December 2010

The shadow board will be a sub-committee of the PCT with the CEO remaining the accountable officer until the dissolution of PCT in 2013. The board will be expected to commission the majority of services, lead on QIPP and deliver financial balance and targets. They will lead with the PCT the transition from PCT to GP commissioning.

The Structure of the Board will be:

Chair
The PCT Director of Commissioning
A PCT Non-executive director
GP Board members with lead roles for:

Mental Health
Non-elective Care
Planned Care
Practice Compliance
Transforming Community Services

There will also be representation from Public Health and the public. A LMC appointee will have observer status.

Job descriptions have been drawn up for these five GP posts and the chair.

In addition, if after the appointment of GPs to these roles one or more “clusters” is not represented at board level, there will be an election in the “Cluster” for a further board member.

There has been a lot of discussion about election/selection to these board posts. These are important posts and the appointees will need specific qualities and competencies to fulfil the roles. It has been decided that the post of Chair of the board will be filled by a selection process to select applicants with the appropriate skills, followed by an election by the GPs in Stoke. The other board roles will be filled by a selection process. This process has been discussed and approved by the LMC.

The selection board will consist of Graham Urwin from the PCT, a non-executive director of the PCT, two members from the LMC who are not standing for any of the board posts or have any close connection with the applicants, and an independent representative from the City Council.

The appointment of the Chair of the board will take place prior to the appointment of other board members and the new Chair will sit on the selection committee for the board members.

Assuming that more than one candidate is deemed suitable for the appointment to the post of Chair of the Board, an election will be held between the selected candidates. This will be facilitated by the LMC.

We have had lots of discussion about the electorate for this election, some believe that all doctors on the performers list of Stoke on Trent should have a vote each, others believe that only GP principles should be voting as they will be responsible for the budgets which are devolved to practices. Neither of these suggestions is equitable and the preferred option is to allocate a number of votes to each practice based on their list size, practices should consult with all doctors working in their practices on how these votes are cast. This should ensure a voice for non principals working in practices.

Any doctor who has been working in a Stoke on Trent practice for at least two sessions per week for a minimum of 12 months by 1^st April 2011 can apply for a post on the board. Thus the posts are open to both principals and sessional doctors.

Applicants must have support from their practice and the commitment of the practice to allow them to take time out of the practice to perform their role.

Job descriptions are now available and will be circulated to practices by email. Copies are also available from Sandra Chadwick who can be contacted at Sandra.Chadwick@stoke.nhs.uk.

The timetable for the appointment is fairly tight. Applications for the post of Chair had to be made by 8^th December with the selection panel sitting on 14^th December. If an election is necessary voting papers will be circulated immediately after 14^th December to be returned by Tuesday 4^th January. The result will be announced on 5^th January.

Applications for the other board posts are to be made by 17^th December with the selection panel sitting on 11^th and 12^th January 2011.

Locality Leads if required to achieve geographical coverage will be decided by an election process to be held at the end of January/early February.

Prescribing Issues

There have been a number of issues raised recently about prescribing. Most of these have been covered in previous newsletters and although there have been no significant changes to previous guidance it is worth repeating here. The most common queries concern:

a) Prescribing Responsibility

BMA guidance states that it is the doctor who signs the prescription who carries legal responsibility, not the doctor who may suggest it. GPs should only prescribe on the recommendation of a consultant if they are in agreement that the medicine is appropriate, and if they are sufficiently knowledgeable about the use/interactions/side effects of the particular medicine to take personal legal responsibility for writing the prescription for it.

Many complex illnesses may be monitored in primary care, with the GP accepting responsibility for some of the necessary prescribing, but then referring back when necessary under ‘shared care’ agreements for a consultant to prescribe treatment with which the GP cannot be expected to be familiar. In general the doctor who has the clinical control of any aspect of the patient’s management should accept the responsibility for prescribing, except where another doctor has willingly agreed to take some of that responsibility under a ‘shared care agreement’. There is no reason why prescriptions cannot be issued by a hospital doctor and posted to a patient who lives at a distance from the hospital. Any GP has the right to refuse to prescribe a drug that they are not prepared to take clinical responsibility for.

