The 2005 NHS Contract

Introduction

In 2005, community pharmacists in England and Wales began operating within the new NHS contract. "Pharmacy contract" is used to describe the new contractual framework.

Pharmacists' previous contract was agreed in 1987 and is now out of step with developments in pharmacy and the NHS. The old contract focused on throughput of a high volume of prescriptions. The new contract has different aims: it will reward high quality services, harness the skills of pharmacists and pharmacy staff, and provide minimum standards for pharmacy.

Basic structure

The new contract is formed of three tiers:

Essential Services

Advanced Services

Enhanced Services

All contractors will be expected to offer essential services. Advanced services will require accreditation of the pharmacist, the pharmacy premises or both. These two tiers form the national pharmacy contract.

On top is the third tier of enhanced services. Although a service specification and value will be agreed nationally for each enhanced service, they will be commissioned locally by primary care trusts.

The contract structure is expected to develop over time, so those services currently classified as enhanced services could be moved to either the essential or the advanced sections of the contract.

The essential services are as follows; they must be provided by all community pharmacy contractors and are not open to local negotiation:

Dispensing

Repeat dispensing

Promotion of healthy lifestyles

Signposting

Support for self-care

Clinical Governance

Waste disposal

Under the new contract, the dispensing service is defined as the supply of both medicines and appliances on NHS prescription forms. The aims of this service can be roughly divided into two - first, to dispense safely and, second, to ensure that the patient knows how to use the dispensed item. The specific jobs to fulfil these aims could be allocated to the pharmacist or other members of staff, so the term "pharmacy staff" is used to cover both in this article. This will present an opportunity to make better use of skill mix within the pharmacy.

Dispensing covers:

• The supply of medicines and appliances,
• The provision of advice about the medicines dispensed
• Possible interactions with other medicines.
• Record of what has been dispensed and possibly the advice given.
• Provision of compliance aids needed by patients with disabilities.

The contract will place new requirements on the dispensing process, some of which might mean that pharmacists' future practice will be different from the way they practise now. All community pharmacists therefore will need to review their practice against the service specification for dispensing.

Within the supply function, the first requirement is that pharmacy staff perform the appropriate legal, clinical and accuracy checks required when a prescription is presented. Next, the pharmacy will be required to have specific systems in place so that it operates its dispensing process safely and so that it can guarantee the integrity of the products supplied. When a prescription is presented, pharmacy staff will be required to dispense it on demand.

To ensure that the patient can use the dispensed medicine or appliance safely, pharmacy staff will have to provide appropriate advice. They will also be required to provide broader advice when appropriate, e.g., about potential side effects or interactions.

Record-keeping requirements are also part of the service specification. All supplies of medicines and appliances will have to be recorded. In addition, when the pharmacist considers it is clinically appropriate, a record of any advice given should be made. On top of this, if a pharmacist needs to make an intervention or refer the patient to another professional, then this, too, should be recorded.

Repeat dispensing will be a new service for the majority of community pharmacists. Pilots of repeat dispensing have been ongoing for over a year and experience from these pilots has helped to inform the service specification in the new contract.

The repeat dispensing service will allow patients to collect regular repeat prescription medicines and appliances direct from the pharmacy for a certain length of time agreed with the prescriber. The prescriber writes a "master" prescription, which is copied onto a specified number of "batch" prescriptions. The aims of this service are to increase patient choice and convenience, to reduce workload at GPs' surgeries and to minimise wastage.

Before providing this service, it is envisaged that all pharmacists will be required to complete a national open-learning package.

The repeat dispensing service will work as follows

The first task will be to educate patients about the repeat dispensing system and how it works. Once a patient has decided to use the service, the master prescription will be stored at the pharmacy. If requested by the patient, the batch prescriptions will also be stored at the pharmacy although patients can choose to keep the batches.

