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Créteil, France

Elsisi G.H.,Pharmacoeconomic Unit | Kalo Z.,Eotvos Lorand University | Eldessouki R.,International Society for Pharmacoeconomics and Outcomes Research | Eldessouki R.,Fayoum University | And 6 more authors.
Value in Health Regional Issues | Year: 2013

Objective: Introduction of economic evaluations for pharmaceuticals or other health technologies can help the optimization of outcomes from resource allocations. This article aims to provide recommendations for researchers in presenting pharmacoeconomic evaluations in Egypt with special focus on pricing and/or reimbursement applications of pharmaceuticals. Methods: The Minister of Health approved the initiative of establishing a focus group of decision makers that included academic and industry experts with experience in health economics, pharmacovigilance, and clinical pharmacy. The focus group has reviewed 17 economic evaluation guidelines available on the Web site of the International Society for Pharmacoeconomics and Outcomes Research for reporting health economic evaluations. To develop core assumptions before preparing a draft report, focus group meetings were held on a regular basis starting June 2012. The recommendations were developed by using the Quasi-Delphi method, taking into account current practices and capacities for conducting pharmacoeconomic evaluations in Egypt. Conclusions: Worldwide, health care decision makers are challenged to set priorities in an environment in which the demand for health care services outweighs the allocated resources. Effective pharmaceutical pricing and reimbursement systems, based on health technology assessment (HTA) that encompasses economic evaluations, are essential to an efficient sustainable health care system. The Egyptian Ministry of Health and Population was encouraged to establish a pharmacoeconomic unit, as an initial step, for the support of pricing and reimbursement decisions. We anticipate that standardization of reporting would lead to a progressive improvement in the quality of submissions over time and provide the Egyptian health care system with health economic evidence often unavailable in the past. Therefore, recommendations for pharmacoeconomic evaluations provide an essential tool for the support of a transparent and uniform process in the evaluation of the clinical benefit and costs of drugs that do not rely on the use of low acquisition cost as the primary basis for selection. These recommendations will help inform health care decisions in improving health care systems and achieving better health for the Egyptian population. © 2013 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Source


Fernandez-Espartero M.C.,Hospital Universitario Of Mostoles | Perez-Zafrilla B.,Complejo Hospitalario Universitario Of Albacete | Naranjo A.,Hospital de Gran Canaria Dr Negrin | Esteban C.,Pharmacovigilance Center | And 3 more authors.
Seminars in Arthritis and Rheumatism | Year: 2011

Objectives: To estimate the rate of demyelinating diseases in patients with rheumatic diseases treated with tumor necrosis factor (TNF) antagonists and to describe the cases reported to 3 different pharmacovigilance sources. Methods: All confirmed cases of demyelinating disease, optic neuritis, and multiple sclerosis (MS) in patients with rheumatic diseases treated with TNF-antagonists were reviewed from 3 different sources: (1) the Spanish Registry of biological therapies in rheumatic diseases (BIOBADASER); (2) the Spanish Pharmacovigilance Database of Adverse Drug Reactions (FEDRA); and (3) a systematic review (PubMed, EMBASE, and the Cochrane Library). In BIOBADASER, the incidence rate per 1000 patients was estimated with a 95% confidence interval (95%CI). Results: In 21,425 patient-years in BIOBADASER, there were 9 patients with confirmed demyelinating disease, 4 with optic neuritis, and 1 with MS. In addition, 22 patients presented polyneuropathies, paresthesias, dysesthesias, facial palsy, or vocal cord paralysis without confirmed demyelination. The incidence rate of demyelinating disease in patients with rheumatic diseases exposed to TNF antagonists in BIOBADASER was 0.65 per 1000 patient-years (95%CI: 0.39-1.1). The incidence of MS in BIOBADASER was 0.05 (95%CI: 0.01-0.33), while the incidence in the general Spanish population was 0.02 to 0.04 cases per 1000. Compared with BIOBADASER, cases in FEDRA (n = 19) and in the literature (n = 48) tend to be younger, have shorter exposure to TNF-antagonists, and recover after discontinuation of the drug. Conclusions: It is not clear whether TNF antagonists increase the incidence of demyelinating diseases in patients with rheumatic diseases. Differences between cases depending on the pharmacovigilance source could be explained by selective reporting bias outside registries. © 2011 Elsevier Inc. Source


Cruz Fernandez-Espartero M.,Hospital Universitario Of Mostoles | Perez-Zafrilla B.,Research Unit | Perez-Zafrilla B.,Complejo Hospitalario Universitario Of Albacete | Naranjo A.,Hospital de Gran Canaria Dr Negrin | And 5 more authors.
Seminars in Arthritis and Rheumatism | Year: 2011

