Representatives Of Regulatory Agencies Research Articles

ECOPHAGE: Combating Antimicrobial Resistance Using Bacteriophages for Eco-Sustainable Agriculture and Food Systems.

The focus of this meeting was to discuss the suitability of using bacteriophages as alternative antimicrobials in the agrifood sector. Following a One Health approach, the workshop explored the possibilities of implementing phage application strategies in the agriculture, animal husbandry, aquaculture, and food production sectors. Therefore, the meeting had gathered phage researchers, representatives of the agrifood industry, and policymakers to debate the advantages and potential shortcomings of using bacteriophages as alternatives to traditional antimicrobials and chemical pesticides. Industry delegates showed the latest objectives and demands from consumers. Representatives of regulatory agencies (European Medicines Agency (EMA) and Spanish Agency of Medicines and Health Products (AEMPS)) presented an update of new regulatory aspects that will impact and support the approval and implementation of phage application strategies across the different sectors.

P21-11 Re-evaluating the need for chronic toxicity studies with therapeutic monoclonal antibodies, using a weight of evidence approach

Different government agencies operating in the European Union regulate different types of chemical products but all require testing for carcinogenicity to support applications for product marketing and commercialisation. A conference was held in Brussels in 2013 where representatives of the pharmaceutical, animal health, chemical and plant protection industries, together with representatives of regulatory agencies, universities and other stakeholders, met under the auspices of The European Partnership for Alternative Approaches to Animal Testing (EPAA) to discuss the varying requirements for carcinogenicity testing, and how these studies might be refined to improve hazard evaluation and risk assessment while implementing principles of the 3Rs (replacement, refinement and reduction in animal studies). While there are some similarities, the regulatory approaches in pharmaceutical, animal health, chemical and plant protection sectors have varying degrees of flexibility in requirements for carcinogenicity testing, to an extent reflecting concerns over the magnitude and duration of human exposure, either directly as in therapeutic exposure to pharmaceuticals, or indirectly through the ingestion of residues of veterinary drugs or plant protection chemicals. The article discusses these differences and other considerations for modified carcinogenicity testing paradigms on the basis of scientific and 3Rs approaches.

Governing gene editing in agriculture and food in the United States

Biotechnologies in agriculture and food are increasingly governed by both state and nonstate actors. In this article, we explore emerging tensions and contestations in the United States over how gene-editing technologies in agriculture and food should be governed and by whom. This article is framed theoretically by the literatures examining the politics of state and nonstate governance of the agrifood and biotechnology sectors. We draw on semistructured interviews with 45 key actors in the United States, including representatives of regulatory agencies, commodity groups, consumer and environmental nongovernmental organizations (NGOs), biotechnology and food industry, and scientists. In contrast to assumptions that commodity group and industry actors would share a preference for limited or self-regulation, we find growing contestations, with some calling for novel forms of regulatory oversight. Our findings reveal new tensions, fractures, and realignments between and among government, industry, and NGOs actors over gene-editing governance. These tensions and realignments reflect and respond to demands for broader engagement of publics and greater transparency in the governance of biotechnologies in agriculture and food. We argue that these emerging tensions and realignments between and among state and nonstate actors reflect efforts by these actors to incorporate lessons from the genetically modified organism labeling fight as they seek to (re)shape the governance of gene editing in a manner that reflects their interests.

