community pharmacy assurance framework (ni): summary …...to support members in ensuring compliance...
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Community Pharmacy Assurance Framework (NI): summary of compliance and NPA support
© The National Pharmacy Association. July 2016. Produced by the Pharmacy Services team. Direct Dial: 01727 891 800 Email: [email protected] Online: www.npa.co.uk
Introduction to the New Community Pharmacy Assurance Framework
The Community Pharmacy Assurance Framework (CPAF) is designed to provide an assurance of safe, effective and high quality pharmaceutical services to
patients and the public. To meet the requirements of the Framework, pharmacy contractors will be expected to comply with the terms of service, service
specifications, related professional standards and best practice guidance.
The Framework consists of two components:
Each year the community pharmacy contractor must complete an annual declaration of compliance (contractors will have six weeks to return the
declaration)
Each pharmacy will undergo an assurance visit by Health and Social Care Board (HSCB) staff every three years
The assurance visit will seek evidence of compliance through observation of evidence in practice, review of documentation and discussion with staff.
Pharmacies will be selected for a visit based on the level of assurance provided, the level of additional assurance sought (for example where there has been
a concern raised) and random selection. More information about the Framework can be found on the Health and Social Care (HSC) Business Service
Organisation (BSO) website.
To support members in ensuring compliance with the framework and preparing for an assurance visit, the NPA has prepared a guide to highlight the
compliance areas, relevant legislation and standards and support resources. These are available to you as a benefit of your NPA membership.
Using this NPA Guide
The guide consists of 6 parts:
The specified requirements as defined in The Pharmaceutical Regulations (Northern Ireland) 1997 Part I General (Terms of Service) or Part II
Provision of Pharmaceutical Services by Chemists (Dispensing Service)
How to comply – suggestions that may assist in complying with the requirement (essential requirements are listed in bold)
Relevant HSCB guidance
Relevant Pharmaceutical Society Northern Ireland (PSNI) requirements
NPA support
Other support
Members should refer to the Framework alongside this guide for detailed information on the specified requirements.
Community Pharmacy Assurance Framework (NI): summary of compliance and NPA support
© The National Pharmacy Association. July 2016. Produced by the Pharmacy Services team. Direct Dial: 01727 891 800 Email: [email protected] Online: www.npa.co.uk
Part 1 – Terms of Service
Requirements
How to comply HSCB guidance PSNI Requirements NPA Support Other
1. Hours of provision of pharmaceutical services
Opening hours meet contracted hours detailed in pharmaceutical list:
Opening hours beyond the contracted hours is at the discretion of the contractor
Pharmaceutical List: www.hscbusiness.hscni.net/services/2053.htm
2. Practice leaflet A practice leaflet is available to members of the public which meets Pharmaceutical Services Regulations (Northern Ireland) 1997: www.legislation.gov.uk/nisr/1997/381/contents/made
Pharmaceutical Services Regulations (Northern Ireland) 1997 www.hscbusiness.hscni.net/services/2539.htm
Practice leaflet template (available soon to download from the NPA website)
3. Health Promotion leaflets
The pharmacy displays up to eight health promotion leaflets.
Pharmaceutical Services Regulations (Northern Ireland) 1997
www.hscbusiness.hscni.net/services/2539.htm
Patient support materials, Ask Your Pharmacist resources: www.npa.co.uk/services-and-support/business-support/promoting-your-pharmacy/
Public Health Agency (PHA): www.publichealth.hscni.net/directorate-public-health/health-protection-1?page=1
Community Pharmacy Assurance Framework (NI): summary of compliance and NPA support
© The National Pharmacy Association. July 2016. Produced by the Pharmacy Services team. Direct Dial: 01727 891 800 Email: [email protected] Online: www.npa.co.uk
