Scholarlink

Background <p>Vitamin D is essential for bone health and immune function, particularly in early life. While its supplementation is widely recommended during infancy, data on prescribing patterns in the pediatric population—especially in a primary health care setting—are limited, particularly in Spain.</p> Objective <p>To determine the prevalence and characteristics of vitamin D prescriptions in infants under one year of age in Spain, and to identify potential safety concerns related to off-label use and excipients.</p> Methods <p>We conducted a cross-sectional, observational study using prescription data from January 2013 to December 2020. All prescriptions of medications containing vitamin D (cholecalciferol or calcifediol) for infants aged &lt; 1 year in primary health care were analyzed. Variables included were pharmaceutical form, dosage regimen, age indication, prescription requirement, and the presence of mandatory-declaration excipients.</p> Results <p>A total of 4,829,158 prescriptions were recorded. Cholecalciferol was the most frequently prescribed active ingredient (96.43%). Considering all vitamin D medications, oral solution was the predominant pharmaceutical form (99.43%), and daily administration was the most common dosing regimen (96.51%). Off-label prescriptions accounted for 4.03% of the total, often involving adult-only formulations or pharmaceutical forms unsuitable for infants, such as tablets/capsules and orodispersible tablets. Several medications included excipients with known pediatric safety concerns, such as ethanol, sorbitol, aspartame, and sucrose.</p> Conclusion <p>This large long-term study provides critical insight into vitamin D prescribing practices in primary care for infants in Spain. While most prescriptions aligned with pediatric recommendations, the presence of off-label use and potentially harmful excipients highlights the need for improved regulatory oversight and prescriber awareness.</p>

错误：搜索内容不能为空，请输入英文关键词
错误：关键词超出字数限制，请精简
高级检索

Prescription of vitamin D in neonates and infants under one year of age in Spain: an eight-year observational study

  • 期刊论文

  • 出版模式：

    开放获取

  • 发表日期：

    2026年2月25日

查看全文
  • Camila Jorge-Novoa,
  • Irene Lizano-Díez,
  • Montserrat Viñas-Bastart,
  • Antonio J. Braza,
  • Mónica Muñoz-Cortés,
  • Carlos Figueiredo-Escribá,
  • Eduardo L. Mariño,
  • Pilar Modamio

摘要

Background

Vitamin D is essential for bone health and immune function, particularly in early life. While its supplementation is widely recommended during infancy, data on prescribing patterns in the pediatric population—especially in a primary health care setting—are limited, particularly in Spain.

Objective

To determine the prevalence and characteristics of vitamin D prescriptions in infants under one year of age in Spain, and to identify potential safety concerns related to off-label use and excipients.

Methods

We conducted a cross-sectional, observational study using prescription data from January 2013 to December 2020. All prescriptions of medications containing vitamin D (cholecalciferol or calcifediol) for infants aged < 1 year in primary health care were analyzed. Variables included were pharmaceutical form, dosage regimen, age indication, prescription requirement, and the presence of mandatory-declaration excipients.

Results

A total of 4,829,158 prescriptions were recorded. Cholecalciferol was the most frequently prescribed active ingredient (96.43%). Considering all vitamin D medications, oral solution was the predominant pharmaceutical form (99.43%), and daily administration was the most common dosing regimen (96.51%). Off-label prescriptions accounted for 4.03% of the total, often involving adult-only formulations or pharmaceutical forms unsuitable for infants, such as tablets/capsules and orodispersible tablets. Several medications included excipients with known pediatric safety concerns, such as ethanol, sorbitol, aspartame, and sucrose.

Conclusion

This large long-term study provides critical insight into vitamin D prescribing practices in primary care for infants in Spain. While most prescriptions aligned with pediatric recommendations, the presence of off-label use and potentially harmful excipients highlights the need for improved regulatory oversight and prescriber awareness.