The ASAS-OMERACT core domain set for axial spondyloarthritis

BackgroundThe current core outcome set for ankylosing spondylitis (AS) has had only minor adaptations since its development 20 years ago. Considering the significant advances in this field during the preceding decades, an update of this core set is necessary. ObjectiveTo update the ASAS-OMERACT core outcome set for AS into the ASAS-OMERACT core outcome set for axial spondyloarthritis (axSpA). MethodsFollowing OMERACT and COMET guidelines, an international working group representing key stakeholders (patients, rheumatologists, health professionals, pharmaceutical industry and drug regulatory agency representatives) defined the core domain set for axSpA. The development process consisted of: i) Identifying candidate domains using a systematic literature review and qualitative studies; ii) Selection of the most relevant domains for different stakeholders through a 3-round Delphi survey involving axSpA patients and axSpA experts; iii) Consensus and voting by ASAS; iv) Endorsement by OMERACT. Two scenarios are considered based on the type of therapy investigated in the trial: symptom modifying therapies and disease modifying therapies. ResultsThe updated core outcome set for axSpA includes 7 mandatory domains for all trials (disease activity, pain, morning stiffness, fatigue, physical function, overall functioning and health, and adverse events including death). There are 3 additional domains (extra-musculoskeletal manifestations, peripheral manifestations and structural damage) that are mandatory for disease modifying therapies and important but optional for symptom modifying therapies. Finally, 3 other domains (spinal mobility, sleep, and work and employment) are defined as important but optional domains for all trials. ConclusionThe ASAS-OMERACT core domain set for AS has been updated into the ASAS-OMERACT core domain set for axSpA. The next step is the selection of instruments for each domain.

Assessing perspectives on artificial intelligence applications to gastroenterology

Assessing perspectives on artificial intelligence applications to gastroenterology

The potential role of patent and proprietary medicine vendors\u2019 associations in improving the quality of services in Nigeria\u2019s drug shops

BackgroundPatent and Proprietary Medicine Vendors (PPMVs) play a major role in Nigeria’s health care delivery but regulation and monitoring of their practice needs appreciable improvement to ensure they deliver quality services. Most PPMVs belong to associations which may be useful in improving their regulation. However, little is known about how the PPMV associations function and how they can partner with relevant regulatory agencies to ensure members’ compliance and observance of good practice. This study sought to describe the PPMV associations’ structure and operations and the regulatory environment in which PPMVs function. With this information we explore ways in which the associations could help improve the coverage of Nigeria’s population with basic quality health care services.MethodsA mixed methods study was conducted across four rural local government areas (LGAs) (districts) in two Nigerian states of Bayelsa and Oyo. The study comprises a quantitative data collection of 160 randomly selected PPMVs and their shops, eight PPMV focus group discussions, in-depth interviews with 26 PPMV association executives and eight regulatory agency representatives overseeing PPMVs’ practice.ResultsThe majority of the PPMVs in the four LGAs belonged to the local chapters of National Association of Patent and Proprietary Medicine Dealers (NAPPMED). The associations were led by executive members and had regular monthly meetings. NAPPMED monitored members’ activities, provided professional and social support, and offered protection from regulatory agencies. More than 80% of PPMVs received at least one monitoring visit in the previous 6 months and local NAPPMED was the organization that monitored PPMVs the most, having visited 68.8% of respondents. The three major regulators, who reached 30.0–36.3% of PPMVs reported lack of human and financial resources as the main challenge they faced in regulation.ConclusionsQuality services at drug shops would benefit from stronger monitoring and regulation. The PPMV associations already play a role in monitoring their members. Regulatory agencies and other organizations could partner with the PPMV associations to strengthen the regulatory environment and expand access to basic quality health services at PPMV shops in Nigeria.

Clinical trial recommendations for potential Alport syndrome therapies

Alport syndrome is experiencing a remarkable increase in preclinical investigations. To proactively address the needs of the Alport syndrome community, as well as offer clarity for future clinical research sponsors, the Alport Syndrome Foundation hosted a workshop to generate consensus recommendations for prospective trials for conventional drugs. Opinions of key stakeholders were carefully considered, including those of the biopharmaceutical industry representatives, academic researchers, clinicians, regulatory agency representatives, and-most critically-patients with Alport syndrome. Recommendations were established for preclinical researchers, the use and selection of biomarkers, standards of care, clinical trial designs, trial eligibility criteria and outcomes, pediatric trial considerations, and considerations for patient engagement, recruitment, and treatment. This paper outlines their recommendations.

Toward Accelerated Authorization and Access to New Medicines for Juvenile Idiopathic Arthritis.

