Medicininių atliekų tvarkymas Ispanijos mieste Barselonoje

RESEARCH ARTICLE
Returned medicines in community pharmacies of Barcelona, Spain
Anna Coma Æ Pilar Modamio Æ Cecilia F. Lastra Æ Marcel L. Bouvy Æ Eduardo L. Marin ˜o
Received: 13 December 2006/Accepted: 19 October 2007/Published online: 16 November 2007  Springer Science+Business Media B.V. 2007

Abstract Objective To monitor the amount of unused drugs and the cost to the public health system. Setting A random sample of community pharmacies in Barcelona, Spain. Method The drugs were collected from 38 community pharmacies over a period of 7 consecutive working days (excluding Sundays). A questionnaire was designed to evaluate each returned medicine. The resulting data were analyzed and evaluated. Main outcome measure The number of drugs collected at the pharmacy, the characteristics of the clients and the reasons why they returned the drugs, and finally the economic value of the drugs returned and the cost to the public health system. Results A total of 227 clients (54.6% women, 64 ± 20 years-old) returned 1,176 packages to the pharmacy. The number of packages collected in one return ranged from 1 to 121. The number of packages collected per pharmacy ranged from 0 to 188. In more than half of the cases (52.4%) the patients returned their drug in person and in 32.2% of the cases a relative returned it on their behalf. The main reason (28.2%) why drugs were returned was the expiry date. In 24.9% of the cases the patient’s condition had improved and there was no further need for the drug. In 20.8% the patient had died. The estimated total cost of the collected drugs was €8,539.9. Over 75% of this amount (€6,463.9) had been paid by the public health system. Conclusion This study
confirms the importance of analyzing the return of unwanted medicines to reduce unnecessary health expenditure. It also highlights the inadequacies of the Spanish health system in the areas of prescription, dispensing and use of medicines. Establishing strategies to reduce the wastage of unused medicines is necessary.
Keywords Community pharmacy  Drug expenditure  Medicine waste  Returned medicine  Spain  Unused drug
Impact on practice
• Significant amounts of medicines are returned to pharmacies. • Principal reasons for returning unused medicines to pharmacies are the expiry date and the fact that the medicine is not used anymore. • Strategies to limit or reduce the proportion of drugs that are unused may help to reduce medicine waste, and the potential hazards of stored drugs to the community.
Introduction
Health care expenditure is rising throughout the developed world. The costs associated with medicines are rising faster than overall health costs. In Spain, the pharmaceutical expenditure in 2004 made up 20.6% of the public health budget, while in other European countries it was closer to 15%. In response to this situation, the Spanish government is stimulating a more rational and efficient use of drugs [1, 2].
A. Coma  P. Modamio  C. F. Lastra  E. L. Marin ˜o(&) Clinical Pharmacy and Pharmacotherapy Unit, Department of Pharmacy and Pharmaceutical Technology, Faculty of Pharmacy, University of Barcelona, Av. Joan XXIII s/n, 08028 Barcelona, Spain e-mail: emarino@ub.edu
M. L. Bouvy SIR Institute for Pharmacy Practice and Policy, Theda Mansholtstraat 5B, 2331 JE Leiden, The Netherlands
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Pharm World Sci (2008) 30:272–277 DOI 10.1007/s11096-007-9177-0
Several studies have shown that a substantial amount of dispensed drugs are not used by the patient [3, 4]. In 2002, an integrated system of collection and management of packages called SIGRE was developed by the Spanish National Association of Pharmaceutical Industry (Farmaindustria). This industry-funded system for the collection and disposal of unused and expired medications and packages, even empty packs, is a group effort between manufacturers, wholesalers and community pharmacies. However, it is not remunerated in any way. Data published by SIGRE show an annual increase in the number of medicines returned by customers to their local pharmacy for appropriate disposal. For example, in 2004 over 1,700 tonnes of packages were collected [5]. However, there are no data available on the economic value of drugs returned to Spanish pharmacies. Several studies have identified reasons why drugs remained unused [6–9]. But Spanish data on the reasons why drugs remain unused are not available.
Aim of the study
The aim of this study was to calculate the quantity and types of medicines returned to community pharmacies and to identify the reasons why they were not used. We also wanted to calculate the cost to the public health system of returned unused medicines.
