The aim of this essay to provide the reader with insight to the term ‘clinical risk management’ and how this is implemented within NHS trusts focusing particularly on the role of Pharmacists in doing this.
Objectives:
Defining ‘clinical risk management’ and discussing its importance
Discussing ways in which trusts implement clinical risk management
Defining what is a medication error and identifying the role of the pharmacist to reduce these
Discussing systems or processes in place in my base hospital to reduce medication errors
1.0 Importance of clinical risk management
Clinical governance was first mentioned in British Health policy in 1997 as a term used to describe the accountability processes for clinical quality of care. It evolved as a system to address and respond to a series of high profile media cases highlighting poor quality patient care as revealed in the Nottingham IT vincristine disaster, Bristol Heart surgery, Shimpan and Alder Hey organ retention.

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During I997 in England, the Department of Health published the white paper the ‘New NHS; modern, dependable’ which introduced Clinical governance as a method of accounting for clinical quality in health care but really came to prominence in 1998 when Scally and Donaldson appraised ‘Clinical governance and the drive for quality improvement in the NHS’  in the British Medical Journal. The paper highlighted four components of quality as initially identified by the World Health Organisation:
Professional performance (technical quality)
Resource use (efficiency)
Risk management (risk of injury or illness associated with the service provided)
Patient satisfaction with the service provided.
Majority of NHS care is of a very high standard and in comparison to the high volume of care provided on a daily basis in hospital and community, incidence of serious failures are uncommon.1 However when they do occur, they have devastating consequences for individual patients and families.1 Greater patient expectations, knowledge and media exposure of high profile cases have resulted in the NHS being scrutinized focusing on its policies of operation, facilities and operating culture.
It is estimated that an average of 850,000 adverse events may occur in the NHS hospital sector each year resulting in a £2billion direct cost in additional hospital days alone.1 Poor clinical performance results in patient harm and loss of patient’s confidence in the NHS services as well as an increase in litigation costs.4 In 2009/10, 6,652 claims of clinical negligence and 4,074 claims of non-clinical negligence against NHS bodies were received by the NHS Litigation Authority, up from 6,088 claims of clinical negligence and 3,743 claims of non-clinical negligence in 2008/09.4 £787 million was paid in connection with clinical negligence claims during 2009/10, up from £769 million in 2008/09.4
Errors are discussed as either ‘human’ or ‘systematic’ in the Department of Health document ‘An organisation with a memory’. As an NHS organisation the focus is systematic, a more holistic approach when dealing with errors. This approach recognises the importance of resilience within organisations and that errors result as a number of interacting factors and failures within the system.1
NHS Quality Improvement Scotland (NHS QIS) clinical governance and risk management standards define risk management as the:
Systematic identification and treatment of risk
Continuous process of reducing risk to organisations and individuals alike
Culture, processes and structures that are directed towards realising potential opportunities whilst managing adverse events
In the past, clinical risk management was poorly managed in the NHS. There were no individuals designated to manage risk management, incident reporting in primary care was largely ignored, there was no standard approach to incident investigation, and existing systems did not facilitate learning across the NHS.1 In the 1990s there was a concerted drive to develop risk management and risk management within NHS organisations.1 Following on from this there has been an increased awareness of the cause of medication errors in NHS trusts and how these can be prevented.1 In 2000, the government made a commitment to reduce the rate of serious errors by 40%. The advances in technology and knowledge in recent decades has resulted in a more complex healthcare system.2 This complexity carries risks and evidence indicates that things do and will go wrong in the NHS sometimes resulting in patient harm.2
The NHS quality improvement strategy1 encompasses;
Clear national quality standards; NICE, NSF
Dependable local delivery; systems of clinical governance in NHS organisations
Strong monitoring mechanisms; a new statutory commission for health improvement, an NHS performance assessment framework, and a national survey of NHS patient and user experience.
It is hoped adaptation of these approaches in individual NHS organisations should have a positive impact on the development to detect, prevent and learn from system failures at a local level.1 The introduction of clinical governance provides NHS organisations with a powerful imperative to focus on tackling adverse health care events1. The time is right for a fundamental re-thinking of the way that the NHS approaches the challenges of learning from an adverse health care event.1
2.0 Implementing Risk Management within NHS trusts
The Department of Health publication ‘An organisation with a memory’ facilitated the patient safety movement in the NHS.2 It proposed solutions to risk management incidences through a culture of openness, reporting and safety consciousness within NHS organisations.2 Four Key areas highlighted from this report were:2
Unified mechanisms for reporting and analysis when things go wrong;
A more open culture in which incidents or service failures can be reported and discussed;
Systems and monitoring processes to ensure that where lessons are identified the necessary changes are put into practice;
A much wider appreciation of the value of the systems approach in preventing, analyzing and learning from patient safety incidents.
