Retail Pharmacy Business, Responsible Pharmacist ad Supervision

What are the relvent laws for Retail Pharmacy Business?

Medicines Act 1968 and Human Medicines Act 2012

What is the definition of a retail pharmacy business?

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

Where are mail orders of pharmaceuticals available from?

the UK only

What are the conditions legally required to sell or supply Ps and POMs?

• the person making the supply is lawfully conducting a retail pharmacy business

• sale of supply from a premises registered by the GPhC as a pharmacy

What is retail sale?

where a medicine is sold or supplied to a person for personal use

What is retail supply?

when a sale or supply is made against a NHS prescription

What titles are protected under the medicines act?

chemist, dispensing chemist, dispensing druggist, druggist, pharmaceutical chemist, pharmaceutical druggist, pharmaceutist, pharmacist and pharmacy

Who can lawfully conduct a pharmacy business?

• not an employee or locum

• a registered pharmacist

• in England and Wales a partnership where both partners are pharmacists

• in Scotland a partnership where one of the partners is a pharmacist

• a body corporate, where the business of keeping/preparing medicines is under the management of a superintendent pharmacist with a responsible pharmacist at each premises

• representatives of a deceased pharmacist, pharmacist that has lost mental capacity or judged bankrupt or enters into a composition or scheme or deed of arrangement with the pharmacists creditors

What happens if a company tries to use one of these titles without approval from the GPhC?

the company registrar will decline the company

What are the requirements of registered premises?

• GPhC approved providing it meets the standard for registered pharmacies

• pay an annual fee

• be subject to inspections against the standards which are under 5 principles

The premises must be registered if it intends to….

• sell P medicines

• supply P or POMs against a prescription for a specific patent or against a veterinary prescription

What is principle 1?

the governance arrangements safeguard the health, safety and wellbeing of patients and the public

What is principle 2?

staff are empowered and competent to safeguard the health, safety and wellbeing of patients and the public

What is principle 3?

the environment and condition of the premises from which the pharmacy services are provides, and any associated premises, safeguard the health, safety and wellbeing of patients and the public

What is principle 4?

the way in which pharmacy services, including the management of medicines ad medical devices, are delivered safeguards the health, safety and wellbeing of patients and the public

What is principle 5?

the equipment and facilities used in the provision of pharmacy services safeguard the health, safety and wellbeing of patients and the public

What pharmacies are except from being registered with the GPhC?

• inpatient and outpatient pharmacy units in hospitals that supply medicines in the course of the business of that hospital

• pharmacies with a service model that consists solely on GSL medicines sale

Why are some hospital pharmacies registered?

• it allows the supply of prescriptions from outside the hospital

• sell P medicines

• take advantage of licensing requirements relating to selling, suppling, manufacturing

What does RP stand for?

responsible pharmacist

What are the rules around RPs and pharmacies?

• all premises that sell medicinal products, other than GSLs, must have an RP to lawfully run the retail pharmacy business

• only one RP is in charge at any one time and they can only be in charge of one premises

What are the roles of a RP?

• safe and effective running of the pharmacy

• retail sale of medicinal products

• supply

• must establish, maintain and keep under review procedures designed to secure the sale and effective running of the business

What are the requirements of an RP to do with the identity of the RP?

• they must be a registered pharmacist

• they must display a notice

• a record must be made of the RP to show who they are at any given date and time

What must an RP notice include?

• name of RP at the time

• the RP’s GPhC registration number

• the fact they are in charge

What are the rules around the absence or change of the RP?

• if the RP is temporarily absent but is still the RP the notice should remain in place

• the notice should be changed as the RP changes

What is a RP record?

a written and/or electronic accurate record of who the responsible pharmacist is and was at any given date and time including absences

Who completes the RP Record? and when?

the responsible pharmacist, should be kept current

Can you do a remote entry into the RP record?

yes, as long as it complies with all of the requirements of and in-person entry

What do you need to do if adding any alterations or amendments to the RP record?

needs to identify when and by whom the alteration or amendment was made

How long must the RP record be kept for and by whom?

5 years, by the pharmacy owner or superintendent pharmacist

What are the specific rules around RP electronic records?

appropriate measures should be made to back up the record and be kept on the pharmacy premises, available for GPhC inspection

True or False the RP record must be available at the premises which it relates to?

True

What needs to be recorded in the RP Record?

• name of RP

• registration number of RP

• date and time when pharmacist became and stopped being the RP

• if absent: date and time RP left and returned from premises

What are the time constraints on RP absence?

the total period of absence of RP(s) between midnight and midnight during the Pharmacy opening hours must not exceed 2 hours

What are the legal requirements if a RP is absent?

• RP can only be absent if pharmacy can still run safely and effectively

• RP must remain contactable with the pharmacy staff (where practical) and is able to return with reasonable promptness

• if RP can’t do above, they must arrange for another pharmacist to be contactable and available to provide advice

What level of RP supervision does the wholesale of meds require?

RP in charge and supervising, pharmacist physically present

What level of RP supervision does emergency supply require?

RP in charge and supervising, pharmacist physically present

What level of RP supervision does suppling meds under PGD require?

RP in charge and supervising, pharmacist physically present

What level of RP supervision does sale/supply of POMs require?

RP in charge and supervising, pharmacist physically present

What level of RP supervision does sale/supply of P meds require?

RP in charge and supervising, pharmacist physically present

What level of RP supervision does a professional check of Rx require?

RP in charge and supervising, pharmacist physically present

What level of RP supervision does assembly of medications require?

RP in charge, pharmacy under supervision but pharmacist does not have to be present

What level of RP supervision does process waste require?

RP in charge but no requirement of supervision, no CDs

What level of RP supervision does patient returns require?

RP in charge but no requirement of supervision, no CDs

What level of RP supervision does the sale of GSLs require?

RP in charge but no requirement of supervision

What level of RP supervision does putting stock away require?

RP not in charge

What level of RP supervision does receiving stock require?

RP not in charge, no CDs

What level of RP supervision does ordering stock require?

RP not in charge, no CDs

What level of RP supervision does date checking require?

RP not in charge, no CDs

What level of RP supervision does cleaning require?

RP not in charge

What level of RP supervision does responding to enquiries require?

RP not in charge, trained staff

What level of RP supervision does accessing PMR require?

RP not in charge, trained staff

What level of RP supervision does receiving Rx require?

RP not in charge

What level of RP supervision does processing Rx forms require?

RP not in charge

What level of RP supervision does receipt patients returns require?

RP not in charge, trained staff

What needs to be done if there is no RP?

a notice should be left that helps to explain to the public what can and can’t legally be done in the absence of a pharmacists