Assessment Committee Research Articles

Diacerein for osteoarthritis

Diacerein for osteoarthritis

Curriculum Integration: A Self-Driven Continuum

There is much interest in curriculum integration in pharmacy as evidenced by Journal articles on integrating learning exercises,1 technologies,2 skills laboratory activities,3 courses,4 and even the entire pharmacy curriculum,5 as well as the publications of Viewpoints on the subject.6 Brain research7 and an era of accountability have driven this. Pearson and Hubbal8 published a review of curricular integration in pharmacy and addressed barriers to integration including time and effort, the established culture, and lack of evidence on the effectiveness of integration. One aspect that was not addressed is the principled responsibility upon faculty members to ensure that the student experience is integrated. This means that faculty members bear responsibility to understand in depth what other faculty members are teaching, Accreditation Council for Pharmacy Education standards 10.2, 13.1 and 13.4.9 Thus, integration first and most, has to be self-driven. What does self-driven mean? Well, as faculty members in a professional program, we want students to see the big picture and to challenge them to make connections between the different disciplines they are learning. For example, science faculty members often stand in front of students and ask. “Do you remember this from anatomy? Biochemistry?” Clinical faculty members may state, “You should know this from pathophysiology or pharmacology!” This is somewhat hypocritical if we do not spend the time and effort to ascertain this so that we help facilitate their learning better. For many years in K-12, the idea of integration and for teachers to spend the time and effort to integrate concepts and disciplines have been more of the norm than the exception.10 However, much of the success of these undertakings depend on the commitment of the teachers and their creativity to develop integrated lesson plans.10 There is much for pharmacy educators to learn from the experience of K-12 teachers and we all should uphold an individual responsibility to carry ourselves up the ladder to become a more competent integrative educator. This continuum up the ladder should start with what we all do, identify courses and concepts which are prerequisites to our course. This should be taken seriously by pinpointing key concepts taught in our courses and tracking back to previous courses to determine the concepts needed to help the students master the content in our courses. The second step is to have purposeful communication with faculty members who are teaching in these prerequisite courses to ensure that these concepts are taught to the depth that we would expect them to be addressed and at the level at which the students should be evaluated. This will help with the third step in the continuum, to reinforce these prior concepts by revisiting them and integrating them with concepts in our courses, for example using technology2 or devising integrated activities in skills laboratory,3 teaching concepts across several disciplines (multidisciplinary),8 developing thematic lesson plans based on different disciplines but a common theme (interdisciplinary),8 and developing higher level assessments integrating these concepts. A must for science faculty in this whole process is to demonstrate the clinical relevance of their content and to tie it to future course work (eg, therapeutics).9 A challenge for clinical and social/administrative faculty members is to make this process bidirectional and to emphasize science. The educational outcomes for the course should be a guide to help in this process including, for example, science faculty members revisiting core competencies from the social and administrative sciences to reinforce specific educational outcomes (eg, professionalism, communication skills). Hence, the emphasis is on supporting the whole curriculum. The highest level for any faculty member in this continuum is to invest the time and effort to conduct a scholarship of teaching and learning (SoTL)11 study to evaluate if his/her methodologies or pedagogy are helping students see the big picture and integrate concepts. Collaborating with faculty members from other disciplines on these projects would help to truly meet Guideline 10.29 (awareness by faculty members of each other’s courses including content, depth, methodologies used, and relationship to adopted curricular competencies and outcomes). Sharing findings of such studies with the curriculum, assessment committee, and the larger academic community is crucial in this effort. Therefore, I strongly believe embracing this continuum will overcome the barriers identified above as it should be easier to overcome the time and effort and the established culture with a power of one rather than the whole faculty. Also, by conducting SoTL, evidence for the value of integration can be established. Consequently, this continuum commitment by each faculty member would be the impetus for making connections across the whole curriculum, ultimately making the learner more responsible for seeing the big picture.

Cardiovascular safety of strontium ranelate: real-life assessment in clinical practice

Cardiovascular safety of strontium ranelate: real-life assessment in clinical practice

Program Assessment: Enough or Too Much?

