1. Introduction
An important waste category, whose management is a complex and difficult problem for humanity in the context of global population growth, is represented by medical waste. According to the World Health Organization (WHO), medical waste is defined as “
waste generated in the diagnosis, treatment or immunization of humans or animals” [
1,
2]. As medical waste is potentially dangerous and polluting, the inappropriate handling and disposal of it poses a risk to public health and to the environment [
2,
3].
Medication represents the main component of medical waste. Its consumption is steadily increasing due to the increasing number of pathologies to be treated, enhanced access to medical services as well as a more frequent self-medication process. Increased consumption leads to a rapid increase in the amount of medical waste, especially in developing countries [
1,
4]. Compared to the European average and other countries in the region, the consumption of medicines in Romania is low, with a percentage close to 50% both for prescription drugs and for over-the-counter (OTC) medicines [
5,
6].
Medicinal waste, synonymous with pharmaceutical waste and unused or expired medicines includes articles intended to prevent, diagnose, and treat diseases in humans or animals [
7,
8]. In recent decades, this kind of waste has been extensively studied [
8,
9,
10]. There are currently more than 3000 active pharmaceutical ingredients (APIs) on the EU market [
9] that are authorized, and more than 4000 are available worldwide. Additionally, annual worldwide drug consumption exceeds 1,000,000 tons [
10] and is steadily increasing. It is estimated to reach 4.5 trillion doses in 2020, which is 24% higher than in 2015, both for prescription-based and OTC medicines [
11]. Emerging markets, such as those in China, India, Brazil, and Indonesia, due to increased use, are largely responsible for this change, which means that more than half of the world’s population will use more than one dose of medicine per day in 2020 [
12].
The medicines reach the environment in various ways, such as inadequate disposal in the sink or toilet, household waste, excretion from the human body (as metabolites or even the base compound), urination/defecation, and by washing them off the skin (creams and ointments) [
13]. Due to the fact that sewerage systems are not properly equipped to eliminate medicines and their compounds in an efficient way, they can be released in water courses and then get into the drinking water supply system [
14] (
Figure 1).
Medicines used in the treatment and prevention of diseases in humans and animals are extremely important healthcare tools for society, designed to exhibit specific biological effects in the human or animal body, whose evolution is still under research [
15,
16,
17,
18,
19]. However, the effects of their interaction, in the environment, with non-target organisms, where they come in the form of metabolites excreted by human or animal organisms that consume them or by the inappropriate disposal of unused medicinal products, are very little understood or even unknown [
20]. They reach the environment and pollute the waters and soil, causing negative effects on the organisms in the environment, but also on human health, interfering with the hormonal system and, very importantly, contributing to the increase of antibiotic resistance [
21,
22,
23]. Negative effects increase with the increasing concentration in active substances. It is extremely important that unused medication be properly managed, given the current context of a consistent increase in the use of pharmaceuticals due to aging populations and the development of new drugs [
24].
Medical residues discharged in waste (open dumping) reach the soil, and they later gather in the water supplies [
25,
26]. Once they reach the groundwater, the drugs and their decomposition derivatives can harm the environment and human life [
27,
28], and disinfection [
29] and purification [
30] is then needed. For example, direct influences of active drugs on the endocrine system determine the feminization of the male fathead minnow, which may lead to an important decrease of the fish population at significant concentrations of this type of substance [
28]. Additionally, the chronic exposure to certain estrogens found in contraceptive pills (such as 17-ethinylestradiol) has led to the feminization of male rats, contributing to a significant population reduction [
31]. Another class of drugs that has harmful effects on aquatic species is antibiotics. There are studies proving that antibiotics lead to the emergence of new strains of antibiotic-resistant bacteria [
32] as well as to the induction of genetic alterations and mutations [
33]. Human health issues are still less worrying from this point of view because antibiotics in drinking water are in concentrations significantly lower than the usual recommended doses during treatment. However, another way of exposing humans to the harmful effects of pharmaceuticals is through the consumption of food. Because the long-term summation of any type of chemical in the body has pathological effects [
28,
31], and pharmaceutical waste is accumulated in the soil and then gets to the plants and animals that are consumed as food, the risks associated with this type of exposure should be taken into account.
