New GPhC inspection regime Gareth Jones MRPharmS NPA Public Affairs Manager
GPhC regulation Professional ‘System’ regulation regulation • Regulating pharmacy professionals • Regulating pharmacies through standards through standards for conduct, ethics and for registered pharmacies performance • Requiring owners and superintendents to • Taking action where the fitness to practise secure compliance with those standards of a registered pharmacy professional may be impaired • If the standards are not met, • If the standards are not met, registration of the pharmacy is at stake registration of that pharmacy • Organisational accountability (through professional at stake owner/superintendent) • Individual professional accountability
GPhC philosophy • Using regulation to promote a culture of patient- centred professionalism in pharmacy • GPhC “committed to regulating in a way which supports pharmacists and pharmacy technicians to embrace and demonstrate professionalism in their work” • Professionalism, not rules and regulations, provides most effective protection for patients • Prescriptive rules let us all off the hook
Standards for registered pharmacies • A focus on outcomes, not prescriptive rules • Leaves it to pharmacists to decide how to deliver safe and effective practice • New accountability structure: pharmacy owners and superintendents are accountable for meeting the new standards
New GPhC inspection regime • Launched 4 th Nov 2013 • Based on new GPhC standards • Pharmacies need to demonstrate compliance with 5 sets of standards • Inspection label (grade) will be issued • Publication of report • Statutory improvement notices
Inspection Cycle Strategic Relationship Registration of nre pharmacy premises Registration of new premises Management Risk assessment Pre-inspection preparation On-site pharmacy inspection Report writing Quality assurance Publication
GPhC standards Principles 1. Governance arrangements 2. Empowered and competent staff 3. Premises environment and condition 4. Delivering pharmacy services 5. Equipment and facilities
Principle 1: Governance arrangements This is all about managing the potential risks that processes and services may pose to patients/public Standard operating procedures (SOPs) NPA standard operating procedure Staff have clear roles Complaints procedure Appropriate records NHS Complaints Record Book Safeguarding Children and vulnerable adults
Governance arrangements Satisfactory Good Procedures are in place that are Proactive and regular review of adverse appropriate to the risks for all pharmacy incidents to identify trends, review services provided procedures, train staff Storage and management of medicines Risk of potential failure or disruption to is appropriate to the risks services planned for There are complaints and feedback Systematic monitoring and review mechanisms mechanisms are in place Patient identifiable information is not Passwords are used and changed shared frequently Staff aware of and apply safeguarding There is a clear culture of safeguarding policies
Governance arrangements • Have I got arrangements in place to regularly review systems and processes? • How have I made sure that staff are clear about what they can and cannot do? • Do I keep records of near misses? • Are patients asked for feedback? • How can I demonstrate that staff act on concerns/complaints from patients?
Principle 2: Empowered and competent staff This is all about the competency of staff, the skill mix and the way that training is managed within the pharmacy This is to Sufficient staff with appropriate skill mix certify that: Training is appropriately supervised Culture of openness, honesty and learning
Empowered and competent staff Satisfactory Good Staffing levels and roles are Staff numbers and skill mix and appropriate continually and systematically reviewed in line with workload All staff are appropriately supervised Staff are actively encouraged to reflect on their performance All staff accept responsibility for their Regular reporting and review of errors mistakes The pharmacy has a whistle-blowing There is a culture in the pharmacy that policy in place means that staff are confident to raise concerns
Empowered and competent staff • Can I demonstrate that there are enough suitably qualified/trained pharmacy staff? • Do staff have 1-2-1 appraisals or team meetings? • Do staff know what to do should they have concerns about the poor professional practice of others?
Principle 3: Managing pharmacy premises This is all about having well-maintained pharmacy premises that are hygienic, well-designed and secure Well-maintained and safe pharmacy premises Compliant with the Health Act Clean and hygienic
Pharmacy premises Satisfactory Good The pharmacy premises are clean, tidy Patient and public feedback informs and well organised the design and layout of the public area of the pharmacy Patients are able to have confidential Confidential discussions take place in conversations with pharmacy staff an area/room which is suitably screened Security measures prevent Security measures are regularly unauthorised access and safeguard reviewed in light of local incidents staff, patients and the public
Pharmacy premises • Can I demonstrate that the size, design and layout of the pharmacy supports safe practice? • Can I demonstrate that there is a quiet area where patients can have confidential conversations?
Principle 4: Delivering pharmacy services This is all about the promotion and accessibility of pharmacy services to the public, and ensuring safe delivery of these Clearly displayed pharmacy services Promotion of healthy lifestyles Stock is sourced, stored, supplied and disposed of appropriately
Delivery of services Satisfactory Good Pharmacy services available are clearly Pharmacy team can articulate to displayed patients benefits of services offered Adequate stock management Patients are actively counselled to procedures are in place promote the return of unwanted/unused medicines There is an audit trail to identify staff Patients receiving high-risk medicines involved in dispensing a medicine are proactively counselled Patients are signposted to other The pharmacy proactively follows up providers when pharmacy can not meet patients who have received a medicine their needs which is not fit for purpose
Delivery of services • Do I signpost to other service providers • Do I tailor services to the local population? • How can I demonstrate that patients are given the right advice about how to take their medicines? • Do I have an audit trail for deliveries? • Can I demonstrate that I have robust stock management arrangements?
Principle 5: Equipment and facilities This is all about ensuring that equipment and facilities used in the pharmacy are safe and for for purpose Well-maintained equipment is available Equipment is fit for purpose and to the appropriate safety standard IT equipment protects confidentiality
Equipment and facilities Satisfactory Good Appropriate equipment and facilities Proactive review of equipment and readily available (eg, internet access) facilities to improve patient care (eg, able to produce large print labels) All equipment is fit for purpose and Equipment regularly monitored to validated identify deficiencies and corrective action taken Equipment is stored securely, safely The pharmacy shares any concerns and appropriately about equipment deficiencies with other pharmacies/organisations Equipment and facilities are clean and hygienic
Equipment and facilities • Do I have all the equipment I need to provide the services I offer? • How can I demonstrate that the equipment is clean, working and properly calibrated? • How can I demonstrate that the pharmacy has up-to-date reference sources? • Are PMR passwords protected?
Early trends – standards not met • Management of medicines & medical devices (4.3) • Risk management identification & management (1.1) • Records management (1.6) • Risk reviewed & monitored (1.2) • Pharmacy services managed & delivered safely (4.2) • Premises safe, clean & properly maintained (3.1)
Inspection label (grade) • Pharmacies will be graded - in line with wider regulatory practice • Result of inspection no longer “met” or “not met” • Allows a more realistic judgement • Use regulation to drive continuous improvement
An excellent pharmacy • Will meet all the standards consistently well but also demonstrate innovation in the delivery of pharmacy services with clear positive health outcomes for its patients • It is envisaged that there will be very few pharmacies where the outcome of the inspection is excellent, especially in the early days of the new inspection model.
A good pharmacy • Will need to be consistently good across the standards and demonstrate some positive outcomes for patients • A good pharmacy is likely to conduct continuous and systematic reviews of its staff, their skills, operating procedures, records, risks and patient needs
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