John Michael Bailey

On 8" April 2011 | commenced an investigation into the death of John Michael Bailey, who was born on 10" February 1937. The investigation concluded at the end of the inquest on 6" September 2013. The conclusion of the inquest was that Mr Bailey died from lung fibrosis which was due to Amiodarone toxicity and which went undiagnosed for a period, because of a lack of awareness of the symptoms for his condition.

Mr Bailey died as a consequence of Amiodarone induced pulmonary fibrosis (APF). | was told during the inquest that Amiodarone is a drug commonly used to treat cardiac rhythm disorders and that APF is a recognised but relatively rare complication associated with it (occurring in between 2% and 4% of cases but with the risk rising in cases where higher doses of the drug are used). In about 10% of cases, APF will be fatal — roughly 0.2% to 0.4% of those who receive the drug. It can be effectively treated in most cases by the withdrawal of Amiodarone and the provision of steroids. It is understood that such treatment is more likely to be effective if commenced soon after the onset of symptoms and that the risk of mortality increases if treatment is delayed. There is no definitive diagnostic test to screen for APF, so it has been suggested that there should be a low threshold for clinicians to suspect it and act where patients present with symptoms suggestive of APF.

in my opinion action should be taken to prevent future deaths and | believe you have the power to take such action. Although | am satisfied that diligent steps have been taken locally to improve both the content of the protocol and its profile amongst relevant medical staff, there would be merit in ensuring that steps are taken nationally to ensure that medical personnel are aware of the risk of APF, and the steps that should be taken to reduce that risk.

| offer the following points for your consideration:

1.

oe

That a National Shared Care Protocol might be devised so as to ensure consistency between all Trusts in the management of Amiodarone. The specifics of that Protocol are plainly a matter for consultation with specialists in the management of that drug and its complications. However the following may be worthy of consideration:

1.1.The Protocol could define clearly the division of responsibility for the management of Amiodarone between primary and secondary care physicians;

1.2. The Protocol could set out the need for regular review of patients (6 monthly was adopted in this case) and define what tests should be carried out at each review;

1.3. The Protocol could provide that baseline tests are carried out and recorded clearly and communicated to the patient’s GP at the time of first prescription.

1.4. The Protocol could require questions to be asked of the patient at each review regarding symptoms of cough or breathlessness;

1.5. The Protocol could require that patients are informed in clear terms at the time that the drug is initiated and at each review what signs and symptoms they are to watch out for and instructed to see their GP as soon as possible if those symptoms present.

1.6.The Protoco! could provide a clear process to be adopted in circumstances where a patient presents to their GP with new symptoms of breathlessness or cough.

1.7.The Protocol could require that the patient's GP sets up warnings on the practice computer system so that GPs who review the patients who attend between their regular reviews know that the patient is taking Amiodarone and alert them to the possible signs and symptoms of Amiodarone toxicity and to the existence of a Shared Care Protocol.

1.8. The Protocol! could require that the GP is provided with, and kept informed of, contact details in the event that their patient presents with symptoms of Amiodarone toxicity.

2. That a monitoring card could be provided to patients who are taking Amiodarone, similar to that provided to patients who are taking Warfarin therapy. That monitoring card could also contain warnings to the patient about symptoms suggestive of Amiodarone toxicity and contact details for their GP and/or hospital clinic in the event that those symptoms manifest.