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Reclassified Medicines

Medicines in Singapore are classified as Prescription Only (POM), Pharmacy only (P) or General Sales List (GSL). POMs can only be supplied by a doctor or by a pharmacist according to a prescription by a doctor. P medicines can be supplied by or under the supervision of a pharmacist without a doctor's prescription, while GSL medicines can be purchased off the shelves. There are two approaches whereby HSA enhances access by the public to safe and effective treatment.
 
Product-specific reclassification
 
Product licence holders (PLH) may submit applications proposing reclassification of their product for HSA's review. Medicines may be reclassified from POM to P, or P to GSL, if they have been deemed sufficiently safe for use with reduced or without medical supervision. For PLHs who wish to submit applications for reclassification of their products, please refer to the Drug Registration Guide

 

Exemptions for supply of POM without prescription

 

As provided under the Medicines (Prescription Only) Order, HSA provides an exemption for limited sale or supply of POM medicines if conditions with respect to dose, quantity, labelling and age restriction are met. This exemption applies to products containing the same active ingredient and of the same strength for similar indication/s which meet the legal requirements for supply by a pharmacist without a prescription, while their legal classification remain as POM.  In the absence of an appropriate consumer pack for the supply of medicine under this exemption, the professional body has been engaged to develop PILs which would be made available for pharmacists to supply upon dispensing. Medicines may also be reclassified to a more stringent forensic status (e.g. P to POM) if emergent safety issues warrant tighter control of supply.

 

Mandatory recording of medicines supplied by pharmacists (P and POM with exemptions for supply without prescription) (Updated 1 Feb 2012)

 

The Health Sciences Authority has phased in the requirement for record keeping which is mandatory for the supply of P medicines and POM with exemptions for supply by pharmacists to enhance safe and responsible use of medicines. This is in line with the existing legal requirements and professional practice of recording supply of POMs. Furthermore, these records would enable proper tracking of medication use especially in the event of polypharmacy.

 

The following fields are required for mandatory recording:  

  • Date of supply
  • Name, identity card number, contact details (address, phone or email) of person to whom the medicine is dispensed
  • Name, strength and quantity of medicine dispensed
  • Dose, frequency and purpose of treatment 

Mandatory recording of the sale and supply of P medicines by pharmacists has been implemented in  phases. From 1 April 2011, mandatory recording was required for the supply of medicines listed below as well as for P medicines reclassified from 1 January 2011:

  • Dental pastes containing triamcinolone (Oracort-E, Oral-T, Keno cream, Kenalog)
  • Minoxidil topical preparations (2%, 3%, 5%)
  • Loceryl (amorolfine) nail lacquer
  • Omeprazole oral solid preparations not exceeding 20mg
  • Oral solid/liquid NSAID preparations (ibuprofen, Aleve, Voltaren Rapid)

A second phase for a list of medicines was implemented effective from 1 October 2011. Please refer to Appendix A for the updated list of medicines.

 

With effect from 1 Feb 2012, mandatory recording for ALL P medicines/POM with exemptions for limited sale and supply without prescription is required.


Memo on mandatory recording

Memo on second phase of mandatory recording (Updated 5 Sept 2011)

FAQs on mandatory recording (Updated 30 Dec 2011)

Email Us for enquiries or feedback on reclassified medicines.


RECENT UPDATES

1 Feb 2012:

A list of products has been reclassified from P to POM effective from Feb 2012 and earlier.

Medicines reclassified from P to POM 2011-2012

1 Jan 2012:

New POMs with exemptions for supply without prescription

The following list includes medicines which have been reclassified or are POM granted exemptions for supply without a prescription. Please use the Online Infosearch instead to determine the updated forensic classification of specific products if these cannot be found from this site.

Active ingredient
Exemptions for supply of POM without prescription (Active ingredient remains as POM if these criteria are not met)
Effective date
Desloratadine/Pseudoephedrine
 
 
As a modified release oral solid dosage form containing desloratadine 2.5mg and pseudoephedrine 120mg
 
Indications: For the relief of symptoms associated with allergic rhinitis including nasal congestion, sneezing, runny nose, itching of the nose and/or eyes
 
It should be administered when both the antihistaminic properties of desloratadine and the decongestant effect of pseudoephedrine are required.
 
Dosing regimen: 1 tablet twice daily
 
Maximum daily dose: 2 tablets
 
Maximum supply: 10 tablets
 
Minimum age: 12 years
1 Jan 2012
Fexofenadine/Pseudoephedrine
(PIL)
As a modified release oral solid dosage form containing fexofenadine 60mg and pseudoephedrine 120mg
 
Indications: For the relief of symptoms associated with allergic rhinitis including nasal congestion, sneezing , runny nose, itching of the nose and/or eyes.
 
It should be administered when both the antihistaminic properties of fexofenadine and the decongestant effect of pseudoephedrine are required.
 
Dosing regimen: 1 tablet twice daily
 
Maximum daily dose: 2 tablets
 
Maximum supply: 10 tablets
 
Minimum age: 12 years
 
1 Jan 2012

Ketotifen (PIL)

As eyedrops not exceeding 0.25mg/ml
 
Indications: For the short-term treatment of symptoms of allegric conjunctivitis (e.g. itchy or watery eyes)
 
Dosing regimen:
Adults, elderly and children (age 3 and older): One drop into the affected eye (s) twice daily (in the morning and evening)
 
Maximum daily dose:
2 drops per affected eye
 
Maximum supply: 10ml
 
Minimum age: 3 years
1 Jan 2012

Amendments to current exemptions for supply without prescription 

 

Active ingredient
Exemptions for supply of POM without prescription (Active ingredient remains as POM if these criteria are not met)
Effective date
Ibuprofen (PIL)
 
As an oral solid preparation containing not more than 200mg
 
Indications: Relief of headache, menstrual pain, backache, muscular and arthritic pain, toothache, and the aches of cold and flu and reduction of fever.

Maximum daily dose: 1.2g
 
Maximum Supply: 10 days. The lowest effective dose should be used for the shortest duration necessary to relieve symptoms.
 
Minimum age: 12 years
 
As an oral liquid preparation not more than 100mg/5ml
 
Indications: Reduction of fever, including post-immunisation pyrexia, and relief of mild to moderate pain such as sore throat, teething pain and toothache, earache, minor aches and sprains

Maximum Daily Dose:
 
6 -12 months: 150-200mg
1-4 years: 300mg
4-7 years: 450mg
7-10 years: 600mg
10-12 years: 900mg
 
Maximum Supply: 3 days. The lowest effective dose should be used for the shortest duration necessary to relieve symptoms
 
Minimum age: 6 months
1 Jan 2012

For earlier reclassified medicines please click on the links below:

 

 


Last updated on 01 Feb 2012 15:32:11
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