The relevance of clinical workplace learning and assessment in CPT

T. Dornan
2013 Clinical Therapeutics  
Abstracts e115 creates new forms of power with specific characteristics: the need of transparent subjects, the participation of patients to the power that aims to take control on their own body, and the growing porosity between the private and public sectors. First applied to the analysis of sexuality, the concept of biopower is nowadays highly relevant to analyze this new turn in medicine practices that involve the full cooperation and transparency of patients. Summary: The treatment of
more » ... treatment of multiple sclerosis as an autoimmune disorder has benefited for several years from the progresses of biotherapeutics. Since the mid-1990s, interferon beta has been proposed as a valuable treatment for certain MS patients due to its immunomodulator properties, followed shortly after by the registration of the polypeptide glatiramer acetate. More recently, monoclonal antibodies have been developed to target selective components of the immune response and provide a selective immunosuppression that could treat the disease with an acceptable safety profile. Natalizumab was the first of these monoclonal antibodies, and other monoclonal antibodies such as rituximab or alemtuzumab, originally developed in oncology, have since been repositioned for autoimmune disorders such as MS. However, these molecules, which are very selective in their targets, often do not appear so favorable during development, and their safety profile could significantly limit their use. More recently, the development of monoclonal antibodies has refocused more on targeting proteins that play critical roles in the pathophysiology of MS, notably on the specific processes of neurotoxicity: these antibodies are now in early clinical development and may bring new avenues in the treatment of MS. Summary: Ever since "modern" pharmacovigilance started in the early 1980s, it has gone through changes of various pace introduced by new concepts (eg, CIOMS I-V), development of science and methodologies (eg, pharmcoepidemiology), technology (eg, databases), or regulatory requirements (eg, risk management, new legislation). Over the period of time, methods of data collection and analysis became easier, which is helpful, taking into account the fast-growing world's population. However, everyday general medical practice did not change much despite great progress in sciences. Large safety data are accessible from organized databases in regulatory bodies, industry, medical insurance, and other organizations, facilitating their analysis and aggregate evaluation, but in many situations, actions are still triggered by the assessment of causal associations based on medical judgment performed on individual cases or case reports. The future of pharmacovigilance should be based on well-thought-through risk management combined with risk minimization activities, which will reflect preceding appropriate benefit/risk assessment. This can be delivered by adequate training in clinical pharmacology, which will include good prescribing practices and the development of regulatory science either within clinical pharmacology or as a separate discipline. In addition, the broad understanding of important safety information
doi:10.1016/j.clinthera.2013.07.356 fatcat:4iubrcpuu5dlzamcjpzjuonk5u