Browsing by Author "Moe, Jeffrey L"
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Item Open Access A Policy Analysis of No Hit Zones: What are barriers to No Hit Zone implementation?(2018-12-05) Mastrangelo, MadisonNo Hit Zones (NHZs) represent a new policy to prevent corporal punishment and to ensure healthy environments for children and their families. NHZs designate spaces where no hitting of any kind is tolerated and serve as an intervention to shift cultural norms away from physical discipline, starting at the institution-wide level. This mixed-methods thesis is divided into two studies that address the substantial research gap in this nascent field. Study 1 provides an overview of the approximately 50 NHZs nationwide and answers the research question, “What are the barriers to No Hit Zone implementation in institutions, such as hospitals and District Attorney’s offices?” Through the analysis of qualitative data from 44 interviews with professionals involved in NHZ implementation, this thesis establishes a comprehensive list of NHZs and their distribution across states and institution types. Study 1 identifies four central barriers to NHZ implementation: social norms surrounding corporal punishment, framing of the NHZ policy, resource issues, and lack of data surrounding training initiatives. Based on Study 1’s identification of the training barrier, Study 2 analyzes quantitative data from surveys administered before and after NHZ training at Children’s Hospital New Orleans and provides preliminary evidence that training programs can impact healthcare professionals’ views about the use of corporal punishment and increase their perceived ability to intervene when they witness hitting.Item Open Access Impact of economic, regulatory, and patent policies on innovation in cancer chemoprevention.(Cancer Prev Res (Phila), 2008-07) Moe, Jeffrey LChemoprevention agents are an emerging new scientific area that holds out the promise of delaying or avoiding a number of common cancers. These new agents face significant scientific, regulatory, and economic barriers, however, which have limited investment in their research and development (R&D). These barriers include above-average clinical trial scales, lengthy time frames between discovery and Food and Drug Administration approval, liability risks (because they are given to healthy individuals), and a growing funding gap for early-stage candidates. The longer time frames and risks associated with chemoprevention also cause exclusivity time on core patents to be limited or subject to significant uncertainties. We conclude that chemoprevention uniquely challenges the structure of incentives embodied in the economic, regulatory, and patent policies for the biopharmaceutical industry. Many of these policy issues are illustrated by the recently Food and Drug Administration-approved preventive agents Gardasil and raloxifene. Our recommendations to increase R&D investment in chemoprevention agents include (a) increased data exclusivity times on new biological and chemical drugs to compensate for longer gestation periods and increasing R&D costs; chemoprevention is at the far end of the distribution in this regard; (b) policies such as early-stage research grants and clinical development tax credits targeted specifically to chemoprevention agents (these are policies that have been very successful in increasing R&D investment for orphan drugs); and (c) a no-fault liability insurance program like that currently in place for children's vaccines.Item Open Access Local Perceptions, Traditional Cultural and Religious Beliefs and Practices on Umbilical Cord Care in Tharu Community of Nepal: A cross sectional study(2017) Hailati, HanatiGlobally, neonatal sepsis accounts for 15% of neonatal death, and nearly half (48%) of neonatal deaths in Nepal. Interventions such as Chlorhexidine (CHX) gel for umbilical cord care have been widely implemented in Nepal after randomized clinical trials (RCT) demonstrated efficacy and safety to reduce infections of the umbilical cord, omphalitis, and sequelae of unresolved infections which include sepsis. However, local traditional cultural or religious beliefs and practices can reduce or eliminate the efficacy of modern cord care which results in a high prevalence of omphalitis. Successful implementation of the CHX intervention, therefore, requires increased knowledge of the local practices which involve the umbilicus, at and shortly after birth, to identify augmentation strategies to the implementation of CHX. This study was carried out in the western rural Terai region in Nepal and compared three groups: the Tharu omphalitis-positive cases, the non-Tharu omphalitis-positive cases, and the Tharu omphalitis-negative cases. In total, 59 structured and semi-structured interviews with recently delivered women (RDW) (in the last seven months) and 17 health facility surveys with delivery and child care providers were conducted.