GMC guidance supports the BMA guidance and goes on to state “There should be full consultation and agreement between general practitioners and hospital doctors about the indications and need for particular therapies. The decision about who should take responsibility for continuing care or treatment after initial diagnosis or assessment should be based on the patient's best interests rather than on the healthcare professional's convenience or the cost of the medicine.”

b) Unlicensed and "off label" prescriptions

We sometimes receive requests to prescribe medications which are unlicensed or “off label” i.e.. outside their licensed indications. The GMC advice on prescribing unlicensed medications is:

You can prescribe unlicensed medicines but, if you decide to do so, you must:

Be satisfied that an alternative, licensed medicine would not meet the patient's needs
Be satisfied that there is a sufficient evidence base and/or experience of using the medicine to demonstrate its safety and efficacy
Take responsibility for prescribing the unlicensed medicine and for overseeing the patient's care, including monitoring and any follow up treatment
Record the medicine prescribed and, where you are not following common practice, the reasons for choosing this medicine in the patient's notes.

On “off label” use GMC guidance states;

You may prescribe medicines for purposes for which they are not licensed. Although there are a number of circumstances in which this may arise, it is likely to occur most frequently in prescribing for children. Currently pharmaceutical companies do not usually test their medicines on children and as a consequence, cannot apply to license their medicines for use in the treatment of children. The use of medicines that have been licensed for adults, but not for children, is often necessary in paediatric practice.

When prescribing a medicine for use outside the terms of its licence you must:

Be satisfied that it would better serve the patient's needs than an appropriately licensed alternative
Be satisfied that there is a sufficient evidence base and/or experience of using the medicine to demonstrate its safety and efficacy. The manufacturer's information may be of limited help in which case the necessary information must be sought from other sources
Take responsibility for prescribing the medicine and for overseeing the patient's care, monitoring and any follow up treatment, or arrange for another doctor to do so
Make a clear, accurate and legible record of all medicines prescribed and, where you are not following common practice, your reasons for prescribing the medicine.

c) Lithium

The National Patient Safety Agency published an alert about the prescribing of lithium last year. The recommendations in the alert have to be implemented by 31st December 2010. The recommendations are:

there are reliable systems in place to make sure that the results of blood tests are communicated between laboratories and prescribers;
at the start of lithium therapy, and throughout their treatment, patients receive appropriate ongoing verbal and written information and a record book to track lithium blood levels and relevant clinical tests;
prescribers and pharmacists check that blood tests are being monitored regularly and that it is safe to issue a repeat prescription or dispense the prescribed lithium;
systems are in place to identify and deal with medicines that might adversely interact with lithium therapy.

The recommendations have been discussed locally and a shared care agreement has been drawn up for the sharing of care between secondary and primary care. Secondary care will be responsible for arranging the necessary blood monitoring and informing GPs of the results.

Copy of the protocol.

Copy of the ESCA.

Because of the requirement for the patient to have a hand held record containing their blood results which they should show to the pharmacist, the process is quite complicated and may well be refined over the coming months. Colleagues are reminded that participation in any shared care agreement is voluntary.

d) Bowel Cleansing Preparations

The National Patient Safety Agency has raised an alert concerning death and harm from electrolyte abnormalities, dehydration and serious gastro-intestinal problems that have been reported following the inappropriate use of oral bowel cleansing solutions, Picolax etc. The alert stated that a clinical assessment is to be undertaken by the clinician authorising the surgery or investigation (including GPs using the direct access route) to ensure that there is no contraindication (e.g. diverticulitis) or risks (concurrent medication such as diuretics) from the use of a bowel cleansing solution. A copy of the report can be found here.

This has been discussed at various committees including the Area Prescribing Committee and an easy solution to the problem not been found. If it is to be prescribed by secondary care they would need to see the patient prior to prescribing to assess the risk. The UHNS have issued guidance without referral to the APC. However as the NPSA advice is that GPs be responsible for prescribing bowel cleansing preparations when referring for direct access colonoscopy etc it is difficult to see any other solution.

e) Requests for weekly prescriptions

Drug dosage cassettes are becoming increasingly popular among elderly patients and community care workers will not take responsibility for the administration of medication unless these systems are used.

Some pharmacies are demanding that GPs issue weekly scripts to help cover the cost of these systems.

MDS systems have a limited role in the safe delivery of medications to patients. The decision to supply a MDS should be undertaken by the dispenser with reference to the concerns from other health professionals and the Disability Discrimination Act. The dispensing fee for community pharmacists includes a payment taking into account the cost of supplying compliance aids (including MDS) or other reasonable adjustments, to patients who meet the criteria included in the Disability Discrimination Act. The provision of a "reasonable adjustment" to support the patient with their medication, which may be the provision of MDS, is funded through the dispensing fee.