In response to an organisation with a memory, the Government report Building a safer NHS for patients focuses on how to implement these recommendations2. It outlined a blueprint for a national Incident reporting system and discussed the role of the National Patient Safety Agency (NPSA).2 The NPSA was set up by the Department of Health in 2001 with the aim of preventing harm from high risk medicines. The NPSA produced the National Incident reporting and Learning system (NRLS) to set priorities, develop and disseminate actionable learning following reports of patient safety incidents.
Following this guidance all NHS trusts should have a risk management strategy in place. This includes systems for the identification of all risks which may compromise delivery of patient care. To aid with this trusts are obliged to deliver patient services in compliance with statutory regulations according to national and local requirements highlighting the level and quality of services required. The implementation of risk management policies within NHS trusts will be overseen by Clinical Governance managers and Risk managers4. Trust Risk management strategies will need to be regularly reviewed and audited; individual trusts will have Risk Managers within each department to oversee this4. The Trust Board will ensure that risk management, quality and safety receive priority and the necessary resources within budgets.
Pharmacy departments will have a medicines management team comprising of a risk management pharmacist to implement risk management at a local level. The Risk management pharmacist will ensure staff are aware of risk management issues both locally and nationally and will update staff on actions to be taken to minimise risk thereby promoting compliance with external risk management standards. The risk management pharmacist will also need to ensure local risk management policies are kept up to date.
In order to deliver the risk management agenda, individual trusts must meet the requirements of the NHS Litigation Authority Risk Management standards and the Care Quality Commission standard’s (CQC) from the Health and Social Act 2008. From April 2010, NHS providers will need to register with the CQC and provide proof of adherence to standards set by the CQC5.
2.1 National Patient safety agency and National Reporting Learning System
In 2001, following the publication of the Department of Health document and ‘Organisation with a Memory’1 the National Patient safety agency (NPSA) was set up. The introduction of the NPSA has for the first time provided a systematic focus on medication safety6. The aim of the NPSA is to lead and contribute to improved, safe patient care by informing, supporting and influencing organisations and people working in the health sector with one core purpose – ‘to improve patient safety by reducing the risk of harm through error’7. The NPSA’s initiative was to identify patterns and trends in avoidable adverse events so that the NHS could implement changes to prevent these incidents from reoccurring.
The NPSA will 2, 8:
Collect and analyze information an adverse events in the NHS
Assimilate other safety-related information from a variety of existing reporting systems
Learn lessons and ensure that they are fed back into practice
Where risks are identified, produce solutions to prevent harm, specify national goal and establish mechanisms to track progress
The NPSA then went onto produce the National Incident Reporting and Learning system (NRLS) which aims to identify and reduce the risks to patients receiving NHS care and leads on national initiatives to improve patient safety. There are NHSLA risk management standards for each type of NHS health care organisation. The standards will address clinical and non-clinical health and safety risks.4 Individual trusts will be examined regularly and measured against standards to ensure a risk management strategy has been devised, it is in place throughout the trust, it is workable.4 This will minimise litigation costs resulting in more funds available to trusts to improve patient care; providing an incentive for better clinical and non-clinical risk management.
The NRLS collects confidential data on medication errors from all NHS trusts in England and Wales and improves patient safety by enabling the NHS to learn from patient safety incidents8. This builds on incident reporting systems that were previously used on an adhoc basis in individual trusts. The NRLS reporting system has been designed to be compatible with local risk management systems that are used in majority of NHS organisations.2 NRLS reports are analyzed by clinicians and safety experts8 and key themes and trends contributing to patient safety incidents are identified.2 Steps are then taken to minimize these risks through the development and prioritisation of national solutions.
‘Trusts reporting incidents regularly suggest a stronger organisational culture of safety’.8 Encouraging staff to report clinical incidents affecting patient safety can help implement risk management strategies within NHS trusts. The more incident reports submitted the more data available to rapidly identify and act upon patient safety incidents. The NRLS suggests trusts should be submitting incident reports monthly.8 In pharmacy these will mostly involve incidents relating to medication errors.
