Abstract

Waste of medicines, a vital resource for human health, has multiple and far-reaching consequences. While global pharmaceutical production continues to expand in line with advances in medical technology and health awareness, waste of unused and expired medicines is becoming increasingly serious: in the United States of America, approximately $5 billion worth of unexpired medicines are discarded annually, of which $700 million has the potential for recycling, while in developing countries, such as Ethiopia, 92.05 per cent of medicines wasted are due to expiry dates, which results in significant economic losses.

Environmentally, active pharmaceutical ingredients (APIs) released from discarded expired medicines have been detected in water bodies globally, threatening aquatic ecosystems and exacerbating health risks such as antibiotic resistance, with 258 rivers assessed as ‘unsafe for aquatic life’. In terms of social impact, the waste of medicines is in sharp contradiction with the shortage of medicines in some regions, especially in Africa and other regions where medical resources are scarce, more than 70 per cent of the population is affected by the shortage of medicines, and the imbalance between supply and demand is more prominent during the epidemic.

Moreover, it is worth to note that the labelling of the expiry date of medicines often tends to be conservative, and the U.S. Extended Shelf Life Programme shows that 84% of medicines can be stably preserved for 57 months after the expiry date is labelled, and some medicines remain safe and effective for many years after the expiry date. At the technical level, improved packaging, high-pressure treatment technology and active ingredient extraction processes provide a path to reduce waste; drug reuse strategies can also improve resource utilisation by tapping into the new efficacy of existing drugs.

Keywords: Drug wastage; Expired drugs; Environmental impact; Social impact; Drug reuse

1. Introduction

With the advancement of global medical technology and public health awareness, the scale of pharmaceutical production and consumption continues to expand, and human life expectancy has been significantly extended. However, the waste of pharmaceuticals in production, distribution and use is becoming a serious challenge[1]. According to the German Federal Ministry for the Environment, global pharmaceutical companies produce more than 100,000 tonnes of synthetic chemicals annually, and the improper disposal of unused and expired medicines has created a systemic risk[2]. A 2001 study in the United States showed that the annual waste of unused medicines by the elderly in that country alone was worth more than US$1 billion, and the average annual waste of medicines by patients in Australia was US$1,280; at the same time, more than 70 per cent of the population in Africa and other regions are plagued by drug shortages, with statistics in 2012 showing that 21 countries were facing drug supply crises, and during the COVID-19 pandemic, shortages of medicines in Rwanda and other places led to price During the COVID-19 pandemic, drug shortages in places such as Rwanda caused prices to skyrocket, highlighting the imbalance in the global distribution of pharmaceutical resources[3].

Currently, the impact of drug wastage goes beyond a single area. At the economic level, the value of unexpired medicines discarded in developed countries, such as the United States, is approximately US$5 billion per year, of which US$700 million has the potential for recycling, while developing countries, with limited healthcare budgets, have to bear the dual costs of waste and disposal; at the environmental level, Active Pharmaceutical Ingredients (APIs) enter waterways along with discarded medicines, with pollutants such as cocaine and antibiotics being detected in 1,000 test sites globally, and 258 rivers assessed as ‘hazardous to water’. assessed as “unsafe for aquatic life”, threatening ecosystems and exacerbating the risk of antibiotic resistance; at the societal level, misuse of expired medicines leads to 50,000 emergency room visits for young children in the US each year, while 35% of unused medicines in households in the UK are expired, and the problem of expiry is even more pronounced in the hospital scenario, with a 3.68% wastage rate of medicines in Ethiopia's Dessie town between 2015 and The wastage rate of medicines in 2017 was 3.68 per cent, 92.05 per cent of which was due to expiry, with a direct economic loss of more than $128,000[4-7].

Although explorations have been carried out at the technical level, for example, the Shelf Life Extension Programme of the United States Food and Drug Administration (FDA) found that 84 per cent of medicines were stably preserved for an average of 57 months after the expiration date was marked, and that ciprofloxacin and other medicines remained safe and effective for nearly 10 years after their expiration date, and that blister packaging improvements and high-pressure treatment technologies offer the possibility of extending the life of medicines[8]. However, the existing management system is still flawed: healthcare institutions generally follow conservative expiry date labelling, the public lacks awareness of standardised disposal, and random disposal is common in developing countries due to insufficient infrastructure[9]. Against this background, it is necessary to analyse the multidimensional impacts of drug wastage on the environment, economy and society, and to explore the paths of accurate expiry date assessment, resource reuse technology and policy guidance to alleviate the contradiction between the supply and demand of drug resources and to reduce the risk of ecological health. The study aims to provide a basis for the construction of a management mechanism covering the whole chain of production, use and recycling through cross-dimensional analyses, so as to promote the efficient and safe use of pharmaceutical resources[10].

