The purposes of occupational medicine are described in terms of its clinical medical, environmental medical, research, and administrative content. Each of these components is essential in different proportions in comprehensive occupational health services for different industries, and can only be satisfactorily provided by occupational physicians and occupational health nurses who are an integral part of their organizations. Two-thirds of the working population in the United Kingdom are without the benefits of occupational medicine. The reorganization of the National Health Service and of local government presents the opportunity to extend occupational health services to many more workers who need them. It is suggested that area health authorities should provide occupational health services for all National Health Service staff and, on an agency basis, for local government and associated services, eventually extending to local industry. Such area health authority based services, merged with the Employment Medical Advisory Service, could conveniently then be part of the National Health Service, as recommended by the British Medical Association, the Society of Occupational Medicine, and the Medical Services Review Committee.
The purpose of this study was to examine the levels of occupational stress and physical symptoms among family medicine residents and investigate the effect of subscales of occupational stress on physical symptoms.
A self-administered questionnaire survey of 1,152 family medicine residents was carried out via e-mail from April 2010 to July 2010. The response rate was 13.1% and the R (ver. 2.9.1) was used for the analysis of completed data obtained from 150 subjects. The questionnaire included demographic factors, resident training related factors, 24-items of the Korean Occupational Stress Scales and Korean Versions of the Wahler Physical Symptom Inventory.
The total score of occupational stress of family medicine residents was relatively low compared to that of average workers. The scores of 'high job demand', 'inadequate social support', 'organizational injustice', and 'discomfort in occupational climate' were within the top 50%. Parameters associated with higher occupational stress included level of training, on-duty time, daily patient load, critical patient assigned, total working days, night duty day, sleep duration, and sleep quality. The six subscales of occupational stress, except for 'Job insecurity', had a significant positive correlation with physical symptom scores after adjustment had been made for potential confounders (total score, r = 0.325 and P < 0.001; high job demand, r = 0.439 and P < 0.001).
After the adjustment had been made for potential confounders, the total score of occupational stress and six subscales in family medicine residents showed a significant positive correlation with physical symptom scores.
Stress; Signs and Symptoms; Family Physicians; Internship and Residency; Questionnaires
This editorial is to announce the Journal of Occupational Medicine and Toxicology, a new Open Access, peer-reviewed, online journal published by BioMed Central. Occupational medicine and toxicology belong to the most wide ranging disciplines of all medical specialties. The field is devoted to the diagnosis, prevention, management and scientific analysis of diseases from the fields of occupational and environmental medicine and toxicology. It also covers the promotion of occupational and environmental health. The complexity of modern industrial processes has dramatically changed over the past years and today's areas include effects of atmospheric pollution, carcinogenesis, biological monitoring, ergonomics, epidemiology, product safety and health promotion. We hope that the launch of the Journal of Occupational Medicine and Toxicology will aid in the advance of these important areas of research bringing together multi-disciplinary research findings.
Background. This study aims to analyze the utilization patterns of patients with lung cancer stratified by surgery status. Methods. A retrospective cohort study was conducted from 1996 to 2010 by using the Longitudinal Health Insurance Database 2005. Results. Among the 7,677 lung cancer patients, 230 (31.17%) and 1,826 (26.32%) who have and have not undergone surgery have used TCM outpatient services, respectively. For lung cancer patients who have not undergone surgery, patients who are aged 70 years and older, males, occupational members, and farmers and fishermen are less likely to avail of TCM services. For lung cancer patients who have undergone surgery, the likelihood of TCM users is higher in residents who used TCM one year prior to lung cancer diagnosis and in patients with insurance amounts ranging from ≥NT$60,000. The total amount paid per visit for WM is higher than that for one year of TCM outpatient care before and after lung cancer diagnosis. Conclusion. The factors associated with TCM use varied according to surgery status. The costs of insurance covering TCM were consistently lower than those covering WM for lung cancer patients. These findings would be useful for health policy makers who are considering TCM and WM integration.
During the last 5 years a fundamental curriculum reform was realized at the medical school of the Ludwig-Maximilians-University. In contrast to those efforts, the learning objectives were not defined consistently for the curriculum and important questions concerning the curriculum could not be answered. This also applied to Occupational and Environmental Medicine where teachers of both courses were faced with additional problems such as the low number of students attending the lectures.
The aims of the study were to develop and analyse a curriculum map for Occupational and Environmental Medicine based on learning objectives using a web-based database.
