Leyla Hannbeck, NPA
Preparing for GPhC inspections Leyla Hannbeck Head of Pharmacy Services NPA
The new inspection model a show me, tell me story Based on FIVE principles and the underpinning GPhC standards 1. Governance arrangements and risk management 2. Empowered and competent staff 3. Managing pharmacy premises 4. Delivering pharmacy services 5. Equipment and facilities The standards are designed to protect the health, safety and wellbeing of patients and the public
Standards Principle 1 Standard operating procedures (SOPs) Staff have clear roles Complaints procedure is in place Appropriate records are kept Patient confidentiality is protected Safeguarding Children and vulnerable adults Principle 3 Well-maintained, clean and safe pharmacy premises Well-designed and compliant with the Health Act and protects patient s privacy Clean and hygienic Secure - ensuring protection of both stock and patient information Principle 2 Sufficient staff with appropriate skill mix Training is appropriately supervised Incentives and/or targets should not affect Professional judgement Culture of openness, honesty and learning Principle 4 Clearly displayed pharmacy services Services benefit the local community Promotion of healthy lifestyles Stock is sourced, stored, supplied and disposed of appropriately Recalls and alerts are actioned Principle 5 Clean, well-maintained equipment is available Equipment is fit for purpose and to the appropriate safety Standard IT equipment protects confidentiality
Meeting the standards Pharmacies should meet the standards every day not just when an inspector calls Pharmacies decide how to demonstrate they are caring for patients and practising safely and effectively NPA standard operating procedure Inspectors talk to the pharmacy team test scenarios observe staff look at documentation
What evidence am I expected to provide? GPhC inspections: A show me, tell me story SOPs Records Evidence Services Layout of pharmacy including work flow and availability of consultation area Competence and skill mix of pharmacy team (training) Insurance arrangements Security arrangements Facilities for all patient groups, including those with disabilities Equipment and facilities are available to provide pharmacy services Professional looking, well maintained, hygienic premises with clearly defined professional area
What can I expect during an inspection? Approximately 2h in duration All pharmacy team involved Observations made on hand-held electronic device Responsible pharmacist (RP) may view the observations The focus is now on patient safety and inspectors will be looking for evidence of this Comments may be added by the RP, before signing to confirm agreement with the report Report sent to the pharmacy owner/superintendent pharmacist shortly after the inspection
How do inspectors grade pharmacies? Poor Has failed to achieve the pharmacy standards overall. There are major concerns that require immediate improvement. Satisfactory Achieves all or the majority of standards and may require some improvement action to address minor issues. Good Achieves all standards consistently well and has systematic review arrangements that ensure continual improvement in the quality and safety of pharmacy services delivered to patients.
How do inspectors grade pharmacies? Excellent!! Demonstrates all the hallmarks of a good pharmacy. In addition, it is either innovative and/or provides unique services that meet the health needs of the local community and that other pharmacies might learn from. Highlight to the inspector all the positive things you do in your pharmacy!!! Demonstrate to the inspector that you are pro-active and that there is huge willingness to provide patient care!
What if my pharmacy receives a poor* judgement? Action plan issued Superintendent pharmacist to respond within two days Must state any remedial action to be carried out, when and who will be responsible for doing so Moderate or high risk to patient safety: Rectify within TEN working days
Reports from inspections so far... Only 55-60% of action plans have been received on time Most common standards not met so far: 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)
Scenario 1 (Principle 1) - Confidentiality An order needs to be placed for a regular unlicensed medicine from the pharmacy specials wholesaler. Whilst the inspector is in the pharmacy, he overhears the member of staff leaving a message on the answer machine with the specials company, in which the medicine and the patient s details are left. The inspector asks what procedures are normally taken for ordering specials. He then asks what would happen if you need to contact a patient about their medicines.
Consider the following: Response 1 1. Providing information to a partner or family member may be a breach of patient confidentiality 1. IG SOPs should be in place covering situations where telephone conversations can be overheard and the procedure for leaving messages with third parties
Scenario 2 (Principle 2)- Staffing level and skills The pharmacy down the road has closed down and six nursing homes that they provided pharmacy services for have approached your pharmacy to see whether you are able to take over the supply of medicines for their patients, most of which are in monitored dosage systems. One of your pharmacy technicians is pregnant, and will be taking her maternity leave soon. Taking on the homes will mean considerably more work for the pharmacy team, as two of the homes have a large number of residents. How can you ensure that patient safety is not compromised?
