Regulations And Classification Of Medicines Flashcards
What is the General Sales List ?
- list of medicines that can be sold without a prescription, available for self-selection by customers.
Where can GSL medicines be sold?
- sold in registered pharmacies and other retail outlets, such as supermarkets and petrol stations
What are pharmacy only medicines (P) ?
- can only be sold in registered pharmacies by a pharmacist or under their supervision.
What is a prescription only medicine (POM) ?
- medicine that can only be supplied with a prescription written by an appropriate practitioner.
What happens when a medicine is reclassified from POM to P or P to GSL?
- provides pharmacists with a larger range of medicines to select from to treat patients
Why might a medicine be reclassified to a different category ?
- it could be due to growing confidence in the safety or effectiveness of the medicinal product
What types of restrictions might apply to reclassified medicines ?
- Maximum strength
• Route of administration
• Purpose of use or specific patient groups
• Pharmaceutical form
• Maximum quantity that can be sold or supplied
What are some benefits of increasing the availability of OTC medicines?
• Quick relief of disorders
• Promotes individual self-care and autonomy
• Provides rapid and convenient access to treatment
What are some barriers to increasing the availability of OTC medicines?
- side effect profile
– possibility of misdiagnosis and delay to treatment
– potential for harm from incorrect use
What are the indications for solid dose OTC codeine and dihydrocodeine?
- used for short-term treatment of acute, moderate pain not relieved by paracetamol, ibuprofen, or aspirin alone
Examples of Pharmacy only medications (P) ?
- Amorolfine nail lacquer
• Anti-malarials
• Chloramphenicol eye drops
• Contraceptives (Desogestrel)/ Emergency contraceptives
• Mometasone 0.05% nasal spray
• Oral lidocaine containing products in children
• Orlistat
• PPIs
• Sildenafil
• Sumatriptan
• Tamsulosin
• Tranexamic acid
• Fexofenadine
What is the classification for pack sizes of codeine and dihydrocodeine greater than 32 units?
- pack sizes greater than 32 units (including effervescent formulations) are classified as Prescription Only Medicines (POM)
What is advised regarding the sale of codeine and dihydrocodeine-containing products?
- it is advised to sell only one pack of codeine or dihydrocodeine-containing products to a customer at a time.
What must be included on the labelling or Patient Information Leaflet (PIL) for codeine and dihydrocodeine products?
- must state that the product can cause addiction, is for short-term use only (three days or less)
- may cause headaches if used for more than three days.
What is the main use of Pseudoephedrine and Ephedrine in pharmacies?
- are widely used as decongestants
