Pharmacists are used to being accountable for the quality of the services that they provide and issues relating to a pharmacist’s professional responsibility and accountability in relation to the supply of dispensed medicines are not new. These issues have, however, recently been the subject of lengthy debate at one of the Society’s Infringement Committee meetings.
The Committee had before it a case where Patient A had handed in two prescriptions to a pharmacy, one for herself and one for Patient B. The prescriptions were dispensed the next day by Pharmacist C. Patient A’s medicines were correctly prepared but incorrectly labelled with Patient B’s name. These items were put in the prescription bag containing Patient B’s medicines. The prescription bag containing both patients’ medicine was then put ready for collection.
A locum, Pharmacist D, who made no checks before supplying the dispensed medicines, handed the bag out the following day. During investigation by a Society inspector, Pharmacist D stated that he was unaware that he had any responsibility for the supply of the medicines that had been dispensed and checked by another pharmacist. However, if Pharmacist D had checked that the names on both prescriptions matched the names on the prescription bag, the error would have been picked up and could have been rectified.
Law
The Committee viewed this case against the legislative backdrop of the Medicines Act 1968 (the Act), under which the Society has enforcement authority. Section 52 of the Act effectively states that supplies of non general sales list medicines against prescriptions from registered retail pharmacy premises must take place by, or under, the supervision of a pharmacist.
It is important to note that this section of the Act relates to the supervision of supply of medicines (and not the preparation or dispensing of medicines, which is covered elsewhere in the legislation) because there is legal liability for the pharmacist supervising supplies of medicines. There is also legal liability on the part of the owners of registered retail pharmacies, including sole traders, partnerships, bodies corporate and the directors, managers, secretaries or other similar officers of bodies corporate.
Section 64 of the Act effectively states that no person shall, to the prejudice of the patient, supply any medicine which is not of the nature or quality specified by the prescription. Prejudice is not intended to mean injury or damage and there is no need to prove actual harm.
Under Section 64, the pharmacist by whom, or under whose supervision, the supply is made is liable in addition to the “person lawfully conducting the retail pharmacy business” (eg, the owner). There is also legal liability on the part of the directors, managers, secretaries or other similar officers of bodies corporate if it is proved that the offence was committed by consent, connivance or negligence (or all of these) of such officers.
Section 85 of the Act refers to the labelling of medicines and Section 58 relates to the unlawful supply of a prescription only medicine (POM) in the absence of a prescription. In the case before the Committee, incorrectly labelled POMs were handed to the wrong patient. However, Section 121 of the Act does provide for a defence due to the default of another person. Hence, where you can prove that the offence occurred as a consequence of the default of another, or that you have exercised all due diligence to ensure that no offences under Sections 64 and 85 were committed, this may be a defence to criminal action.
Ethics
In addition to the legislative provisions surrounding the supply of medicines and dispensing errors, the Committee considered the concepts of professional responsibility and accountability, which are central to any profession. To be responsible is to be prepared to give an account of your professional judgements, acts and omissions in relation to your professional role. Accountability flows from such responsibility. Hence, anyone who is responsible is also accountable.
In professional ethics accountability is of paramount importance. The pharmacy profession is, therefore, not unique in enshrining concepts of accountability and responsibility in its Code of Ethics. In particular, Part 2 A.1 of the Code states: “Pharmacists assuming responsibility for any pharmacy functions whether as an employee, locum, adviser or otherwise are professionally accountable for all decisions to supply a medicine or offer advice … ”
Additional duties are placed on pharmacists who own a pharmacy, superintendent pharmacists and pharmacist managers in hospitals and trusts and other fields of practice under Part 2 A.2 of the Code. In particular, pharmacists are responsible for “ensuring that a retrievable record of the pharmacist taking responsibility for the provision of each pharmacy service is maintained and that an identifiable pharmacist is accountable for all activities of non-pharmacists involved in the provision of pharmacy services.”
Because the case before the Infringements Committee raised several important issues in relation to where each pharmacist’s professional responsibilities begin and end in relation to dispensing, a Law and Ethics Bulletin was published (PJ, 28 February, p261). This stated:
“… Pharmacists are advised that an identifiable pharmacist must be accountable for every professional activity undertaken. The transfer of medicines to the patient forms part of the dispensing process and, therefore, the pharmacist on duty when the supply is made cannot absolve himself or herself from responsibility for that supply on the basis that he or she did not dispense the medicine.”
