Storage and disposal of expired medicines in home pharmacies: emerging public health problems

Mayra Rodrigues Fernandes Roberta Carvalho de Figueiredo Luanna Gabriella Resende da Silva Rafaela Silva Rocha André Oliveira Baldoni About the authors

ABSTRACT

Objective

To characterize storage and disposal practices associated with expired medicines in home pharmacies of Primary Care users.

Methods

Cross-sectional study based on data collected from 423 users of 15 Primary Care units located in a Brazilian city, between August 2014 and July 2016. Data were collected via face-to-face interviews. Categorical (demographic and socioeconomic characteristics) and continuous variables were expressed as proportions and means and standard deviations, respectively . Storage behaviors and disposal practices associated with unused and expired medicines were described as frequencies.

Results

Most (83%) interviewees were female and approximately 70% had completed high school. The kitchen was the most common medicine storage place (58.6%). Approximately 75% of participants reported inappropriate medicine disposal practices.

Conclusion

This study revealed high rates of inappropriate medicine disposal practices with direct impacts on pharmacological treatment and the environment. Continuing education of healthcare professionals and the general public is required to raise awareness about proper medicine use and disposal.

Drug storage; Drug stability; Toxicology; Medical waste; Environment

RESUMO

Objetivo

Caracterizar o armazenamento e o descarte de medicamentos vencidos contidos em farmácias caseiras de usuários da Atenção Primária à Saúde.

Métodos

Estudo transversal, realizado com 423 usuários de 15 unidades de saúde da Atenção Primária em um município brasileiro. Os dados foram coletados de agosto de 2014 a julho de 2016, por meio de entrevistas face a face. As características demográficas e socioeconômicas foram descritas por meio de proporções para as variáveis categóricas. As formas de armazenamento e o descarte de medicamentos vencidos ou não vencidos foram descritos em forma de frequência.

Resultados

Dentre os entrevistados, 83% eram do sexo feminino e aproximadamente 70% possuíam Ensino Médio completo. A cozinha foi o local mais citado para armazenamento de medicamentos (58,6%). Cerca de 75% dos participantes relataram descartar os medicamentos de forma incorreta.

Conclusão

O estudo evidenciou que grande proporção dos entrevistados possui hábitos incorretos de descarte, que, por sua vez, impactam diretamente no tratamento medicamentoso e na natureza. Assim, é necessária a educação continuada dos profissionais de saúde e da população, a fim de conscientizar a população sobre a correta utilização e o descarte de medicamentos.

Armazenamento de medicamentos; Estabilidade de medicamentos; Toxicologia; Resíduos de serviços de saúde; Meio ambiente

INTRODUCTION

Medicines are the most common form of therapy in society and an integral part of almost all care levels.11. Schenkel EP, Fernándes LC, Mengue SS. Como São Armazenados Os Medicamentos Nos Domicílios? Acta Farm Bonaer. 2005;24(2):266-70. , 22. Pereira JR, Soares L, Hoepfner L, Kruger KE, Guttervil ML, Tonini KC, et al. Riscos da automedicação: tratando o problema com conhecimento. Santa Catarina: Universidade da Região de Joinville; 2010. This contributes to ease of purchase, promoting self-medication and accumulation of medicines in houses. Medicines stored at home (“home pharmacy”) are often purchased over-the-counter, on recommendation from third parties and with no professional advice.33. Schwingel D, Souza J, Simonetti E, Rigo MP, Ely LS, Castro LC, et al. Farmácia caseira x Uso racional de medicamentos. Rev Cad Pedagogico. 2015;12(3):117-30. Hence, medicine accumulation, storage of expired medicines and inappropriate disposal are common practices.44. Santos SL, Barros KB, Prado RM, Oliveira FR. Aspectos toxicológicos do descarte de Medicamentos: uma questão de educação em saúde. Revinter. 2016;9(3):7-20.