Furthermore we aimed to evaluate student perception about the curricular structure.
Using a web-based learning objectives database, a curriculum map for Occupational and Environmental Medicine was developed and analysed. Additionally online evaluations of students for each course were conducted.
The results show a discrepancy between the taught and the assessed curriculum. For both curricula, we identified that several learning objectives were not covered in the curriculum. There were overlaps with other content domains and redundancies within both curricula. 53% of the students in Occupational Medicine and 43% in Environmental Medicine stated that there is a lack of information regarding the learning objectives of the curriculum.
The results of the curriculum mapping and the poor evaluation results for the courses suggest a need for re-structuring both curricula.
With an aging population, internists will provide care to a growing number of older adults, a population at risk of developing multiple chronic medical conditions and geriatric syndromes. For this update in geriatric medicine, we highlight recent key articles focused on preventive strategies and lifestyle changes that reduce the burden of disease and functional decline in older adults.
We identified English-language articles published between March 1, 2010 and March 31, 2011 by review of the contents of major geriatrics/general medicine journals and journal watch services including: New England Journal of Medicine, Annals of Internal Medicine, Journal of the American Medical Association, Lancet, Archives of Internal Medicine, British Medical Journal, Journal of the American Geriatrics Society, and the Journals of Gerontology. We also reviewed updates to the Cochrane database of systematic reviews and articles highlighted by the ACP Journal Club and Journal Watch. Inclusion criteria included (1) randomized controlled trials, (2) conditions exclusive or common to older adults, and (3) commonly seen in generalist practices. After abstract review, each author selected five articles, and these were reviewed again by all authors. Through multiple discussions, consensus was reached on the final articles selected for inclusion based on their quality and potential to improve the health of older patients cared for by generalists.
geriatrics; aging; dementia; prevention
In this review I describe the development of environmental medicine as a specialized field of clinical medicine in Germany. New scientific societies were founded, based on traditions of public hygiene and occupational medicine, as a reaction to environmental issues concerning human health. Environmental medicine issues were also addressed by independent "critical" physicians. The first institutions to accept patients were centers for environmental medicine affiliated with research institutions and/or with the public health service. Medical professional organizations, particularly the German General Medical Council, described the need for and formulated conditions for additional qualification for doctors in environmental medicine, including a 200-hr course. This course and a qualifying exam were passed by about 3,000 doctors, mainly from the public health service and from occupational medicine. Unfortunately, few general physicians in primary outpatient care were similarly trained. To date, no representative study has been conducted on environmental patients, but I include in this review a typical list of patients' complaints. I also summarize research activities typical for environmental medicine in Germany. Present problems concern accounting systems and, for example, diagnosis and treatment of patients with multiple chemical sensitivities (MCS). A coordinated research program on MCS has been started.
Research in the fields of Preventive Medicine, Occupational/Environmental Medicine, Epidemiology and Public Health play an important role in the advancement of knowledge. In order to map the research production around the world we performed a bibliometric analysis in the above fields.
All articles published by different world regions in the above mentioned scientific fields and cited in the Journal Citation Reports (JCR) database of the Institute for Scientific Information (ISI) during the period 1995 and 2003, were evaluated. The research production of different world regions was adjusted for: a) the gross domestic product in 1995 US dollars, and b) the population size of each region.
A total of 48,861 articles were retrieved and categorized. The USA led the research production in all three subcategories. The percentage of articles published by USA researchers was 43%, 44% and 61% in the Preventive Medicine, Epidemiology, and Public Health subcategories, respectively. Canada and Western Europe shared the second position in the first two subcategories, while Oceania researchers ranked second in the field of Public Health.
USA researchers maintain a leadership position in the production of scientific articles in the fields of Preventive Medicine, Occupational/Environmental Medicine and Epidemiology, at a level similar to other scientific disciplines, while USA contribution to science in the field of Public Health is by all means outstanding. Less developed regions would need to support their researchers in the above fields in order to improve scientific production and advancement of knowledge in their countries.