Repeat supplies will be dispensed against the batch prescriptions. The timing of supplies will be determined by the directions on the master prescription unless no specific instructions are given in which case the pharmacist should use professional judgement to determine when an item should be dispensed. However, batch prescriptions will be valid for a maximum of one year (or less if specified by the prescriber).

For each repeat supply, the pharmacist must ensure that the patient is taking or using the medicine or appliance appropriately and is likely to continue to do so.

The pharmacist should also ensure that the patient is not suffering any side effects caused by the treatment. Finally, the pharmacist should ensure that the medicine or appliance is still appropriate - this will include checking that any changes to the patient's medication regimen or changes to the patient's health since the repeat was authorised by the prescriber. If any problems are identified, the pharmacist can refuse to dispense an item and can contact or refer the patient to the prescriber.

If it is safe to make a supply, then the item should be dispensed and a record of supply should be made so that it is clear which batch issues have been dispensed. There will also be a requirement to inform the prescriber of any clinically significant issues that occur in relation to the repeatable items

Both the dispensing and repeat dispensing services will change substantially when electronic transmission of prescriptions (ETP) is introduced. When this will be is unclear; certainly a paper-based system will be in place when the new contract is first implemented.

Public health has moved up the agenda in the past few years, so one of the essential services in the new community pharmacy contract is "promotion of healthy lifestyles". Linked to public health are two other essential services: signposting and support for self-care.

"Promotion of healthy lifestyles" will include opportunistic one-to-one counselling on smoking cessation and coronary heart disease risk factors, promoting vaccination against influenza and providing education about appropriate use of antibiotics.

The public health essential service is formed of two components: first, the provision of opportunistic advice to patients obtaining prescriptions from the pharmacy and, second, involvement in public health campaigns.

The aim of this service is to increase public knowledge about key healthy lifestyle messages. In particular, it is hoped that it will target the "hard to reach" sectors of the population who are not frequently exposed to health and social services so might miss health promotion activities.

Under the prescription-linked intervention part of the service, pharmacists and pharmacy staff will be expected to give opportunistic advice on specified public health topics to patients presenting prescriptions. This advice will be given verbally but could also be backed up with written information, e.g., leaflets, if appropriate. It might also be necessary to refer the patient to another health professional or organisation.

Advice given will need to be recorded on the patient's record held at the pharmacy. The need for records is two-fold: for follow-up with the patient and for audit purposes.

The public health topics about which pharmacists will advise are: Smoking cessation with targeted focus towards high risk groups such as pregnant women, at those at high risk of coronary heart disease and at young people. Another topic is reducing CHD risk factors, again targeted at those at particular risk. Providing advice about obesity and healthy diet presents many opportunities, for example, highlighting messages such as eating five portions of fruit and vegetables a day, increasing physical activity, reducing salt intake and limiting alcohol consumption. Advice on these topics could be given to people who are overweight, particularly those who already have other risk factors. A further possibility is advising people about the need for influenza immunisation.

Pharmacists are also expected to take part in national and local public health campaigns. The campaign topics will be decided by primary care trusts, which will provide support such as briefing packs and patient literature for the campaigns. During the campaign periods, pharmacists and pharmacy staff will have to be pro-active in providing public health information to both patients and general visitors to the pharmacy. Provision of written information and in-store displays might also be necessary.

Signposting patients to other health care providers is also an essential service. Linked to this is support for self-care; this essential service will include receiving referrals from NHS Direct and provision of advice to patients on treatment of minor ailments, thus reducing burdens on GPs.

Pharmacists already refer people to other health professionals or organisations and this role is to be formalised as an essential service in the new contract.

The service means that if the pharmacy is unable to provide the support, advice or treatment that is required, the pharmacy staff will refer the person to a health or social care provider, or another appropriate organisation such as a patient group. It might be considered appropriate to provide written referral notes. If the patient is known at the pharmacy, and the pharmacist deems the referral to be of clinical significance, then the referral will be recorded in the patient's record at the pharmacy.

