Seeking truer measures of success: Moving toward more rigorous evaluations of industry-led access to medicines programs.
Ontology highlight
ABSTRACT:
SUBMITTER: Ramirez CL
PROVIDER: S-EPMC8141331 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:BackgroundThere has been increased demand for greater public accountability and transparency of private sector-led global health partnership programs. This study critically reviews and pilot tests the World Health Organization (WHO) medicine program checklist as a framework for public reporting and assessing of programs.MethodsWe reviewed each question on the WHO checklist for clarity and usability. Next, we pilot tested the subset of checklist questions focused on program assessment. We extracted and analyzed publicly available information on one randomly selected program from each of the 20 largest research-based biopharmaceutical companies. For each program, we assessed whether publicly available information allowed for an assessment of each relevant question in the checklist.ResultsChecklist questions fit in four main categories: [1] national health and development plans, needs, capacity, laws and policies; [2] financial, performance, and public accountability; [3] risk management and mitigation strategies; and [4] long-term sustainability. Nearly all (21 of 22) questions in the checklist require information best provided by companies; one question requires information best provided by governments.Programs frequently reported on the public health needs of their programs (100%), program objectives and activities (100%) and the actual or expected program outputs (95%). There was less information on program alignment with country plans and capacity (50%), detailed program monitoring and evaluation plan (20%), risks mitigation strategies (5%), program needs assessment (5%), and additional resources required from or contributed by government (0%).ConclusionThe WHO checklist of key considerations for evaluating proposals for access to medicine programs could be a useful framework for public reporting of program information as most of checklist questions ask for data that should be available to those leading the program. Further revisions of the WHO checklist will help refine it to improve clarity and content validity.
| S-EPMC7098075 | biostudies-literature
Project description:Although value-based purchasing (VBP) holds promise for encouraging quality improvement and addressing rising costs, currently there is limited evidence about how best to structure and implement VBP programs. In this commentary, we highlight several issues for improving evaluations of VBP programs. Implementation research can be enhanced through early and continuous assessment and greater variation in program designs. Impact research can be improved by creating better outcome measures, increasing the availability of linked patient-level data, and advancing synthesis research. We offer several recommendations for improving the foundation to conduct evaluations of VBP programs to better inform policy and practice.
| S-EPMC2965892 | biostudies-other
Project description:BackgroundIn September 2003, the Canadian government committed to developing legislation that would facilitate greater access to affordable medicines for developing countries. Over the course of eight months, the legislation, now known as Canada's Access to Medicines Regime (CAMR), went through a controversial policy development process and the newspaper media was one of the major venues in which the policy debates took place. The purpose of this study was to examine how the media framed CAMR to determine how policy goals were conceptualized, which stakeholder interests controlled the public debate and how these variables related to the public policy process.MethodsWe conducted a qualitative content analysis of newspaper coverage of the CAMR policy and implementation process from 2003-2008. The primary theoretical framework for this study was framing theory. A total of 90 articles from 11 Canadian newspapers were selected for inclusion in our analysis. A team of four researchers coded the articles for themes relating to access to medicines and which stakeholders' voice figured more prominently on each issue. Stakeholders examined included: the research-based industry, the generic industry, civil society, the Canadian government, and developing country representatives.ResultsThe most frequently mentioned themes across all documents were the issues of drug affordability, intellectual property, trade agreements and obligations, and development. Issues such as human rights, pharmaceutical innovation, and economic competitiveness got little media representation. Civil society dominated the media contents, followed far behind by the Canadian government, the research-based and generic pharmaceutical industries. Developing country representatives were hardly represented in the media.ConclusionsMedia framing obscured the discussion of some of the underlying policy goals in this case and failed to highlight issues which are now significant barriers to the use of the legislation. Using the media to engage the public in more in-depth exploration of the policy issues at stake may contribute to a more informed policy development process. The media can be an effective channel for those stakeholders with a weaker voice in policy deliberations to raise public attention to particular issues; however, the political and institutional context must be taken into account as it may outweigh media framing effects.
| S-EPMC2827390 | biostudies-literature
Project description:This study applies two variables in the measurement of company patent deployment strategies: patent family depth and earn plan ratio. Patent family depth represents the degree to which certain fields and markets are valued by the patent owner. Earn plan ratio defined as the ratio of the number of patent forward citations to patent family size. Earn plan ratio indicates the degree to which a patent family could be cited by later innovators and competitors. This study applies a logistic regression model in the analysis LED industry data. The results demonstrate that patent value has a positive relationship with the patent family depth, and earn plan ratio.