Response 2 Consider the following: 1. Assess the workload are there sufficient staff in the pharmacy to be able to provide the service in a safe and timely manner? 2. Contingency plan in place 3. Review the skills mix and assess the training needs of the pharmacy team 4. It may be possible to spread the workload over the day/week so that it does not impact on pharmacy services 5. Sufficient space should be available within the pharmacy premises for the increased workload
Scenario 3 (Principle 3) - Security A representative from the cosmetics company asks one of your staff members if they can use the telephone in the dispensary to phone through an order. The counter assistant shows the representative where the telephone is, which is next to the pharmacy checking area, with the dispensary computer screen in use and in full view.
Response 3 Consider the following: 1. IG SOPs security of patient sensitive information by the presence of unauthorised individuals in the pharmacy safe haven 2. Staff should be aware of persons with permission/authorised access to the dispensary area 3. Confirm whether there is a risk of patient sensitive information (bag labels, the computer screen, prescriptions in the process of being dispensed) being on display to unauthorised persons. 4. Pharmacists need to ensure that patient sensitive information is not visible to members of the public, unauthorised staff, delivery drivers and cleaners, for example
Scenario 4 (Principle 4) Disposal of stock A large bag of medicines has been returned to the pharmacy by one of your patients following a stay in hospital when all of their medicines were reviewed and changed. The DOOP bin is already full with a further plastic carrier bag awaiting disposal, from which some sticky liquid is oozing. There is evidence of ants around the bag. The waste contractor is not due for collection for a further four weeks.
Response 4 Consider the following: 1. SOPs available for the disposal of medicines, including the disposal of patient-returned CDs and pharmacy stock of CDs; review the frequency of collection of waste 2. Details available for waste contractors this should include what would happen if contractors need to make an emergency collection. Staff should be aware of the maximum fill line for the DOOP bins. 3. T28 exemption is in place for the destruction of CDs 4. Advice given to customers returning sharps (signposting if sharps waste is not collected as part of a needle exchange scheme) 5. Other pharmacy waste, including the procedures for customers returning batteries for recycling 6. Procedures for preventing pest control and managing an infestation the local council may be able to assist 7. SOP on infection control
Scenario 5 (Principle 5) - Equipments A new patient arrives in your pharmacy with an instalment prescription for methadone oral solution. There hasn t been a prescription for methadone oral solution in the pharmacy for some time and fortunately there is sufficient stock. However, when you come to measure out the methadone there are no measures marked for methadone only. One of the pharmacy technicians explains that it was broken a few weeks ago whilst cleaning the sink area and was not replaced as there was no need at the time.
Response 5 Consider the following: 1. Appropriate facilities and equipment should be available in the pharmacy to dispense the methadone 1. Procedure for audit, maintaining and instructions for safe use of pharmacy equipment/facilities 1. Disposal of sharps/glass with regards to health and safety 1. Cleaning matrix; records for maintenance of equipment; audit sheets for dispensary stock
We asked the GPhC inspection team... There have been comments that multiples are treated more favourably than Independents what are your comments? There are concerns that pharmacists busy schedule is not taken into account by inspectors. What are your comments? Are there any plans to announce the visits in the future so that superintendents and owners can schedule their holidays etc?
We asked the GPhC Inspection team... What would happen if the owner or superintendent does not agree with the report and refuses to sign? Is there going to be any changes to the current rating system? Are there any specific training for inspectors to ensure they can tailor their communication to pharmacy staff (not just pharmacists)?
A show me, tell me story by the NPA Video clips for pharmacists and their teams on NPA Website! Evidence How am I doing? Principles In practice scenarios Signposting
Remember The focus of the inspections is patient safety Inspectors are not looking to penalise minor issues It does not matter what methods are used to achieve standards The more prepared you are, the less time the inspection will take Highlight all your success to the inspector Be innovative and stand out The NPA Pharmacy Services Support and toolkits