Facility delivery was common among the study population, yet seeking health care service from non-facility sources was high in omphalitis-positive cases. Subjects reported application of traditional substances (i.e. mustard oil and ginger powder) was common in the community and that substances application had three main purposes: 1) application of mustard oil was common amongst all groups for “preventative” (maintain good health) purposes; 2) after infection of umbilical cord, substances were applied for “treatment” purpose in some omphalitis-positive cases; and 3) application to hasten cord separation after cord separation was perceived to be delayed was also reported in some omphalitis-positive cases. Almost all women from the Tharu omphalitis-positive cases reported a “naming ceremony”, giving the child its given names in a religious/culture ceremony with family and friends, should follow the cultural tradition to be held after cord separation, which is reported amongst few women from the Tharu omphalitis-negative cases and half of women from the non- Tharu cases. Holding the naming ceremony before the 12th day after birth was reported as very common amongst the non-Tharu cases. Among all the sub-groups studied, women reported having a limited power to make health-related decisions, as compared to their mother-in-law, father-in-law, and husband who the respondents described as having more power.
This study concludes that traditional cultural/religious beliefs and practices play an important role, particularly as they relate to cord care, in the western rural Terai region of Nepal. The introduction of CHX intervention do not replace but integrate into the existing traditional practices. In the discussion, an interaction is observed where CHX gel formulation, onset of omphalitis, and traditional cord care practices may delay cord separation which postpones the naming ceremony for tradition-observing the Tharu peoples. It would be useful as a follow up study to compare dry and gel formulations of CHX, in single and multi-dose regimens, in conditions where traditional cord care practices are used and not used. This would provide even greater insight into how best to proceed to reduce omphalitis and its complications. The current study is underpowered to make conclusive observations, but it is clear that in spite of CHX single dose being applied in the clinic at birth, infections are occurring at higher rates among those peoples who use traditional cord care practices. Subjects in this study report they have been counseled on the use of CHX and the desirability of not using any other agents on the cord stump, but they continue to do so in the belief it may prevent infection, may treat infection and may accelerate cord separation. Given that cord separation is linked to a socially significant cultural admission of the child into the community, the “naming ceremony”, it is not surprising that traditional practices continue given the high social valence of the ceremony. This study also provide implication for policy and practice that a redesign of community campaign to destigmatize delayed naming ceremony and empower women in making healthcare decisions. This study suggests that the efficacy of CHX to reduce infections may be reduced in the natural setting where traditional cord care continues after CHX is applied in a single dose administration. Determining the best formulation and dosing of CHX that can be effective in conjunction with traditional cord care practices is needed to reduce infections among the Tharu and other traditional peoples who use cord care practices. This is particularly needed where cord separation is linked to a cultural significant event such as the “naming ceremony” and the likelihood of completely extinguishing traditional cord care practices is low.
Item Open Access Priority Review Voucher: Policy Barriers and Opportunities to Increase Access to Voucher-Winning Medicines(2018) Bandara, ShashikaBackground: Access to medicines is a vital component of upholding the right to health. However, there is a gap in access to medicines, especially in resource poor settings, that leads to poor health outcomes. The priority review voucher (PRV) is a ‘pull’ incentivizing mechanism designed to encourage new drug development for otherwise neglected diseases. This mechanism also reduces the cost of the end-product via incentives provided after the product has been developed. This study aims to understand policy and implementation barriers related to access to the PRV-winning drug bedaquiline. Bedaquiline is the first drug approved for multi-drug resistant tuberculosis (MDR-TB) in over 40 years. Based on an understanding of access barriers to this new drug, the study also aims to suggest policy recommendations to improve access for PRV winning drugs for tropical diseases.
Methods: The study used semi-structured qualitative interviews with multiple stakeholders at the global level and at the country level in South Africa. These were combined with data from research literature and advocacy materials and analyzed using thematic analysis, organized using Kingdon’s three streams model. The model includes three streams: the problem stream, politics stream, and policy stream. The model also identifies policy entrepreneurs and policy windows. The data were further analyzed using Lewin’s forcefield analysis (FFA) identifying supporting and opposing forces related to increasing access to bedaquiline.
Results: Overcoming policy and implementation access barriers related to bedaquiline is the responsibility of multiple stakeholders. The main barriers to access for bedaquiline currently include (i) barriers to registration of the drug at the country level, (ii) lack of research data (especially phase III trial data), (iii) weak health systems, and (iv) the lack of a sustainable pricing model. The manufacturer has a significant role to play, and this role is common among other PRV winners for tropical diseases as well.
Conclusion: PRV as an incentivizing mechanism to develop drugs for otherwise neglected diseases should strongly consider including an access plan requirement as part of the application process. The plan should be made available to the public for evaluation.