Occupational and environmental diseases are underrecognized. Among the barriers to the successful diagnosis, treatment, and prevention of these conditions are inadequate consultative and information resources. We describe the 10-year clinical and training experiences of an academically affiliated referral center that has as its primary goal the identification of work-related and other environmental diseases. The University of Washington Occupational and Environmental Medicine Program has evaluated 6,048 patients in its diagnostic and screening clinics. Among the 2,841 seen in the diagnostic clinics, 1,553 (55%) had a work-related condition. The most prevalent diagnoses included asbestos-related lung disease (n = 603), toxic encephalopathy (n = 160), asthma (n = 119), other specific respiratory conditions (n = 197), carpal tunnel syndrome (n = 86), and dermatitis (n = 82). The clinics serve as a training site for fellows in the specialty training program, primary care internal medicine residents, residents from other medical specialties, and students in industrial hygiene, toxicology, and occupational health nursing. The program serves two additional important functions: providing consultative services to community physicians and training specialists and other physicians in this underserved area of medicine.
Over the last century, environmental and occupational medicine has played a significant role in the protection and improvement of public health. However, scientific integrity in this field has been increasingly threatened by pressure from some industries and governments. For example, it has been reported that the tobacco industry manipulated eminent scientists to legitimise their industrial positions, irresponsibly distorted risk and deliberately subverted scientific processes, and influenced many organisations in receipt of tobacco funding. Many environmental whistleblowers were sued and encountered numerous personal attacks. In some countries, scientific findings have been suppressed and distorted, and scientific advisory committees manipulated for political purposes by government agencies. How to respond to these threats is an important challenge for environmental and occupational medicine professionals and their societies. The authors recommend that professional organisations adopt a code of ethics that requires openness from public health professionals; that they not undertake research or use data where they do not have freedom to publish their results if these data have public health implications; that they disclose all possible conflicts; that the veracity of their research results should not be compromised; and that their research independence be protected through professional and legal support. The authors furthermore recommend that research funding for public health not be directly from the industry to the researcher. An independent, intermediate funding scheme should be established to ensure that there is no pressure to analyse data and publish results in bad faith. Such a funding system should also provide equal competition for funds and selection of the best proposals according to standard scientific criteria.
An attempt to achieve an agreed set of priorities for research in occupational medicine was undertaken by the Delphi technique. Fifty three senior practitioners of occupational medicine in academe (25) and industry or government (28) were canvassed about their views and choices for priority activity. Forty six (86%) responded to the initial enquiry and 48 (91%) provided rank order choices from a second, more detailed questionnaire. The first priority for more research on the natural history of work related ill health identified musculoskeletal disorders of the back and upper limbs followed by asthma, accidents, skin disorders, vibration induced disease, suicide and depression, and finally hearing loss. The second priority area was audit and particularly the need for its use in occupational health screening procedures. Environmental impact of industrial activity was third with the community health effects being more important than individual health effects. Stress related disease was fourth with emphasis on risk factors. The fifth area was neuropsychological effects of work exposures particularly the need for more research on diagnostic tests. Other assorted areas of concern were the cost effectiveness of occupational health, risk assessment, reproductive hazards, the effects of pharmacological agents, and the development of biomarkers as early evidence of an exposure effect. The remarkable degree of unanimity on the issues and choices and the general agreement between physicians from academe and industry on what constitute the priorities warrants further discussion and positive action.
This paper describes a prototype information sources map (ISM), an on-line information source finder, for Occupational and Environmental Medicine (OEM). The OEM ISM was built as part of the Unified Medical Language System (UMLS) project of the National Library of Medicine. It allows a user to identify sources of on-line information appropriate to a specific OEM question, and connect to the sources. In the OEM ISM we explore a domain-specific method of indexing information source contents, and also a domain-specific user interface. The indexing represents a domain expert's opinion of the specificity of an information source in helping to answer specific types of domain questions. For each information source, an index field represents whether a source might provide useful information in an occupational, industrial, or environmental category. Additional fields represent the degree of specificity of a source in individual question types in each category. The paper discusses the development, design, and implementation of the prototype OEM ISM.
OBJECTIVES—To evaluate the fate of manuscripts rejected by Occupational and Environmental Medicine (OEM).
METHODS—A Medline search was conducted, up to March 2001, to find out whether and where articles submitted to OEM in 1995, 1996, and 1997, but not accepted for publication, were published. The articles were matched by authors and title, sometimes using the abstract to help decide whether the published article was the one that had been previously submitted to OEM.
RESULTS—Out of 405 manuscripts rejected (44% of those submitted), 218 articles (54%) were traced in 72 different journals, with more than half being published in seven other major journals dealing with occupational and environmental health (rather than in specialty journals). Most papers were published within 2 years of their initial submission to OEM. Only a small proportion (10%) were published in a journal with a higher impact factor than OEM (1.96 in 1999).