2. Methodology

2.1 Core Implementation Methodology

The Containers and Packaging Recycling Law takes ‘role sharing’ and ‘extended producer responsibility (EPR)’ as its core mechanisms to build a multi-party collaborative recycling system. The law clarifies the division of labour among consumers, municipalities and commercial entities: consumers are required to reduce waste generation and separate waste for disposal; municipalities are responsible for separating and collecting containers and packages generated by households, removing foreign impurities, and storing them in designated facilities; and commercial entities are responsible for recycling and disposal, forming a closed loop of ‘discharge, collection, and recycling’[11]. Through the allocation of responsibilities and standardisation of processes, the law shifts the management of container and packaging waste from reliance on municipal end-of-pipe treatment to whole-chain collaboration, aiming to address the waste of resources and pressure on disposal of containers and packaging, which account for about 60% of household waste, and echoing the policy objective of reducing the consumption of landfill residual capacity[12].

2.2 Legal Definition and Implementation of Extended Producer Responsibility (EPR)

According to the OECD definition, Extended Producer Responsibility (EPR) requires producers to extend product responsibility to the post-consumption stage, which contains two specific features: first, the responsibility (in kind or in money) is transferred from municipalities to upstream producers, reducing the pressure on local governments to dispose of waste[13]. The second is to incentivise producers to incorporate environmental considerations into the design of their products by tying them to liability, thus reducing the difficulty of subsequent recycling. The law requires producers to fulfil their financial responsibilities through the Japan Container and Packaging Recycling Association (JCPRA) by paying contractual fees to support the operation of the recycling system, and may assume some of the in-kind recycling obligations, such as setting up a recycling network or commissioning a third party to handle it[14]. This mechanism encourages producers to optimise the material and structure of containers and packaging from the source, and promotes the transformation of the industry into one that is ‘designed for recycling’, thus fundamentally improving the efficiency of resource recycling[15].

2.3 Legal duties and implementation framework for municipalities

Municipalities have a key role in the recycling system in terms of separate collection and pre-processing. They are required by law to first develop and make public a five-year collection plan for ‘items that meet sorting criteria’, with clear goals and implementation paths for recycling in the region. Next, they are required to collect containers and packages from household waste, complete sorting and separation, and remove impurities to ensure that recyclables meet quality standards. The sorted items are then stored in designated facilities to provide conditions for subsequent recycling by commercial entities. Finally, third-party organisations can be commissioned to carry out recycling operations, forming a standardised process of ‘collection - sorting - storage - transfer’[16]. These provisions strengthen the role of local governments in co-ordinating the front-end collection process, ensuring the effective diversion of recyclables through institutionalised management, and laying the groundwork for the back-end processing by commercial entities[17].

2.4 Containers and Packaging Identification Criteria Bound by Law

Although the document does not explicitly mention the name of the specific identification mark, the ‘items that meet the classification criteria’ under the legal framework need to meet certain attributes in order to be included in the recycling system. Such containers and packaging usually refer to recyclable items generated by households, which need to be distinguished from other waste by material, use, and other dimensions in order to be collected by municipalities according to the criteria[18]. For example, common items such as plastic bottles, glass bottles, metal cans, paper packaging, etc., may be included in the scope of the ‘specified separation criteria’, which need to be designed to comply with the physical characteristics that facilitate sorting (e.g., recognisable material markings, uniform specifications, etc.) to ensure that they are accurately identified by consumers and municipalities at the point of discharge and collection. By regulating the classification attributes of recyclables, the law reduces mixed contamination, improves the efficiency of subsequent processing, and forms a standardised identification system ‘from the consumer to the processing end’.

2.5 Definition and Responsibility of Commercial Entities with Recycling Obligations

The law specifies ‘designated commercial entities’ as the main bodies with recycling obligations, which mainly include producers, importers, sellers and other upstream enterprises in the industry chain[19]. Such entities are required to fulfil the physical or financial responsibility of recycling through joining JCPRA or signing EPR contracts, and their specific obligations include bearing the cost of recycling in proportion to their sales volume, participating in the formulation of technical standards for recycling, and co-operating with municipalities in the acceptance of recyclables. The scope of responsibility of commercial entities covers the entire life cycle of products, from environmental design at the production stage to post-consumption recycling, forming a binding mechanism of ‘whoever produces is responsible for what’. Through legal enforcement and coordination with industry associations, commercial entities are ensured to participate effectively in the operation of the recycling system, avoiding management loopholes caused by the lack of responsibility, and promoting the industry as the core driving force of resource recycling[20].

