THE CLIMATE CRISIS IS A HEALTH CRISIS BUT WHAT ARE WE DOING ABOUT IT?

This toolkit provides information for NHS organisations to support the design and implementation of a local or regional inhaler postal recycling scheme. The information and supplementary documents provided are based on the ‘Take AIR’ (Take Action for Inhaler Recycling) scheme set up by Chiesi Ltd (Chiesi) and piloted in the Leicestershire, Leicester and Rutland (LLR) area from January 2021 with the support of Leicestershire and Rutland Local Pharmaceutical Committee (LPC) and University Hospitals of Leicester NHS Trust (UHL).

The pilot scheme operated with the continued support of many of the community pharmacies in the LLR area and the pharmacy team at UHL at a time of great challenge to the UK healthcare system. Our thanks go to them for helping to make the scheme a success and working with the project team to capture and analyse the data needed to enable replication.

Why is it important to recover and recycle inhalers?

Inhalers are the mainstay of treatment for a range of lung conditions such as asthma and chronic obstructive pulmonary disease (COPD) in the UK.¹

There are different types of inhaler devices including pressurised metered dose inhalers (pMDI), dry powder inhalers (DPI), and soft mist inhalers (SMI). The composition of inhaler devices can vary across the three main types. In general, DPIs are plastic units and the medicine is delivered in the form of a dry powder,² whilst pMDIs use a propellant to deliver a fixed volume of liquid solution or suspension to the patient in the form of an aerosol.²

pMDIs contain a hydrofluoroalkane gas (HFA) which acts as a propellant to deliver the medicine to the patient’s lungs. The propellant most commonly used in inhalers is HFA-134a, with a smaller proportion using HFA-227ea in the UK.³ The HFAs currently used in inhalers are known greenhouse gases which have a global warming potential (GWP).^3,4

The measurement of GWP was developed to allow comparisons of the global warming impacts of different gases. Specifically, it is a measure of how much energy the emissions of 1 tonne of a gas will absorb over a given period of time, relative to the emissions of 1 tonne of carbon dioxide (CO₂). The larger the GWP, the more that a given gas warms the Earth compared to CO₂ over that time period.⁵ As well as the propellant, inhalers also contain plastics which cause harm to the environment if disposed of incorrectly.

Therefore, reducing the environmental impact of inhalers is an important action in the global challenge against climate change.

Across a respiratory pathway there are multiple opportunities to reduce carbon emissions. Organisations such as the Primary Care Respiratory Society have provided an interactive tool which aims to help clinicians work with patients to identify a greener approach to delivering high quality, patient centred respiratory care.⁶ Inhaler recycling is included as one of those elements.

What is the problem we are trying to solve?

More than 60 million inhalers are prescribed each year in the UK,⁷ with the vast majority disposed of in landfill.⁸ Some of these inhalers may be out of date, no longer wanted or seem empty to the patient i.e. the dose counter is at zero. Most pMDIs are manufactured with a small amount of extra contents known as the ‘overage’.⁹ Even when the inhaler seems empty to patients, there can still be some propellant remaining.

The propellant contained in pMDIs, when disposed of through domestic waste, can be released into the atmosphere where it can remain for up to 270 years.^3,8 In 2018, the UK Parliament Environmental Audit Committee (EAC) recommended that either medical companies or the NHS should establish a pharmacy recycling system to ensure that inhaler propellants are recycled rather than ending up in landfill and the propellant released into the atmosphere.⁸

The link between inhaler recycling and NHS Net Zero targets

The NHS has declared its intention to be the world’s first ‘net zero’ national health service, by reducing the carbon emissions it controls directly and indirectly, known as scope 1 and scope 2, aiming to reach an 80% reduction by 2028-2032.¹⁰ For all emissions, including all other indirect carbon emissions (scope 3), the NHS aims to be net zero by 2045, with an ambition to reach an 80% reduction by 2036 to 2039.¹⁰

One area of focus in the NHS net zero targets is reducing the use of short-acting bronchodilator inhalers and switching to dry powder where clinically appropriate, which uses significantly less fluorinated gases than traditional metered dose inhalers.¹¹

The pharmaceutical sector has acknowledged the need to develop inhalers that will be sustainable for the future and a number of companies have publicly announced investments in low-carbon propellants.^12,13,14 In the meantime, prescribers and patients can play a part in helping to reduce the carbon impact of inhalers when their devices are no longer needed or used.

