Drug assessment by a Pharmacy and Therapeutics committee: from drug selection criteria to use in clinical practice.

BACKGROUND In Spain, hospital medicines are assessed and selected by local Pharmacy and Therapeutics committees (PTCs). Of all the drugs assessed, cancer drugs are particularly important because of their budgetary impact and the sometimes arguable added value with respect to existing alternatives. This study analyzed the PTC drug selection process and the main objective was to evaluate the degree of compliance of prescriptions for oncology drugs with their criteria for use. METHODS This was a retrospective observational study (May 2007 to April 2010) of PTC-assessed drugs. The variables measured to describe the committee's activity were number of drugs assessed per year and number of drugs included in any of these settings: without restrictions, with criteria for use, and not included in formulary. These drugs were also analyzed by therapeutic group. To assess the degree of compliance of prescriptions, a score was calculated to determine whether prescriptions for bevacizumab, cetuximab, trastuzumab, and bortezomib were issued in accordance with PTC drug use criteria. RESULTS The PTC received requests for inclusion of 40 drugs, of which 32 were included in the hospital formulary (80.0%). Criteria for use were established for 28 (87.5%) of the drugs included. In total, 293 patients were treated with the four cancer drugs in eight different therapeutic indications. The average prescription compliance scores were as follows: bevacizumab, 83% for metastatic colorectal cancer, 100% for metastatic breast cancer, and 82.3% for non-small-cell lung cancer; cetuximab, 62.0% for colorectal cancer and 50% for head and neck cancer; trastuzumab, 95.1% for early breast cancer and 82.4% for metastatic breast cancer; and bortezomib, 63.7% for multiple myeloma. CONCLUSION The degree of compliance with criteria for use of cancer drugs was reasonably high. PTC functions need to be changed so that they can carry out more innovative tasks, such as monitoring conditions for drug use.

Liver safety assessment: required data elements and best practices for data collection and standardization in clinical trials.

A workshop was convened to discuss best practices for the assessment of drug-induced liver injury (DILI) in clinical trials. In a breakout session, workshop attendees discussed necessary data elements and standards for the accurate measurement of DILI risk associated with new therapeutic agents in clinical trials. There was agreement that in order to achieve this goal the systematic acquisition of protocol-specified clinical measures and lab specimens from all study subjects is crucial. In addition, standard DILI terms that address the diverse clinical and pathologic signatures of DILI were considered essential. There was a strong consensus that clinical and lab analyses necessary for the evaluation of cases of acute liver injury should be consistent with the US Food and Drug Administration (FDA) guidance on pre-marketing risk assessment of DILI in clinical trials issued in 2009. A recommendation that liver injury case review and management be guided by clinicians with hepatologic expertise was made. Of note, there was agreement that emerging DILI signals should prompt the systematic collection of candidate pharmacogenomic, proteomic and/or metabonomic biomarkers from all study subjects. The use of emerging standardized clinical terminology, CRFs and graphic tools for data review to enable harmonization across clinical trials was strongly encouraged. Many of the recommendations made in the breakout session are in alignment with those made in the other parallel sessions on methodology to assess clinical liver safety data, causality assessment for suspected DILI, and liver safety assessment in special populations (hepatitis B, C, and oncology trials). Nonetheless, a few outstanding issues remain for future consideration.

The appropriate use of neurostimulation of the spinal cord and peripheral nervous system for the treatment of chronic pain and ischemic diseases: the neuromodulation appropriateness consensus committee.