PCTs will be expected to provide pharmacies with the contact details of health and social care providers and local patient support groups to whom patients can be referred.

One of pharmacists' key roles is to provide patients with advice and support to enable self-care. Through this service, pharmacy staff provide advice to patients and carers who request help with the self-treatment of minor illness and chronic conditions. This includes providing general information about the management of the condition. In addition, and when appropriate, advice should be given about the use of non-prescription medicines. The final part of the advisory role will be to make interventions to promote healthy lifestyles, in a similar manner to the public health essential service described earlier in this article.

It is expected that both NHS Direct and other health professionals will refer patients to the pharmacy for self-care advice. And, as for the signposting service, pharmacy staff will refer patients who need additional help to other care providers when appropriate.

If the patient is known at the pharmacy, and the pharmacist considers the interventions made to be clinical significant, then a record of advice given, products purchased or referrals made should be added to the patient's record at the pharmacy.

Clinical governance is an essential requirement for the contract. Contractors will be expected to ensure that standard operating procedures are used, that adverse incidents are reported to the National Patient Safety Agency, that continuing professional development is undertaken by pharmacists, that services are audited, that patient satisfaction questionnaires are carried out and that interventions are monitored.

Clinical governance is defined as a framework through which NHS organisations are accountable for continually improving the quality of their services and safeguarding high standards of care by creating an environment in which excellence flourishes.

Principles of clinical governance
The new contract contains three principles of clinical governance. They are:

• Clinical governance should be built into all professional services
• Clinical governance is driven by a genuine desire to improve the service delivered to patients
• The development of clinical governance in community pharmacy is supported and encouraged by primary care organisations

Seven components of clinical governance are used by the Commission for Healthcare Audit and Inspection (now commonly called the Healthcare Commission) to assess how well an organisation meets clinical governance requirements. The clinical governance essential service in the new pharmacy contract is based on these seven components. Each of the components are described below (using the original CHAI definitions) and then examined separately in terms of the requirements for pharmacists in the new contract.

Patient and public involvement

Patient and public involvement is covered in the first set of requirements of the clinical governance section of the new contract. The first requirement is that pharmacies should have a practice leaflet. Pharmacies will be expected to notify patients of the NHS services they provide. This information could appear in the practice leaflet or by displaying a notice in the pharmacy.

Contractors will have to carry out a patient satisfaction survey. Guidance will be produced that will state what must be assessed and a national template will be made available. Topics likely to be included are promptness of supply, quality of service and quality of facilities. Following a survey, pharmacists will have to review the results and consider making improvements where appropriate.

In addition to conducting their own patient satisfaction surveys, pharmacists will have to co-operate with a number of other organisations. First is a requirement to co-operate with visits from local Patient and Public Involvement Forums and to consider taking any action that the forum advises. PPI forums are made up of local volunteers and exist in every PCT in England. Their role is to monitor independently the quality of health services through regular visits. All NHS service providers fall within the remit of PPI forums, including GP surgeries, dentists, opticians and pharmacies in primary care, and acute trusts. NHS trusts are legally obliged to listen to PPI forums and to provide a response to issues they raise.

Contractors will also be expected to co-operate with the local primary care trust and other external bodies that are monitoring or auditing pharmacy services. This might include organisations such as the Healthcare Commission or local authorities.

A final step to improve communication with patients is a requirement for every pharmacy to have a complaints system. In fact, pharmacies should already have a complaints system in place. The rules around NHS complaints (which cover any NHS-funded care provider, including pharmacists) changed this year when the Healthcare Commission became responsible for the second stage of NHS complaints. The first stage is to take the complaint to the organisation or practitioner involved. Only if it is unresolved will it be taken up by the Healthcare Commission.

Another requirement in the patient and public involvement section of the new contract is compliance with the Disability Discrimination Act 1995. The Act came into force this month and it means that contractors are expected to make "reasonable adjustments" to the physical features of the pharmacy premises to enable access.

