Pharmacy law and ethics 5: Retail Pharmacy Business, Responsible Pharmacist and Supervision

Where are laws regarding retail pharmacy business?

HMR 2012 and Medicines act 1968

Retail pharmacy business

a business which includes the retail sale of medicinal products that are not subject to general sale

Where can sell P and POM medicines?

registered retail pharmacy business registerd by the GPhC as a pharmacy

Retail sale

personal use

Retail supply

Supply against NHS prescription

Who can conduct a retail pharmacy business?

registered pharmacist- cant be locum or employee

> england and wales partnership where all partners are pharmacists

> scotland partnership but only one needs to be pharmacist

> body corporate ie boots which are overseen by superintendent registered pharmacist plus registered pharmacist at each premises

> representative of dead or who has lsot mental capcity pharm

Titles protected under medicines act

chemist, pharmacy, druggist, needs approval for business from GPhC

Premises must be registered by GPhC if they intend to

> Sell P medicines

> Supply P or POMs against a prescription for a specific patient or against a veterinary prescription

Does it cost to have a registered premises?

yes, annual fee

Premises is subject to investigation against standards: 5 principles

- Principle 1 The governance arrangements safeguard the health, safety and wellbeing of patients and the public.

- Principle 2 Staff are empowered and competent to safeguard the health, safety and wellbeing of patients and the public

- Principle 3 The environment and condition of the premises from which pharmacy services are provided, and any associated premises, safeguard the health, safety and wellbeing of patients and the public.

- Principle 4 The way in which pharmacy services, including the management of medicines and medical devices, are delivered safeguards the health, safety and wellbeing of patients and the public.

- Principle 5 The equipment and facilities used in the provision of pharmacy services safeguard the health, safety and wellbeing of patients and the public.

Do inpatient and outpatient pharmacy units have to be registered with GPhC?

no

Do shops that sell GSL medicines need to be registered with GPhC?

no

Are many hospital pharmacies registered?

yes

Why are many hospital pharmacies registered?

> Allows supply of prescriptions from outside the hospital e.g., NHS FP10 prescriptions

> Sell P medicines

> Take advantage of licensing requirements relating to selling, supplying, manufacturing and wholesale dealing of medicines

What must all premises that sell medicinal products, other than GSLs have?

a responsible pharmacist (RP)

How many RPs are in charge at one time?

one

How many pharmacies can a pharmacist be RP for?

one at time

Role of responsible pharmacist:

> Safe and effective running of the pharmacy

> Retail sale of medicinal products (inc. GSLs)

> Supply (i.e., supply against NHS prescriptions)

> Must establish (if not already in place), maintain and keep under review procedures designed to secure the sale and effective running of the business (inc. ordering, storing, preparing, selling and supply, delivery and disposing of meds)

> Display a notice

> Make a record of the RP to show who the RP is at any given date and at any time

What must RP notice contain?

Name of RP at that time

• Their GPhC registration number

• The fact that they are in charge

• If the RP is temporarily absent but remains the RP the notice should remain in place

Format of RP record

written, electronic or both

What must RP record contain?

Accurately reflects who the responsible pharmacist is and was at any given date and time (including any absences)

When should record be done and by who?

current, responsible pharm

How should alterations be done?

needs record of when and by whom it was done

How long should pharmacy owner or superintendent pharmacist keep RP record for?

5 years and must be available at said premises

What must a RP record contain?

• The responsible pharmacist's name

• The responsible pharmacist's registration number

• The date and time at which the pharmacist became the responsible pharmacist

• The date and time at which the responsible pharmacist stopped being the responsible pharmacist

• If you are absent from the premises:

> The date of absence

> The time which the responsible pharmacist left the pharmacy premises

> The time at which the responsible pharmacist returned to the pharmacy premises

How long can the RP be legally absent during pharmacy's business hours?

up to 2 hours

If more than one RP how long can they be absent?

no longer than 2 hours total

RP is only able to be absent if...

pharmacy can continue to run safely and effectively and remain contactable with the pharmacy staff, where this reasonably practical and be able to return with reasonable promptness, if not arrange for another pharmacist to be contactable to provide advice instead

RP in charge and supervising pharmacist physically present

•Professional check of Rx

•Sale/ supply P meds

•Sale/ supply POMs (incl handing out Rxs)

•Supply meds under PGD

•Wholesale of meds

•Emergency Supply

RP in charge, pharmacy under supervision but supervising pharmacist may not be physically present

• Assembly of medications (labelling, taking meds of shelves, counting tablets, accuracy check)

RP in charge but does not require supervision

•Sale of GSLs

•Process waste/ patient returns (not CDs)

RP not in charge

•Ordering stock/ receiving stock (not CDs)/ putting stock away

•Date checking (not CDs)

•Cleaning

•Respond to enquires (trained staff only)

•Access PMR (trained staff only)

•Receive Rx

•Process Rx forms (e.g. counting dispensed items)

•Receipt patient returns (with training (consider CDs)

If there is no RP...

display RPS sign to public and sign to staff

• cannot supplu GSL medicines agasint a prescirbption unless second pharmasit present.

• cannot sell P medicines unless seconmd P present

• cannot hand out pre-bagfed and checked medinces unles SPP.

• cannot sell or suppy medicines incl GSl if RP is absent more than 2 hours unless anotjer RP appitnted