| S-EPMC4476752 | biostudies-literature
Project description:Background There is a major drive within healthcare to reduce patient readmissions, from patient care and cost perspectives. Pharmacist-led innovations have been demonstrated to enhance patient outcomes. Objective To assess the impact of a post-discharge, pharmacist-led medicines optimisation clinic on readmission parameters. Assessment of the economic, clinical and humanistic outcomes were considered. Setting Respiratory and cardiology wards in a district general hospital in Northern Ireland. Method Randomised, controlled trial. Blinded random sequence generation; a closed envelope-based system, with block randomisation. Adult patients with acute unplanned admission to medical wards subject to inclusion criteria were invited to attend clinic. Analysis was carried out for intention-to-treat and per-protocol perspectives. Main Outcome Measure 30-day readmission rate. Results Readmission rate reduction at 30 days was 9.6% (P?=?0.42) and the reduction in multiple readmissions over 180-days was 29.1% (P?=?0.003) for the intention-to-treat group (n?=?31) compared to the control group (n?=?31). Incidence rate ratio for control patients for emergency department visits was 1.65 (95% CI 1.05-2.57, P?=?0.029) compared with the intention-to-treat group. For unplanned GP consultations the equivalent incident rate ratio was 2.00 (95% CI 1.18-3.58, P?=?0.02). Benefit to cost ratio in the intention-to-treat and per-protocol groups was 20.72 and 21.85 respectively. Patient Health Related Quality of Life was significantly higher at 30-day (P?<?0.001), 90-day (P?<?0.001) and 180-day (P?=?0.036) time points. A positive impact was also demonstrated in relation to patient beliefs about their medicines and medication adherence. Conclusion A pharmacist-led post-discharge medicines optimisation clinic was beneficial from a patient care and cost perspective.
| S-EPMC7476989 | biostudies-literature
Project description:Access to essential medicines for children is a big challenge, particularly in low-income and middle-income countries. In China, the average availability of essential medicines for children is 1.6%-46.5%. The availability of generics was generally higher than original brands in public hospitals and the prices of generics were relatively lower and more reasonable (generics: availability, 27.3%-46.5%, prices, 0.52-4.28 times the international reference prices; original brands: 1.6%-33.0%, 2.59-11.38 times the international reference prices). In terms of affordability of medicines for children, generics were more affordable than original brands and tablets/capsules were more affordable than injections. Most commonly used anti-infective medicines (such as amoxicillin capsule, azithromycin tablet, cefuroxime tablet) and antipyretics (such as ibuprofen suspension) were relatively affordable. Six commonly used medicines in paediatrics, including amoxicillin/clavulanic acid, beclomethasone, cefazolin, ceftazidime, ceftriaxone, cyclosporine were unaffordable. Since August 2011, China has successively issued several policies to ensure the accessibility of medicines for children, covering research and development, production, procurement and prices of medicines. The accessibility of medicines for children has been partially improved, but still needs continuous improvement.
| S-EPMC9756215 | biostudies-literature
Project description:Background and aimsBiliary cannulation, although critical to procedural success in ERCP, can be difficult and, if unsuccessful, can lead to longer hospital stays, repeat procedures, and increased costs. Expertise in adjunct techniques, including access fistulotomy, can increase success rates and potentially avoid these issues. The aim of this case series is to describe the technique of access fistulotomy and illustrate key points that are important for successful biliary access.MethodsThree cases are reviewed in which access fistulotomy was used to achieve biliary access. The steps for the procedure are reviewed, and key technical tips and anatomic landmarks are illustrated in the video.ResultsSuccessful biliary access is obtained using fistulotomy in 3 cases. In each case, the anatomic landmarks of the papilla and intraduodenal biliary segment are reviewed. The first case illustrates a large papilla in which initial incision followed by careful exposure reveals a clear "onion ring" structure corresponding to the bile duct. The second case requires stepwise incision, each guided by anatomic landmarks before the biliary adventitia is identified, leading to biliary cannulation. In the third case, the utility of fistulotomy in a duodenal diverticulum is illustrated. Recognition of the distorted anatomy allowed precise, careful incision leading to biliary access.ConclusionsAccess fistulotomy is an invaluable technique to aid in biliary access. Knowledge of key landmarks and careful evaluation of the incision are critical to successful biliary access when performing fistulotomy.
