Updates on newly reclassified medicines in Singapore
Medicines in Singapore are classified as Prescription Only Medicine (POM), Pharmacy only (P) medicine or General Sales List (GSL) medicine with varying levels of access control according to their risk profiles. In general, a medicine would be reclassified from POM to P (eg, Aleve® containing naproxen sodium 220mg ) or P to GSL (eg, Miconazole dermatological preparations not exceeding 2%) when it had been deemed by regulatory authorities to be sufficiently safe and appropriate for use with reduced medical supervision. Conversely, a medicine would be reclassified from P to POM or GSL to P/POM when there is evidence to suggest that a P or GSL medicine should be used under greater medical supervision.
In order to facilitate access by the public to commonly used medicines, HSA has embarked on a biannual review of POM medicinal products to identify those which may be supplied without prescription by pharmacists under exemptions where they are deemed sufficiently safe for use with reduced medical supervision. In the recent review, eight POM active ingredients have been assessed to meet the criteria to be granted exemptions for supply without prescription as of 1 July 2011.
Enhancing the appropriate and safe use of Reclassified Medicines
Additionally, HSA has developed tools to ensure that all P medicines and medicines granted exemption for supply of POM without prescription are judiciously dispensed to members of the public. One such tool is record-keeping mandated for the supply of these medicines. This has been implemented in stages since 1 April 2011 and with effect from 1 February 2012, mandatory recording is required for all P medicines, or POMs granted exemption for supply without prescription by pharmacists. Another tool co-developed with the pharmacy professional body is the publication of Patient Information Leaflets (PIL) for these medicines, that is available at HSA's website. Pharmacists are strongly encouraged to refer to these PILs when counselling their patients on the use and side effects of the medicine.
Exemptions for supply of POM medicine without prescription with effect from 1 July 2011
- Triamcinolone acetonide topical paste containing not more than 0.1%
- Bromhexine oral solid preparations containing not more than 8mg
- Bromhexine oral liquid preparations containing not more than 4mg/5ml
- Ambroxol oral solid preparations containing not more than 30mg
- Ambroxol oral liquid preparations containing not more than 30mg/5ml
- Desloratadine oral solid preparations containing not more than 5mg
- Desloratadine oral liquid preparations containing not more than 0.5mg/5ml
- Fexofenadine oral solid preparations containing not more than 120mg
The monitoring of the above list of medicines for any adverse reactions is crucial especially during its first few years on the market as a POM with exemptions for supply without prescription. All healthcare professionals are encouraged to report adverse reactions related to these medicines to the Vigilance Branch of HSA. For more information on the list of reclassified medicines and their regulatory conditions of use, downloadable PILs and mandatory recording requirements, please visit our website at:
https://www-hsa-gov-sg.cwp.sg/announcements/Reclassified-Medicines/Therapeutic-Products