Ian Hall
PFD Report
Partially Responded
Ref: 2021-0202
Coroner's Concerns (AI summary)
Incorrect medication was dispensed, and pharmacies lack checks to prevent vulnerable adults, whose non-clinical carers administer medications, from receiving wrong prescriptions.
View full coroner's concerns
1. It was unclear how Amitriptyline rather than Atenolol had been dispensed in the community.
2. It was unclear what checks the pharmacy in question had or any pharmacy has to avoid the inadvertent dispensing to a vulnerable adult where the carers role is to administer whatever medications are collected from the pharmacy in the name of the individual. The inquest was told that the carers in this situation generally will have no clinical training. Therefore, their role is to check the medication is in an individual’s name and give it to the individual in compliance with what is on the label. It is not part of their role to cross check previous medications or query changes to medication.
2. It was unclear what checks the pharmacy in question had or any pharmacy has to avoid the inadvertent dispensing to a vulnerable adult where the carers role is to administer whatever medications are collected from the pharmacy in the name of the individual. The inquest was told that the carers in this situation generally will have no clinical training. Therefore, their role is to check the medication is in an individual’s name and give it to the individual in compliance with what is on the label. It is not part of their role to cross check previous medications or query changes to medication.
Responses
Action Planned
The MHRA will review the packaging of the amitriptyline and atenolol medicines and if improvements could be made they will contact the pharmaceutical manufacturers who supply these medicines and seek changes. (AI summary)
The MHRA will review the packaging of the amitriptyline and atenolol medicines and if improvements could be made they will contact the pharmaceutical manufacturers who supply these medicines and seek changes. (AI summary)
View full response
Dear Ms Mutch,
Regulation 28 report into the death of Ian Hall
Thank you for your report under Regulation 28 following the inquest into the tragic death of Mr Ian Hall.
We note that one of the concerns that you raise is incorrect dispensing of a product in a pharmacy and your report states it is unclear how amitriptyline rather than atenolol had been dispensed in the community. The MHRA is responsible for the assessment of the labelling of all licensed medicines to ensure that the statutory information required to appear is clear, legible and easily assimilated by those who select and administer medicines.
It would be helpful to know which particular amitriptyline and atenolol products the pharmacy held at the time Mr Hall was supplied with amitriptyline instead of his prescribed atenolol. Without this, it is difficult to be certain whether and to what degree the medicines packaging may have contributed to the mis- selection in the pharmacy.
The primary purpose of medicines labelling is the unambiguous identification of the medicinal product contained within the packaging. We have issued best practice guidance to the pharmaceutical industry which includes amongst other things, a need to ensure that medicines which may be stored together or used concomitantly by patients are well differentiated from each other by the judicious use of colour to reduce the likelihood of medication error.
We also issued an article in our 2018 Drug Safety Update (DSU) bulletin to remind healthcare professionals on the need for continued vigilance for these sorts of errors https://www.gov.uk/drug- safety-update/drug-name-confusion-reminder-to-be-vigilant-for-potential-errors. That guidance highlighted a known confusion between atenolol and amiodarone (another antihypertensive) but confusion between atenolol and amitriptyline has not been reported to us previously.
The MHRA will review the packaging of these medicines and if we consider on assessment that improvements could be made we will contact any pharmaceutical manufacturers who supply these medicines and seek changes so that the likelihood of future errors of this nature may be reduced.
For your information, Ian Hall’s case has been recorded on our adverse drug reaction database with the Yellow Card reference number .
Ms Alison Mutch Senior Coroner, Greater Manchester South
27 July 2021
Regulation 28 report into the death of Ian Hall
Thank you for your report under Regulation 28 following the inquest into the tragic death of Mr Ian Hall.
We note that one of the concerns that you raise is incorrect dispensing of a product in a pharmacy and your report states it is unclear how amitriptyline rather than atenolol had been dispensed in the community. The MHRA is responsible for the assessment of the labelling of all licensed medicines to ensure that the statutory information required to appear is clear, legible and easily assimilated by those who select and administer medicines.
It would be helpful to know which particular amitriptyline and atenolol products the pharmacy held at the time Mr Hall was supplied with amitriptyline instead of his prescribed atenolol. Without this, it is difficult to be certain whether and to what degree the medicines packaging may have contributed to the mis- selection in the pharmacy.
The primary purpose of medicines labelling is the unambiguous identification of the medicinal product contained within the packaging. We have issued best practice guidance to the pharmaceutical industry which includes amongst other things, a need to ensure that medicines which may be stored together or used concomitantly by patients are well differentiated from each other by the judicious use of colour to reduce the likelihood of medication error.
We also issued an article in our 2018 Drug Safety Update (DSU) bulletin to remind healthcare professionals on the need for continued vigilance for these sorts of errors https://www.gov.uk/drug- safety-update/drug-name-confusion-reminder-to-be-vigilant-for-potential-errors. That guidance highlighted a known confusion between atenolol and amiodarone (another antihypertensive) but confusion between atenolol and amitriptyline has not been reported to us previously.
The MHRA will review the packaging of these medicines and if we consider on assessment that improvements could be made we will contact any pharmaceutical manufacturers who supply these medicines and seek changes so that the likelihood of future errors of this nature may be reduced.
For your information, Ian Hall’s case has been recorded on our adverse drug reaction database with the Yellow Card reference number .
Ms Alison Mutch Senior Coroner, Greater Manchester South
27 July 2021
Sent To
- Medicines and Healthcare Products Regulatory Agency
- NHS Stockport Clinical Commissioning Group
Response Status
Linked responses
1 of 2
56-Day Deadline
9 Aug 2021
About PFD responses
Organisations named in PFD reports must respond within 56 days explaining what actions they are taking.
Source: Courts and Tribunals Judiciary
Report Sections
Investigation and Inquest
On 17th November 2020 I commenced an investigation into the death of Ian Hall. The investigation concluded on the 3rd June 2021 and the conclusion was one of Narrative: Died from aspiration pneumonia following a choking incident after admission following a fall in combination with Covid-19 pneumonitis. The medical cause of death was 1a Aspiration pneumonia on a background of a choking incident, Covid-19 pneumonitis; II Alzheimer's dementia
Circumstances of the Death
Ian Hall had Alzheimer's and was vulnerable. He had carers in the community. He was admitted to Stepping Hill Hospital on 27th October following a fall. No injuries resulted from the fall. On 28th October during a post admission medicines reconciliation check at Stepping Hill Hospital it was identified that in the community he had been dispensed by the community pharmacy Amitriptyline rather than Atenolol which was on his prescription. Amitriptyline would have led to increased drowsiness and an increased falls risk. On 28th October he choked on medication. He subsequently developed aspiration pneumonia and was treated but continued to deteriorate. On 2nd November a Covid-19 swab was positive. He was treated for Covid-19 but deteriorated further. On 14th November 2020 he died in Stepping Hill Hospital from a combination of aspiration pneumonia and Covid-19 pneumonitis.
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Data sourced from Courts and Tribunals Judiciary under the Open Government Licence.