The development and promotion of the NHS ‘fair blame’ culture encouraged error reporting reassuring staff the root causes of errors will be looked into. However, lack of awareness and fear of disciplinary action remain as some of the main barriers to incident reporting.8 To overcome this staff need to be adequately trained on when and how to report clinical incidents. At my base hospital, incident-reporting training is included in the trust induction and at a local pharmacy level as an in-house induction.
Each trust incident is graded in accordance to standardised NPSA scoring systems; 1 being minor with no harm to patient ranging to catastrophic level 5 i.e. patient death. Following the completion of an online incident form, the risk lead for that particular area will receive a copy of the report. These reports will be analysed and appropriately graded and any serious incidents will then be reported to the Trust Board via the risk management committee.
A report by the NPSA stated the most commonly reported medicine related incidents to be:8
Wrong dose, strength and frequency of medicines
Wrong medicine
Delayed and omitted doses
Medicine related incidents will be reported to the Risk Management pharmacist who will provide feedback to the pharmacy team. All category 4 and 5 incidents have a full root-cause analysis performed and are submitted to the NRLS. These reports are then analysed by the NPSA, and if necessary rapid response alerts are produced.1, 8 Rapid response alerts act as a crucial means to focus the efforts of trust clinical risk managers into proven high risk areas.8 Delayed and omitted doses of medication led to the production of a recent rapid response alert. This alert was delivered to trusts by the NPSA via the NHS’s Central Alerting system.8 On receipt of this alert, trusts were expected to respond and act upon requests contained within it within the specified deadline provided. Each alert contains instructions for regular audits in order to review the action taken.
3.0 Medication Errors
Most medication are not without adverse effects and most side effects and adverse events are predictable, thus exposure to these adverse events can be minimised or avoided through careful prescribing and usage. Nevertheless some adverse effects are unpredictable and therefore unavoidable.6 However medication errors occurring as a result of mistakes or lapses when medications are prescribed dispensed or used are avoidable. These can be related to practice, procedures, products or systems. 6
Medication errors as defined by the NPSA are
‘any preventable event(s) that may cause or lead to inappropriate medication use or patient harm while the medication is in the control of the health care professional, patient or consumer. Such events may be related to professional practice, health care products, procedures and systems, including prescribing; order communication; product labeling, packaging and nomenclature; compounding; dispensing; distribution; administration; education; monitoring; and use.’ 10
Numerous studies have been conducted to investigate the incidence and outcomes of medication-related harm. A 2008 study conducted in an emergency department in Scotland found 2.7% of admissions were related to adverse drug reactions. 11 In 56.7% of cases the adverse drug reaction was the documented reason for admission but only 13.3% were considered to be unavoidable.11 Another study carried out by Charles Vincent reviewed more than 1000 records and found that 10.8% of patients experienced an adverse event and that half of these were preventable.12 It was found that a third of these adverse events led to either serious consequences or death.12 Medication errors also occur in other health care systems, and is estimated harmful errors occur in 1.8% of hospital admissions in the United States, leading to about 7,000 deaths each year.6 Similarly, an Australian study showed that 0.8% of inpatients suffered a harmful medication error.6
3.1 Why do medication errors occur?
To be able to reduce the risk of medication errors, the cause of medication errors need to be understood.6 Previously medication errors were thought to be the sole responsibility of the individuals considered to be the cause of the error. However, now a more holistic approach is taken and it is acknowledged errors occur when both human and system factors interact in a chain of events – often complex- resulting in an undesirable outcome.6 Not only the individual at fault but latent conditions within an organisation and triggering factors in clinical practice should also be considered as important causes of error as well.6 As Lucian Leape, the Physician and Professor at Harvan school of Public Health said:
‘Human beings make mistakes because the systems, tasks and processes they work in are poorly designed.’ 6
Human factors result from the individual and may occur due to lack of training and education and lapses in concentration. System errors result from the running of the organisation and the lack of policies and procedures in place to reduce clinical risk. Recent experience shows in certain situations those safeguards have not been adequate and have failed to prevent serious error and harm to the patient.6
Active failures and latent conditions cause holes in the defence system to open up.6
The active failures occur as a result of unsafe practices of the people working with a system, examples include the prescriber failing to double check a prescription, or the pharmacist failing to identify an incorrect dose on a prescription.6 Latent conditions occur due to the structure of the organisation and its resources, management and processes in place.6 These either alone or in combination with an active failure, can lead to error. Examples include the lack of a computerised prescribing system with inbuilt systems to highlight an erroneous prescription or the lack of an effective communication system between primary and secondary care.6
3.2 The role of the pharmacist in managing medication errors
Pharmacists as experts in medicines have an invaluable role in reducing medication errors. As a profession and specialists in the careful use of medicines we are best placed to minimise the risks associated with medication usage.12
The government ‘safety of doses’ report recommended seven action points to improve medication safety. These are:13
Increase reporting and learning from medication incident.
