Medicines Law 2
- Created by: amazingemilyjones
- Created on: 07-04-19 13:20
Legal Categories
Some medicines fall into more than one legal category, depending on:
- Quantity
- Formulation
- Strength
- Indication (what it is being used for)
- Marketing authorisation
Quantity - Specific Products
- Paracetamol (500mg) or aspirin (<325mg) tablets & capsules:
GSL P POM
Maximum pack size 16 32 N/A
Maximum no. 100 100 N/A
- Enteric coated aspirin 75mg tablets: pack size up to 28 GSL, maximum 100 tablets
- Does not apply to granules, powders, effervescent tablets and liquids
Quantity - Specific Products
Ibuprofen
- Medicines and Healthcare Products Regulatory Agency (MHRA) will only permit a maximum of 16 tablets or capsules (200mg only) to be sold as General Sales List (GSL)
Pseudoephedrine and Ephedrine
- <720mg pseudoephedrine or <180mg ephedrine total in a pack as a pharmacy (P) medicine
- Cannot be sold together
- Liable to misuse (making of crystal meth)
Quantity - Specific Products
Codeine and Dihydrocodeine
- Maximum pack size 32 (including effervescent)
- Not less than pharmacy (P) medicine
Checking the Classification
- BNF (British National Formulary) - good for checking if POM or not, not good for separating GSL/P
- EMC (Electronic Medicines Compendium) website
- MEP (Medicine, Ethics and Practice) website
- Product pack
Reclassification of Medicines
A medicines category can change to make it:
A. less restricted, e.g.:
- ranitidine POM --> P --> GSL
- chloramphenicol eye drops POM --> P
- domperidone POM --> P (2010)
- diclofenac POM --> P --> GSL
Reclassification of Medicines
B. more restricted, e.g.:
- domperidone P --> POM (2014)
- diclofenac GSL --> POM (2014)
- children's cough & cold medicines GSL --> P
A change in category is often associated with limitations on pack size/dose/indication.
Medical Devices
An instrument, apparatus, appliance, material or other article which-
a) is intended to be used for human beings for the purpose of:
- diagnosis, prevention, monitoring, treatment or alleviation of disease or injury
- investigation, replacement or modification of the body, or
- control of conception; and
b) does not achieve its main action by pharmacological, immunological or metabolic means (even if those means help)
Medical Devices
- Includes devices intended to administer a medicine
- Medical devices without a CE mark cannot be marketed in Europe
- The CE mark shows that the device meets the regulatory requirements, i.e. it is safe and works properly
Herbal Products
- If marketed as food/cosmetic - does not have to comply with medicines law, so no medicinal claims allowed
- If marketed as medicinal product - must comply with law, including having a Marketing Authorisation
- If marketed as traditional herbal medicine - must comply with law, but does not have a Marketing Authorisation so cannot make claims about efficacy (no clinical trials carried out) e.g. St. John's work, echinacea. These will have a THR number (Traditional Herbal Registration)
Some herbal products have been banned in UK, e.g.:
- Aristolochia (Mu Tong)
- Kava Kava
Homeopathic Products
- Not the same as herbal products
- Contain no active ingredient
- Homeopaths believe that 'like cures like' and that repeated dilution of the compound believed to cause the symptoms, to a point where there is no substance left, will treat the patient. They think the more dilute the product, the stronger it is.
- To register a homeopathic medicine, it is necessary to prove only safety and quality, not efficacy
Homeopathic Products
'The Royal Pharmaceutical Society (RPS) does not endorse homeopathy as a form of treatment because there is no scientific basis for homeopathy nor any evidence to support the clinical efficacy or homeopathic products beyond a placebo effect.'
The Responsible Pharmacist
- Every pharmacy must have a 'Responsible Pharmacist' who is legally responsible for the safe and effective running of that pharmacy.
- The owner of the pharmacy must appoint the Responsible Pharmacist
The Responsible Pharmacist's Responsibilities
- Check procedures are in place that support the safe and effective running of the pharmacy
- Complete the pharmacy record to show who was the Responsible Pharmacist at any given time
- Display a notice with their name and registration number, and stating that they are in charge of the pharmacy
- There can only be one Responsible Pharmacist at any given time
- A pharmacist can only be responsible for one pharmacy at a time
The Pharmacy Record
- Must be kept for 5 years after last entry (if paper) or indefinitely (if electronic)
- Required information: date, full name, GPhC number, sign in time, sign out time, time of leaving/returning (if applicable)
- Good practice to include: total time absent, reason for absence
Responsible Pharmacist Absence
- It is legally acceptable for a pharmacy to operate (in a limited capacity) while the Responsible Pharmacist is not physically on the premises, providing:
- they remain contactable (if this is impossible, they must arrange for another pharmacist to be available to give advice)
- the pharmacy can continue to run safely and effectively (e.g. there are adequate Standard Operating Procedures (SOPs) in place)
- they are able to return with reasonable promptness if necessary
- The Responsible Pharmacist can be absent for a total maximum of 2 hours in a 24 hour period
Responsible Pharmacist Absence
- The Responsible Pharmacist remains responsible for the activities undertaken when he or she is absent.
- With the prior permission of the absent Responsible Pharmacist, staff may sell GSL medicines and take prescriptions in from patients.
- Staff may also assemble medicines if competent and capable - Standard Operating Procedures (SOPs) must be in place.
- Staff cannot sell P medicines or hand out pre-bagged or checked prescriptions unless a second pharmacist is there. This includes prescriptions for GSL medicines.
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