Legislation Lecture 5:Pharmacies and Pharmacists Flashcards
Legislation
- Pharmacies
Medicines Act 1968 + Pharmacy order 2010 (Register)
Pharmacists &
2.Pharmacy Technicians
Health Act 1999, SI 2007 no 289
3..Supervision, personal control & responsible pharmacist
-Medicines (Pharmacies) (Responsible Pharmacist) Regulations 2008
-Health Act 2006, SI 2008 no 2789
-HMR 2012 – Clause 220 (amended 2020 due to Brexit
The General Pharmaceutical Council (GPhC) is responsible for
Register of Pharmacists, Pharmacy Technicians and Pharmacy premises
Disciplinary control of Pharmaceutical profession
Sale & Supply of MPs (except GSL)
A Retail Pharmacy Business (RPB)
means a business (other than a professional practice carried on by a doctor or dentist) which consists of or includes the retail sale of medicinal products that are not subject to general sale
Who can legally operate a retail pharmacy business?
Persons Lawfully Conducting a Retail Pharmacy Business (PLCRPB)
A retail pharmacy business may, subject to certain conditions, be lawfully conducted by:
Pharmacist or Partnership where all partners are pharmacists (Scotland – one partner is pharmacist)
Body Corporate (must have superintendent)
Pharmacist’s representative when the pharmacist
Dies (5 years)
Becomes bankrupt (3 years)
Is mentally ill (3 years)
The person lawfully conducting a retail pharmacy business is the owner of the pharmacy
Certain Conditions’All Pharmacies
In all cases, at each set of premises
(a)The business concerning the retail sale of MPs must have a Responsible Pharmacist
(b) A notice stating the name and registration number of the Responsible Pharmacist must be conspicuously displayed
A Body Corporate must employ a Superintendent Pharmacist who
Is responsible for the management of the business so far as it concerns the keeping, preparing, dispensing & supplying of MPs
Can not be superintendent to more than 1 company at a time.
must notify GPhC as to whether or not is a member of the Board
The term ‘chemist’ can only be used if the superintendent is a member of the Board
A Body Corporate can be
Single pharmacy - owner / proprietor
Small multiple – manager of one branch with other branches managed by other pharmacists
Large multiple – at ‘head office’ with each branch having a manager
Each pharmacy must also have a Responsible Pharmacist
Pharmacy Order 2010
-Establishes the GPhC
-Regulates pharmacists and pharmacy technicians in Great Britain
-Regulation of pharmacies.
-Registration renewed annually
-Fees paid
The Register
Part 1 – Pharmacists other than visiting practitioners
Part 2 – Pharmacy technicians other than visiting practitioners
Part 3 – Premises
Part 4 - Pharmacists who are visiting practitioners.
Part 5 – Pharmacy technicians who are visiting practitioners
GPhC : Standards for registered pharmacies
The purpose of these standards is to create and maintain the right environment, both organisational and physical, for the safe and effective practice of pharmacy. The standards apply to all pharmacies registered with the General Pharmaceutical Council
GPhC : Standards for registered pharmacies Jun 2018- principles
Principle 1: The governance arrangements
Principle 2: Staff are empowered and competent
Principle 3: The pharmacy premises
Principle 4: The way in which pharmacy delivers services, including management of pharmacy devices and medicines
Principle 5: The equipment and facilities
Responsible PharmacistHealth Act 2006
The Responsible Pharmacist (RP) must:
Secure the safe and effective running of the pharmacy, including during periods of absence.
Display a notice with name and registration number and that they are charge of the pharmacy at that time
Complete the pharmacy record to identify who is the RP at that time
Establish, maintain and keep under review pharmacy procedures that set out how activities are to be carried out in the pharmacy for safe working
Responsible PharmacistRecords
Record must include
Name and registration number of RP
Date and time that they became RP
Date and time that they ceased to be RP
Date and time any absence began and ceased
Pharmacy owner must ensure that the record of the RP is properly maintained and preserved for no less than 5 years
Responsible PharmacistHealth Act 2006- duties
Duties
The responsible pharmacist ensures the safe & effective running of the pharmacy as far as it concerns the retail sale or supply of all medicinal products
& must be satisfied that tasks are delegated to competent staff working within Standard Operating Procedures (SOPs).
Responsible PharmacistAbsence
The responsible pharmacist can be absent for 2h in every 24h & may delegate, for example,
receiving Rx
assembling medicines on Rx
selling GSL medicines (but not P meds)
to trained staff during the absence
RP who is absent must:
Only be absent if the pharmacy can continue to run safely and effectively
Remain contactable
Be able to return with reasonable promptness and do so if they feel it is necessary
Responsible PharmacistIn their absence: staff
Can
Sell GSL medicines over the counter
Take in prescriptions.
Put dispensary stock away
Cannot –
Supply a GSL medicine against a prescription
Sell P medicines
Hand out pre bagged and checked medicines to patients or delivery drivers
GPhC – Committees
The Investigating committee
Fitness to Practice Committee
Appeals to the high court.