Program and institutional assessment have gained considerable momentum because of the major emphasis in higher education in the mid-1980s and in pharmacy education in the early 2000s. Regional and specialty accreditation agencies have increased the requirements in meeting standards related to assessment and have focused on the incorporation of assessment processes throughout institutions and programs as part of continuous improvement and accountability.1 As a result, colleges and schools of pharmacy have responded remarkably by expanding the responsibilities of existing administrators or creating new administrative positions to oversee assessment activities; creating assessment committees or adding those responsibilities to other committees; and increasing the number, scope, and quality of assessment activities.2 Colleges and schools of pharmacy have assessment activities that support major program decisions and self-studies with assistance from outside vendors. The American Association of Colleges of Pharmacy also provides assistance through curriculum quality surveys, other institutional research data, and the Assessment and Accreditation Management System. However, the growing expectations in assessment do not seem to have an endpoint or target. How do we know if the assessment efforts are sufficient to meet program needs and expectations or if they have gone too far and have unintended negative consequences? Pellegrino indicated the need to develop methods “to understand and analyze the cost-benefit consequences of the shift in assessment foci,”3 and provide a reasonable general approach to answer these difficult questions. Program assessment activities are sufficient when programs have collected and used pertinent information to assess the major program outcomes and strategic initiatives in the program and unit. This depends initially on the development and selection of the college or school of pharmacy’s major outcomes and initiatives based on prioritization and importance of the quality, sustainability, and improvement in the program and academic unit. Next, assessments must be selected to support the needed monitoring and decision-making based on reliable, accurate, and meaningful information from more than 1 source on each of those major outcomes and initiatives. The goal is not to assess every objective or initiative, but instead to provide a reasonable measure of the status, strengths, and areas in need of improvement for the major outcomes and initiatives. A highly effective and efficient assessment program will likely have assessment activities that are well integrated and embedded in the curriculum.3-5 These same principles should be considered for standing committees and administrative offices by integrating and embedding assessments within the functions of those entities and their reports on a routine and annual basis. Each institution will have its unique challenges in making these determinations. The consequences of not having sufficient assessment activities would include not having the data and processes needed to monitor and enhance the quality of the academic program and unit, in addition to being at risk for unfavorable accreditation actions. Is more assessment always better? No. Can too much assessment be done? Yes. A number of factors may indicate that the program assessment efforts are excessive. A prime example is the collection of massive amounts of assessment data that are never analyzed, shared, or used, or that have little relevance to the major outcomes or initiatives. Some excesses can be expected, but this becomes a problem when the collection, storage, maintenance, and analysis of data impair other assessment activities or other pertinent unit functions. Triangulation is needed to provide an accurate assessment of major outcomes and initiatives, but excessive duplication of assessment efforts that focus on similar methods may be wasteful. Additionally, it may be problematic when the discussions on assessments activities alone displace or delay discussions on quality improvement. Assessment efforts may be imbalanced with an overemphasis on certain components (curriculum, for example) and an underemphasis on other components (student services, research and scholarship, facilities, etc). Finally, there should be a reasonable balance of resources and efforts that are put into assessment activities compared to other fundamental operations of the college or school of pharmacy. A general cost-benefit approach, as mentioned by Pellegrino,3 should be considered when evaluating assessment activities and determining if there is an appropriate emphasis on those activities. In summary, assessment activities should be done efficiently and sufficiently to fully support, but not impair, program delivery, quality improvement, and accountability. In addition to the selection of major outcomes and initiatives and appropriate assessment activities, the integration and embedding of assessment activities into ongoing processes (curricular, administrative, services, etc) should be considered to enhance the cost-benefit nature of assessment activities within colleges and schools of pharmacy.