A meeting was organized to bring together multiple stakeholders involved in the testing and authorization of new medications for juvenile idiopathic arthritis (JIA) to discuss current issues surrounding clinical trials and access to new medications for children and adolescents with JIA. The Childhood Arthritis and Rheumatology Research Alliance invited representatives of regulatory agencies (Food and Drug Administration and European Medicines Agency), and major pharmaceutical companies with JIA-approved products or products in development, patient and parent representatives, representatives of an advocacy organization (Arthritis Foundation), and pediatric rheumatology clinicians/investigators to a 1-day meeting in April 2018. The participants engaged in discussion regarding issues in clinical trials. As the pharmacologic options to treat inflammatory arthritis rapidly expand, registration trial designs to test medications in JIA patients must adapt. Many methodologies successfully used in the recent past are no longer feasible. The pool of patients meeting entry criteria who are willing to participate is shrinking while the number of medications to be tested is growing. Suggested solutions included proposing innovative clinical trial methods to regulatory agencies, as well as open discussions among stakeholders. Ensuring that new medications are authorized in a timely manner to meet the needs of JIA patients worldwide is critical. Approaches should include open dialog between regulatory agencies, pharmaceutical companies, and other stakeholders to develop and implement novel study designs, including patient and clinician perspectives to define meaningful trial outcomes, and changing existing study plans.

Looking beyond the WRIB Decennial Index of the White Papers in Bioanalysis.

Looking beyond the WRIB Decennial Index of the White Papers in Bioanalysis.

Identifying a Core Domain Set to Assess Psoriasis in Clinical Trials

There is no consensus on which domains should be measured or which instruments should be used in clinical trials for psoriasis therapies. To achieve international consensus among psoriasis stakeholders on a core set of domains that should be measured in all psoriasis clinical trials. Literature review, pre-Delphi survey exercises, nominal group discussions, and audience voting at 4 stakeholder meetings were used to develop candidate domains for 2 rounds of a Delphi survey. Stakeholders were patients or advocates of patients with psoriasis and health care professionals (HCPs) with expertise in psoriasis, including physicians, scientists, advocacy organization representatives, and regulators. Delphi surveys were conducted electronically from October through December 2015 and between September and October 2016. Stakeholder discussions with audience response voting were conducted at live meetings in the United States, Canada, and Italy from January 2013 to December 2016 to refine and ratify the core set of domains. Two rounds of an electronic Delphi survey were used to determine consensus. A domain was considered "core" (ie, should be measured in all trials) if a threshold consensus of at least 70% was met in both patient and HCP groups. Domains meeting consensus in only 1 group were considered to be important but were not required to be measured in all trials ("middle ring"). These domains were included for rerating in round 2. Domains that did not meet consensus in either of the groups ("outer ring") were considered to be of uncertain importance and were placed in the research agenda. In round 1 of the Delphi survey, 107 HCPs and 14 patients participated. Most HCPs (72 [67%]) were dermatologists between 46 and 64 years old (71 [66%]), white (78 [73%]), and male (75 [70%]) from North America (60 [57%]) and Europe (34 [32%]).There were 10 pharmaceutical industry clinical or health economic scientists, 3 advocacy organization representatives, 2 regulatory agency representatives, and 5 "other." In the second round, 77 HCPs and 15 patients participated. Of the 20 candidate domains, the following 6 met consensus as core domains: skin manifestations, psoriasis and psoriatic arthritis symptoms, health-related quality of life, investigator global assessment, patient global assessment, and treatment satisfaction. Secondary skin manifestations as well as nail, inverse, genital, and guttate psoriasis were classified as important but not mandatory. Psoriatic arthritis signs, work productivity or participation, economic impact (direct and indirect cost), and cardiovascular disease comprised the research agenda. This iterative Delphi process yielded international consensus among professional and patient stakeholders on 6 domains that should be measured in all clinical trials for psoriasis. Future International Dermatology Outcome Measures group efforts will focus on development of a core outcome measurement set for psoriasis trials.

More food, low pollution (mo fo lo Po): a grand challenge for the 21st century.

