The Royal Pharmaceutical Society has launched a document setting out a framework for clinical governance in pharmacy. Called "Achieving excellence in pharmacy through clinical governance", the document sets out pharmacy's accountability for clinical governance, itemises further support systems that the Society intends to develop, and makes a range of recommendations to help pharmacists fulfil the requirements of clinical governance.
Some recommendations are directed at practising pharmacists. Others are for action by local National Health Service bodies — health authorities (HAs), health boards (HBs), primary care groups (PCGs), local health groups (LHGs) and NHS trusts — or by the Department of Health (DoH) and the National Assembly for Wales (NAW).
In its introduction, the document says that, although clinical governance is a new term, many of the principles behind it are not new and have been used in other quality initiatives. It says that clinical governance has four main components and that bringing them together into a cohesive programme offers significant opportunities. The components are:
The document goes on to point out that, with its long history of innovation and quality improvement, pharmacy brings many strengths to clinical governance. The Pharmacy in a New Age strategy is wholly compatible with clinical governance, and most of the Society's strategic aims reflect the principles of clinical governance.
The introduction adds that, in developing a framework for clinical governance in pharmacy, the Society has built on pharmacy's strengths and highlighted areas that require further development. As well as needing a mechanism to implement clinical governance in its own activities, pharmacy also needs to feed into an overall clinical governance structure for all health care professionals. This is less easy in primary care than secondary care, because of a need for pharmacy to develop new mechanisms in order to integrate into the primary care clinical governance structures. For this to happen, pharmacists need to establish better links with the rest of primary care and also with HAs and HBs.
On lines of responsibility and accountability for the overall quality of clinical care, the document says that the quality of clinical care provided by community pharmacies should remain the responsibility of the superintendent or proprietor pharmacist. However, some commonality with other professions is needed in the arrangements for clinical governance. PCGs, LHGs and their equivalents would need a lead pharmacist or body to liaise with, as would HAs and HBs.
In the hospital sector, the chief pharmacist of a trust would usually have responsibility for the quality of clinical care provided by the pharmacy department and the handling of medicines in the hospital as a whole. There would usually be a line management relationship with either the chief executive of the trust or a director. The chief pharmacist would usually retain professional responsibility for all pharmacists employed in the trust, even where not managerially responsible for them.
A variety of job titles are used in hospital pharmacy to signify the most senior pharmacist, of which chief pharmacist is probably the most common. The term "chief pharmacist" is not defined in either law or the Society's Code of Ethics.
On accountability, the document says that the question of accountability for community pharmacy is complex, particularly in England, where community pharmacy is accountable to the HA for clinical governance of services under its core NHS contract and to the PCG/PCT for services under separate contract. The document says that these arrangements have led to confusion among some HAs and PCGs, and that clarification from the DoH would be welcome.
In Wales, the situation is more straightforward, with accountability devolved to LHGs and a community pharmacist serving on each LHG.
Recommendation for community pharmacists and local NHS bodies The Society proposes a framework for local clinical governance accountability as follows:
In each HA/HB area, the LPC should nominate a local community pharmacist as clinical governance lead for community pharmacy. In Wales, this appointment may be at an LHG level. The Society recommends that the LPC involve the Society's local inspector in the selection of an individual to perform this role.
The role of the clinical governance lead for community pharmacy will be to:
The role of clinical governance lead for community pharmacy will require time and resources. We would expect such a role to require a minimum of one to two sessions per week. It will require adequate funding from the HA /LHG.
Recommendation for hospital pharmacists The chief pharmacist should take professional responsibility for all pharmacists and pharmacy staff in the NHS trust and liaise with the clinical governance lead in the trust. The chief pharmacist should sit on the clinical governance committee of the trust. A formal definition of the term "chief pharmacist" may need to be developed.
Action by Society To develop meaningful comparisons between pharmacies and pharmacists, the Society will develop a small number of quality indicators for both community and hospital pharmacy. It is likely that suitable indicators would deal with participation in CPD and clinical audit; record keeping (patient medication records); presence of procedures; critical incidents such as complaints; additional services such as health screening (eg, cholesterol testing) and some hospital pharmacy specific indicators regarding clinical pharmacy.
Recommendation for local NHS bodies PCGs/PCTs and LHGs should consider appointing a local community pharmacist to their clinical governance subcommittee.
The document says that the Society has supported the development of clinical audit for several years. It has published downloadable examples of clinical audits on its website, and the audit development fellow has provided training and support for pharmacists wishing to undertake clinical audit in England. (Wales has separate arrangements.)
