Int J Clin Pharm (2014) 36:556–563 DOI 10.1007/s11096-014-9936-7

Issues around household pharmaceutical waste disposal through community pharmacies in Croatia Danijela Jonjic´ • Ksenija Vitale

Received: 19 September 2013 / Accepted: 24 March 2014 / Published online: 1 April 2014  Koninklijke Nederlandse Maatschappij ter bevordering der Pharmacie 2014

Abstract Background Croatian regulations mandate pharmacies to receive unused medicines from households. Pharmacies are considered as producers and holders of pharmaceutical waste and are obliged to finance this service. Model where pharmacies are responsible for financing disposal of unused medicines without reimbursement is not common in Europe. Present service was not tested before implementation. Objective To investigate the elements of the pharmaceutical waste disposal service provided by pharmacies, and to gain insight into the factors that might influence the effectiveness of the service. Setting All pharmacies in the city of Zagreb. Method Each pharmacy was asked to weigh the collected waste from the public during a period of 30 days, between June 1st and July 10th of 2011, absent from any media advertisement and answer a specifically designed questionnaire that was exploring possible connections between the amount of collected waste, type of pharmacy ownership, discretion while disposing, location of the container, appropriate labeling and to compare the amount of collected waste between neighborhoods. Main outcome measure Quantity of collected unused medicines from the public. Results Of 210 pharmacies, 91 participated completing the questionnaire (43 % response rate). The total amount of collected waste was 505 kg. Pharmacies owned by the city of Zagreb had higher response rate (74 %) than privately owned pharmacies (36 %), and collected significantly higher amount of waste. Anonymity when disposing influenced collected quantity, while labelling and location of the

container did not. There were differences in the amount of collected waste between neighborhoods due to the demographic characteristics and number of pharmacies per capita. Conclusion The effectiveness of the pharmacy service of collecting unused medicines in Croatia shows a number of weaknesses. The amount of collected medicines is below the European average. Functioning of the service seems to be negatively influenced by the type of pharmacy ownership, distribution of pharmacies and lack of anonymity when disposing unused medicines. Additionally, type of ownership is connected with financial burden for pharmacies. Governmental bodies should examine current legislation regulating pharmaceutical waste disposal, particularly financial responsibility for providing the service, in order to increase pharmacies’ compliance. Advertising of the service may increase awareness of the importance of proper disposal of unused medicines. Keywords Croatia  Disposal  Household waste  Pharmaceutical waste  Pharmacies  Unused medicines

Impact of the findings on practice •

• D. Jonjic´ (&)  K. Vitale School of Medicine, School of Public Health ‘‘Andrija Sˇtampar’’, University of Zagreb, Rockfellerova 4, 10 000 Zagreb, Croatia e-mail: [email protected]

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Involving community pharmacies and their representatives in creating legislation that regulates pharmacies’ waste management service and having their agreement on proposed conditions of providing that service is necessary for its effectiveness. Ensuring the public can dispose unused medicines at a pharmacy with discretion and anonymously greatly increases effectiveness of the service. Existing service of collecting medicines through network of community pharmacies in Croatia needs to be improved.

