POM to P Flashcards
What are P medicines?
Sold in a pharmacy without a prescription Under the supervision of a pharmacist
What are GSL medicines?
Can be sold in general retail outlets without supervision of a pharmacist
List 3 requirements for reclassification from POM to P
- Ministers must be satisfied that it would be safe to allow it to be supplied without a prescription
- Unlikely to present a danger to human health if used without the supervision of a doctor
- Difficult to use incorrectly
List 3 requirements for reclassification from P to GSL
- Ministers must be satisfied that the medicine can be sold or supplied by someone other than a pharmacist and without their supervision
- Need for special precaution is small
- Wider sale would be of convenience to the purchaser
Why could a P medicine be reclassified to a POM?
When new risks are identified Likely to present a danger to human health, even when used correctly, if used without the supervision of a doctor
List 2 examples of recently reclassified drugs from P to POM
- Diclofenac
- Domperidone
Due to new evidence indicating a small increased risk of serious cardiac effects
What are new medicines usually classified as?
POM
What causes a product to be reclassified?
A request from the company which holds a marketing authorisation for it
Which agency evaluates applications to reclassify medicines?
MHRA Medicines and Healthcare Products Regulatory Agency
How does the MHRA reclassify a medicine?
Advice from a suitable expert committee
Public consultation
The reclassification application is to a specific marketing authorisation - other products with the same active ingredient will need to make separate applications
What are the 2 options of EHC (emergency hormonal contraception)
- Levonorgestrel 1500mcg tablet (= Levonelle)
2. Ulipristal acetate 30mg tablet (= ellaOne)
How do EHCs work?
Inhibit or delay ovulation so that fertilisation cannot take place
What are the different age ranges that Levonelle and ellaOne are licensed for?
Levonelle = women over 16 ellaOne = women of childbearing age including adolescents
What are the different time frames that Levonelle and ellaOne must be taken in to be effective?
Levonelle = up to 72 hours after unprotected sex ellaOne = up to 120 hours after unprotected sex
What is the mechanism of action of Levonelle?
Unclear but thought to delay ovulation by 5-7 days and arrests the development of the ovarian follicle