Responsibility and accountability
Feedback from the Bulletin has highlighted the fact that many pharmacists are confused about the boundaries of their responsibilities and accountabilities. The preparation, dispensing and supplying of medicines by pharmacists is still such an integral part of many pharmacists’ roles that further clarification is warranted, together with an understanding of how the implications of this case can be handled practically in the workplace.
Accountability is a complex issue and the level of an individual’s accountability can vary depending on the circumstances as the examples below seek to show.
Example 1 Pharmacist E undertakes a clinical check of a prescription but fails to identify that the prescriber has ordered an overdose of a particular drug. The medicines are assembled, dispensed, checked and bagged up by adequately trained technicians. The medicines are then supplied to the patient by Pharmacist F who has the details of the prescription in front of him but who also fails to identify the overdose.
Who is professionally liable in these circumstances? Both pharmacists have a duty of care to the patient and both are professionally accountable for those parts of the dispensing process for which they are responsible. In the absence of written standard operating procedures (SOPs) defining individual responsibilities, both pharmacists are likely to be professionally accountable.
Example 2 The second scenario is identical to the first except that the pharmacy has written procedures. According to these procedures, the first pharmacist accepts responsibility for undertaking the clinical check and there is an audit trail to identify the responsible professional for each part of the dispensing process. Who is liable professionally in these circumstances?
Both pharmacists have a duty of care to the patient and both are professionally accountable for those parts of the dispensing process that they take responsibility for. Here there are clear lines of responsibility and clear audit trails identifying each professional accountable for each stage of the process. However, the second pharmacist accepts responsibility for supplying the medicine to the patient and has access to the prescription at the time of supply.
It is still likely that both pharmacists would be professionally accountable. However, the presence of written procedures identifying the responsibilities of each professional coupled with a comprehensive audit trail throughout the dispensing process may mitigate the second pharmacist’s professional accountability on the basis that he should have been entitled to rely on his colleague’s skill and competence to undertake the clinical check (see below for further comment on competence).
Example 3 The third scenario is identical to the second, but Pharmacist F does not have access to the patient’s prescription. In these circumstances, both pharmacists have a duty of care to the patient and both are professionally accountable for those parts of the dispensing process that they are responsible for.
Again, there are clear lines of responsibility and clear audit trails. However, because the supplying pharmacist does not have the prescription when handing over the dispensed medicines it is arguable that he is entitled to rely on the skills and competence of his colleague who has undertaken the clinical check of the prescription.
From the three scenarios, it is clear that responsibility and accountability is a ques-tion of degree. Sometimes responsibilities are clear but more often there is a blurring of the lines between individuals’ responsibilities.
In the case before the Committee it was decided that an advisory letter should be issued to Pharmacist D, which outlined his professional responsibilities in relation to the supply of medicines. A harsher view was taken of Pharmacist C in the light of his recent previous history of dispensing errors.
Individual cases are looked at on their merits.
Practice points
As far back as 1999 the Society published a document “Achieving excellence in pharmacy through clinical governance”1. It listed the four main components of clinical governance as:
· Defining clear lines of responsibility and accountability for the overall quality of care
· Establishing a comprehensive programme of quality improvement activities
· Having clear policies aimed at managing risks
· Establishing procedures for all professional groups to identify and remedy poor performance.
Although these components have been refined over time, the fundamental concepts still hold true. Below are some practical ways to ensure that you are operating safe dispensing systems, by incorporating the principles of clinical governance. At the end of the day this safeguards not only the patient’s best interests but also your own.
Employee pharmacists should be aware of any policies or procedures that their employer has in place to minimise risks.
Written standard operating procedures The Society recognises the importance of the use of written SOPs to assist in defining the lines of responsibility and accountability for each stage of the dispensing process. From 1 January 2005, pharmacists will be required to put into place and operate written SOPs for dispensing. This applies to both community and hospital sectors and will cover all of the activities that occur from the time a prescription is received in the pharmacy, or by a pharmacist, until medicines or other prescribed items have been collected or supplied to a patient.
In practical terms this will assist pharmacists clarify which pharmacist is responsible for what part of the dispensing process (see ‘Medicines, ethics and practice — a guide for pharmacists’ for full details2).