Disposing of inhalers in the most environmentally friendly way, recovering the propellant gas and reusing in other industries (e.g. refrigeration and air conditioning), can help to reduce carbon emissions and support the ambitions to achieve net zero.

Currently there is a disposal route for all medicines through community pharmacies in the UK (known as the NHS Unwanted Medicines Service)¹⁵ which disposes of medicines similar to other forms of healthcare waste via incineration.¹⁶ However evidence suggests that patients are most likely to dispose of their inhaler in their domestic waste.^17,18

Preliminary research

Prior to initiating the recycling scheme, research was undertaken to inform action for next steps. Chiesi research followed two routes:¹⁹

• Patient opinion survey
  487 patients were surveyed and asked what they knew about the services available for handling inhalers that are no longer needed or used. They were also asked what services they would like to have to support them with inhaler recycling. Patient responses were anonymised to prevent patient identification.
• Review of other industries
  Recycling schemes from different industries were analysed, such as those for printer ink cartridges, coffee capsules, batteries, water filters and contact lens.

Options appraisal for inhaler return and recycling schemes

All the potential options for inhaler return and recycling schemes were scoped and scored using an unweighted scoring matrix, including options that may have seemed unsuitable. From this ‘long list’ a short priority list using the following criteria (in alphabetical order) was formed:

• Alignment with patient opinions
• Estimated costs of service
• Known providers of services
• Minimal additional carbon emissions from scheme process (e.g. additional transport)
• Carbon emissions reduced
• Feasibility of upscaling
• Maximum opportunity for recycling of materials
• Regulatory barriers (medicines regulations/waste regulations/other relevant regulations)

Decision on right framework for the scheme

For the Leicestershire, Leicester and Rutland pilot, Chiesi were keen to recycle as much of the returned material as possible, following guidance from the Department for Environment, Food and Rural Affairs (DEFRA).²¹

Applying the waste hierarchy ranks waste management options according to what is best for the environment. The guidance prioritises prevention of waste. Once waste is created, the guidance ranks preparation for re-use, then recycling, then recovery, and lastly disposal (e.g., landfill).²¹

Chiesi, with support from external waste management experts, concluded that it would be beneficial to test a model for the recovery and recycling of inhalers using the established UK postal system. From the research, it was decided that a request would be made to the community pharmacies to assist the scheme by providing an envelope at the point of dispensing to each patient and providing patients with materials which Chiesi had provided.

Set up challenges

This next section highlights some of the regulatory and supplier/partner considerations that needed to be worked through for set-up of the Chiesi postal scheme.

Regulatory barriers

Disposal of any waste is subject to legislation and regulated by the Environment Agency; disposal of medicines waste adds further complexity.

For the postal inhaler recycling scheme, one would need to consider the following three sets of regulations:

• Medicines Legislation
  The Human Medicines Regulations 2012 provides the main legal framework for the prescribing, supply, storage, and administration of medicines. The Regulations classify medicines into 3 categories (prescription-only-medicine, pharmacy, general sales list).²² Inhalers fall within the Prescription Only Medicines (POM) classification²³ and as such are required to be stored securely with controlled access.²⁴ This should also apply to the storage of unwanted POMs once a patient has ‘discarded’ the medicine.²⁵ This is a key consideration for those involved in a local recycling scheme who may be storing the used inhaler devices. In general, POMs for disposal need to be securely stored with controlled access, until they are collected by a registered waste provider via an agreed route.^25,26
• UK Waste Legislation

  The nature and classification of the waste being handled will determine the requirements for anyone disposing of that waste. Whilst inhalers containing propellants are not classed as flammable waste (due to the low volumes of propellant),^26,27 they are classed as clinical waste and therefore certain requirements for documenting the waste are necessary.^28,29

  For the Chiesi scheme, it was essential that patients should not have to provide personal details or complete any form of documentation. To ensure this was acceptable by the regulator, contact and agreement with the Environment Agency was essential.

