Our standards for Chief Pharmacists to set out the responsibilities, knowledge, conduct, and performance required by a Chief Pharmacist or equivalent role to support their organisation and staff to deliver safe and effective pharmacy services.
Chief Pharmacists (or equivalent with a different job title) have a vital leadership role in making sure pharmacy services are delivered safely and effectively. They usually work in hospitals or settings such as care homes, some Integrated Care Boards (ICBs), some ambulance trusts, prisons, and other places.
We developed the standards for Chief Pharmacists following legislative orders which remove the threat of criminal sanctions for inadvertent preparation and dispensing errors for pharmacy staff working in hospitals and similar settings. These defences already applied to pharmacy staff working in registered pharmacies.
To benefit from the defences as set out in the order, the hospital (or relevant setting) must have a Chief Pharmacist or equivalent in post, who must be a registered pharmacist with the appropriate skills, training, and experience; and who must meet the standards for Chief Pharmacists.
To meet the standards, Chief Pharmacists must:
provide strategic and professional leadership
develop a workforce with the right skills, knowledge, and experience
delegate responsibly and make sure there are clear lines of accountability
maintain and strengthen governance to ensure safe and effective delivery of pharmacy services
They must also meet the standards for pharmacy professionals, which need to be met by all pharmacy professionals.
Strengthening pharmacy governance
Developing these new standards is part of our strengthening pharmacy governance work, which aims to provide clarity around how pharmacies are organised and managed to help us to make sure patients and the public continue to receive safe and effective pharmacy care.
In the future we will also be developing and consulting on rules and standards for Responsible Pharmacists, and standards for Superintendent Pharmacists.
The Pharmacy (Preparation and Dispensing Errors – Hospitals and Other Pharmacy Services) Order 2022, came into force on 1 December 2022 and amended the Medicines Act 1968 by extending the defences to certain criminal offences relating to inadvertent preparation and dispensing errors involving medicinal products for human use so that they are now available to pharmacists, pharmacy technicians or people supervised by them working in certain pharmacy settings which include hospitals, care homes, places where people are lawfully detained, such as prisons and pre-departure accommodation for people facing deportation, and other similar facilities.
The purpose of The Pharmacy (Preparation and Dispensing Errors – Hospitals and Other Pharmacy Services) Order 2022 was to enable pharmacy staff working in a range of pharmacy settings, not just pharmacies registered with us or the Pharmaceutical Society of Northern Ireland (PSNI), to be able to benefit from the defences.
The changes made by the Order were intended to make it less likely that pharmacy staff would be prosecuted and convicted in the event of committing inadvertent preparation and dispensing errors and also to incentivise increased reporting of dispensing errors and learning from errors, which in turn would improve patient safety.
Yes, although there are some slight differences in how it applies. For example, in Northern Ireland pharmacy technicians are not currently regulated so the defences will only be available to pharmacists and people they supervise.
The pharmacy service must be a “relevant pharmacy service”. In essence relevant pharmacy services are pharmacy services registered with or subject to inspection by relevant authorities such as the Care Quality Commission in England, Regulation and Quality Improvement Authority (NI), Healthcare Improvement Scotland or Healthcare Inspectorate Wales.
The definition of what is meant by a “relevant pharmacy service” is set out in section 67F of the 1968 Act (article 9 of The Pharmacy (Preparation and Dispensing Errors – Hospital and Other Pharmacy Services) Order 2022).
Pharmacy services are “relevant pharmacy services” if two conditions are met. Firstly, the pharmacy service has to be the pharmacy service for a facility where certain regulated activities are carried on – hospitals, care homes, places where people are lawfully detained such as prisons and pre-departure accommodation for people facing deportation and other similar facilities. Secondly, the pharmacy service must have a Chief Pharmacist.
If you are unsure whether your organisation meets the requirements of a “relevant pharmacy service” you may wish to seek advice from your organisation’s legal advisors to clarify your position.
To access the defences a “relevant pharmacy service” must have a Chief Pharmacist. The postholder must be a registered pharmacist who plays a significant role in the making of decisions about how the activities of the pharmacy service are managed or organised, or actually manages or organises those activities. The Chief Pharmacist must have the authority to make decisions that affect the running of the pharmacy service relating to the sale or supply of medicinal products and be responsible for ensuring that the pharmacy service is carried on safely and effectively.