Training and continuing professional development It goes without saying that you need to ensure that you can rely on the skill and competence of fellow professional colleagues if you are to be in a position to accept their professional judgement. Ensuring that members of the dispensing team are suitably trained, up to date and competent to undertake the tasks for which they are responsible is important if you are not to be placed in a position of double checking everything that they do.
Quality improvement activities Audit is one way to identify where improvements to a system need to be made. It involves a systematic evaluation of professional work against set standards. For example, the use of error logs and regular auditing of such logs can identify possible problems and individual training needs.
Audits can identify risk areas in processes and flag up a need to change a system or process in order to minimise the risk of errors. Audits can also identify errors occurring in the handing out of dispensed medicines and a review can lead to changes in the dispensing process, such as the use of numbered dockets when patients hand in prescriptions or the retention of the original prescription with the dispensed medicine until the medicine is supplied.
In the wider context, error reports made to the National Patient Safety Agency can help to identify national trends in medication errors and enable steps to be taken to reduce the incidence of such errors. The agency collect reports from the whole country and initiates preventative measures, so that all can learn from each case, and patient safety throughout the NHS can be improved. In addition, many primary care organisations operate local reporting systems for community pharmacy and pharmacists are encouraged to report medication errors at local level in order that a wider picture of the errors made can be obtained and steps taken to minimise risks.
Audit trails The importance of audit trails cannot be overstated. These are a means to identify responsible professionals throughout each stage of the dispensing process. The IT systems used in pharmacy do not easily capture this information but, it is hoped, this situation will improve with the electronic transfer of prescriptions. Currently, many pharmacies use “dispensed by” and “checked by” boxes on dispensing labels to maintain an audit trail for the assembly and accuracy checking processes, which are useful in determining responsibilities at each of these stages.
Other risk management policies There are many other ways to minimise risks of dispensing errors. Some of these are fairly obvious but include: patient counselling, use of proper accuracy checking procedures and remedying poor performance.
The Society deals with many dispensing errors, some of which would have been easily picked up if the patient or representative had been adequately counselled at the point of supply. Proper accuracy checking includes ensuring that staff are only delegated dispensing duties within their sphere of competence. The Society advises the use of a double checking procedure for dispensed medicines. On occasions when pharmacists are working alone, a mental break should be taken between dispensing and checking so that any preconceived ideas about the prescription are forgotten. It is essential that all accuracy checks are made against the prescription, re-reading the prescription first.
The use of transparent dispensing bags enables a final visual check of the dispensed medicines at the point of supply and they are a useful example of an attempt to add safety checks into the dispensing operation system. However, this is by no means a fail safe method of final checking — it is unlikely that errors involving medicines dispensed from bulk packs would be detected because the original stock pots are not available to check against.
Summary
Remedying poor performance is imperative if pharmacists are to operate in a safe environment. Pharmacists are currently under a duty to report to the Society concerns that a member’s professional competence or ability to practise may be impaired and could put the public at risk.
This duty to report is to be extended to other health care professionals in light of recent high profile cases, in particular Harold Shipman. In the interim, work is on going at the Society to provide comprehensive guidelines to any pharmacist involved in setting up local schemes to identify and remedy poor performance. This includes advisers within the NHS, or on a local pharmaceutical committee, managers of pharmacists in hospitals or in a pharmacy chain.
However, in my experience of investigating errors, most problems occur because of systems problems not individuals. Pharmacists, therefore, need to ensure the systems they use have been thought through carefully and adopt the principles of clinical governance.
It is important to remember that, whatever systems are put in place, errors with medicines will occur. Thankfully, within the pharmacy profession, the number of reported errors are a small percentage of the total number of items dispensed. If you find yourself in the position of having made an error you will be held to account. You need to be in a position to ensure that you have taken all reasonable steps to minimise the risk in your dispensing process and that you have taken all reasonable steps to deal with the error and its consequences once you are made aware of the error.
References
1. Royal Pharmaceutical Society of Great Britain. Achieving excellence in pharmacy through clinical governance, 1999. (accessed 22 June 2004).
2. Royal Pharmaceutical Society of Great Britain. Medicines, ethics and practice – a guide for pharmacists, number 27, July 2003.
This article is intended to assist with the interpretation of the requirements of the Code of Ethics in relation to pharmacists’ responsibilities for the supply of dispensed medicines. It is not intended to constitute authoritative advice on issues relating to civil liability (i.e. where a pharmacist may be sued for damages by a patient or other party).