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Introduction As the production and consumption of medicines is increasing worldwide, so do the pharmaceutical residues and their metabolites in the environment [1–6]. Along with environmental pollution through metabolite excretion of treated humans and animals, improper disposal of unused medicines adds to the polluting waters and soil-harming aquatic organisms [7–9]. Additionally, pharmaceutical residues in the environment may have harmful effects on human health, primarily contributing to the increase in antibiotic resistance and interfering with the human hormonal system [3–6]. Research in Croatia determined pollution with pharmaceutical residues in wastewaters, waters in the vicinity of the biggest landfill in the country as well as the soil under it, speculating that a few points of concentrated pharmaceutical waste could be identified in the landfill itself [10–13]. All unused and expired medicines, except for cytostatic and cytotoxic drugs, have been categorized in Croatia as nonhazardous medical waste [14]. Still they are not allowed to be disposed as communal waste. Croatian regulations mandate pharmacies to collect unused medicines that originate from households in impermeable, sealed, green containers labeled ‘‘pharmaceutical waste’’ [14]. Currently, the size of the container and where it should be located inside the pharmacy is not defined. Very little advertisement is being directed to the public regarding this service, although studies have shown that the amount of properly disposed medicines could be increased by clear guidelines for the public and by advertising the service [15–18]. The main way in which the public is aware of this service is through the presence of waste containers in the pharmacies. According to the Ministry of Environmental and Nature Protection, the basic principle of environmental protection in Croatia is ‘‘the polluter pays,’’ polluters being the producers and holders of waste [19]. Pharmacies are considered producers and holders of pharmaceutical waste and therefore obliged to finance the service of collecting unused medicines from the public. The costs include container price plus the price of takeaway service of a full container based on its weight in kilograms by a licensed collecting company. The average price is 13€ for the container and 5€ per kilogram of waste. In Croatia, it is commonly held that medicines destined for disposal should not be touched, so the public is disposing the medication fully packaged. In a previous campaign of pharmaceutical waste gathering from the public, waste was also disposed fully packaged [20, 21]. The collecting companies do not advise what to do with the waste or packaging. It is in their interest to have heavier containers because they charge for the services based on weight.

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A report from the European Environment Agency states that Croatia is collecting a very small amount of household pharmaceutical waste compared to other European countries despite the fact that pharmacies in Croatia are legally required to receive unused medicines from the public [14, 19, 22]. It can therefore be suspected that in Croatia certain amounts of unused medicines from households are improperly disposed.

Aim of the study The aim was to investigate the factors that might influence the effectiveness of the pharmaceutical waste disposal service provided by pharmacies using the example of the city of Zagreb by determining the amount of unused medicines collected from the public during a specific period and in the absence of any additional media advertisements. Specific objectives were to explore possible connections between the amount of collected waste and: the type of pharmacy ownership, discretion while disposing the waste, the location of the container, appropriate labeling and to compare the amount of collected waste between neighborhoods.

Method The study was conducted in 2011 between June 1st and July 10th in all pharmacies in Zagreb. According to the 2011 census, Zagreb had 790,017 inhabitants, which is around 20 % of the total Croatian population [23]. There are 210 registered pharmacies in the city and each was sent by mail a questionnaire (‘‘Appendix’’) designed for this study [24]. The questionnaire had two sections: first determined the facts regarding collection including: discretion while disposing the waste (anonymous disposal indicated direct disposing in the container designed as customer ‘‘drop-off’’ as opposed to the waste being handed to a pharmacist or pharmacy technician), the location of the container (the waste container located in the customer area or behind the counter), the labeling of the container (according to the regulation, or otherwise) and the amount of gathered waste in kilograms; the second part collected data about the type of ownership and the location of the pharmacy (the population ratio per pharmacy varies from neighborhood to neighborhood). The types of pharmacy ownership in Croatia are: privately owned pharmacies (the owner must be a pharmacist and own only one pharmacy); private pharmacy chains (a private company consisting of at least two pharmacies, the owner does not have to be a pharmacist); leased pharmacies (a pharmacy located within a health institution whose founder is a county, giving

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tenure to pharmacists who fulfill the conditions prescribed by the Pharmacy Act); and pharmacies owned by the city of Zagreb [25]. Pharmacists were asked to collect from the public unused medicines together with the packaging during any consecutive 30 days within the indicated period. A fortyday period was given so they could organize empty containers (usually owned by a collecting company). After 30 days, they weighed the collected waste and subtracted the weight of the container, which was obtained through the data from the producer’s manuals or by weighing the empty containers before collection. Pharmacists did not touch the waste itself. According to the total mass of collected weight, duration of the collection, and number of inhabitants, the average amount of unused medicines per capita annually was calculated. Analysis of the types of pharmaceutical waste collected was not the subject of this study. Completed questionnaires were returned anonymously in a self-addressed and postage paid envelope. Pharmacies did not receive any economic incentive for participation. In the informal conversations, many pharmacists supported this study and were happy to participate because they believed it might help in changing the current practice of charging them as an intermediary party in the collection of unused household medicines. For a description and distribution of the variables, descriptive statistics was used. For the determination of the association of categorical variables, v2 test was used with a determined level of significance as P \ 0.05. Ethical approval for this study was not required due to the fact it did not include human participants.

