In November 2006 PSNC determined its target service development priorities for the year ahead. They were:

Advanced services:   Obesity/Diabetes screening

                                      Sexual health – EHC & Chlamydia screening

                                      Minor ailments

                                      Stop smoking

Enhanced services:  Seasonal influenza vaccination

                                      Independent prescribing

This paper updates the committee on the work/research undertaken so far and highlights the challenges and issues that exist in relation to these services; a number of discussion points for the committee are included.

Commissioning context

These priorities have been widely publicised in the professional press and have been discussed with DH officials and ministers. At the last meeting with a minister (Andy Burnham), a robust discussion was had on the need for development of Advanced services; DH’s default position continues to be that service development should be determined locally by PCTs.   The Chairman and CEO are meeting Lord Hunt on 23 May and will press the arguments for national services.

PCT officials tend to hold the contrary view that some national service development would be beneficial, in addition to locally responsive commissioning through Enhanced services. In recent discussions with PCT and SHA staff, the need for local engagement in any national service developments has been highlighted. Anecdotal reports suggest that many PCT staff perceive their relationship with GPs and dentists to be stronger than that with their pharmacists. This feeling exists in areas where significant contract monitoring has been undertaken; relationships with GPs and dentists appears to have been developed by the forced engagement with individual clinicians that has happened at QOF review visits and during the local discussions that precede the signing of GMS/PMS and dental contracts.

SHA and PCT staff have suggested that any future commissioning of Advanced services should include a locus for PCT activity (probably mandated centrally) in order to build local responsibility for and ownership of the service.

Obesity/Diabetes screening

Obesity

Obesity is the second most common preventable cause of death after smoking in Britain today and is responsible for more than 9,000 premature deaths per year in England.  At present, more than half of the British adult population is overweight and obesity has trebled in the last 20 years to 22% of men and 23% of women. The same scale of problem is true for children also. There has been a 22% increase in overweight (including obese) and a 38% increase in childhood obesity since 1995. Forecasting Obesity to 2010 warns that if current trends continue more than a quarter of British Adults will be obese by 2010.

Obese people have an increased risk of dying prematurely or developing Cardiovascular Disease, Type 2 Diabetes, Hypertension, Dyslipidemia, some cancers, musculo-skeletal problems and other diseases. The ‘Choosing Health’ White Paper (2004) recognised obesity as a key priority and included a commitment to ‘halt the year-on-year rise in obesity among children under 11 by 2010, in the context of a broader strategy to tackle obesity in the population as a whole’. This is monitored through a national Public Service Agreement target.

NICE issued ‘Obesity – guidance on the prevention, identification, assessment and management of overweight and obesity in adults and children’ in December 2006; this guidance must be followed by the NHS, but is supplemented by the DH ‘Care pathway for the management of overweight and obesity’.

Draft service specifications have been developed for adult and childhood obesity identification and management, based on the NICE guidance.

Obesity and overweight are stratified in the NICE guidance into a number of groups, with higher risk groups receiving more intensive interventions, including pharmacotherapy and surgery:

The treatment algorithm (see service specification) for the service is based on the NICE guidance; only lifestyle factors will be addressed with the patient. The algorithm is based on a number of considerations:

• The white group (in the table above) will receive only basic advice, but not the full service (as recommended by NICE). Any people in this group who present prescriptions for dispensing at a pharmacy are legitimate targets for the Prescription-linked Healthy Lifestyle Advice element of the Essential level Public Health service.



• The target population for this service is the light grey groups (in the table above);



• The higher risk groups (dark grey and black) are likely to require pharmacotherapy and management of co-morbidities. Consequently lifestyle advice needs to sit alongside medical management of the condition(s). This group of patients could enter the pharmacy programme, as long as their GP consents to this.



• The pharmacy programme should not include pharmacotherapy due to:
  
  
  
  
  • the need to demonstrate that community pharmacy can make an effective lifestyle intervention within a national service;
  
  
  
  • the challenge of making a legal supply, without the use of  independent prescribing or a plethora of local PGDs;
  
  
  
  • the increase in cost that any drug therapy would bring; and
  
  
  
  • the need for most patients who would require drug treatment to also need management of co-morbidities.
  
