I. Introduction
Securing global public health is listed as goal number 3 of the United Nations (UN) Sustainable Development Goals. During the last few decades, innovation in the pharmaceutical sector has been astounding,Footnote 1 successfully fighting illnesses previously considered fatal and improving the living conditions of people facing short- and long-term medical conditions. Now, in the midst of the COVID-19 pandemic, we turn our eyes towards the pharmaceutical sector in the hope of rapid treatment development. Access to treatment has also been improving, although it still faces multiple barriers, especially in developing countries. While celebrating these advances, we have been shutting our eyes to a threat: what happens when pharmaceuticals enter the environment as waste through their production, use and disposal? This concern has been lingering above our heads since the 1960s,Footnote 2 but has not sparked enough interest to initiate substantial action. Regulators have mostly reacted by imposing mandatory environmental impact assessments during pharmaceutical marketing authorisation procedures. However, in many jurisdictions (including the European Union (EU)), in the case of pharmaceuticals for human use, even a negative assessment does not prevent marketing authorisation. In other words, ensuring access to treatment for the human population remains the major concern, and society may be willing to take greater risks with respect to medicinal products than other chemicals, making pharmaceutical waste a challenging issue to tackle.
With growing scientific evidence on the detrimental effects of pharmaceutical residues in the environment on other species and ecosystems, such as the feminisation of fish or near-extinction of certain species,Footnote 3 the possible effects on humans have come to the centre of attention of scientists and regulators alike.Footnote 4 The rise of antimicrobial resistance is of particular concern.Footnote 5 However, regulatory action lags behind intentions.
Pharmaceuticals enter the environment through production processes, patient use and disposal of unused and expired medicines. We focus on the last route regarding pharmaceuticals for human use and their disposal in households. While acknowledging that industrial and veterinary processes as well as pharmaceutical waste disposal by health professionals pose similar threats, they pose different social and regulatory challenges. We thus refer to household pharmaceutical waste as consumer medication leftovers (ie unused and/or expired pharmaceuticals accumulated in households).Footnote 6 Household pharmaceutical waste is often disposed of through municipal waste or sewage systems. Such improper disposal leads to pharmaceuticals entering the environment, especially in the water and soil.
The aim of this report is to redirect the discourse on the “pharmaceuticals in the environment” problem from the natural science area to patient behaviours with respect to household pharmaceutical waste. We propose redesigning current inefficient regulations on takeback schemes connected with the possible introduction of pharmaceutical re-dispensing. We base our suggestions on the results of research into patients’ behavioural patterns regarding pharmaceutical waste management.
II. Context
The problem of household pharmaceutical waste is most urgent in developed countries, with the USA and Europe leading the pack, being responsible for about two-thirds of global pharmaceutical sales. Regulators in these parts of the world address some of the suboptimal decisions when dispensing medicines on individual and institutional levels that lead to unnecessary discardFootnote 7 through regulating the dispensed amounts (especially after hospitalisation) or the pharmaceutical packaging size. Yet, surprisingly, there has only been limited inquiry into patients’ and consumers’ attitudes towards the proper disposal of household pharmaceutical waste (ie after they have acquired and used the medication). The available evidence shows that the legal framework, lack of information and perceived inconvenience of takeback schemes are the primary influences of patients’ behaviours.Footnote 8 However, other factors, such as individuals’ demographics and mind-sets (values, attitudes, motivations and emotions), have not been systematically investigated, despite the fact that studies on other types of waste suggest that these factors are potentially important.Footnote 9 Patients’ or consumers’ decisions on the disposal route for pharmaceuticals thus often represent a trade-off between environmental protection and convenience.
It seems unrealistic to expect that the production and use of medicines and consequently the production of household pharmaceutical waste would decrease considering both the positive and negative features of the globalised society. On the positive side, while the global population is growing and ageing, new treatments are constantly being developed and access to (cheaper) medicines improved. On the negative side, we face current and future pandemics, and even without them, we must fight against medicine overuse and overprescription.Footnote 10 Considering the remaining gaps in the scientific evidence on the harmful effects of pharmaceuticals in the environment on human health, especially with respect to mixture toxicity and long-term low-level exposure,Footnote 11 as well as the strength of the pharmaceutical lobby, taking more precautionary action by regulators does not seem feasible.