Method
The study was conducted in community pharmacies in Barcelona (Spain). In January 2005 the population of Barcelona was 1,593,075 (52.6% women), with a mean age of 43 years (men 41 and women 45). Life expectation in 2003 was 80.3 years (men 76.8 and women 83.5). The number of community pharmacies opening on ordinary workdays (from 9.00 to 1.30 p.m. and from 4.30 to 8.00 p.m.) was 905. Pharmacies that opened for 13 (n = 112) or 24 h (n = 17) were excluded because their greater activity would compromise the homogeneity of the sample. A randomly selected, representative sample of 118 pharmacies (margin of error\0.05, P = 0.05) were identified as potential candidates for participation in the study. In October and November 2004 the study was presented to the owners of these pharmacies. They were visited by one of the researchers and also invited to attend a general meeting informing them of the study. Finally, they were phoned to confirm their participation. Data were collected from February to April 2005. The time period for data collection in each pharmacy was seven
consecutive workdays, excluding Sundays. Pharmacists were not asked to encourage their customers to return their drugs, but they were asked to collect the drugs that were being returned voluntarily. The first day of data collection began when the pharmacy collected the first drug, and continued for the 7-day period. If, after 2 weeks, no medicines had been returned, the pharmacy in question was still included in the study. When a medicine was returned, the pharmacist interviewed the person returning it, in order to complete a part of a questionnaire that was developed specifically for the study. The questionnaire included both open and closed questions. Each patient was then given a study code. The information recorded on the questionnaire included: pharmacy data, study code, who was returning the drug (user/ relative/acquaintance/nursing home/other), patient data (year of birth, sex), returned medicine data (trade name, preparation, strength, package size, who prescribed or recommended it, indication, drug regimen, duration of use, reasons for returning, who decided to discontinue the administration) and any pharmacist intervention that may have occurred. All returned medicines for each patient were packaged individually together with a copy of the completed interview questionnaire. The remaining section of the questionnaire was then completed for each returned medicine. This included other data about the drug such as amount remaining in the package (number of pills or ml of syrup or cream), expiry date, price and type of medicine (prescription drug, OTC). All drugs were coded according to the Anatomical Therapeutic Chemical (ATC) classification system of the WHO [10]. The cost of the returned drugs was estimated by multiplying the price marked on the box by the fraction remaining in the package returned. Inhalers and sprays were excluded from the costs analysis because of the difficulty in calculating the amount remaining. Samples and foreign medications were also excluded due to the complexity of determining accurate pricing information. The collected data from the questionnaires of each returned drug and for each pharmacy entered into a database. Descriptive statistical analysis was performed with SPSS1 (13.0).
Results
Of the 118 community pharmacies initially informed about the study, 38 (32%) agreed to participate. The most representative district in Barcelona with 19 pharmacies (50%) was an Eixample. Other districts had between 1 and 4 pharmacies, and Nou Barris and Sant Andreu had none.
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A total of 227 customers returned at least one drug from February to April 2005 (range 0–15: in 5 of the 38 pharmacies no drug was returned, and in one pharmacy 15 customers returned drugs). Sex was identified in 83.2% of the cases (54.6% women) and age in 67.8% with a mean of 64 years (SD ± 20). In total, 1,176 packages were returned; range of packages per patient: a maximum of 121 and a minimum of 1; range of packages per pharmacy: a maximum of 188 and a minimum of 0. The majority were medicines (96.6%), and the rest were medical supplies or devices (0.5%) or other products sold in the community pharmacy (2.9%; e.g., personal care, nutrition). Most medicines returned were drugs for human use (99.8%) and only 0.2% were for veterinary use. Drugs for human use included compounded medication (0.3%), homeopathic medication (0.1%) and foreign medication (1.3%). Foreign drugs, medical supply and devices and other products were excluded on the analysis of the prescription’s requirement. So, 78.0% (n = 918) of the returned drugs required a prescription, 7.4% were OTC (n = 87) and 9.9% (n = 116) were drugs that the physician can prescribe but that the pharmacist can also dispense without prescription. Of the 1,176 packages, 5.6% could not be coded according to the ATC system. The predominant groups were A (Alimentary tract and metabolism) with 18.3%, N (Nervous system) with 18.2% and C (Cardiovascular system) with 11.7% (Table 1).
