2) Regulations and Classifications of Medicines Flashcards
How are sales and supplies of human medicines regulated?
Under three classifications under the Human Medicines Regulations Act 2012
What does the Human Medicines Regulations Act 2012 allow pharmacists to do?
Allows pharmacists to refuse to sell or supply any medicines according to their own professional judgement, providing they have good reason
How many regulations are put in place for veterinary medicinal products?
several classes
What are the three classifications?
- General Sales List (GSL)
- Pharmacy Only Medicines (P)
- Prescription Only Medicines (POM)
Where are GSL meds available as and where from?
• Available as ‘self-selection’ from: – Registered pharmacies • Only when a ‘Responsible Pharmacist’ is in place. – Other retail outlets that can be ‘closed to exclude the public’, such as supermarkets, petrol stations, vending machines
Is a pharmacist required for the sale and supply of GSLs?
no
Can you purchase GSLs from a registered pharmacy?
Yes BUT only when a responsible pharmacist is in place
What are GSLs like as drugs?
Have well established safety profile and is at the lowest risk category
Where can P medicines be sold?
From a registered pharmacy premises by a pharmacist or a person acting under the
supervision of a pharmacist.
Are P medicines accessible to the public by self-selection.?
They must not be, no
What are GSL & P medicines collectively known as?
Over-the-counter (OTC) or non-
prescription medicines.
What is needed before you have access to a P medicine?
Have to interact with a pharmacy professional before you have access to them
What are POM medicines?
Medicines that are generally subject to the restriction of requiring a prescription written by an appropriate practitioner.
– Doctors, Dentists, Pharmacists, Nurses, Dieticians etc.
– Check MEP for full list of appropriate practitioners.
What do POMs require?
- Require a legal prescription for a medicine for a specific person and purpose.
• Require supervision for safe use
• Responsible pharmacist must be on the premises
Why do POMs require supervision for safe use?
– Monitoring required
– Prone to misuse
– New product (so not enough evidence around its safety)
– Parenteral use
Examples of reclassifications?
• Medicines reclassified from POM to P, P downgraded to a GSL
- Equally, medicines ca be upgraded
What does degrading a medicine allow?
Provides pharmacists with a larger range of medicines to select from to treat patients with without having to refer the patient to an alternative practitioner for a prescription
How are restrictions places for reclassified medicines?
Undergo a reviewing process and may be restrictions related to:
– Maximum strength
– Route of administration
– Purpose of use or use in a specified group
of people
– Particular pharmaceutical form
– Maximum quantity that can be sold or supplied
What are these reclassifications based on?
- Evaluation of evidence focusing on the risk to the public
- These risks will be managed through restrictions such as maximum strength etc
Classification of paracetamol and aspirin?
Can be GSL, P or POM depending on the way the product is packaged and how many is being provided within the pack or its dosage form eg tablet or effervescent?
Paracetamol, non-effervescent tablets?
16 = GSL
32 = P
100 (96) = POM
Paracetamol effervescent tablets?
No legal limits on quantity of OTC effervescent tablets, powders, granules or liquids that can be sold to a person at any one time.
Use professional judgement to decide the appropriate quantity to supply.
Why are these restrictions put in order for paracetamol?
- People can misuse paracetamol and overdose on it
- Severe implications bc difficult to correct an OD and can have lasting effects on the liver
Aspirin non-effervescent tablets?
16 GSL
32 P
100 (96) POM
Aspirin effervescent tablets?
No legal limits on quantity of OTC effervescent tablets, powders, granules or liquids that can be sold to a person at any one time. Use professional judgement to decide the appropriate quantity to supply.
Ibuprofen?
200mg + 16 tablets = GSL 200mg + 24 tablets = p 400mg + All = P 600mg + All = POM 800mg + All = POM
What is needed from pharmacists in the case of misuse?
• Appropriate supervision by a pharmacist or trained pharmacy staff should identify and handle potential cases of misuse
CHECK THIS eg not suffering from symptoms but asking for medications
Possible signs of misuse (MEP), symptoms that sounds rehearsed or formulaic, patients that sound impatient so they don’t raise red flags, people that come at busy times so the workers are distracted, people that come in bc of smth but still ask for a specific drug for it and nothing else
why are there licensing restrictions for codeine and dihydrocodeine?
Are addictive so only used for short term treatment of acute, moderate pain not relieved by paracetamol, ibuprofen or aspirin, therefore indications such as cold, flu,
cough, sore throat are removed.
Pack size of codeine and dihydrocodeine?
Can sell no more than 32 units (including effervescent formulations). more than that is a POM
Labelling/ Patient Information Leaflet requirements for codeine and dihydrocodeine?
– ‘Can cause addition. For three days use only’
– PIL and packaging must state indication and that
can cause addiction or headache if used for more
than three days.
– Advised to only sell one pack of codeine or
dihydrocodeine containing products
Pseudoephedrine & Ephedrine?
- Widely used decongestant pharmacy medicines.
* Potential for misuse in the illicit production of methylamphetamine (crystal meth) – a class A Controlled Drug
Pseudoephedrine & Ephedrine? max supply?
Max supply a product or combination of products that contain more than 720mg of pseudoephedrine OR 180mg of ephedrine at any one time, without a prescription
Is training necessary for pseudoephedrine?
Yes. They need to know how to deal with recognising potential misuse
• It is unlawful to sell or supply any pseudoephedrine product at the same time as an ephedrine product without a prescription
• Sales or supplies of pseudoephedrine or ephedrine should either be made personally by the pharmacist or by pharmacy staff who have been trained and are competent to deal with pseudoephedrine and ephedrine issues, and who know when it is necessary to refer to the pharmacist
