30 Mar 2021

Significant event audit: informed consent

RCVS Knowledge describes a quality improvement case example concerning human medication prescribed to a dog.

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RCVS Knowledge

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Significant event audit: informed consent

QI Vets is back with another significant event audit (SEA) in practice.

QI Vets is a fictional team, but based on true stories from UK practices, created by RCVS Knowledge’s Case Example Working Party to help veterinary teams apply quality improvement (QI) to real situations.

This time, a medication is prescribed without obtaining informed consent. This case example will go into more detail about what happened and what the practice did as a result.

What is an SEA?

An SEA is a QI technique. It is a retrospective audit that looks at one case in detail from beginning to end to either increase the likelihood of repeating outcomes that went well or to decrease the likelihood of repeating outcomes that went badly.

SEAs may result in further development of guidelines, protocols or checklists, and may result in the need for additional clinical audits to measure whether the changes have been adopted (process audits) or whether the change led to an improvement (auditing either structural changes or outcomes).

SEAs are conducted by bringing your team and the relevant case notes together to discuss the event. It is important that the event is discussed without any blame – allowing team members to provide honest and constructive feedback on how they contributed to the care process.

An SEA is completed in six stages. RCVS Knowledge provides a free template, guide and course as part of its QI support for practices at www.rcvsknowledge.org/quality-improvement

The case example featured in the panel below will take you through the event and the steps that this practice took to put its SEA into practice.

Further information

RCVS Knowledge has teamed up with members of the profession to develop free resources for SEAs – especially for practice-based veterinary teams. The resources include:

  • a free 20-minute online CPD course
  • a quick guide to take you through what you need to do when conducting an SEA
  • a template so you can record the incident and the audit
  • other significant event case examples like this one
  • some handy tools to help you identify the root cause of the event

RCVS Knowledge has similar resources for practices to complete clinical audits and create guidelines. For more details, visit www.rcvsknowledge.org/quality-improvement

Case study

Boris, a 15-year-old Jack Russell terrier, had become very stiff on his back end and was having trouble getting out of his basket. His owner, Mr Murray, hadn’t taken Boris to the vets for quite a while, but he took him in to QI Vets.

Serena, the vet who examined Boris, found he had severe hindlimb pain on extension of his hips and recommended radiographs.

Mr Murray did not want to have Boris anaesthetised and was reluctant to spend money on x-rays. He asked if there were some tablets he could give Boris instead. He asked for it not to be meloxicam, as he thought Boris had that before about four years ago and was very sick afterwards. Serena prescribed gabapentin.

Nothing more was heard about Boris until a solicitor’s letter arrived three months later. Boris had died 10 days after starting the medication and Mr Murray thought that gabapentin, a human drug, had killed his dog.

He stated he had not been made aware that it was not authorised for dogs. He was asking for compensation and was intending to complain to the RCVS, too.

SEA meeting findings

Serena said she felt pressured by Mr Murray as he didn’t want any investigations. She was worried that Boris needed effective pain relief and did not think Mr Murray would bring Boris back, so she wanted to give him something quite strong from the start.

The previous records were not available as the PMS system had been changed, and only the past three years of notes were accessible with the new system.

Serena said she was unfamiliar with the cascade as it did not apply in quite the same way in Italy. She was also unsure which medicines were not authorised.

In the letter, Mr Murray said he was suspicious when he read the patient leaflet with the medicine, and it mentioned driving and operating heavy machinery. He had then researched gabapentin. The practice did not give out any other information with the medicine.

On checking through the records, it was also discovered that the label did not have Serena’s name or initials down as the vet responsible for prescribing under the cascade.

Why did it happen?

The team discussed and recorded the factors that had led to this event as follows:

System factors

  • The practice did not have a protocol for use of unauthorised medicines.
  • The consent forms for unauthorised medicines were not easily accessible.
  • Human medicines were not clearly identified in the dispensary.
  • Previous clinical records from four years ago were not readily available as the PMS changed when the practice was sold three years before.

Human factors

  • Serena qualified in Italy and had only been in the UK for six months at the time of the complaint.
  • Serena was not aware of UK medicines regulations or the cascade.

Patient factors

  • None.

Owner factors

  • The owner read the leaflet in the pack, which stated “no drinking alcohol or operating heavy machinery”, so he realised gabapentin was a human drug. He then looked it up on the internet.

Communication factors

  • No communication, either verbally or in writing, about unauthorised medications.

Other

  • None.

What has been learned?

All the other vets sympathised with Serena as, although they knew what they should be doing, there was no clear practice protocol and in a busy evening surgery it was very easy to forget. They also stated they could never find the consent forms either.

One of the veterinary nurses, Clare, mentioned that in her old practice they had used the BSAVA patient information leaflets for unauthorised medicines, which explained their use in dogs and cats to owners.

Boris had been prescribed 90 days of gabapentin. The practice manager, Helen, who had just been on a dispensing course, said that as it is a Schedule 3 controlled drug it is best practice to only prescribe or dispense 28 days at a time. The team did not know that gabapentin is now a Schedule 3 controlled drug and, therefore, subject to special prescription writing requirements.

What has been changed?

CPD/training required

  • CPD for Serena on UK Veterinary Medicines Regulations.
  • Training for the whole team on cascade use.
  • Training for the whole team on the practice unauthorised medicine protocol.
  • Training for the whole team on informed consent and use of consent forms.
  • Training for the whole team on controlled drugs.

New or updated protocols/checklists/guidelines

  • Unauthorised medicine protocol.
  • PMS to automatically prompt to use consent form when dispensing human POM.
  • PMS to automatically generate consent form.
  • PMS to automatically generate correct label.
  • BSAVA client information leaflets to be used to give animal-specific advice on gabapentin and other unauthorised medicines.
  • BSAVA patient information leaflets to be automatically generated when dispensing human POM.

Further audit required?

  • Process audit of use of consent forms for human POM.

Other

  • Information bullet points from CPD courses to be presented to the rest of the team at practice meetings or on the intranet.
  • The whole corporate group to look at the induction of overseas vets and training on UK Veterinary Medicines Regulations.

Follow-up date

A follow-up date of 22 October was decided.