Stefan Johansson Posted October 24, 2016 Share Posted October 24, 2016 I have finally come across a probiotics product, produced in the UK (?), and classified as a dietary supplement in the UK. However, the regulatory aspects seem a bit complex. For example, it seems that we would need permission from the Swedish Medical Product Agency Authority before we could start to administer it to preterm infants in the NICU. It is possible that the authority would not approve it as a dietary supplement but consider it as a pharmaceutical, which means that a more complicated regulatory framework kicks in. My question to you - how are you able to use probiotics in your units? Do you have pharmaceutical classification of probiotics or are the products used classified as dietary supplements? Do you use probiotics "off-label" without permission from authorities? Link to comment Share on other sites More sharing options...
ali Posted October 26, 2016 Share Posted October 26, 2016 Hi Stefan, Although my unit doesn't use probiotics I have colleagues in other units who do, and paediatric pharmacist. Will get back to you. Best wishes Al 1 Link to comment Share on other sites More sharing options...
selvanr4 Posted October 27, 2016 Share Posted October 27, 2016 In india ,we do not need to get permission to use probiotics. but many neos have reservations in using them though the fears are unfoynded. 1 Link to comment Share on other sites More sharing options...
Stefan Johansson Posted October 27, 2016 Author Share Posted October 27, 2016 @ali looking fw to hear back! I would like to import biofloratech.com used in the UK - our authorities seem uncertain how to classify this product. Link to comment Share on other sites More sharing options...
livesynapse Posted October 28, 2016 Share Posted October 28, 2016 We are using Biogaia (R) (lactobacillus reuteri) for preterm babies who are on antibiotics and other preterm babies who don't have access to early human milk feedings. We usually start it when trophic feedings are well tolerated. The evidence in favor of probiotics is sound, and we can use it without special authorization at our hospital so we do. 1 Link to comment Share on other sites More sharing options...
Tasnim Posted November 2, 2016 Share Posted November 2, 2016 We have Biogaia approved by our authority to be used in neonates. And in my previous unit, we used it after local approval from the hospital's PTC in preterm infants with the start of the trophic feeds. And it follows the regulation of pharmaceuticals. 1 Link to comment Share on other sites More sharing options...
Recommended Posts
Create an account or sign in to comment
You need to be a member in order to leave a comment
Create an account
Sign up for a new account in our community. It's easy!
Register a new accountSign in
Already have an account? Sign in here.
Sign In Now