CONCLUSION—More than half the articles rejected by OEM found their way into the scientific literature covered by Medline. This figure is comparable with the few available data from other journals. It would be interesting to know the fate of articles published by OEM before they were submitted to our journal.
Keywords: journalology; bibliometry; impact factor
Accessory Deep Peroneal Nerve (ADPN) is an anatomic variation that can potentially cause disturbance in electrodiagnostic studies. This anomaly could be detected by nerve conduction studies. There are no recent updates about prevalence of this anatomic variation. Electrodiagnostic medicine clinic is the best environment for detecting presence and prevalence of this nerve, so present study enrolled.
Materials & Methods
In this cross sectional descriptive study that take place from March 2009 to July 2010, 230 cases comprising 460 legs referred for electrodiagnostic studies of upper limbs problems participated in the study. Compound muscle action potential (CMAP) and Nerve conduction Velocity (NCV) of Deep Peroneal Nerve (DPN) were measured by using EMG machine by stimulating DPN at knee, ankle and lateral malleolous areas accordingly, with recording from extensor digitorum brevis muscle. Results were analyzed and conclusion made.
The study population included 120 females (52%) and 110 (47%) males with mean age of 42.1 ± 13.5 years. ADPN was detected in 28 patients (12%). Among them,10(17.9%) had bilateral ADPN and in remained 18 cases (82.1%) APN was unilateral. In 8 patients there was no recorded CMAP from EDB by proximal and distal stimulation implying EDB agenesis. Gender distribution was similar which means half of the cases (14 patients) belonged to each gender.
The prevalence of ADPN in this study was 12.2%, (17.9% bilateral and 82.1% unilateral).
Using Evidence Based Medicine (EBM) in clinical practice is an important strategy for improving and updating medical services. Therefore, EBM has recently attracted a lot of attention in many medical schools around the world. In this study we tried to evaluate the familiarity of clinical residents who are one of the main clinical decision makers in public hospitals and also the next generation of specialists with EBM and EBM databases.
This was a cross–sectional study in 2010 in which clinical residents of Kerman Medical University (KMU) participated. Residents were asked about the four main EBM databases. The data was collected by a self-administered questionnaire.
The data showed that from the respondents only 26.6% knew about EBM and only 28.7% of the respondents were familiar with “Up to Date”, 22.3% were familiar with “Ovid EBM Reviews”, 6.4% were familiar with “Cochrane” and 5.3% were familiar with “BMJ Clinical Evidence”. The frequencies of those that actually used the databases for clinical decision making and could answer the search questions were even less.
The results showed most of the residents lack sufficient knowledge about EBM and its databases. The reason is probably the inexistence of a systematic and comprehensive curriculum for EBM education during their residency program or undergraduate program. Thus, due to the importance of learning EBM in this group, there is a necessity to plan a comprehensive and proper education schedule for EBM and EBM database use at the beginning or further stages of residency.
Evidence Based Medicine; EBM database; Clinical Residents; Postgraduate Curriculum
This article presents an update on addiction-related medical literature for the calendar years 2010 and 2011, focusing on studies that have implications for generalist practice. We present articles pertaining to medical comorbidities and complications, prescription drug misuse among patients with chronic pain, screening and brief interventions (SBIs), and pharmacotherapy for addiction.
Primary care; Alcoholism; Addictive behavior; Drug abuse; Substance-related disorders; Screening and brief intervention
In a ten-year period at the Occupational and Environmental Medicine Program (OEMP) of the University of Washington in Seattle, 71 patients were determined by attending physicians to have work-related asthma. In this cross-sectional descriptive study, we describe these patients. Data were obtained from a database maintained by the OEMP and from chart reviews. We found that the three most common specific agents causing asthma were isocyanates, red cedar, and crabs. At least one pulmonary function study was available for all patients and was positive in 56 patients (79%). Among the 71 asthma cases reported in this article, 18 (25%) were attributed to reactive airways dysfunction syndrome (RADS); 19 (27%) to exacerbation of pre-existing asthma; 27 (38%) to sensitization; and 7 (10%) had undetermined causes. We conclude that occupational asthma presents as a result of diverse exposures in multiple work settings and with an array of characteristics. Prevention efforts need to recognize this diversity.
