Medicines and Medical Devices Flashcards
What are GSLs?
general sales medicines
are those that can be made available as self-selection items for sale in registered pharmacies and other retail outlets
- must be able to exclude the public
are licensed except those designated as food or cosmetics
are covered by a marketing authorisation (MA) and the MHRA has designated it its classification
What are some products that cannot be sold as GSL?
eye ointments
parenteral administration
enemas
irrigation of wounds, bladder, vagina or rectum
aspirin for children
anthelmintics (treat infections of animals with parasitic worms)
a product containing vitamin A with more than a daily dose of 7500 iu
a product containing vitamin D with more than a daily dose of more than 400 iu
What are PO medicines?
pharmacy only medicines
a substance which contains GSL so is licensed as a GSL but the manufacturer wishes to restrict sales or supplies through pharmacies
no need for pharmacist supervision but a responsible pharmacist must be appointed
public may self select
- fybogel
What are P medicines?
pharmacy medicines
a substance which is not subject to POM requirements or included in GSL medicines
medicinal products made up in the pharmacy for sale from that pharmacy without an MA is classed as a P
- even if the products are GSL
How can P medicines be sold?
can only be sold from registered pharmacies by:
- pharmacists (acting as the RP)
- those acting under the supervision of a pharmacist
= must be competent
must not be accessible by self selection
What are GSL, P and PO medicines collectively known as?
over the counter medicines
What are POM medicines?
a substance which can only be sold orsuppliedto the public on a practitioners prescription
practitioners
- doctors, dentists, supplementary prescribers, EEA and Swiss approved health professionals, community practitioners
are designated POMs by MA
What does the restriction of aspirin and paracetamol depend on?
formulation and pack size
non-effervescent tablets and capsules
- cannot sell more than 100 to any person
= pack sizes are 16/32 so only 96 can be sold
effervescent tablets, granules, powers and liquids
- have not legal restrictions
= must use professional judgement
What does the restriction of codeine and hydrocodeine depend on?
indication
- are now restricted to the short-term treatment of acute, moderate pain that is not relieved by paracetamol, ibuprofen or aspirin alone
pack size
- can only be sold as one pack size of 32 (anymore is a POM)
patient information leaflet and labels
- must say ‘may cause addiction’ and ‘for three days use only’
Why aren’t cough and cold medicines generally used for children? What are the different types?
lack of effectiveness in children under 6
ingredients are linked to causing
- allergies, sleep disturbances and hallucinations
antitussives - dexomethorphan, pholcodine
expectorants - guaifenesin, ipecacuanha
nasal decongestants - ephedrine, oxymetazoline
antihistamine - chlorphenamine
can be used in 6-12 years old but as second line treatment
What are some medicines that except to POM restrictions?
hydrocortisone for some indications become a P
- cannot be stronger than 1% and exceed 15g
some CDs when they are below a stated strength and with maximum dose/daily dose not exceeding a specific maximum
- codeine in co-codamol
some products for specific conditions at doses not exceeding certain maxima
What are the restrictions on pseudoephedrine and ephedrine?
cannot supply a product or combination of products that contain the following without a prescription:
- more than 720mg of pseudoephedrine
- more than 180mg of ephedrine
cannot sell or supply any pseudoephedrine product at the same time as a ephedrine product
What are pseudoephedrine and ephedrine?
are decongestants
are P medicines
- require pharmacist supervision
= due to their potential misuse in the illicit production of methylamphetamine (Class A CD)
What are the signs of that can indicate someone is misusing a product?
lack of symptoms
nervous or guilty behaviour
- avoiding eye contact, timid
rehearsed answers
impatient or aggressive
- in a rush or hurrying to complete the transaction
opportunistic
- coming at times where it is busy or inexperienced workers are working
specific products
- wants products that contain only pseudoephedrine or ephedrine
paraphernalia
- wants to purchase other products that can be used to make methylamphetamine
= lithium batteries, chemicals such as acetone
frequency
- frequent requests
quantities
- large volumes requested
What are the types of emergency hormonal contraception? What is the age of consent for sexual intercourse?
oral levonorgestrel
- 1500 microgram tablet
- licensed for women aged 16 and over within 72 hours of unprotected sexual intercourse
ulipristal acetate
- 30 milligram tablet
- licensed for use within 120 hours (5 days) of unprotected sexual intercourse
copper intrauterine device
children under the age of 13 are too young to consent to any sexual activity
