Critical evaluation of the off-label indication and of the risks associated to the use of multi-dose vials on the treatment of age-related macular degeneration

Barbosa, Bruna Renata Dutra; Barbosa, Savio Fujita; Tavares, Guilherme Diniz; Chacra, Nádia Araci Bou; Pinto, Terezinha de Jesus Andreoli

doi:10.1590/s1984-82502011000100006

Cited by 3 publications

(2 citation statements)

References 34 publications

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“…As shown in the PRISMA diagram (eFigure in the Supplement), the electronic searches identified 983 potentially relevant publications, of which 271 duplicates (27.6%) were removed and 712 references (72.4%) proceeded to title/abstract screening. Full-text reports were obtained for 158 articles (16.1%) for further eligibility assessment; 87 studies (8.9%) were deemed ineligible (eTable 2 in the Supplement for a list of exclusions and the reference list), and 71 studies (7.2%) met the a priori criteria and were included (eTable 3 in the Supplement for detailed study characteristics).…”

Section: Resultsmentioning

confidence: 99%

Appraising the Quality of Systematic Reviews for Age-Related Macular Degeneration Interventions

et al. 2018

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IMPORTANCE Age-related macular degeneration (AMD) is a leading cause of vision impairment. It is imperative that AMD care is timely, appropriate, and evidence-based. It is thus essential that AMD systematic reviews are robust; however, little is known about the quality of this literature.OBJECTIVES To investigate the methodological quality of systematic reviews of AMD intervention studies, and to evaluate their use for guiding evidence-based care.EVIDENCE REVIEW This systematic review adhered to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement. All studies that self-identified as a systematic review in their title or abstract or were categorized as a systematic review from a medical subject heading and investigated the safety, efficacy and/or effectiveness of an AMD intervention were included. Comprehensive electronic searches were performed in Ovid MEDLINE, Embase, and the Cochrane Library from inception to March 2017. Two reviewers independently assessed titles and abstracts, then full-texts for eligibility. Quality was assessed using the Assessing the Methodological Quality of Systematic Reviews (AMSTAR) tool. Study characteristics (publication year, type of intervention, journal, citation rate, and funding source) were extracted.FINDINGS Of 983 citations retrieved, 71 studies (7.6%) were deemed eligible. The first systematic review relating to an AMD intervention was published in 2003. More than half were published since 2014. Methodological quality was highly variable. The mean (SD) AMSTAR score was 5.8 (3.2) of 11.0, with no significant improvement over time (r = −0.03; 95% CI, −0.26 to 0.21; P = .83). Cochrane systematic reviews were overall of higher quality than reviews in other journals (mean [SD] AMSTAR score, 9.9 [1.2], n = 15 vs 4.7 [2.2], n = 56; P < .001). Overall, there was poor adherence to referring to an a priori design (22 articles [31%]) and reporting conflicts of interest in both the review and included studies (16 articles [23%]). Reviews funded by government grants and/or institutions were generally of higher quality than industry-sponsored reviews or where the funding source was not reported.CONCLUSIONS AND RELEVANCE There are gaps in the conduct of systematic reviews in the field of AMD. Enhanced endorsement of the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement by refereed journals may improve review quality and improve the dissemination of reliable evidence relating to AMD interventions to clinicians.

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Section: Resultsmentioning

confidence: 99%

Appraising the Quality of Systematic Reviews for Age-Related Macular Degeneration Interventions

et al. 2018

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“…Foram levantados 74 casos, envolvendo 43 companhias e 65 fármacos (VILHELMSSON; DAVIS; MULINARI, 2016). Um trabalho efetuado sobre a utilização "off label" de bevacizumabe demonstrou que os riscos do uso "off label" estão aumentados comparados com o fármaco de indicação específica (ranibizumabe) (BARBOSA et al, 2014). Em outro estudo, verificou-se que a prescrição off--label de medicamentos para crianças com enxaqueca excedeu a prescrição on-label (LAI et al, 2017).…”

Section: Discussionunclassified

“Mais Magra, Mais Calma E Mais Inteligente”: A Internet Como Facilitadora Do Uso Off-Label De Medicamentos

Rosa

Almeida

2019

Publ. Biologicas

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Este trabalho objetivou identificar sites do Brasil que veiculam informações sobre medicamentos para perda de peso, ansiedade e melhoramento cognitivo, com a finalidade de dimensionar o estímulo à prática do uso off-label de medicamentos para essas situações. A identificação dos sites se deu em busca no Google a partir dos seguintes descritores: "remédios para ficar mais magra", "remédios para ficar mais calma" e "remédios para ficar mais inteligente". O enfoque no público feminino se deve ao fato de que as mulheres constituem o principal público que busca informações sobre saúde na Internet. A confiabilidade dos sites foi analisada pelos critérios da Health On The Net Foundation e a indução do uso off-label, propriamente dito, foi dimensionada pela análise dos títulos e dos conteúdos dos textos. Na sequência, a discussão do tema foi levada à comunidade por artigos publicados em jornais de circulação regional e posts de Facebook. A amostra foi constituída por 17 sites. Quanto à confiabilidade, apenas dois critérios foram atendidos integralmente. Os sites da pesquisa "remédios para ficar mais inteligente" foram os que mais se relacionaram com o uso off-label, envolvendo modafinila e metilfenidato. Concluindo, este estudo demonstrou que as informações sobre saúde disponibilizadas na Internet induzem ao uso off-label de medicamentos.

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Evaluation of subvisible particles in human immunoglobulin and lipid nanoparticles repackaged from a multi-dose vial using plastic syringes

Hada

Jeong

et al. 2023

International Journal of Biological Macromolecules

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Critical evaluation of the off-label indication and of the risks associated to the use of multi-dose vials on the treatment of age-related macular degeneration

Cited by 3 publications

References 34 publications

Appraising the Quality of Systematic Reviews for Age-Related Macular Degeneration Interventions

Appraising the Quality of Systematic Reviews for Age-Related Macular Degeneration Interventions

“Mais Magra, Mais Calma E Mais Inteligente”: A Internet Como Facilitadora Do Uso Off-Label De Medicamentos

Evaluation of subvisible particles in human immunoglobulin and lipid nanoparticles repackaged from a multi-dose vial using plastic syringes

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