medicines collected per pharmacy was 0 kg, and the maximum 30.00 kg. The total amount of collected waste was 505 kg. The average amount of unused household medicines along with packaging was estimated to 7.78 g/capita annually. Table 1 shows the response rate and the amount of pharmaceutical waste in kilograms based on the type of pharmacy ownership. Amount of pharmaceutical waste collected was significantly different according to the type of pharmacy ownership (v2 = 18.277, P \ 0.01). Pharmacies owned by the city of Zagreb collected significantly higher amounts of pharmaceutical waste than the combined amounts from all private and leased pharmacies. Table 2 shows the amount of pharmaceutical waste collected according to anonymity. The amount of waste varies considerably due to the method of collecting. In most pharmacies pharmaceutical waste was handed over directly to the pharmacist or the pharmacy technician. However, pharmacies that collected significantly higher amounts of waste were those that collected anonymously (v2 = 5.743, P \ 0.01). Although most of the pharmacies answered that the container was in the customer area (N = 62), there was no statistically significant difference in the amount of collected pharmaceutical waste regarding the location of the container. The labeling of the containers varied from: ‘‘wasted pharmaceuticals,’’ ‘‘medicines,’’ a triangle with a skull to an exclamation mark. It was not possible to establish a link between the specific label and the quantity of collected waste. Also, there was no statistically significant difference in the amount of collected waste between neighborhoods. The population data, pharmacy status and collected waste between neighborhoods are presented in Table 3.

Results

Table 2 Pharmacy response and the amount of collected household pharmaceutical waste based on offered anonymity

Of the 210 pharmacies operating in the city of Zagreb, 91 pharmacies completed the questionnaire (43 % response rate). There were 43 private chains at time of survey, but it was not possible to identify how many chains and how many pharmacies per chain answered. Pharmacies owned by the city of Zagreb responded in a much higher percentage than the combined response rate of all pharmacies of private ownership. The minimum amount of unused

Provided anonymity

Table 1 Response based on the type of pharmacy ownership and the amount of collected household pharmaceutical waste based on the type of pharmacy ownership

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Pharmacies by type of ownership

N (%)

Mass (kg)

Mass per pharmacy (kg/pharmacy) ± SD

Anonymity provided

28 (31)

232

8.30 ± 6.38

No anonymity provided

37 (41)

136

3.68 ± 3.92

Sometimes provided

26 (28)

137

5.26 ± 6.25

Total

91

505

5.55 ± 5.75

N total

N response (%)

Mass (kg)

Mass per pharmacy (kg/pharmacy) ± SD

Private independently owned

29

15 (52)

40

2.69 ± 3.11

Leased

26

10 (38)

72

7.17 ± 5.23

Private chains Owned by the city of Zagreb

120 35

40 (33) 26 (74)

124 269

3.09 ± 2.53 10.37 ± 7.10

Total

210

91 (43)

505

5.55 ± 5.75

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Table 3 Population data, pharmacy response rate according to the pharmacy ownership type, pharmacy distribution, and the amount of collected waste between neighborhoods [21] City neighborhoods

Donji Grad Gornji Grad/ Medvesˇc´ak Trnje Maksimir Pesˇc´enica/ Zˇitnjak

Neighborhood area (km2)

Population

Population [65 years

N total population per pharmacy

Mass (kg)