The Pharmaceutical Year That Was, 2013

Last year ended with Europe wallowing in its Euro-crisis, the United States (US) Congress wrangling over its budget (eventually unresolved, leading to a legislative ‘sequestration’), the promise of a Pharmacovigilance Risk Assessment Committee (PRAC) within the European Medicines Agency (EMA), a European initiative towards publication of clinical trials data, and an unremarkable number of truly new product approvals on both sides of the Atlantic [1]. Much of that carried on this year, while the economic situation continues to stagger and stutter. As mentioned last year, 2013 has seen the PRAC getting into its stride at the EMA [2]. The PRAC advises the Committee for Medicinal Products for Human Use (CHMP), the Co-ordination Group for Mutual Recognition and Decentralised Procedures-Human (CMDh), the EMA secretariat and the European Commission on all aspects of pharmacovigilance and risk management. The PRAC is comprised of: a Chairperson, a member (or alternate) from every member state, six members ex officio and technically qualified from the European Commission (EC), and another two EC members (with alternates) for public calls of interest for healthcare professionals and patients. They all have 3 year terms, renewed easily the first time, and after competition thereafter. The PRAC aims to review all Product Licence Applications (PLAs) from the point of view of proposed pharmacovigilance and risk management activities. These are all Module 1 components of the electronic Clinical Trials Dossier (eCTD), and thus are restricted to the European marketplaces. In addition, the PRAC will be reviewing Periodic Safety Update Reports (PSURs; these now require formal risk-benefit assessments), Post-Assessment Safety Studies (PASS), as well as doing general signal detection and making ‘for cause’ pharmacovigilance inspection decisions. For licensed products, these responsibilities differ little between centralised process and other approvals. Lastly, the PRAC is empowered to take urgent action on its own initiative in cases of serious threats to the public health. Flexing its muscles, in January 2013 PRAC recommended the withdrawal of three products from the entire EU, and most recently (September 2013) is recommending against short-acting beta-agonists in pregnancy [3]. A slang has developed in the United Kingdom: purity, efficacy and safety come first, and then the National Institute for Health and Care Excellence (NICE) has become known as a ‘fourth hurdle’. The PRAC might yet become known as the fifth hurdle. A new distraction this year is that the US Food and Drug Administration (FDA) doesn’t quite know whether it can regulate ‘electronic cigarettes’ [4]. In ordinary parlance, these breath-actuated inhalational devices deliver vaporized nicotine, and are shaped like a cigarette. The amusing angle of this regulatory uncertainty is that the FDA is, however, now attempting to regulate tobacco itself. The Family Smoking Prevention and Tobacco Control Act (2009) gave the FDA the authority to regulate products containing tobacco. A regulatory pathway for tobacco products has been contrived, based upon the notion of ‘‘substantial equivalence’’. On this basis, there have been two new product approvals and at least four rejections [5]. The two approvals so far (‘‘Newport Non-menthol Gold Box 100s’’ and ‘‘Newport Non-menthol Gold Box’’) had A. W. Fox is the Consulting Editor for Pharmaceutical Medicine.

Subjective endpoints in clinical trials: the case for blinded independent central review

Primary efficacy and safety endpoints in clinical trials are often subjective assessments made by site personnel. For international confirmatory trials conducted over broad geographic regions and different clinical practice settings, variability in these subjective assessments can be substantial. Centralized endpoint assessment committees (EACs) offer a mechanism through which to reduce assessment bias and potentially increase assessment precision and accuracy, particularly in open-label trials. An overview of regulatory agencies' rationales for an EAC is reviewed. In addition, the two main types of EACs, the blinded independent central review, and the consensus panel are compared. Selection of endpoints for EAC evaluation and design of EAC process to maximize EAC value proposition are also discussed.

