Current medical research and opinion
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Multicenter Study Observational Study
ADA_ETA_BIO2021: real-world evaluation of adherence, persistence, and cost-effectiveness of originator and biosimilar biologic drugs in the treatment of rheumatoid arthritis: a multicenter study in Italy.
The objective was to assess the adherence, persistence, and costs of bDMARDs through a multicentre study of nine Italian hospital pharmacies. ⋯ This multicentre retrospective observational study of bDMARDs used in the treatment of RA showed that, for all the drugs studied, there was no problem with adherence to treatment but rather a difficulty in maintaining treatment with the same drug over time.
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Observational Study
Development, validation and implementation of the medical affairs pharmaceutical physician work-related quality of life instrument.
Medical affairs pharmaceutical physicians (MAPPs) are at risk for low work-related quality of life (WRQoL). The aim of this study was to develop, validate and implement the first WRQoL instrument for this population. ⋯ Discriminant validity of the 39-item MAPPWRQoL instrument was confirmed. The Jandhyala method successfully developed and validated a specific WRQoL instrument and may be applied to similar populations, such as junior doctors and UK general practitioners.
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Observational Study
Patients' experience and utilization patterns of diclofenac gel in Germany: a real-world study with a prospective longitudinal survey and a retrospective analysis of pharmacy data.
Describe and characterize treatment patterns, satisfaction, improvement in pain and functional impairment (health-related quality of life [HRQoL]) in users of over the counter (OTC) Voltaren gel diclofenac (VGD) 2.32% and 1.16% in a real-world setting. ⋯ This study provides the first real-world insights into OTC VGD use in Germany. The participants using VGD reported a decrease in pain severity and an improvement of HRQoL while under treatment, as well as resulting satisfaction with treatment. Patients infrequently switched to alternate topical therapies/NSAIDs.
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Although dosing regimens of targeted therapies (TT) for ulcerative colitis (UC) and Crohn's disease (CD) are guided by market authorizations and clinical guidelines, little is known about clinical guideline adherence or outcomes in patients receiving escalated doses of TT due to lack of response. This real-world study explored the prevalence of dose escalation and compared outcomes between patients receiving standard and escalated TT doses. ⋯ Dose escalation is not always an effective approach to resolve inadequate or loss of response in UC and CD, highlighting a need for more therapeutic options or alternative treatment strategies in patients unresponsive to TT.
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The pharmaceutical industry requires a highly qualified workforce with diverse skillsets. Medical affairs pharmaceutical physicians (MAPPs) have unique qualifications among pharmaceutical company employees, but the exact contribution of their education and training is unknown. This study aimed to identify the medical education and training competencies MAPPs use in the pharmaceutical industry in relation to the four external stakeholders, regulators, payors, prescribers, and patients. ⋯ MAPPs develop a highly specialized set of competencies during medical education and training from which they use distinct subsets to meet the needs of external stakeholders in the pharmaceutical industry. Undergraduate and postgraduate competency-based medical education appears to prepare MAPPs for cognitive and technical work. Further exploration may aid understanding of how they develop soft skills.