Implementation and audit of NPSA medication alerts guidance.
Improve staff training and competence.
Minimising dose errors.
Ensure medicines not omitted.
Ensure correct medicine correctly labeled gets to the patient.
Document patient allergy status.
The three areas of focus in medication error reduction for Pharmacists to detect and prevent are:12
Risk in the medicine itself.
Risk in the manufacture, storage, and distribution of medicines.
Risk in use of medicines.
Pharmacy departments as a whole are similar to high quality manufacturing units and test each stage in the production, storage and distribution of medicines.12 Pharmacists are involved in almost all stages of the medication cycle from clinically checking of the prescription to the accuracy checking and final release of the medication dispensed. Within the pharmacy culture there is the expectation for errors to occur and consequently systems have been developed and put in place to minimise these.12 Examples of pharmacy services to reduce medication related errors in hospitals are:12
Checking of prescriptions and supplying of drugs.
Ward drug charts.
Use of our knowledge and pharmacokinetics to assess toxic and sub-therapeutic doses.
Quality control and assurance measures.
3.2.1 Ward based Pharmacy services
Pharmacy services at ward level were first proposed as a health policy in 1970 and have proven to detect and prevent prescribing errors.12 The role of the pharmacist is ever evolving and pharmacists are becoming recognised as an integral part of the multi-disciplinary team. The pharmacists role has moved on from the traditional ‘supply role’ to a more ‘clinical role’ allowing pharmacists to use their specialist knowledge surrounding medication use to reduce medication errors at ward level. Pharmacists are a lot more active at ward level and as such are now the first port of call for advice on medication by patients and other health care professionals. The pharmacist’s role also extends to medicines management and formulary development, medicines information and involvement in various dispensing stages. Throughout these different roles the pharmacist’s remain active in promoting safer practice and reduction of medication errors.
3.2.2 Medicines Reconciliation
Medicines reconciliation is a process designed to ensure that all medication a patient is currently taking is correctly documented on admission and at each transfer of care. It encompasses:
Collection
Checking
Communicating
The National Institute for Health and Clinical Excellence (NICE) in collaboration with the NPSA issued guidance to ensure appropriate processes are in place to assure any medication patients are taking prior to admission is properly documented on admission to hospital.8 The NPSA reported the number of incidents of medication errors involving admission and discharge as 7070 with 2 fatalities and 30 that caused severe harm (figures from November 2003 and March 2007).8 An accurate medication history is necessary to aid safe prescribing.
To improve medicines reconciliation at hospital admission NICE/NPSA has recommended that:8
pharmacists are involved in medicines reconciliation as soon as possible after admission
the responsibilities of pharmacists and other staff in the medicines reconciliation process are clearly defined; these responsibilities may differ between clinical areas
strategies are incorporated to obtain information about medications for people with communication difficulties.
At my base hospital, medicines reconciliation involves doctors, nurses, pharmacists and pharmacy technicians. Systems and policies are in place to deliver medicines reconciliation in different areas of care and to ensure all staff involved in the medicines reconciliation process are accredited and adequately trained.
3.2.3 Education and Training
At my base hospital information regarding clinical risk management is widely accessible to all staff through a variety of sources; alongside co-operate clinical mandatory training sessions and in-house local training sessions, a wide variety of information is available on the local trust intranet. These include a governance newsletter entitled ‘Lessons Learned’ detailing adverse events which have occurred and steps taken to prevent reoccurrence of such events, risk management manuals available on-line and the NPSA patient safety literature. At a local pharmacy level, the monthly medicines management bulletin includes medication safety updates and is distributed to all pharmacy staff.
