Contract monitoring

Contract monitoring

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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 2015/16

NHS England approached PSNC early in 2015 to seek support for a revised CPAF process.  The new process includes a short questionnaire consisting of 10 questions which all pharmacies would be asked to complete.  The information yielded would be considered with other information collated by NHSBSA and a number of pharmacies would then be asked to complete the full CPAF questionnaire – many of these pharmacies would be visited for contract monitoring purposes.  This shortened version is being issued by NHSBSA and will be available to complete electronically from 5 October for a period of four weeks. 

PSNC’s Health Policy and Regulations subcommittee was asked to consider an abbreviated Community Pharmacy Assurance Framework (CPAF) questionnaire, which contains 10 questions, each covering parts of the terms of service set out in the NHS (Pharmaceutical and Local Pharmaceutical Services) Regulations 2013. The results of this together with additional information collated by NHSBSA and NHS England will be used to prioritise monitoring visits to help ensure that patients and members of the public receive safe, effective and high quality pharmaceutical services. The full CPAF will then be sent to those pharmacy contractors that are being considered for a visit.

PSNC agreed that the full CPAF provides a useful tool for pharmacy contractors to self check their compliance with the terms of service once it is available (probably January or February 2016).  It also agreed that all contractors should be asked to complete the shortened version as a preliminary screening exercise.

The closing date for responses has now passed and NHSBSA confirm that more than 96% of NHS pharmacy contractors have completed the abbreviated CPAF questionnaire. Well done! 

For the 2015/16 questionnaire NHS England has requested NHSBSA carry out the administration of CPAF at a national level on their behalf and this will be facilitated by a secure on-line mechanism for contractors to complete their returns.

Contract monitoring next steps 2015/16

Community pharmacies across England were asked to complete an initial screening questionnaire in October 2015 as part of the updated Community Pharmacy Assurance Framework. The results of this screening questionnaire, along with other locally held information, will help NHS England local teams to identify which pharmacies should be considered for a contract monitoring visit and asked to complete the full CPAF questionnaire.

The updated 2016/17 process (September 2016) describes 2 parts:

  • Follow up visits to a selection of pharmacies to validate the answers given in the screening questionnaire
  • Consideration and process to be followed to identify those pharmacies where a comprehensive contract monitoring visit is required.

For 2015/16 it is anticipated that 2-4% of pharmacies in a region will be visited before the end of May 2016. This number includes those that may have been visited before the CPAF screening process, those visited to validate their self-assessments and those who are visited following completion of the full CPAF questionnaire.

Contract monitoring for 2016/17

Community pharmacies across England will be asked to complete an initial screening questionnaire in June 2016 as part of the updated Community Pharmacy Assurance Framework. The results of this screening questionnaire, along with other locally held information, will help NHS England local teams to identify which pharmacies should be considered for a contract monitoring visit and asked to complete the full CPAF questionnaire.

The updated 2016/17 process (September 2016) describes 2 parts:

  • Follow up visits to a selection of pharmacies to validate the answers given in the screening questionnaire
  • Consideration and process to be followed to identify those pharmacies where a comprehensive contract monitoring visit is required.

For 2016/17 it is anticipated that 3-5% of pharmacies in a region will be visited throughout the course of the year including those visited to validate their self-assessments and those who are visited following completion of the full CPAF questionnaire.

In order to align more with community pharmacies’ usual compliance timeframes – avoiding “pressure points” e.g. particular busy periods in community pharmacy such as the flu season, the 2016/17 CPAF screening questionnaire will be available via NHSBSA from Monday 6th June 2016 for four weeks. It is anticipated that pharmacy contractors will receive an individual email with links to the CPAF screening questionnaire on or around  6th June 2016 if not slightly before this date.

NHS England will then identify a small number of pharmacies for a monitoring and some will be asked to complete the full CPAF questionnaire – as this is a lengthy document which includes questions related to all services, pharmacies are recommended to not leave this to the last minute before completing it.

The PharmOutcomes based CPAF is no longer used by NHS England teams but has been available to pharmacy contractors for self assessment purposes.

The full NHSBSA CPAF questionnaire is available as a PDF document on NHS BSA’s website for use as a training tool or to allow continuous monitoring of compliance against the community pharmacy contract.

PSNC in discussion with NHS England has agreed contract monitoring arrangements for 2016/17. A letter will be sent out shortly in terms similar, if not, identical to the contents which appears here.

The CPAF screening questionnaire for 2016/17 ran from Monday 6th June 2016 and was available for completion on NHS BSA’s website for four weeks. The closing date for responses has now passed and NHSBSA confirmed that more than 97% of NHS pharmacy contractors had completed the CPAF screening questionnaire.

PSNC also published a number of news stories on 22 April 20163 June 201617 June 2016 , 1 July 2016, 15 July and 17 October 2016 with further information for pharmacy contractors.

PSNC has also developed a short 10 minute podcast on contract monitoring which may be helpful. 

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:

Essential service

Requirements

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:

  • the pharmacy has notified the prescriber that a supply of medicines or appliances have been refused,
  • the patient is referred back to prescriber for further advice if supply of medicines or appliances has been refused,
  • the pharmacy notifies the prescriber of any clinically significant issues arising in connection with the prescription.

Public Health

Prescription linked interventions:

Where a person using a pharmacy presents a prescription and it appears to the pharmacist or staff that the person:

  • has diabetes,
  • is at risk of coronary heart disease, especially those with high blood pressure, or
  • smokes or is overweight,

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:

  • auditing of the provision of the service by the pharmacy, and
  • follow-up care for the person who has been given the advice.

Signposting

The pharmacy must, in appropriate cases, keep and maintain a record of any information given or referrals made in relation to signposting.

Signposting includes:

  • referral to another provider of health or social care services or support where the pharmacy cannot provide the advice, support or treatment needed,
  • referral to another pharmacy or dispensing appliance contractor where, on presentation of a prescription form or repeatable prescription, the pharmacy is unable to provide an appliance or stoma appliance customisation because the provision of the appliance or customisation is not within the pharmacy’s normal course of business.

The records must be in a form that facilitates:

  • auditing of the provision of the service by the pharmacy, and
  • follow-up care for the person who has been given the information or in respect of whom the referral has been made.

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:

  • on treatment options, including advice on the selection and use of appropriate drugs which are not prescription only medicines; and
  • on changes to the patient’s lifestyle.

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:

  • auditing of the provision of the service by the pharmacy; and
  • follow-up care for the person to whom or in respect of whom the advice has been given.

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.



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