GSL Medicines MPHM15 2024 - PDF

WEEK 17 Sale and supply of medicines – Part 1 General Sales Medicines (GSL) John Sherwood MRPharmS 20th November 2024 Slide 1 of 12 OSPAP MPHM15 Sale and Supply of Medicines - G...

WEEK 17 Sale and supply of medicines – Part 1 General Sales Medicines (GSL) John Sherwood MRPharmS 20th November 2024 Slide 1 of 12 OSPAP MPHM15 Sale and Supply of Medicines - GSL WEEK 17 Learning outcomes List the legal classifications of medicines in the UK and explain how the classification of a medicine can be found Explain what ‘PO’ medicines are and describe their legal sale Understand how medicines may be declassified and list the advantages and disadvantages of this from the perspective of the Government, the NHS, the patient and the pharmacy profession Define how a medicine is classed as GSL Explain the circumstances which must be fulfilled for a GSL medicine to be lawfully sold (including on aeroplanes and trains) List the medicine types which are never GSL medicines Describe the changes to the OTC sale of stimulant laxatives Slide 2 of 12 OSPAP MPHM15 Sale and Supply of Medicines - GSL WEEK 17 Classes of medicinal products There are three legal classes of medicinal products in UK: General sale medicines (GSL) Pharmacy medicines (P) Prescription-only medicines (POM) ‘PO’ – Pharmacy only All are legally classified as GSL Sale is restricted to pharmacies by the manufacturer ‘PO’ is NOT a legal classification Do NOT confuse with ‘P’ medicines NB The term ‘Over the counter’ (OTC) is used to refer to medicines which are available to purchase OTC (i.e., GSL and P medicines) Slide 3 of 12 OSPAP MPHM15 Sale and Supply of Medicines - GSL WEEK 17 Medicines switching classes Medicines may move classifications if they are re-classified by the MHRA Usual move is POM P GSL Restrictions may include indication pack size, strength, route of administration (check carefully before selling) Widens patients access to medicines Greater use of pharmacists’ expertise Government is keen to declassify medicines – self-care agenda, removes cost from the NHS More recent POM to P switches include sildenafil (2018), fexofenadine (2020), desogestrel (2021), topical vaginal oestrogen (2022), tadalafil (2023) Pharmacy profession not keen on switches from P to GSL Products may (rarely) move GSL P POM RPS has guidance for the sale of recent switched products Slide 4 of 12 OSPAP MPHM15 Sale and Supply of Medicines - GSL WEEK 17 Human Medicines Regulations 2012 Chapter 2 regulates dealings in medicinal products Basic principle (set out in regulation 220) is that medicinal products may be sold, or supplied in circumstances corresponding to retail sale, only from registered pharmacies, and by or under the supervision of a pharmacist…….......unless they are products on a general sale list or otherwise subject to an exemption Slide 5 of 12 OSPAP MPHM15 Sale and Supply of Medicines - GSL WEEK 17 General Sales Medicines More commonly known as GSL (General Sales List (but there is no list!)) A GSL medicine is defined in the HMR 2012 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’ How can you find out whether a medicine is a GSL medicine? Note that some medicines may be GSL only when in a smaller pack size, or lower strength, or for certain indications or only in a particular form – care with selling! Slide 6 of 12 OSPAP MPHM15 Sale and Supply of Medicines - GSL WEEK 17 Retail sale of GSL medicines (1) 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 If the product is included in Schedule 15 then it must be sold in accordance with the requirements specified in that Schedule Note that GSL medicines may be sold from vending machines provided the above is complied with If sold from a pharmacy, a ‘responsible pharmacist’ must have signed in and assumed this role (see later lecture) Exception to the above Supply of medicinal products in the event or anticipation of a pandemic disease Slide 7 of 12 OSPAP MPHM15 Sale and Supply of Medicines - GSL WEEK 17 Retail sale of GSL medicines (2) 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 Slide 8 of 12 OSPAP MPHM15 Sale and Supply of Medicines - GSL WEEK 17 Products that are not General Sale Containing greater than a specified maximum daily dose of vitamin A or vitamin D for use as an eye ointment for use as anthelmintics (*) for parenteral administration (*) for use as an enema (*) for use wholly 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 Slide 9 of 12 OSPAP MPHM15 Sale and Supply of Medicines - GSL WEEK 17 Changes to the legal status of OTC stimulant laxatives (1) The safety of stimulant laxatives available OTC in the UK has been under review by the MHRA due to issues of misuse and abuse Stimulant laxatives available OTC are products containing senna/sennosides, bisacodyl and sodium picosulfate. (Note that co- danthramer and co-danthrusate are stimulant laxatives which are POM products). In August 2020, the MHRA announced changes to the regulation of stimulant laxatives available OTC. New regulations include pack size restrictions, revised recommended ages for use and new safety warnings Smaller packs continue to be available as GSL for the treatment of short- term, occasional constipation for use in adults only. GSL products are limited to a pack size of two short treatment courses (up to 20 standard- strength tablets, 10 maximum-strength tablets or 100ml solution/syrup). Larger packs (up to 100 tablets) are now P medicines. Slide 10 of 12 OSPAP MPHM15 Sale and Supply of Medicines - GSL WEEK 17 Changes to the legal status of OTC stimulant laxatives (2) GSL products are only licensed for use in patients 18 years or older. Stimulant laxatives should not be used in children under 12 years without advice from a prescriber, while products for children aged 12 - 17 years can only be supplied under the supervision of a pharmacist (i.e. they are P medicines). Warnings in the patient information leaflets advise patients that overuse of stimulant laxatives may be harmful due to the risk of fluid and electrolyte disturbances and potential disruption of intestinal function. A warning also appears that these products do not aid weight loss. Warnings also appear on the product packaging to support awareness. The RPS has produced further information on this topic on their website. Slide 11 of 12 OSPAP MPHM15 Sale and Supply of Medicines - GSL WEEK 17 GSL Medicines: True or False? 1) GSL medicines may be sold from a supermarket which does not have a pharmacy on the premises 2) GSL medicines can be sold from an automatic vending machine located in a pub 3) GSL medicines can be sold from a stall at an open-air pop festival 4) Water for injection is classified as a GSL medicine, because water is not a medicine 5) A medicine for treating threadworms will never be classified as GSL 6) GSL medicines may be sold from a car boot in a car boot sale 7) GSL medicines may be sold from a mobile pharmacy van that attends public entertainment events 8) GSL medicines can be sold like any other commodity because they are relatively safe 9) In a pharmacy, GSL medicines may legally be sold by any member of staff 10) It is possible for a medicine to move from POM to GSL (i.e. no P stage) Slide 12 of 12 OSPAP MPHM15 Sale and Supply of Medicines - GSL