Chapter 8 Clinical governance – an overview
Clinical governance is defined by the Department of Health as ‘the system through which NHS organisations are accountable for continuously improving the quality of their services and safeguarding high standards of care, by creating an environment in which clinical excellence will flourish’.
Clinical governance was introduced following a series of well publicized lapses in patient quality in the 1990s as part of a broader government agenda to improve the quality of care delivered to patients by the NHS. It is a set of processes that healthcare professionals are expected to work with in order to learn from the successes and failures of both their own practice and those of others and to promote an open culture where experiences are shared to promote best practice for their patients.
The NHS document A First Class Service: Quality in the New NHS (Department of Health 1998) introduced the term ‘clinical governance’ stating that ‘for the first time, the NHS will be required to adopt a structured and coherent approach to clinical quality, placing duties and expectations on local healthcare organisations as well as individuals. Effective clinical governance will make it clear that quality is everybody’s business’.
The NHS publication Clinical Governance: Quality in the NHS (1999) outlines four main components of clinical governance. These are:
The publication also provides examples of quality improvement activities, including:
Clinical governance should underpin the practice of all healthcare professionals as they strive for the best quality of care for their patients and continually seek improvement in their practice. Practising good clinical governance ensures a consistent approach to decision making, minimizes risk and ensures that patients are the priority and focus of the professional practice of pharmacists and all other healthcare professionals.
Standards are set by clinical guidelines such as the National Service Frameworks (NSFs). These are documents that aim to guide decisions in a specific area of health care, as defined by an authoritative examination of current evidence. Decisions to prescribe medicines should be evidence based. Evidence-based medicine is defined as the use of clinical methods and decision making that have been thoroughly tested by properly controlled, peer-reviewed medical research.
Quality health care should be delivered by well trained and motivated healthcare professionals who are well managed and are committed to self-development through continuing professional development (CPD; see Ch. 10). NHS staff should communicate openly with other healthcare professionals and should be encouraged to share best practice. Errors, service failures or ‘near misses’ should be recorded, reflected upon and shared among others so they are not repeated and a ‘no-blame’ culture should be adopted for mistakes. NHS staff should be regularly appraised on their performance and poor performance identified and remedied. The NHS document Organisation with a Memory (Department of Health 2000) requires that mechanisms are introduced for ensuring that, where lessons are identified, the necessary changes are put into practice and a wider appreciation of the value of preventing, analysing and learning from errors becomes the norm.
The NHS document Clinical Governance in Community Pharmacy (Department of Health 2001) first introduced clinical governance into community pharmacy, although it was not part of the contract at that time. Clinical governance facilitators were introduced at a local level, whose role was to inform and educate community pharmacists on the primary care organizations’ policies for good clinical governance. The new contract for community pharmacists was launched in April 2005 with the inclusion of clinical governance as an essential component of the terms of service. The new contract requirements on clinical governance include the following areas:
Professional governance in the pharmacy profession forms part of clinical governance, the aim of which is to:
Professional governance in pharmacy could be defined as:
Pharmacists have a duty of care to the public and their patients imposed by law to ensure that the public is protected. The law would expect that pharmacists practise pharmacy to a level of competence expected by the profession and indeed practised by the average pharmacist. Pharmacists are expected to exercise reasonable care when supplying the public and patients with medicines and pharmaceutical and other professional advice. In their practice, pharmacists are subject to criminal law (e.g. Medicines Act, Misuse of Drugs Act), administrative law (e.g. contractual agreements with the primary care organizations), civil law and the Code of Ethics of the Royal Pharmaceutical Society of Great Britain (RPSGB).
Mistakes or errors do happen. However, the vast majority of these are relatively minor and are usually quickly and easily rectified without concern. Unless a pharmacist causes deliberate harm to a patient it is unlikely that he or she would be subject to criminal charges; however, this is a possibility. In fact, a pharmacist and pre-registration trainee were initially charged with manslaughter following the incorrect dispensing of a supply of peppermint water that caused the death of a 3-week-old baby in 1998. The charge of manslaughter was later dropped in favour of prosecution under the Medicines Act instead.
If the mistake by a pharmacist does lead to resulting damages then a more likely charge of negligence may be pursued in a civil court. For a breach in a duty of care to be proven then the prosecution must prove that a duty of care exists, that this duty of care has been breached and that the patient has suffered damages resulting from the breach. Often an expert witness from the pharmacy profession would be called to explain how a ‘standard’ or ‘normal’ member of the profession would have acted in this case.