Article 10 of The Pharmacy (Preparation and Dispensing Errors – Hospital and Other Pharmacy Services) Order 2022 gave us and the PSNI powers to set standards for Chief Pharmacists. We published our Standards on 22 January 2025 and Chief Pharmacists or individuals performing the responsibilities of the role using a different job title, must comply with the standards to ensure the pharmacy service they are responsible for is managed safely and effectively and that their organisation’s staff can benefit from the defences in the event of an inadvertent preparation or dispensing error.
No. In recognition of the diverse governance arrangements across the UK and the need for flexibility, organisations do not need to adopt the title of Chief Pharmacist. However, organisations who satisfy the requirements of a “relevant pharmacy service” and who intend for their staff to be able to benefit from the defences, should ensure they have a pharmacist in post whose role includes the responsibilities of the Chief Pharmacist which are set out in section 67F(4) of the Medicines Act 1968.
There are criminal offences relating to the sale or supply of medicines which can be prosecuted under the Medicines Act 1968. Two offences relating to preparation or dispensing errors are found in sections 63 and 64 of the Medicines Act 1968.
Section 63 makes it an offence for someone to add any substance to, or abstract any substance from, a medicinal product which affects the composition of the product in a harmful way, intending that the product shall be sold or supplied in that state, or sell or supply, or offer or expose for sale or supply, or have in their possession for the purpose of sale or supply, any medicinal product whose composition has been changed in a harmful way by the addition or abstraction of any substance.
Section 64 makes it a criminal offence for someone to, to the prejudice of the person purchasing the item, sell any medicinal product which is not of the required nature or quality.
There are defences available to offences prosecuted under sections 63 and 64 found in sections 67A – 67D of the Medicines Act 1968. Previously those defences were only available if the preparation or dispensing error took place at a pharmacy registered with us or the PSNI. However, the changes made to the Medicines Act 1968 by The Pharmacy (Preparation and Dispensing Errors – Hospital and Other Pharmacy Services) Order 2022, now mean that in Great Britain the defences are available to registered pharmacists, pharmacy technicians or persons supervised by them, if the act happens either in a registered pharmacy or as part of the activities of a “relevant pharmacy service”, (e.g. services provided by a hospital, care home etc).
Each of the defences contained within sections 67A-67D list the specific conditions a person charged with an offence under section 63 or 64 should satisfy to prevent conviction. The conditions applicable to each defence differ depending on which offence the person is charged with, and whether the medicine was actually sold or supplied.
There is no universal definition of a dispensing error. A dispensing error is often viewed as an error which has been made at any point during the dispensing process from receipt of the prescription, or a decision to dispense in accordance with a direction, through to the supply of the medicine, where the error means that the patient actually receives a medicine that they should not. Examples of preparation and dispensing errors include, but are not limited to:
an ingredient is omitted or inadvertently added when making up a medicine.
a medicine intended for one patient is supplied to another patient.
the wrong medicine is dispensed.
the medicine is dispensed at the wrong strength or in the wrong form.
Fortunately, dispensing errors where the incorrect medicine is supplied to a patient only occur in a small proportion of cases.
In cases where a person is charged with an offence under sections 63 (a) or (b) of the Medicines Act 1968 involving an incorrect medicine having been sold or supplied, for that person to benefit from the defence in section 67B, they must satisfy the conditions set out in section 67B (a) – (d).
The condition at section 67B (d) requires that in circumstances where the error was identified after the medicine was sold or supplied, and before the person was charged with the offence, for the defence to be successful, all reasonable steps are required to be promptly taken to ensure that the patient is notified of the error, unless either the person who adulterated the medicine, or their supervising registrant, or the person in charge of the registered pharmacy or relevant pharmacy service, reasonably decides it is not necessary nor appropriate to notify the patient of the error.
Pharmacy staff should always act responsibly and exercise their professional judgment in deciding whether it is necessary and appropriate to notify a patient of the error. However not all pharmacy staff can reasonably form the view that the patient does not need to be notified of a preparation or dispensing error.
For example, it will not be reasonable for pharmacy students or for more junior, or less experienced members of pharmacy staff to decide the matter alone, even if they made the error. They would need to refer the matter to the supervising registrant because decisions about whether to notify the patient of the error needs to be made by someone who can reasonably be responsible for a decision not to notify a patient of the error.
Registrants are healthcare professionals and have a duty of candour, this is a professional responsibility to be open and honest with patients when something goes wrong with their treatment or care which causes, or has the potential to cause, harm or distress. Registrants should always have regard to the duty of candour in circumstances involving preparation or dispensing errors.
