Development of one paediatric and one neonatal formulary list in hospital settings

Haslund-Krog, Sissel Sundell; Christensen, Hanne; Bjerager, Mia Ortved; Holst, Helle

doi:10.1111/bcp.13444

Cited by 3 publications

(3 citation statements)

References 20 publications

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“…This is worth consideration, because there is no international consensus on which dose to adopt. Consensus may be difficult to achieve, as compilation varies by the review of available scientific evidence, and drug use is based on national clinical experience, when studies are lacking [ 54 ].…”

Section: Discussionmentioning

confidence: 99%

Development of the Swiss Database for dosing medicinal products in pediatrics

Tilen

Panis²,

Aeschbacher³

et al. 2021

Eur J Pediatr

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In daily paediatrics, drugs are commonly used off-label, as they are not approved for children. Approval is lacking because the required clinical studies were limited to adults in the past. Without clinical studies, evidence-based recommendations for drug use in children are limited. Information on off-label drug dosing in children can be found in different handbooks, databases and scientific publications but the dosing recommendations can differ considerably. To improve safety and efficacy of drugs prescribed to children and to assist the prescribers, stakeholders in Swiss paediatrics started a pilot project, supported by the Federal Office of Public Health, with the aim to create a database, providing healthcare professionals with so called “harmonised” dosage recommendations based on the latest available scientific evidence and best clinical practice. A standardised process for dosage harmonisation between paediatric experts was defined, guided and documented in an electronic tool, developed for this purpose. As proof of principle, a total of 102 dosage recommendations for 30 different drugs have been nationally harmonised in the pilot phase considering the current scientific literature and the approval of the most experienced national experts in the field.Conclusion: This approach paved the way for unified national dosage recommendations for children. Reaching the project’s milestones fulfilled the prerequisites for funding and starting regular operation of SwissPedDose in 2018. Since then, the database was extended with recommendations for 100 additional drugs. What is Known:• Prescribing off-label is a common practice among paediatricians, as many drugs are still not authorised for use in children.• Some countries developed national drug formularies providing off-label dosage recommendations. What is New:• Comparison of published dosage recommendations in known drug handbooks and online databases show substantial differences and heterogeneity, revealing the need for harmonisation.• The design of a tool for standardised harmonisation of dosage recommendations, based on information collected on currently applied dosages, latest scientific evidence and the approval of experts.

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Section: Discussionmentioning

confidence: 99%

Development of the Swiss Database for dosing medicinal products in pediatrics

Tilen

Panis²,

Aeschbacher³

et al. 2021

Eur J Pediatr

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“…[21][22][23]. Unavailability of licensed drugs appropriate for children in countries with small populations makes it challenging to avoid the use of extemporaneous formulations [24,25]. For example, marketed prednisolone products are available in UK, Germany, The Netherlands, France and Italy, interestingly with different dose recommendations for treatment of acute asthma, see supplementary Table S1.…”

Section: Discussionmentioning

confidence: 99%

Variation in Extemporaneous Glucocorticoid Formulations and Doses for Asthma-like Symptoms in Children

Schmidt¹,

Haslund-Krog²,

A³

et al. 2019

J Pediatr Perinatol Child Health

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Treatment strategies for asthma-like symptoms are challenging with no international consensus on dose of systemic glucocorticoids. Despite, asthma-like symptoms remain one of the most common medical conditions seen in infants and preschool children. This is further complicated by limited licensed preparations and use of various extemporaneously prepared formulations in some countries. In Denmark, all extemporaneous formulations are produced according to GMP, which is different from other European countries. This retrospective cohort study examined the type and dose of extemporaneously prepared glucocorticoid formulations prescribed to infants and preschool children 0-5 years of age with acute asthma-like symptoms over a three-year period at three paediatric departments in the Capital Region of Denmark covering 1.8 mill inhabitants. In total 4877 patients were screened for eligibility. In addition, length of hospitalisation, prescribed co-medication, readmission, and adverse events were registered. Almost one in ten of the patients were treated with extemporaneous prednisolone. Eight different formulations were used interchangeably despite lack of studies supporting therapeutic equivalence between these formulations. Further, a higher dose did not result in shorter hospitalisation.

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“…The Delphi methodology, which uses expert experience and opinions to decide on certain matters (McMillan et al, 2016), is applied when evidence is insufficient. Sources of information may include but are not limited to a summary of product characteristics, statutory information from the medical regulatory authorities, expert clinical and pharmaceutical advisers, international peer-reviewed medical works, comments from the pharmaceutical industry, Cochrane systematic reviews, health expert consensus guidelines, and medical textbooks (Lenney, 2015;Haslund-Krog et al, 2018).…”

Section: Writing Of Hospital Formularymentioning

confidence: 99%

Medicine formulary writing for hospitals: A systematic review on development, approval, dissemination, and review

Zimbwe,

Kizenga,

Francis

et al. 2024

Pharm Educ

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Background: A hospital formulary is a guiding manual developed to enhance the rational prescribing of medicines based on the local prevalence of diseases and hospital settings. This systematic review aimed to identify and evaluate the existing literature on hospital formulary development and management to ensure the availability of safe, cost-effective, quality, and efficacious medicines that all practitioners must use. Methods: A qualitative evidence and experience synthesis approach was chosen to create evidence on the development and use of hospital formulary. PubMed was the database used to search for similar reviews using Boolean operators. Results: Out of 1,347 potentially relevant literature and abstracts identified and screened, 25 publications were used in developing the hospital formulary. The hospital formulary should be developed and reviewed after using the current STG/NEMLIT to use updated medicine lists and indications. Medicines selected for the model are “medicines of choice.” The development of hospital formularies should be based on a comprehensive and transparent process that involves a multidisciplinary team of experts, a clear selection criterion, a reliable and updated source of information, and a regular evaluation of the clinical and economic outcomes. Conclusion: Hospital formularies promote the rational, safe use of medicines to improve the quality and efficiency of healthcare.

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Development of one paediatric and one neonatal formulary list in hospital settings

Abstract: The process is time-consuming as studies are lacking and age-appropriate dosage forms and concentrations differ amongst countries. Nevertheless, the process should be somewhat similar between countries, albeit different drugs may be selected for the final formulary lists.

Cited by 3 publications

References 20 publications

Development of the Swiss Database for dosing medicinal products in pediatrics

Development of the Swiss Database for dosing medicinal products in pediatrics

Variation in Extemporaneous Glucocorticoid Formulations and Doses for Asthma-like Symptoms in Children

Medicine formulary writing for hospitals: A systematic review on development, approval, dissemination, and review

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