Law & MEP Flashcards
Define GSL medicine.
~ Sold in registered pharmacy or retail outlet that can close to the public
~ Hold an EU/UK Marketing Authorisation or Traditional Herbal registration or GSL homeopathic product.
Can GSL medicines be sold in the absence of the responsible pharmacist?
Yes, providing they have signed in as RP on the pharmacy Record. Unless they have been absent for over 2 hours- then you can’t unless another pharmacist becomes the RP.
If they have not (i.e. they are late) then GSL sale can only commence once the RP has signed in.
Can P medicines be sold in the absence of the RP?
NO- not in absence of RP, unless a second pharmacist is present.
What cannot take place when the Responsible pharmacist is absent for under 2 hours?
Sale of P Medicines
Handing out prescriptions and bagged meds
Handing prescriptions to delivery driver
These CAN all take place if a second Pharmacist is present.
What two active ingredients used in cold and flu remedies must NOT be sold at the same time?
Pseudoephedrine
Ephedrine
What are the two licensed EHC drugs that can be obtained from a pharmacy?
Levonorgestrel 1500 mcg (Levonelle One Step)
Ulipristal Acetate 30mg (Ella One)
How many days after unprotected sex is Levonorgestrel licensed for?
What about Ulipristal Acetate?
Levonorgestrel= 3 days (72 hours)
Ulipristal acetate= 5 days (120 hours)
What age is Levonorgestrel licensed for?
Levornorgesterel is licensed for use in over 16 years. Can be given to under 16’s only if a locally commissioned PGD is in place.
What age is Ulipristal Acetate licensed for?
Ella One can be used in any girl of child-bearing age- so can be used in under 16’s
At what age must you report sexual activity of a patient requesting EHC?
Children under 13 legally too young to consent to any sexual activity.
Any younger requesting reported to social services.
Children under 16 also not legal although its may be consensual i.e. with male also under 16.
Can pharmacists legally provide an advanced supply of EHC?
Yes
If you decided to supply a child under 16 with EHC, can patient information be disclosed without consent?
No- still need to obtain consent in order to disclose information. Info can be shared if safeguarding an issue- judge on a case by case basis.
If the patient vomits within how many hours of Levonelle/ Ella One should they take another dose?
2 hours of taking Levonorgesterel
3 hours of taking Ella One (Ulipristal)
At what point in the menstrual cycle should EHC be taken? Can it be taken more than once per cycle?
Can be taken at any point.
SPC for Levonelle states It is not advisable to take more than 1 per cycle as it can disrupt the cycle.
NB: RPS guidance says that women can take more than one if appropriate but should be advised about cycle disruption.
A patient, who you are aware has alcoholic liver cirrhosis, asks for EHC. What do you do?
Refer.
Neither EHC are recommended in severe liver dysfunction
What medication can Levonorgestrel increase the toxicity of?
Ciclosporin
Can EHC be used in breast feeding women?
Levonorgestrel appears in small amounts in breast milk- should not be harmful, but take tablet after a feed to allow maximal team until next feed.
Ulipristal acetate is present in breast milk for 1 week after administration. Advise mother not to BF in this time but express and discard the milk to maintain lactation.
Which EHC drug can reduce the efficacy of COC and POP pills?
Ulipristal acetate.
Patients should use barrier methods until next period as their normal contraceptive cover will be reduced.
A patient has received EHC, and asks if they have unprotected sex again before their next period, will the be okay?
No - it does not provide protection against pregnancy for rest of cycle- they will need to use contraceptive measures if they want to have sex again such as start pill or condoms.
What is the max number of paracetamol non effervescent and aspirin non effervescent you can buy OTC?
100 of each.
Come in packs of 16 and 32 so you would not be able to sell this amount anyway
What is OTC codeine/ dihydrocodeine products indicated for?
Short term (3 days max) treatment of acute - moderate pain not relieved by paracetamol, ibuprofen or aspirin alone.NOT for cold, flu sore throat etc.
What is the largest pack size of codeine/ dihydrocodeine products available OTC?
32
Anything bigger requires an MA as a POMRPS recommends the sale of just one pack of 32 at any one time.
Why are many cough and cold remedies now no longer used in children under 6 years?
Limited evidence of efficacy. Ingredients linked to SEs including allergic reactions, sleep disturbances and hallucinations.
Medicines containing what 4 types of cough and cold remedy ingredients have been deemed unsuitable for children under 6 years?
Antitussives (eg dextromethorphan, pholcodine)
Expectorants (eg Guaifenesin)
Nasal decongestants (pseudoephidrine, phenyephidrine, oxymetazoline)
Antihistamines- but still used in hayfever
THESE should ONLY be used 2nd line in children 6-12 years, for maximum of 5 days