Objectives: To estimate the rate of demyelinating diseases in patients with rheumatic diseases treated with tumor necrosis factor (TNF) antagonists and to describe the cases reported to 3 different pharmacovigilance sources. Methods: All confirmed cases of demyelinating disease, optic neuritis, and multiple sclerosis (MS) in patients with rheumatic diseases treated with TNF-antagonists were reviewed from 3 different sources: (1) the Spanish Registry of biological therapies in rheumatic diseases (BIOBADASER); (2) the Spanish Pharmacovigilance Database of Adverse Drug Reactions (FEDRA); and (3) a systematic review (PubMed, EMBASE, and the Cochrane Library). In BIOBADASER, the incidence rate per 1000 patients was estimated with a 95% confidence interval (95% CI). Results: In 21,425 patient-years in BIOBADASER, there were 9 patients with confirmed demyelinating disease, 4 with optic neuritis, and 1 with MS. In addition, 22 patients presented polyneuropathies, paresthesias, dysesthesias, facial palsy, or vocal cord paralysis without confirmed demyelination. The incidence rate of demyelinating disease in patients with rheumatic diseases exposed to TNF-antagonists in BIOBADASER was 0.65 per 1000 patient-years (95% CI: 0.39-1.1). The incidence of MS in BIOBADASER was 0.05 (95% CI: 0.01-0.33), while the incidence in the general Spanish population was 0.02 to 0.04 cases per 1000. Compared with BIOBADASER, cases in FEDRA (n = 19) and in the literature (n = 48) tend to be younger, have shorter exposure to TNF-antagonists, and recover after discontinuation of the drug. Conclusions: It is not clear whether TNF antagonists increase the incidence of demyelinating diseases in patients with rheumatic diseases. Differences between cases depending on the pharmacovigilance source could be explained by selective reporting bias outside registries. © 2011. Source


Bae Y.-J.,University of Ulsan | Bae Y.-J.,Health Screening and Promotion Center | Hwang Y.W.,Pharmacovigilance Center | Yoon S.-Y.,University of Ulsan | And 11 more authors.
PLoS ONE | Year: 2013

Background:Non-ionic radiocontrast media (RCM) is rarely associated with hypersensitivity reactions. Premedication of patients who reacted previously to RCM with systemic corticosteroids and/or antihistamines can help reduce recurrent hypersensitivity reactions. However, premedication is still not prescribed in many cases for various reasons. This study aimed to determine the effectiveness of our novel RCM hypersensitivity surveillance and automatic recommending system for premedication.Methods and Results:Hospitalized patients with a history of RCM hypersensitivity were identified in an electronic medical record system that included a mandatory reporting system for past adverse drug reactions. In 2009, a novel automatic prescription system was added that classified index RCM reactions by severity and dispensed appropriate corticosteroid and/or antihistamine pretreatment prior to new RCM exposures. The data from 12 months under the previous system and 12 months under the current system were compared.The two systems had similar overall premedication rates (91% and 95%) but the current system was associated with a significantly higher corticosteroid premedication rate (65% vs. 14%), which significantly reduced the breakthrough reaction rate (6.7% vs. 15.2%). The current system was also associated with increased corticosteroid and antihistamine premedication of patients with a mild index reaction (61% vs. 7%) and a reduction in their breakthrough reaction rate (6% vs. 15%).Conclusions:Premedication with corticosteroid and/or antihistamine, which was increased by our novel automatic prescription system, significantly reduced breakthrough reactions in patients with a history of RCM hypersensitivity. © 2013 Bae et al. Source


Droitcourt C.,Rennes University Hospital Center | Droitcourt C.,University of Rennes 1 | Droitcourt C.,French Institute of Health and Medical Research | Rybojad M.,Hopital Saint Louis | And 31 more authors.
Chest | Year: 2014

BACKGROUND: Th alidomide use in cutaneous sarcoidosis is based on data from small case series or case reports. The objective of this study was to evaluate the efficacy and safety of thalidomide in severe cutaneous sarcoidosis.METHODS: This study consisted of a randomized, double-bind, parallel, placebo-controlled, investigator-masked, multicenter trial lasting 3 months and an open-label study from month 3 to month 6. Adults with a clinical and histologic diagnosis of cutaneous sarcoidosis were included in nine hospital centers in France. Patients were randomized 1:1 to oral thalidomide (100 mg once daily ) or to a matching oral placebo for 3 months. In the course of an open-label follow-up from month 3 to month 6, all patients received thalidomide, 100 mg to 200 mg daily. The proportions of patients with a partial or complete cutaneous response at month 3, based on at least a 50% improvement in three target lesions scored for area and infiltration, were compared across randomization groups.RESULTS: The intent-to-treat population included 39 patients. None of them had a complete cutaneous response. Four out of 20 patients in the thalidomide group (20%) vs four out of 19 patients in the placebo group (21%) had a partial cutaneous response at month 3 (difference in proportion of 2 1% [95% CI, 2 26% to 1 24%] for thalidomide vs placebo, P 5 1.0). Eight patients with side effects were recorded in the thalidomide group vs three in the placebo group. We observed a large number of adverse event-related discontinuations in patients taking thalidomide in the first 3 months (four patients with thalidomide, zero with placebo) and in the 3 following months (five patients).CONCLUSIONS: At a dose of 100 mg daily for 3 months, our results do not encourage thalidomide use in cutaneous sarcoidosis.TRIAL REGISTRY: ClinicalTrials.gov; No.: NCT0030552; URL: Www.clinicaltrials.gov. © 2014 AMERICAN COLLEGE OF CHEST PHYSICIANS. Source

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