Evaluation of the Anterior Chamber Angle in Glaucoma: A Report by the American Academy of Ophthalmology

To assess the published literature pertaining to the association between anterior segment imaging and gonioscopy and to determine whether such imaging aids in the diagnosis of primary angle closure (PAC). Literature searches of the PubMed and Cochrane Library databases were last conducted on July 6, 2011. The searches yielded 371 unique citations. Members of the Ophthalmic Technology Assessment Committee Glaucoma Panel reviewed the titles and abstracts of these articles and selected 134 of possible clinical significance for further review. The panel reviewed the full text of these articles and identified 79 studies meeting the inclusion criteria, for which the panel methodologist assigned a level of evidence based on a standardized grading scheme adopted by the American Academy of Ophthalmology. Three, 70, and 6 studies were rated as providing level I, II, and III evidence, respectively. Quantitative and qualitative parameters defined from ultrasound biomicroscopy (UBM), anterior segment optical coherence tomography (OCT), Scheimpflug photography, and the scanning peripheral anterior chamber depth analyzer (SPAC) demonstrate a strong association with the results of gonioscopy. There is substantial variability in the type of information obtained from each imaging method. Imaging of structures posterior to the iris is possible only with UBM. Direct imaging of the anterior chamber angle (ACA) is possible using UBM and OCT. The ability to acquire OCT images in a completely dark environment allows greater sensitivity in detecting eyes with appositional angle closure. Noncontact imaging using OCT, Scheimpflug photography, or SPAC makes these methods more attractive for large-scale PAC screening than contact imaging using UBM. Although there is evidence suggesting that anterior segment imaging provides useful information in the evaluation of PAC, none of these imaging methods provides sufficient information about the ACA anatomy to be considered a substitute for gonioscopy. Longitudinal studies are needed to validate the diagnostic significance of the parameters measured by these instruments for prospectively identifying individuals at risk for PAC. Proprietary or commercial disclosure may be found after the references.

Contractualisation interne : expérience du service de transfusion et d’immunologie de Rabat

The management by objectives method has become highly used in health management. In this context, the blood transfusion and haemovigilance service has been chosen for a pilot study by the Head Department of the Ibn Sina Hospital in Rabat. This study was conducted from 2009 to 2011, in four steps. The first one consisted in preparing human resources (information and training), identifying the strengths and weaknesses of the service and the identification and classification of the service's users. The second step was the elaboration of the terms of the contract, which helped to determine two main strategic objectives: to strengthen the activities of the service and move towards the “status of reference.” Each strategic objective had been declined in operational objectives, then in actions and the means required for the implementation of each action. The third step was the implementation of each action (service, head department) so as to comply with the terms of the contract as well as to meet the deadlines. Based on assessment committees, the last step consisted in the evaluation process. This evaluation was performed using monitoring indicators and showed that management by objectives enabled the Service to reach the “clinical governance level”, to optimize its human and financial resources and to reach the level of “national laboratory of reference in histocompatibility”. The scope of this paper is to describe the four steps of this pilot study and to explain the usefulness of the management by objectives method in health management.

Social Psychology’s Contribution to a Sustainable Future

John Houghton (2011), the past chair of the Intergovernmental Panel on Climate Change (IPCC) scientific assessment committee, contends that global climate change is now “the greatest problem the world faces.” The IPCC conclusions—supported by the national science academies of the eleven most developed countries in the world—are undergirded by the most “thoroughly researched and reviewed” scientific effort in human history. The consensus facts are as follows:

Instruction Coordinators and Higher Education Accreditation: A Study of Awareness and Assessment Documentation Use

This study gauges instruction and information literacy coordinators' awareness of higher education accreditation processes at their institutions and provides a picture of how coordinators use assessment documentation produced by units external to the library. The study took the form of a survey sent to a random sample of instruction coordinators and information literacy librarians stratified by regional accrediting body. Results showed that instruction coordinators generally are aware of accreditation processes but that only about half use documentation relating to student learning assessment, which may include written student learning outcomes at the institution, program, or course level, plans for assessing learning outcomes, and reports on assessment activities and results, to further their information literacy goals. Accreditation awareness is influenced by time in position, time in the profession, and, to some extent, regional accreditor. Use of and considered importance of assessment documentation is influenced by size of institution, regional accreditor, and, to some extent, time in position. Suggestions for increasing awareness and use of documentation include introducing the accreditation process to new librarians in library school, encouraging contribution of experiences with assessment documentation to the literature and regional conferences, and advocating for instruction coordinators to serve on campus assessment committees.