INTRODUCTION: The Neuromodulation Appropriateness Consensus Committee (NACC) of the International Neuromodulation Society (INS) evaluated evidence regarding the safety and efficacy of neurostimulation to treat chronic pain, chronic critical limb ischemia, and refractory angina and recommended appropriate clinical applications. METHODS: The NACC used literature reviews, expert opinion, clinical experience, and individual research. Authors consulted the Practice Parameters for the Use of Spinal Cord Stimulation in the Treatment of Neuropathic Pain (2006), systematic reviews (1984 to 2013), and prospective and randomized controlled trials (2005 to 2013) identified through PubMed, EMBASE, and Google Scholar. RESULTS: Neurostimulation is relatively safe because of its minimally invasive and reversible characteristics. Comparison with medical management is difficult, as patients considered for neurostimulation have failed conservative management. Unlike alternative therapies, neurostimulation is not associated with medication-related side effects and has enduring effect. Device-related complications are not uncommon; however, the incidence is becoming less frequent as technology progresses and surgical skills improve. Randomized controlled studies support the efficacy of spinal cord stimulation in treating failed back surgery syndrome and complex regional pain syndrome. Similar studies of neurostimulation for peripheral neuropathic pain, postamputation pain, postherpetic neuralgia, and other causes of nerve injury are needed. International guidelines recommend spinal cord stimulation to treat refractory angina; other indications, such as congestive heart failure, are being investigated. CONCLUSIONS: Appropriate neurostimulation is safe and effective in some chronic pain conditions. Technological refinements and clinical evidence will continue to expand its use. The NACC seeks to facilitate the efficacy and safety of neurostimulation.

Final Report, Secondary Road Fund Distribution Advisory Committee, 2002-2005

This report presents the findings and recommendations of the Secondary Road Fund Distribution Advisory Committee (SRFDAC) established by SF 2192 of the 2002 Iowa Acts.

Report to Government Oversight Committee Regrading Soil and Water Conservation Districts Competition with Small Business, 2006

At the request of the Government Oversight Committee, the Ombudsman gathered information regarding competition by county Soil and Water Conservation Districts (SWCD) with small business through the sale of products and services. The goal of the Ombudsman’s review was to assist the Government Oversight Committee (Committee) in gaining an objective understanding of the issues so the Committee can ascertain whether there is a problem that requires legislation this legislative session. The Ombudsman focused on gathering specific information from four SWCD offices in central Iowa; Dallas, Greene, Guthrie and Jasper. These offices were specifically identified in documentation presented to the Government Oversight Committee by affected small business owners (contractors), Jon Judson of Diversity Farms and Dan Brouse of Iowa Restorations. However, with 100 SWCDs in Iowa,1 each with their own elected commissioners and each with different practices, priorities and fundraising activities, what the Ombudsman learned about these four counties may not be applicable to all the SWCDs in Iowa. The Ombudsman assigned the case to the Assistant Citizens’ Aide/Ombudsman for Small Business, Kristie Hirschman. For reference purposes in this report, actions taken by Ms. Hirschman will be ascribed to the Ombudsman.

Perceptions of representatives of a committee against dengue in the health education actions, Goiás, Brazil.

This study aimed to analyze how the educational actions of prevention and control of dengue are performed in Goiás, from the perspective of representatives of the State Mobilization Committee against Dengue. It is a cross-sectional descriptive-analytical study, carried out in Goiânia with 43 representatives of public-private institutions, members of the State Mobilization Committee against Dengue of Goiás, in 2013. The data collection was done through questioning about the perception of health education for dengue prevention. Data were analyzed using content analysis and the WebQDA software. Three dimensions emerged from the analysis: educational aspects, management aspects, and community involvement. Respondents recognized the importance of health education for the prevention of dengue, and of the planning to strengthen the activities of the Committee.

Final Report of Emergency Services Interim Study Committee, February 2007

The Legislative Council established the Emergency Services Interim Study Committee in 2006 and authorized the Committee to meet for two days during the 2006 Legislative Interim. Upon request by the Committee, the Legislative Council subsequently approved a third meeting. The Committee was charged to study the governance, structure, and funding of the state's emergency services and available training for emergency services providers, and receive input from the Department of Public Defense's Division of Homeland Security and Emergency Management; Departments of Human Services, Public Health, and Public Safety, including the State Fire Marshal; and representatives of emergency services providers, including the Iowa Firemen's Association, Iowa Fire Chiefs' Association, Iowa Association of Professional Fire Chiefs, Iowa Professional Fire Fighters, Iowa Emergency Medical Services Association, and emergency room physicians.

Guidelines for imaging retinoblastoma: imaging principles and MRI standardization.