N pharmacies N total/N respondentes

N privately owned/N city owned

N respondents privately owned/N responded city owned

3.02

37.024

10.481

1.543

82

24/10

16/8

4/7

10.19

30.962

7.751

2.815

15

11/2

6/5

0/2

7.36

42.282

8.100

3.252

18

13/6

11/2

5/1

14.97

48.902

9.293

2.876

38

17/9

14/3

5/3

35.29

56.487

8.537

3.323

44

17/8

14/3

5/3

79.18

117.158

16.099

4.881

79

24/11

22/2

10/1

5.81

55.425

9.696

3.079

35

18/6

16/2

4/2

9.84

66.674

8.615

3.922

56

17/9

16/1

8/1

24.23 40.26

38.546 61.841

6.624 7.338

3.212 6.184

27 34

12/7 10/5

10/2 9/1

5/2 4/1

Dubrava Donja

10.81

36.363

3.886

4.040

28

9/5

8/1

4/1

Stenjevec

12.18

51.390

3.596

17.130

11

3/3

3/0

3/0

Podsused/ Vrapcˇe

36.16

45.759

5.438

3.520

22

13/3

10/3

2/1

Podsljeme

59.43

19.165

2.620

3.833

10

5/3

4/1

2/1

Novi Zagreb Tresˇnjevka/ Sjever Tresˇnjevka/ Jug Cˇrnomerec Dubrava Gornja

Sesvete

165.24

70.009

6.240

4.667

6

15/4

14/1

4/0

Brezovica

127.33

12.030

1.666

6.015

0

2/0

2/0

0

Total

641.32

790.017

11.598

3.762

505

210/91

175/35

65/26

Discussion When comparing the annual European average of unused household medicines of 10 g to 100 g/capita (50 g/capita in Portugal and Spain, 100 g/capita in Sweden), it is noticeable that amounts collected in Zagreb are below the European average [22]. Switzerland collects the highest amounts of unused medicines in Europe (237 g capita/year), followed by France, Luxembourg, Ireland and Sweden (above 100 g/capita) [18, 22]. Findings of this study could explain some of the factors contributing to such low declared amounts of collected waste. General low pharmacies’ response rate could indicate that pharmacies did not want to reveal what they actually do with disposed waste from households; whether they collect it properly or dispose it, for example, with communal waste. In a few cases, it was observed that some pharmacies opt to use umbrella stands and cardboard boxes as disposing containers. The reason is unknown: it may be to bridge the cost of purchasing or renting a container for pharmaceutical waste, or to mislead the customers. The smaller amounts of

collected waste could be the consequence of that, because when there is no container or it is not visible, customers are not passively reminded of the possibility of waste disposal. The finding that pharmacies belonging to the city had higher response rate and declared more waste than privately owned pharmacies could be explained by the fact that the cost of waste disposal and containers is compensated by the city authorities; containers are regularly provided and taken away without too much involvement of the pharmacists. Pharmacists in the city owned pharmacies have fixed salaries that are not influenced by realized commerce or the cost of disposal service. On the contrary, the cost of pharmaceutical waste disposal affects the overall spending of private pharmacies and consequently lowers the owner’s income. It may also affect the salary of the employees if their salary depends on pharmacy profit. This is visible particularly in pharmacies owned by one pharmacist who works and manages the business as his/her single source of income. The income of the pharmacy chains is affected in the same way and employees act upon manager’s recommendation. According to the data from