You may remember that one of the key components of clinical governance is that there must be ‘Procedures for all professional groups to identify and remedy poor performance’. This role in the governance of the professional is vital to ensure that patients are protected and confidence in the profession is maintained. This role currently falls within the remit of the RPSGB; however, by 2010, parliamentary time permitting, this role will be undertaken by a new regulatory body for pharmacists and pharmacy technicians. The new independent General Pharmaceutical Council (GPhC) was proposed in the government White Paper entitled Trust, Assurance and Safety and will be approved in 2009 ready to take on the substantive functions of the GPhC in 2010. It is proposed that the GPhC will:
To complicate matters in the meantime, the RPSGB has had to implement new fitness to practise committees in 2007 following the publication of the Pharmacists and Pharmacy Technicians Order 2007. The order came into force on 7 February 2007 and new fitness to practise rules came into force on 30 March 2007 (see later). The order established three new statutory committees:Under the old rules the RPSGB was only able to consider allegations of misconduct and had limited sanctions available to it. Under the new scheme the RPSGB is able to consider a wider range of allegations including those relating to a registrant’s health, and has a number of new sanctions including imposing conditions on registration and suspensions from the registers of up to 1 year, as well as the power to direct removal of the registrant’s name from the appropriate registers.
The Investigating Committee receives an ‘allegation’ and determines in the first instance whether that allegation should be referred to either the Disciplinary Committee or the Health Committee. If referral is unnecessary then it may issue:
The Health Committee determines whether or not the fitness to practise of the person of whom the allegation is made is impaired based on the health of the person. If the committee finds that fitness to practise is impaired it may:
The Disciplinary Committee determines whether or not the fitness to practise of the person of whom the allegation is made is impaired based on allegations that are not normally health related. If the committee finds that fitness to practise is impaired it may:
Pharmacists are only human and, despite best intentions and safeguards, mistakes do happen. It is how mistakes are dealt with and whether or not lessons are learned from them that will normally determine whether incidents are referred for further investigation.
When a dispensing error occurs the pharmacist is ideally placed to determine the potential risk to the patient. When dealing with dispensing or prescribing mistakes it is vital that pharmacists place the welfare of the patient first and seek immediate medical attention if necessary. An investigating committee would take a very dim view of pharmacists covering up a mistake, not assessing the risk of a mistake to the health of a patient or repeated mistakes where they have clearly not taken remedial action in preventing errors from recurring.
While this is not a comprehensive checklist it may be helpful to consider the following when an error occurs:
When a medication error does occur it is seen as good practice to record the error in a medication error log. Pharmacists should maintain such a log as part of practising good clinical governance and its use should form part of the SOP for dispensing. In March 2007 the council of the RPSGB agreed the criteria for which single dispensing errors are likely to amount to misconduct and would warrant referral to the Investigating Committee (Box 8.1). The criteria for referral include both the lack of systems to record errors in the pharmacy and the failure to make an error log if the pharmacist was aware that one had occurred. The RPSGB inspectorate may, as part of the routine visits to a pharmacy, ask to see evidence that a system is in place to deal with dispensing errors, including the maintenance and use of medication error logs. Inspectors will not normally ask to view the actual logs unless investigating a specific complaint relating to a dispensing error, and may then request to see that specific medication error log. The RPSGB has also stated that it may be particularly helpful if the error log describes any review of systems carried out at the pharmacy in light of the incident. If there are concerns regarding a pharmacist’s fitness to practise then it may be that the entire medication error log may be examined, particularly if there was a concern for public safety.
Box 8.1 Criteria for consideration of single dispensing errors
Single dispensing errors are not likely to be referred to the Investigating Committee unless one or more of the following statements is true:
NPSA definitions for grading patient safety incidents are shown in Box 8.2. See also Examples 8.1 and 8.2.