4. Record keeping: What is the process used for keeping records of all HSC prescriptions dispensed?
The pharmacy must maintain records of all HSC prescriptions dispensed:
All client data should be handled appropriately, in line with data protection
Prescriptions and paper patient records (for example, Medicines Use Review (MUR) forms) should be stored securely
Software manual should be available for patient medication records (PMR) and electronic prescription registers (if appropriate) in case of issues
Pharmaceutical Services Regulations (Northern Ireland) 1997: www.hscbusiness.hscni.net/services/2539.htm
HSCB Guide for handling client data www.medicinesgovernance.hscni.net/wpfb-file/hscb-guide-for-community-pharmacists-handling-of-patient-client-data-aug10-pdf-104kb-pdf/
The Code: Professional standards of conduct, ethics and performance for pharmacists in Northern Ireland: “Standard 2.3: Record, store and process data clearly and accurately”: www.psni.org.uk/about/code-of-ethics-and-standards/
Patient care cards for PMR keeping: www.npasales.co.uk/link/en/patient-services/record-keeping/pharmacy-care-cards/a/?parm=NOM041%20%20%20%20%20abaiab&cat=NPA
Department of Health “Good Management, Good Records, Disposal Schedule Work Areas – Section M” outlines the requirements for retention and disposal of community pharmacy held records: www.health-ni.gov.uk/articles/disposal-schedule-section-m
Community Pharmacy Assurance Framework (NI): summary of compliance and NPA support
© The National Pharmacy Association. July 2016. Produced by the Pharmacy Services team. Direct Dial: 01727 891 800 Email: [email protected] Online: www.npa.co.uk
5. Complaints procedure
The pharmacy has a current complaints procedure, evidenced by a Complaints SOP. There should be a specified contact for complaints in the pharmacy:
Staff should know how to deal with complaints arising from service provision
Records should be kept of all complaints and associated correspondence. This may include action plans as a result of a complaint.
Copy of complaints poster and complaints leaflet www.hscbusiness.hscni.net/services/2659.htm
Link to e-learning on the management of complaints www3.hscni.net/fps_elearning_complaints/
The Code: Professional standards of conduct, ethics and performance for pharmacists in Northern Ireland: “Standard 1.2.2: Ensure that an effective complaints procedure is readily available for the patient or service user and follow that procedure at all times”: www.psni.org.uk/about/code-of-ethics-and-standards/
“Responsible Pharmacist (NI): dealing with complaints about the pharmacy business” (available soon to download from the NPA website)
FAQ: “Dealing with Complaints (NI)” www.npa.co.uk/news-and-events/news-item/faq-dealing-with-complaints-northern-ireland/
NIdirect –information for the public: www.nidirect.gov.uk/articles/make-complaint-against-health-service
6. MUR – consultation area requirements
MURs are provided in an area of the pharmacy which meets the requirements set out in the MUR service specification.
HSC BSO: www.hscbusiness.hscni.net/services/2427.htm
MUR guidance and SOP for delivery of service: www.npa.co.uk/information-and-guidance/medicine-use-review-service-ni/
Guidance on use of consultation area: www.npa.co.uk/infor
Community Pharmacy Assurance Framework (NI): summary of compliance and NPA support
© The National Pharmacy Association. July 2016. Produced by the Pharmacy Services team. Direct Dial: 01727 891 800 Email: [email protected] Online: www.npa.co.uk
mation-and-guidance/making-the-best-use-of-consultation-areas/
Equipment for consultation area, for example, door signs available from NPA Sales on 0330 123 1035
Part 2 – Core Essential Service:
Dispensing
HSCB Guidance PSNI requirements NPA Support Other
1. Dispensing SOPs
SOPs must be in place for all dispensing processes. Staff should know where/what SOPs are and have read and understood them. Staff should demonstrate competency and their roles should be performed in line with the SOPs. Named staff should have their responsibilities defined in the SOPs.
The Code: Professional standards of conduct, ethics and performance for pharmacists in Northern Ireland “Standard 4.4: Supervise and delegate effectively”
Standards and Guidance on The Responsible Pharmacist Regulations www.psni.org.uk/documents/352/Standards+on+the+Responsible+Pharm_.pdf
Responsible Pharmacist SOPs: www.npa.co.uk/information-and-guidance/?search=q:Responsible%20Pharmacist%20SOP
Locum Handbook: www.npa.co.uk/information-and-guidance/locum-handbook/
“CPAF: pharmacy staff training log”: www.npa.co.uk/information-and-guidance/community-pharmacy-assurance-framework-northern-
Community Pharmacy Assurance Framework (NI): summary of compliance and NPA support
© The National Pharmacy Association. July 2016. Produced by the Pharmacy Services team. Direct Dial: 01727 891 800 Email: [email protected] Online: www.npa.co.uk
SOPs are in date. SOPs are regularly reviewed – every two years, or following an incident. A process should be in place for reviewing SOPs.
ireland/
2. Clinical assessment of prescriptions
Describe the process of how a clinical assessment is performed by the pharmacist as per SOPs. Clinical queries are dealt with directly with the prescriber (where possible) and interventions and referrals are recorded in a log book/PMR.
