Off-label drugs use is widespread in ophthalmology due to the delay in drug approvals and package inserts update. It has been found to vary among different medical institutions in China, leading to safety problems since inappropriate use. Guidance is urgently needed regarding how best to use the drugs for unapproved indications and routes of administration. We aimed to develop an evidence-based guideline to guide off-label drugs used in ophthalmology in China. The practice guideline was developed by the Hospital Pharmacy Professional Committee, Chinese Pharmaceutical Association, following the WHO handbook for guideline development. The guideline was initially registered in the International Practice Guidelines Registry Platform (IPGRP-2021CN096). The clinical questions included in the guideline were identified through a three-round Delphi vote. Databases search was performed in PubMed, Embase, the Cochrane Library, ClinicalTrials.gov, Chinese National Knowledge Infrastructure, and WanFang Database from their inception to 31 March 2021. Systematic reviews and meta-analyses for each clinical question were conducted individually to synthesize available scientific evidence. The Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach was used to assess the quality of evidence and grade the recommendations\' strengths. The multidisciplinary guideline groups were set up, including ophthalmologists, pharmacists, methodology experts, pharmacologists, pharmacoeconomists, and lawyers. The guideline identified 25 clinical questions included. A total of 32 systematic reviews, including 24 conducted by the systematic review group and eight high-relevance published within 2 years, were referred to address these questions. Finally, the guideline presented 32 recommendations addressing 25 clinical questions, involving five strong recommendations and 27 weak recommendations for the treatment of ocular fundus, corneal disease, glaucoma, and endophthalmitis. Current evidence from clinical studies supports the off-label drugs used in ophthalmology. We developed an evidence-based guideline using a rigorous multidisciplinary approach to guide these usages in route clinical practice.

Tripterygium wilfordii Hook F (TwHF) is one of the most commonly used and effective traditional Chinese herbal medicines against rheumatoid arthritis (RA). Both Tripterygium Glycoside Tablets (TGT) and Tripterygium wilfordii Tablets (TWT) are the representative TwHF-based agents enrolled into the 2019 edition of Medicine Catalog for National Basic Medical Insurance, Injury Insurance, and Maternity Insurance. However, individual differences in TGT/TWT response across patients usually exist in the process of treating RA, implying that the clinical application of the two agents may not be standardized leading to the ineffective treatment and the risk of side effects. Growing evidence show that the bioactive constituents of TwHF may often have toxicity, the package insert of TGT and TWT may not be described in detail, and the therapeutic windows of the two agents are narrow. Thus, it is an urgent task to develop a standardized clinical practice guideline for TGT and TWT in the treatment of RA. In the current study, a group of clinical experts of traditional Chinese medicine and Western medicine in the research field of rheumatism diseases, pharmacists, and methodologists of evidence-based medicine were invited to select the clinical questions, to determine the levels of the evidence and the strength of the recommendations, and to develop the recommendations and good practice points. The guideline is formed based on the combination of clinical research evidence and expert experience (evidence-based, consensus, supplemented by experience). The clinical problems which are supported by clinical evidence may form recommendations, and the clinical problems without clinical evidence may form experts\' suggestions. Both recommendations and experts\' suggestions in this guideline summarized the clinical indications, usage, dosage, combined medication, and safety of TGT and TWT against RA systematically and comprehensively, which may offer a professional guidance in the context of the clinical application of the two TwHF-based agents.

METHODS: A rural paediatric hospital in Bo, Sierra Leone.
OBJECTIVE: To assess the level of adherence to standard treatment guidelines among clinicians prescribing treatment for children admitted with a diagnosis of malaria and/or lower respiratory tract infection (LRTI), and determine the association between (non) adherence and hospital outcomes, given that non-rational use of medicines is a serious global problem.
METHODS: Secondary analysis of routine programme data.