Prescriptions for 7 days should only be issued to patients when clinically necessary. Examples where a 7-day supply may be appropriate include:

Safety concerns about supplying more than
one week at a time
Unstable patients whose medication regimen
may be susceptible to change – shorter
prescription length may help to reduce waste
Recently discharged patients awaiting
medication review

If there is a need for MDS, it should not be funded by increased GP workload.

f) Private Prescriptions

Can a GP issue a private prescription to NHS patients for medication which are cheaper when obtained private? There are some differing opinions on this. An NHS circular in 1994 stated "the Department's legal advisers have given the opinion that a general practitioner may issue a private prescription at the request of, or with the consent of the patient, provided that in such circumstances the doctor takes account of whether the patient is exempt from NHS prescription charges. A private prescription would never be appropriate for a patient who was exempt from paying an NHS prescription charge".

The GP cannot of course charge for the provision of such a private prescription.

This implies that if an item that is in the drug tariff may be obtained more cheaply by a patient by having a private prescription written, then the doctor is able to do so, so long as they do not make any charge for the private prescription. The GP, however, is not required to provide a private prescription and could refuse. Equally a patient can choose whether they wish a private prescription to be written or not.

The strict advice, therefore, is that if a GP writes an FP10 and the patient then, in discussion with the GP, decides that they also wish to have a private prescription then the doctor may write a private prescription and it is then a matter for the patient to choose which one should be dispensed. This has, of course, the obvious danger of providing two prescriptions for the patient, which I would have thought is not a particularly satisfactory scenario. However, it does mean that the GP is not in breach of their Terms and Conditions of Service and, at the same time, satisfying the patients need.

The other issue is that although the GP may be aware that the tariff price for a particular drug may appear to be cheaper for the patient by using a private prescription this is, of course, very much dependent on the mark up that the pharmacy decides to charge the patient and it is quite possible that a patient could end up paying the same amount; giving rise to patients complaining that they had been misled by their GP.

The documents which support the advice in the above sections and well worth reading are:

BMA guidance "Information and Guidance on Prescribing in General Practice"

BMA guidance "Prescribing and the Primary and Secondary Care Interface"

The NHS Guidance of 1991,, which as far as I am aware has not been superseded.

GMC Guidance "Good Practice in Prescribing Medicines"

Vault Smears

There has again been some suggestion that GPs should be responsible for follow up of patients who require vault smears. The advice given by the GPC is that:

Within the national cervical screening programme, the responsibility for follow-up vault smears has been shifted from GPs to the gynaecologists who performed the hysterectomy.

There are two main reasons for this shift:

it is essentially a post-operative follow-up issue, as if there has been incomplete excision of neoplastic changes, this will require further intervention by the gynaecologist;
there has been considerable difficulty in performing vault smears (knowing which part of the vault to smear and ensuring that the 'corners' of the scar are adequately sampled); this is very difficult to do properly in the primary care setting, so national advice is now that it should be done by colposcopic viewing and sampling, thus ensuring a good valid sampling and greater safety for the patient.

Patients requiring vault smears should not be referred back to the GP for this at any stage; it is the responsibility of the gynaecologist to follow up his/her patient, whether this entails a single vault smear and discharge from screening, or smears every 6/12 months for 9 years or more. The only patients that vault smears are (possibly) required in will be those with vaginal intraepithelial neoplasia (VaIN), who should really be under colposcopic management since vaginal cytology is very unreliable. This move will probably uncover a number of women who have been having unnecessary vault smears, since the evidence relating to their effectiveness has evolved significantly over recent years.

GPs with patients already listed for post-hysterectomy follow-up should be transferring their care to colposcopy/gynae clinics via the referrals process.

Record Keeping and Complaints

Unfortunately we all receive complaints from time to time, only a small number of which are serious enough to warrant further investigation by the PCT or even the GMC. However, a relatively common observation running through the complaints which come to the PCTs attention is poor record keeping. This sometimes reflects poor practice, but can also makes it difficult to provide evidence of good practice. Records should contain a good history, details of examination, including relevant negative findings and a plan of action for treatment and follow up.

