The Pharmaceutical Journal
Vol 275 No 7378 p692-693
3 December 2005

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What do the contract regulations mean?

The six-month transitional period for the new contract ended on 30 September, so pharmacists must now comply fully with the regulations. Steven Lutener and Helen Rhodes provide an update on the new requirements of the terms of service and Secretary of State directions

When attending events and reading articles on the new pharmacy contract, you will hear and read many references to “the regulations”. In this context, it will usually be the NHS (Pharmaceutical Services) Regulations 2005 that are referred to. Another familiar phrase is “terms of service”, which are set out in Schedule 1 to the Regulations. The advanced and enhanced tier services (known in the regulations as “directed services”) are required by the regulations to be carried out in accordance with the Pharmaceutical Services (Advanced and Enhanced Services) Directions 2005 issued by the Secretary of State.

Community pharmacists will not often refer to the regulations, but must be aware of their relevance to their pharmacy business and professional practise.

Terms of service — essential services

Dispensing There are few changes from the position that existed on the day before the new contractual framework came into effect — pharmacists are required to dispense all medicines “with reasonable promptness” and must carry out checks into exemption claims, and collect prescription charges. Pharmacists have been required by the Royal Pharmaceutical Society to have in place standard operating procedures since 1 January 2005.

Pharmacists are required to keep records of all prescriptions dispensed and of clinically significant interventions. For some pharmacists, this will increase the amount of record keeping but, since this improves patient care, this additional burden is justified. Developments in pharmacy computer systems are already making the recording of this information easier to complete.

One significant change is that pharmacists may now refuse to dispense a prescription if a patient is violent or commits or threatens to commit a criminal offence on the premises (such as shoplifting). Pharmacists are also now able to refuse to dispense if the prescription is clinically inappropriate. It is not expected that pharmacists will regularly exercise these new provisions but they are a useful safeguard in appropriate cases.

Repeat dispensing The roll-out of repeat dispensing arrangements has been slow, but is gathering pace. Pharmacists providing repeat dispensing services are required to undertake appropriate training. Successful completion of the Centre for Pharmacy Postgraduate Education course “From pathfinder to practice” is one method by which pharmacists can demonstrate that they have received appropriate training.

Before dispensing a repeatable prescription, a pharmacist is required to establish if the patient is taking the medicine and is likely to continue to take the medicine appropriately, and is not suffering from side effects that suggest that there should be a review of the treatment. A pharmacist should also establish that there has been no change to the patient’s medication or to the health of the patient that suggests that it is appropriate to review the treatment. These additional steps for repeat prescriptions are essential because the patient will not normally see the prescriber for up to a year between prescriptions.

If a pharmacist retains the batch issues (the documents used to authorise and reimburse the repeat supplies), then these must be stored securely.

Disposal of unwanted medicines Although disposal of unwanted medicines is a new service, many pharmacies previously had arrangements in place. The regulations require that staff are properly trained to handle waste and deal with spills, and appropriate protective equipment should be available. It is a primary care trust responsibility to make arrangements for the collection of waste from pharmacies and to ensure that pharmacies have appropriate waste medicine bins.

Promotion of healthy lifestyles Healthy lifestyle promotion is in two parts. The first part is a prescription-linked intervention where a pharmacist is required proactively to offer advice (if appropriate) to patients who appear to have diabetes, who are at risk of coronary heart disease, who smoke or who are overweight. This advice can be supplemented by leaflets or by referral to other sources of assistance. The regulations require a pharmacist to keep appropriate records of advice given. The second part requires pharmacists and their staff to participate in PCT-organised public health campaigns. All that the regulations require is the display of appropriate information and handing out of leaflets if provided by the PCT. Records are required only of the number of people to whom information has been given.

Signposting Signposting is also a new service, but pharmacists have performed it informally for years. The regulations require a pharmacist to direct people to sources of advice and support, if the PCT has provided a signposting resource. In appropriate cases, a pharmacist should keep records.

Self care Pharmacists have for many years been the main provider of advice and support for patients who wish to look after their own health care needs. The regulations introduce a degree of formality, requiring records to be made of significant advice.

Hours of opening Pharmacies were required to notify PCTs of their opening hours by 30 June. These comprise the 40 “core” hours that are required under the regulations (unless fewer are agreed, or the pharmacy opened under the exemption for “100 hour” pharmacies), together with supplementary hours (during which the pharmacy is normally providing pharmaceutical services). The regulations require a pharmacist to apply to the PCT if he or she wishes to amend the 40 core hours, but otherwise a pharmacist is free to amend the opening hours, subject only to giving 90 days’ notice.

Clinical governance The regulations require pharmacists to participate in an acceptable system of clinical governance. This includes programmes for patient and public involvement, clinical audit, risk management, clinical effectiveness, staffing and staff management, and use of information. Overall, most pharmacies have operated a clinical governance system for some time, supported by their local pharmaceutical committees and PCTs; the regulations introduce a degree of formality, requiring improved record keeping.

Advanced services (medicines use reviews)

Many of the queries received by the Pharmaceutical Services Negotiating Committee concern the requirements for undertaking medicines use reviews (MURs). A pharmacy must meet only three conditions in order to provide MUR services:

· A pharmacist undertaking an MUR must have an MUR certificate (the pharmacy contractor should supply a copy to the PCT before commencing MURs)

· A pharmacy must have a consultation area meeting the criteria (see later)

· A pharmacy must be providing the essential services and must have an acceptable system of clinical governance

Pharmacists may seek accreditation from a number of higher education institutions. Some pharmacists may have been able to undertake the assessment without undergoing additional training, although many have benefited from enrolment on distance learning courses.

Most of the questions received concerned the specifications of the consultation area. The directions set down only three criteria. A consultation area:

· Must be a clearly designated area for confidential consultations which is distinct from the general public areas of the pharmacy

· Must be an area where both the person receiving MUR services and the pharmacist providing MUR services can sit down together

· Must be an area where the pharmacist and person receiving the MUR can talk at normal speaking volumes without being overheard by other visitors to the pharmacy or by any other person, including pharmacy staff

There is no requirement for a sink, for a computer, for a door or for visual screening of the area. There is no requirement for the consultation area to be accessible by patients with a disability, although pharmacists must ensure that they do not discriminate against patients with a disability, so would need to make suitable arrangements if the consultation area is not, for example, accessible by wheelchair.

Where a pharmacist wishes to undertake MURs elsewhere, for example, in a consulting room at the local surgery, or in a patient’s own home, or exceptionally by telephone, he or she must seek the consent of the PCT.

Monitoring compliance

The NHS has published a monitoring toolkit designed for PCTs, the “Community pharmacy assurance framework”, which is available via www.primarycarecontracting.nhs.uk. The toolkit sets out the requirements of the pharmacy contractual framework and suggests methods by which compliance can be determined.

The Pharmaceutical Services Negotiating Committee published a workbook to complement the toolkit, giving advice to pharmacy contractors as well as providing a suitable document for recording information that may be required during a monitoring visit. This document is available by accessing the PSNC website at www.psnc.org.uk

Conclusion

As with any piece of secondary legislation, the NHS (Pharmaceutical Services) Regulations 2005 is an extensive document.

The regulations are some 173 pages long and have already been amended twice.

Few pharmacists will have the desire or the time to study the regulations in detail but those who wish to see the legislative source of the above can refer to regulations on the website of the Office of Public Sector Information (www.opsi.gov.uk).