Pharm manager meeting v3(2)81210

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HSA-initiated Reclassification & Mandatory Recording for P Medicines Pharmacy managers presentation :

HSA-initiated Reclassification & Mandatory Recording for P Medicines Pharmacy managers presentation Health Products Regulation Group

Agenda:

Updated HSA-initiated reclassification process Mandatory recording of P medicines Q&A Agenda

Background:

Reclassification of medicines from POM to P or P to GSL as a means to enhance public access to safe and effective treatments Background

Reclassification Routes :

Reclassification Routes

HSA-initiated Reclassification:

Provision for P supply when specified conditions for sale and supply as a P medicine is fulfilled Product remains as a POM if it does not meet the specified criteria E.g. cimetidine for duodenal ulcer (POM), hyperacidity (P) HSA-initiated Reclassification

HSA-initiated Reclassification:

Recently reclassified medicines Omeprazole oral solid dosage preparations not more than 20mg for heartburn. Maximum 2 weeks supply. PIL produced by PSS and reviewed by HSA HSA-initiated Reclassification

Reclassification Workflow:

Reclassification Workflow HSA will notify all pharmacies of the products to be reclassified in March and September HSA will officially reclassify these products in July and January HSA will also update the reclassified medicines website and provide a link to the PIL PIL can be printed out by individual institutions

Mandatory Recording for P Medicines :

Mandatory Recording for P Medicines

Mandatory Fields :

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

Mandatory Recording:

A licensing condition in the Certificate of Registration of Pharmacy – under Medicine Act Records kept for 2 years from date of sale or supply Records checked during conduct of routine pharmacy audits Mandatory Recording

Implementation Timeline:

From 1 st April 2011 Mandatory recording for the following list of P medicines: Implementation Timeline

P Medicines to be recorded from 1st Apr 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) P Medicines to be recorded from 1st Apr 2011

Implementation Timeline:

From 1 st October 2011 Mandatory recording for ALL P medicines Implementation Timeline

Special Considerations:

Codeine preparations Pharmacies are expected to maintain sale and supply records of codeine cough preparations, in a format according to Rule 17 of Poisons Rules. Double recording is not required if the recording satisfies both requirements. Oral dental gums The current recording requirement for chewing gums remains unchanged and is not affected by the new requirements. Special Considerations

References:

HSA reclassification webpage http://www.hsa.gov.sg/publish/hsaportal/en/health_products_regulation/western_medicines/reclassified_medicines.html Contacts in HSA Mark Wong (mark_wong@hsa.gov.sg) Pe Shu Ai ( Pe_shu_ai@hsa.gov.sg ) Choo Qiuyi (choo_qiuyi@hsa.gov.sg) References

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