  
  
  

Diabetes screening

In November the committee decided that an obesity service should sit alongside screening for diabetes for any obese patients who were identified as high risk for the disease. The NHS National Screening Committee (NSC) has for a long while held the view that population screening for diabetes is not an effective intervention, but some targeted screening of at risk populations may prove beneficial in certain circumstances. This view was to be reviewed in light of ongoing research in 2005.

The Diabetes, Heart Disease and Stroke (DHDS) Pilot Prevention Project, funded by the Department of Health, which assessed the feasibility of screening for Type 2 diabetes in primary care ran from 1st October 2003 to 30th September 2005.

A significant idea to emerge during the course of the DHDS Pilot Prevention Project was the concept of thinking in terms of ‘the vascular syndrome’, as opposed to individual diseases such as coronary artery disease or diabetes. People who happen to be diagnosed as having diabetes almost always have vascular disease and the prevalence of diabetes in people with, for example, coronary artery disease is significantly higher than in the general population.

Another important theme is to move away from tackling risk factors, either singly or in combination, rather to focus on people at risk. Therefore, diabetes can be viewed as another risk factor for vascular disease, as well as a condition in its own right. Also, controlling the risk factors for vascular disease is seen as being as important as the management of blood glucose levels in people with diabetes. This finding was included in the proposal for a Vascular Disease Risk Factor Assessment And Management Programme — submitted to the NSC meeting 29th November 2005.

As a result of the DHDS prevention project, the NSC recommended to the four CMOs, the introduction of a Vascular Risk Management Programme, in which the whole population (over 40 years) would be offered risk assessment that could include measurement of risk factors such as blood pressure, cholesterol and glucose.

A number of different options are being considered by DH, NICE, and the NSC at present.   These include:

1. self-assessment of risk through the NHS Health Check Programme;



2. record-based assessment to identify people at highest risk who are not receiving comprehensive risk advice and management. This would involve interrogation of GP records, basing assessments on data already held on individuals; and



3. primary care population-based risk assessment which would use the primary care populations to offer those who are not at highest risk, as identified by record-based assessment, the opportunity of risk assessment

The interventions that will be used include blood cholesterol measurement and blood glucose measurement for a sub-set of the population, and this will constitute screening for Type 2 diabetes.

Guidance on vascular risk assessment is currently being prepared, and will be presented to the UK National Screening Committee (NSC). In England, the Department of Health (DH) Vascular Programme Board is reviewing the recommendations from the NSC, and will discuss them with stakeholders.

These developments clearly provide an opportunity for community pharmacy to play a role in vascular risk assessment, specifically by providing a venue for option 3 – the population-based risk assessment. This would involve a service that assessed vascular risk in the 40+ target population, who are not in regular contact with their GP, hence will not have been assessed by the record-based approach. This screening service would be an adjunct to the obesity service, but would not be limited to overweight/obese people because of the imperative to screen the whole population.

A draft service specification, based on the current information available is being prepared and it is proposed that the obesity and vascular risk services are discussed with DH (a meeting has already been arranged to meet MPI, the DH obesity team and the DH diabetes team/Czar).

The committee is asked to comment on the service specifications, these proposals and the following points that have arisen during internal discussions:

1. Are the target groups for the obesity service appropriate? Does community pharmacy have the capacity to take on all this workload (it is not possible to get estimates of the number of people in the different obesity sub-groups, but a cap on activity would probably have to be used similar to the MUR service).



2. Should the service cover children? (They are potentially a more challenging group to deal with, but there would always be a necessity to work with the parents as well, who may themselves be potential candidates for the service. The PSA target is aimed at childhood obesity).



3. How do we manage the tension created by the Essential services requirement to provide advice to overweight people with scripts? Could this requirement be extended to all people visiting a pharmacy that provides the obesity service (as there will be a driver to talk to these people anyway in order to recruit them to the service – but the assessment of weight goes beyond the Essential requirements, but is in line with NICE guidance)?



4. How can skill mix be maximised in the provision of both services? Should support staff undertake the recruitment of patients and the initial assessments, including tests?



5. Does the provision of the obesity service across the network of pharmacies, rather than in targeted geographical locations, increase the risk of health inequalities being widened? (possibly yes, but the NICE guidance requires this advice to be provided to all overweight/obese patients).