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the Croatian Chamber of Pharmacists, in one pharmacy chain the costs of this service went up to 1300 € in the year 2009 [26]. Additionally, if the pharmacy does not have proper storage space it has to call the disposal service more often. In Croatia, there is a lack of official guidance and any kind of advertising of this service such as posters, pharmacy information guides, newspapers or websites. There are no instructions on outer or inner packaging on how to dispose unused medicines despite the fact that this is required by law. Policy makers argue that instructions for disposal should be noted on the packaging only in the case when the medication’s environmental risk assessment indicated the need [27, 28]. On the other hand, literature demonstrates existence of uncertainty among customers about unused medicines disposal, so clear instructions on safe disposal should be noted on the packaging for all medicines, regardless of its environmental safety classification, as suggested by German Advisory Council on Environment [18, 27]. During 2007, The Zagreb Institute of Public Health and the pharmaceutical company Pliva Hrvatska d.o.o. in the city of Zagreb organized a collection of unused medicines from the public through the network of primary healthcare centers. This campaign was followed by strong media advertisement, which could explain why the amount of collected medicines was 1.6 times more than in our study [20, 21]. The present study indicates that significantly more waste is collected if medicines are anonymously disposed into containers located in the pharmacy rather than handed over to pharmacists or pharmacy technicians. Previous studies that may add to the explanation of our results have shown that people may feel singled out or ashamed when returning unused medicines, especially if they frequently visit the same pharmacy [16, 29, 30]. In Croatia, pharmacists are worried that infectious waste, including sharp objects, blood stained material could be disposed through anonymous collections which could be hazardous to health and increase the weight of the container, so they prefer to see what is disposed [26]. At the same time, the authors suspect that in some pharmacies the unused medicines are disposed together with communal waste in order to diminish the total cost of disposal. Contrary to our expectations, there was no significant link between the location of the container and the amount of waste collected. The authors speculate that the pharmacies involved in this study may have stated that the container was located in the customer area as ‘‘the desirable response’’ since they are aware of the legal obligations on waste collection. Regarding difference between the neighborhoods, we can observe trend that in historically older neighborhoods like downtown Zagreb more waste is collected. This could be explained by the fact that those neighborhoods are

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inhabited with predominantly senior demographic group, which has higher prevalence of chronic diseases, they are greater medication consumers and visits pharmacies more often, which in other studies has been shown to be associated with a greater likelihood that the unused medicines will be disposed in appropriate manner [16–18]. Also, older neighborhoods have more city owned pharmacies than privately owned pharmacies. The opening of new pharmacies is regulated by the law which combines the number of people in the area and the distance between pharmacies, meaning that two pharmacies can be opened for 8,000 people and every next one for 5,000 people more. In the downtown area, numerous pharmacies were opened before the ratification of that law, so today there is one pharmacy for every 1,600 people [25]. It is interesting to notice that the downtown area has the highest number of highly educated inhabitants between ages of 25 and 64, while those with the lowest (Brezovica and Sesvete) collected the least amounts of waste [31]. Various studies suggested that patient education is important for the behavior regarding proper unused medicine disposal [16–18]. There are no data on how much health professionals (physicians, nurses and pharmacists) in Croatia advise patients on how to deal with unused medicines. However, results from the study conducted in rural Croatia on seniors 65? showed that pharmacists have been the only educators on proper disposal of unused medicines for this population [32]. The most viable channel of educating pharmacists as public educators on safe unused medicine disposal might be through the national educational program called ADIVA-Health through Advice. This program is training pharmacists in providing pharmacy services for chronic patients and due to its very high attendance rate might serve as platform for additional education [33]. Pharmacists in Croatia remain an untapped resource in providing various health related information although they are recognized as the most accessible health professionals both in terms of waiting time and cost [34]. In most European countries, pharmaceutical waste disposal costs are paid or funded by local authorities, health insurance companies, the pharmaceutical industry or the government. Moreover, in Great Britain and Denmark, pharmacies are even recompensed for providing the collecting service. If the cost is borne by the pharmacy, then the cost is being reimbursed (Czech Republic) or is calculated within the pharmacy margin (Sweden) [35–37]. In Spain pharmaceutical companies pay a fee for each packaging of medicine marketed through community pharmacies and in France they pay special tax for this purpose [38]. In Luxemburg all pharmacies collect pharmaceutical waste although they are not obligated to, and the Ministry of Environment funds the service [37]. Similar to Europe, pharmacies in Australia and Canada are designated to

