General Sales List Medicines

General Sales List Medicines

• Medicines in the UK are legally classified, and classification must be verified before it may be sold
• A manufacturer may want to classify a medicine as "PO"
• It is important to understand why medicines may be declassified and the advantages and disadvantages of declassification from the perspective of the Government (NHS), patient, and pharmacy profession
• It is important to understand the circumstances which must be fulfilled for a GSL medicine to be lawfully sold
• Some medicine types can never be GSL medicines

Human Medicines Regulations 2012

• Chapter 2 governs dealings in medicinal products
• Basic principle is that medicinal products may be sold or supplied in circumstances corresponding to retail sale only from registered pharmacies, unless they are products classified as general sale

Classes of Medicinal Products

• There are 3 legal classes of medicinal products in UK
  • General sale medicines (GSL)
  • Pharmacy medicines (P)
  • Prescription-only medicines (POM)

'PO' - 'Pharmacy Only'

• Legally, designated as GSL medicines
• Sale is restricted to pharmacies by manufacturer
• Distinct from 'P' medicines
• 'PO' is not a legal classification

Note About Over The Counter

• Over the counter (OTC) is a term meaning medicines which are available to purchase OTC (i.e., GSL and P)
• Controlled drugs belong to one of the legal classifications

Medicines Switching Classes

• Medicines may move classifications if re-classified by the MHRA
• Usual move is POM -> P-> GSL
• Restrictions may include indication, pack size, strength, route of administration, check carefully before sale
• Widens patients' access to medicines
• Greater use of pharmacists' expertise
• Government is keen to declassify medicines - self-care agenda, saves costs for the NHS
• Recent POM to P switches include fexofenadine, desogestrel, topical vaginal oestrogen, tadalafil
• Pharmacy profession not keen on switches from P to GSL
• Products may (rarely) move GSL -> P-> POM

General Sales Medicines

• More commonly known as GSL (General Sales List but the list is no longer being used!)
• A GSL medicine is defined in the HMR 2012 as a product that is:
  • Not a POM or a P
  • Is covered by a marketing authorisation that the product should be available on general sale
• These medicines can be legally sold or supplied with reasonable safety at places other than pharmacy premises and without the supervision of a pharmacist
• Some medicines may be GSL only when in a smaller pack size, lower strength, for certain indications, or in a particular form - care with selling

Retail Sale of GSL Medicines

• May only be sold or supplied at a registered pharmacy or anywhere else if 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
• If the product is included in Schedule 15 then it must be sold in accordance with the requirements specified in that Schedule
• GSL medicines may be sold from vending machines provided the machine is located in premises which the occupier is able to close so as to exclude the public
• If sold from a pharmacy, a responsible pharmacist must have signed in and assumed this role
• Exception to the above:
  • Supply of medicinal products in the event or anticipation of a pandemic disease
• 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
  • Be stored in a part of the aircraft or train which the operator is able to close so as to exclude the pub

Products That Are Not GSL

• Products containing greater than a specified maximum daily dose of vitamin A or vitamin D
• eye ointments
• anthelmintics
• for parenteral administration
• enemas (inserting liquid into rectum to help poop)
• 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