Clinical audit (clinical governance)

In order to comply with the clinical audit section of the clinical governance service, contractors will be expected to participate in two clinical audits each year. One is likely to be a practice-based audit. The other will be a multidisciplinary audit, determined by primary care trusts, through which it is hoped team working will be developed. Both must have a clear outcome so that they can be used to help develop patient care.

To meet risk management requirements, contractors need to ensure that procedures are in place to guarantee that stock is procured and handled properly and that equipment is maintained appropriately.

Maintaining a log of patient safety incidents at all stages of the medication process, not just dispensing errors, will be a requirement of the new contract. The information collected will be used to fill the mandatory fields of the reporting form in the National Patient Safety Agency's national reporting and learning system.

Contractors will have to demonstrate that they are not only recording incidents but also monitoring, analysing and learning from them. Critical incidents should be analysed by the whole pharmacy team to inform both individuals and the organisation. To assist with this, pharmacists should be competent in risk management, including root cause analysis. The Centre for Pharmacy Postgraduate Education is planning to produce a distance learning pack on risk management next year.

Contractors should have standard operating procedures in place, covering the areas specified by the Royal Pharmaceutical Society as a minimum. SOPs should also be produced for advanced and enhanced services.

Waste disposal systems will need to be developed for clinical and confidential waste. All confidential paper waste should be considered, from paperwork associated with services to unused labels, which state patients' names.

Contractors will have to comply with other guidance, including health and safety legislation, and local and national guidance relating to child protection procedures.

Finally, each pharmacy will need one member of staff to become its clinical governance lead. This person does not necessarily have to be a pharmacist.
Clinical effectiveness
To ensure that standards of clinical effectiveness are met in the provision of self-care advice, SOPs or other protocols will have to be put in place. Another way in which pharmacists will contribute to improving clinical effectiveness is through the medicines use review service.
Staff management
The first requirement of the staff management section is for contractors to ensure that all staff and locums are given appropriate induction training on issues such as confidentiality, health and safety, and security. Furthermore, all staff should be trained or be undergoing training, and contractors should identify and support the ongoing developmental needs of staff.

The qualifications of all staff should be checked and references taken. For pharmacists, this will be supported by the introduction of PCT-held lists. This list will be called a "supplementary list" and will be in addition to the main pharmaceutical list, which contains the names of contractors and company directors. All employed pharmacists and locums will have to register on one PCT's supplementary list in order to work in pharmacies providing NHS services in England.
Training and development
To fulfil training and development requirements, pharmacists will have to be able to demonstrate a commitment to continuing professional development using a CPD record. They will also have to obtain any necessary accreditation before providing enhanced or advanced services.
Use of information
In terms of information requirements, contractors will have to provide access to up-to-date reference sources (such as the BNF and the Drug Tariff) and appropriate IT links to electronic reference sources.

To protect patient data, confidentiality policies will need to be in place for all staff. Records should be made of interventions and advice given, as well as basic recording of medication supplied.

Contractors will also have to ensure that the PCT and NHS Direct are aware of the pharmacy's actual working hours so that these organisations can provide accurate information to the public.
Key points

Disposal of unwanted medicines is an essential service under the new community pharmacy contract in England and Wales. This means that it is something that all community pharmacists will have to provide. However, pharmacies do not have to start providing the service until the local primary care trust has made suitable arrangements to collect the unwanted medicines from the pharmacy.

The aim of this service is to ensure that the public can easily and safely dispose of unwanted medicines. This should reduce risk for a number of reasons. First, if people keep large stocks of medicines at home, there is an increased risk of accidental poisoning and of diversion of medicines to someone not authorised to possess them. Second, if people try to dispose of the medicines themselves they could choose a non-secure method that results in other people being exposed to the unwanted medicine. Finally, if someone uses an inappropriate method of disposal it could lead to environmental damage.
What the service involves
The community pharmacy's role will be to act as a collection point for the public's unwanted medicines. In this context, the "public" includes individuals and care homes that were previously registered as residential homes, but not nursing homes. Waste from nursing homes is classified as "industrial clinical waste". Pharmacies, unless they are specially licensed, can only accept "household clinical waste" - hence waste from individuals and residential homes.

