Date of prep: December 2020
Prescribing information and
adverse events reporting
For healthcare professionals only
Shanté Andreé Marie Turay-Thomas was allergic to nuts and on 18th September 2018, she told her mother that she had eaten hazelnuts. Shanté tragically died of acute anaphylaxis in September 2018 shortly after.
At the conclusion of the subsequent inquest, the coroner wrote to senior leaders and organisations to highlight these concerns. He outlined his concerns that future deaths may occur if actions were not taken to prevent.
The failings were far-reaching and involved multiple people and organisations involved in Shanté’s care. Her general practitioners, the NHS 111 call handling team, the company who manufactured the adrenaline pen and event the National Institute for Health & Care Excellence were criticised.
Of relevance to pharmacists and pharmacy teams were the references the coroner made to the switching of brands of adrenaline pens and also the dosing.
The GPs had not identified Shanté (who had a high BMI and was severely allergic) as being at particularly high risk from her allergies and asthma and had no awareness that they were the sole providers of Shanté’s allergy care.
Shanté’s GPs knew that she should carry two adrenaline auto-injector (AAI) pens at all times, and they may have mentioned this to her, but they failed to record this and they did not emphasise it to her.
They failed to emphasise to Shanté and her family that the reason for carrying two pens is primarily because in the event of severe acute anaphylaxis, the very strong likelihood is that both pens will need to be administered, one five minutes after the other, to keep the patient alive until the arrival of an emergency ambulance.
The GPs did not explore with Shanté the reason for her erratic requests for a pen. They did not explore with her where she kept her pens. They did not test her understanding of medical advice.
The Emerade AAI accompanying leaflet does include the advice that two pens should be carried at all times, but the advice is not re-iterated on the outside of the box.
The Emerade AAI is sold singly. It could be sold in boxes of two as the norm and only singly in the alternative.
When Shanté’s AAI was changed from an EpiPen to an Emerade, her GPs failed to reconsider the prescription and to increase her dose from 300mgs to 500mcgs.
Following the scriptswitch, the GPs failed to ask Shanté to come into the surgery for training in the use of the Emerade. The coroner highlighted that this would also have presented an ideal opportunity to explore Shanté’s understanding of the use of her pens and to ensure that she understood she needed to carry two at all times.
The GPs relied upon the advice given by Enfield Clinical Commissioning Group (CCG) that the scriptswitch was simply the replacement of one branded product with another branded product of the same drug/device. This gave false reassurance. The CCG joint formulary committee introduced a new drug for GPs but then gave the wrong advice to accompany this.
The CCG failed to draw prescribers’ attention to the need, following scriptswitch from EpiPen to Emerade, to reconsider the dose and to prescribe the higher dose of 500mcgs for patients at higher risk (which would have included Shanté).
The CCG failed to inform prescribers that the Emerade pen requires different training to the EpiPen because different AAIs do not operate in the same way. In fact, the CCG gave the opposite advice.
You can read the full coroner’s report below.
Elements of this article are being shared under the Open Government Copyright licence.
Pharmacy in Practice is a UK pharmacy publication with its roots in Scotland.