  To enable the postal scheme to operate within the requirements of the waste regulations, Chiesi registered as a Waste broker and dealer with the Environmental Agency. This placed a duty of care on Chiesi to ensure the waste is appropriately collected and managed in accordance with the regulations.

• Mail Carriage Regulations

  Chiesi chose to partner with Royal Mail, though other partners were available, for the provision of the pre-payment of carriage of small parcels of inhalers and the transportation of the parcels from local letter boxes to a named waste management provider. In practice, this meant that the inhalers were put into pre-paid envelopes and returned through the post to the waste management company. Royal Mail required that the content of the envelopes complied with their terms of carriage.

  The propellant within the inhalers was initially considered a concern because of the potentially flammable nature of propellants HFA-134a and HFA-227ea. These propellants are considered non-flammable but given unsatisfactory conditions could explode.³⁰ Chiesi provided clarification of the volumes of propellant likely to be included in the parcels posted by patients. The information enabled Royal Mail to assess the risk as low and make appropriate arrangements for the parcels to be transported through their network by road and rail, avoiding transport via aviation.

The ‘Take-AIR’ Inhaler Postal Recycling Process

Overview of the process

The Take AIR scheme launched at the end of January 2021, initially as a 12-month pilot across Leicestershire, Leicester and Rutland with the support of University Hospitals of Leicester NHS Trust (UHL), Leicestershire and Rutland Local Pharmaceutical Committee (LPC).

The scheme enabled patients to collect pre-paid, pre-addressed envelopes from their local pharmacy. It was expanded in October 2021 to include inhaler users who were discharged from one of UHL’s three hospitals. The patient (or carer) can then, in their own time, insert empty, unwanted, or out-of-date inhalers of any brand or type into the pre-paid envelope, and post them via a Royal Mail post box directly to the waste management provider.

The envelope can hold up to a maximum of 4 inhalers. The instructions with the envelope encourage the patient to wait until they had 3-4 inhalers before sealing the envelope and posting it.

What happens to the inhaler parts during the Take AIR Scheme?

Once the inhalers reached the recycling centre, they were sorted and separated into two waste streams:

• Metered dose inhalers containing propellant (pMDIs)
  • Aluminium canisters are crushed together to form solid blocks
  • During the crushing process, propellant gas is extracted to be reused in items such as fridges and air conditioning units
  • Any recyclable plastic is made into pellets and recycled
• Other remaining inhalers
  • Similar to some components of pMDIs, any recyclable plastic is made into pellets and recycled
  • Non-recyclable materials are converted into energy through a process called energy-from-waste

Evaluating the impact

To evaluate the scheme, qualitative and quantitate evaluations with pharmacies and patients who participated in the scheme were conducted. The reduction in carbon emissions as a result of the scheme was also calculated. All feedback given can be found in the Evaluating the Process document. Chiesi would suggest the consideration of the following points for local replication, based on the qualitative feedback we collected.

The qualitative feedback was gathered utilising:

• Feedback calls by the third-party pharmacy service provider to the pharmacies within LLR
• Questionnaires sent out to pharmacies involved in the scheme
• Questionnaire responses from anonymised patient feedback

Quantitative feedback was gathered utilising:

• Reports from the third-party service provider, outlining the number of pharmacies signed up, the number of envelopes ordered by pharmacies and those which were delivered
• Reports from the waste management company on the number of envelopes and inhalers returned via Royal Mail
• Reports from Royal Mail for the number of tracked envelopes per month through their system

The quantitative data was used for the basis of our carbon emissions calculation. The calculation required researching the proportion of the propellant added to the pMDI in manufacturing to ensure the correct number of labelled doses are available to the patients. This is known as the overage. The overage will differ by brand, device, and dosage. For the calculation, it was assumed that all pMDIs will be returned when the patient had used all the labelled doses and therefore, the amount remaining will be the overage.

From the weight data provided by our waste management provider, we know that many inhalers returned weighed more than an empty inhaler and therefore the calculation from the overage is only a base-case. In reality the amount of carbon emissions saved from the scheme might be greater.

The exact breakdown of the methodology will be available in a separate publication.

