Clinical governance and risk management

Clinical governance and risk management

Clinical governance, with its focus on quality, is an essential element of MI practice. The concept of clinical governance was introduced into the NHS by A First Class Service: Quality in the New NHS. Subsequently, the Royal Pharmaceutical Society published a framework for clinical governance in pharmacy. It identified four main components for achieving excellence:

· clear lines of responsibility and accountability for overall quality of clinical care

· a comprehensive programme of quality improvement activities (including audit, continuing professional development, research and development)

· clear policies aimed at managing risks

· procedures for identification of poor performance.

This approach has been reinforced following various reviews where quality of healthcare has been seen to fall below acceptable standards.

Table 8.4 Legal and ethical issues in medicines information (MI)

Issue Details

Negligence and liability

An MI pharmacist has a duty to ensure that all information and advice supplied is as accurate and comprehensive as could reasonably be expected. If that information or advice, when acted on, causes loss or damage to a patient, the MI pharmacist may be liable in negligence. For the MI pharmacist to be shown to be negligent it must be established that the MI pharmacist had a duty of care towards the patient, that the duty of care was breached and that damage to the patient occurred. It is, therefore, incumbent on an MI pharmacist to keep up to date as far as is reasonable with current developments and knowledge, to use all reasonably available resources to provide the information required, to present that information in a usable and intelligible form and to act in a professional manner which is appropriate to the skills possessed and the service offered by an MI pharmacist. Working to defined standards with agreed minimum resources and complying with standards for safe systems of work and documentation are part of this process

Unlicensed and clinical trial medicines

MI pharmacists can provide information and advice about unlicensed medicines or unlicensed uses of medicines as long as the enquirer or user is clearly informed that this is the case

Proactive information

The same principles apply to written proactive information, for example, that supplied in bulletins or new-product evaluations. MI pharmacists should be able to demonstrate the process undertaken to produce the information. Disclaimers, although bringing to the attention of the information users their responsibilities in using that information, do not negate the liability of the MI pharmacist supplying the information. These issues apply to both hard copy and electronically published information

Defamation

MI pharmacists have a duty when providing information to ensure that information is accurate, fair and produced from demonstrable and quality evidence. Failure to do so, leading to unreasonable loss of commercial success of a medicine, could lead to the pursuance of defamation of product by a pharmaceutical company. However, a genuine error or omission would not normally be grounds for such an action

The UKMi network has implemented a comprehensive clinical governance programme and utilises a range of tools to support this programme. The tools are common to other areas of healthcare provision and include defined national practice standards, quality assurance programmes, training and competency frameworks. UKMi has also developed a research strategy.

Standards

National standards for MI services were first introduced in 1990. Since then they have been revised and expanded to cover all of the principal elements of the service. In defining the standards, account is taken of identified best practice, policy and regulatory developments, technology advancements and the requirements of commissioners, stakeholders and other organisations with which MI work. The current standards cover six core areas relevant to most MI centres and a seventh that is specific to those centres providing a national specialist service.

The first standard states that an MI centre must have appropriate space, facilities and resources to ensure the provision of a safe and efficient service. The elements of this standard include staffing levels, the working environment and the availability of appropriate equipment, facilities and information resources. Information resources that are considered to be essential to local and regional/national MI centres to enable them to provide a safe and robust enquiry-answering service are defined.

Provision of the enquiry-answering service has four associated stan-dards. Achievement of these standards requires that the service is easily accessible and organised to allow prompt handling of enquiries, that it meets quantifiable and consistent criteria to measure user satisfaction and that it meets quantifiable and consistent criteria for assessing the quality of enquiry answers. The latter includes assessment of the analysis of the enquiry, the utilisation and interpretation of appropriate resources and the construction and delivery of an appropriate, timely and evidence-based answer that incorporates relevant practical, clinical advice and is tailored to a specific patient.

A further standard for enquiry-answering, and for the production of pro-active information, for example bulletins and guidelines, is adequate docu-mentation of the process and adequate procedures for record management. These have always been important for provision of an efficient MI service to prevent duplication of work and allow information to be retrieved if follow-up is required (for example, complaint or legal case). However, with the call for greater transparency in decision-making, the implementation of the Freedom of Information Act and the introduction of the NHS information governance framework these are now imperative. The experience MI staff have developed in this area puts them in an excellent position to act as knowledge managers for the pharmacy department, advising on best practice for documentation and information storage.

The standard for publications and proactive work includes other elements relating to text production, proofreading and accuracy checking, and adher-ence to legal requirements such as copyright. The training standard covers the requirements for training of MI staff and training provided within MI centres. MI staff deliver a significant amount of training to other members of the pharmacy service, providing them with skills relating to problem-solving and critical appraisal that are transferable to all aspects of professional practice.

A relatively new standard relates to research and service development. It requires the manager of an MI service to develop the service and demonstrate its value through participation in audit, practice research and other similar activities. The standard reflects the launch of the UKMi national research strategy in 2006 with the aim of driving innovation, improving service quality and sharing good practice, as well as providing data relating to the impact of MI on the wider organisation.