| S-EPMC7806498 | biostudies-literature
Project description:Monitoring access to pediatric medicines as part of the Sustainable Development Goal (SDG) agenda for 2030 requires surveying age-appropriate medicines. This study aimed to develop tracer sets of essential age-appropriate medicines for use in SDG indicator 3.b.3 or in conjunction with other methodologies for monitoring access to medicines. Two sets of medicines were developed, one for young children (1 month to 5 years) and one for school-aged children (5-12 years). Priority diseases were selected based on the global burden of disease and linked to active ingredients of first choice according to treatment guidelines and the World Health Organization (WHO) Model List of Essential Medicines for Children (EMLc). To ensure clinical relevance, the Delphi technique was employed to identify areas of (dis)agreement among clinical pediatric experts. During two consultation rounds, experts were invited to indicate (dis)agreement. Five experts per age group were largely in agreement with the initial selections, but various therapeutic alternatives were suggested for addition. A second consultation round with five experts did not lead to major adjustments. The final sets included 26 treatment options for both groups. Specific age-appropriate formulations were selected from the WHO EMLc 2023. These two globally representative tracer sets of medicines consider the particular needs of children and could aid countries in the critical monitoring of accessibility to pediatric medicines.
| S-EPMC10969351 | biostudies-literature
Project description:ObjectiveA number of studies have explored delayed help-seeking practices for acute coronary syndrome (ACS) and have indentified multiple intersecting factors which may play a role, for example, attributing symptoms, age, gender, ethnicity and contextual influences. However, the pathway to diagnosis for suspected coronary heart disease (CHD) symptoms in a rapid access chest pain clinic (RACPC) context is underexplored. The objective of this study was to examine patients' help-seeking experiences of accessing RACPC services, from the point at which they notice and interpret symptoms, to their decision to seek help from their general practitioner.DesignQualitative study.SettingInterviews were conducted in the RACPC at Queen Mary's Roehampton Hospital, London, UK.ParticipantsMaximum variation sampling was used to recruit 30 participants (15 men and 15 women) referred to a RACPC, using sampling dimensions of age, ethnicity and occupation.MethodsSemi-structured interviews focussed on the patient experience of their pathway to the RACPC. Thematic analysis was used to analyse the interview data.ResultsParticipant interpretation of symptoms was shaped by multiple influences; reluctance to seek help contributed to delay; various factors acted as drivers as well as barriers to help-seeking; and GP referrals to RACPC were based on symptoms as well as patients' need for reassurance.ConclusionWe found complex issues shaped the patient's decision-making when accessing the RACPC, including making sense of symptoms and help-seeking practices. These findings can be used to develop health promotion literature to encourage early help-seeking and improve RACPC services.
| S-EPMC7678391 | biostudies-literature
Project description:IntroductionThere is an increasing awareness to counteract problems due to incorrect antimicrobial use. Interventions that are implemented are often part of an Antimicrobial Stewardship Program (ASPs). Studies publishing results from these interventions are increasing, including reports on the economical effects of ASPs. This review will look at the economical sections of these studies and the methods that were used.MethodsA systematic review was performed of articles found in the PubMed and EMBASE databases published from 2000 until November 2014. Included studies found were scored for various aspects and the quality of the papers was assessed following an appropriate check list (CHEC criteria list).Results1233 studies were found, of which 149 were read completely. Ninety-nine were included in the final review. Of these studies, 57 only mentioned the costs associated with the antimicrobial medication. Others also included operational costs (n = 23), costs for hospital stay (n = 18), and/or other costs (n = 19). Nine studies were further assessed for their quality. These studies scored between 2 and 14 out of a potential total score of 19.ConclusionsThis review gives an extensive overview of the current financial evaluation of ASPs and the quality of these economical studies. We show that there is still major potential to improve financial evaluations of ASPs. Studies do not use similar nor consistent methods or outcome measures, making it impossible draw sound conclusions and compare different studies. Finally, we make some recommendations for the future.
| S-EPMC4399335 | biostudies-literature