Medicine Regulation - Political And Legal Frameworks II

Question 1

Regulation of the pharmacy profession

Answer 1

The General Pharmaceutical Council (GPhC) was created by the Pharmacy Order 2010.

The creation of the GPhC resulted in the separation of the regulatory and professional leadership roles.

The Professional Standards Authority for Health and Social Care (PSA), oversees the work of the GPhC

Question 2

What is the structure of the GPHC?

Answer 2

The GPhC has a chair and 13 other members of the Council appointed by the Public Appointments Commission.

Seven members are registrants and seven are lay members.

Question 3

What does the GPhC ensure?

Answer 3

Ensure a balance of qualities, skills and experience, and to reflect the diversity of the public and of the pharmacy profession

Question 4

GB and UK - GPhC

Answer 4

> The GPhC has regulatory powers in England, Scotland and Wales.

> The Pharmaceutical Society of Northern Ireland is the pharmacy regulator for Northern Ireland,

> The two organisations work collaboratively via a Memorandum of Understanding.

Question 5

What are the function of the GPhC?

Answer 5

1) Establish and maintain a register of pharmacists, pharmacy technicians and premises at which a retail Pharmacy business is, or is to be, carried on

2) To set and promote standards for the safe and effective practice of pharmacy at registered pharmacies

3) To set requirements by reference to which registrants must demonstrate that their fitness to practise is not impaired

4) To promote the safe and effective practice of pharmacy by registrants (including, for example, by reference to any code of conduct for, and ethics relating to, pharmacy)

5) To set standards and requirements in respect of the education, training, acquisition of experience and CPD that it is necessary for pharmacists and pharmacy technicians to achieve in order to be entered in the Register or to receive an annotation in the Register and to maintain competence

6) To ensure the continued fitness to practise of registrants

Question 6

List the simplified functions of the GPhC?

Answer 6

1) Register
2) Standards for pharmacies
3) Fitness to practise
4) Standards for pharmacists
5) Education/training
6) Ongoing

Question 7

Education and training of pharmacists

Answer 7

Standards for the initial education and training of pharmacists.

PART 1 - comprises learning outcomes

PART 2 - comprises standards fro anyone providing initial education and training

PRE-REGISTRATION / FOUNDATION
GPhC set out conditions for the period of training to be undertaken prior to registration.
Successful completion of a registration assessment

Question 8

Requirement for Registration:

Answer 8

“a person practises as a pharmacist or a pharmacy technician if, while acting in the capacity of or purporting to be a pharmacist or a pharmacy technician, that person undertakes any work or gives any advice in relation to the preparation, assembly, dispensing, sale, supply or use of medicines, the science of medicines, the practice of pharmacy or the provision of healthcare”.

Question 9

The Register
in parts:

Answer 9

Part 1 relating to pharmacists
Part 2 relating to pharmacy technicians
Part 3 relating to premises

Question 10

Other conditions for registration:

Answer 10

• Not impaired by reason of physical or mental health
• Good character
• Knowledge of English for safe and effective practice
  E.g. IELTS 7

Question 11

Pharmacy Staff - who is the GPhC responsible for?

Answer 11

The GPhC responsible for registration as a pharmacy technician

The GPhC does not register pharmacy support staff such as dispensing assistants and medicine counter assistants (but it does accredit courses for them.)

Question 12

Revalidation and continuing professional development

Answer 12

Keep professional skills and knowledge up to date

Reflect on how to improve

Show how you provide safe and effective care

Question 13

Revalidation - what are pharmacists required each year and SUBMIT?

Answer 13

Four CPD entries, at least two of which must be planned learning activities

One peer discussion

One reflective account

Question 14

Conducting a Retail Pharmacy Business
The Medicines Act 1968

Answer 14

a registered pharmacist

a partnership in which all the partners are pharmacists

a business (usually a limited company)

the representatives of a deceased pharmacist, a pharmacist who has lost mental capacity or who is adjudged bankrupt or enters into a composition or scheme or deed of arrangement with the pharmacist’s creditors

Question 15

What is the role of a Superintendent pharmacists?

Answer 15

if an offence was committed by a business, there was a person who could be held to account in a court of law

Question 16

The Medicines Act 1968 - superintendent pharmacists:

Answer 16

1) Must be a pharmacist
2) Cannot be the superintendent pharmacist of
more than one business at the same time
3) Keeping, preparing and dispensing of
medicinal product other than those on a
General Sale List

Question 17

Registered pharmacy premises

Answer 17

Certain activities by pharmacists can only be conducted from registered pharmacy premises.
E.g. sale of Pharmacy medicines and the sale or supply of Prescription Only Medicines

Question 18

Why is it a duty for the GPhC to keep register of all Pharmacy premises? Think of an exmaple…

Answer 18

A supermarket might have an area which is a registered pharmacy and a separate area (which is not a pharmacy) where GSL medicines are sold.

Question 19

List the 5 standards for pharmacies:

Answer 19

1. The pharmacy must be managed safely and effectively
2. The staff working in the pharmacy must be competent and empowered to do their roles
3. The pharmacy premises must be appropriate to provide pharmacy services
4. The pharmacy must supply medicines and provide other services safely and effectively
5. The pharmacy’s equipment and facilities must be safe and effective

Question 20

Inspections - What power do the GPhC have?(1/2)

Answer 20

GPhC may conduct routine inspections of registered pharmacies
Inspectors have the power to enter any registered pharmacy or any other premises at a reasonable hour
to enforce the GPhC’s standards or to assist the GPhC in investigations

Question 21

What happens if anyone intentionally obstructs an inspector of the GPhC when trying to inspect a pharmacy?

Answer 21

OFFENCE - CAN BE PROSECUTED

Any person who intentionally obstructs an inspector in exercising their powers, who fails to give assistance that is reasonably required, who provides false information or who fails to provide a document or record when required by an inspector is guilty of an offence.

Question 22

Inspections - can a inspector take/seize docs etc. during investigation? (2/2)

Answer 22

Where an inspector seizes a substance, article, document or other thing, they must inform the person
There may be occasions when an inspector operates undercover

Question 23

Inspection reports - examples

Answer 23

“excellent practice”
“good practice”
“standards met”
“standards not all met”

Question 24

What action must be taken by the GPhC if “the standards are not met” after investigation?

Answer 24

An improvement notice must set out the grounds of the inspector’s belief that there is a failure, specify the measures that must be taken to rectify the failure and specify the period within which those measures must be taken

Question 25

Restricted titles - Medicines Act 1968
e.g. ‘Chemist VAPE SHOP’

Answer 25

Registered pharmacy:
Chemist
Chemist and druggist
Druggist
Dispensing chemist
Dispensing druggist
Pharmacy

Registered pharmacist:
Pharmaceutical Chemist
Pharmaceutist
Pharmacist (or Fferyllydd)