Medical advances during the last century have resulted in the dramatic increase in life expectancy and quality of life. This astonishing progress in healthcare has been accompanied by an increase in the volume of pharmaceutical waste, primarily due to the rise in the number of patients, prescriptions, consumption and overproduction of medications. Consequently, this pharmaceutical waste has resulted in ecological, economical and ethical burdens that need to be understood from different perspectives [1
The Consumer Healthcare Products Association has reported that, over-the-counter medication (OTC) retail sales in the US have doubled between 2008 and 2018, from USD 16.8 bn to USD 35.2 bn [2
]. Additionally, Variant Market Research, a data mining and information analysis company based in India, estimated that the universal OTC market is expected to grow from USD 125 bn in 2016 to USD 273 bn by 2024 [3
]. In parallel, it has been reported by the German Federal Ministry for the Environment, that pharmaceutical companies in both the industrialized and the developing world are producing a variety of synthetic chemicals at a rate of 100,000 tons per year [4
]. From this, only a fraction is being utilized whilst the greater portion eventually will be unused and/or expired resulting an important volume of pharmaceutical waste.
The impact of pharmaceutical waste is therefore multifaceted. In an economic sense, this waste entails a massive loss of financial resources. A cross-sectional study conducted in 2001 reported that the value of unused medications generated by the population of US senior citizens alone is estimated to be over USD 1 bn per year [5
]. Similar situations have been observed in other developed countries. In Australia, the economic value of pharmaceutical waste per patient and year sums up to USD 1280 [6
Besides the financial losses imposed on the healthcare systems of countries and on individual patients, the disposal of expired medications is equally problematic. These pharmaceutical products contain biologically active and often toxic substances, and therefore also threaten the ecosystem, especially if disposed inappropriately. The presence of these pharmaceuticals poses many risks on the aquatic environment. The U.S Geological Survey, for instance, discovered intersex fish in the Potomac River due to estrogen contamination [7
]. In this context, another study realized by researchers in Canada detected 25 antibiotics in drinking water in small concentrations [8
]. In addition, there are numerous studies indicating the presence of minute amounts of active pharmaceutical ingredients in the soil and waterways. These minute quantities of active drugs eventually enter the food chain, where they may actually become enriched again, and subsequently return—unintentionally—to the human population which had previously disposed of them [9
The loss of expired medications is particularly frustrating as many developing countries suffer from an acute shortage of pharmaceuticals, such as antibiotics. Would it therefore be wise to redirect expired medications to the developing world, therefore avoiding “waste” on one side and shortages on the other?
In 1977, the World Health Organization (WHO) created a list for indispensable medications and recommended that countries should consider such medication as a type of national survival resource [10
]. The WHO also created a depository for specific medications in case of emergencies. Whilst, a donation program aiming to redistribute unused medication in developing countries, could be a good initiative to avoid the waste of medication. The WHO, however, recommends in a guideline published in 1999 that expired or unused pharmaceuticals should never be reused [11
The current handling of unused medication, including expired ones, has become a global canker. The disposal of pharmaceuticals by garbage and sewer is still the most common method in many countries with the absence of the proper disposal of expired medications from the patient side [12
]. Besides, there is no specific outlined strategies for pharmaceutical waste from the legal and the healthcare authority side.
The objective of this study, then, is to provide a better understanding of the issue of “expired medications” from societal, regulatory and ethical perspectives. In this context, our areas of investigation can be summarized as follows: exploring the current situation about social behavior regarding proper medical disposal, listing the regulation to control medical disposal, and discussing the different strategies of waste management. In this sense, tracking the life cycle of expired medications will guide us to develop a discussion and to suggest some recommendations for appropriate disposal practices.
In this paper, first, we have reviewed the recent literature on the current disposal methods. We, then, have presented the results of an empirical survey conducted at Saarland University, Germany, about individual disposal practices. Essential recommendations and regulations for proper medical disposal and different local waste management strategies have also been highlighted and commented on. Finally, we have developed a novel understanding of the concept of “expired medications”, which will emphasize their value and utilize their benefits.
Nowadays, the world is facing massive pharmaceutical waste pollution, which represents a major ecological issue. Commercialized drugs can end up in the environment through diverse routes such as medication production and waste management, livestock, pet or human metabolization, the excretion of chemicals or even the inappropriate recycling of unused or expired medication [80
]. A massive volume of pharmaceuticals has been found in the environment in soils and waters [81
]. Even with those pieces of evidence, it is still difficult to assess the real impact or side effects those contaminants have on health. It is almost obvious, however, that releasing chemical substances in the ecosystem will have a dramatic effect in the future by enhancing pollution and global warming. In general, the ecological situation is getting worse and worse and precautionary behavior regarding drug disposal should be adopted for ethical purposes.
The present data collected from literature clearly illustrates that people around the world still lack awareness of appropriate disposal practices. These results shed a singular light on important facts regarding current and also popular methods of handling pharmaceutical waste.
