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      Desprescripción de tratamientos de larga duración con bisfosfonatos para la osteoporosis en atención primaria en el País Vasco Translated title: Deprescribing long-term treatments with bisphosphonates for osteoporosis in primary care in the Basque Country (Spain)

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          Abstract

          Resumen Objetivo: Evaluar el impacto de una intervención multifactorial para promover la desprescripción de tratamientos con bisfosfonatos de duración superior a 5 años (BF5a) en la Comarca Gipuzkoa y compararlo con la intervención estándar en el resto de las organizaciones de servicios (OS) de Osakidetza. Métodos: Estudio de evaluación del impacto de dos intervenciones con medida de resultados antes y después, con un seguimiento de 8 meses. Se incluyeron todos los pacientes de Osakidetza que en julio de 2013 tenían un tratamiento activo con BF5a (prescripción electrónica). La intervención estándar (9 OS) consistió en el envío de un documento de consenso sobre desprescripción de BF5a y en facilitar los identificadores de pacientes con BF5a para su revisión por el médico de atención primaria. La intervención multifactorial (Comarca Gipuzkoa) incluyó, además, un consenso local con los especialistas de referencia y sesiones de formación en los centros de salud. Resultados: Se incluyeron 18.725 pacientes, el 94,7% mujeres. Con la intervención estándar, los porcentajes de desprescripción oscilaron entre el 26,4% (C. Bilbao) y el 49,4% (C. Araba), siendo del 37,2% en su conjunto. Con la intervención multifactorial la desprescripción fue del 44,6%, un 7,4% superior a la estándar (p <0,0001; intervalo de confianza del 95% [IC95%]: 5,4-9,4). Los desplazamientos a otros tratamientos fueron menos frecuentes con la intervención multifactorial, con una diferencia del 3,7% (p <0.0001; IC95%: −2,2 a −5,2). Conclusiones: Las intervenciones estándar y multifactorial son muy efectivas para disminuir los tratamientos innecesarios con bisfosfonatos. La intervención multifactorial es más efectiva que la estándar, aunque más compleja de llevar a cabo.

          Translated abstract

          Abstract Objective: To evaluate the impact of a multifactorial intervention to promote bisphosphonate deprescription after over 5 years of use (BF5y) in a health care organisation (HCO) in Gipuzkoa (Spain) and to compare it with the standard intervention in other HCOs in the Basque Health Service-Osakidetza. Methods: An 8-month follow-up study (results from before and after) to assess the impact of two interventions. All patients from Osakidetza receiving BF5y treatment (electronic prescription) in July 2013 were included. The standard intervention (9 HCOs) consisted of mailing a consensus statement on BF5y deprescribing and facilitating patient identifiers with BF5y prescription for review by the primary care physician. The multifactorial intervention (Gipuzkoa) also included a local consensus with leading specialists and training sessions in health centres. Results: 18,725 patients were included; 94.7% were women. Standard intervention deprescribing rates ranged from 26.4% (Bilbao) to 49.4% (Araba), being 37.2% overall. The multifactorial intervention deprescribing rate was 44.6%, 7.4% (p <0.0001; 95% confidence interval [95%CI]: 5.4-9.4) higher than standard intervention. Changes to other treatments were less common with the multifactorial intervention, with a difference of 3.7% (p <0.0001; 95%CI: −2.2 to −5.2). Conclusions: Standard and multifactorial interventions are very effective in reducing unnecessary treatments with bisphosphonates. The multifactorial intervention is more effective than the standard one, although more complex to implement.

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          Effects of continuing or stopping alendronate after 5 years of treatment: the Fracture Intervention Trial Long-term Extension (FLEX): a randomized trial.

          The optimal duration of treatment of women with postmenopausal osteoporosis is uncertain. To compare the effects of discontinuing alendronate treatment after 5 years vs continuing for 10 years. Randomized, double-blind trial conducted at 10 US clinical centers that participated in the Fracture Intervention Trial (FIT). One thousand ninety-nine postmenopausal women who had been randomized to alendronate in FIT, with a mean of 5 years of prior alendronate treatment. Randomization to alendronate, 5 mg/d (n = 329) or 10 mg/d (n = 333), or placebo (n = 437) for 5 years (1998-2003). The primary outcome measure was total hip bone mineral density (BMD); secondary measures were BMD at other sites and biochemical markers of bone remodeling. An exploratory outcome measure was fracture incidence. Compared with continuing alendronate, switching to placebo for 5 years resulted in declines in BMD at the total hip (-2.4%; 95% confidence interval [CI], -2.9% to -1.8%; P<.001) and spine (-3.7%; 95% CI, -4.5% to -3.0%; P<.001), but mean levels remained at or above pretreatment levels 10 years earlier. Similarly, those discontinuing alendronate had increased serum markers of bone turnover compared with continuing alendronate: 55.6% (P<.001) for C-telopeptide of type 1 collagen, 59.5% (P < .001) for serum n = propeptide of type 1 collagen, and 28.1% (P<.001) for bone-specific alkaline phosphatase, but after 5 years without therapy, bone marker levels remained somewhat below pretreatment levels 10 years earlier. After 5 years, the cumulative risk of nonvertebral fractures (RR, 1.00; 95% CI, 0.76-1.32) was not significantly different between those continuing (19%) and discontinuing (18.9%) alendronate. Among those who continued, there was a significantly lower risk of clinically recognized vertebral fractures (5.3% for placebo and 2.4% for alendronate; RR, 0.45; 95% CI, 0.24-0.85) but no significant reduction in morphometric vertebral fractures (11.3% for placebo and 9.8% for alendronate; RR, 0.86; 95% CI, 0.60-1.22). A small sample of 18 transilial bone biopsies did not show any qualitative abnormalities, with bone turnover (double labeling) seen in all specimens. Women who discontinued alendronate after 5 years showed a moderate decline in BMD and a gradual rise in biochemical markers but no higher fracture risk other than for clinical vertebral fractures compared with those who continued alendronate. These results suggest that for many women, discontinuation of alendronate for up to 5 years does not appear to significantly increase fracture risk. However, women at very high risk of clinical vertebral fractures may benefit by continuing beyond 5 years. clinicaltrials.gov Identifier: NCT 00398931.
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            Continuing bisphosphonate treatment for osteoporosis--for whom and for how long?