Disposal of medicines within and beyond the expiry date is a public health concern. These products may cause health problems and generate emerging contaminants, and should therefore not have the same final destiny as common waste.55. Brasil. Presidência da República. Lei no12.305 de 2 de agosto de 2010, dispõe sobre a Política Nacional de Resíduos Sólidos, cria o Comitê Interministerial da Política Nacional de Resíduos Sólidos e o Comitê Orientador para a Implantação dos Sistemas de Logística Reversa, e dá outras providências [Internet]. Brasília (DF): Presidência da República do Brasil; 2010 [citado 2018 Jul 17]. Disponível em: http://www.planalto.gov.br/ccivil_03/_Ato2007-2010/ 2010/Lei/L12305.htm
http://www.planalto.gov.br/ccivil_03/_At...

6. Brasil. Presidência da República. Decreto n. 7.404, de 23 de dez.de 2010. Regulamenta a Lei no12.305, de 2 de agosto de 2010, que institui a Política Nacional de Resíduos Sólidos, cria o Comitê Interministerial da Política Nacional de Resíduos Sólidos e o Comitê Orientador para a Implantação dos Sistemas de Logística Reversa, e dá outras providências [Internet]. Brasília (DF): Presidência da República do Brasil; 2010 [citado 2018 Jul 17]. Disponível em: http://www.planalto.gov.br/ccivil_03/_ato2007-2010/2010/Decreto/D7404.htm
http://www.planalto.gov.br/ccivil_03/_at...
- 77. Ramos HM, Cruvinel VR, Meiners MM, Queiroz CA, Galato D. Medication disposal: a reflection about possible sanitary And environmental risks. Ambiente & Sociedade (São Paulo). 2017;20(4):149-72. Disposal in common waste or sewage networks may contaminate the soil, superficial waters ( i.e ., rivers, lakes and oceans) and groundwaters.88. Vaz KV, Freitas MM, Cirqueira, JZ. Investigação sobre a forma de descarte de medicamentos vencidos. Cenarium Pharmacêutico. 2011;4(4):1-25. Public administration, manufacturers, importers, distributers and sellers have a shared responsibility for product life cycles.55. Brasil. Presidência da República. Lei no12.305 de 2 de agosto de 2010, dispõe sobre a Política Nacional de Resíduos Sólidos, cria o Comitê Interministerial da Política Nacional de Resíduos Sólidos e o Comitê Orientador para a Implantação dos Sistemas de Logística Reversa, e dá outras providências [Internet]. Brasília (DF): Presidência da República do Brasil; 2010 [citado 2018 Jul 17]. Disponível em: http://www.planalto.gov.br/ccivil_03/_Ato2007-2010/ 2010/Lei/L12305.htm
http://www.planalto.gov.br/ccivil_03/_At...
- 66. Brasil. Presidência da República. Decreto n. 7.404, de 23 de dez.de 2010. Regulamenta a Lei no12.305, de 2 de agosto de 2010, que institui a Política Nacional de Resíduos Sólidos, cria o Comitê Interministerial da Política Nacional de Resíduos Sólidos e o Comitê Orientador para a Implantação dos Sistemas de Logística Reversa, e dá outras providências [Internet]. Brasília (DF): Presidência da República do Brasil; 2010 [citado 2018 Jul 17]. Disponível em: http://www.planalto.gov.br/ccivil_03/_ato2007-2010/2010/Decreto/D7404.htm
http://www.planalto.gov.br/ccivil_03/_at...

Disposal and storage of expired products are not the only problems in home pharmacies. Storage conditions stand out as a significant factor in preservation and efficacy of medicines, as well as in prevention of domestic accidents.

Inadequate storage of medicines compromises quality, with potential harm to patients, the environment and even more to the aquatic microenvironment.99. Bila DM, Dezotti M. Fármacos no meio ambiente. Química Nova. 2003; 26(4):523-30. Therefore, periodic inspection (at least twice a year) of medicines stored at home and disposal of expired or apparently damaged products is required to prevent poisoning or improper use.1010. Fernandes LC, Petrovick PR. Os medicamentos na farmácia caseira. In: Schenkel EP. Cuidados com os medicamentos. 4. ed. rev. e amp. Porto Alegre: Editora da UFRGS; 2004. p. 39-42. Pharmacists play a vital role in public education regarding proper storage and disposal of medicines.1111. Brasil. Conselho Federal de Farmácia (CFF). Resolução 386, de 12 de novembro de 2002. Dispõe sobre as atribuições do farmacêutico no âmbito da assistência domiciliar em equipes multidisciplinares [internet]. Diário Oficial da União: Brasília (DF); 2002 [citado 2019 Abr 16]. Disponível em: http://www.cff.org.br/userfiles/file/resolucoes/386.pdf
http://www.cff.org.br/userfiles/file/res...

