Responsible Pharmacist Regulations 2023

Responsible Pharmacist (RP) Regulations 2008

• The RP regulations cover legal, contractual, and ethical requirements for pharmacists
• This knowledge is linked to other pharmacy legislation
• Pharmacists use the regulations in their daily practices impacting how they work
• The role of the RP is relevant to situations where a pharmacist isn't the pharmacy owner or the pharmacy isn't registered with the GPhC

Important Changes (2023-2024)

• The RP regulations have been amended transferring power from the responsibility of the pharmacist owner to the General Pharmaceutical Council (GPhC)
• The GPhC will create rules regarding RP roles and responsibilities
• The given information is current until the GPhC releases their updated rules; updates will be made as more information becomes available

Overview of RP Role

• A pharmacist is responsible for the safe and effective running of the pharmacy
• At any given time there can only be one designated responsible pharmacist for any pharmacy
• The RP can only be responsible for one pharmacy at a time
• To fulfil responsibilities the pharmacist must ensure professional competence

What the Regulations Cover

• The RP is responsible for pharmacy records
• This includes maintaining pharmacy procedures
• The information must be preserved if any absence arises from the responsible pharmacist
• It is important to note procedures for maintaining pharmacy records during pharmacist absences

Responsible Pharmacist Notice

• The notice must be legally displayed; minimum information is legally required
• The notice allows patients and the public to identify who's in charge of the pharmacy
• Examples of what is included are the responsible pharmacist's name and registration number

Record Keeping

• Keeping a record of the pharmacist on duty is legally required
• This record is useful in case of incidents to complete needed audits
• The record keeping can be kept in a written or electronic format
• It must be completed by the responsible pharmacist
• Any amendment must be clear detailing the corrections and changes
• Records must be kept for 5 years and available for inspection

Pharmacy Procedures

• Pharmacists are responsible for the safe and effective running of the pharmacy
• They must establish, maintain, and review pharmacy procedures, making sure these are available for inspections
• Reviewing procedures regularly, especially after incidents, is essential
• Secure record-keeping is crucial to create a complete audit trail

Procedures: Considerations

• The RP is responsible for ensuring safe and effective medicinal product handling
• This includes ordering, storing, preparing, selling items in retail circumstances including outside the pharmacy, as well as disposing of out-of-date items or items that are returned
• The responsible pharmacist must manage the pharmacy during the absence of another pharmacist
• This includes how to handle complaints or incidents, staff changes and knowing how to handle patient advice

Absence from the Pharmacy

• An RP is limited to 2 hours away from the pharmacy during business hours
• If there are multiple responsible pharmacists, only one absence is permitted
• The pharmacist must remain contactable or have another pharmacist able to take responsibility

What Happens When the RP is Absent

• The pharmacy remains open
• GSL (General Sale List) medicines can be sold normally
• Pharmacy procedures that don't require direct supervision can continue
• Prescription (P) medicines cannot be sold during absence

Contractual Issues

• NHS terms of service mandates a pharmacist's presence in the pharmacy during contractual hours
• Any changes to contractual hours must be notified in advance
• Any pharmacist leaving during contractual hours could potentially put the pharmacy in breach of contract

Requirements for Pharmacy Owners and Superintendent Pharmacists

• Owners and superintendents are legally required to keep pharmacy records
• They must ensure these records are preserved
• If the owner/superintendent is not the RP, there must still be a supervision plan in accordance with the RP for the specific pharmacy
• Responsibility may be transferred to the superintendent pharmacist in the future

Do the RP Regulations Apply to Non-Registered Premises?

• The regulations generally apply to healthcare settings where dispensing occurs.
• In situations where a registered pharmacy is not the only service, an RP is needed for the registered pharmacy only.

Explore the latest updates on the Responsible Pharmacist (RP) regulations, focusing on legal, contractual, and ethical aspects essential for pharmacists. Learn how these changes impact daily practices and the role of the RP, especially in relation to the General Pharmaceutical Council (GPhC). Stay informed about the evolving responsibilities and regulations that govern pharmacy management.