Box 8.2 NPSA definitions for grading patient safety incidents
Incident prevented – any patient safety incident that had the potential to cause harm but was prevented, and no harm was caused to patients receiving NHS-funded care. Incident not prevented – any patient safety incident that occurred but no harm was caused to patients receiving NHS-funded care
Any patient safety incident that required extra observation or minor treatment and caused minimal harm to one or more patients receiving NHS-funded care. (Minor treatment is defined as first aid, additional therapy or additional medication. It does not include any extra stay in hospital or any extra time as an outpatient, or continued treatment over and above the treatment already planned; nor does it include a return to surgery or readmission)
Any patient safety incident that resulted in a moderate increase in treatment and that caused significant but not permanent harm to one or more patients receiving NHS-funded care. (Moderate increase in treatment is defined as a return to surgery, an unplanned readmission, a prolonged episode of care, extra time in hospital or as an outpatient, cancelling of treatment or transfer to another area such as intensive care as a result of the incident)
Any patient safety incident that appears to have resulted in permanent harm to one or more patients receiving NHS-funded care. (Permanent harm directly related to the incident and not related to the natural course of the patient’s illness or underlying condition is defined as permanent lessening of bodily functions, sensory, motor, physiological or intellectual, including removal of the wrong limb or organ, or brain damage)
Example 8.1
You are a community pharmacist manager and you are asked to deal with a complaint from Mrs A.B. who claims she was supplied with the wrong medication for her mother yesterday. You establish that she was supplied with 28 amiodarone 100 mg tablets instead of 28 atenolol 100 mg tablets. What action should you take?
It is important to first of all establish whether or not the patient has taken any of the incorrect medication. If so, then you are best placed to use your knowledge of medicines to determine the risk to the patient. If there is any risk to the health of the patient then you must advise the patient to seek urgent medical attention. It may be necessary to telephone the A&E department in advance of the patient arriving to provide as many details as you can. It would also be good practice to telephone the patient’s GP to inform them of the risk to the patient.
Mrs A.B. informs you that her mother did take one of the amiodarone tablets this morning.
You should advise her not to take any more and ask her to seek medical attention. You should then phone the patient’s GP to discuss the incident. The Code of Ethics for Pharmacists and Pharmacy Technicians requires you to ‘make the care of patients your first concern’. Once you have taken all reasonable steps to assure the patient’s health and safety have been considered then it is important to document the incident in the medication error log while it is fresh in your mind. If you are working for a company then you should inform the superintendent pharmacist and if appropriate you could also seek advice from the RPSGB inspectorate.
How should you reflect on this incident and prevent it or similar errors from reoccurring?
Pharmacists and other healthcare professionals are only human and accordingly dispensing and prescribing errors do happen. What is important is to learn from them and take action to prevent this or other similar errors from occurring. Good clinical governance involves auditing and reflecting on our own professional practice and when something goes wrong taking action to improve systems and minimize risk.
Example 8.2
You receive a letter from the PCT indicating that there is a member of the public purporting to be a medical practitioner who is contacting pharmacies in the area with a view to obtaining illegal supplies of prescription only medicines (POMs) and controlled drugs. What action should you take now and what should you do if you find that you have supplied him with a medicine illegally?
Practising good clinical governance is not just about preventing mistakes from recurring, it is about auditing our policies and SOPs to ensure they protect the public and are robust enough to allow for all eventualities, including preventing medicines getting on to the black market.
In this case you should ensure that your SOP requires that all personal requests for prescription only medicines and controlled drugs by persons purporting to be medical practitioners, whether in person or by telephone, are dealt with personally by the responsible pharmacist and all early warning letters such as these are made available to all pharmacists practising from your pharmacy. It is essential that all unknown doctors are authenticated and if necessary confirmation verified by a phone call to the medical practice and if necessary the General Medical Council.
While reviewing your procedures with the pharmacy assistants, a member of staff indicates that a doctor visited the pharmacy last Saturday requesting the purchase of a number of medicines. She informs you that the relief pharmacist dealt with the requests. You check the POM register but find no record of the sale of POM medicines to a GP last Saturday. What should you do now?
You must act on this information and assure yourself that POMs were not supplied illegally from the pharmacy. Although you were not the responsible pharmacist last Saturday you would be as culpable as the pharmacist who was if you later found out that the public was put at risk and you did nothing about it.
You should contact the pharmacist in charge on that day to ascertain the facts. If POMs or controlled drugs (CDs) were sold to a member of the public who was purporting to be a doctor then you must inform the police, the PCT, the superintendent pharmacist and the RPSGB inspector. You should make a full record of the events that occurred and ask the relief pharmacist to do likewise.