|Pharmacy Regulations 2013|
NHS England’s local offices have responsibility for monitoring the provision of Essential and Advanced services. Arrangements for monitoring locally commissioned services may be set out in local contracts or Service Level Agreements.
NHS England’s local offices use the Community Pharmacy Assurance Framework (CPAF) to monitor pharmacy contractors’ compliance with the terms of the community pharmacy contractual framework (CPCF).
Community Pharmacy Assurance Framework (CPAF)
The Community Pharmacy Assurance Framework was developed by NHS Primary Care Commissioning as a toolkit to assist Primary Care Trusts in assessing compliance and quality under the Community Pharmacy Contractual Framework (CPCF). The first toolkit was published in September 2005 as the CPAF and updated versions were produced by PCC, working with PSNC, over the subsequent years.
CPAF is made up of two parts – a pre-visit questionnaire which is completed by the pharmacy contractor before the monitoring visit and a section used by the commissioner during a monitoring visit.
In 2013 NHS England updated CPAF and NHS England’s Area Teams (now local NHS teams) used this version of the CPAF to undertake contract monitoring during 2013/14.
Contract monitoring arrangements have developed since and are described below. Please refer to the current year’s arrangements in the drop down heading.
Click on a heading below for more information.
Contract monitoring for 2018/19
The 2018/19 Community Pharmacy Assurance Framework (CPAF) screening questionnaire was available for completion for four weeks from Monday 4 June 2018 until Sunday 1 July 2018. This was extended until 11.59pm on Friday 6 July 2018 as some CPAF communications were not received as planned.
The 2018/19 CPAF process is outlined here.
Now in its fourth year, the process asks all NHS community pharmacy contractors to complete a short screening questionnaire consisting of 10 questions; NHS England will then select a small number of pharmacies for a monitoring visit and / or to complete the full CPAF questionnaire.
At the request of NHS England, this year the screening questionnaire was revised as follows:
- Retire two questions – prescribed medicines advice (question 2) and owings (question 5);
- Add two new questions – safeguarding (question 11) and pharmacy-based audit (question 12); and
- Revise one question – repeat dispensing (question 4).
Like previous years, there remains 10 active questions.
PSNC has published PSNC Briefing 032/18: CPAF screening questionnaire changes which explains the changes and provides clarification on record-keeping relating to prescription-based interventions (question 6), signposting (question 7) and locums (question 9). The appendix contains the screening questionnaire in full so that contractors can view all the information prior to completing it.
Level 2 is the minimum standard expected to demonstrate general compliance with the terms of service.
The NHS Business Services Authority (NHSBSA) will continue to carry out the administration of CPAF at a national level on behalf of NHS England and this has been facilitated by a secure on-line portal for contractors to complete their screening questionnaires. Contractors should have received a link to complete the screening questionnaire either via email from the NHS Business Services Authority (NHS BSA) or from their own Head Office. A link to the questionnaire, guidance on completing the questionnaire and FAQs are available on the NHS BSA website.
Contractors are advised to contact NHS BSA by emailing email@example.com if they have any problems or queries.
For 2018/19, more than 98% of pharmacies completed the screening questionnaire which is consistent with the positive trend in recent years. This should help contractors avoid facing unnecessary monitoring visits.
PSNC has also developed a short 10 minute podcast on contract monitoring for information.
Contract monitoring visits
Within the pharmacist’s terms of service, a pharmacist shall allow persons authorised in writing by NHS England to enter and inspect his pharmacy at any reasonable time for the purpose of ascertaining whether or not the pharmacist is complying with the requirements of their terms of service. Where the pharmacist requests it, the LPC can be present at the inspection.
Any visit should be planned carefully so as not to impact negatively on the day-to-day running of the pharmacy. Patients of pharmacies do not require appointments therefore any inspection teams should not necessarily expect to have the pharmacist devoted to them during any visit, nor should any inspection disrupt the concentration of pharmacy staff in the provision of care to patients.
Monitoring the use of SOPs
The Essential Service specifications require the pharmacy to have appropriate SOPs for dispensing, repeat dispensing and support for self-care.
Monitoring compliance requires only the determination of whether the pharmacy has an appropriate SOP. It does not require NHS England to carry out a detailed analysis of the content of the SOPs. Indeed, it would be unwise for NHS England to carry out any detailed examination, because it will be unable to determine what is appropriate for the individual pharmacy concerned, and any shortcomings not identified, or suggestions made which themselves cause problems in delivery of the services, could lead to NHS England itself being involved in litigation.
For this reason, the most appropriate way for NHS England to determine whether the pharmacy has an appropriate SOP is to ask to see it during a monitoring visit (but without reading it in detail), then to ask appropriate members of staff suitable questions about their procedures to establish the level of understanding and compliance with the SOP.
