Background: Schizophrenia negative symptoms (SNS) contribute substantially to poor functional outcomes, loss in productivity and poor quality of life. It is unclear which instruments may be used for assessing quality of life in patients with SNS.Objective: The objective of this review was to identify instruments assessing health-related quality of life (HRQoL) validated in patients with SNS and to assess their level of validation.Data sources: We conducted a systematic literature review in Medline and the ISPOR database in March 2016 to identify studies on the quality of life in patients with SNS published by March 2016.Data extraction: Psychometric properties and validation steps.Data synthesis: After applying inclusion/exclusion criteria, 49 studies were selected for the analysis of HRQoL instruments; however, none of these instruments only addressed patients with SNS. Of these, 19 HRQoL instruments used in patients with schizophrenia or including patients with SNS among others, in the context of instrument validation, were identified (4 generic, 10 non-specific mental health, 5 schizophrenia-specific).Conclusion: No HRQoL instrument has been validated in patients with SNS only; for the remaining instruments identified, it remains unclear whether they were intended to capture HRQoL in patients with SNS.
Background: Orphan drugs (ODs) are pharmaceuticals manufactured for rare conditions that affect less than 200,000 people in the US. ODs are therefore produced in small quantities to meet sparse demand. Since 2010, OD shortages have become frequent, but no comprehensive, quantitative studies exist.Objective: The objective of this study is to assess the rates of OD shortages per therapeutic class and their trends over time in the United States.Study design: OD approvals were collected from publicly available information on the US Food and Drug Administration (FDA) website on 13 June 2016. Data on OD shortages were collected from the FDA and the American Society of Health-System Pharmacists (ASHP) websites. We reviewed the number of shortages per year and per therapeutic area. Multiple indications for the same drug were counted individually.Results: Of 569 ODs approved, 50% were approved in the decade ending in 2015. Oncology was found to be the most represented therapeutic area (34% of all OD approvals), followed by endocrinology (11%). Shortage data were available from 2008. In total, there were 66 (12%) OD shortages, with an average shortage duration of 455.5 days. Shortages were observed mainly for oncology products (19 cases, 13% of oncology ODs) and endocrinology products (14 cases, 22% of endocrinology ODs)Conclusion: Despite the FDA strategic plan for preventing and mitigating drug shortages (October 2013), remaining OD shortages still pose an enduring challenge to patient care, with a median shortage duration of almost 15 months. In many instances, ODs are the only available therapy for rare diseases, and OD shortages can lead to serious health deterioration and death. More research is needed to elucidate the causes of shortages and their impact on patients’ health.
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Objectives: In the Turkish medical device industry, budgetary concerns usually overweight other crucial issues like quality and effectiveness of medical devices on clinical and economical outcomes. Reimbursement application and assessment principles have not been regulated until very recently by the Social Security Institution (SSI), the only competent authority for reimbursement. After productive communications and collaboration between SSI and industry, the new directive, "Procedures and Principles of Medical Device Applications" and its guideline "Medical Device Application" has been published by SSI on Apr, 20th 2016,Objective of this study is to describe reimbursement application and assessment procedures for Medical Devices and the critical points of the guideline and the directive. MethOds: The Directive and Guidelines dated 20.04.2016 are analyzed. Results: Ministry of Health (MoH) registration is a prerequisite for reimbursement in Turkey. All medical devices are subject to specialty-based positive listing, consisting of generic definitions and codes with corresponding ceiling reimbursement prices set by SSI. For inclusion into the positive lists, the manufacturer/ distributor has to submit a "reimbursement dossier" to SSI. To get a new reimbursement code for innovative, first-in-it-class products (Type A) and for product differentiation in terms of size or specifications (Type B); high-level clinical evidence and local health economics and budget-impact analyses are required. C and D type applications are for matching to an existing code and getting reimbursement approval for new barcodes of the already reimbursed products. cOnclusiOns: Local economic analysis and information on reimbursement status in reference countries may seem challenging to companies, due to lack of local data and difference between Turkish and reference countries' healthcare systems. However, longwaited Directive regulates the decision mechanism of SSI and provides opportunity of fair competition to the industry. It may be seen as an evidence indicating the mindset shift of SSI towards the value based approach.
Objectives: To characterize unmet medical needs among adults with a history of moderate-to-severe atopic dermatitis (AD) in the United Kingdom (UK), Germany, and France. MethOds: Data were from the 2014 Adelphi AD Disease-Specific Programme, a cross-sectional survey of physicians from UK (n= 136), Germany (n= 134), France (n= 137) and their patients with history of moderate-to-severe AD (UK, n= 666; Germany, n= 649; France, n= 661). Each physician completed a Patient Record Form for up to 5 patients on demographic/disease characteristics, treatment, and physician-perceived current AD severity. AD was classified as controlled or uncontrolled, with uncontrolled defined by either currently flaring AD; deteriorating/changeable AD; or physician dissatisfaction with current control. Patients voluntarily completed a questionnaire including the Dermatology Life Quality Index (DLQI) scale. Descriptive statistics characterized the populations. Results: Patient demographics were similar across countries. Disease onset was predominantly during adolescence. Current severity was mainly moderate (54%-65%); 10% (Germany) and 16% (France, UK) were severe. Substantial proportions of patients in each country were uncontrolled (54%-59%) even though 23%-39% of uncontrolled patients were currently receiving any systemic immunosuppressant or phototherapy including cyclosporine (6%-10%). Uncontrolled AD was high regardless of current severity: 85%-88% of severe patients were uncontrolled, as were 56% (France) to 70% (UK) of moderate patients. Quality-of-life was worse among uncontrolled patients, and in particular among patients treated with immunosuppressants or phototherapy in the past 12 months: 68%, 40%, and 40% of uncontrolled patients previously on immunosuppressants or phototherapy in UK, Germany, and France, respectively, had DLQI > 10 (threshold for very large effect on patient's life). cOnclusiOns: Adults with history of moderate-to-severe AD have poor disease control even when treated with systemic agents. A substantial proportion of uncontrolled patients previously treated with immunosuppressants or phototherapy report a very large effect of AD on their quality-of-life. These results demonstrate high unmet medical needs associated with AD.
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