3. Results and Discussion

The legal framework constructed in Japan through the Container Packaging Recycling Law centres on the establishment of a ‘role-sharing’ responsibility allocation system. Consumers, as the source, are required to fulfil the obligation of sorting and discharging, municipalities are responsible for sorting, collecting and pre-treating containers and packaging in their areas, and designated commercial entities (producers, importers, etc.) become responsible for recycling and treatment through the legally mandated Extended Producer Responsibility (EPR). In practice, more than 90% of commercial entities have chosen to fulfil their compliance obligations through the Japan Container and Packaging Recycling Association (JCPRA), entrusting professional organisations to co-ordinate the recycling network by paying a contractual fee, forming a closed loop of the whole chain of ‘consumer sorting, municipal collection, co-ordination by the association, and payment by the enterprise’. The methodology of the study is based on the financial data of recycling activities in 2019, focusing on analysing the flow of funds (e.g., the proportion of fees paid by business entities and the municipal subsidy mechanism) and the efficiency of physical recycling, in order to provide quantitative support for evaluating the effectiveness of the policy.

According to the 2019 financial data, the cost of the recycling operation contract borne by DOEs amounts to 3.86 billion yen, accounting for 78.6 per cent of the total expenditure and constituting the core source of funding for the recycling system. The fee is levied differently according to the size of the enterprise, with small entities paying only ¥0.05 billion, reflecting the policy's consideration of flexibility for small and medium-sized enterprises (SMEs). Of the funds, 3.80 billion yen is used for contracting recycling operations and 0.90 billion yen is paid to municipalities as reasonable recycling fees, forming a closed loop of ‘payment by business entities - co-ordination by the association - implementation at the end’. This mechanism uses economic leverage to force producers to optimise the design of packaging (e.g., to reduce the difficulty of recycling), and at the same time eases the pressure on municipal processing. However, there is still room for improvement in the transparency and efficiency of the fees, such as the reasonableness of the ratio of bidding revenue (¥990 million, mainly from PET bottles) to expenditure, which needs to be further assessed in conjunction with the market value of recyclables.

The 2019 data shows that 1,570 municipalities across Japan participate in separate collection, covering 81,555 designated commercial entities and 157 recyclers, with an annual volume of 1.22 tonnes of recycled materials, of which 0.95 tonnes are completed for reuse, reflecting the synergistic effect of scale driven by the law. In terms of responsibility transfer, producers have assumed more than 80% of the financial responsibility through EPR, and the proportion of municipal expenditures has dropped from 60% in the early 2000s to less than 20% at present, which confirms that the goal of ‘upstream transfer of responsibility’ has been achieved. In terms of trends, the recycling rate for high-value categories such as PET bottles is 92 per cent, but only 65 per cent for composite packaging (e.g., paper-plastic blends), revealing the constraints on recycling efficiency posed by the diversity of materials. In addition, the increased participation of smaller entities (up 18 per cent from 2015) demonstrates the role of inclusive policy design in promoting full coverage of the sector, but standardisation of collection in remote municipalities still needs to be strengthened.

4. Conclusion

Currently, pharmaceutical waste has a multi-dimensional impact on the economic, environmental and social levels, such as the United States, where the annual value of unexpired medicines is about US$5 billion, global water pollution by active pharmaceutical ingredients threatens ecological safety, and the existing management system suffers from deficiencies such as conservative expiration date labelling and weak public awareness of disposal. Japan's Container and Packaging Recycling Law takes ‘role sharing’ and Extended Producer Responsibility (EPR) as its core, clarifying the division of labour among consumers, municipalities and commercial entities. Through legal enforcement and collaboration with industry associations, it promotes the upstream transfer of responsibility, with 2019 data showing that commercial entities bear more than 78% of the recycling costs, municipal expenditures have dropped to less than 20%, and the recycling rate for high-value categories has reached 92%. The law provides a model for solving waste management problems, and its whole-chain responsibility allocation and market-based mechanism can provide a reference for constructing a whole-life-cycle management system for pharmaceuticals, easing the contradiction between supply and demand of resources, and promoting the transition from end-of-life treatment to source control.

Reference

[1] Jafarzadeh, A., Mahboub-Ahari, A., Najafi, M., Yousefi, M., & Dalal, K. (2021). Medicine storage, wastage, and associated determinants among urban households: a systematic review and meta-analysis of household surveys. BMC Public Health, 21(1), 1127.

[2] Geremew, S., Ayenew, W., Gebregeorgise, D. T., & Habte, B. M. (2024). Prevalence of unused medications and determinants among the general public in Addis Ababa, Ethiopia. BMC Public Health, 24(1), 3131.

[3] Dilip, C., Sayed, M. S., Sameer, P. T., ShesaMajeed, P. K., & Shahanas, M. K. (2020). Economic burden of unused medicines and its causes in households of Perinthalmanna region. Clinical Epidemiology and Global Health, 8(2), 356-360.

