PharmaBag: A Sustainable Packaging System to Reduce Pharmaceutical Waste and Support a Net-Zero NHS (PharmaBag)

Introduction This project aims to support the NHS net zero carbon targets1 by piloting a sustainable prescription over-packaging system (the 'PharmaBag') that enables the safe reuse of returned medications. Medicines are estimated to account for 25% of NHS carbon emissions2 and 4.5% of global greenhouse gases, surpassing even the automotive industry.3 Pharmaceutical manufacturing is resource-intensive, requiring material extraction, water consumption, and land use, alongside emissions and pollutants generated during supply and disposal.4-6 Pharmaceutical waste therefore represents a source of preventable environmental harm across the entire product lifecycle.

Medicine wastage is also economically damaging. In 2009, the annual cost of unused primary care medicines in the UK was estimated at £300 million.7 When accounting for waste from secondary and tertiary care, alongside rising prescription volumes and post-Brexit import costs, the current figure is likely to be substantially higher. This inefficiency also contributes to medication shortages, which can seriously affect patient care.

Many causes of pharmaceutical waste are preventable, such as over-prescribing, incorrect use of medicines (e.g., inhalers), and stockpiling.8 The NHS has implemented several effective strategies to reduce these, including patient and staff education, medication reviews, and 28-day prescribing cycles.1, 8 Despite these measures, a substantial portion of pharmaceutical waste stems from causes that cannot be lessened at the source, including unwanted side effects, lack of efficacy, dosage changes, or patient death. This can only be addressed by enabling the redistribution of unused medications. However, current UK regulations prohibit medicines from re-entering the supply chain even if they are unopened and within date.9 This policy constraint limits how non-preventable waste can be managed and underscores the need to develop and validate reuse-enabled packaging.

Pharmaceutical waste is particularly prominent in the use of oral anti-cancer medicines (OACMs). These agents now account for approximately 25% of all anti-cancer prescriptions, a figure that continues to increase alongside growing cancer rates.10 While they offer more convenient and often better-tolerated alternatives to infusion-based treatments,11 their production is both environmentally and economically demanding. Manufacturing can involve energy-intensive synthesis, specialised packaging, and, in many cases, complex cold-chain logistics.12 These treatments can also cost more than £100,000 per patient each year.13 Nevertheless, around one-third of patients discontinue treatment early, often due to toxicity, poor response, or death. Targeting this drug class with the PharmaBag therefore offers a key opportunity to achieve meaningful reductions in waste and emissions. Demonstrating safety, patient acceptability, and both carbon footprint and cost savings in this context could also pave the way for broader adoption across other treatment areas.

International experience demonstrates that medicine reuse is feasible within regulated healthcare systems, 15,16, 17, 18 with programmes operating in several countries and limited reuse permitted in the UK during the COVID-19 pandemic. 19 However, most existing approaches rely primarily on the integrity of original packaging and offer limited verification of storage conditions.

The ROAD study 12, 20 in the Netherlands evaluated the reuse of returned oral anti-cancer medicines using additional outer-packaging with temperature monitoring and demonstrated that a proportion of unused medicines can be safely identified as suitable for redispensing. While effective, this approach relied on resource-intensive electronic monitoring, limiting scalability and environmental benefit. These findings highlight the need to develop and evaluate lower-cost, lower-resource packaging solutions that maintain safety while improving environmental and economic sustainability.

Aims and Objectives This project aims to support the NHS in achieving its net zero carbon targets by addressing pharmaceutical waste. Specifically, it will evaluate the 'PharmaBag', an environmentally friendly, low-cost prescription over-packing system. Returned medications in the PharmaBag will be assessed for suitability for redispensing based on predefined quality criteria. While no medications will be reused during this project, findings will provide evidence to inform future regulatory discussions and support wider adoption of sustainable medicines reuse across the NHS.

Primary objective:

• To determine the potential environmental benefit of the PharmaBag as a safe return and redispensing system for unused OACMs in UK clinical practice.

Secondary objectives:

• To assess the quality and quantity of OACMs returned using the PharmaBag.
• To determine the potential NHS cost savings from the PharmaBag as a safe return and redispensing system for unused OACMs.
• To explore the usability and acceptability of the PharmaBag Methodology Overall Design: This research study will be a prospective, single-group intervention evaluating the quantity and quality of returned unused OACMs dispensed in the PharmaBag system. Data will be used to determine the potential environmental and economic benefit of the Pharmabag based on the proportion of returned medicines that could have been safely redispensed following quality checks.

Returned medicines will not be redispensed to patients during this study. Instead, they will be assessed for theoretical suitability for reuse based on predefined safety and quality criteria (e.g., packaging integrity and expiry date).

Population, Sample Size, and Setting: We aim to recruit 1,000 adult patients (aged ≥18 years) with a current cancer diagnosis who are prescribed OACMs for home use by a CCC clinician. Although formal power calculations are not typically required for economic and sustainability evaluations,22 this sample size aligns with comparable intervention studies in the field12, 20 and will provide adequate power for stratified economic and sustainability analyses, with an anticipated one-third (~333) of patients discontinuing treatment,12, 14, 20 and half of these (~167) with unused medications.12, 20, 23

Participants will be recruited from all five CCC sites to ensure coverage of a diverse and representative population across Cheshire and Merseyside. The eligibility criteria are broad to support inclusivity:

• Inclusion criteria: Adults aged ≥18 years, with a cancer diagnosis, prescribed OACMs by CCC clinicians, and able to provide informed consent.
• 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.

Recruitment and Consent: Participants will be identified through CCC pharmacy records or the oncology outpatient clinic and recruited using a combination of postal invitations, email, telephone, and in-person contact. Initial contact may be made by the pharmacy technician, consultant, or member of the research delivery team who will provide a brief study brochure outlining the purpose and requirements of participation.

Interested patients will be given a Participant Information Sheet (PIS) containing full details about the study, including the aims, procedures, potential benefits and risks, data handling, and participant rights. Patients who wish to take part will provide informed consent either via a secure digital platform or, for those without digital access, using a paper consent form. Patients who do not wish to take part will have the option to provide a reason, enabling us to better understand barriers to participation and potential reluctance to use the system.

To avoid repeated contact, all recruitment attempts will be recorded in both the pharmacy dispensing system and the hospital's electronic medical record system (Meditech). For patients who provide consent, registration will also be recorded in these systems to support coordination across the research and pharmacy teams.

Recruitment will take place over 12 months with an additional six months for follow-up (total study duration 18 months). Each participant may remain on the study for up to one year. Participation in the study is entirely voluntary, and patients are free to withdraw at any point without giving a reason and without affecting their clinical care.

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 CCC'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.

After receiving their 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 will include 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. The recruitment and intervention pathway is shown in Figure 2.