PFD report

Jason Brown · Prevention of Future Deaths report

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Issued 12 Mar 2024•Sunderland

Report record

Published report and response evidence

This page connects the concerns raised in this report with statements found in recipients’ published responses. A link shows a clear evidence connection; it does not assign responsibility.

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Concerns
1

Raised in this report

Recipients
4

Named on the report

Responses found
4

Of 4 recipients

Stated actions
3

Described in responses

Recipients and published responses

Source document

Full report text

This is the full text from the original published report.

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Concerns and recipient responses

Select any concern, action or position to view the source wording.

Concerns raised1

  1. Failure to prevent full-pack dispensing of Zuclopenthixol to patients prescribed weekly doses with suicidal risk and previous overdose attempts
    Part of recurring concern: Medication quantity controls failing to prevent unsafe access to excessive amounts
Responses linked to these concerns

Each statement is shown once, even when linked to more than one concern.

Actions described in response An action is something a recipient says it has done, is doing, or plans to do in response to a concern raised.3

  1. Action

    Raise concerns with the Department of Health and Social Care about clopixol pack sizes and special container status at forthcoming meetings.

    Stated by National Pharmacy AssociationStated plannedThe respondent said that this action was planned when they made their response on 19 March 2024.
  2. Action

    Provide stability data for Lundbeck zuclopenthixol tablets to support assessment of special container status.

    Stated by Lundbeck LimitedStated completedThe respondent said that this action was complete when they made their response on 19 March 2024.
  3. Action

    Consider communications to raise pharmacy-profession awareness of special-container quantity exceptions.

    Stated by General Pharmaceutical CouncilStated plannedThe respondent said that this action was planned when they made their response on 19 March 2024.

Respondent positions A position is what a recipient says about a concern when it does not describe a specific action.7

  1. Position

    Determining whether a particular medicine has special container status is outside the respondent’s influence and authority.

    Stated by National Pharmacy AssociationOutside remitThe respondent said that this matter was outside its role or authority.

Source evidence

How this individual concern was interpreted

PFD Monitor created a concise, searchable interpretation from the report wording shown below. Response links show a clear evidence connection; they do not assign responsibility.

PFD Monitor interpretation

Failure to prevent full-pack dispensing of Zuclopenthixol to patients prescribed weekly doses with suicidal risk and previous overdose attempts

Wider context from the report

“At the Inquest I heard evidence that prior to his death on 6th September 2022, Jason Brown received from the pharmacy his prescribed medication in a form of a full pack of ████████ tablets of Zuclopenthixol dihydrochloride (clopixol). The pharmacy confirmed in evidence that this had been dispensed as a full pack in accordance with its special container status. Jason was prescribed his medication in weekly doses due to a history which included previous attempts to take an overdose of his medication. Jason received this full pack of tablets only 17 days before taking an overdose of this medication on 6th September 2022. The pharmacy also confirmed that another patient at the practice received the same medication in a 7-day monitored dosage system (MDS) but could not confirm whether the remaining pack was then disposed of for that patient. I am concerned that, due to a special container status, a box of ████████ tablets of Zuclopenthixol dihydrochloride (clopixol) must be dispensed in its own special container as a full pack of ████████ tablets (original pack dispensing) and that this can endanger the safety of a patient with a history of suicidal risk and previous overdose attempts. Deaths may be prevented if the original pack dispensing guidance was reviewed for this medication. ”

Is this part of a recurring concern?

Yes — Medication quantity controls failing to prevent unsafe access to excessive amounts.

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Source evidence

How this respondent action was interpreted

PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

PFD Monitor interpretation

Raise concerns with the Department of Health and Social Care about clopixol pack sizes and special container status at forthcoming meetings.

Verbatim wording from the response

“We will, however, raise concerns over Zuclopenthixol dihydrochloride (clopixol) coming in packs of ████████ and having a special container status at forthcoming meetings with the DHSC. You might consider that the DHSC is a more appropriate body to include in this Regulation 28 Report as they are ultimately responsible for the regulatory system.”

Source location

Response from National Pharmacy Association
Page 1 · response
Published 19 March 2024

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Source evidence

How this respondent action was interpreted

PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

PFD Monitor interpretation

Provide stability data for Lundbeck zuclopenthixol tablets to support assessment of special container status.

Verbatim wording from the response

“• Following your current request, Lundbeck Ltd has queried the NHS Business Authority on 13 March 2024, regarding the criteria for assigning products as special containers and included that stability data are available supporting the storage of zuclopenthixol 2mg tablets being kept out of the container for up to 4 weeks if required.”

Source location

Response from Lundbeck Ltd
Page 1 · response
Published 19 March 2024

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Source evidence

How this respondent action was interpreted

PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

PFD Monitor interpretation

Consider communications to raise pharmacy-profession awareness of special-container quantity exceptions.

Verbatim wording from the response

“Going forward, we will consider whether there are any communications we can issue to the pharmacy professions to raise awareness, including about the exceptions to the rules around quantity to supply for special containers.”