Value-Based Interventional Pain Management: A Review of Medicare National and Local Coverage Determination Policies

Major policies, regulations, and practice patterns related to interventional pain management are dependent on Medicare policies which include national coverage policies – national coverage determinations (NCDs), and local coverage policies – local coverage determinations (LCDs). The NCDs are Medicare coverage policies issued by the Centers for Medicare and Medicaid Services (CMS). The process used by the CMS in deciding what is and what is not medically necessary is lengthy, involving a review of evidence-based literature on the subject, expert opinion, and public comments. In contrast, LCDs are rules and Medicare coverage that are issued by regional contractors and fiscal intermediaries when an NCD has not addressed the policy at issue. The evidence utilized in preparing LCDs includes the highest level of evidence which is based on published authoritative evidence derived from definitive randomized clinical trials or other definitive studies, and general acceptance by the medical community (standard of practice), as supported by sound medical evidence. In addition, the intervention must be safe and effective and appropriate including duration and frequency that is considered appropriate for the item or service in terms of whether it is furnished in accordance with accepted standards of medical practice for the diagnosis or treatment of the patient’s condition or to improve the function. In addition, the safe and effective provision includes that service must be furnished in a setting appropriate to the patient’s medical needs and condition, ordered and furnished by qualified personnel, the service must meet, but does not exceed, the patient’s medical need, and be at least as beneficial as an existing and available medically appropriate alternative. The LCDs are prepared with literature review, state medical societies, and carrier advisory committees (CACs) of which interventional pain management is a member. The LCDs may be appealed by beneficiaries. The NCDs are prepared by the CMS following a request for a national coverage decision after an appropriate national coverage request along with a draft decision memorandum, and public comments. After the request, the staff review, external technology assessment, Medicare Evidence Development and Coverage Advisory Committee (MedCAC) assessment, public comments, a draft decision memorandum may be posted which will be followed by a final decision and implementation instructions. This decision may be appealed to the department appeals board, but may be difficult to reverse. This manuscript describes NCDs and LCDs and the process of development, their development, issues related to the development, and finally their relation to interventional pain management. Key words: Interventional pain management, interventional techniques, national coverage determinations (NCDs), local coverage determinations (LCDs), contractor medical director (CMD), Centers for Medicare and Medicaid Services (CMS), Department of Health and Human Services (HHS), guidelines, evidence-based medicine, evidence development with coverage

Process Without Purpose

Process Without Purpose

Identification of technical item flaws leads to improvement of the quality of single best Multiple Choice Questions

The purpose of the study was to identify technical item flaws in the multiple choice questions submitted for the final exams for the years 2009, 2010 and 2011. This descriptive analytical study was carried out in Islamic International Medical College (IIMC). The Data was collected from the MCQ's submitted by the faculty for the final exams for the year 2009, 2010 and 2011. The data was compiled and evaluated by a three member assessment committee. The data was analyzed for frequency and percentages the categorical data was analyzed by chi-square test. Overall percentage of flawed item was 67% for the year 2009 of which 21% were for testwiseness and 40% were for irrelevant difficulty. In year 2010 the total item flaws were 36% and 11% testwiseness and 22% were for irrelevant difficulty. The year 2011 data showed decreased overall flaws of 21%. The flaws of testwisness were 7%, irrelevant difficulty were 11%. Technical item flaws are frequently encountered during MCQ construction, and the identification of flaws leads to improved quality of the single best MCQ's.

Development and Validity and Reliability of Korean Comprehensive Assessment Tools for Geriatric Ambulatory Care

Department of Family Medicine, Seoul National University College of Medicine, Seoul, Functional Assessment Committee for the Elderly, Korean Geriatric Society, Seoul, Department of Internal Medicine, Inje University College of Medicine, Busan, Department of Preventive Medicine, Seoul National University College of Medicine, Seoul, Korea Institute of Health and Social Affairs, Seoul, Department of Family Medicine, Hallym University College of Medicine, Chuncheon, Department of Family Medicine, Kyung Hee University School of Medicine, Seoul, Department of Family Medicine, Hanyang University College of Medicine, Seoul, Department of Family Medicine, Incheon Eunhye Hospital, Incheon, Korea

How multi-agency are Multi-Agency Risk Assessment Committees?