Clinical assessment advice is available from the HSCB Medicines Safety Matters newsletters: www.medicinesgovernance.hscni.net/primary-care/newsletters/medicines-safety-matters-community-pharmacists/
Guidance on professional communications between GPs and community pharmacists is stated in the HSCB letter, “Communication between GPs and Community Pharmacies about
The Code: Professional standards of conduct, ethics and performance for pharmacists in Northern Ireland: “Standard 3.2: maintain professional boundaries” and “Standard 3.4: be open and honest in relation to legal or disciplinary proceedings”: www.medicinesgovernance.hscni.net/primary-care/
Log book to record interventions and onward referral www.npasales.co.uk/link/en/dispensary/record-keeping/pharmacy-referral/a/?parm=NOM041%20%20%20%20%20acajad&cat=NPA
Community Pharmacy Assurance Framework (NI): summary of compliance and NPA support
© The National Pharmacy Association. July 2016. Produced by the Pharmacy Services team. Direct Dial: 01727 891 800 Email: [email protected] Online: www.npa.co.uk
patient clinical concerns”: www.medicinesgovernance.hscni.net/primary-care/medicines-safety-advice-letters/
3. Accuracy of dispensing
Describe the process of how an accuracy check is carried out on all prescriptions. A double check should be built into the dispensing process:
Incidents or near misses are recorded, processes reviewed and any necessary action taken to ensure that safety is not compromised
Date checking procedures should be in place
Anonymous Reporting of Adverse Incidents by Community Pharmacy Services: www.medicinesgovernance.hscni.net/anonymousincidentsform/
Professional Standards and Guidance for the Sale and Supply of Medicines Principle 3 states that patients are entitled to expect the dispensing service provided to be accurate; Standard 3.14 requires procedures to be in place to minimise the risk of dispensing errors: www.psni.org.uk/wp-content/uploads/documents/313/standards_on_sale_and_supply_of_medicines.pdf
“Medicines with similar names: list” www.npa.co.uk/information-and-guidance/medicines-with-similar-names/
Learnings from patient safety incidents can be accessed by viewing “MSO quarterly updates”: www.npa.co.uk/services-and-support/practical-support/medication-safety-officer/
“CPAF: pharmacy date checking log”: www.npa.co.uk/information-and-guidance/community-pharmacy-assurance-framework-northern-ireland/
4. Provision of PILs
Describe the process to ensure that Patient
PSNI Professional Standards and Guidance
Product information available through
EMC website: www.medicines.
Community Pharmacy Assurance Framework (NI): summary of compliance and NPA support
© The National Pharmacy Association. July 2016. Produced by the Pharmacy Services team. Direct Dial: 01727 891 800 Email: [email protected] Online: www.npa.co.uk
Information Leaflets (PILs)are routinely issued with full and part packs when dispensing, including MDS.