In more than half of the cases the patients in person (52.4%) or a relative (32.2%) returned their drug (Fig. 1). Relatives returned a significantly higher number of drugs than patients themselves, 8.6 vs. 3.4, respectively. In only 33.4% of all cases was it reported who prescribed or recommended the drug. The majority of drugs had been prescribed by the general practitioner (17.3%), or other physicians (9.1%). Pharmacists recommended 2.6% of the returned drugs and 2.7% were chosen by the patient. In the 1176 cases of packages returned, reasons were given on 1,155 occasions: some respondents gave two reasons. In 24.9% of the drugs the treated condition had improved and/or there was no further need for the drug; in 20.8% the patient had died; and in 11.7% there had been therapy changes. In 28.2% the expiry date had passed accordingtothepatient.Accordingtotheexpirydateoneach package, over half (53.7%) of the returned drug had expired when collected, but 44.7% had not. In 18 drugs it was not possible find this information in the package (Fig. 2). In 42.1% of cases it was reported who decided to discontinue drug treatment. Physicians 22.8% (n = 268) were the main initiators of discontinuation. In 14.9% the patients themselves decided; in 3.7% unknown and in 0.7% the pharmacist. By examining the drug invoice, returned medicines were categorized into prescription drugs that could be reimbursed partially or totally by the public health system or private medicalinsurance, and drugs notreimbursable and therefore paid for totally by patients. 53.5% Of returned drugs had been paid for by the public system (total or partially), and
Table 1 Unused drugs (number and percentage) according to the ATC system
ATC Number (%)
A. Alimentary tract and metabolism 215 (18.3) B. Blood and blood forming organs 32 (2.7) C. Cardiovascular system 137 (11.6) D. Dermatologicals 85 (7.2) G. Genito urinary system and sex hormones 50 (4.3) H. Systemic hormonal preparations excluding sex hormones and insulins 17 (1.4) J. Antiinfectives for systemic use 77 (6.5) L. Antineoplastic and immunomodulating agents 22 (1.9) M. Musculo-skeletal system 88 (7.5) N. Nervous system 214 (18.2) P. Antiparisitic products, insecticides and repellents 2 (0.2) R. Respiratory system 103 (8.8) S. Sensory organs 63 (5.4) V. Various 5 (0.4) Missing 66 (5.6) Total 1176 (100.0)
Fig. 1 Person who returned the unused drug
Fig. 2 Reasons to return the unused drug reported by the person
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30.2% by the patients themselves although 46.2% of medicines paid for by the patients could have been paid for by the public health system. There were 192 drugs (16.3%) categorized as ‘‘unknown’’, which included packages with their labels removed or damaged and some samples provided by pharmaceutical representatives and foreign drugs. In regards to the cost of the medicines returned, there were also some problems with missing information in addition to the difficulty (previously discussed) in calculating the amount remaining in inhalers or sprays or in determining the accurate pricing information for samples and foreign drugs. Thus, the cost was finally calculated on the basis of 1,119 of the total (1,176) of cases. The estimated total cost was €8,539.9, which represents 74.7% of the initial cost of all drugs collected. The mean drug price was €10.20, however in 90% of the cases the drug price was lower than or equal to €25.90. Correlating the cost of returned drug and the information with who had initially paid for them, it was observed that over 75% of the cost (€6,463.90) had been borne by the public health system.
Discussion
Amount of drugs collected
The total amount of drugs collected was small in this study. Only 38 community pharmacies participated, five of which did not receive any return of drugs during the study period. They were nevertheless included since this result could be considered within the normal variability among pharmacies, their location and number of patients, and also taking into account that the study period could have been insufficient in some cases. It should also be noted that community pharmacies participated voluntarily in the study, without any remuneration, although this entailed addition to their daily activities. The completion of the questionnaires was also difficult. Some community pharmacies admitted that they did not always have time to complete the first part of the questionnaires when they received large amounts of returned drugs. Besides, pharmacies that open for 13 h or 24 h were excluded; although we are aware that they are frequented by large number of patients and that a larger number of drugs could have been returned. However, these pharmacies, which accounted for \15% of total number of pharmacies in Barcelona in 2004, could have introduced a loss of homogeneity in the study.
Who returned the unused drug
The relatives returned a larger amount of drugs than the patients themselves. This may have been the result of
cleaning out the medicine cabinet at home [3] or because the patient had died and the relatives returned all the drugs found in the patients’ home [11].
Reasons for returned drugs
In some cases the non-use of a drug is unavoidable. For instance when it produces a serious adverse event and the use has to be stopped. The patient’s death or change of treatment, were reasons most commonly reported in other studies carried out without campaign-induced returns in Sweden [9], and the United Kingdom [8]. In contrast, in our study the most common reason was that the treated condition had improved and there was no further need for the drug. These returns could have been avoided, for example, by reducing the dispensed package size, or by adapting the pack to the most frequent dosages, or even by dispensing through an individualized dosing system, depending on each prescription. However, Spanish pharmacies dispense medicines in the original package produced by the pharmaceutical industry, and package sizes are often too big for the therapy required. On the other hand, non-compliance with the treatment could have been masked by such answers as ‘‘he didn’t need it anymore’’ or ‘‘he was cured’’ [12]. In relation to the expiry date, nearly half the drugs had been kept until they expired (44.7% of returned drugs had not expired). However, no information about the date of dispensing could be recorded in order to evaluate how long people tend to keep drugs they have stopped using [13, 14]. We agree with Ekedahl [9], who considers that information on the reason for returning each drug/package together with a note stating the age of the returned drug would help to provide a quantitative estimate of the relative importance of the reasons for drugs being returned unused.