Whilst flushing unused pharmaceuticals down the sewer or throwing them in the garbage, for instance, are globally common disposal practices, they result in a risky and detrimental leakage of pharmaceuticals into the environment. The sewer route results in the presence of these active ingredients in the aqueous environment directly. Moreover, the detrimental effect of the garbage route on the environment varies, depending on the solid waste management strategy of each country, whether it will be burned, landfilled, or collected in open dumps.
One eco-friendly approach to handle unused medications is called the drug take-back program (DTP). It is a program established in many developed countries by official agencies or local communities. This program aims to prevent pharmaceuticals from entering the environment improperly by providing a “safe” method of disposing of drugs. The current study, however, reveals an absence of a systematic application of the Drug Take Back Program in several countries.
Above all, these findings obtained from reviewed literature are corroborated by our local survey. Therefore, there exists an obvious urgency for increasing public awareness on the issue of medication disposal, the impact on the environment and health, and exploring means to lessen the consequences of the issue. Awareness-raising sessions that aim to improve proper medical disposal should be planned, with a special focus on the senior population as a target group. The complexity of medications should be considered in the elderly, where deprescribing or stopping medication is frequent, leading to the accumulation of unused drugs. It was reported that patients aged 65 years and older in the USA use 40% of all prescription drugs [82
]. Surveys about disposal medication should be encouraged to gather more information that allow to plan actions for increasing public awareness. The form of our local survey (Supplementary Materials S2
) could be a recommended form for conducting more surveys in many other countries.
Besides, with regard to some reported global waste management strategies, undoubtedly, it is clear that the current global handling of pharmaceutical wastes could cause enormous environmental damage via undesirable leakage of pharmaceuticals into the ecosystem, necessitating the urgent need to adopt particular legislation to control the disposal of expired medications.
In the light of the above, expired medications consist a large amount of pharmaceuticals waste and it seems like the current understanding of their concept, it is counterproductive to the purpose of wellbeing.
The World Health Organization (WHO) defines the expiry date as follows: "the date given on the individual container of a pharmaceutical product and including the date on which the product is expected to remain within the specific action, if stored correctly. It is established for each batch by adding the shelf-life to the date of manufacture.” [83
]. The United States Food and Drug Administration’s (USFDA) definition reads: “the date placed on the container/labels of an API designating the time during which the API is expected to remain within established shelf-life specifications if stored under defined conditions and after which it should not be used." [84
The administration of a medication which passed its expiration date, however, does not necessarily indicate inevitable inefficacy or even toxicity. Apart from some cases, many drugs generally remain effective and safe even beyond their expiration dates, which indicates that expiry dates deserve a closer inspection [85
The expiration date is usually designated by the manufacturer. In fact, it is the final day on which the manufacturer of the medication guarantees fully its quality and safety, and this date is determined by stability testing. Hence, the expiration of this guarantee does not necessarily imply that the drug will be somewhat inefficient or even toxic after this specific date. Rather, the chemical composition has taken a step into the unknown beyond the date established by the stability test. The issue with the management of expired medications stems from the lack or even absence of knowledge regarding the chemical composition, hence quality and safety after this date.
After passing the expiration date, a drug’s chemical composition is left to chances related to its stability, which is tied to handling and storage conditions. The drug enters a hibernation state (purple) in terms of its chemical epistemic capacities. Is the drug still valid (blue)? Has the drug decayed and decomposed beyond retreat (red)? An action is required to investigate the epistemic state of purple medications.
In an attempt to appraise the underlying epistemic capacities of the chemical composition of medications; specific colors will be assigned. The term “Blue Medication” would refer to the drug which is within the period of validity before the expiration date. “Red Medication” would refer to the drug which passes its expiration date and undergoes degradation. Between blue and red areas there is the medication which passes its expiration date and its stability is unknown. It has two possibilities at the same time before being tested, which are degradation or validation. It is more logical to define it as “Purple Medication” instead of “expired”. Reassessing the chemical composition by conducting stability tests on purple medications exemplifies an appropriate tipping point to distinguish true “waste” from remaining “value”.
Bayer® Aspirin, for instance, typically has an expiration date up to three years after manufacture. A report has shown, however, that Bayer® Aspirin remains valid up to five years [85
]. Empirically, this specific medication proved to be blue (valid) for two extra years; after passing the expiration date, it becomes purple (unknown), yet, theoretically, it was assigned a reduced and lessened utility period, and labeled red (expired) after just three years. Furthermore, a study conducted on eight long-expired medications (28 to 40) years containing 14 APIs, demonstrated that 12 compounds out of the 14 were at least 90% still intact [85
A waste of pharmaceuticals is, to some extent, a waste of ethics. According to a report by the UN, more than 1.5 million people died in Africa in 2015 due to preventable or treatable diseases with affordable, yet locally unavailable medicines [86
]. In contrast, tons of unused medicines are thrown or burnt every year in developed countries. Since these medicines offer hope to the sick and dying. There have been attempts to render the waste of one party into the means of survival of others.
