good health self-perception, having not been bedridden in the last 15 days, zero to three medical appointments in the last year, no hospitalization in the last year, regular physical activity in the last 15 days to practice physical exercise, having between zero and three comorbidities and no severe hypoglycemia in the last 30 days were explained 41.3 percent of QoL. The type of insulin therapy, GLA or NPH, did not enter into the final multiple regression model.
Conclusions:
The findings of this study pointed to a lack of correlation between insulin therapy and QoL of patients with T1DM. Sociodemographic and clinical factors were more important to explain the QoL of diabetics. In addition, the evidence pointed to the importance of episodes of hypoglycemia for Qol. Of the 191 episodes of hypoglycemia (non-severe and severe) reported, 66 percent were from patients treated with GLA.
Rheumatoid arthritis (RA) is an inflammatory, autoimmune disease of unknown etiology that usually results in joint lesions and physical incapacitation. RA treatment includes disease-modifying antirheumatic drugs (DMARD), synthetic (sDMARD) and/or biologics (bDMARD). In this study we carried out a cost-utility analysis comparing Adalimumab (ADA) versus Etanercept (ETA), with or without synthetic DMARDs (± sDMARD).
METHODS:
Effectiveness measures used were the Clinical Disease Activity Index (CDAI) and Quality-Adjusted Life Years (QALY) obtained from an open prospective cohort study with Brazilian RA patients. Costs were obtained from a historical cohort composed of every patient who was prescribed medicines to treat RA in the State of Minas Gerais, Brazil. A public sector perspective was adopted. The Markov model included six-month cycles, time horizon of 5 years and 5 percent discount rates. Sensitivity analyses were performed by varying costs and outcome values.
RESULTS:
There was no significant difference in effectiveness between the two bDMARDs. Treatment with ETA (± sDMARD) was more expensive after 5 years of follow-up: incremental cost of USD28,210.87. Overall, treatment with ADA (± sDMARD) was more cost-effective: incremental cost-effectiveness ratio for ETA (± sDMARD) was USD79,148.34/ QALY. Sensitivity analysis showed that this was sensitive to changes in the cost of ETA (± sDMARD).
CONCLUSIONS:
Currently two Anti-tumour Necrosis Factor Alpha (anti-TNF alpha) medicines – ADA and ETA are available within the Brazilian public health system in addition to infliximab. Treatment with ADA (±sDMARD) was more cost-effective with an incremental cost effectiveness ratio for ETA (±sDMARD) at USD79,148.34 per QALY. Sensitivity analysis showed that outcomes are sensitive to changes in the cost of ETA (± sDMARD) treatment. Overall, both therapeutic alternatives are valuable from the public sector perspective especially when the Clinical Protocol and Therapeutic Guidelines are properly applied in patients no longer responding to treatment. Alternatives are needed as some patients will respond differently to different anti-TNF alpha medicines.
Biological disease-modifying anti-rheumatic drugs (bDMARDs) have become firmly established in the management of patients with rheumatoid arthritis (RA), but some patients do not improve despite therapy. This study evaluated the predictors of effectiveness of the bDMARDs on a cohort of patients with rheumatoid arthritis (RA) in the Brazilian Public Health System.
METHODS:
RA individuals treated with bDMARDs, were included in the open prospective cohort study. The Clinical Disease Activity Index (CDAI) was used to assess the effectiveness comparing results at baseline and after 6 months of follow-up. The association between socio-demographic and clinical characteristics with the disease activity measured by the CDAI was also investigated. The bDMARDs was considered effective when the patient achieved remission or low disease activity and considered not effective when there was still moderate or high disease activity. Pearson's chi-square was applied for the univariate analysis to evaluate the association of effectiveness measured by the CDAI with the socio-demographic (gender, education, marital status and race) and clinical variables (type of drug, EuroQol (EQ)-5D and Health Assessment Questionnaire (HAQ)). Logistic regression was applied in the multivariate analysis of the variables that presented a p< .20 value during the univariate analysis.
RESULTS:
All 266 RA patients completed six months of follow-up. The most widely used bDMARDs was adalimumab (57.1 percent), with etanercept used by 22.2 percent, golimumab by 7.5 percent, abatacept by 4.5 percent, tocilizumab by 3.4 percent, infliximab by 2.6 percent, certolizumab by 1.5 percent, and rituximab by 1.1 percent. The bDMARDs reduced disease activity as measured by CDAI at six months of follow-up (p<.001). The percentage of patients achieving remission or low disease activity was 40.6 percent. bDMARDs were more effective in patients with better functionality (Odds Ratio, OR = 2.140 / 95 percent Confidence Interval, CI 1.219 - 3.756) at beginning of treatment and in patients who not had a previous bDMARDs (OR = 2.150 / 95 percent CI 1.144 - 4.042).
