Jason Brown

David Place 
Assistant Coroner for the City of Sunderland 

7 May 2024 

Dear Mr Place 

Re: Regulation 28 Report to Prevent Future Deaths: Mr Jason Brown 

Thank you for sending us your Regulation 28 report regarding the death of Mr Jason Brown. We are 
sorry to hear about this sad death and we would like to pass on our sincere condolences to Mr Brown’s 
family.  

You have raised a concern that, due to a special container status, zuclopenthixol dihydrochloride 2mg 
tablets (Clopixol®) must be dispensed in its own special container, as a full pack of 100 tablets (original 
pack dispensing), and that this can endanger the safety of a patient with known suicide risks, including 
previous overdose attempts. 

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.  

As detailed in your report, Clopixol® 2mg tablets are manufactured in a pack size of 100, and this is 
classed as a Special Container in the Drug Tariff. This means that if a prescription is received for 28 
tablets, then the pharmacy is directed to dispense a full pack of 100 and will be paid for a pack of 100. 
This can cause a disparity between the information that a prescriber holds regarding what has been 
prescribed, and the actual number of tablets a patient has received.  

According to the Summary of Product characteristics (SmPC) for Clopixol® 2mg tablets, the 
manufacturer (Lundbeck) directs that the tablets are stored in the original container in order to protect 
from light. This further reinforces the messaging to the pharmacy to store and dispense the Clopixol® 
2mg in the original container. 

pharmacyregulation.org | info@pharmacyregulation.org |020 3713 8000 

 
 
 
 
 
 Community Pharmacy England (CPE), formerly PSNC, produced a factsheet in June 2020 with regards to 
dispensing special containers. There are two particularly relevant points in this guidance.  

The first directs the pharmacy to dispense the original pack:  

“Where the quantity of a product ordered by the prescriber does not coincide with that of an original 
pack size and the product is considered a special container (as a complete pack or sub-pack size), 
contractors are required to supply the special container or combination of containers nearest to the 
quantity ordered and endorse the prescription form with the number and size of these containers”. 

And the second indicates that for a small number of cases the exact quantity should be dispensed:  

“Exceptions to the rules around quantity to supply for special containers. In a small number of cases, 
where there is an over-riding clinical requirement to dispense the exact quantity ordered rather than 
the nearest complete pack or sub-pack size (for example, if the drug is required to be packaged into a 
weekly compliance aid or if there is a risk that the patient may misuse the drug), pharmacists would 
need to assess the clinical appropriateness of splitting the pack to dispense the exact quantity bearing in 
mind the impact on the stability of the drug once removed from its original packaging. There may be 
patient safety issues to consider if a pharmacist decides to dispense the exact quantity ordered (if not a 
multiple of the sub-pack size). For example, if a hygroscopic drug is not stored and used correctly, 
exposure to moisture could affect the integrity of the drug by potentially decreasing its stability and/or 
efficacy”. 

This indicates the need for a pharmacist to use their professional judgement when there is an over-
riding clinical requirement to dispense the exact quantity. This would involve assessing the risk of doing 
so for the individual patient, balancing against the relevant storage requirements or other relevant 
guidance.  

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.  

We hope this information is helpful. If you should require any further information, please do not 
hesitate to contact me. 

Yours sincerely, 

Chief Executive and Registrar

Lundbeck Ltd 
Iveco House  
Station Road  
Watford  
Hertfordshire 
WD17 1ET 

07 May 2024 

Dear Mr Place, 

Re: Regulation 28 Report - Jason Brown (Deceased) (Ref: 11445076) 

In response to the Regulation 28 Report concerning the unfortunate passing of Mr Jason Brown which was 
received  from  Ms  Julia  Laidler  on  12  March  2024,  we  acknowledge  the  necessity  for  transparency  and 
compliance.  

First, we at Lundbeck Ltd extend our deepest sympathy for the passing of Mr Jason Brown. We are committed 
to cooperating fully in providing the necessary information in relation to your concerns. 

As stated in your report, your concerns relate to the special container status of Lundbeck branded Clopixol 
2mg (zuclopenthixol dihydrochloride) film coated tablets. You have requested that our response contain 
details of action taken or proposed to be taken, along with a timetable for action and if no action is 
proposed, we must provide an explanation. 