OBJECTIVE

To identify and characterize storage and disposal practices associated with medicines stored at home among Primary Care users.

METHODS

A cross-sectional study based on data from a survey of individuals aged 18 years or older seen at Primary Care Units, located in the city of Divinópolis (State of Minas Gerais/MG). Population of Divinópolis was estimated at 230,848 inhabitants at the time of this study.1212. Instituto Brasileiro de Geografia e Estatística (IBGE). O seu município em números, 2016 [Internet]. Rio de Janeiro: IBGE; 2016 [citado 2018 Set 25]. Disponível em: https://ww2.ibge.gov.br/downloads/folders/eleicao2016/31/ 3122306.pdf
https://ww2.ibge.gov.br/downloads/folder...
The city comprises 34 Primary Care Units and five public pharmacies belonging to the Medicines of the Basic Component of Pharmaceutical Services.

A standardized questionnaire was developed based on literature data and study objectives and submitted to appreciation by three pharmacoepidemiology experts for correction and adaptation. The instrument was then tested in a pilot study with ten participants to check for question understanding. Pilot study participants were not included in this sample.

Briefly, the questionnaire aimed to characterize home pharmacies. The sample comprised 423 Primary Care Units users. The following sample calculations were employed: 50% prevalence, given the lack of scientific evidence regarding the prevalence of expired medicines in home pharmacies, 5% precision, 95% confidence level and 10% of losses. Fifteen primary care units were randomly selected for this study. Units located in rural areas and in places with high levels of urban violence were not included.

Individuals were invited to participate in the study prior to or after medical visits in selected units. The interviewer explained the study objectives and collected patient contact information. Data were collected between August 2014 and July 2016 via face-to-face interviews. Interviews were conducted by trained interviewers using a structured questionnaire including questions about medication use, storage, expiry date and disposal. Sociodemographic data were also collected.

The questionnaire allowed characterizing home inventories, storage and disposal practices, and collection of data about exposure to humidity and/or high temperatures or direct sunlight. Use of raised storage areas (1.5m high or higher) out of children’s reach was also interrogated.

Inappropriate storage was defined as exposure to direct sunlight, humidity and/or dirt, or within reach of children (less than 1.5m high). Storage of thermolabile products outside the fridge, in the fridge door or freezer was defined as inappropriate storage, whereas storage away from fridge walls, in the middle shelf, lower portion or vegetable drawer was defined as appropriate storage, as long as medicines were kept in their original packaging or, in the case of insulin, in sealed plastic or metal containers.1313. Sociedade Brasileira de Diabetes (SBD). Diretrizes da Sociedade Brasileira de Diabetes 2017-2018 [Internet]. São Paulo: Clannad Editora Científica; 2017 [citado 2019 Abr 4]. Disponível em: https://www.diabetes.org.br/profissionais/images/2017/diretrizes/diretrizes-sbd-2017-2018.pdf
https://www.diabetes.org.br/profissionai...

Inadequate disposal was defined as disposal in domestic waste, toilet, bathroom/kitchen sink and rivers/lakes. Burying and/or storage of expired medicines or donation to neighbors or relatives were also defined as inadequate practices. Adequate disposal was defined as drop off at care units, public or private pharmacies.

Categorical variables (demographic and socioeconomic characteristics) were expressed as proportions. Storage and expired medicine disposal practices were expressed as frequencies. Data were entered into Epi Info™, version 7. Statistical analyses were conducted using software (Stata, version 12.0, Stata Corporation, College Station , United States).

Ethical aspects

This study was approved by the Research Ethics Committee of Universidade Federal de São João del-Rei (UFSJ), Campus Centro-Oeste Dona Lindu, CAAE: 3091.231.4.0.0.5545, opinion 655.930.