CONCLUSIONS:
In this real-world study, functionality and use of previous bDMARDs are predictors in patients with RA treated with bDMARDs.
The socioeconomic burden of diseases is increasing in Africa. For instance in 2011, 70 percent of the world's human immunodeficiency virus (HIV) population resided in sub-Sahara Africa. There are also growing rates of Antimicrobial Resistance (AMR), which necessitates newer more expensive antibiotics adding to costs. There is also a growing burden of non-communicable diseases (NCDs), three out of four patients with hypertension currently live in low and middle income countries (LMICs), with prevalence rates up to 30 to 45 percent among adults in Africa. Alongside this, up to 70 percent of total healthcare expenditure is spent on medicines in LMICs; much of this out-of-pocket. Consequently, there is an urgent need to strengthen collaborative research to improve medicine use.
METHODS:
Summary of groups working together in Africa including the Medicines Utilisation Research in Africa (MURIA) group.
RESULTS:
African Strategies for Health identifies and advocates best practices, as well as works with others to develop sustainable solutions. Pharmacology for Africa (PharfA) organises and promotes pharmacology on the African continent, including research in clinical pharmacology, alongside the International Union of Basic and Clinical Pharmacology (IUPHAR) sub-division. International Society for Pharmacoeconomics and Outcomes Research (ISPOR) Africa co-ordinates activities from the different African country chapters. The South African Health Technology Assessment Society (SAHTAS) is a scientific and professional society for all those who produce, use, or encounter Health Technology Assessment (HTA) in Southern Africa, and the World Health Organization (WHO) International and Regional groups are improving antibiotic drug utilization capabilities in Africa. The MURIA group was established in 2015 (1). Ongoing collaborative research includes (i) initiatives to optimize antibiotic use; (ii) methods to enhance adherence to anti-infective prescribing guidance, (iii) approaches to improve adherence to HIV and NCDs; (iv) researching current anti-hypertensive utilization patterns and knowledge; (v) approaches to enhance Drugs and Therapeutic Committees (DTC) activities, and (vi) strengthening medicine utilization capabilities (2,3). These activities have already strengthened research ties across Africa.
CONCLUSIONS:
A number of groups are already working across Africa to enhance appropriate medicine use, and should continue. Ongoing MURIA activities include antibiotic point-prevalence studies, ongoing research into infectious diseases, NCDs and DTCs including adherence as well as the third workshop and symposium in Namibia in 2017.
Anti-tumor necrosis factor drugs (anti-TNF) are the last line of treatment for psoriatic arthritis (PsA) in the guideline of Brazilian Public Health System (SUS). Data of effectiveness of these drugs are scarce in the Latin American population. This study evaluated the effectiveness of the anti-TNF on a cohort of patients with PA in the SUS.
METHODS:
PsA patients treated with anti-TNF, were included in an open prospective cohort study. The Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) and Clinical Disease Activity Index (CDAI) were used to assess the effectiveness at six months of follow-up. The anti-TNF was considered effective when the patient achieves scores of four or less measured for BASDAI or scores of ten or less for CDAI. Frequency distributions were compiled for the sociodemographic variables and mean and standard deviation (SD) was used for clinical variables. The paired Student t-test was established to evaluate the differences between baseline and 6 months evaluated for BASDAI and CDAI.
RESULTS:
Fifty-four patients with PsA completed six months of follow-up. The mean age of patients was 54.03 years (10.44) and the mean disease duration was 8.00 years (7.49). Furthermore, 50 percent of the patients were female, 61.1 percent white and 59.6 percent married. The most used anti-TNF was adalimumab (63.0 percent), followed by etanercept (20.4 percent) and infliximab (16.7 percent). The anti-TNF reduced disease activity measured by BASDAI and CDAI at six months of follow-up (p<.001). The percentage of patients achieving the effectiveness with anti-TNF was 61.1 percent measured by BASDAI and 53.7 percent by CDAI.
CONCLUSIONS:
Anti-TNF drugs demonstrated to be effective in more than half of patients at six months. This result highlighted the importance of the treatment with the anti-TNF drugs in the Brazilian population. Long-term data are needed to confirm these results.
Beta-interferons are used as first-line therapy for relapsing-remitting multiple sclerosis in Brazil. In order to evaluate the possible inferiority of one of the beta-interferons available and support a guideline update, we conducted an eleven-year (January 2000 to December 2010) nationwide real-world performance assessment using the Unified Health System (SUS) databases.
METHODS:
We assessed whether patients using subcutaneous beta-interferon switched treatment, relapsed or died (composite event) earlier than patients using intramuscular beta-interferons. Patients without a dispensing registry longer than three months were censored. We used the Kaplan-Meier method to estimate the cumulative probability of persistence on initial treatment, and compared groups with the Log-rank test. The influence of the drug on the occurrence of event was assessed with Cox proportional hazards analysis.