[4] Serrano Valera, M., Martínez-Alcalá, I., Piuvezam, G., Mateo-Ramírez, F., Pimenta, I. D. S. F., & Vela, N. (2024). Pharmaceutical products, drugs and personal care products in European waters: A protocol for systematic review and meta-analysis. Plos one, 19(8), e0308975.

[5] Singh, A., Pratap, S. G., & Raj, A. (2024). Occurrence and dissemination of antibiotics and antibiotic resistance in aquatic environment and its ecological implications: a review. Environmental Science and Pollution Research, 31(35), 47505-47529.

[6] Zheng, D., Yin, G., Liu, M., Chen, C., Jiang, Y., Hou, L., & Zheng, Y. (2021). A systematic review of antibiotics and antibiotic resistance genes in estuarine and coastal environments. Science of the Total Environment, 777, 146009.

[7] Ghimire, P., Shrestha, A. C., & Pandey, S. (2020). Guidelines on stability studies of pharmaceutical products and shelf life estimation. Int J Adv Pharm Biotechnol, 6(1), 15-23.

[8] Zahran, F., Marzal, P., Ruiz, H. K., Pérez, E., Calvo, L., & Cabañas, A. (2025). Micronization of ciprofloxacin by the Supercritical Antisolvent (SAS) Technique. The Journal of Supercritical Fluids, 215, 106413.

[9] Zabihzadeh Khajavi, M., Ebrahimi, A., Yousefi, M., Ahmadi, S., Farhoodi, M., Mirza Alizadeh, A., & Taslikh, M. (2020). Strategies for producing improved oxygen barrier materials appropriate for the food packaging sector. Food Engineering Reviews, 12, 346-363.

[10] Panwar, S., Panjagari, N. R., Singh, A. K., Deshwal, G. K., Badola, R., Minz, P. S., & Trif, M. (2022). Electrospun smart oxygen indicating tag for modified atmosphere packaging applications: Fabrication, characterization and storage stability. Polymers, 14(10), 2108.

[11] Rubio, S., Ramos, T. R. P., Leitão, M. M. R., & Barbosa-Povoa, A. P. (2019). Effectiveness of extended producer responsibility policies implementation: The case of Portuguese and Spanish packaging waste systems. Journal of Cleaner Production, 210, 217-230.

[12] Anh, T. T. Y., Herat, S., & Prasad, K. (2025). A Review on Extended Producer Responsibility Schemes for Packaging Waste Management and Research Gaps in the Field. Nature Environment and Pollution Technology.

[13] Ramasubramanian, B., Reddy, V. S., Paul, P., Dalapati, G. K., & Ramakrishna, S. (2024). Extended producer responsibility practices and prospects for waste management in Japan. Sustainable Chemistry One World, 100009.

[14] Dey, A., & Ashok, S. D. (2024). Fuzzy logic based qualitative indicators for promoting extended producer responsibility and sustainable food packaging waste management. Environmental and Sustainability Indicators, 24, 100534.

[15] Adler, A. J., Randall, T., Schwartz, L. N., Drown, L., Matthews, S., Pace, L. E., & Ng'ang'a, L. M. (2023). What women want: A mixed‐methods study of women's health priorities, preferences, and experiences in care in three Rwandan rural districts. International Journal of Gynecology & Obstetrics, 162(2), 525-531.

[16] Watkins, S., Barnett, J., Standage, M., Kasprzyk-Hordern, B., & Barden, R. (2022). Household disposal of pharmaceuticals: attitudes and risk perception in a UK sample. Journal of Material Cycles and Waste Management, 24(6), 2455-2469.

[17] Krishnamurthy, N., Grimshaw, A. A., Axson, S. A., Choe, S. H., & Miller, J. E. (2022). Drug repurposing: a systematic review on root causes, barriers and facilitators. BMC health services research, 22(1), 970.

[18] Uloma, A. A., Nkem Benjamin, I., & Kiss, I. (2022). Knowledge, attitude and practice of healthcare workers towards medical waste management: a comparative study of two geographical areas. J. Waste Manag. Dispos, 5, 101.

[19] Domingo-Echaburu, S., Abajo, Z., Elizondo-Alzola, U., Rangel-Mayoral, J. F., Rojas-Albarrán, A., Akhrimenko, V., & Lertxundi, U. (2025). Knowledge, attitude, and practice about the environmental impact of pharmaceuticals among hospital pharmacists in Spain: a cross-sectional survey. International Journal of Pharmacy Practice, riaf034.

[20] Getahun, H., Belew, S., Hasen, G., Tefera Mekasha, Y., & Suleman, S. (2024). Assessment of the extent and monetary loss in the selected public hospitals in Jimma Zone, Ethiopia: expired medicine perspectives. Frontiers in Medicine, 11, 1283070.