Reduced carbon emissions calculation – inhaler propellant

The carbon equivalence calculation was developed using guidance from DEFRA and the Environmental Agency.³¹

Chiesi’s response to Inhaler Recycling FAQs

Q. How is ‘Take AIR’ paid for?

All the costs of the scheme, from materials, postage, and waste management were covered by Chiesi. Pharmacies and the hospitals of UHL took part in the scheme on a voluntary basis.

Q. Were pharmacies paid to be involved?

No. Community pharmacies signed up to the scheme on a voluntary basis.

Q. How did Chiesi track which envelopes came from which pharmacy?

A number of ways to track the envelopes was considered. A contract with the Royal Mail for the ‘Track 48’ product was chosen due to a combination of cost and time constraints. This provides sequential bar codes that can be printed on to envelopes together with the address of the waste management company. The envelopes were then distributed to pharmacies.

The third-party service provider managed the supply and distribution of envelopes to pharmacy as outlined earlier.

When the envelopes are posted, they are scanned so the postage can be paid which also indicated how many envelopes are returned by patients.

The third-party service provider was also able to track which pharmacies were ordering more envelopes. This has enabled us to keep track of levels of activity from the participating pharmacies.

Q. How has Chiesi assessed the return rate of inhalers?

The inhaler return rate is a useful proxy measure to see how many inhalers were being returned to our waste management company, and how many inhalers were being included in each envelope. To work this out we:

• Assessed the number of inhalers prescribed in a region in a 12-month period (A) using business intelligence data
• Number of inhalers returned to the waste management provider over the course of a year (B)

Introducing inhaler postal recycling in your area

The section of the toolkit is to help support local implementation of a postal inhaler recycling scheme.

The section is made up of several steps that, based on our experience, should be considered to achieve a successful implementation. However, an alternative approach may be needed depending on your local requirements. The annex contains useful editable templates to suit local needs.

Communication and Engagement

For a recycling project to be successful, there will be interested and relevant stakeholders who will need to be a part of early discussions and/or to have awareness of the programme. Below is a list of suggested stakeholders who you may want to involve in discussions regarding a recycling scheme:

• Budget holder
• NHS staff involved in the scheme, such as GPs, Consultants, Pharmacists, Specialist Nurses, Physiotherapist, Pharmacy Team members and anyone else involved in managing or prescribing inhalers
• Local Pharmaceutical Committee (LPC and or Pharmacy Teams)
• Project management support relevant to your organisation. This support should include a Project Lead, Project Manager, Communications Lead and others as applicable.
• Patient representative

It is important for any project to have a shared aim and vision. This can be achieved through a comprehensive external communications plan, whilst also creating relevant branded resource materials which make the scheme easy to set up for the pharmacists and accessible to the patients.

There are several templates available to download as supporting materials that may be useful in enabling a scheme to be launched. Included in the supporting material templates are the following:

• Introduction letter to pharmacies – providing the background and overview of the scheme
• NHS staff involved in the scheme, such as GPs, Consultants, Pharmacists, Specialist Nurses, Physiotherapist, Pharmacy Team members and anyone else involved in managing or prescribing inhalers
• Welcome letter for pharmacies – further information if they agreed to join the scheme
• Healthcare professional checklist – 1 pager to help healthcare professionals introduce the scheme to patients
• A guide for a counter-top display unit – visible place in the pharmacy to store envelopes

Public Awareness

Patients will need to be aware of your scheme and how they can take part. Consideration is required to link in any existing national or local return schemes that may be running.

A range of supporting materials for local adaptation are available within the annex.

The following are included:

• Scheme information leaflet – to be given to patients when they collect their medication to inform them of the scheme
• Scheme information Posters – highlight the scheme
• Stickers – attached on medication bags to remind patients of the scheme

Processes

Awareness of local medicines returns processes is essential. As part of national schemes, unused and unwanted medicines should be returned by patients to community pharmacies. Understanding how your inhaler recycling scheme aligns is important as it will help you understand the local route for disposal for medicines. It will also help you to consider what current waste disposal methods are in place locally i.e. energy from waste process or a recycling service.

Process mapping can be useful in trying to understand the steps required to implement an inhaler recycling postal scheme.

Legislation

As mentioned in previous sections, understanding current legislation, and identifying roles and remits within a recycling scheme is essential. Section 2 highlights this point further.