Int J Clin Pharm (2014) 36:556–563

provide this service but also are not required to pay the costs of waste disposing [15, 39]. The literature indicates that the model where pharmacies are responsible for financing the disposal of unused medicines without some kind of reimbursement or other incentive is not common in Europe. Despite this, the present service in Croatia has not been tested before implementation and this study is the first research on the topic. The presented results indicate that a different source of disposal financing should be established. The funding could come from various levels of government, drug manufacturers, local authorities or other participants in medicinal waste management chain [40]. A similar problem is present in the south east European region that once belonged to the same model of health care [41]. Our study also brought to attention prescribing medicines and patients’ adherence to therapy. Earlier studies in Croatia demonstrated that physicians frequently prescribe medicines on patient demand, and that therapy compliance is low and does reflect on health care budget [42–45]. Financial value of medicines collected during campaign in 2007 was estimated at 100,000 € [20, 21]. Therefore education should go towards all: patients, medical doctors and pharmacists. In the meantime pharmacies in Croatia are providing a service of interest to the entire community, so they should receive encouragement, not the financial burden perceived as punishment. Drawbacks of the study relate to the fact that the behavior on proper unused medicines disposal might be different in big cities and rural areas of Croatia. Studies in other domains of life have shown cultural, educational and social differences, so it is reasonable to expect that they would influence this study as well.

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public may increase the awareness of the importance of proper disposal of unused medicines in Croatia. Acknowledgments We thank The Croatian Chamber of Pharmacists for assistance in data collection and all pharmacies who participated in this study. Funding The study was funded by the non-governmental organization ‘‘PIN Partnership-Information-Networking for Health’’, Zagreb, Croatia. Conflicts of interest The authors have no conflicts of interest to declare.

Appendix: Questionnaire 1.

Information about the collection of pharmaceutical waste

Please specify: •



• •

Are citizens providing pharmaceutical waste in the containers anonymously, or handing over to the pharmacist or pharmaceutical technician? Are the containers for pharmaceutical waste located in the customer area or behind the counter in the pharmacist’s area? Please indicate what is written as the label for the pharmaceutical waste containers in your pharmacy. The amount of pharmaceutical waste collected from households during the period from 1st of June 2011 to 10th of July 2011: ____________________________ _________ (kg)

2.

Pharmacy neighborhood and ownership type



Pharmacy neighborhood location (please circle the appropriate letter):

Conclusion The effectiveness of the pharmacy service of collecting unused medicines in Croatia shows a number of weaknesses. The amounts of collected medicines are below the European average per capita annually. Our results suggest that functioning of the service is negatively influenced by the type of pharmacy ownership, distribution of pharmacies and lack of anonymity when disposing unused medicines. Additionally, the type of ownership is connected with financial burden for pharmacies. In most European countries it is not common to find a model where pharmacies are financially responsible for the waste disposal; on the contrary, they are rewarded for providing the service. The authorities should find a way to cover the expenses by involving all the participants in the medical waste management chain. The elimination of financial obligations for pharmacies, advertising and promoting service to the

a. Cˇrnomerec b. Tresˇnjevka North c. Tresˇnjevka South

i. Sesvete j. Donja Dubrava

d. Trnje

k. Gornja Dubrava l. Pesˇcˇenica—Zitnjak

e. Downtown

m. New Zagreb—East

f. Uppertown

n. New Zagreb—West

g. Podsljeme

o. Maksimir

h. Medvescak

p. Podsused-Vrapcˇe s. Stenjevec



Form of pharmacy ownership (please circle the appropriate letter):

a. b.

private independent pharmacy leased pharmacy

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c. d.

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private pharmacy chain pharmacy owned by the city of Zagreb

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21.

22.

23.

24. 25. 26.

27.

28. 29.

30. 31.

32.

33. 34.

35. 36.

37.

38. 39.

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Issues around household pharmaceutical waste disposal through community pharmacies in Croatia.

Croatian regulations mandate pharmacies to receive unused medicines from households. Pharmacies are considered as producers and holders of pharmaceuti...
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