for the Sale and Supply of Medicines Standard 3.15 states that a PIL is issued with a medicine at the time of dispensing
Pharmacy Services: www.npa.co.uk/iris/
org.uk/emc/
MHRA website: www.mhra.gov.uk/spc-pil/
Advice on the supply of PILs is given by the Medicines Regulatory Inspectors in their newsletter Issue 3, November 2007 and in respect of MDS in Issue 6, December 2010: www.health-ni.gov.uk/publications/pharmacy-inspector-newsletters-june-2006-june-2015
5. Labelling Labels of dispensed products should be clear and legible, computer-generated and where appropriate include any cautionary and advisory labelling recommended by the BNF:
It may be
Professional Standards and Guidance for the Sale and Supply of Medicines Standard 3.11 states that labelling of dispensed products is clear and legible, computer-generated and where appropriate, includes any cautionary and advisory labelling
DHSSPS Pharmacy Inspectors Newsletter No 10 March 2015: www.health-ni.gov.uk/publications/pharmacy-inspector-newsletters-june-2006-june-2015
Community Pharmacy Assurance Framework (NI): summary of compliance and NPA support
© The National Pharmacy Association. July 2016. Produced by the Pharmacy Services team. Direct Dial: 01727 891 800 Email: [email protected] Online: www.npa.co.uk
necessary to provide labels in different languages and font sizes
Consider including a description of the medicine on the label of MDS
recommended by the BNF: www.psni.org.uk/wp-content/uploads/documents/313/standards_on_sale_and_supply_of_medicines.pdf
6. Provision of advice to patients
Appropriate advice is given to patients (or their representatives) on their prescribed medicines including home deliveries, with special care taken with new medicines, changes to medicine dose or formulation and high risk medicines:
This should be part of the SOP
Staff should be adequately trained to provide advice or refer to the pharmacist when necessary
HSCB High Risk Medicines Poster Community Pharmacy: www.medicinesgovernance.hscni.net/wpfb-file/high-risk-medicines-poster-cp-2015-pdf/
Professional Standards and Guidance for the Sale and Supply of Medicines Standard 3.3 requires that the patient receives sufficient information and advice to enable the safe and effective use of the prescribed medicine; and Standard 6.3 states that the pharmacist must ensure that the delivery mechanism used enables the medicine to be delivered securely and promptly to the intended recipient with any necessary information to enable safe and effective use of his medicine: www.psni.org.uk/wp-content/uploads/documents/313/standards_on_sa
Prescription alert stickers: www.npasales.co.uk/link/en/dispensary/prescription-handling/prescription-alert-stickers/a/?parm=NOM041%20%20%20%20%20acaiaa&cat=NPA
Patient information on insulin, methotrexate, steroids and lithium available from NPA Sales on 0330 123 1035
Delivering Medicines Safely and Effectively course for delivery drivers: www.npa.co.uk/training/training-a-z/delivering-
Community Pharmacy Assurance Framework (NI): summary of compliance and NPA support
© The National Pharmacy Association. July 2016. Produced by the Pharmacy Services team. Direct Dial: 01727 891 800 Email: [email protected] Online: www.npa.co.uk
le_and_supply_of_medicines.pdf
medicines-safely-effectively/
7. Safe storage of medicines
Patients should be advised on the safe storage of medicines:
Advice to patients should be part of the SOPs
Pharmacies may wish to promote the safe disposal of unwanted waste in the pharmacy and take part in HSCB campaigns, for example, DUMP
Patients should be made aware that unwanted medicines should be returned to the pharmacy for destruction. Medicines should be provided in suitable packaging, checks made on suitability of medicines that are supplied in MDS.
Medicines Safety Matters Community Pharmacy Vol 3 Issue 2 (July 2015) focused on incidents involving MDS, how to reduce the associated risks and advice on drug stability
Information on the stability of medicines prior to dispensing in MDS can be accessed through UK Medicines Information Medicines Compliance Aid database: www.ukmi.nhs.uk/applications/mca/
Professional Standards and Guidance for the Sale and Supply of Medicines Standards 1.7 and 3.10 www.psni.org.uk/wp-content/uploads/documents/313/standards_on_sale_and_supply_of_medicines.pdf
MDS guidance: www.npa.co.uk/information-and-guidance/monitored-dosage-systems/
Prescription alert stickers:www.npasales.co.uk/link/en/dispensary/prescription-handling/prescription-alert-stickers/a/?parm=NOM041%20%20%20%20%20acaiaa&cat=NPA
Denaturing kits www.npasales.co.uk/link/en/dispensary/drug-destruction/denaturing-kits/a/?parm=NOM051%20%20%20%20%20acabaa&cat=NPA
