Medicines Safety Updates – from MHRA and the Staffordshire MSO Network!

Medicines Safety Updates – from MHRA and the Staffordshire MSO Network!

December 20, 2018

Please find below the December Edition of the Staffordshire Medicines Safety Officer Network Newsletter:

December Newsletter FINAL

Furthermore, the December MHRA Drug Safety Update can be found HERE – the key items include:

  • Valproate medicines: are you in acting in compliance with the pregnancy prevention measures? Although use of valproate medicines in female patients continues to slowly decline, there is wide variation in prescribing between Clinical Commissioning Groups (CCGs). Women continue to report instances when they have not received patient information with their dispensed valproate medicine. All healthcare professionals must continue to identify and review all female patients on valproate, including when it is used outside the licensed indications (off-label use) and provide them with the patient information materials every time they attend their appointments or receive their medicines (including the Patient Information Leaflet at dispensing).
  • Emollients: new information about risk of severe and fatal burns with paraffin-containing and paraffin-free emollients: Warnings about the risk of severe and fatal burns are being extended to all paraffin-based emollients regardless of paraffin concentration. Data suggest there is also a risk for paraffin-free emollients. Advise patients who use these products not to smoke or go near naked flames, and warn about the easy ignition of clothing, bedding, dressings, and other fabric that have dried residue of an emollient product on them.
  • Oral lidocaine-containing products for infant teething: only to be available under the supervision of a pharmacist: Oral lidocaine-containing products for infant teething are only to be available under the supervision of a pharmacist so that parents and caregivers can receive guidance about managing infant teething symptoms. Non-medicinal options such as a teething ring or massaging the gum should be the first line for relieving infant teething symptoms, and lidocaine-containing products should only be used when simple measures have failed to provide sufficient relief.



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