The dilemma

You are a pharmacy manager. One morning, as normal, you sign in on the computer system as the responsible pharmacist (RP).

Head office has arranged half-day locum cover for the afternoon so you can catch up on paperwork. However, there is a rush on walk-in prescriptions during the handover and you forget to sign out as the responsible pharmacist.

The locum is quite inexperienced in the pharmacy's processes and does not sign in as the RP. A serious dispensing error occurs during the afternoon and the patient is subsequently admitted to hospital.

Who is responsible?

Your views

"It would be the responsibility of the pharmacist who checked the prescription but the RP could be blamed. Make sure that you sign out. This is a trivial scenario. Do not let fear of it encroach into your normal working practice. Fear breeds mistakes."

Derek Noble, locum pharmacist

"Assume you stay on the premises to do some paperwork and the full premises are registered. You start your paperwork at 2pm and the locum started at 1pm. The error happens at 2.30pm.

You would be responsible for the error as you have signed the RP register and, thus, have stated that you are following the RP regulations and that there are procedures for safe and effective dispensing of medicines. The error shows this has not happened – from a purely legal viewpoint.

As RP, you could be deemed liable for the error, but a claim could be brought against you and the locum pharmacist or you could join that pharmacist in the claim if the patient decided to bring a claim against you. The contractor has the NHS contract to dispense. So a claim could also be brought against the contractor.

If you leave the premises you are still the RP but absent. Nothing changes. However, questions would be asked regarding why you had not recorded an absence and would recording an absence to do paperwork be a sufficient reason in the spirit of the RP regulations.

 [Assuming you leave the premises at 1pm], the two-hour absence rule means anything that happens after 3pm happens in a pharmacy with no RP. Responsibility then falls to the superintendent (SP).

You can be fined under the Medicines Act for failing to keep the RP record, as can the locum pharmacist and the SP. And a criminal record would result, so fitness to practise would be automatically impaired under Article 51, Pharmacy Order 2010. You would then have to inform the GPhC under the seven-day rule.

As for the error, it would be difficult to show the RP was responsible as there was no RP. However, liability would fall between the locum and the SP, with the locum being the one with the lion's share of the liability, in my opinion."

Paul Summerfield, pharmacist

"If you are recorded as the RP you are legally responsible for anything that happens within the premises.

This scenario (minus the dispensing error!) is not uncommon when as a locum I am employed as the second pharmacist and the regular manager who has recorded themselves as the RP announces that they will be using my presence to help them catch up with paperwork, MURs or NMS and that I should deal with all the rest. Sign every label you check and, if in the SOP, the checking matrix on the prescription. If there was an owing and you checked that add "owing only" next to your signature and if you checked, eg two of three items, note which two.

A full audit trail is your best defence."

David Wayles, community pharmacist

The expert advice

The responsible pharmacist (RP) has a legal and ethical obligation to ensure that the pharmacy operates safely and effectively. This includes an obligation to ensure that the pharmacy has appropriate standard operating procedures in place.

However, the RP does not assume legal responsibility for everything that happens in the pharmacy simply because he is signed in as the RP. In this scenario, provided that there were appropriate procedures in place, there is no reason to assume that the RP would be responsible for a dispensing error that arose from the actions of a locum pharmacist.

Noel Wardle, partner, Charles Russell LLP

In this dilemma there are several issues to consider. First, an investigation should be held, following the company's standard operating procedure (SOP), into the circumstances surrounding the dispensing error. This should establish who was involved and what steps can be taken to prevent this type of error occurring again. With regards to the responsible pharmacist (RP) requirements, the pharmacy should have SOPs that cover this and the investigator should consider whether these were being followed and whether handover systems between pharmacists were in place. Finally, the investigation should establish the time that the error occurred and whether the pharmacy manager was absent from the pharmacy when it took place. It is important to fully investigate any dispensing error that occurs so that what went wrong and what lessons can be learnt can be established. It is also imperative to ascertain who was involved in the dispensing error and who completed the accuracy check. This may not necessarily have been the locum pharmacist as there may have been other members of staff involved in the dispensing and accuracy-checking process. Before the sale or supply of medicines or any operational activities can take place in a pharmacy, a registered pharmacist is required to be in charge of the pharmacy and assume the role of the RP. The pharmacy record shows who the RP is at a specific date and time and is a legal document that can be used as an audit trail. In the General Pharmaceutical Council (GPhC) document Guidance for Responsible Pharmacists 2010, Section 3.1 instructs pharmacies to "ensure the pharmacy record is accurate and reflects who the responsible pharmacist is, and was, at any given date and time (including whether or not the responsible pharmacist is, or was, absent from the registered pharmacy)". Standard operating procedures should be in place to ensure that when there is a change of RP, a set procedure is followed. An investigation should confirm that there is an SOP in place and that this is up to date and is being reviewed regularly. Although there may have been an SOP in place within this pharmacy, an investigator would need to consider whether this had been followed and implemented.

The locum is quite inexperienced in the pharmacy's processes and locums should be advised to read and understand the SOPs before the role of RP is undertaken. Until the locum pharmacist is satisfied that they have secured the safe and effective running of the pharmacy they are working in, they should not sign the pharmacy record as the RP. If the locum was unaware of how they should sign in on the computer system, they should have alerted someone – they may have needed further training on this procedure. An investigator should also ask why the pharmacy manager had not signed out. They may have forgotten to do so if they were in a rush or they may not have understood the full implications of not doing so. However, legally, they would still be the RP according to the pharmacy record. In a 24-hour period from midnight to midnight, an RP may be absent for a cumulative maximum period of two hours. If there is more than one RP during this time, this two-hour period will include the absence of all of the RPs. During this time, only certain activities can be carried out in the pharmacy under the absence provisions. If the pharmacy manager was doing their paperwork on the registered pharmacy premises and had not signed out, then from a legal point of view they would still be the RP. If the error occurred two hours after the locum pharmacist had started, then the pharmacy manager would still be signed in as the RP but the two-hour absence provision would have been breached. The superintendent pharmacist may be asked why the pharmacy was still operating when the absence provision had been breached.

Leyla Hannbeck, head of pharmacy, NPA

Tips for your CPD entry on RP requirements

Reflect Who do you feel is responsible for errors when SOPs are not followed?

Plan Read the dilemma and consider who you feel would be responsible in the circumstances.

Act Read the responses and expert advice.

Evaluate Do you understand the RP rules and the ethical and legal obligations they place upon you?