An update of outer space medicine is given emphasizing main areas such as cardiopulmonary responses, vestibular functions, physiology, weightlessness, ecosystems, and radiation. A prospective view is also presented on the medical problems resulting from various hazards of outer space and planetary missions. Although an outgrowth of aviation and environmental medicine, this relatively new, special branch of medicine is currently undergoing an unprecedented rise as a vital modern specialty. The aims of the United States, Russia, and the nations of Europe in space research are shown to be in accord in learning how to live and work in space when confronted with the unique factors of zero gravity, cosmic radiation, and magnetic variations.
Acetylcholinesterase (AChE) is a key enzyme in the nervous system. It terminates nerve impulses by catalysing the hydrolysis of neurotransmitter acetylcholine. As a specific molecular target of organophosphate and carbamate pesticides, acetylcholinesterase activity and its inhibition has been early recognized to be a human biological marker of pesticide poisoning. Measurement of AChE inhibition has been increasingly used in the last two decades as a biomarker of effect on nervous system following exposure to organophosphate and carbamate pesticides in occupational and environmental medicine. The success of this biomarker arises from the fact that it meets a number of characteristics necessary for the successful application of a biological response as biomarker in human biomonitoring: the response is easy to measure, it shows a dose-dependent behavior to pollutant exposure, it is sensitive, and it exhibits a link to health adverse effects. The aim of this work is to review and discuss the recent findings about acetylcholinesterase, including its sensitivity to other pollutants and the expression of different splice variants. These insights open new perspective for the future use of this biomarker in environmental and occupational human health monitoring.
Technological advances in molecular biology over the past 2 decades have offered more complex techniques that can be used to study the role of specific exogenous agents and host variables that cause ill health. Increasingly, studies in human populations use this new technology, combined with epidemiological methods, to shed light on the understanding of the biological processes associated with development of disease. This approach has many potential applications in occupational and environmental medicine (OEM), and some aspects of the work in this growing field are reviewed. An understanding of biochemistry and genetics at the molecular level, specific knowledge on metabolism and mechanisms of action, and epidemiology have become increasingly important for the OEM practitioner. This is necessary to consider the major question of validation and relevance of these molecular biomarkers. As end users, OEM practitioners should also consider the impact of these advances on their practices. For example, the availability of genetic tests to identify susceptible workers raises issues of ethics, individual privacy, right to work, and the relevance of such tests. Several studies have presented data on the association of environmental measurements and various biomarkers for internal and biologically effective dose, genetic polymorphisms, and early response markers. Given the limitations of individual molecular biomarkers in assessing risk to health, and the multifactorial nature of environmental disease, it is likely that such an approach will increase our understanding of the complex issue of mechanisms of disease and further refine the process of risk assessment.
Background. More than 400 agents have been documented as causing occupational asthma (OA). The list of low-molecular-weight (LMW) agents that have been identified as potential causes of OA is constantly expanding, emphasizing the need to continually update our knowledge by reviewing the literature. Objective. The objective of this paper was to identify all new LMW agents causing occupational asthma reported during the period 2000–2010. Methods. A Medline search was performed using the keywords occupational asthma, new allergens, new causes, and low-molecular-weight agents. Results. We found 39 publications describing 41 new LMW causal agents, which belonged to the following categories: drugs (n = 12), wood dust (n = 11), chemicals (n = 8), metals (n = 4), biocides (n = 3), and miscellaneous (n = 3). The diagnosis of OA was confirmed through SIC for 35 of 41 agents, peak expiratory flow monitoring for three (3) agents, and the clinical history alone for three (3) agents. Immunological tests provided evidence supporting an IgE-mediated mechanism for eight (8) (20%) of the newly described agents. Conclusion. This paper highlights the importance of being alert to the occurrence of new LMW sensitizers, which can elicit OA. The immunological mechanism is explained by a type I hypersensitivity reaction in 20% of all newly described LMW agents.