It says that clinical audit is taught at undergraduate level, is a component of most postgraduate diploma courses and is being incorporated into several continuing education courses. It is well developed in hospital pharmacy, with pharmacists participating in uni- and multiprofessional clinical audit. In addition, most hospital pharmacies conduct drug use reviews, which usually fulfil all the criteria for good clinical audit, but often fail to be reported to the trust as clinical audit.
In community pharmacy, the document says, clinical audit has been slower to develop, mainly because of difficulties in accessing local audit expertise and support, particularly in England and Wales. But despite these difficulties, there have been significant developments. The Society has worked with groups of pharmacists across England supporting their local work, multiple pharmacy companies have developed in-house clinical audit structures, and audit is a component of most HA accreditation schemes.
Action by the Society The Society will publish further examples of both uni- and multiprofessional clinical audits in pharmacy and continue to offer support to pharmacists wishing to develop clinical audit.
Recommendation for local NHS bodies HAs/HBs and NHS trusts should ensure that pharmacists have access to clinical audit expertise and support at the local level.
Recommendation for hospital pharmacists Drug use reviews should be reclassified as clinical audit and reported to the clinical governance committee.
On continuing professional development, the document says that pharmacy's national continuing education centres are a major strength, preparing and disseminating evidence-based training to community pharmacists. Hospital pharmacists, who can access training in work time, have access to good quality in-house training schemes linked with clinical pharmacy diploma courses and are encouraged to obtain further qualifications.
The document refers to the Society's piloting of a new approach to CPD, which involves reflecting on current and future CPD needs, making appropriate development plans and then putting the plan into action. But it adds that the Society has concerns about CPD funding and has urged the Government to provide adequate funding to ensure full participation in CPD in both community and hospital pharmacy.
Action by the Society The Society will continue to develop its new approach to CPD and will roll it out depending on the results of the pilot.
Recommendation for community pharmacists and hospital pharmacists Staff appraisal should be used as an opportunity to help pharmacists identify their training needs.
Recommendation for Government The Government should ensure that adequate funds are made available to ensure full participation in CPD in pharmacy.
On clinical guidelines and evidence-based practice, the document says that there is often national input by pharmacy into the development of clinical guidelines. This is likely to be improved by the presence of a pharmacist on the partners council of the National Institute for Clinical Excellence and the liaison between the audit development fellow and the NICE.
However, it adds, local adaptation of clinical guidelines is often conducted without pharmaceutical input, especially in primary care, and local clinical guidelines are not routinely circulated to community pharmacists.
The document refers to the Society's recently published study on getting research into pharmacy practice, with its series of recommendations for improving the generation, dissemination and use of research evidence in pharmacy.
Action by the Society The Society will implement the recommendations about getting research into pharmacy practice.
Recommendation for local NHS bodies Health authorities and trusts should ensure that pharmacists have proper access to sources of evidence-based research literature, both paper based and electronic media.
Recommendation for local NHS bodies and Government Clinical guideline producers at both the national and local level should ensure that they obtain appropriate pharmaceutical expertise, preferably from those working in the sector that the guideline is aimed at.
On research and development, the document says that clinical governance must be supported by reliable, robust research-based data. Progress made by the Society in commissioning and publishing rigorous scientific work in the field of health services research has strengthened its claim to be involved and to contribute to wider initiatives. Other work to identify and prioritise the research agenda in pharmacy is beginning to reap rewards as pharmacy related work steadily enters the research strategies of the large R&D funders. The Society's contributions to wider NHS debates on developing the R&D workforce capacity and changing professional behaviour through the dissemination and uptake of research results have placed pharmacy at the forefront of thinking in these complex areas.
Action by the Society The recommendations of the Society are contained in various papers about practice research papers published by the Society: "A new age for pharmacy practice research: Promoting evidence-based practice in pharmacy" (1999); "Medicines, pharmacy and the NHS: Getting it right for patients and prescribers" (1999); "Drug therapy and pharmacy: Setting the research agenda" (1999); and "Self care and pharmacy: Setting the research agenda" (1998).
On the effective monitoring of clinical care with high quality systems for clinical record keeping and the collection of relevant information, the document says that clinical care cannot be effectively monitored unless health care professionals have access to appropriate information and record relevant information.
The document points out that, although most community pharmacies maintain computerised patient medication records, they do not have access to patients' clinical notes, nor do they routinely record interventions made on prescriptions or advice given to other health care professionals. This is a weakness of community pharmacy and one that will need national solutions, it says.
On hospital pharmacy, the document says that hospital pharmacists keep more comprehensive records than their community colleagues do and also have free access to patients' hospital medical records. However, there are no nationally agreed standards for the recording of pharmacist's interventions and contributions to individual patient care, which leads to an inability to compare practice across trusts.
