Effect of omega-3 on heart disease is negligible, finds Cochrane review

Effect of omega-3 on heart disease is negligible, finds Cochrane review

July 19 2018 Cochrane researchers have published research indicating that omega 3 supplements...

BLF highlights decline in stop smoking prescriptions

BLF highlights decline in stop smoking prescriptions

July 18 2018 There has been a 75% decline in stop smoking treatments being prescribed by GPs and...

Welsh National Survey includes OTC medicine purchases for first time

Welsh National Survey includes OTC medicine purchases for first time

June 28 2018 Over half the population in Wales has reported having bought an over the counter...

Recall issued for several own label glycerine and blackcurrant cough syrups

Recall issued for several own label glycerine and blackcurrant cough syrups

June 20 2018 A Class 2 Drug Recall has been issued for 15 batches of own-brand children’s...

Bath emollients have ‘no benefit beyond standard eczema care for children’

Bath emollients have ‘no benefit beyond standard eczema care for children’

May 9 2018 A study has found no evidence of clinical benefit from including bath emollients in...

  • Effect of omega-3 on heart disease is negligible, finds Cochrane review

    Effect of omega-3 on heart disease is negligible, finds Cochrane review

    Thursday, 19 July 2018 10:21
  • BLF highlights decline in stop smoking prescriptions

    BLF highlights decline in stop smoking prescriptions

    Wednesday, 18 July 2018 17:32
  • Welsh National Survey includes OTC medicine purchases for first time

    Welsh National Survey includes OTC medicine purchases for first time

    Thursday, 28 June 2018 16:55
  • Recall issued for several own label glycerine and blackcurrant cough syrups

    Recall issued for several own label glycerine and blackcurrant cough syrups

    Wednesday, 20 June 2018 18:29
  • Bath emollients have ‘no benefit beyond standard eczema care for children’

    Bath emollients have ‘no benefit beyond standard eczema care for children’

    Wednesday, 09 May 2018 15:28

Umesh Modi is a chartered accountant, and Pamini Jatheeskumar is a chartered certified accountant at Silver Levene...
  Don Lavoie is alcohol programme manager at Public Health England and Gul Root is lead...
Don Lavoie is alcohol programme manager at Public Health England and Gul Root is lead pharmacist, Health and Wellbeing Directorate, Public Health England
More inWhite Papers  

MHRA1March 21 2016

A consultation on changing the legal category of Ibuprofen Seven Plus 200mg/5ml Oral Suspension from prescription only medicine (POM) to pharmacy only (P) is underway.

Ibuprofen 100mg/5ml suspension is available without prescription, but the Commission on Human Medicines has now advised that a 200mg/5ml strength can be made available as a P medicine.

Setting out its proposals, the medicines regulator, the MHRA, has flagged up a potential risk of confusion over the different strengths as no other OTC ibuprofen 200mg/5ml preparations are available at the moment. “The risk is that a parent/carer, who may be used to giving quantities of suspension suitable for the 100mg/5ml product, might give twice the dose to a child if they give the same amount of this product,” says the consultation document ARM 91.

To address this concern, “the company has proposed appropriate risk minimisation measures to manage the risk of confusion. This will be done by clear warnings on the leaflet and label, and by adding the words, ‘double strength’ clearly highlighted to the outer box and to the label on the bottle itself.

“Additionally, as a P medicine, this product will be supplied only from pharmacies under the supervision of a pharmacist and therefore pharmacy staff can provide additional advice on correct use.”

Ibuprofen Seven Plus 200mg/5ml Oral Suspension is made by Pinewwood Laboratories, and is licensed for rheumatic or muscular pain, headache, dental pain, feverishness, symptoms of cold and influenza in children aged 7-12 years.

The consultation runs until April 4.

Links:

MHRA announcement

MHRA ARM 91 consultation document

OTC News

July 20 2018 A consultation asking for views on how the safety features required under the Falsified Medicines Directive should be implemented has been issued.
July 20 2018 A consultation asking for views on how the safety features required under the Falsified Medicines Directive should be implemented has been issued. The MHRA has launched the consultation with...