Source location

Response from General Pharmaceutical Council
Page 2 · response
Published 19 March 2024

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Source evidence

How this respondent position was interpreted

PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

PFD Monitor interpretation

Determining whether a particular medicine has special container status is outside the respondent’s influence and authority.

Verbatim wording from the response

“The NPA has no influence over determining if/whether a particular medicine has a special container status. We can only advise our member pharmacies to follow the special container status rules as set out by the Department of Health and Social Care (DHSC) in the Drug Tariff (Part II Clause 10), and Schedule 4 of the National Health Service (Pharmaceutical and Local Pharmaceutical Services) Regulations 2013, which all pharmacy contractors are required to follow.”

Source location

Response from National Pharmacy Association
Page 1 · response
Published 19 March 2024

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Source evidence

How this respondent position was interpreted

PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

PFD Monitor interpretation

The Department of Health and Social Care is ultimately responsible for the regulatory system and is the more appropriate body to address the matter.

Verbatim wording from the response

“We will, however, raise concerns over Zuclopenthixol dihydrochloride (clopixol) coming in packs of ████████ and having a special container status at forthcoming meetings with the DHSC. You might consider that the DHSC is a more appropriate body to include in this Regulation 28 Report as they are ultimately responsible for the regulatory system.”

Source location

Response from National Pharmacy Association
Page 1 · response
Published 19 March 2024

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Source evidence

How this respondent position was interpreted

PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

PFD Monitor interpretation

Responsibility for action on the Prevention of Future Deaths report rests with the General Pharmaceutical Council, whose response closes the regulatory review.

Verbatim wording from the response

“Patient safety is our top priority, and we carefully consider the findings of all Prevention of Future Death reports. The General Pharmaceutical Council (GPhC) is responsible for action for the Prevention of Future Deaths, and I can confirm that the response led by the GPhC also closes the Medicines and Healthcare products Regulatory Agency review. The GPhC led on the response to the report, shared on 7 May 2024, for which we support the response.”

Source location

Response from MHRA
Page 1 · response
Published 19 March 2024

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Source evidence

How this respondent position was interpreted

PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

PFD Monitor interpretation

The NHS Business Services Authority independently assigns special container status under the applicable Drug Tariff criteria.

Verbatim wording from the response

“• The criteria for assigning products as special containers are listed within the NHS England and Wales Drug Tariff (Part II, Clause 10B)² and the NHS Business Service Authority (NHSBSA) implement the criteria.”

Source location

Response from Lundbeck Ltd
Page 1 · response
Published 19 March 2024

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Source evidence

How this respondent position was interpreted

PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

PFD Monitor interpretation

The manufacturer does not specify or classify the product as requiring special container status in its regulatory documents.

Verbatim wording from the response

“• Lundbeck Ltd does not specify, classify, or make any reference to zuclopenthixol 2mg tablets, nor any strength of Lundbeck branded zuclopenthixol tablets as requiring “special container status” within the Summary of Product Characteristics (SmPC) or any regulatory documents associated with this product. This classification is assigned and assigned independently².”

Source location

Response from Lundbeck Ltd
Page 1 · response
Published 19 March 2024

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Source evidence

How this respondent position was interpreted

PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

PFD Monitor interpretation

Licensing, medicine status and pack size fall outside the respondent’s direct regulatory role.

Verbatim wording from the response

“The General Pharmaceutical Council (GPhC) has a statutory purpose to protect patients by setting and upholding the standards for registered pharmacies and the standards for pharmacy professionals, to ensure that registered pharmacies are safe to provide services, and that pharmacy professionals are fit to practise. We do not have a direct role in relation to the licensing, status or pack size of medicines. These would be matters for the Medicines and Healthcare Products Regulatory Agency (MHRA), the Department of Health and Social Care and the medicines manufacturer. However, we do have a role in supporting professionals to meet our standards and to dispense safely, taking account of relevant national policy and guidelines.”

Source location

Response from General Pharmaceutical Council
Page 1 · response
Published 19 March 2024

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Source evidence

How this respondent position was interpreted

PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

PFD Monitor interpretation

The MHRA, Department of Health and Social Care, and manufacturer are responsible for medicine licensing, status and pack size.

Verbatim wording from the response

“The General Pharmaceutical Council (GPhC) has a statutory purpose to protect patients by setting and upholding the standards for registered pharmacies and the standards for pharmacy professionals, to ensure that registered pharmacies are safe to provide services, and that pharmacy professionals are fit to practise. We do not have a direct role in relation to the licensing, status or pack size of medicines. These would be matters for the Medicines and Healthcare Products Regulatory Agency (MHRA), the Department of Health and Social Care and the medicines manufacturer. However, we do have a role in supporting professionals to meet our standards and to dispense safely, taking account of relevant national policy and guidelines.”

Source location

Response from General Pharmaceutical Council
Page 1 · response
Published 19 March 2024

Open published response
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Information checked against the published report and official responses · Data reviewed 7 Sep 2026 · About data quality and limitations

Data last updated 7 September 2026