Updates on the exemptions for supply of Prescription-Only Medicine (POM) without prescription

To facilitate public access to commonly used 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 supply without prescription as of 1 January 2012. There has also been an amendment to the current exemptions for ibuprofen solid and liquid oral preparations.

Table 1: Exemptions for supply of POM medicine without prescription with effect from 1 January 2012

1. Desloratadine/Pseudoephedrine modified release oral solid dosage forms containing desloratadine 2.5mg and pseudoephedrine 120mg
2. Fexofenadine/Pseudoephedrine modified release oral solid dosage forms containing fexofenadine 60mg and pseudoephedrine 120mg
3. Ketotifen eyedrops not exceeding 0.25 mg/ml

Amendment to exemptions for supply without prescription with effect from 1 January 2012

1. Ibuprofen oral solid preparations containing not more than 200mg and oral liquid preparations not more than 100mg/5ml

In this amendment, the exemptions for maximum daily dose and minimum age for ibuprofen have been included. Changes have also been made to the maximum supply of ibuprofen oral solid and liquid preparations.

Record Keeping

With effect from 1 February 2012, the requirement for mandatory record keeping of supply of P medicines and POM with exemptions for limited sale and supply without prescription has been implemented. This requirement is intended to better safeguard consumers who buy medicines from the pharmacist. The records also assist the pharmacist in following up with consumers should there be any issues concerning the use and quality of these medicines. To raise public awareness of this initiative, HSA has produced educational material to be displayed at pharmacies to inform the public on the need for record keeping.

In addition, the HSA Consumer guide on how drugs are regulated in Singapore has been updated, with a new link as follows: www.hsa.gov.sg/regulatingmedicines

Pharmacists are encouraged to refer members of the public to this website for an overview of drug regulation. This weblink will also be displayed on the educational materials provided to members of the public.

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 (PILs), Frequently Asked Questions (FAQs) and mandatory recording requirements, please visit our website at: https://www.hsa.gov.sg/announcements/Reclassified-Medicines/Therapeutic-Products.

Published: 20 Apr 2012

Safety Alerts