Several organizations published guidelines for drug donation in the 1980s. In 1990, for instance, an emergency shipment of medical assistance was sent to South Sudan. All the drugs were labeled in French, which is not commonly spoken there. In addition, most of the medications did not meet the recipients’ needs in a country devastated by war. The shipment included expired antibiotics, hypercholesterolemia drugs, X-ray solutions, and contact lens solutions [87
]. Moreover, in 1991, Pharmacists Without Borders collected four million kilograms of unused medications from 4000 pharmacies in France for international aid programs. They found only 20% of the collected drugs could be used, and 80% had to be burned. It is believed, according to a report by WHO, that the reason behind such high percentage of deterioration is due to poor handling and storage conditions [87
In 1986, the Shelf Life Extension Program (SLEP) was established by both the U.S. Department of Defense (DoD) and the USFDA. It was a federal program aiming to save government resources by extending the shelf-life of medications in military stockpiles. More than 3000 batches of medications (122 different drug products) were tested by the FDA, and approximately 90% were valid for use after the expiration date. Consequently, the average extension period was 5.5 years, and some of the batches were extended by more than 20 years. The expiration date of Naproxen tablets, for instance, was extended for an average of 4.5 years. The expiration date of calcium chloride Injection-solution also was extended up to about 7 years [88
The Shelf Life Extension Program represents a successful strategy for managing the American Army medical resources. Still, such programs cannot tackle the global problems related to pharmaceutical waste because this program is private to special government agencies and not available to the wider public. One reason is that all medications in military stockpiles are preserved in ideal storage conditions, while these conditions are not available in the case of randomly collected drugs for the public.
By and large, the drug take-back program aims to reduce environmental contamination by providing a relatively safe disposal of expired medications upon collecting from the public. Yet, the critical fault of such programs is throwing the collected medications in the incinerator, which enables pharmaceuticals to enter the environment. Thus, reducing or postponing their destructive entrance to the environment and preventing twofold economic loss is an urgent priority [89
]. The lack of innovation to enhance proper medical disposal methods is a major challenge. One answer could be the use of mathematical modeling to stimulate the improvement of recycling logistics networks at better costs [90
Medication recycling programs, as an alternative to incineration, could bear a high economic effectiveness. This is of particular importance in the case of a medication which has an expensive API. One tablet of ZOFRAN (Ondansetron), for instance, costs around USD 24 [91
]. Theoretically, the API can be extracted and reemployed in a new formulation to render it of “value” again. Such an approach could be a new revolution in the field of pharmacy, by creating an opportunity for new recycling companies which are different from synthetic companies. Their main duties would revolve around extracting, purifying, and repacking. Although such programs could be losing out in economic terms, it would be an environmentally beneficial strategy.
Finally, a limitation of this study was the limited number of countries covered in reviewed surveys. In addition, it should be pointed out that results recorded in the reviewed surveys might vary depending on different factors, such as the year of the study, demographical characteristics of participants, and their social environment. There is a need for conducting more surveys in many other countries. Besides, these studies need to be updated continuously to evaluate changes in public awareness. A standardization of the questionnaire is also essential to facilitate the comparison of practices by the public around the world. This paper, however, points out the need for more research regarding medical waste management.
The excessive production, prescriptions, and consumption of pharmaceuticals has led to a vast volume of expired medications which have multifaceted harmful impacts, especially to the environment. Noteworthily, the issue of expired medications is an interrelated problem being contributed by all parties involved in the production and consumption process of pharmaceuticals. On this basis, there is an urgent need to adopt a collaborative effort to address this issue by each of legislation authorities, pharmaceutical companies, and patients.
The issue of expired medications stems from the absence of particular legislation to control the disposal of expired medication. Currently, in the epoch of growing pharmaceutical industries, putting forward and adopting particular legislation to control the disposal of expired medication is an urgent must.
Pharmaceutical companies, for their part, need to take greater responsibility of the life cycle of their products. They should, first, consider the balance between production and consumption. In addition, an extension of the expiration date of a drug, utilizing innovative stability testes, would help in reducing the annual volume of expired medications. Furthermore, most of them ought to mention the instructions of proper disposal practices on the package, for instance “please contact your local drug take-back program for the disposal of this product.” This simple mention would be of great contribution to raising public awareness regarding the appropriate disposal practices.
Finally, the present data collected from the literature illustrate, undoubtedly, that participants indicating a significant lack of public awareness regarding the appropriate disposal practices, it demonstrates also an absence of the Drug Take Back Program in several countries. Therefore, there is a need to make Drug Take Back Program more popular and effective. Public awareness campaigns would also be an action towards the raising wider public awareness of this “side effects” of pharmacy and pharmaceuticals on the wider human society and the environment.