Pharmacy owners, and those in charge of a registered pharmacy or relevant pharmacy service should also apply the duty of candour in making decisions regarding the pharmacy activities and services they provide.
The term “promptly” is not defined in the legislation. This was deliberate to reflect that the circumstances of each case have to be examined on their own merits. Applying the ordinary every day meaning of the word, “promptly” may mean without delay or quickly. Pharmacy professionals should exercise their judgment in deciding when to notify a patient of a medication error and recognise delays in notifying a patient of the error may be challenged.
Yes. A pharmacy professional must use their professional judgement to make the care of the patient their first priority. If there are legitimate and good reasons to do so, this may mean, on occasion that it is appropriate to deviate from a SOP. The legislation was not intended to restrict registered professionals from exercising their professional judgment in the best interests of a patient. Not following a SOP does not in itself prevent a pharmacy professional from being able to benefit from the defences in the event of being prosecuted for a preparation or dispensing error.
No. The Order does not remove the criminal offences in the Medicines Act 1968 relating to preparation or dispensing errors made by registered pharmacy professionals and those supervised by them. The offences are retained because they apply to all sales or supplies on prescription, not just to those by pharmacy professionals in registered pharmacies or relevant pharmacy services such as hospitals or other regulated settings. They also apply to sales of medicines in shops and to sales made by herbalists.
There may still be circumstances where a prosecution is in the public interest and where pharmacy professionals will not be able to benefit from the defences. For example, where the professional has shown a deliberate disregard for patient safety or has not discharged their professional duty of candour responsibilities to advise patients promptly of errors. In these circumstances, the errors will be caught by the offences and individuals may still be prosecuted and convicted.
Irrespective of whether a person is prosecuted under the Medicines Act 1968 in connection with a preparation or dispensing error, we may also investigate concerns relating to the error(s) through our fitness to practise processes.
Yes, preparation or dispensing errors involving emergency supplies of medicines or medicines supplied in accordance with a PGD are covered by the defences. The emergency supply of medicines usually involves the supply of a medicine without a prescription. The defences apply to errors where the medicine was sold or supplied in accordance with a prescription, or directions given by a relevant prescriber, or a patient group direction, or a prescription only medicine that was sold or supplied in circumstances where there was an immediate need for it to be sold or supplied and a prescription could not have been obtained without undue delay.
Yes. Circumstances involving a preparation or dispensing error where a pharmacist was both the prescriber and dispenser are covered by the defences. In practice this scenario is uncommon, as prescribing and dispensing by the same person should only occur where the service provider, and in particular its Chief Pharmacist, is satisfied that this can be done safely and effectively. The practice of prescribing, preparing and dispensing medicines in hospitals or other relevant pharmacy services should be risk assessed to identify and manage risk(s) to patient safety.
Yes. Although it is relatively rare that offences under sections 63 and 64 of the Medicines Act 1968 are prosecuted, by extending the defences from prosecution to pharmacy staff working in a range of regulated settings, not just registered pharmacies, the intention was to further reduce the likelihood of inadvertent preparation or dispensing errors resulting in prosecution and conviction where the conditions of the defences are satisfied.
For an organisation’s pharmacy staff to be eligible to access the defences in the Medicines Act 1968 in the event of prosecution in connection with a preparation or dispensing error, the organisation must satisfy the requirements in section 67F of a “relevant pharmacy service” which includes (but is not limited to) having someone in post performing the responsibilities of the Chief Pharmacist which are set out in section 67F(4). If you are in any doubt whether your organisation meets the requirements get in touch with your legal advisors.
Provided a preparation or dispensing error occurs at either a registered pharmacy or a “relevant pharmacy service”, and the other specific conditions of the defences found in sections 67A-67D of the Medicines Act 1968 are satisfied, (including but not limited to there being a Chief Pharmacist in post whose responsibilities meet the requirements of section 67F(4) in the case of the error happening at a relevant pharmacy service), then pharmacy staff involved in the error may benefit from the defences in the event of a prosecution.
No. Section 10 of the Medicines Act 1968 requires that only pharmacists can supervise the sale and supply of prescription only medicines (POMs) and pharmacy (P) medicines. This has not changed.
If a pharmacy technician was involved in the preparation or supply of medicines without being supervised by a pharmacist, they are unlikely to be able to satisfy the conditions of the defences within the Medicines Act 1968 and therefore may be at risk of conviction for an offence involving an inadvertent preparation or dispensing error.
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