6. Will sufficient pharmacies provide the service if it is commissioned nationally (the MUR roll out experience has provoked questions from DH on the appetite of contractors for more services)? Would it be possible to provide DH with robust estimates of the likely service coverage across the country?



7. Should pharmacies have to be providing the MUR service before they can offer either of these new services (this approach is being taken in some local schemes, e.g. Coventry; the same consultation area requirements apply to all services and the new services could be linked to MURs for many patients)?



8. What training/accreditation will be required for the service? Training on brief motivational interviewing technique will probably be required; this is also relevant to stop smoking services and other public health interventions.



9. Should a pharmacy be able to provide the service for any patient, rather than only for regular patients of the pharmacy?  This would be consistent with the objective, but is a departure from the MUR service.

Sexual health – EHC & Chlamydia screening

EHC

Unwanted teenage pregnancy continues to be a major issue in England, and this is reflected in a PSA target. EHC supplies from pharmacies has a role to play in increasing access, but recently questions have been asked about whether the increased access to EHC is actually exerting a downward pressure on the number of unwanted pregnancies and terminations of pregnancy.

An EHC service specification has been previously agreed within the Enhanced tier of the contract. This specification has been modified to provide a draft national service specification.

There are currently no national figures on the number of PCTs that commission local EHC services, but the perception is that a high number do.

A number of challenges stand in the way of a national EHC service; these are outlined below with possible solutions and further matters that will need to be considered:

Supply route

In order to have an EHC service commissioned at a national level, there would need to be a legal supply route, such as a PDG, in place in each commissioned pharmacy. Alternatively the pharmacy medicine version of Levonelle could be used, however this would prevent the use of the service by under 16s, due to the terms of the P product authorisation. Clearly the exclusion of under 16s from the service would severely reduce its health impact.

Currently there are no provisions to allow the use of ‘national’ PGDs – all PGDs have to be signed off at a PCT/Trust level (the Scottish emergency supply service has used a nationally agreed PGD that is then implemented at a local level).

It may be possible for DH to direct PCTs to commission a local EHC service using a national service specification/PGD. This would be similar to Directed Enhanced Services (DES) used in the GMS contract.

Child protection

The supply of EHC to under 16s via PGD necessitates the provision of child protection support to community pharmacists, in order that they can refer on children at risk into the local safeguarding system. This requirement helps to support the case for any national commissioning to be provided through direction to PCTs.

Age group covered

Some local schemes currently restrict the service to certain age groups. Should a national service contains such a restriction?

Funding

A DES approach would require earmarked funding to provide the service; careful thought would need to be given to the allocation of the funding across the PCTs.

Additionally, PCTs would need to make provision for the cost of the product supplied.

Impact on OTC sales

The sales of the pharmacy medicine Levonelle are substantial (exact figures are being sourced). An unrestricted national EHC service could have a significant impact on this market.

Chlamydia screening

Genital Chlamydia trachomatis infection is the most commonly diagnosed bacterial sexually transmitted infection in genitourinary medicine (GUM) clinics in the UK; 10-30% of infected women develop pelvic inflammatory disease (PID). A significant proportion of cases, particularly amongst women, are asymptomatic and so, are liable to remain undetected, putting women at risk of developing PID. Screening for genital Chlamydia infection may reduce PID and ectopic pregnancy.

Chlamydia screening via community pharmacies fits well with the provision of EHC, due to the user/target groups often being the same. Chlamydia screening is currently carried out across England as part of the National Chlamydia Screening Programme (NCSP).   The NCSP covers the whole country and its aim is to screen all sexually active males and females under 25 years of age. National standards apply to the programme and funding has been provided to PCTs to commission the service. Local Chlamydia Screening Offices (CSOs) coordinate the service locally across one of more PCTs. Screening, using first-void urine samples or self-taken vulva-vaginal swabs, is initiated in a range of settings, both clinical and non-clinical. Samples are sent to a laboratory for analysis and the results are returned to the CSO who inform patients of their result and conduct contact tracing with people with positive results and offer them and their partner’s treatment.