8. Checking patient details
Procedures are in place to ensure
“HSCB Community Pharmacy Right
Professional Standards and Guidance for the
Delivery driver’s record book:
Community Pharmacy Assurance Framework (NI): summary of compliance and NPA support
© The National Pharmacy Association. July 2016. Produced by the Pharmacy Services team. Direct Dial: 01727 891 800 Email: [email protected] Online: www.npa.co.uk
patient details are confirmed before handing out prescriptions both In the pharmacy and when medicines are delivered
Staff should be adequately trained to hand out prescriptions correctly
Person Poster 2016” is available at: www.medicinesgovernance.hscni.net/primary-care/posters-leaflets/
Sale and Supply of Medicines Standard 3.14, requires that procedures are in place to minimise the risk of dispensing errors: www.psni.org.uk/wp-content/uploads/documents/313/standards_on_sale_and_supply_of_medicines.pdf
www.npasales.co.uk/link/en/pharmacy-supplies/deliveries/record-book/a/?parm=NOM041%20%20%20%20%20aaacab&cat=NPA
9. Patient Safety Processes should be in place to disseminate patient safety communications to dispensing staff. Incidents or near misses are recorded, processes reviewed and any necessary action taken to ensure that safety is not compromised:
Evidence of shared learning amongst staff should be available to learn from each others’ mistakes and make
Medicines safety advice, letters and newsletters are available from Medicines Governance NI website: www.medicinesgovernance.hscni.net/primary-care/
The Code, Professional standards of conduct, ethics and performance for pharmacists in Northern Ireland “Standard 2.2 – Manage Risk”: www.medicinesgovernance.hscni.net/primary-care/
Professional Standards for the Sale and Supply of Medicines Standard 3.14 requires procedures to be in place to minimise the risk of dispensing errors or contamination of medicines and a record of errors and near-miss incidents must be made and practices
Patient Safety: www.npa.co.uk/services-and-support/practical-support/medication-safety-officer/
Dispensing Process – best practice: www.npa.co.uk/information-and-guidance/dispensing-process-best-practice/
“CPAF (NI): medicines safety/HSCB alert log”: www.npa.co.uk/information-and-guidance/community-pharmacy-assurance-framework-northern-ireland/
Community Pharmacy Assurance Framework (NI): summary of compliance and NPA support
© The National Pharmacy Association. July 2016. Produced by the Pharmacy Services team. Direct Dial: 01727 891 800 Email: [email protected] Online: www.npa.co.uk
improvements to their own work processes
Staff should be suitably trained for their tasks
reviewed in light of such incidents www.psni.org.uk/wp-content/uploads/documents/313/standards_on_sale_and_supply_of_medicines.pdf
“CPAF (NI): pharmacy drug and device alert log”: www.npa.co.uk/information-and-guidance/community-pharmacy-assurance-framework-northern-ireland/
Near miss register www.npasales.co.uk/link/en/dispensary/record-keeping/near-miss/a/?parm=NOM041%20%20%20%20%20acajac&cat=NPA
Whistleblowing suite of resources: www.npa.co.uk/information-and-guidance/whistleblowing/
Safeguarding suite of resources: www.npa.co.uk/news-and-events/news-item/northern-ireland-new-safeguarding-resources/
10. Beta blockers Relevant HSCB communications should be shared
Medicines Safety Matters Newsletter, August 2013:
Product information available through Pharmacy Services:
Community Pharmacy Assurance Framework (NI): summary of compliance and NPA support
© The National Pharmacy Association. July 2016. Produced by the Pharmacy Services team. Direct Dial: 01727 891 800 Email: [email protected] Online: www.npa.co.uk
and discussed with staff
Changes to practice should be made as a result of the relevant communications
Other relevant learns should be discussed with HSCB
www.medicinesgovernance.hscni.net/primary-care/newsletters/medicines-safety-matters-community-pharmacists/
HSCB/PHA “Safety and Quality Learning Letter: Dispensing Beta Blockers – Selection Errors” (May 2014): (see “Appendix 1: HSCB dispensing b-blockers”: www.npa.co.uk/information-and-guidance/community-pharmacy-assurance-framework-northern-ireland/)
HSCB “Letter to community pharmacists re Further Dispensing Errors involving Beta blockers” (July 2015): www.medicinesgovernance.hscni.net/primary-care/medicines-safety-advice-letters/
www.npa.co.uk/iris/
Patient Safety: www.npa.co.uk/services-and-support/practical-support/medication-safety-officer/
“CPAF (NI): pharmacy drug and device alert log”: www.npa.co.uk/information-and-guidance/community-pharmacy-assurance-framework-northern-ireland/