Neonatal vitamin K prophylaxis in Great Britain and Ireland: the impact of perceived risk and product licensing on effectiveness

• Published in: Archives of disease in childhood 2007-09, Vol.92 (9), p.754-758
• Main Authors: Busfield, Alison, McNinch, Andrew, Tripp, John
• Format: Article
• Language: English
• Subjects: Administration, Oral; Antifibrinolytic Agents - administration & dosage; Antifibrinolytic Agents - supply & distribution; Babies; Biological and medical sciences; Births; bleeding; Body Weight; Breastfeeding & lactation; Directories; Disease prevention; Dosage and administration; Drug Approval; Female; Food and nutrition; General aspects; Humans; Infant, Newborn; infants; Infants (Newborn); Injections, Intramuscular; Injections, Intravenous; Intention; intracranial haemorrhage; Ireland; Leukemia; Licensing, certification and accreditation; Maternal child nursing; Medical sciences; Midwifery; Miscellaneous; National Surveys; Newborn infants; Original; Pregnancy; Prevention; Prevention and actions; Prophylaxis; Public health. Hygiene; Public health. Hygiene-occupational medicine; State Surveys; United Kingdom; Vitamin K; Vitamin K - administration & dosage; Vitamin K - supply & distribution; Vitamin K deficiency; Vitamin K Deficiency Bleeding - prevention & control; Young Children
• ISSN: 0003-9888; 1468-2044
• DOI: 10.1136/adc.2006.105304

Objective:To determine current use of vitamin K (VK) prophylaxis in newborns and review the efficacy and effectiveness of regimens used.Design:Efficacy and effectiveness calculated using current practice details, data from Southern Ireland and two previous surveys, together with contemporaneous studies of vitamin K deficiency bleeding (VKDB).Setting:Current survey: United Kingdom (Great Britain and Northern Ireland). Efficacy and effectiveness tables: United Kingdom and Southern Ireland.Main outcome measures:Current VK prophylaxis following uncomplicated term deliveries. Relative risk of VKDB calculated for the VK actually received and for “intention to treat”.Results:Questionnaire response rate 95% (n = 243), all recommending VK prophylaxis. No association between unit size and route of administration. For uncomplicated term deliveries, 60% recommended intramuscular (IM) prophylaxis, 24% oral and 16% offered both routes without bias. All units offering IM gave a single dose, mostly 1 mg Konakion Neonatal. Oral regimens showed more variation: two thirds gave 2 mg (range 0.5–2 mg), the number of doses ranged from 1 to 11 and many used preparations off-licence or the unlicensed Orakay. IM prophylaxis, if given, provided the best protection (most efficacious) against VKDB. However, on an intention-to-treat basis (effectiveness), there is no statistically significant difference between the risks of VKDB after intended IM VK and after oral prophylaxis intended to continue beyond a week.Conclusions:Although the principles of VK prophylaxis is now accepted by all, there is no uniformity in practice. Omission of prophylaxis appears to be a greater problem for IM than for multi-dose oral prophylaxis, affecting overall effectiveness.