This article reports on the observations of a combined level 2 and 3 Multi-Agency Risk Assessment Committee (MARAC) over a 12 month period. It considers agency representation and discusses this in respect to attendance and the nature of relationships between representatives. The key findings are structured around the experiences of three identifiable groups of panel members and leads to a discussion of how the status of agencies and the informal roles adopted by the different members are defined by power relationships based on possession of knowledge. These relationships reflect cultural traditions in working with high risk offenders, but are also shaped by statutory responsibilities placed on different agencies within the MARAC forum.

Global-Warming Warnings

Global warming is occurring at record levels and is due to increasing atmospheric greenhouse gases generated by human activities, according to several new government scientific reports issued in recent weeks. The rapidity of greenhouse gas impacts will make projections and mitigation efforts increasingly difficult and will result in a drastic transformation of Earth’s environment, the reports say. In a related development, researchers are reporting that airborne black carbon particles—which are a component of soot—hold twice the warming potential as previously thought. Rising seas, heat waves, erratic and intense rainfall, storm surges, and droughts are among the effects accelerating climate changes now under way. That is one conclusion of a draft report by the National Climate Assessment & Development Advisory Committee, a 60-member federal advisory body established to advise the President and Congress on climate-change issues. The draft assessment presents a grim picture of the ongoing impact from clima...

La evaluación del Trabajo Fin de Grado a través de la rúbrica

The Final Year Project 1 , a new compulsory subject linked to Social Sciences, has been recently introduced in the Spanish University Degrees. Given its novelty and the difficulties its assessment entails, those agents, involved in evaluating the students’ performance on this subject (e.g. supervisors, members of the assessment committee), need a fresh set of guidelines to assist their work. In order to meet this need in the Degrees of Preschool and Primary Education, our objective in this paper is to propose an alternative assessment model to help supervisors judge the TFGs by means of a rubric, and we offer two examples of this instrument. These assessment tools have been adapted for the TFGs where students specifically carry out a bibliographic

Pharmacovigilance and risk management in the EU

A major revision of the pharmacovigilance legislation came into force in the European Union (EU) in 2010 and applies from July 2012. A technical implementing regulation and detailed guidance have been issued in 2012 to facilitate this enhancement of EudraVigilance. Major emphasis has been put on further strengthening the role of EudraVigilance as regards simplifying adverse reaction reporting, collecting adverse reactions, detecting new risks, monitoring known or potential risks and providing stakeholders with adequate access to adverse reaction data. The legislation has created the Pharmacovigilance Risk Assessment Committee that is responsible for assessing all aspects of the risk management of medicines for human use. The Risk management system are a set of pharmacovigilance activities and interventions designed to identify, characterise, prevent or minimise risks relating to medicinal products. The requirements in the Directive and Regulation include provisions for post-authorisation efficacy studies, in addition to post-authorisation safety studies.

Risk Assessment Committee

Risk Assessment Committee

The new pharmacovigilance legislation and impact on observational studies

ABSTRACT BACKGROUND: After the publication of the Regulation (EU) No 1235/2010 and Directive 2010/84/EU on 31st of December 2010, the new legislation on pharmacovigilance came into operation for the better protection of public health through a further strengthened EU system for medicines safety. REMARKS: The main changes include the new definition of adverse reactions, Eudravigilance becoming the single receipt point for all pharmacovigilance information through the EU, the Pharmacovigilance Risk Assessment Committee, and strengthened PASS/PAES, and requirement of a risk management planning for all new medicines. The possible increase in PA(E)SS may be a concern in terms of access to appropriate data and so obtaining necessary authorisations without delays. CONCLUSION: The new legislation will provide good vigilance practice standards with increased transparency of pharmacovigilance data. The communication will improve with the involvement of patient and public. With better access to real-life data, better protection of public health will be ensured. KEYWORDS: pharmacovigilance legislation, pharmacoepidemiology, observational study, regulations, European Directive