Sale of GSL and P medicines

Question 1

what are the 3 legal classes of products in the UK?

Answer 1

General sale medicines (GSL)
*Pharmacy medicines (P)
*Prescription-only medicines (POM)

Question 2

what does PO stand for?

Answer 2

*Sale restricted to pharmacies by the manufacturer
*All are GSL
*Do NOT confuse with ‘P’ medicines
*‘PO’ is NOT a legal classification

Question 3

what is the usual reclassification of medicines?

Answer 3

POM>P>GSL

Question 4

what are the benefits of switching classes of medicines?

Answer 4

Widens patients access to medicines
*Greater use of pharmacists’ expertise

Question 5

what is a GSL product defined by?

Answer 5

as a product that is
*not a POM or a P
*and is covered by a marketing authorisation that the product is to be available on general sale
These are medicines that ‘can with reasonable safety be sold or supplied otherwise than by, or under the supervision of, a pharmacist’

Question 6

what are products that are NOT GSL?

Answer 6

Products containing greater than a specified maximum daily dose of
vitamin A or vitamin D
for use as an eye ointment
*for use as an anthelmintic ()
for parenteral administration ()
for use as an enema ()
for use wholly or mainly for irrigation of wounds or of the bladder,
vagina or rectum ()
for administration wholly or mainly to children being a preparation
of aloxiprin or aspirin ()
() unless the marketing authorisation classifies them as GSL

Question 7

where may a GSL be sold?

Answer 7

May only be sold or supplied at a registered pharmacy or anywhere else where the following conditions are
fulfilled:
*the premises can be closed so as to exclude the public
*the product must have been made up for sale in a container elsewhere and not have been opened since then

Question 8

can a GSL be sold from a vending machine?

Answer 8

Note that GSL medicines may be sold from vending
machines provided the above requirements are
complied with

Question 9

can a GSL be sold from a pharmacy if the RP isnt there?

Answer 9

*If sold from a pharmacy, a ‘responsible pharmacist’ must have signed in and assumed this role

Question 10

can GSL medicines be sold on an aircraft/ train?

Answer 10

*The sale of GSL medicines is permitted from aircraft and trains
*The sale must be made by the operator or commander of an aircraft or the operator of a train
*The medicinal product that is sold
*Must have been made up for sale or supply in a container elsewhere than at the place at which it is sold or supplied
*Must be stored in a part of the aircraft or train which the operator is able to close so as to exclude the public

Question 11

who can laxatives now be sold to?

Answer 11

Stimulant laxatives should not be used in children under 12 years
without advice from a prescriber, while products for children aged
12 to 17 years can only be supplied under the supervision of a
pharmacist (i.e. they are P medicines)

Question 12

when are some POMs Ps?

Answer 12

Some POMs are Ps when they are sold in smaller pack sizes, or strengths, or for certain indications, or in a certain pharmaceutical forms

Question 13

what is the max amount of paracetamol you can buy?

Answer 13

100

Question 14

what is the good practice requirement for paractamol quantity?

Answer 14

*Pack size of 16 – GSL
*Pack size of 32 – P

Question 15

what is the limit in paracetamol-soluble?

Answer 15

no max

Question 16

who may sell P medicines?

Answer 16

May not be sold by any person unless:
*They are lawfully conducting a pharmacy business
*The premises is a registered pharmacy
*They are a pharmacist or, if they are not, they are acting
under the supervision of a pharmacist

Question 17

what is the legal definition of supervison?

Answer 17

The pharmacist must be aware of the sale and be in a position to intervene where necessary

Question 18

can a P medicine be supplied when the pharmacist isnt present?

Answer 18

Sale or supply of a P medicine cannot be said to be supervised when the pharmacist is absent from the pharmacy, no matter for how short a period

Question 19

what is the guidance surrounding patient experience and patient centred care?

Answer 19

*Patients are supported in their decision-making about medicines
*Patients are treated with dignity and respect by pharmacy staff
*The pharmacy team respect privacy and confidentiality and are empathic to patient sensitivities
*The views of patients and carers are actively sought in the development
and delivery of pharmacy services
*Patients have access to high quality information and support in order to
make informed choices about the use of medicines in a manner they can easily understand
*Pharmacists support the provision of clear, understandable information about medicines throughout the organisation
*Patients can ask to discuss their medicines with a pharmacist

Question 20

what does the law say in relation to the sale of P medicines in a pharmacy?

Answer 20

The law does not state where in the pharmacy P medicines should be merchandised
*It is a professional and good practice requirement that P medicines should
not be placed on self selection shelves
-traditionally OTC for supervision
or empty boxes
- glass lockable doors

Question 21

what is the legal max quantity of pseudoephedrine and ephedrine that can be sold?

Answer 21

*720mg pseudoephedrine
*180mg ephedrine

Question 22

should you sell pseudoephedrine and ephedrine product together?

Answer 22

unlawful

Question 23

what is the max pack size of codehine/ DHC?

Answer 23

max of 32 units- more than this are POM

Question 24

what about medicines that come with a free gift?

Answer 24

deemed unacceptable by the MHRA- but not illegal

Question 25

what may price promotions encourage?

Answer 25

stock piling of medicines
medicnes going out of date