RESULTS

A total of 612 individuals seen at 15 Primary Care Units were invited to participate in this study. Of these, 26.6% (n=163) refused to participate and 4.3% (n=26) agreed to participate then chose to drop out. The final sample comprised 423 interviews. Sample distribution was as follows: 83% of participants were women (n=351), 70% had completed high school and 4% higher education. The most common medicine storage place was the kitchen, followed by the bedroom and the living room (58.6%, 57.2%, and 14.4% respectively), as shown in table 1 .

Table 1
Places and conditions of medicine storage in home pharmacies reported by Primary Care users

Approximately 8% (n=32) of interviewees reported inappropriate storage of thermolabile products and 17% reported exposure to sunlight and humidity. Storage within reach of children was often reported (66%).

Disposal of expired medicines in inappropriate places was reported 437 times (disposal in domestic waste reported 257 times). Storage and/or donation of expired medicines was reported by 1.5% (n=8) of participants. Appropriate disposal of expired medicines (drop off at primary care units or public/private pharmacies) was reported by 8.3% (n=46) of interviewees. A similar number of interviewees (8.0%) reported having received professional advice regarding disposal. Inappropriate disposal of expired medicines was reported by 75.4% of participants. Disposal directly in the environment ( i.e. , domestic waste, toilet, kitchen/bathroom sink, rivers and lakes) accounted for 74% of these cases ( Table 2 ).

Table 2
Disposal practices associated with expired medicines stored in the homes of Primary Care users

DISCUSSION

High prevalence of women at Primary Care Units has been reported in a study by Malta et al., In that study, health-related concerns were more frequently expressed by female compared to male patients.1414. Malta DC, Bernal RT, Lima MG, Araújo SS, Silva MM, Freitas MI, et al. Noncommunicable diseases and the use of health services: analysis of the National Health Survey in Brazil. Rev Saude Publica. 2017;51 Suppl 1:4s.

The kitchen was the most common place of medicine storage in this sample. Ease of access, proximity to water filters or other liquids suitable for medication intake and easy access to kitchenware, such as spoons for dosing of solutions and suspensions, may explain this finding.1515. Santos RC, Lopes ML. A farmácia domiciliar e a utilização de medicamentos em residências da zona rural do município de Ubá (MG). Rev Cient Faminas. 2017;12(2):27-36. The fact that storage in humid ( e.g. , the bathroom), hot or cold places may affect physical and chemical properties of drugs and interfere with their efficacy effectiveness should be emphasized. Presence of sanitation and chemical products in bathrooms may also increase the chances of contamination.1616. Milanez MC, Stutz E, Rosales TO, Penteado AJ, Perez E, Cruciol JM, et al. Avaliação dos estoques domiciliares de medicamentos em uma cidade do Centro-Sul do Paraná. Rev Ciênc Méd Biol. 2013;12(3):283-9. Similar findings have been reported by Schwingel et al.,33. Schwingel D, Souza J, Simonetti E, Rigo MP, Ely LS, Castro LC, et al. Farmácia caseira x Uso racional de medicamentos. Rev Cad Pedagogico. 2015;12(3):117-30. who described 59% of participants storing medicines in the kitchen, 30% in the bedroom and 14.0% in the living room. Storage of medicines within reach of children, the leading cause of human poisoning in Brazil, is another important issue that needs to be addressed.1717. Silva TJ, Oliveira VB. Intoxicação medicamentosa infantil no Paraná. Visão Acadêmica (Curitiba). 2018;19(1):55-61. According to the National System of Toxicologic and Pharmacological Information [ Sistema Nacional de Informações Tóxico Farmacológicas ] (SINITOX) estimates,1818. Brasil. Ministério da Saúde. Fundação Oswaldo Cruz. Sistema Nacional de Informações Toxico-Farmacológicas. Dados de intoxicação [Internet]. Rio de Janeiro; 2016 [citado 2019 Mar 6]. Disponível em: http://sinitox.icict.fiocruz.br/dados-nacionais
http://sinitox.icict.fiocruz.br/dados-na...
22,395 cases of drug poisoning were reported between 2003 and 2012, with 17,725 hospital admissions and 75 deaths in children aged under 5 years.1717. Silva TJ, Oliveira VB. Intoxicação medicamentosa infantil no Paraná. Visão Acadêmica (Curitiba). 2018;19(1):55-61. , 1919. Maior MC, Osorio-de-Castro CG, Andrade CL. Hospitalizations due to drug poisoning in under-fiveyear-old children in Brazil, 2003-2012. Epidemiol Serv Saude. 2017;26(4):771-82.