Family physicians are naturally concerned with the work effects or causes of their patients' health problems. As occupational risk factors have become better understood, however, a new specialty of occupational medicine has been recognized by the Royal College of Physicians and Surgeons in 1984, two years after the Canadian Board of Occupational Medicine started its own certification. Occupational physicians are available to act as an extension of the family doctor's care and can provide trustworthy medical resources in the workplace. The family physician should be aware of some of the games poorly trained or ill-informed personnel managers may play in the workplace if they have no medical consultant to rely on. New human rights legislation has given more opportunities to rehabilitate workers back to their jobs, and occupational physicians and family physicians can achieve a great deal in co-operation as a result.
family medicine; occupational medicine; pre-employment examination; rehabilitation
The Scientific Board of the California Medical Association presents the following inventory of items of progress in occupational medicine. Each item, in the judgment of a panel of knowledgeable physicians, has recently become reasonably firmly established, both as to scientific fact and important clinical significance. The items are presented in simple epitome and an authoritative reference, both to the item itself and to the subject as a whole, is generally given for those who may be unfamiliar with a particular item. The purpose is to assist busy practitioners, students, research workers or scholars to stay abreast of these items of progress in occupational medicine that have recently achieved a substantial degree of authoritative acceptance, whether in their own field of special interest or another.
The items of progress listed below were selected by the Advisory Panel to the Section on Occupational Medicine of the California Medical Association and the summaries were prepared under its direction.
OBJECTIVES—To identify the common core competencies required for occupational physicians in Europe.
METHOD—A modified Delphi survey was conducted among members of the European Association of Schools of Occupational Medicine (EASOM), the Occupational Medicine Section of the Union of European Medical Specialities (UEMS), and of the European Network of Societies of Occupational Physicians (ENSOP). An initial questionnaire based on the training syllabus of the United Kingdom Faculty of Occupational Medicine was circulated and respondents were asked to rate the importance of each item. The results were discussed at a conference on the subject of competencies. A further questionnaire was developed and circulated which asked respondents to rank items within each section.
RESULTS—There was a 74% response in the first round and an 80% response in the second. Respondents' ratings from most important to least important were; occupational hazards to health, research methods, health promotion, occupational health law and ethics, communications, assessment of disability, environmental medicine, and management. In the second round, among those topics ranked most highly were; hazards to health and the illnesses which they cause, control of risks, and diagnoses of work related ill health. Topics such as principles of occupational safety and selection of personal protection equipment were of least importance. Although the assessment of fitness was regarded as important, monitoring and advising on sickness absence were not highly rated. Management competency was regarded as of low importance.
CONCLUSION—This survey identified that respondents had traditional disease focused views of the competencies required of occupational physicians and that competencies were lagging behind the evolving definition of occupational health.
Keywords: competencies; Delphi study; occupational medicine training
This paper summarizes the scientific review of the application leading to approval of ofatumumab for the treatment of chronic lymphocytic leukemia in the European Union.
After completing this course, the reader will be able to:
Evaluate the evolving risk-benefit profile of ofatumumab when considering treatment in patients with CLL.Identify patients with CLL who may be appropriate candidates for treatment with ofatumumab.
This article is available for continuing medical education credit at CME.TheOncologist.com.
On April 19, 2010, the European Commission issued a conditional marketing authorization valid throughout the European Union (EU) for ofatumumab (Arzerra®; Glaxo Group Ltd, Greenford, Middlesex, U.K.). The decision was based on the favorable opinion of the Committee for Medicinal Products for Human Use recommending a conditional marketing authorization for ofatumumab for the treatment of chronic lymphocytic leukemia (CLL) in patients refractory to fludarabine and alemtuzumab. A conditional marketing authorization means that additional data to confirm the benefit–risk balance of ofatumumab are awaited. The active substance of Arzerra® is ofatumumab, a monoclonal antibody medicinal product (ATC code L01XC10). The recommended dose is 300 mg of atumumab for the first infusion and 2,000 mg of atumumab for all subsequent infusions. The infusion schedule is eight consecutive weekly infusions, followed 4–5 weeks later by four consecutive monthly (i.e., every 4 weeks) infusions. Ofatumumab targets CD20, a cell surface marker of B lymphocytes, which is followed by cell lysis via complement-dependent cytotoxicity and antibody-dependent cell-mediated cytotoxicity. The benefit of ofatumumab is the control of CLL in patients who are refractory to both fludarabine and alemtuzumab, which was indicated by a high response rate. The most common side effects are infections and infusion reactions. The objective of this paper is to summarize the scientific review of the application leading to approval in the EU. The detailed scientific assessment report and product information, including the summary of product characteristics, are available on the EMA website (http://www.ema.europa.eu).
Ofatumumab; Chronic lymphocytic leukemia; CLL; EMA; European Medicines Agency