Synthetic nitrogen fertilizer has been a double-edged sword, greatly improving human nutrition during the 20th century but also posing major human health and environmental challenges for the 21st century. In August 2013, about 160 agronomists, scientists, extension agents, crop advisors, economists, social scientists, farmers, representatives of regulatory agencies and nongovernmental organizations (NGOs), and other agricultural experts gathered to discuss the vexing challenge of how to produce more food to nourish a growing population while minimizing pollution to the environment. This collection of 14 papers authored by conference participants provides a much needed analysis of the many technical, economic, and social impediments to improving nitrogen use efficiency (NUE) in crop and animal production systems. These papers demonstrate that the goals of producing more food with low pollution (Mo Fo Lo Po) will not be achieved by technological developments alone but will also require policies that recognize the economic and social factors affecting farmer decision-making. Take-home lessons from this extraordinary interdisciplinary effort include the need (i) to develop partnerships among private and public sectors to demonstrate the most current, economically feasible, best management NUE practices at local and regional scales; (ii) to improve continuing education to private sector retailers and crop advisers; (iii) to tie nutrient management to performance-based indicators on the farm and in the downwind and downstream environment; and (iv) to restore investments in research, education, extension, and human resources that are essential for developing the interdisciplinary knowledge and innovative skills needed to achieve agricultural sustainability goals.

Barriers and strategies for the clinical translation of advanced orthopaedic tissue engineering protocols

Research in orthopaedic tissue engineering has intensified over the last decade and new protocols continue to emerge. The clinical translation of these new applications, however, remains associated with a number of obstacles. This report highlights the major issues that impede the clinical translation of advanced tissue engineering concepts, discusses strategies to overcome these barriers, and examines the need to increase incentives for translational strategies. The statements are based on presentations and discussions held at the AO Foundation-sponsored symposium "Where Science meets Clinics 2013" held at the Congress Center in Davos, Switzerland, in September, 2013. The event organisers convened a diverse group of over one hundred stakeholders involved in clinical translation of orthopaedic tissue engineering, including scientists, clinicians, healthcare industry professionals and regulatory agency representatives. A major point that emerged from the discussions was that there continues to be a critical need for early trans-disciplinary communication and collaboration in the development and execution of research approaches. Equally importantly was the need to address the shortage of sustained funding programs for multidisciplinary teams conducting translational research. Such detailed discussions between experts contribute towards the development of a roadmap to more successfully advance the clinical translation of novel tissue engineering concepts and ultimately improve patient care in orthopaedic and trauma surgery.

Advancing the 3Rs in regulatory toxicology – Carcinogenicity testing: Scope for harmonisation and advancing the 3Rs in regulated sectors of the European Union

Different government agencies operating in the European Union regulate different types of chemical products but all require testing for carcinogenicity to support applications for product marketing and commercialisation. A conference was held in Brussels in 2013 where representatives of the pharmaceutical, animal health, chemical and plant protection industries, together with representatives of regulatory agencies, universities and other stakeholders, met under the auspices of The European Partnership for Alternative Approaches to Animal Testing (EPAA) to discuss the varying requirements for carcinogenicity testing, and how these studies might be refined to improve hazard evaluation and risk assessment while implementing principles of the 3Rs (replacement, refinement and reduction in animal studies). While there are some similarities, the regulatory approaches in pharmaceutical, animal health, chemical and plant protection sectors have varying degrees of flexibility in requirements for carcinogenicity testing, to an extent reflecting concerns over the magnitude and duration of human exposure, either directly as in therapeutic exposure to pharmaceuticals, or indirectly through the ingestion of residues of veterinary drugs or plant protection chemicals. The article discusses these differences and other considerations for modified carcinogenicity testing paradigms on the basis of scientific and 3Rs approaches.

How to Improve the Implementation of Academic Clinical Pediatric Trials Involving Drug Therapy? A Qualitative Study of Multiple Stakeholders