A trial of Chlamydia screening from pharmacies in London is currently being conducted in branches of Boots. This trial is due to complete in November 2007 and will inform future roll out of a pharmacy based service. The trial is being evaluated for DH by TNS. Though not part of the NCSP, the trial follows a similar protocol, i.e. distribution of test kits in Boots stores, with appropriate advice; samples are returned to the store to be forwarded to the laboratory; negative test results are managed by Boots, using a range of communication methods; positive results are managed by the CSO, including contact tracing; treatment of positives can be provided by Boots stores under a PGD for azithromycin, or other local treatment options can be chosen by the patient.

An interim report has been published which indicated screening numbers substantially below those anticipated in the planning phase; most other issues raised in the report related to low levels of patient feedback, as part of the evaluation of the service.

A number of other pharmacies are involved in screening: pharmacies in Cornwall are distributing testing kits, in some cases using self-selection promotional dump bins; a Lloydspharmacy in Manchester is providing a full screening service, including treatment and contact tracing (contact details are obtained from the patient and then forwarded to the CSO to follow up).

It seems likely that DH will resist any movement towards roll out of a national scheme until the final evaluation of the Boots trial is complete in early 2008. It is also likely that they will resist the development of a parallel pharmacy system running alongside the NCSP. However PSNC should consider highlighting to DH what we could offer now.

A number of options are available including:

1. A distribution service (all management of results/tracing/treatment dealt with by CSO)



2. A distribution plus treatment service (treatment would rely on locally agreed PGDs)



3. A distribution plus treatment service and contact of negatives



4. A distribution plus treatment service and contact of all patients including contact tracing

Questions:

• What benefit would pharmacies deliver in managing negative results, over the normal CSO option?



• Would all pharmacies want to provide a tracing service? Would they all have the capacity to undertake this service?



• Would all pharmacies wish to provide a treatment service under a local PGD?

Discussions with a small number of pharmacists have so far suggested that most would not want to be involved in providing tracing, but that treatment of positives would be acceptable.

The first option could be proposed to DH as a new Essential service (similar to the signposting and waste services, in that the service would be provided locally as long as the CSO provided the kits and appropriate details for referral and service management). This approach would substantially expand the current number of screening venues in the NCSP. As a relatively uncomplicated and moderate cost (to contractors) service, it could be used as a lever to help persuade DH to commission a combined EHC + Chlamydia service. If it is felt that this approach is worth considering, the next step would be to discuss wider pharmacy involvement with officials at the NCSP.

Minor Ailments Service (MAS)

Around half of PCTs currently commission a MAS from some of their pharmacy contractors and a national Enhanced service specification already exists.

PSNC previously pushed to get a national minor ailments service included in the first negotiations on the contract. DH refused, citing the need to allow local commissioning where there was a demonstrated need for the service and the difficulty of them commissioning a national service which cost PCTs additional money due to the cost of drugs supplied locally. Concern has also been expressed about the potential for misuse of MAS by people who use the service to ‘stock up’ their home medicines cupboards; DH have failed to demonstrate any evidence of this activity in existing schemes, nor have any PCTs reported this as a local problem.

Lord Hunt has recently reiterated the DH refusal to consider a national scheme in a C&D interview.

PSNC is in the process of amending the Enhanced spec to convert it to an Advanced specification and developing a restricted base formulary that could be used in a national service (these will be available at the sub-committee meeting for consideration).

It is suggested that PSNC makes a final approach to DH to make the argument again for a national service, but that consideration is also given to alternative options to use in the circumstance that DH reject the proposal again.

Two options to facilitate local roll out of the service in areas that are not yet commissioning MAS have been identified:

• Produce a sales pack, including example documentation and evidence from existing schemes, to be used in local discussions with PCTs/PBC commissioners. It may be appropriate to provide dedicated sales support to LPCs to assist them in making the pitch to local commissioners. SHAs could also be targeted as part of this approach.



• Offer to provide project management support to implement a scheme locally once agreement has been reached.

It is likely that PBC groups would be a key target, as many are likely to be looking for ways in which to build primary care capacity to facilitate transfer of services from secondary care.

Seasonal Influenza vaccination

A draft Enhanced service specification for seasonal influenza vaccination is set out at the end of this Appendix for consideration.