RESULTS: Data were collected for 865 children admitted with an entry diagnosis of malaria and 690 children with LRTI during the period January to April 2011; some patients were classified in both categories. Non-adherence to guidelines comprised use of non-standard drug regimens, dosage variations, non-standard frequency of administration and treatment duration. Cumulative non-adherence to guidelines for LRTI cases was 86%. For malaria, this involved 12% of patients. Potentially harmful non-adherence was significantly associated with an unfavourable hospital outcome, both for malaria and for LRTI cases.
CONCLUSIONS: Overall non-adherence to standard treatment guidelines by clinicians in a routine hospital setting is very high and influences hospital outcomes. This study advocates for the implementation of routine measures to monitor and improve rational drug use and the quality of clinical care in such hospitals.
Un hôpital pédiatrique rural à Bo, Sierra Leone.
Evaluer le niveau d’adhésion aux directives standard de traitement parmi les cliniciens prescrivant des traitements aux enfants admis pour un diagnostic de malaria et/ou une infection du tractus respiratoire inférieur (LRTI), et déterminer l’association entre la (non-) adhésion et les résultats acquis à l’hôpital, étant donné que l’utilisation irrationnelle de médicaments constitue un grave problème mondial.
Analyse secondaire de données de routine du programme.
Pendant la période de janvier à avril 2011, on a colligé les données concernant 865 enfants admis avec un diagnostic d’entrée de malaria et 690 enfants atteints de LRTI, certains patients étant classés à la fois dans les deux catégories. La non-adhésion aux directives a compris l’utilisation d’un régime de médicaments non-standard, des variations de doses, une fréquence non-standardisée d’administration ainsi que la durée du traitement. La non-adhésion cumulative aux directives pour les cas de LRTI a été de 86% ; pour la malaria, elle concernait 12% des dossiers de patients. Une non-adhésion potentiellement néfaste a été en association significative avec un résultat défavorable à la sortie de l’hôpital tant pour les cas de malaria que de LRTI.
Globalement, la non-adhésion aux directives par les cliniciens dans un contexte hospitalier de routine est très élevée et a une influence sur les résultats obtenus à l’hôpital. L’étude plaide en faveur de la mise en œuvre de mesures de routine pour suivre et améliorer l’utilisation rationnelle des médicaments ainsi que la qualité des soins cliniques dans ces hôpitaux.
Un hospital pediátrico en la zona rural de Bo, en Sierra Leona.
Evaluar la observancia de las directrices de tratamiento normalizado por parte de los médicos que deciden el tratamiento de los niños hospitalizados con diagnóstico de malaria o infecciones de las vías respiratorias inferiores (LRTI) y se determinó la asociación entre el incumplimiento de las normas y los desenlaces clínicos en el momento del alta hospitalaria, visto que la utilización incorrecta de los medicamentos constituye un grave problema a escala mundial.
Se llevó a cabo un análisis secundario de los datos corrientes del programa.
Se recogieron los datos de los niños hospitalizados entre enero y abril del 2011 con diagnóstico de ingreso de malaria en 865 casos y de LRTI en 690 casos; algunos pacientes se clasificaron en ambas categorías. El incumplimiento de las directrices consistió en el uso de un régimen terapéutico diferente o en la modificación de las dosis terapéuticas, la frecuencia de administración o la duración del tratamiento. El incumplimiento acumulado de las directrices relacionadas con las LRTI fue de 86%. En los casos de malaria, se encontró una falta de observancia en el 12% de los casos. Se observó que un incumplimiento terapéutico posiblemente nocivo se asocia de manera significativa con desenlaces hospitalarios desfavorables en ambas enfermedades.
En general, el estudio puso en evidencia un alto grado de incumplimiento médico con las directrices de tratamiento normalizado en un entorno hospitalario corriente, con repercusiones notables en los desenlaces de la hospitalización. Se promueve la introducción de medidas sistemáticas que permitan supervisar y mejorar la utilización de los medicamentos y asegurar la calidad de la atención clínica en estos entornos hospitalarios.