Storage of thermolabile products also require special attention, given the direct impact on therapeutic effects.2020. Becker TA, Teixeira CR, Zanetti ML. Nursing intervention in insulin administration: telephone follow-up. Acta Paul Enferm. 2012;25(1):67-73. Use of inappropriately stored and/or expired medicines may cause serious health problems, such as poisoning and severe adverse events. The expiry date is the time period during which maximal therapeutic effects with minimal adverse events and retention of physical, chemical and pharmacological properties can be expected, provided the product is stored according to manufacturer’s recommendations.2121. Marin N, Luiza VL, Osorio-de-Castro CG, Machado-dos-Santos S. Assistência farmacêutica para gerentes municipais. Rio de Janeiro (RJ): OPAS/OMS. 2003. p. 373. , 2222. Santin PO, Virtuoso S, Oliveira SM. Farmácia domiciliar: uma caixa de surpresas. Visão Acadêmica (Curitiba). 2007;8(2):39-45. The National Health Surveillance Agency [ Agência Nacional de Vigilância Sanitária ] (ANVISA) recommends disposal of unused medications. Should medications purchased over-the-counter be stored at home for emergency situations, the expiry date should be constantly checked, and expired or unused products disposed.2323. Agência Nacional de Vigilância Sanitária (ANVISA). O que devemos saber sobre medicamentos? [Internet]. Brasília (DF): ANVISA; 2010 [citado 2019 Fev 10]. Disponível em: http://portal.anvisa.gov.br/documents/33836/2501339/O+que+devemos+saber+sobre+medicamentos/f462f5a1-53b1-4247-9116-a6bcd59cae6c
http://portal.anvisa.gov.br/documents/33...
Abovementioned problems may be mitigated or solved with proper pharmaceutical advice regarding medication storage or by reading of package inserts.2424. Leite EG. Estabilidade: importante parâmetro para avaliar a qualidade, segurança e eficácia de fármacos e medicamentos [Dissertação]. Porto Alegre: Universidade Federal do Rio Grande do Sul; 2005.

Inadequate disposal of expired medicines is also a significant public health and environmental concern in the United States. Frequent disposal in domestic waste, sinks and toilets in that country2525. Glassmeyer ST, Hinchey EK, Boehme SE, Daughton CG, Ruhoy IS, Conerly O, et al. Disposal practices for unwanted residential medications in the United States. Environ Int. 2009;35(3):566-72. Review. has been associated with increased concentration of drugs in wastewater and effluents.2626. Kolpin DW, Furlong ET, Meyer MT, Thurman EM, Zaugg SD, Barber LB, et al. Pharmaceuticals, hormones, and other organic wastewater contaminants in U.S. streams, 1999-2000: a national reconnaissance. Environ Sci Technol. 2002;36(6):1202-11. , 2727. Zuccato E, Calamari D, Natangelo M, Fanelli R. Presence of therapeutic drugs in the environment. Lancet. 2000;355(9217):1789-90. Low rates of appropriate disposal reflect lack of education among health professionals, as pointed out by Costa, in a study conducted in Campina Grande (State of Paraiba, Brazil). In that study, only a small proportion of participants reported having received professional advice about drug disposal.2828. Costa MF. Orientação sobre descarte de medicamentos no distrito de São José da Mata [Trabalho de Conclusão de Curso]. Campina Grande: Universidade Estadual da Paraíba; 2017.