III. Suggestion
What seems more feasible is to better manage household pharmaceutical waste. For example, it is a legal requirement that EU Member States implement appropriate collection systems (takeback schemes) for pharmaceutical products that are unused or have expired.Footnote 12 However, the EU does not provide any guidelines on the implementation of these schemes. The vagueness of the legal text and the lack of proper guidelines have contributed to the absence of the introduction of such collection systems in some Member States, significant differences among the current collection systems in the Member States where they exist and an overall lack of effectiveness. It is reported that 50% of unused medicines in the EU are disposed of improperly, representing between 5% (Sweden) and 90% (France) of all sold and unused (respectively) medicines on national markets.Footnote 13 To put these amounts into a financial context, the unused and discarded medicines in the UK amount yearly to about €375 million.Footnote 14 This amount is literally frittered away.
Given the complex problems of household pharmaceutical waste and finding a balance between health and environmental issues, reducing household pharmaceutical waste is something we can and should strive for. Improving the malfunctioning takeback schemes or introducing new ones is one path to achieve this objective. This is in consonance with the new Strategic Approach to Pharmaceuticals in the Environment of the EU (2019), which recommends for us to “assess the implementation of collection schemes for unused pharmaceuticals and consider how their availability and functioning could be improved, how to increase public awareness of the importance of using them, and how extended producer responsibility could play a role in reducing inappropriate disposal”.Footnote 15
We propose that when (re-)designing the takeback schemes, attention should be paid to reframing the household pharmaceutical waste problem: for example, from framing it as an environmental issue (a bigger problem that is further away from an individual and harder to be perceived and to be dealt with) to a personal health issue (a smaller but personally felt problem)Footnote 16 or as an in-group intervention.Footnote 17 Furthermore, when we consult psychology and behavioural science, we identify other possible improvements that should inform the regulatory process. For example, governments can provide a supportive context by adopting legislation on more user-friendly labels and packaging of medicines and regulating direct-to-consumer marketing practices. Producers can help with innovative product and packaging solutions to allow for easy withdrawal of small amounts while the rest remains usable. Retailers can be proactive by reminding patients and consumers and making them commit to return pharmaceuticals to be disposed.Footnote 18 Similarly, campaigners and non-governmental organisations can trigger consumers’ interest and action.Footnote 19
Household pharmaceutical waste reduction has not been at the centre of attention. Awareness-raising campaigns are rare. We believe that we should encourage patients and consumers to become aware of the extent and consequences of pharmaceutical waste and how small changes in habits may help tackle the problem. However, information alone does not necessarily change behaviour.Footnote 20 Therefore, steering behavioural changes, such as through choice architecture, could prove helpful. We do have evidence from other strategies on waste (eg e-waste or food waste) that consumers may be responsive to perceived behavioural control,Footnote 21 recycling convenienceFootnote 22 and the possibility of surplus redistribution.Footnote 23 Such strategies should be (experimentally) tested for usability and effectiveness with respect to household pharmaceutical waste.
Besides focusing on takeback schemes, waste creation could be avoided through the reuse of pharmaceuticals. So far, re-dispensing of returned medicines is not allowed due to concerns regarding biochemical integrity. For example, improper storage by a patient may degrade the active ingredients of pharmaceuticals. This concern can be tackled by increasing the safekeeping of household medications and the on-time return of the pharmaceuticals to be reused. Nevertheless, we must be careful not to trade the increased societal focus on household pharmaceutical waste avoidance for dismissing legitimate pharmaceutical safety concerns by patients. There is a fragile balance between health, moral, legal, economic and public acceptance issues, and thus all pharmaceutical policy goals should be aligned.
IV. Conclusion
Better management of household pharmaceutical waste is a step that can be taken immediately without waiting for conclusive scientific evidence on the detrimental effects of pharmaceuticals in the environment on human health. Moreover, it is a step that most stakeholders – including the pharmaceutical industry and citizens – will likely agree upon. The challenge is to overcome biases, decades of bad habits and inflexible regulations, to align individual incentives with societal ones and to support them with adequate policy and regulation. In doing that, we must bear in mind that household pharmaceutical waste cannot be treated only as a side effect of (over)consumption, but also (and mainly) as a side effect of the privilege of broad access to treatments. We call for more interdisciplinary research from the fields of public health, psychology, law and medical science to successfully face the problem and inform policymakers.