Testing a sustainable packaging system to reduce pharmaceutical waste and support a net-zero NHS

ISRCTN	ISRCTN11479933
DOI	https://doi.org/10.1186/ISRCTN11479933
Integrated Research Application System (IRAS)	368405
Central Portfolio Management System (CPMS)	72531
Sponsor	Clatterbridge Cancer Centre NHS Foundation Trust
Funder	National Institute for Health and Care Research

Submission date: 11/03/2026
Registration date: 01/04/2026
Last edited: 07/05/2026

Recruitment status: Recruiting
Overall study status: Ongoing
Condition category: Other

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Background and study aims
Every year, a lot of NHS medicine goes to waste. This can happen for many reasons. Sometimes treatment plans might change. Sometimes patients get side-effects. Sadly, some patients die before they finish their medicine. Even if medicines are still in date and unopened, UK rules say they must be thrown away. This is because we can’t tell if they’ve been stored safely and are still okay to use.

Wasting medicines is harmful in many ways. Making and moving medicines creates more pollution than all the cars on the road. When unused medicines are thrown away, they can leak into soil and water, damaging the environment. It’s also expensive. This waste costs the NHS over £300 million every year. Also, when we throw away medicines that could have been reused, it can cause medicine shortages, making it harder for others to get the treatments they need.

This project will test a new medicine bag called the PharmaBag which can tell if a medicine has been opened or kept too hot or too cold. If an unopened medicine is returned in a PharmaBag, and it has been stored safely, it might be possible to safely reuse it. This could be especially important for expensive cancer medicines, which are often left unused due to side effects or
treatment changes.

Who can participate?
Adult patients aged ≥18 years diagnosed with cancer and prescribed oral anti-cancer medicines (OACMs) by clinicians at The Clatterbridge Cancer Centre, UK.

What does the study involve?
Patients in the study who are prescribed oral anti-cancer medicines will be given their normal prescription inside the PharmaBags. This will help us see how well the bags work in real NHS settings. The study will measure how many medicines are returned, what condition they’re in, and whether they could have been safely reused. This information will be usedto calculate how this system could reduce waste, save NHS money, and help the environment.

What are the possible benefits and risks of participating?
In future, this new system could help stop medicine waste across the NHS. If it works well and is safe, it could even help change national rules, so that safe, unused medicines don’t have to be thrown away. This could save money, help the environment, and help patients get the care they need.

Participation in this study is considered low risk. All medications will continue to be prescribed and dispensed according to the participant’s usual treatment plan, and no changes to clinical care will be made. The PharmaBag is an additional packaging system designed to support the safe return of unused medication.

Any potential burden is minimal, as unused medications will be returned either during routine clinic visits or via the existing home delivery and collection service. Participants will be provided with clear instructions, and support will be available from the study team if needed.

Where is the study run from?
Clatterbridge Cancer Centre NHS Foundation Trust, UK.

When is the study starting and how long is it expected to run for?
August 2026 to July 2027

Who is funding the study?
National Institute for Health and Care Research (NIHR), UK.

Who is the main contact?
Dr Seamus Coyle, seamus.coyle@nhs.net

Contact information

Dr Seamus Coyle
Principal investigator, Scientific, Public

Clatterbridge Hospital
Clatterbridge Road
Bebington
Wirral
CH63 4JY
United Kingdom