Recording advice, interventions and referrals in community pharmacies
As part of the NHS Terms of Service for community pharmacies in England, there are various requirements for pharmacies to keep records of advice, interventions and referrals.
What sort of records need to be kept?
Records need to be kept in relation to:
|Dispensing||Pharmacies need to keep and maintain records in appropriate cases, of advice given and any interventions or referrals made.|
|Repeat dispensing||Pharmacies need to keep and maintain records of clinically significant interventions in cases involving repeatable prescriptions. These will include instances where:
Prescription linked interventions:
Where a person using a pharmacy presents a prescription and it appears to the pharmacist or staff that the person:
The pharmacy must, as appropriate, provide advice to the person with the aim of increasing the person’s knowledge and understanding of the health issues which are relevant to that person’s personal circumstances.
In appropriate cases, the pharmacy must keep and maintain a record of the advice given in a form that facilitates:
The pharmacy must, in appropriate cases, keep and maintain a record of any information given or referrals made in relation to signposting.
The records must be in a form that facilitates:
|Self- care||In order to minimise the inappropriate use of health and social care services, pharmacies are required to support patients by providing advice where appropriate to help the patient manage a medical condition. The support may include advice:
The pharmacy must, in appropriate cases, keep and maintain a record of any advice given and of any drugs supplied when the advice was given.
The record must be in a form that facilitates:
What is the reason for keeping the records?
The terms of service require records to be kept ‘where appropriate’ or when ‘clinically significant’ so the pharmacy will need to consider for each provision of advice, intervention, or referral whether a record should be kept. The record will be of no value if it is made just for the sake of making it – it must be linked to improving patient care, maintaining high quality service from the pharmacy or in some cases managing risk. For example records enable:
- the pharmacy to ensure that there is continuity of care e.g. a particular brand of medicine is supplied for a patient, allergies to particular excipients, medication is supplied with larger label fonts or in specific containers etc.
- other pharmacists and staff to understand what you discussed with a patient if you are not working in the pharmacy the next time the patient comes in to the pharmacy
- you to follow up on advice given or treatment recommended to enhance patient care particularly if you would want to double check that a patient had taken on board important advice.
Another reason to keep records is to manage risk. It is important to keep records of anything that concerns you in case you need to refer back to it in the future.
Where should we keep the records?
The records should be kept in the best way for your pharmacy that enables all pharmacy staff to make use of them to provide a high quality of service for the people who use your pharmacy.
This is most likely to be somewhere on your PMR ideally linked to the patients dispensing record.
If the records are kept separately in a book or a log for example, you will be less likely to be able to use them for the purposes described above.
NHS England may wish to discuss records of advice, interventions and referrals with you as part of a contract monitoring visit. It is important that you can describe what you do and provide some evidence.
How should we decide which pieces of advice and which interventions to record?
Pharmacies are unlikely to be able to record all the advice, interventions and referrals they make and indeed there is little benefit in recording every single piece of advice given. In deciding what to record think about:
- Risk management – is there something that has worried you?
- Have you made a significant difference to the patient?
- Is it something that another pharmacist or member of staff might need to know about the next time the patient visits?
- Is it something that you may need to refer back to in the future?
Who should make the records?
Any member of staff can make the records and this may be covered in your SOPs. It will depend where you make the records and how your pharmacy works.
It may be more likely that the pharmacist or other staff in the dispensary makes records in relation to dispensing and repeat dispensing. For public health, signposting and self-care, there could be a whole team approach.
We make interventions and records as part of doing MURs. Why do we need to make separate records?
The requirements described in this Q&A are all part of essential services (i.e. the core services). Therefore advice, interventions and referrals need to be made and appropriate records kept that form part of the core pharmacy work outside of the MUR process. REMEMBER – Pharmacies must be compliant with essential services in order to be able to provide advanced services.
Where interventions are made as part of the MUR process they do not need to be recorded separately to the MUR record, however if they are important for the continuity of patient care then a link or note of the intervention may need to be made in the PMR to alert colleagues to the MUR intervention and its importance for patient care.
How many records should we make?
The number of records will vary from pharmacy to pharmacy. Experience has shown that pharmacy recording of advice, interventions and referrals have varied significantly and it is likely that patient care could be improved if more records were kept, which could then be acted upon at a later date. There is no specified number of records required by the terms of service because each pharmacy will be different, but if you are giving advice every day, you are having to intervene several times a week and you find that referrals back to the GP are frequent, then your procedures which should encourage consideration of every incident to determine whether a record is needed, could lead to more records being kept than previously.