Update on Prescription-Only Medicines (POMs) exempted for limited sale and supply without prescription

In order to facilitate consumers' access to medicines, HSA has embarked on a biannual review to identify Prescription Only Medicines (POM) which may be supplied without prescription by pharmacists under exemptions where they are deemed sufficiently safe for use with reduced medical supervision. Three new POMs have been assessed to meet the criteria to be granted exemptions for limited sale and supply without prescription as of 1 July 2012. The current exemptions for ibuprofen and domperidone solid and liquid oral preparations have also been amended.

Exemptions for limited sale and supply of POM without prescription with effect from 1 July 2012

1. Azelaic acid topical preparations containing 20% w/w for treatment of mild to moderate acne vulgaris

2. Triamcinolone intranasal spray containing not more than 55 mcg/actuation for prevention and treatment of allergic rhinitis

3. Levocetirizine oral solid and liquid preparations containing not more than 5mg and 5mg/ml respectively for symptomatic treatment of allergic rhinitis and chronic idiopathic urticaria

Amendment to exemptions for limited sale and supply without prescription with effect from 1 July 2012

1. Amendment of maximum daily dose of ibuprofen oral solid and liquid preparations from age-based to a weight-based dosing.This is to align the recommendation to the current prescribing practice whereby weight-based maximum daily dose of ibuprofen of 30mg/kg would be more appropriate for children.This is also aligned to current dispensing practice.

2. Amendments to the maximum daily dose, maximum supply and minimum age of domperidone oral solid and liquid preparations.These restrictions are implemented in view of the potential increased risk of cardiac disorders such as serious ventricular arrhythmia and sudden cardiac death associated with chronic use of domperidone above 30mg daily.

Record keeping and patient confidentiality

The requirement for mandatory record keeping of supply of Pharmacy Only (P) medicines and POM with exemption for limited sale and supply without prescription has been fully implemented as of 1 Feb 2012. This requirement is intended to better safeguard consumers who buy P medicines. Pharmacists would be able to follow up with their customers/patients, should there be any issues concerning the use and quality of these medicines. These records would also assist the pharmacist in the identification of potential interactions between medicines or inappropriate use by patients thereby contributing further to quality patient care and patient safety. All pharmacists are reminded to keep all records relating to patients and their medications strictly confidential in accordance to the Code of Ethics (available from the Singapore Pharmacy Council website at www.spc.gov.sg).

All healthcare professionals are encouraged to report adverse reactions related to these medicines to the Vigilance Branch of HSA. For more information on reclassified medicines and POMs with exemptions for limited sale and supply without prescription, including downloadable patient information leaflets, frequently asked questions and mandatory recording requirements, please visit our website at: https://www.hsa.gov.sg/announcements/Reclassified-Medicines/Therapeutic-Products