classification of medicines

Question 1

Under what regulation are medicines classified?

Answer 1

Human Medicines Regulation 2012

Question 2

Restrictions to sale of GSL meds?

Answer 2

self selection
pharmacies and other outlets that can close to exclude the public

Question 3

when can a GSL be sold in a pharmacy?

Answer 3

only when a RP is assigned but they can be absent during sale

Question 4

restrictions to sale of P meds?

Answer 4

sold by a pharmacist or under supervision of one
not accessible to public by self selection

Question 5

what are POMs?

Answer 5

medicine that requires prescription by an appropriate practitioner

Question 6

restriction to supply of POMs?

Answer 6

RP must be present
supervision for safe use

Question 7

why would a medicine be reclassified?

Answer 7

growing confidence in safe use
awareness of side effects

Question 8

law surrounding supply of pseudoephedrine and ephedrine?

Answer 8

unlawful to sell or supply both at the same time without a prescription

Question 9

Maximum amount of pseudoephedrine without prescription?

Answer 9

720mg

Question 10

Maximum amount of ephedrine without prescription?

Answer 10

180mg

Question 11

signs of possible misuse?

Answer 11

lack of symptoms
rehearsed answers
impatient or aggressive
specific products/ paraphernalia
quantities and frequency
opportunistic

Question 12

where would you report suspicions of misuse?

Answer 12

local GPhC inspector
controlled drugs liaison officer

Question 13

what are the 3 methods of emergency contraception?

Answer 13

copper IUD
oral ulipristal acetate
oral levonorgestrel

Question 14

license of levonorgestrel for EHC?

Answer 14

16 or over
within 72 hours

Question 15

license of acetate for EHC?

Answer 15

within 120 hours (5 days)

Question 16

can you provide an advance supply of OEC?

Answer 16

yes, assess patient to ensure competent in use
if clinically appropriate

Question 17

paracetamol and aspirin OTC legal restrictions?

Answer 17

16 - GSL
32 - P
100 (96) - POM

Question 18

limit on effervescent paracetamol or aspirin?

Answer 18

no legal limit on quantity at any one time
use professional judgement

Question 19

indications for use of codeine and dihydrocodeine OTC?

Answer 19

short-term, acute moderate pain not relieved by paracetamol, ibuprofen or aspirin alone

Question 20

restriction to pack size of codeine and dihydrocodeine?

Answer 20

> 32 dose units is POM

Question 21

PIL and labels for codeine and dihydrocodeine?

Answer 21

‘can cause addiction, for three days use only’ must be clear