Who paid for the unused drugs
The public health system paid for over 50% of the unused drugs, which means that 75% of the total cost was lost [12]. On the other hand, in this study only 7.4% of the drugs were over the counter (OTC). This could be because fewer OTC purchases go unused, since they are not patientspecific and other household members can use them [13]. In Spain, the cost of a drug is covered by the national health system upon retirement or when a person is incapacitated. The rest of the population is required to pay 40% of the cost of the drugs listed by the Ministry of Health, except for some chronic treatments or special cases, when the patient pays only 10%. In this study it was not possible to distinguish whether the drug was reimbursed completely
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by the public health system, or only partially. However, official data [15] showed that the percentage paid by the patient in the year 2003 represented only 7.4% of the total cost of the drugs paid by the Spanish public health system. In addition, the results were extrapolated to national level to provide an estimate of the total annual cost of such medicines to the public health system [16]. Considering that in Spain almost all of the 20,461 community pharmacies participated in the selective collection of unused medicines to facilitate correct disposal [5], 129.8 million Euro in drugs would be spent unnecessarily in only one year. This represented 1% of the Spanish health system budget for pharmacy in 2003 [17]. This is probably underestimated, given that returns to pharmacies are likely to represent less than a third of all unused medicines [18]. Besides, there was a disposal of unwanted medicines and poisons (DUMP) campaign in Spain on November 2004 [5] that targeted the larger quantities of unused medicines in primary care centres, residential care homes and also patients’ homes [19, 20]. According to these results, it seems necessary to consider measures to reduce the volume and the cost of unused drugs in Spain [12, 13, 18]: more efficient prescription and dispensing systems; a change patients’ behaviour in their interaction with medicines, such as adherence to treatments prescribed or increased awareness of the true cost of their medicines; and also increasing the pharmacist’s role in patient care. If implemented, such measures should reduce wastage. Finally, improper drug use has major ramifications not only in therapeutic and economic fields, but also from the environmental perspective [11, 12], since numerous medications have been found in trace amounts in groundwater, surface water, and drinking water [21]. Safety concerns and drug-related accidents associated with these unused medications should become a focus for future inquiry.
Limitations of the study
This study has been carried out in Barcelona, a wealthy city of Spain placed in a wealthy region, and with only a 32% response rate. Besides, the high variability of the data, depending on the pharmacy, the patient or the drug, makes it difficult to extrapolate the results to the general population and to national level. However, other studies [6–9, 11–14] used a variety of designs, although most of the authors used their results as general indicators to analyse the significance of unused drugs in their respective geographic context. On the same basis, we believe that our results could also be considered to describe a situation that is more generalized than the sample strictly studied.
Other limitations include the fact that the questionnaire on the returned medicines was answered by either the patient, a relative or a caregiver, which highlights the subjectivity of the answers [11]. In some instances, respondents may not have known why the medicines had not been used, especially when the patient was deceased [9]. The quality of the data entered into the database was variable. In some cases data were absent or ambiguous, and in those cases the analyses have been limited to the available data. It should also be noted that not all the drugs returned to the pharmacies were included in the economic calculation. For example, the quantity remaining in inhalers and sprays was not estimated and thus the costs were not calculated. Future studies could potentially compare the weight of a partially used inhaler with that of a filled one to estimate the quantity remaining. The return of unused medicines may be subject to seasonal variation, so data must be collected over a longer period (at least 1 year) before a reasonable annual figure can be estimated.
Conclusion
Based on our findings for the responding pharmacies in Barcelona, it is likely that unused drugs represent a significant cost to the health care system in Spain. The funds unnecessarily spent by our public health system and some of the contributing factors may serve to alert pharmacists and highlight the need for a more detailed revision of several measures to reduce drug wastage.
Acknowledgements We would like to sincerely thank the following community pharmacies of Barcelona: Alba `, Alomar, Arranz, Balanya `, Bregante, Buil, Carbonell, Casala `, Castellvi, Cava, Ciurana, De Frutos, Donada, Escudero, Fiol, Flores, Frisch, Gibert-Paris, Gil, Herrero, Laporte, Mandianes, Mas, Massegue ´, Mesia, Mugueta, Olivart, Olive ´, Puig, Rodrı ´guez-Alsina, Rull, Sardar, Segura, Serra, Taberner, Tarre ´s, Veciana, Vives-Ferrer for their voluntary participation in this study.
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