Responsible Pharmacist Regulations Overview

Responsible Pharmacist (RP) Regulations

• The Responsible Pharmacist (RP) or Medicines (Pharmacies) (Responsible Pharmacist) Regulations 2008 are legal guidelines for pharmacies.
• Objectives of the lecture include reviewing legal, contractual, and ethical aspects of these regulations, their links to other legislation, and how pharmacists practically apply them.
• The lecture also discusses what happens when a pharmacist is not the owner or the pharmacy isn't registered with the GPhC.

Important Changes

• The Responsible Pharmacist regulations have been amended to transfer power to the General Pharmaceutical Council (GPhC) to define the roles and responsibilities of the Responsible Pharmacist.
• The GPhC will publish detailed rules in the future.
• Until the rules are published, existing guidelines remain in effect, and information updates will be provided.

Overview of Role

• A pharmacist is responsible for a pharmacy's safe and effective operation.
• Only one pharmacist can be the responsible pharmacist at any given time for each individual pharmacy.
• Pharmacists must ensure professional competence to fulfill their duties.

Scope of Regulations

• The regulations cover responsible pharmacist notices, pharmacy records, procedure maintenance, and pharmacist absence scenarios.

Responsible Pharmacist Notice

• Pharmacies must display a notice identifying the current Responsible Pharmacist.
• The notice should specify the Responsible Pharmacist's name and registration number.
• This enables patients and the public to easily identify the pharmacist in charge.

Record Keeping

• Pharmacies must maintain records of the responsible pharmacist on duty.
• Records are essential for audits and incident investigations.
• Records can be written or electronic.
• All modifications must be clearly documented and dated.
• Records must be kept for 5 years and be readily accessible.
• Records must include details like the RP's name and the date and time the RP was in charge.
• Any absences must also be documented with full details.

Pharmacy Procedures

• The Responsible Pharmacist maintains proper pharmacy procedures.
• Procedures must be established, documented, and routinely reviewed, especially after any incidents.
• These procedures need to be accessible for inspection.
• Secure storage of records and documents is crucial for an effective audit trail.

Procedures Considerations

• The Responsible Pharmacist ensures safe and compliant practices related to ordering, storing, selling, and disposing of medicines.
• Procedures need to address pharmacy operations during pharmacist absence, staff-to-patient interaction, complaint handling, and incident management.

Absence from the Pharmacy

• A Responsible Pharmacist can be absent from the pharmacy for a maximum of 2 hours during business hours.
• In cases where there's more than one Responsible Pharmacist on duty, only one absence is allowed.
• The absent pharmacist must remain contactable or arrange for another pharmacist.

Absence Impact

• During a Responsible Pharmacist's absence, only General Sale List (GSL) medicines can be dispensed.
• Dispensing of prescription-only medicines (P medicines) is prohibited and must remain suspended during absence period.
• The pharmacy can stay open in these cases.

Contractual Issues

• The NHS terms of service require a pharmacist's presence during business hours.
• Any changes to contractual hours must be communicated in advance.

Requirements for Pharmacy Owners/Superintendents

• Pharmacy owners are legally responsible for maintaining records.
• The superintendent must ensure proper records are maintained.
• If the Responsible Pharmacist is not the owner, their work should follow the superintendent’s instructions.
• Responsibility for certain tasks might be passed on from the Responsible Pharmacist to the superintendent pharmacist.

Non-Registered Premises

• The regulations apply to pharmacies registered with the GPhC.
• A responsible pharmacist might not be needed at healthcare settings providing pharmacy services that aren't registered by the GPhC.
• If a registered pharmacy shares premises with a non-registered pharmacy, the registered premises must have a responsible pharmacist on duty.

This quiz covers the Responsible Pharmacist (RP) Regulations 2008, detailing the legal guidelines that govern pharmacies. It explores the roles, responsibilities, and ethical considerations surrounding pharmacists, as well as recent amendments involving the General Pharmaceutical Council (GPhC). Stay informed about the practical application of these regulations in pharmacy operations.