In addition, for historical reasons, pharmacy remains one of the few hospital professions not to contribute routinely to the patient's notes. This can lead to clinicians being unable to identify the reasons for changes in medication when reviewing a patient's history.
Action by the Society The Society will develop national solutions to assist community pharmacists to record their contributions to clinical care.
Action by the Society A common data set needs to be developed for clinical pharmacy services in hospital. This would allow comparison of the clinical pharmacy services between hospital pharmacies and the identification of where improvements can be made. The Society will facilitate a meeting to start this process.
Recommendation for Government Pharmacists need access to relevant patient clinical data and to record their contributions in a way that allows other health care professionals to access the information. The development of the electronic patient record may help this situation providing that community pharmacists are given access and allowed to contribute more than just dispensing data.
Recommendation for hospital pharmacists Hospital pharmacists need not wait for the electronic patient record before recording their contributions in patient's records. This is something that could be negotiated locally and should be the norm rather than the exception.
In a section on ensuring that there are clear policies aimed at managing risks, the document says that pharmacists are well aware of the potential for harm caused by dispensing errors or poor advice to either doctors or patients. To manage these and other risks, pharmacists have developed a range of procedures and protocols.
The document adds that pharmacists also have a significant role to play in the risk management of other professions, because they check the prescribing of doctors and identify errors and omissions in therapy — a role that is more complete where pharmacists have access to clinical information about the patient.
The document accepts that formal risk assessment and risk management rarely feature in pharmacy training courses, although some pharmacists receive risk management advice and training in trusts.
Recommendation for community pharmacists and hospital pharmacists Pharmacists should ensure that they have robust procedures in place, especially for activities that carry the most risk.
Action by the Society Continuing professional development providers should include risk management in their training programme.
Recommendation for local NHS bodies Health authorities and NHS trusts should ensure that pharmacists can access training and advice about risk assessment and risk management.
In a section on procedures for all professional groups to identify and remedy poor performance, the document outlines the role of the Society's inspectorate in identifying poor performance in community pharmacy. It adds that LPCs (and their equivalents) may have a role once complaints are made, while employers have a role in monitoring the performance of employee pharmacists.
On hospital pharmacy, the document refers to existing monitoring procedures and the Medicines Control Agency's inspection and enforcement role in hospital pharmacy production units.
The document points out that the Society, through its Statutory Committee, has a limited range of disciplinary measures that can be taken or enforced against pharmacists with poor standards.
Action by the Society The inspectorate should remain as the Society's main means of identifying poor performance and encouraging improvement. However, the Society needs the power to fine or otherwise take action against pharmacists with poor standards.
Action by the Society and recommendation for Government The Society is seeking reforms to its present disciplinary structures, through the establishment of a standards tribunal, which will give it the ability to deal more effectively with poor performance.
In a section on making clinical governance work as a cohesive whole, the document says that the Society is playing its part in linking the elements of a comprehensive programme of quality improvement activities together with accountability and the management of poor performance, and has made strong links between clinical audit, continuing professional development, research and development, clinical guidelines and evidence-based practice.
The document says that pharmacists contribute to the clinical governance of the overall care of patients in a variety of ways, most obviously through prescription monitoring before dispensing. Other relevant activities include medicines management, prescribing advice to GPs and hospital doctors, drug and therapeutics committees, hospital prescription monitoring and intervention services, medication reviews in primary care, and patient counselling. These activities should integrated with the work of other health care professionals and their clinical governance arrangements, at both a local level and a national level.
Action by the Society The Society will continue to forge links between the different aspects of a comprehensive programme of quality improvement.
Action by the Society The Society will maintain and develop its links with NICE and the royal colleges and professional bodies so that an integrated approach to quality may be developed.
Recommendation for community pharmacists and local NHS bodies Clinical governance leads for community pharmacy should work with the clinical governance leads for PCGs/LHGs and their equivalents) and health authorities/health boards to develop an integrated approach to quality locally.
Copies of the document are initially being sent to local pharmaceutical committees, the Society's branches, senior hospital pharmacists, other pharmacy bodies and tutors of the national centres for pharmacy postgraduate education. Copies will also be sent shortly to the chief executives of health authorities and primary care groups in England and their equivalents in Scotland and Wales.
Others wishing to obtain a copy of the full document will shortly be able to download it from the Society's internet website (www.rpsgb.org.uk) as a PDF file. Alternatively, copies may be obtained from the Society’s audit development fellow, Mr David Pruce, at the Royal Pharmaceutical Society, 1 Lambeth High Street, London SE1 7JN (tel 020 7735 9141 ext 211; e-mail dpruce@rpsgb.org.uk).
Mr Pruce also welcomes comments on the document. It is intended to be a working document and will be amended in the light of suggestions received.