Consultations

Outcome of consultation on change to warning statements on labels of oral non-steroidal anti-inflammatory drugs (NSAIDs) available without a prescription

About the consultation

In July 2017 Medsafe published a consultation on a proposed change to warning statements on labels of non-steroidal anti-inflammatory drugs (NSAIDs) available without a prescription. The consultation sought feedback on the proposal by 15 September 2017. Medsafe would like to thank everyone who took the time to prepare a submission.

Please click here for additional information on this consultation

Submissions received

Submissions received in response to the consultation are published below.

Intern Pharmacist (PDF 60 KB, 3 pages)

Pharmacy Guild (PDF 224 KB, 3 pages)

RNZCGP (PDF 254 KB, 5 pages)

Note: submissions have had personal information removed.

All submissions have been reviewed by Medsafe.

Consultation feedback and Medsafe’s response

Question	Feedback	Medsafe’s response
Whether you support the proposed changes to warning statements regarding use in pregnancy	All submissions supported the proposed changes to warning statements regarding use in pregnancy.	Noted.
	One submission proposed alternative wording to include other healthcare professionals (eg, midwives and pharmacists) involved in a pregnant woman’s care.	Medsafe recognises that there are other healthcare professionals involved in a pregnant woman’s care. The proposed warning statement includes women who are trying to become pregnant and this group of women are not generally under the care of midwives. The proposed warning statement will allow for harmonised package labelling for New Zealand and Australia. Since the Label Statements Database allows for words of a similar meaning to be used provided the intent is not changed, sponsors may choose to include other healthcare professionals in the statement
Do you agree with the proposed list of medicines these statements should apply to?	One response agreed with the proposed list of medicines.	Noted.
	One response agreed with the proposed list but also considered that these warnings should be extended to prescription-only NSAIDs.	Medsafe has requested and is working with sponsors to ensure all NSAID data sheets contain updated information on use in pregnancy and in women trying to become pregnant.
What is a suitable target date for implementation?	Two responses were received: one response suggested 12 months and the other suggested early 2018.	Medsafe considers an implementation timeframe of 18 months is suitable. Therefore the implementation date will be 1 June 2019
Are there any other comments you would like to make?	One submission was concerned that some NSAIDs are classed as general sales medicines and can be purchased from retail outlets without healthcare professional advice or counselling.	Noted.
Are there any other comments you would like to make?	Another submission suggested that Medsafe should consider a wide review of warning statements for NSAIDs available over the counter particularly those relating to use in children.	Noted.

Outcome

After careful consideration of these responses Medsafe concludes that the label statements database should be updated to change the current NSAID warning statements relating to pregnancy to:

Do not use [product name] if trying to become pregnant, or during the first 6 months of pregnancy except on doctor’s advice.
Do not use at all during the last 3 months of pregnancy.

The above warning statements will be required for all oral dose forms (solid and liquid) of the following NSAIDs available without a prescription for all indications and all age groups:

ibuprofen
diclofenac
naproxen
mefenamic acid
flurbiprofen

Implementation

The change in the warning statement will be required to be placed on labels from 1 June 2019. The Label Statements Database will be updated to this effect.