Returned medicines should be stored in approved containers. These containers will be provided to the pharmacy by the waste disposal contractor (arranged by the PCT). Pharmacy staff will have to separate the waste into four types: solid dosage form medicines and ampoules, liquids, aerosols and some Controlled Drugs. Liquids will have to be stored in special liquid waste containers (also provided by the waste disposal contractor) and aerosols should be stored separately from the other waste.

Controlled Drugs that are categorised in Schedule 2 or 3 should be segregated from other medicines waste. These CDs have to be rendered irretrievable (i.e., denatured) before they can be disposed of since waste disposal contractors will not be authorised to possess CDs. Until such time as these CDs are denatured, the pharmacy will have to store them in a locked CD cupboard. It is worth bearing in mind that the requirements around disposal of CDs might change depending on the outcome of the Shipman Inquiry. Another issue yet to be resolved is how to allow pharmacies to denature CDs since this activity currently requires a waste management licence. This is being discussed by the Department of Health, the Department for the Environment, Food and Rural Affairs, and the Environment Agency.

Pharmacy staff will also have to deal with another category of waste medicines. This is waste produced in the pharmacy: medicines held in stock but not dispensed. This waste should be stored separately from unwanted medicines returned by the public.

The reason for the separation of waste that this service requires is that the Special Waste Regulations 1996 say that different categories of waste should not be mixed. This also means that prescription-only medicines, which are classified as "special waste", should not be mixed with pharmacy or general sale list medicines. P and GSL medicines only become special waste if they possess hazardous properties, e.g., they are flammable, oxidising, irritant, harmful, toxic or corrosive.

As part of this service, community pharmacies will have to comply with waste management legislation. First, they will have to register their conditional exemption to store returned waste pharmaceuticals with the local office of the Environment Agency. If the pharmacy employs a driver or company to collect waste medicines from peoples' homes or residential homes, then the driver or company will have to register as a waste carrier with the local Environment Agency.

Other legislation requirements are that waste medicines have to be stored securely, for no longer than six months and the amount stored must not exceed 5 cubic metres at any time. Pharmacies will have to retain special waste consignment notes on a register for at least three years, and retain descriptions and transfer notes for at least two years.

Pharmacy contractors will have to ensure that their staff are made aware of the risk associated with the handling of waste medicines. Correct procedures should be put in place to minimise risks. This will include having appropriate protective equipment, including gloves, overalls and materials to deal with spills. All should be available at the place where waste medicines are being stored.
PCT responsibilities
The PCT is responsible for ensuring that suitable arrangements are in place to collect unwanted medicines from the pharmacy and then to dispose of them afterwards. This will involve using a registered specialist contractor to collect the waste from the pharmacy on a regular basis. The frequency of collections should be agreed between the contractor and PCT, and pharmacies should be able to request extra collections if a need arises. The PCT should also provide a point of contract for queries relating to the disposal of returned medicines. In order to fulfil these roles, the PCT will have to register as a broker for the collection and disposal of medicines with the local Environment Agency.
Clinical waste
Clinical waste, such as used sharps and swabs for finger-prick blood tests, falls into a separate waste category from medicines waste. As diagnostic testing becomes more widespread in community pharmacy, disposal of clinical waste is an issue that more pharmacists will have to consider. Under the current regulations, pharmacies cannot store clinical waste unless they have a full waste management licence from the Environment Agency (this does not apply to needle exchange). Doctors' surgeries and nursing homes are exempt from this requirement but an exemption has not been put in place for community pharmacies. DEFRA is currently conducting a consultation on changing these regulations.