Retinoblastoma is the most common intraocular tumor in children. The diagnosis is usually established by the ophthalmologist on the basis of fundoscopy and US. Together with US, high-resolution MRI has emerged as an important imaging modality for pretreatment assessment, i.e. for diagnostic confirmation, detection of local tumor extent, detection of associated developmental malformation of the brain and detection of associated intracranial primitive neuroectodermal tumor (trilateral retinoblastoma). Minimum requirements for pretreatment diagnostic evaluation of retinoblastoma or mimicking lesions are presented, based on consensus among members of the European Retinoblastoma Imaging Collaboration (ERIC). The most appropriate techniques for imaging in a child with leukocoria are reviewed. CT is no longer recommended. Implementation of a standardized MRI protocol for retinoblastoma in clinical practice may benefit children worldwide, especially those with hereditary retinoblastoma, since a decreased use of CT reduces the exposure to ionizing radiation.

Low-Income Home Energy Assistance Program and Weatherization Program Interim Study Committee, 2007

The Low-Income Home Energy Assistance Program (LIHEAP) and Weatherization Program Interim Study Committee was created by the Legislative Council and charged to review issues involving the Low-Income Home Energy Assistance Program (LIHEAP) and Weatherization Program including financial assistance, the application and intake processes, the community action agencies' assessment and resolution proposal, and whether to involve the Department of Human Services in the administration of the programs to enable low-income persons to access additional assistance programs through a single location.

Continuity of Government Planning Interim Study Committee, March 2007

The Legislative Council established the Continuity of Government Planning Interim Study Committee in 2006 and authorized the Committee to meet during the 2006 Legislative Interim. The Committee was given the following charge: Examine issues relating to the continued functioning of state government following a disaster, including gubernatorial succession, replacement of constitutional officers and department heads, legislative elections to fill vacancies, and continued funding of state government if the General Assembly is unable to meet and pass a budget.

What do outside experts bring to a committee? Evidence from the Bank of England

We test whether outside experts have information not available to insiders by usingthe voting record of the Bank of England's Monetary Policy Committee. Memberswith more private information should vote more often against conventional wisdom,which we measure as the average belief of market economists about future interest rates. We find evidence that external members indeed have information notavailable to internals, but also use a quasi-natural experiment to show they mayexaggerate their expertise to obtain reappointment. This implies that an optimalcommittee, even outside monetary policy, should potentially include outsiders, butneeds to manage career concerns.

Competing engines of growth: Innovation and standardization

We study a dynamic general equilibrium model where innovation takes theform of the introduction of new goods whose production requires skilled workers.Innovation is followed by a costly process of standardization, whereby these newgoods are adapted to be produced using unskilled labor. Our framework highlightsa number of novel results. First, standardization is both an engine of growth anda potential barrier to it. As a result, growth is an inverse U-shaped function ofthe standardization rate (and of competition). Second, we characterize the growthand welfare maximizing speed of standardization. We show how optimal protection of intellectual property rights affecting the cost of standardization vary withthe skill-endowment, the elasticity of substitution between goods and other parameters. Third, we show that, depending on how competition between innovatingand standardizing firms is modelled and on parameter values, a new type of multiplicity of equilibria may arise. Finally, we study the implications of our model forthe skill-premium and we illustrate novel reasons for linking North-South trade tointellectual property rights protection.

The INTERNORM project : bridging two worlds of expert- and layknowledge in standardization

This paper presents a pilot project to reinforce participatory practices in standardization. The INTERNORM project is funded by the University of Lausanne, Switzerland. It aims to create an interactive knowledge center based on the sharing of academic skills and the experiences accumulated by the civil society, especially consumer associations, environmental associations and trade unions to strengthen the participatory process of standardization. The first objective of the project is action-oriented: INTERNORM provides a common knowledge pool supporting the participation of civil society actors to international standard-setting activities by bringing them together with academic experts in working groups and by providing logistic and financial support to their participation to meetings of national and international technical committees. The second objective of the project is analytical: the standardization action initiated through INTERNORM provides a research field for a better understanding of the participatory dynamics underpinning international standardization. The paper presents three incentives that explain civil society (non-)involvement in standardization that try to overcome conventional resource-based hypotheses: an operational incentive, related to the use of standards in the selective goods provided by associations to their membership; a thematic incentive, provided by the setting of priorities by strategic committees created in some standardization organization; a rhetorical incentive, related to the discursive resource that civil society concerns offers to the different stakeholders.