RESULTS:
The number of patients included was 12,154, and the majority started treatment with subcutaneous beta-interferon-1a (45.7 percent), followed by subcutaneous beta-interferon-1b (27.7 percent) and by intramuscular beta-interferon (26.6 percent). Women represented 73.1 percent and the mean age was 38.93±11.34 years old. The group of patients who used intramuscular beta-interferon switched treatment, relapsed or died earlier (median 47 months; 95 percent Confidence Interval, CI 44–52) than patients using the subcutaneous beta-interferons, (69 months (95 percent CI 64–76) for beta- interferon 1a and 73 (95 percent CI 66–84) months for beta-interferon 1b) (p< .0001 for both comparisons). Accordingly, the use of intramuscular beta-interferon was associated with a higher probability of event (Hazard ratio, HR 1.38; 95 percent CI 1.29-1.48), while the use of the other beta-interferons had a protective effect (1a: HR .86; 95 percent CI .81-.92; 1b: HR .89; 95 percent CI .83-.95).
CONCLUSIONS:
The inferiority of intramuscular beta-interferon found in the real-world corroborates findings from head-to-head studies and systematic reviews conducted by Cochrane and the National Commission for Technology Incorporation in SUS (CONITEC/Brazil). This result led to disinvestment in intramuscular beta-interferon and was the first case of clinical guideline update using real-world evidence in Brazil.
Dengue virus is a serious global health problem with an estimated 3.97 billion people at risk for infection worldwide. In December 2015, the first vaccine (CYD-TDV) for dengue prevention was approved in Brazil, developed by Sanofi Pasteur (1). However, given that the vaccine will potentially be paid via the public health system, information is needed regarding consumers willingness to pay for the dengue vaccine in the country, as well as discussions related to the possible inclusion of this vaccine into the public health system at prices suggested by the manufacturer. This was the objective of this research.
METHODS:
We conducted a cross-sectional study with residents of Greater Belo Horizonte, Minas Gerais, about their willingness to pay for the CYD-TDV vaccine. Respondents had to be over 18 years and not currently have the disease although they may have had dengue in the past (2,3).
RESULTS:
Five-hundred and seven individuals were interviewed, who were mostly female (62.4 percent), had completed high school (62.2 percent), were working (74.4 percent), had private health insurance (64.5 percent) and did not have dengue (67.4 percent). The maximum median value of consumers willingness to pay for the CYD-TDV vaccine, assuming vaccine efficacy against virologically-confirmed symptomatic dengue illness of approximately 60 percent, is USD33.61 (BRL120.00) for the complete 3-course schedule and USD11.20 (BRL40.00) per dose. At the price currently being assessed by the Brazil's regulatory chamber of pharmaceutical products market (CMED) for Dengvaxia® for three doses, only 17 percent of the population expressed a willingness to pay for the vaccine at this price.
CONCLUSIONS:
Brazil is currently one of the largest markets for dengue vaccine in the world and the price established is a key issue. The manufacturer should asses the possibility of lowering its price in Brazil to reach a larger audience among the Brazilian population, especially as other public health activities to control the disease will continue.
Over the past decades, early awareness and alert (EAA) activities and systems have gained importance and become a key early Health Technology Assessment (HTA) tool. While a pioneer in HTA, Sweden had no national level EAA activities until recently. We describe the evolution and current status of the Swedish EAA System.
METHODS:
This was a historical analysis based on the knowledge and experience of the authors supplemented by a targeted review of published and grey literature, as well as documents produced by or relating to the Swedish EAA System. Key milestones and a description of the current state of the Swedish EAA System are presented.
RESULTS:
Initiatives to establish a system for the identification and assessment of emerging health technologies in Sweden date back to the 1980s. Since the 1990s, the Swedish Agency for Health Technology Assessment and Assessment of Social Services (SBU) supported the development of EuroScan and was one of its founding members. In the mid-2000s, an independent regional initiative, driven by the Stockholm Drug and Therapeutics Committee, resulted in the establishment of a regional horizon scanning unit. By 2009, this work had expanded to a collaboration between the four biggest regions in Sweden. The following year it was further expanded to the national level. Today, the Swedish EAA System carries out identification, filtration and prioritization of new drugs, early assessment of the prioritized drugs, and dissemination of the information. Its outputs are used to select new drugs for inclusion in the Swedish national process for managed introduction and follow-up.
CONCLUSIONS:
The Swedish EAA System started as a regional initiative and rapidly grew to become a national level activity. An important feature of the system today is its complete integration into the national process for managed introduction and follow-up of new drugs. The system will continue to evolve as a response both to the changing landscape of health innovations and to new policy initiatives at the regional, national and international levels.