ORCID ID	0000-0002-4761-9703
Phone	+44 01513188291
Email	seamus.coyle@nhs.net

Study information

Primary study design	Interventional
Allocation	N/A: single arm study
Masking	Open (masking not used)
Control	Uncontrolled
Assignment	Single
Purpose	Device feasibility
Scientific title	PharmaBag: a sustainable packaging system to reduce pharmaceutical waste and support a net-zero NHS
Study acronym	PharmaBag
Study objectives	The overarching aim of this study is to evaluate the potential environmental benefits of the PharmaBag system as a safe return and redispensing pathway for unused oral anti-cancer medicines (OACMs). To achieve this aim, the study has the following objectives: • To determine the quantity and proportion of returned OACMs suitable for potential redispensing using the PharmaBag system. • To estimate the potential environmental impact of the PharmaBag system through life cycle assessment modelling. • To estimate the potential NHS cost savings associated with medicines suitable for redispensing. • To explore the usability and acceptability of the PharmaBag system among patients receiving oral anti-cancer medicines.
Ethics approval(s)	Not yet submitted
Health condition(s) or problem(s) studied	Patients receiving oral anti-cancer medicines
Intervention	Consenting participants will receive their prescribed OACM in its standard manufacturer packaging, but contained within the PharmaBag over-packing system. They will receive written instructions outlining how to store and handle the medication, how to preserve the integrity of the PharmaBag, and how to return any unused medication. This information will also be discussed during the recruitment and consent process, either in person or via telephone. Participants will be advised to return any unused OACMs by bringing the PharmaBag to their next scheduled clinical visit, or via the Clatterbridge Cancer Centre's pre-existing, risk-assessed home medication collection and delivery service. No additional hospital visits will be required so as not to inconvenience the participant. Three weeks after receiving their first PharmaBag packaged medication, participants will complete a digital questionnaire via email, a paper questionnaire supplied with their medications if requested, or a telephonic questionnaire administered by the pharmacy technician or research delivery team. The questionnaire has been developed with input from patients and clinicians and includes structured items addressing ease of use, confidence in returning medications, satisfaction with packaging, and any perceived barriers, as well as questions designed to assess whether the intervention has improved knowledge or awareness about safe medication storage at home. The PharmaBag intervention does not alter clinical care or prescribing; all medications will continue to be dispensed according to the participant’s usual treatment plan. The additional packaging will enable quality assurance checks to support information on the reusability of returned medications. Following these checks and data recording, the medicines will be disposed of using normal pharmacy disposal procedures.
Intervention type	Device
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	PharmaBag
Primary outcome measure(s)	Quantity and proportion of returned oral anti-cancer medicines (OACMs) suitable for redispensing measured using the number and proportion of returned OACMs returned via the PharmaBag system that meet predefined quality criteria for potential redispensing following pharmacist assessment at the point of medicine return and evaluation
Key secondary outcome measure(s)	Estimated environmental impact associated with medicines suitable for redispensing measured using a cradle-to-grave Life Cycle Assessment (LCA) comparing conventional linear pharmaceutical distribution with the circular PharmaBag model and reporting indicators including global warming potential (kg CO₂e) relative to the functional unit of oncology treatment for one patient over one year at the completion of data collection Estimated NHS cost savings associated with medicines suitable for redispensing measured using economic impact assessment through a cost-benefit analysis comparing the costs of developing and implementing the PharmaBag system with potential NHS and Personal Social Services savings (£) from reduced pharmaceutical waste and medication reuse, incorporating monetised environmental benefits using UK Government carbon values at completion of data collection Participant-reported usability and acceptability of the PharmaBag system measured using a questionnaire, including measures of ease of use, clarity of instructions, and overall acceptability assessed at 3 weeks following collection or delivery of the first prescription packaged using the PharmaBag Global warming potential (kg CO₂e): Net change in global warming potential (kg CO₂e), measured using data on the number, type, and dose of oral anti-cancer medicines prescribed, returned, and suitable for redispensing, collected from prescribing and pharmacy records at the completion of data collection Resource use: Net change in resource use, measured using data on the number and type of oral anti-cancer medicines returned and suitable for redispensing, collected from pharmacy records at the completion of data collection Fossil resource depletion: Net change in fossil resource depletion, measured using data on the number and type of oral anti-cancer medicines returned and suitable for redispensing, collected from pharmacy records at the completion of data collection Pharmaceutical waste avoided: Reduction in pharmaceutical waste, measured using data on the number and proportion of oral anti-cancer medicines suitable for redispensing, collected from pharmacy records at the completion of data collection Economic Outcome Measure: Estimated cost savings (£), measured using measured using data on the number, type, and unit cost of oral anti-cancer medicines suitable for redispensing, collected from prescribing and pharmacy records, at the completion of data collection Economic Outcome Measure: Net cost benefit (£) measured using data comparison of the costs of implementing the PharmaBag system with the estimated cost savings from medicines suitable for redispensing, using data collected from project financial records, prescribing records, and pharmacy records, at the completion of data collection Economic Outcome Measure: Cost savings per patient (£), measured using measured by dividing total estimated cost savings by the number of participants enrolled in the study, using data collected from prescribing and pharmacy records, at the completion of data collection Economic Outcome Measure: Monetised environmental benefit (£), measured using measured using data on the quantity of oral anti-cancer medicines suitable for redispensing and associated reduction in carbon emissions, applying UK Government carbon values, at the completion of data collection
Completion date	31/07/2027

Eligibility

Participant type(s)
Age group	Mixed
Lower age limit	18 Years
Upper age limit	100 Years
Sex	All
Target sample size at registration	1000
Key inclusion criteria	1. Adults aged ≥18 years 2. Diagnosis of cancer 3. Prescribed oral anti-cancer medicines (OACMs) by clinicians at The Clatterbridge Cancer Centre 4. Able to provide informed consent
Key exclusion criteria	Severe co-morbidities considered by the study team to interfere with the individual's ability to complete requirements of the study, or to provide informed consent.
Date of first enrolment	01/08/2026
Date of final enrolment	29/01/2027

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

The Clatterbridge Cancer Centre NHS Foundation Trust

Clatterbridge Hospital
Clatterbridge Road
Bebington
Wirral
CH63 4JY
England

Results and Publications

Individual participant data (IPD) Intention to share	No

Editorial Notes

07/05/2026: Internal review.
11/03/2026: Study's existence confirmed by the National Institute for Health and Care Research (NIHR) (UK).