As well as these measures education and training to other health care professionals and patients on medication is paramount. Pharmacists are the professionals best placed to do this. The Central Manchester Foundation Trust took part in a prescribing error audit known as the EQUIP study. This showed pharmacists as experts in medicines held invaluable knowledge and through organised education programmes can help reduce medication errors.14 The main cause of prescribing errors amongst newly qualified medical staff was simply due to lack of knowledge regarding medicines.14 Results demonstrated the need for pharmacists at ward based level and the prevention of potentially serious medication errors through their presence on the ward.14 Pharmacists on wards gave medical staff immediate access to advice regarding dosing, interactions and therapeutic monitoring of drugs.14 Pharmacists are also more likely to complete incident reports involving medicines and should encourage other staff to do the same. Ensuring staff are aware the only way to improve the systems in place is to learn what we are doing wrong.
Pharmacists are also involved in developing and delivering teaching sessions for various groups of staff. Examples included at my base hospital are VTE prophylaxis, IV drug calculations and monitoring for unfractionated heparin. All Pharmacists are encouraged to deliver and attend teaching sessions early on in their career. As well as educating medical staff, pharmacists counselling of patients in outpatients and at discharge will also aid reduction in medication errors.
As well as delivering information and teaching packages, pharmacists need to ensure information provided is sufficient, easily accessible and up to date. Medicine information pharmacists will review how best to provide information for safe prescribing and drug administration.6 The formulation and dissemination of medicine policies and clinical guidelines by pharmacists contributes to risk management. Pharmacists also advice clinicians on risk issues arising from quality assurance reports e.g. NPSA, national and local clinical audit.4
3.3 Reduction in medication errors
Medication errors occur due to a number of failures. Pharmacists clinically reviewing a prescription can detect and prevent prescribing errors, but prescribing is only one aspect of the medication cycle.7 Failures in the processes of reviewing, dispensing, administering and monitoring of medicines also occur.7 To overcome these adequate systems and checks to prevent medication errors need to be in place. Examples of such systems include:13
Effective communication
Education of all health care professionals
Integrated electronic care records
Systems and policies in place for ordering, dispensing, administering and transporting in medicines
Providing 24 hours medicines information services and support to medical staff
Increase specialists staff, more training for junior staff from an undergraduate level and improved discharge procedures
Development of information technology services and standardised electronic incident reporting systems
3.3.1 Information Technology
The developments of technological systems have helped in the running of medicine based services and include automated dispensing systems and electronic prescribing. Similar packagings of medications by the same manufacture lead to frequent dispensing errors. The implementation of an automated dispensing robot in my trust has significantly reduced error rates through the incorrect selection of medication. It also minimises administration errors through the production of standard warning labels such as Methotrexate weekly dosing warnings, and reminders to attach ‘penicillin containing’ stickers to relevant antibiotics. However, the system is not fool proof and as such errors still occur mainly due to over reliance causing staff to become deskilled. Near miss audits to identify potential errors are conducted regularly within my trust to highlight areas of concern and systems put in place to prevent these errors reoccurring.
Implementation of electronic prescribing systems (medisec) for discharge and electronic dose calculator on our neonatal unit has also proven to reduce medication errors. Medication errors due to illegible handwriting no longer occur minimising risk of dispensing errors. The availability of drug name, dose, formulation and dosing schedule have also reduced the risk of medication errors.7
3.3.2 Medication safety at discharge
Poor communication between different health care professionals can lead to medication errors at discharge. Medicines reconciliation on admission has proven to be useful in linking patient’s care at primary care and secondary care. However, more focus needs to be placed on ensuring community pharmacists and GPs are aware of changes to medication at the point of discharge. Improved communication will prevent GPs from prescribing drugs that are no longer indicated, contra-indicated or even duplicate drugs.7 The implementation of the electronic discharge system medisec and the automated electronic copy of the discharge summary detailing information regarding medication changes has proven to be a useful tool in improving communication to GPs, and maintaining the link between primary care and secondary care. In addition to this, patients receiving a copy of their discharge summary and being counseled on their medication at the point of discharge will contribute to reducing medication errors.
4.0 Conclusion
The need to manage risks is particularly important in the NHS because of:
Finite resource – the NHS has a limited amount of money and staff to provide a service
Complexity – the service we provide is extremely complex because of both the size and nature of the task
Expectation – we strive to meet the expectations of an increasingly aware public
Clinical Risk Management is an integral part of clinical governance and thus everyone’s business. Managers in all areas are responsible for ensuring that risks in the area are identified, monitored and controlled in line with the Trust’s Risk Management Strategy. This will contribute to improved delivery of services by providing a structured approach to decision-making. . All staff working in the NHS have a responsibility to be aware of and implement risk management within their individual job roles. The development of technology, systems and processes and education of all staff will be the key to implement clinical risk management at local and national levels in individual trusts.
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