ObjectiveThe need for encouraging pediatric drug research is widely recognized. However, hospital-based clinical trials of drug treatments are extremely time-consuming, and delays in trial implementation are common. The objective of this qualitative study was to collect information on the perceptions and experience of health professionals involved in hospital-based pediatric drug trials.MethodsTwo independent researchers conducted in-depth semi-structured interviews with principal investigators (n = 17), pharmacists (n = 7), sponsor representatives (n = 4), and drug regulatory agency representatives (n = 3) who participated in institutionally sponsored clinical trials of experimental drugs in pediatric patients between 2002 and 2008.ResultsDissatisfaction was reported by 67% (16/24) of principal investigators and pharmacists: all 7 pharmacists felt they were involved too late in the trial implementation process, whereas 11 (65%) principal investigators complained of an excessive regulatory burden and felt they were insufficiently involved in the basic research questions. Both groups perceived clinical trial implementation as burdensome and time-consuming. The sponsor and regulatory agency representatives reported a number of difficulties but were not dissatisfied.ConclusionsThe heavy burden related to regulatory requirements, and suboptimal communication across disciplines involved, seem to be the main reasons for the major delays in pediatric drug trial implementation. The pharmaceutical aspects are intrinsically tied to trial methodology and implementation and must therefore be examined, in particular by involving Clinical Research Pharmacists at early stages of study conception.

Meeting Report: PDA Virus and TSE Safety Forum

The report provides a summary of the presentations and discussions of the Virus & TSE (transmissible spongiform encephalopathy) Safety Forum 2011 that was organized by the Parenteral Drug Association and held in Barcelona, Spain, on 28-30 June, 2011. The conference was accompanied by a workshop named "Virus Removal by Filtration: Trends and New Developments." A summary of the workshop is provided as a separate report and will be published in this journal as well. The risk of virus contamination and mitigation strategies for medicinal products, sequence-based methods for virus detection, and virus reduction studies that characterize the capacity of specific unit operations for virus removal/inactivation were reported during the Virus Safety Forum. The application of the design of experiment concept to virus safety studies, and the extensive work performed to understand the mechanism of action and to identify critical process parameters for virus removal/inactivation, have produced considerable data. They were provided during the conference and discussed. This report summarized not only the presented data; it also provides a summary of the panel discussion, which included representatives of regulatory agencies from different areas (USA, Europe, Japan) as well as experts from universities and industry. The TSE Safety Forum provided first an overview of the scientific data considering the occurrence of TSEs and the epidemiological situation in different areas. For production of cell-derived medicinal products, the risk of contamination occurs from bovine-derived raw materials like fetal bovine serum or from other raw materials produced with animal-derived components. The current risk of plasma-derived medicinal products from contamination of plasma with the variant Creutzfeldt-Jakob disease agent was considered, and gaps in knowledge and interpretation of TSE studies were discussed from the regulatory standpoint. Current understanding and gaps were intensively discussed by a panel of experts from universities, regulatory agencies and industries; they are summarized in this report. The report provides a summary of the presentations and discussions on the Virus & TSE (transmissible spongiform encephalopathy) Safety Forum 2011 that was organized by the Parenteral Drug Association and held in Barcelona, Spain, on 28-30 June, 2011. The conference was accompanied by a workshop named "Virus Removal by Filtration: Trends and New Developments." A summary of the workshop will be published separately in this journal. The risk of virus contamination and mitigation strategies for medicinal products, sequence-based methods for virus detection, and results of virus reduction studies were reported during the Virus Safety Forum. The application of the design of experiment concept to virus safety studies and data identifying critical process parameters for virus removal/inactivation were discussed. This report summarises the presentations and the panel discussion, which included representatives of regulatory agencies from different areas (USA, Europe, Japan) as well as experts from universities and industry. The TSE Safety Forum considered the occurrence of TSEs in different areas. The TSE risk from raw materials and the risk of contamination with the variant Creutzfeldt-Jakob disease agent from human plasma were considered, and gaps in knowledge and interpretation of TSE studies were discussed from the regulatory standpoint. The results of the conference were discussed by a panel of experts. They are summarized in this report.

