MSOP-1009 Responsible Pharmacist Guidelines PDF

 The Responsible Pharmacist (RP) or The Medicines (Pharmacies) (Responsible Pharmacist) Regulations 2008 Mr A Lea Objectives for this lecture To review the legal, contractual and ethical requirements of the responsible pharmacist regulations...

 The Responsible Pharmacist (RP) or The Medicines (Pharmacies) (Responsible Pharmacist) Regulations 2008 Mr A Lea Objectives for this lecture To review the legal, contractual and ethical requirements of the responsible pharmacist regulations To review how this knowledge links to other legislation related to pharmacy To review how pharmacists implement these regulations in their working practices To consider what happens where the pharmacist is not the owner of the pharmacy or working in a pharmacy not registered with the GPhC Important Changes Due in 23-24 The Responsible Pharmacist regulations have been amended to transfer powers to the GPhC to determine the roles and responsibilities of the Responsible Pharmacist. The GPhC will publish ‘rules’ in due course. Until these are released the following information will be in force. We will update you as soon as more information becomes available Overview of role Pharmacist responsible for the safe and effective running of the pharmacy Only 1 pharmacist may be the responsible pharmacist at any one time The responsible pharmacist can only be responsible for one pharmacy at any one time Have to ensure that you are professionally competent to fulfil role. What do the regulations cover? Responsible pharmacist notice Pharmacy record Maintaining pharmacy procedures Absence of the pharmacist Responsible Pharmacist notice Legally required to display Minimum information required… Allows patients and the public to identify who is in charge of the pharmacy. Record keeping Legally required to keep a record of the responsible pharmacist on duty Useful for completing audits in the event of an incident Can be written or electronic Must be completed by the RP If an amendment needs to be made this must be clear Records must be kept for 5 years and available for inspection Record keeping Must record RP details Date and time RP was in charge Details of any absence EXAMPLE RP RECORD Pharmacy procedures Pharmacist responsible for the safe and effective running of the pharmacy Establish, maintain and review pharmacy procedures Ensure written procedures are available for inspection Procedures must be reviewed regularly and after any ‘incidents’ Ensure that records and documents are kept securely to ensure there is an audit trail.  Procedures: What do you need to consider? RP responsibility to ensure that medicinal products are safely and effectively:- Ordered, stored and prepared sold by retail or supplied in circumstances corresponding to retail sale delivered outside the pharmacy Disposed of when out of date or returned by a patient Procedures: What do you need to consider? What happens in the pharmacy during a pharmacists absence What happens when there is a change of responsible pharmacist How complaints are dealt with What happens in the event of an ‘incident’ Procedures: What do you need to consider? Which staff can give advice to patients Which staff can perform specified tasks in the pharmacy How staff are informed of changes to procedures Absence from the pharmacy RP may be absent for a maximum of 2 hours during the pharmacy’s business hours If more than one responsible pharmacist during the day then only 1 absence is permitted Must remain contactable or arrange for another pharmacist to be contactable What happens when the RP is absent? The pharmacy stays open GSL medicines can be sold Procedures that do not require the physical presence of the pharmacist to supervise can continue P medicines cannot be sold What procedures do you think can continue in the absence of a pharmacist? What happens when the RP is absent? Tasks that CANNOT continue Tasks that CAN continue Contractual issues The NHS terms of service require a pharmacist to be present in the pharmacy Contractual hours must be maintained and any changes to those hours must be notified in advance If an RP leaves the pharmacy during contractual hours the pharmacy may be in breach of contract NHS Contracting lectures will be given later this term, Requirements for pharmacy owners and superintendent pharmacists Legally required to keep the pharmacy record Ensure the responsible pharmacist keeps a pharmacy record Must ensure records are preserved Where the RP is not the owner or superintendent the RP must work subject to the direction of the superintendent. Proposals currently being discussed will transfer some of the roles of the responsible pharmacist to the superintendent pharmacist in the future Do the RP regulations apply to non-registered premises? There are some healthcare settings where dispensing and other pharmacy services occur In these situations, a responsible pharmacist is not needed If the pharmacy premises is registered with the GPhC there must be a responsible pharmacist present If there are registered pharmacy premises on a site where services are also provided from a non-registered pharmacy department, an RP is needed for the registered premises.