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Questions and Answers
Stimulant laxatives are available as GSL products for patients aged 16 and older.
Stimulant laxatives are available as GSL products for patients aged 16 and older.
False
Larger packs of stimulant laxatives can contain up to 100 tablets and are classified as P medicines.
Larger packs of stimulant laxatives can contain up to 100 tablets and are classified as P medicines.
True
Stimulant laxatives can be used in children under 12 years without any prescriber advice.
Stimulant laxatives can be used in children under 12 years without any prescriber advice.
False
Recommended ages for using stimulant laxatives have been revised to include children aged 12 and older without supervision.
Recommended ages for using stimulant laxatives have been revised to include children aged 12 and older without supervision.
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Warnings indicate that stimulant laxatives can aid in weight loss.
Warnings indicate that stimulant laxatives can aid in weight loss.
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GSL medicines can only be sold in registered pharmacies.
GSL medicines can only be sold in registered pharmacies.
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A responsible pharmacist must sign in before GSL medicines can be sold from a pharmacy.
A responsible pharmacist must sign in before GSL medicines can be sold from a pharmacy.
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GSL medicines can be stored in areas accessible to the public when sold from aircraft.
GSL medicines can be stored in areas accessible to the public when sold from aircraft.
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Certain products may be classified as GSL despite containing higher doses of vitamin A or vitamin D.
Certain products may be classified as GSL despite containing higher doses of vitamin A or vitamin D.
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Vending machines can be used to sell GSL medicines under specific conditions.
Vending machines can be used to sell GSL medicines under specific conditions.
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Stimulant laxatives available OTC in the UK are under review due to safety concerns.
Stimulant laxatives available OTC in the UK are under review due to safety concerns.
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All medicines can be sold without any restrictions during a pandemic.
All medicines can be sold without any restrictions during a pandemic.
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The sale of GSL medicines is allowed from unregistered outlets with no restrictions.
The sale of GSL medicines is allowed from unregistered outlets with no restrictions.
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General Sales Medicines (GSL) are classified as Prescription-only medicines (POM).
General Sales Medicines (GSL) are classified as Prescription-only medicines (POM).
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Pharmacy-only (PO) medicines are legally classified under the same category as GSL medicines.
Pharmacy-only (PO) medicines are legally classified under the same category as GSL medicines.
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Medicines can be reclassified from POM to GSL to increase patient access.
Medicines can be reclassified from POM to GSL to increase patient access.
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The Human Medicines Regulations 2012 allow certain products to be sold without pharmacist supervision if they are GSL.
The Human Medicines Regulations 2012 allow certain products to be sold without pharmacist supervision if they are GSL.
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Stimulant laxatives are classified as General Sales Medicines.
Stimulant laxatives are classified as General Sales Medicines.
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The sale of GSL medicines is subject to various legislative restrictions.
The sale of GSL medicines is subject to various legislative restrictions.
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Sildenafil was switched from a Prescription-only medicine to a GSL in 2018.
Sildenafil was switched from a Prescription-only medicine to a GSL in 2018.
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The government supports the declassification of medicines to alleviate costs from the NHS.
The government supports the declassification of medicines to alleviate costs from the NHS.
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Medicines can only be moved from GSL to POM under rare circumstances.
Medicines can only be moved from GSL to POM under rare circumstances.
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Over the counter (OTC) medicines include both GSL and P medications.
Over the counter (OTC) medicines include both GSL and P medications.
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Study Notes
OSPAP Programme: Sale and Supply of Medicines - Part 1 (General Sales Medicines (GSL))
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Learning Outcomes:
- List legal classifications of UK medicines and explain how to find a medicine's classification.
- Explain "P0" medicines and describe their legal sale.
- Understand how medicines are declassified and list advantages/disadvantages from the government, NHS, patient, and pharmacy perspectives.
- Define how a medicine is classified as GSL.
- Explain circumstances for lawful GSL sales (including on planes/trains).
- List medicines that are never GSL.
- Describe changes to OTC stimulant laxative sales.
Classes of Medicinal Products
- Three legal classes: General Sale Medicines (GSL), Pharmacy Medicines (P), and Prescription-only Medicines (POM).
- "PO" medicines are legally classified as GSL.
- Sale restricted to pharmacies by manufacturers.
- "PO" is not a legal classification, distinct from P medicines.
- "Over-the-counter" (OTC) refers to GSL and P medicines available for purchase without prescription.
Medicines Switching Classes
- Medicines can change classifications if reclassified by the MHRA.
- Typical move is POM → P → GSL.
- Restrictions might include pack size, strength, and administration route.
- Widens patient access to medicines.
- Government desires declassification for self-care and cost reduction.
- Recent examples of POM to P switches include sildenafil, fexofenadine, desogestrel, topical vaginal oestrogen, and tadalafil.
- Pharmacy profession may be hesitant toward P to GSL switches.
- Recent switches to GSL are subject to RPS guidance.
Human Medicines Regulations 2012
- Chapter 2 regulates medicinal product dealings.
- The basic principle is that medicines can only be sold or supplied from registered pharmacies, or under pharmacist supervision, unless on a general sales list or exempt.
General Sales Medicines (GSL)
- GSL medicines are defined in HMR 2012 as products for general sale, not POM or P.
- Covered by marketing authorization for general sale.
- Can be sold without pharmacist supervision if reasonably safe for sale.
Retail Sale of GSL Medicines (1)
- GSL sales must occur in registered pharmacies or other locations under specified conditions.
- Premises must be closeable to exclude the public.
- Products must be packaged elsewhere for sale.
- Products cannot be opened before sale.
- Note GSL sales permitted from vending machines if specified conditions met.
- Pharmacy sale requires "responsible pharmacist" present and signed in.
Retail Sale of GSL Medicines (2)
- GSL sales are permitted from aircraft and trains, with specific conditions.
- Sale must be made by the operator or commander.
- Products must be pre-packaged and stored separately from the rest of the aircraft/train to allow closure for public exclusion.
Products that are NOT General Sale
- Vitamins with a daily dose exceeding specified maximums are not GSL.
- Eye ointments, anthelmintics, parenteral administration products, enemas for use entirely for irrigation or for children are also not GSL.
- Preparations like aloxiprin or aspirin intended for children are also not GSL, unless the marketing authorization specifies otherwise.
Changes to the Legal Status of OTC Stimulant Laxatives (1)
- MHRA reviewing safety of OTC stimulant laxatives due to misuse and abuse.
- Senna/sennaosides, bisacodyl, and sodium picosulfate are examples of stimulant laxatives.
- Co-danthramer and co-danthrusate are POM products.
- August 2020, MHRA changed regulations for stimulant laxative packaging and use.
- Smaller packs (short-term, occasional use) are still GSL for adults.
- Larger packs (up to 100 tablets) are now considered P medicines.
Changes to the Legal Status of OTC Stimulant Laxatives (2)
- GSL stimulant laxatives are licensed only for use in patients 18+.
- Stimulant laxatives for ages 12-17 require pharmacist supervision.
- Overuse warnings regarding fluid/electrolyte imbalances and weight loss are common in patient information.
- Recommendations, warnings are also on product packaging.
- Further information is available from the RPS website.
GSL Medicines: True or False?
- (1) False
- (2) False
- (3) False
- (4) False
- (5) True
- (6) True
- (7) True
- (8) False
- (9) False
- (10) True
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