Core Outcome Domains for Controlled Trials and Clinical Recordkeeping in Eczema: International Multiperspective Delphi Consensus Process

There is wide variation in the use of outcome measures for eczema. We performed a three-stage web-based international Delphi exercise to develop consensus-based sets of core outcome domains for eczema for "controlled trials" and "clinical recordkeeping". A total of 57 individuals from four stakeholder groups (consumers, clinical experts, regulatory agency representatives, and journal editors) representing 13 countries were asked to rate the importance of 19 outcome domains for eczema and to choose which domains should be included in two core sets of outcomes. Forty-six individuals (81%) participated. Participants received standardized feedback, including the group median, interquartile range, and previous responses, and the assessment was repeated in two subsequent rounds. We defined consensus a priori if at least 60% of the members of at least three stakeholder groups, including consumers, recommended domain inclusion in the core set. Consensus was achieved for inclusion of symptoms, physician-assessed clinical signs, and a measurement for long-term control of flares in the core set of outcome domains for eczema trials. We recommend including these three core outcomes in future eczema trials in order to enhance clinical interpretability and to enable meta-analyses across different studies. For recordkeeping, consensus was reached to regularly monitor eczema symptoms in clinical practice. Future work is needed to select which existing or new scales should be used to measure the domains identified as relevant for the core set.

Produced-Water-Volume Estimates and Management Practices

Summary Produced water is the largest byproduct stream associated with oil and gas production. Within the United States, nearly 1 million oil or gas wells are producing hydrocarbons with various volumes of produced water. In the past, several estimates of the annual volume of produced water have been made, but none are highly accurate, nor are they current. This paper describes a study conducted by Argonne National Laboratory for the US Department of Energy (DOE) in 2009 to develop accurate estimates of produced-water volumes for 2007. The estimates were developed through contacts with regulatory-agency representatives from each of the 31 states that produce oil and gas, as well as several federal agencies that oversee onshore and offshore production on federal lands. A few states maintained detailed records of produced-water volumes, many provided estimates from underground injection records, and a few do not maintain accurate records for estimation. For those states, estimates were developed using various extrapolation methods. Where possible, the produced-water volumes are provided separately for different hydrocarbon types (i.e., crude oil, conventional gas, coalbed methane, tight-shale gas). This allows calculations of water/hydrocarbon ratios for different states and different hydrocarbon types. In addition to providing a recent accurate volume estimate, the paper discusses the ways in which the produced water is managed in the different states and in the US offshore. While much of the onshore produced water is reinjected for enhanced recovery or disposal and much of the offshore produced water is discharged to the ocean, various other methods are used also. The Argonne study and this paper provide the most-complete and -recent picture of produced-water management in the United States.

Ecologic: Nanotechnology, Environmental Assurance Bonding, and Symmetric Humility

ABSTRACT To date, the turn toward market-based regulatory tools in the environmental, health, and safety context has tended to focus on taxes, tradable permits, and information disclosure rules, With comparatively little attention devoted to environmental assurance bonds. This paper argues that environmental assurance bonding offers particularly attractive regulatory approach for contexts--such as the present state of nanoscale science and engineering--in which both the risk and the benefit sides of the regulatory equation are characterized by great uncertainty. Historical examples and existing scholarly analyses of environmental assurance bonding are reviewed, and the resulting lessons are situated within the larger debate over economic cost-benefit balancing and precautionary approaches to environmental law and policy. In particular, the paper argues that environmental assurance bonding displays the virtue of symmetric humility, paying due heed to the dynamism and complexity both of sociolegal systems such as markets and of biophysical systems such as aquatic ecosystems. ********** I. INTRODUCTION II. UNCERTAINTY AND COMPLEXITY IN THE ENVIRONMENT A. Sociolegal Systems B. Biophysical Systems III. UNCERTAINTY AND COMPLEXITY IN THE MIND A. Rationality in Social Choice B. Rationality in Individual Choice IV. THE PROMISE OF ENVIRONMENTAL ASSURANCE BONDING A. Environmental Assurance Bonding B. Symmetric Humility V. CONCLUSION I. INTRODUCTION Human history becomes more and more race between education and catastrophe. H.G. Wells, Outline of History (1920) On January 30, 2009, U.S. President Barack Obama issued memorandum to the heads of executive departments and agencies expressing an intention to study and revise the manner in which the Office of Information and Regulatory Affairs (OIRA) within the Office of Management and Budget (OMB) conducts regulatory impact review, including economic cost-benefit analysis of proposed rules. He wrote: The fundamental principles and structures governing contemporary regulatory review were set out in Executive Order 12866 of September 30, 1993. A great deal has been since that time. Far more is now known about regulation--not only about when it is justified, but also about what works and what does not. Far more is also known about the uses of variety of regulatory tools such as warnings, disclosure requirements, public education, and economic incentives. Years of experience have also provided lessons about how to improve the process of regulatory review. In this time of fundamental transformation, that process--and the principles governing regulation in general--should be revisited. I therefore direct the Director of OMB, in consultation with representatives of regulatory agencies, as appropriate, to produce within 100 days set of recommendations for new Executive Order on Federal regulatory review. Among other things, the recommendations should offer suggestions for the relationship between OIRA and the agencies; provide guidance on disclosure and transparency; encourage public participation in agency regulatory processes; offer suggestions on the role of cost-benefit analysis; address the role of distributional considerations, fairness, and concern for the interests of future generations; identify methods of ensuring that regulatory review does not produce undue delay; clarify the role of the behavioral sciences in formulating regulatory policy; and identify the best tools for achieving public goals through the regulatory process. Under pressure from nongovernmental organizations such as the Center for Progressive Reform, (1) the Executive Order review process was opened up for broader public comment. The resulting input suggested that, despite the President's suggestion that a great deal has been learned about the design and impact of regulations, civil society remains deeply split regarding the desirability of regulatory cost-benefit analysis (CBA) as tool for evaluating proposed policies. …