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              Impact of FDA drug risk communications on health care utilization and health behaviors: a systematic review.

              To review literature on the impact of The Food and Drug Administration (FDA) drug risk communications on medication utilization, health care services use, and health outcomes. The authors searched MEDLINE and the Web of Science for manuscripts published between January 1990 and November 2010 that included terms related to drug utilization, the FDA, and advisories or warnings. We manually searched bibliographies and works citing selected articles and consulted with experts to guide study selection. Studies were included if they involved an empirical analysis evaluating the impact of an FDA risk communication. We extracted the drug(s) analyzed, relevant FDA communication(s), data source, analytical method, and main outcome(s) assessed. Of the 1432 records screened, 49 studies were included. These studies covered 16 medicines or therapeutic classes; one third examined communications regarding antidepressants. Most used medical or pharmacy claims and a few rigorously examined patient-provider communication, decision making, or risk perceptions. Advisories recommending increased clinical or laboratory monitoring generally led to decreased drug use, but only modest, short-term increases in monitoring. Communications targeting specific subpopulations often spilled over to other groups. Repeated or sequential advisories tended to have larger but delayed effects and decreased incident more than prevalent use. Drug-specific warnings were associated with particularly large decreases in utilization, although the magnitude of substitution within therapeutic classes varied across clinical contexts. Although some FDA drug risk communications had immediate and strong impacts, many had either delayed or had no impact on health care utilization or health behaviors. These data demonstrate the complexity of using risk communication to improve the quality and safety of prescription drug use, and suggest the importance of continued assessments of the effect of future advisories and label changes. Identifying factors that are associated with rapid and sustained responses to risk communications will be important for informing future risk communication efforts.
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                Author and article information

                Contributors
                Role: ND
                Role: ND
                Role: ND
                Role: ND
                Role: ND
                Role: ND
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                Role: ND
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                Journal
                gs
                Gaceta Sanitaria
                Gac Sanit
                Ediciones Doyma, S.L. (Barcelona, Barcelona, Spain )
                0213-9111
                February 2017
                : 31
                : 1
                : 35-39
                Affiliations
                [5] San Sebastián Guipúzcoa orgnameOSI Donostialdea orgdiv1Hospital Universitario Donostia orgdiv2Servicio de Reumatología España
                [1] Hernani Guipúzcoa orgnameOSI Donostialdea orgdiv1Farmacia de Atención Primaria España
                [2] Tolosa Guipúzcoa orgnameOSI Tolosaldea orgdiv1Centro de Salud de Tolosa España
                [6] San Sebastián Guipúzcoa orgnameOSI Donostialdea orgdiv1Hospital Universitario Donostia orgdiv2Servicio de Ginecología España
                [3] San Sebastián Guipúzcoa orgnameRed de Investigación en Servicios de Salud en Enfermedades Crónicas (REDISSEC) orgdiv1Unidad de Investigación de Atención Primaria de Gipuzkoa España
                [4] Hernani Guipúzcoa orgnameOSI Tolosaldea orgdiv1Farmacia de Atención Primaria España
                Article
                S0213-91112017000100035
                10.1016/j.gaceta.2016.07.003
                09406d89-1e5a-4cbf-bd12-a4117739851e

                This work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License.

                History
                : 01 April 2016
                : 04 July 2016
                Page count
                Figures: 0, Tables: 0, Equations: 0, References: 21, Pages: 5
                Product

                SciELO Public Health


                Implementación,Drug-related adverse reactions,Bisphosphonates,Osteoporosis,Deprescription,Inappropriate prescription,Implementation,Efectos adversos relacionados con fármacos,Bisfosfonatos,Desprescripción,Prescripción inapropiada

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