PHARMACY MEDICINES Flashcards
What are the conditions for selling P medicines (3)?
- Must be sold in a GPhC registered pharmacy
- Responsible Pharmacist must have taken responsibility for safe & effective running
- Person supplying must be a pharmacist or under the supervision of one
What 5 things are medicinal products that are to be available only from a pharmacy?
- Anthelmintics
- Parenterals
- Enemas
- For irrigation of wounds or bladder/vagina/rectum
- Aloxiprin/aspirin for children aged under 16 years
How are P medicines different to POM/GSL? (4)
- Different strength/ dose
- Conditions of their marketing authorisation are met, e.g age
- Different quantities
- Product covered by the exemptions from licensing for pharmacists (counter prescribed)
What classifies a medicine as POM (3)?
- In Part 1 of Schedule 1 in HMR
- a medicinal product with a Marketing Authorisation which classifies it as POM
- a medicinal product that uses a POM
What medicinal products are POM products? (7) (according to The Schedule 1 Medicinal Products in HMR 2012)
- Medicinal product for parenteral administration
- Controlled drug (unless MA states otherwise)
- Cyanogenic substances (except for external use)
- Medicinal products which emit or generate radiation (+ used for their radiation)
- Restrictions for products containing aloxiprin, aspirin or paracetamol
- Restrictions for products containing pseudoephedrine salts or ephedrine base/salts
- Product that isn’t covered by a MA and is a POM because of it’s specifically addressed in Prescription Only Medicines (Human Use) Order 1997
What can change a POM in Schedule 1 of the HMR into a P? (4)
- Its strength
- Its pharmaceutical form
- Its route of administration
- Packaging showing max dose not exceeding the dose specified in schedule
Give 3 examples of medicines that are exempted from POM status (to be a P medicine)
- Budesonide for prevention/treatment of seasonal allergic rhinitis
- Econazole for external use of treatment of vaginal candidiasis
- Chloroquine phosphate for prophylaxis of malaria
What exemptions must CDs satisfy to be classified as P medicines (3)?
If all the following exemptions are satisfied:
- Only contain ONE CD2 substance
- At a specified max dose
- Supplied in specified form and packaging
Which 6 controlled drugs are exempt from POM status?
- Codeine
- Dihydrocodeine
- Ethylmorphine
- Morphine
- Pholcodine (+ their salts)
- Medicinal opium
What are the conditions of counter prescribed medicines? What is the classification of them? (4)
- Pharmacist may be request by customer to ‘make up’ a medicinal product for treatment of condition
- Person who requires medicine must be present in pharmacy
- These medicines are regarded as P medicines, even if contents are GSL
- POMs cannot be counter prescribed
What are the conditions for the sale of pseudoephedrine and ephedrine (4)?
- Not sold together
- No more than 720mg pseudoephedrine
- No more than 180mg ephedrine
- Sold using professional judgement
When can EHC be given as a P medicine?
When provided as a single dose
What are some examples of OTC oral Emergency Hormonal Contraception?(4)
- Levonelle 1500 (POM)
- Levonelle One-step (P)
- 72 hours
- Ulipristal acetate 30mg (POM)
- EllaOne 30mg tablet (P)
- Within 120 hours (5 days)
What are the restrictions for the sale of codeine and dihydrocodeine as a P medicine (4)?
- Only for short-term use - 3 days
- Maximum quantity is 32
- On the PIL and packaging - needs to the possibility of addiction and that it should only be used for 3 days
- Codeine linctus only for over 18s
What ingredients are present in nasal decongestants cough and cold medicines that are not suitable for children? (5)
- Ephedrine
- Oxymetazoline
- Phenylephrine
- Pseudoephedrine
- Xylometazoline