B1 Regulation of pharmacies Flashcards
(47 cards)
in terms of pharmacy, what does retail mean?
- selling to the public
- supplying on NHS prescription is not a sale, but covered by the same law
- selling or supplying to another pharmacy is not retailing but wholesaling
what is regulated within the pharmacy profession?
- people
- premises
- products
- businesses
- online services
how are people regulated in the pharmacy profession? how?
- GPhC
- through registration
how are premises regulated in the pharmacy profession? how?
- GPhC
- through registration and inspection
how are products regulated in the pharmacy profession? how?
- MHRA
- marketing authorisations
how are businesses regulated in the pharmacy profession?
GPhC
how are online services regulated in the pharmacy profession? how?
- GPhC and Care Quality Commission
- through inspection, reports and MHRA advertising
state 3 legislations (laws) made by the parliament relevant to pharmacy
- Medicines Act 1968
- Human Medicines Regulations 2012
- Misuse of Drugs Act 1971
in various legislations, it is stated that the sale of any medicines not on the GSL is prohibited. state what is meant by prohibited and state the exception to this
- ‘prohibited’ means that sales or supplies are criminal offences
- prohibitions often start with ‘no person shall’ then there are exceptions underneath
- exception: a person who is ‘lawfully conducting a retail pharmacy business’
describe premises in pharmacy and their legal requirements. what kinds of premises does this include?
- registered with GPhC
- premises inspected and reports published
- includes online, remote, distance selling pharmacies
what happens in the case of a breach of GPhC standards being found upon premises inspection?
power to impose conditions of registration
what are restricted titles? state some in pharmacy
- you can only call yourself these titles if you have been through the protocol and studying of becoming registered to have this title
eg.
pharmacy
chemist
pharmacist
pharmacist independent prescriber
pharmacy technician
who is ultimately responsible for issues in a pharmacy?
the owner
what is the owner of a pharmacy classified as?
- the person who conducts the business
- employees, locums and managers are not the owners (unless the manager is also the owner)
what are the requirements for an owner of a pharmacy?
owner must be:
- a body corporate (usually a limited company registered at Companies House) OR
- a registered pharmacist OR
- a partnership of registered pharmacists (England or Wales) OR
- a partnership in which at least one partner is a registered pharmacist (Scotland)
other than the requirements for being an owner of a pharmacy, what else must be met?
conditions
describe Condition 1 for Responsible Pharmacist
- only responsible for one set of premises at one time
- must be at the premises
- signed in and notice displayed at premises
- permitted absence up to 2 hours in a day
Responsible Pharmacists are permitted to be absent from their premises for up to 2 hours a day. describe what sales can occur during this time
- GSL medicines can be sold in their absence
- other medicines being sold is currently a grey area that will be clarified in the future but generally it would not be allowed
what is the legal duty of the RP?
to secure the safe and effective sale and supply of ALL medicines:
- at or from the particular premises
- only while they are on duty and
- only when the premises are open for sale or supply of medicines or
- being assembled or dispensed
how will the law change for RPs?
GPhC will make rules about:
- whether and for how long the RP can be absent
- whether and when the RP can be RP at more than one set of premises at the same time
describe Condition 2 for Superintendent pharmacists
- every company must have a superintendent pharmacist
the SP must:
- sign notification of appointment sent to GPhC
- be a senior manager of the retail pharmacy business
- have the authority to make decisions that affect the running of the retail pharmacy business so fas as concerns retail sale or supply of all medicines (I.e. including general sale medicines)
what is the legal duty of the SP?
to secure that at all times, the business is carried on in ways that ensure its safe and effective running … so far as concerns the retail sale or supply of all medicinal products including GSL medicines
simply describe the duties of a SP
- senior manager of the business
- decision-making authority
- more than one company
- safe and effective running of the business, so far as concerns sale or supply of all medicines
- notification to GPhC
- 24/7
simply describe the duties of a RP
- acts at direction of SP
- the business at the pharmacy
- one pharmacy
- safe and effective running of the business at the premises, so far as concerns sale or supply of all medicines
- notice displaying name at premises
- only when signed in as RP
