Submission to the TGA consultation on Required Advisory Statements for Medicine Labels

Comments by The Pharmacy Guild of Australia on the corrected advisory statements for: • cimetidine • famotidine • nizatidine • ranitidine

October 2015

National Secretariat Level 2, 15 National Circuit, Barton ACT 2600 PO Box 7036, Canberra Business Centre ACT 2610 P: +61 2 6270 1888 • F: +61 2 6270 1800 • E: [email protected] www.guild.org.au Ref: SP1006-18-1196

Overview

The Pharmacy Guild of Australia welcomes the opportunity to comment on the corrected advisory statements for cimetidine, famotidine, nizatidine and ranitidine prepared by the Therapeutic Goods Administration (TGA).

The Guild supports the amended RASML for the reasons outlined by the TGA.

• CAUTION - This preparation is for the relief of minor and temporary ailments and should be used strictly as directed. If symptoms persist or recur within two weeks, consult a doctor.

In addition, the Guild believes the instruction to consult a doctor should be broadened to pharmacists or health professionals more generally. Therefore the proposed addition to the RASML could one of the following

• Option 1- CAUTION - This preparation is for the relief of minor and temporary ailments and should be used strictly as directed. If symptoms persist or recur within two weeks, consult a doctor or pharmacist.

• Option 2 - CAUTION - This preparation is for the relief of minor and temporary ailments and should be used strictly as directed. If symptoms persist or recur within two weeks, consult a health professional.

A patient who is not getting sufficient relief from heartburn or Gastroesophageal Reflux Disease (GORD) symptoms using a H2-receptor antagonist may simply require treatment with another OTC product such as a Proton Pump Inhibitor (PPI) which studies have shown to be more efficacious.1 Proton pump inhibitors (PPIs) have a slower onset of action than H2-receptor antagonists, but inhibition of acid secretion is greater and more sustained.2

Pharmacists are in a position to determine whether a patient should try a PPI as an alternative treatment or whether a referral to a doctor for further examination is required. The Guild notes that a reference to a doctor or pharmacist is common in RASMLs for other OTC medicines such as aspirin, diclofenac and Proton Pump Inhibitors (PPIs).3

Recommendation

The Guild believes the instruction to consult a doctor as part of the advisory statement should be broadened to pharmacists or health professionals more generally.

1 Van Pinxteren, B., Sigterman, K. E., Bonis, P., Lau, J., & Numans, M. E. (2006). Short‐term treatment with proton pump inhibitors, H2‐receptor antagonists and prokinetics for gastro‐oesophageal reflux disease‐like symptoms and endoscopy negative reflux disease. The Cochrane Library. 2 Therapeutic Guidelines online – Proton Pump Inhibitors 3 Medicines Advisory Statements Specification 2014

The Pharmacy Guild of Australia – corrected advisory statements for cimetidine, famotidine, nizatidine and ranitidine p 2 of 2