Dentistry and Health Care Reform in the USA

What will the practice of dentistry look like in the United States when the health care delivery systems are changed? This question makes two likely assumptions. One assumption is that the health care systems are going to change. It is hard not to see the wave of demand for improvements in this sector. The other is that it is hard to imagine that some of the very significant changes under discussion will not impact dentistry and orthodontics. We all know that potential contentious issues are best addressed before they are encountered. We also know that orthodontics draws many of the finest minds in dentistry. It is human to lean toward favoring the status quo when we are doing well, but it is time that we begin to look at the effect some of the proposed changes can make on our discipline. The buzz I hear these days’ is about the presumed efficiency and cost savings inherent in the transfer of many patient care duties to a lesser trained person. This arises from the concept of a transfer of the medical nurse practitioner concept to dentistry. The concept is tantamount to saying that a portion of health care is technical in nature and can be properly and more economically delivered by someone with lesser education and training. The debate is largely focused on capturing the economy of such a shift with the resistance citing the need to guarantee the patients’ quality of care. While there are undoubtedly many approaches being discussed in various states, the one I hear most commonly cited is the Minnesota proposal. This is where I live and the facts are that the Minnesota legislature did address this question in 2008. The first proposal to enlarge upon dental hygiene education for certain hygienists was replaced by a second bill that is now law. This second bill provides for the creation of a new level of dental care provider, the oral health practitioner. Under the new legislation, The Board of Dentistry will license the new oral health practitioner and the oral health practitioner will work under the supervision of a dentist. The details of the final bill can

Incorporating Radiation Dose Assessments Into the ACR Appropriateness Criteria®

In 2006, the ACR convened a group of radiologists, medical physicists, industry and regulatory agency representatives, and a patient advocate to address issues related to the risks of radiation exposure in medical imaging. This group, the Blue Ribbon Panel on Radiation Dose in Medicine, developed a series of recommendations aimed at optimizing radiologic image quality and radiation dose and preventing the inappropriate use of procedures involving ionizing radiation [ 1 Amis Jr, E.S. Butler P.F. Applegate K.E. et al. American College of Radiology white paper on radiation dose in medicine. J Am Coll Radiol. 2007; 4: 272-284 Abstract Full Text Full Text PDF PubMed Scopus (699) Google Scholar ]. Several of their recommendations relate to educating referring physicians about radiation exposure risk. One recommendation in particular calls for the incorporation of radiation dose information into the ACR Appropriateness Criteria, a guide for the selection of proper imaging procedures for particular medical conditions. In response to this recommendation, relative radiation level (RRL) designations were added to the Appropriateness Criteria in September 2007. These designations indicate which imaging procedures expose patients to radiation and the relative magnitude of that exposure. By adding RRL designations, referring physicians using the Appropriateness Criteria will not only be advised of the appropriate imaging procedure for medical conditions but will also be steered toward procedures that minimize radiation dose to their patients.