NHS Email

We have found that some GPs are not included in the global email addresses used to circulate all GPs in North Staffordshire and Stoke on Trent PCTs. I ask that GPs and practice managers check that all GPs including sessional GPs and locums, and practice managers working in their practices receive global emails. If anyone is found not to be included in the global address, this should be brought to the attention of the IT team at the PCT.

NHS Appraisal Toolkit

The contract between the Department of Health and SCHIN for the provision of the Appraisal Toolkit expired on 31st October.

Both Stoke-on-Trent PCT and North Staffordshire PCT have agreed to fund the use of the NHS Appraisal Toolkit for a further 12 months.

Discussions have been continuing with SCHIN in order to agree how to facilitate the contract expiry while providing continuity for doctors. The agreement we have reached is as follows.

SCHIN will be able to continue to make the ATK available until 31 March 2012 and we understand that this is their intention.
Doctors who wish to download their forms and uploaded documents from the ATK will be able to do so free of charge up to and beyond 31 October and for as long as the ATK is available.
The underlying blank forms used in the ATK will be available in MS Word format for use by any doctors who do not wish to continue with the ATK or other electronic appraisal systems, to exchange with their appraisers via secure electronic communication.

For those individual doctors who wish to use the ATK for their appraisals from November 2010 onwards, SCHIN has confirmed that there will be an associated subscription cost. The details can be viewed at the ATK website.

Individuals who do not subscribe to the ATK from November 2010 will be able to download their appraisal forms and uploaded documents free of charge at anytime that the ATK is available. Individuals who choose this option are also advised to discuss with SCHIN the transfer of their data to other systems if that is their intention. They may also wish to instruct SCHIN to delete their records from the system once they have retrieved their documentation. Detailed instructions will be available on the ATK website from 1 November 2010 at the following address: https://www.appraisals.nhs.uk/.

SCHIN has made available to the Department blank templates of the forms that appear on the ATK, in MS Word format.

Copies of these forms can be found here.

Pre-appraisal Forms

Post- appraisal Forms

Items from GPC News November 2010

NHS White Paper

The GPC has published two new guidance documents in its series on the NHS White Paper:

(i)The form and structure of GP-led commissioning consortia

This document provides advice to GPs and LMCs on the form and structure of GP-led commissioning consortia. It identifies a range of considerations regarding the discussions that will need to had locally, the relationships will need to built and the decisions that will need to made as this agenda moves forward. A copy of the document can be found here.

(ii)Shadow consortia: Developing and electing a transitional leadership

This guidance outlines a number of options that will need to be considered when developing the transitional leadership structures that will take shadow consortia forward. It also gives guidance on how to appoint the transitional leadership, giving information about elections, and selection / election processes. A copy of the document can be found here.

Transitional arrangements

The future destination of the current raft of functions that are performed at PCT level has yet to be decided. Those shadow consortia that are beginning to form should not make any arrangements with PCTs for the transfer of duties, nor should PCTs insist that consortia take on some of their responsibilities. The government will make clear in due course which organisations will be responsible for PCT and SHA functions, and local arrangements should be avoided until these details are available.

Pathfinder consortia

At the end of October, the Department of Health announced the introduction of an early adopters, or pathfinders, programme for GP commissioning consortia. The purpose of the programme is to identify and support groups of practices who are keen to make faster progress and can demonstrate capability and capacity. It will enable GPs to work with other health and care professionals, to test different design concepts for GP consortia and identify issues and areas of learning. They will create learning networks to enable others to learn from experience and best practice.

Applications for groups of GPs to form pathfinder sites can be made to SHAs from October 2010. It is expected that by December there will be about 30 pathfinder sites announced and these will be established and operational by January 2011. It is expected that other groups will follow shortly after.

To join the pathfinder programme, a group of practices needs to be able to demonstrate:

evidence of local GP leadership and support
evidence of LA engagement
ability to contribute to the local QIPP agenda in their locality.

Once established it is essential that the pathfinder sites are flexible. The initial leaders may not be the eventual leaders of the consortium, while the shape and size of the consortium may evolve in time. The early progress made by pathfinders will support emerging consortia; in sharing their experiences they will shape the way in which GP consortia work in the future.
More details can be found here.

Care Quality Commission registration

On the 10 November CQC held a stakeholder workshop for NHS primary medical care providers about registration. The GPC and LMC representatives at the event were told about the application process and the tools that will be used by CQC to monitor compliance. CQC are working on the detail of registration for GPs and used this workshop to inform its development. This workshop will be followed CQC ‘applying for registration’ pilots in January 2011.