The legislation is deficient and directed to health facilities, not informing details that guide the population66. Brasil. Presidência da República. Decreto n. 7.404, de 23 de dez.de 2010. Regulamenta a Lei no12.305, de 2 de agosto de 2010, que institui a Política Nacional de Resíduos Sólidos, cria o Comitê Interministerial da Política Nacional de Resíduos Sólidos e o Comitê Orientador para a Implantação dos Sistemas de Logística Reversa, e dá outras providências [Internet]. Brasília (DF): Presidência da República do Brasil; 2010 [citado 2018 Jul 17]. Disponível em: http://www.planalto.gov.br/ccivil_03/_ato2007-2010/2010/Decreto/D7404.htm
http://www.planalto.gov.br/ccivil_03/_at...
Thus, there is rarely adequate collection of this waste by public and private health institutions.2929. Ueda J, Tavernaro R, Marostega V, Pavan W. Impacto ambiental do descarte de fármacos e estudo da conscientização da população a respeito do problema. Rev Cien Ambiente Online. 2009;5(1):1-6. However, it is clear that this policy was not effectively implemented, as there is a lack of disclosure to the population about the collection. In addition, reverse logistics involves financial resources that companies are not always willing to fund.

Therapeutic waste collection programs reduce the amount of medicines reaching the environment. As professionals involved in all types of medication-related activities, pharmacists should take responsibility for the final stage of drug life cycle and be concerned about patient safety and the environment.3030. Medeiros MS, Moreira LM, Lopes CC. Descarte de medicamentos: programas de recolhimento e novos desafios. Rev Cienc Farm Básica Apl. 2014;35(4):651-62. Pharmacists should also use related knowledge to encourage and promote reflection and debate among health professionals, managers, politicians and the public at large, in an effort to mitigate the impacts of inappropriate medicine disposal and improve health and quality of life.1111. Brasil. Conselho Federal de Farmácia (CFF). Resolução 386, de 12 de novembro de 2002. Dispõe sobre as atribuições do farmacêutico no âmbito da assistência domiciliar em equipes multidisciplinares [internet]. Diário Oficial da União: Brasília (DF); 2002 [citado 2019 Abr 16]. Disponível em: http://www.cff.org.br/userfiles/file/resolucoes/386.pdf
http://www.cff.org.br/userfiles/file/res...

The general public should be co-responsible for this process, properly informed and involved in awareness raising about waste generation and rational use of medicines, as well as about measures required to reduce surplus medicine accumulation due to unnecessary purchases or lack of compliance with therapeutic regimens prescribed.3131. Alvarenga LS, Nicoletti MA. Descarte doméstico de medicamentos e algumas considerações sobre o impacto ambiental decorrente. Rev Saúde UNG-Ser. 2010;4(3):34-9.

This sample comprised exclusively users of the National Public Health System (SUS - Sistema Único de Saúde ). Therefore, findings cannot be extrapolated to users of the private health system. However, methodological rigor should be emphasized. Diversity sampling and accurate responses obtained via home visits to all participants allowed true identification and characterization of medicine storage and disposal practices among primary care users.

CONCLUSION

The kitchen was the most common place of medicine storage. Most interviewees reported inappropriate medicine storage behaviors, such as storage at inadequate temperatures, exposure to light, humidity and dust and/or storage within reach of children. High rates of inappropriate disposal practices and lack of related information emphasize the need for continuing education of health professionals and the public at large for increased awareness about proper medication use and disposal. More strict surveillance to ensure compliance with national and state laws regulating pharmaceutical reverse logistics are also required to mitigate potential clinical and environmental impacts of inadequate medicine disposal.

ACKNOWLEDGMENTS

This study was financed in part by the Coordenação de Aperfeiçoamento de Pessoal de Nível Superior - Brasil (CAPES) - Finance code 001.

REFERENCES

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    Vaz KV, Freitas MM, Cirqueira, JZ. Investigação sobre a forma de descarte de medicamentos vencidos. Cenarium Pharmacêutico. 2011;4(4):1-25.
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    Milanez MC, Stutz E, Rosales TO, Penteado AJ, Perez E, Cruciol JM, et al. Avaliação dos estoques domiciliares de medicamentos em uma cidade do Centro-Sul do Paraná. Rev Ciênc Méd Biol. 2013;12(3):283-9.
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Publication Dates

  • Publication in this collection
    17 Feb 2020
  • Date of issue
    2020

History

  • Received
    12 Mar 2019
  • Accepted
    3 Oct 2019
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