Risk management

The sixth standard relates to risk management, although this plays a major element in all the other standards. Hospital trusts have wider risk management programmes with which MI services will comply. In addition, MI centres in the UK should develop their own risk management plans, reviewed annually, to provide a framework for safe working. A risk management-based approach to quality-assuring written information has been suggested to address this approach, utilising broad risk management techniques.

As part of the risk management standard, MI centres must have a specified set of standard operating procedures (SOPs). A number of these have been produced nationally for local adaptation. They are available on the UKMi website (www.ukmi.nhs.uk). This portfolio includes SOPs on handling and documenting enquiries, dealing with enquiries in the absence of an MI pharmacist, dealing with difficult callers and enquiries that might be consid-ered for onward referral and adverse incident reporting.

An important component of clinical governance is learning from experi-ence, both of success and failure. MI has established an incident-reporting scheme to record errors and near-misses occurring within the service, similar to those in place for dispensing and aseptic manufacture. The Incident Reporting in Medicines Information System (IRMIS) was introduced in 2005 and is held on a secure web-based database hosted by NHSnet. The scheme is intended to complement existing reporting schemes within NHS organisations and users are asked to report any incidents to their trust system in addition to IRMIS. The aim of the system is to enable the network to collate data on anonymous reports, identify common themes and look at ways to avoid future incidents. Quarterly reports are distributed to all MI staff and are used as a learning tool within individual centres, at local meetings and on national training courses. Recurrent incidents include confusion over drug names and calculation errors. The system has also identified errors within manufacturers’ information and published resources. These have been incorp-orated into UKMi guidance on risk issues with commonly used MI sources.

Monitoring standards

MI centres are recommended to undertake regular peer review sessions. These focus principally on enquiry-answering and provide opportunities to identify poor practice systematically and also to provide opportunities for learning and sharing, and as such, form an element of MI staff’s continuing professional development. In addition, the aim is that all MI centres are externally audited against relevant national standards every 3 years. An audit tool has been developed to document the standards that centres have achieved, to identify improvement over time and also to provide a pathway for achieving excellence.

The framework developed in the UK for achieving quality within MI services through implementing an appropriate clinical governance process is outlined in Figure 8.2.

In addition to improving their own performance, MI pharmacists are well placed to contribute to a wider clinical governance agenda within the NHS by supporting evidence-based practice across pharmacy and the wider trust, for example supporting formularies and contributing to educational programmes and knowledge management systems.

Customers and users

The historical user base of MI services has been principally drawn from hospital healthcare professions, mainly from pharmacy, medicine and nursing. Clinical pharmacists are often the largest user group of a local MI service because ward-based clinical pharmacists have a high profile in prob-lem-solving and facilitating optimum patient care. Therefore, they act as the primary contact for medicines-related issues, for which MI services provide their first-line back-up. However, there are many situations in which a clinical pharmacist is not available for dealing with such issues, such as in less acute clinical areas and outpatient clinics, when direct contact by the doctor or nurse with the MI service is appropriate. More recently, independent non-medical prescribers – nurses and pharmacists – have emerged to take over some traditional medical prescribing. MI services have a significant role in training and supporting the prescribing activities of these new groups. There are also many other hospital-based healthcare professions that have an interaction with drug therapy and who therefore may need to utilise the MI service; such groups include dieticians, physiotherapists, psychologists and laboratory services.

MI services have expanded their activities to include primary care. The majority of this activity is directed towards those groups with direct patient care responsibilities, general practitioners, community pharmacists, nurses (community, practice, midwives) and health visitors. However, profes-sional advisers in primary care organisations, such as primary care trusts, also require MI services support to facilitate safe and cost-effective pre-scribing. This more strategic role is largely being provided from regional MI services. It is important that MI services recognise the critical nature of the link between primary and secondary care, thereby facilitating the transparent and seamless treatment of patients, wherever they receive their care.

Patients have a high requirement for information on medicines and this is provided in a number of ways. All patients, whether in hospitals or in the community, should receive a patient information leaflet with any licensed, dispensed medicines. This, in many circumstances, is augmented with counselling from a hospital or community pharmacist. NHS Direct (England and Wales) and NHS24 (Scotland) are telephone and internet services established to provide the general public with instant information on any aspect of healthcare, including medicines. Although these services have trained staff and limited resources to deal with medicines-related

issues, they utilise MI services to deal with more complex clinical issues. In addition, in the UK, local MI services are providing medicines/patients telephone helplines for patients who have received medi-cines, either as inpatients or outpatients, so that specific enquiries regarding their hospital-dispensed medication, or more general issues, can be resolved. These services therefore are aimed at improving both safety and concordance.

Other groups, such as the police, coroners, self-help groups and the media, also have a requirement to use MI services, although there are specific guide-lines for dealing with such groups which address issues such as confidentiality. Different professional groups, and levels and specialties within these groups, have differing requirements of the service, both in term of reactive clinical problem-solving and educational and current awareness services, and this is an important feature for MI services to recognise.