In response to your request, please find below key information relating to the storage and packaging of 
Lundbeck branded Clopixol 2mg (zuclopenthixol dihydrochloride) film coated tablets in the UK for which 
Lundbeck Ltd holds the Marketing Authorisation: 

•  As per the SmPC for zuclopenthixol 2mg tablets, the tablets should be stored in the original 

container in order to protect from light1. In the UK, zuclopenthixol 2mg tablets are supplied in a 
white high-density polyethylene (HDPE) container with low density polyethylene (LDPE) twist-off 
cap including desiccant in quantities of one hundred (100) tablets. 

• 

• 

• 

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.  

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 assessed and assigned independently2. 

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. 

•  On 22 March 2024, Lundbeck Ltd received a response from the NHS Business Authority which 
provided the information outlined within the second bullet point on assignment of special 
container status. Within this response, the NHS Business Authority requested information on the 
stability of Clopixol 10mg and Clopixol 25mg packs which Lundbeck Ltd supplied on 03 May 2024. 

As outlined above, the decision to classify this medicinal product as requiring special container status is a 
decision  that  is  made  independently  from  Lundbeck  Ltd.  We  hope  that  by  providing  the  supportive 
summarised stability data for Lundbeck branded zuclopenthixol 2mg, 10mg and 25mg tablets, it will prove 
helpful  in  any  future  assessment  of  the  special  container  status  classification  of  all  strengths  of  Lundbeck 
branded zuclopenthixol film coated tablets. 

Should you require any further information or clarification, please do not hesitate to contact us. 

e
v
o
b
 A
s
A

:
e
c
i
f
f

O

.
g
e
R

.

8
9
7
0
4
0
1

.

o
n

.
g
e
R

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 Lundbeck Ltd 
Iveco House  
Station Road  
Watford  
Hertfordshire 
WD17 1ET 

Yours sincerely  

Country Manager 
Lundbeck United Kingdom  

References 

1.  Lundbeck UK Limited. Clopixol 2mg tablets Summary of Product Characteristics: June 2022; 
Available from: Clopixol 2 mg film-coated tablets - Summary of Product Characteristics 
(SmPC) - (emc) (medicines.org.uk)[Accessed April 2024] 

2.  NHS England and Wales Drug Tariff. NHS Electronic Drug Tariff; Available from: NHS 

.Electronic Drug Tariff (nhsbsa.nhs.uk) [Accessed April 2024] 

e
v
o
b
 A
s
A

:
e
c
i
f
f

O

.
g
e
R

.

8
9
7
0
4
0
1

.

o
n

.
g
e
R

10 South Colonnade 
Canary Wharf 
London 
E14 4PU 
United Kingdom 
gov.uk/mhra 

Mr David Place 
His Majesty’s Assistant Coroner for the City of Sunderland 
By Email: 

Reference: 

10 March 2025 

Dear Mr Place, 

Zuclopenthixol dihydrochloride (clopixol) 

Thank you for your email of 12 March 2024 concerning the Regulation 28 Report in respect of 
Mr Jason Brown (Deceased). I am very sorry for the delay in responding to you which is due 
to an administrative error.  

I would like to offer my sincere condolences to Mr Brown’s family on their tragic loss.  

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. 

Should you have any further questions, please do not hesitate to contact my office: 

Yours sincerely 

Chief Executive  
Medicines and Healthcare products Regulatory Agency 
E:

Mr David Place 
His Majesty’s Assistant Coroner for the City of Sunderland 
Office of HM Coroner for the City of Sunderland 
City Hall, Plater Way, Sunderland SR1 3AA 

28th March 2024 

Dear Mr Place, 

Response to the Regulation 28 Report to prevent future deaths - Jason BROWN (Deceased) 

This is the National Pharmacy Association’s (NPA) response to your Regulation 28 report made under 
paragraph 7, Schedule 5, of the Coroners and Justice Act 2009 and Regulations 28 and 29 of the 
Coroners (Investigations) Regulations 2013, dated 12th March 2024, following the tragic death of 
Jason Brown on 6th September 2022.  

Our response is based on the information contained in the Regulation 28 report, as we were not an 
Interested Person or involved in the Inquest into the death of Mr Brown. 

We are very saddened to hear about the death of Mr Brown and I would like to express our deepest 
condolences to his family and friends.  

The NPA is a trade association and representative voice of independent community pharmacies 
across the United Kingdom and a key provider of services to the pharmacy sector. The vast majority 
of the approximately 6,000 independent community pharmacies in the UK are NPA Members.  

Matter of concern 
“Deaths may be prevented if the original pack dispensing guidance was reviewed for this 
medication.”  

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.  

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. 

Thank you again for highlighting the matter of concern and giving us the opportunity to respond.  

Yours sincerely, 

Director of External & Corporate Affairs 
National Pharmacy Association