The second tier of the contract is advanced services. In order to provide them, pharmacists will have to be accredited or the pharmacy premises will have to fulfil certain requirements. Although part of the national contractual framework, not all contractors are likely to provide advanced services from day one because of the additional requirements. However, it is hoped that, in time, all contractors will provide advanced services.

There are two advanced services: medicines use review and a prescription intervention service.

The medicines use review

The medicines use review involves a pharmacist undertaking a face-to-face review with a patient. The review will be concordance-centred and identify any problems the patient has with his or her current medication and then address these problems. It will also examine the patient's knowledge of his or her medication and help the patient to develop this knowledge. Information will then be fed back to the patient's GP.

The prescription intervention service

The prescription intervention service is similar to the medicines use review but is initiated differently. Instead of a planned review, the prescription intervention service will be a review triggered by a pharmacist identifying a significant issue with a patient's prescription.

The advanced services represent the first time that community pharmacists have had a nationally recognised and remunerated clinical service. The Pharmaceutical Services Negotiating Committee is clear that pharmacists have to get this service right. If they do not meet the quality standards set out in the specification for the service, it will be the first and last national clinical service.

Service aims
The aim of both services is the same: to help people to use their medicines more effectively. Specifically, the aims are to improve patient knowledge, concordance and use of medicines. This will be achieved through:

• Establishing the patient's actual use, understanding about and experience of taking his or her medicines
• Identifying, discussing and resolving poor or ineffective use of medicines
• Identifying side effects and drug interactions that may affect compliance
• Improving the clinical and cost-effectiveness of prescribed medicines
• Reducing medicine wastage

Accreditation requirements
In order to provide advanced services, both the pharmacy premises and the pharmacist will have to meet certain accreditation requirements.

The premises must have a designated consultation area in which both the patient and pharmacist can sit down together. The area should be clearly signposted and be distinct from the general public areas of the pharmacy. Within the consultation area, the patient and pharmacist should be able to talk at normal speaking volume without being overheard either by people in the pharmacy or by members of pharmacy staff. Initially, contractors will be asked to self-assess their consultation area for compliance with the criteria. Primary care trusts will check this compliance during their monitoring of the contract.

Every pharmacist who provides the service will have to be accredited. This accreditation will be based on nationally agreed competencies. These competencies are currently being finalised but responsibility for accreditation will fall to higher education institutes.

How the service works
Medicines use reviews will be aimed at people who are taking multiple medicines on an ongoing basis. This service will be increasingly important with the Government's current focus on improving the management of long-term conditions. Medicines use reviews should ideally be carried out every 12 months and the idea is that pharmacists will see patients regularly.

It is likely that PCTs will identify specific groups of patients that pharmacists could target for medicines use review. This will depend on the local population's needs and what other medication review services are being carried out locally. Other health professionals may also refer patients to pharmacists for review.

Pharmacists should offer advice on both prescribed and over-the-counter medicines to introduce concordance and to develop compliance, including ensuring that patients know how and when to use "when required" medicines. Advice should also be given on tolerability and side effects of medicines, and on use of different dosage forms. If practical problems with ordering, obtaining, taking or using medicines are identified, pharmacists should try to find solutions.

Enhanced services will be commissioned locally by primary care trusts. A service specification and value - either in pounds or, like the new GP contract, in points - will be agreed nationally but PCTs will be able to vary these according to local needs.

Because enhanced services are commissioned, how many of them a particular pharmacy provides are determined by local needs so a definitive list of all the enhanced services pharmacists could offer is impossible to determine. However, some examples of enhanced services, which are commonplace, are:

• Minor ailments management
• Diabetes screening
• Substance misuse services
• Coronary heart disease screening
• Disease-specific medicines management
• Palliative care services
• Emergency hormonal contraception
• Full clinical medication review (i.e., "Room for Review" level three)
• Concordance services
• Out-of-hours services
• Care home and intermediate care services
• Prescriber support services
• Domiciliary assessments
• Head lice management
• Smoking cessation service
• Gluten-free food supply service