Gemma Rafferty, CQC’s Regulatory Strategy Manager, will be giving a presentation on CQC registration at a practice registration workshop at the LMC Secretaries Conference on 25 November.

We would like to make clear that NHS GP practices do not yet have to comply with CQC standards. NHS GP Practices will begin to be invited to apply for registration with CQC from 1 October 2011 and all will need to be registered from 1 April 2012. In the application practices will need to declare compliance with 16 standards. Monitoring of compliance with the CQC standards will not commence until 1 April 2012.

However, it is worth noting that PCTMS practices should be registered with CQC because PCTs needed to be registered from 1 April 2010. Also organisations that provide some NHS primary medical services but whose main purpose is to provide other services, such as private healthcare, social care or NHS acute services need to have been registered for all of their services from 1 October 2010.

The GPC will be producing a guide on how to complete the application form for CQC registration and on how your practice can comply with each of the CQC standards. We aim to publish this guide in the spring of 2011.

CQC have also launched a consultation on proposed fees for all health care and adult social care (ASC) providers in England. NHS GP practices will enter the CQC registration scheme on 1 April 2012 and will be included within the fees scheme from that date. In autumn 2011 there will be a further consultation on the fees scheme. The GPC will be responding to the current consultation as part of the BMA response. The consultation can be viewed online.

Pharmaceutical Services Regulations

We have been working with the Department of Health, NHS Employers and PSNC on the drafting of a new set of NHS Pharmaceutical Services Regulations, which will be introduced in spring 2011.

As far as GPs and LMCs are concerned, these will preserve the existing rules around dispensing doctors. In the course of the work, and in relation to the current round of Pharmaceutical Needs Assessments (PNAs) which PCTs should now be drafting and consulting on, we have considered the issue of historic rights to dispense by GPs. We have agreed joint explanatory guidance which can be found at the links below. The second refers to the Clothier Report of 1977 (the old GMSC had representatives on the committee which drafted the report) which gave rise to many of the issues which were finally resolved in the 2005 Pharmaceutical Services Regulations.

If anybody has any questions about this guidance, or the work we are doing on the 2011 regulations, please contact Matt Isom on misom@bma.org.uk.

Rurality, controlled localities and the provision of pharmaceutical services by doctors - an explanation of the history can be found online.

The Clothier report can be found online.

Using NICE guidance in general practice

NICE have launched a new website to keep primary care professionals up to date with NICE guidance. It gives access to guidance during a consultation, steps to ensure a practice is up to date with clinical guidance and support for commissioners.

NICE are accepting feedback on the site until 1 December. Please go to the NICE website for further information.

NICE Role

The GPC discussed the recent Government announcement that NICE is to lose its role in determining the cost-effectiveness of therapies and recommending which treatments are available on the NHS. A number of concerns with the proposals have been raised, and the BMA response will be discussed at BMA Council next week.

Revalidation

The GMC has published the response to its revalidation consultation, along with a “statement of intent”, agreed between the GMC, CMOs for England, Northern Ireland and Wales, the Deputy Chief Medical Officer for Scotland and the Medical Director of the NHS in England. The response is available on the GMC website. The main points outlined in the two documents are as follows:

A plan to launch revalidation in late 2012, subject to a test of readiness in summer 2012, which involves a number of key criteria having to be met (this follows the decision by Andrew Lansley earlier in the year to extend the revalidation piloting period for a year).
Commitments to simplifying and streamlining the process, making it sufficiently flexible to apply to non-mainstream doctors and ensuring that it is cost effective. The response states that the GMC will work with its revalidation partners to ensure that this occurs.

The response reflects many of the key concerns outlined in the BMA's response to the GMC's revalidation consultation but as the GMC response recognises, work needs to be done to determine how these improvements will be achieved.

The revalidation pathfinder pilots are continuing. The Revalidation Support Team has published an interim report into these pilots and this is available online.

Sessional GPs Subcommittee election results

The results of the election to the GPC Sessional GPs Subcommittee for 2010-2013 have now been announced and the full list of members is available on the BMA website. The subcommittee held its first meeting on 2 December.

NORTH STAFFORDSHIRE

LOCAL MEDICAL COMMITTEE

Newsletter December 2010

GP Commissioning