Medicine And Law Part Three Flashcards
Describe the restrictions for sale of P medicines:
- Medicines are avaliable for purchase OTC without a prescription
- Can only be sold through a registered pharmacy
- Can only be sold under the supervision of a pharmacist
- Pharmacist must be present in the pharmacy
- May be restrcited pack sizes or indications for use
Desrcibe the restrictions of GSL medicines
- Can be sold directly to the public from any lockable business premises
- No superivsion is required
- May only be sold in unopened manufacturers packs
- Often the quantity of medicine in the pack or even the number of packs is limited
- All the active ingredients are listed in the general sales list
- Must be licensed (must have a marketing authorisation)
- Strict controls (strength, use, form and route of administration
- Maximum dose or maximum daily dose
- Pack size restrictions
May only be sold from pharmacies and:
- Premises that can be closed to exclude the public. Automatic machines musy be located in such premises
- The container must not have been opened since made up for sale. Origional packaging
GSL sales from pharmacies:
- Do not need to be supervised by pharmacists
- The pharmacy must have a RP on duty
- GSL medicines may be sold in the absense of the RP if sale is made by trained staff during the maximum two hours a day authorised absense
What information needs to be included on GSL products packaging?
- Product name, strength and form
- Statment of active ingredients per dosage unit
- Pharmaceutical form
- Contents - by weight, volume or number of doses
- List excipients which have a recognised effect
- Method and route of administration
- ‘store out of reach and sight of children’
- Special warnings required by the marketing authorisation
- Expiry date (month and year)
- Special storage requirements
- Precautions for disposal of waste
- Name, address of marketing authorisation holder
- MArketing authorisation number
- Manufacturers batch number
- Instructions for use
What are P medicines?
- Any medicinal product that is not GSL or POM
- No specific list exists
- Includes medicines made up in the pharmacy which have no narketing authorisation but contain GSL ingredients
Are there any restrictions of sale for P medicines?
The person making the sale must be:
- Lawfully conducting a retail pharmacy business
- Either a pharmacist or acting under the supervision of a pharmacist
- A RP must be present and the premises must be a registered pharmacy
- Not generally avaliable for self selection, usually kepot being the pharmacy sales counter
- Often specific pack sizes or licensed indications for use
If a medicine has recently been reclassified from POM to P, what should happen?
- Sale should be referred to the pharmacist
- Questions asked to ensure the safe and appropriate use
- May be a specific questionnaire to be completed or records to be maintained as professional practice
How can medicines be misused?
- Using for unlicensed purpose
- Using high doses
- Using for prolonged periods
- Using the prevent illness
- Addiction or prevention of withdrawal symtpoms due to overuse
- Use along with other medicaitons
- Mask symptoms of serious disease
What categoires of patients can supplies be made on the NHS for P or GSL medicines which may be free of charge?
- Must be made on prescription
- Other contractual arrangment with the NHS (e.g. minor ailment schemes) to allow for payment to be claimed and must be supervised by the pharmacist
What legislation governs pharmacy and the sale and supply of medicines?
The medicines act 1968
The human medicines regulations 2012
What are P medicines?
Medicines that can be purchased over the counter without a prescriptions
Can only be sold through a registered pharmacy
Can only be sold under the supervision of a pharmacist
Pharmacist has to be present in the pharmacy
May be restricted pack size or indications for use
What are GSL medicines?
Can be sold directly to the public from any lockable business premises
No supervision is required
May only be sold in an unopened manufacturers stack
Often the quantity of medicine in the pack or even the number of packs that can be sold is limited
All the active ingredients are listed in the general sales list
Must be licensed - have marketing authorisation
Strict controls on strength, use, form and route of administration
Maximum dose or maximum daily dose
Pack size restrictions
May only be sold from pharmacies and:
Premises that can be closed to exclude the public. Automatic machines must be located in such premesis
The container must not have been opened since made up for sale so must be in original packaging
Are there any restrictions on GSL medicines sold in pharmacies?
Pharmacist does not need to supervise GSL sales
The pharmacy must have a responsible pharmacist present
GSL medicines may only continue to be sold in the absence of the responsible pharmacist if the sale is made by a trained member of staff during the maximum two hours a day authorised absence.
This restriction does not apply to a non-pharmacy
What information has to be include on GSL medicine packaging?
Product name, strength and form
Statement of active ingredients per dosage unit
Pharmaceutical form
Contents (by weight, volume or number of doses)
List excipients which have a recognise effect
Method and route of administration
‘Store out of sight and reach of children’
Special warnings required by the marketing authorisation
Expiry date (month and year)
Special storage requirements
Precautions for disposal of waste
Name, address of marketing authorisation holder
Marketing authorisation number
Manufacturers batch number
Instructions for use