Drug treatment at a patient’s home often generates pharmaceutical waste. This waste is eliminated in an improper manner worldwide, since people choose the easiest and quickest way to get rid of unnecessary medicines, for example, they throw them in the garbage, down the toilet or in the sink [
34,
35,
36]. In recent years, the issue related to drug disposal, and to the development and implementation of efficient collection strategies, has been an important concern at the European level and has generated numerous researches [
8,
37]. In Germany, a pharmaceutical waste take-over system was set up in 1995, and local pharmacies were used as collection points [
38]. In 1999, the WHO, through the European Centre for Environment and Health (located in France), initiated an international working group in charge of developing a practical guide that addresses, in particular, issues relating to the management of medical waste in developing economies [
16]. In 2004, art. 127b of the European Union Directive on the Creation of a Community Code Relating to Medicinal Products for Human Use (2004/27/EC) stipulated the establishment of collection systems for unwanted drugs at European level. This Directive introduces the obligation of all Member States to have and implement “
specific precautions relating to the disposal of unused medicinal products” and appropriate collection systems (Article 127). In article 8c of Directive 2008/105/EC (as amended by Directive 2013/39/EU), there is a provision obliging the European Commission to develop a strategic approach to the pollution of water caused by pharmaceuticals. However, several studies mention that the implementation of these collection systems have an efficiency that varies widely across the EU member states and it is not clear whether all EU countries have implemented these requirements. In the case of Cyprus, Malta, and Bulgaria, there is no information to clarify the existence of such collection systems [
39,
40].
In Romania, unused pharmaceutical products generated by ambulatory treatments became subject to a legal framework only in 2014 [
41]. The existing legislation in Romania (namely Law No. 211/2011 on the waste regime [
42] and the Order of the Minister of Health No. 1226/2012 [
43]) set up the directions to be followed regarding the management of wastes from medical activities. The National Public Health Institute (a public institution with legal status, subordinated to the Ministry of Health) was appointed as the representative responsible for the management of information on a national scale relating to wastes from medical activities, and it was authorized to approve waste collection on-site, separating it on previously established categories as waste-generating medical activities.
The formulated directions concerned only the specialized units that are the main generators of pharmaceutical waste. Specialized units are considered as follows: Units approved for the sale or distribution of pharmaceuticals (pharmacies, drugstores); units of production, warehousing, and storage of medicines and biological products; pharmaceutical research institutes; pre-clinical units of universities and pharmacy colleges; and the National Agency for Medicines and Medical Devices (NAMMD). Another component of pharmaceutical wastes is represented by medicines used in home treatment, in the form of unwanted, expired or unused medicines. Their disposal is established by Order No. 119/2014, which states that: “
Expired medicines derived from the population will be submitted to the nearest pharmacy or pharmaceutical point in order to be disposed of and further destroyed by incineration” [
41].
However, in the case of medicinal waste taken from the population, the law is not sufficiently explicit. First, it does not clarify very important issues, such as the procedure according to which they are to be taken from patients, namely, handing them over to specialized operators for incineration, and who actually bears the costs of the disposal of the medicines handed over to pharmacies: Manufacturers, pharmacies or local authorities. Practically, costs are supported by pharmacies. In the absence of proper legislation, with well-defined application rules, medications taken from patients follow a complicated and difficult route that “blocks” some of the pharmacy staff.
On the other hand, research studies carried out in Romania on unused drug disposal practices [
44,
45,
46] have revealed that the methods used by the population were totally inappropriate and inconsistent with legal demands. Thus, both prior to 2014 [
44], when the disposal of these wastes was not regulated, and after 2014 [
45,
46], most of the interviewed persons, irrespective of their age or education, threw them down the toilet or sink, or threw them in the garbage [
44,
45]. Moreover, until the interview, these people did not even have a problem with eliminating this type of waste in a different way. The results of these studies have shown that the involvement of pharmacists in campaigns that inform and educate citizens can significantly change the way people dispose of pharmaceutical waste. Pharmacists are considered key factors for the functioning and effectiveness of a drug collection system. However, after 4 years of regulation and numerous media campaigns, aimed at raising the awareness among the population about the effects of drug pollution, the collection is still difficult and there are still pharmacies that refuse to take medicines from the population under different pretexts. The latest studies carried out in our country have indicated the presence of a large number of pharmaceutical compounds in the Danube waters [
47], important rivers [
15], soil [
48], and plants [
49,
50,
51,
52]. This context calls for more in-depth studies on issues related to the management of pharmaceutical waste in Romania. That is the reason why the present research studies the factors that negatively influence the collection of drug wastes from the point of view of the practitioner pharmacists directly involved in this process. Thus, we have applied a questionnaire that investigates their opinion/attitude related to the system of collecting and disposing the pharmaceutical waste of the population.
The objective of this study is to identify the factors that could have an impact on the efficiency of pharmacies in collecting and disposing the medicinal waste of the population in order to develop appropriate strategies and policies. The results obtained from this survey can provide a reference point for competent authorities in developing and implementing a take-back program for waste medicine whose efficiency is superior to the existing ones. Preliminary survey investigations on existing situations can certainly help to identify existing punctual problems at the institutional and national level [
8].
4. Discussion
According to the analysis of the data presented, the Romanian population shows little concern and poor information regarding the disposal/use of pharmaceutical waste [
39,
40,
41,
42]. For this reason, more information campaigns are necessary to inform and educate the population on the proper storage as well as the appropriate and secure disposal of medical waste in order to reduce the hazard of toxicity and the incidental exposure to medication, mainly concerning children and pets. One of the ways to avoid the abuse of medication [
58] at patients’ residences is to decrease the quantity of prescribed medicines, especially for acute needs [
57]. By means of public education campaigns, citizens’ attitudes can be changed significantly. There were 5 randomly selected pharmacies who participated in a study [
44] conducted in the north-western part of Romania. At the beginning of the study, all of them had no request from patients for the collection of medical waste. It turned out that, after the implementation of an information and education campaign for the population (for a 6-month period), over 585 kg (378 kg in urban areas and 207 kg in rural areas) of drugs were collected from the population. These medicines were from all therapeutic categories, from OTC to special prescription medications, with a rigorous release regimen, requiring special disposal conditions. Before the campaign, the percentage of the population that returned expired medicine to pharmacies was only 1.1%, and the percentage increased considerably to 87.3% after the campaign [
44]. This fact reveals the huge impact pharmacists have on educating the population concerning the responsible use and disposal of unwanted/expired medicines.
The results of our study showed that the complicated procedure/lack of time, lack of legislation/way of collecting, lack of procedures, and high costs are the main factors that cause some pharmacists to refuse to take unused drugs from the population. These issues, together with the population’s low interest, poor information (on how to remove pharmaceutical waste), and increased drug use require specific and comprehensive legislation. Laws, strategies and methodologies, dedicated to recovering pharmaceutical waste from the population, must provide for clear responsibilities and information/awareness campaigns for both staff and citizens.
In most European countries, the cost of collecting and disposing medical waste is not borne by pharmacies or, if pharmacies pay for this service, all costs are refunded [
59]. Moreover, the imposition of costs to pharmacies in some countries has been associated with a collection rate below the European average [
56]. In other European countries, pharmaceutical waste disposal is supported by Local Authorities, Pharmaceutical Industry Groups, Government, or Pharmacies [
57]. This study is the first research on this topic in Romania, and its results indicate the need to allocate funds from other sources for the disposal of medical waste. In most European countries, the collection system is a simple one in special containers located in pharmacies, health clinics, household waste disposal sites, street containers, depending on the policy and strategy implemented in each country or region [
57]. Most of the suggestions in this study are similar to the collection systems in other countries. One of the most important suggestions was the implementation of a unitary system at the national level. This would increase the efficiency of the take-over service and greatly reduce the current confusion of both pharmacists and patients.
Pharmacists’ discontent with the current collection program leads to a clear observation that it is imperative for pharmacists’ representatives to be directly involved in the drafting of legislation. Moreover, they have to agree on everything that works in pharmacies, including the collection of the medical waste of the population, if national policies want these methodologies to be operative, effective, and have a satisfactory result.
Several studies have shown that informing and educating patients is essential when it comes to the proper disposal of unused medicines [
60,
61,
62]. There are no specific data on the number of health professionals (pharmacists, doctors, and nurses) in Romania who advise patients on how to properly dispose of unused medications. The data gathered in this study indicate the availability of the Romanian pharmacists in educating patients, and most of the participants considered that informing patients about the correct way to dispose of unused medications is extremely important. If the population is correctly informed on the appropriate manner of disposing the unused/unwanted medicines (mainly by pharmacists that are in direct contact with the patients), the population is ready to learn and use these disposal procedures of pharmaceutical waste. As the waste generated by the population is considerable, measures to determine a lower consumption of drugs (and, consequently, a lower resultant waste) are imposed.