Abstract
Improper and unsafe disposal of expired and unwanted medicines could cause harm to both people and the environment and therefore it is of public health importance. The objective of the study was to determine the methods employed by community pharmacist and their clients in the disposal of unwanted and expired medicines. Furthermore, the role of the pharmacists in the assessment of clients left over medicines was also explored. A cross sectional study design was employed with a sample of 120 pharmacy staff and 200 clients. Semi structured questionnaires were developed and administered to the two groups. Ethical approval was obtained. Data collected were analyzed using the Statistical Package for Social Sciences (SPSS v.24). Two hundred and eighty medicines were assessed from 131 respondents (65.5%) who brought their unused or left-over medicines to the pharmacy. These included analgesics 102(36.4%), antibiotics 50 (17.9%) and antacids 22 (7.9%). Disposal of expired and left-over medicines cited by respondents were the general-purpose bin 58(77.0%) and down the sink 11(14.3%). The majority 99(82.9%) of community pharmacies also disposed of solid dosage forms through the general-purpose bin. In addition, 90(75%) community pharmacies disposed of liquid waste in general purpose bin. Lack of enforcement of legislation was cited by community pharmacy staff as a barrier to the proper disposal of pharmaceutical waste. The predominant method of disposal of expired/unwanted medicines by community pharmacies and their clients was via the general-purpose bin. Implementation of interventions such as take back programmes that will enhance proper disposal of expired and left over medicines should be initiated.
Introduction
The safe and responsible disposal of unwanted medications (UMs) is an important public health initiative that directly involves both pharmacists and consumers because improper storage and disposal of UMs have the potential for negative consequences, including harm to the environment, accidental poisonings and drug diversion (Paut Kusturica et al., 2017). UMs include expired, unused, spilt and contaminated pharmaceutical products, drugs and vaccines that are no longer required and leftovers generated from extemporaneous preparations in the pharmacy (World Health Organization (WHO), 2017). Medicines may go waste because of medication misuse, poor medication adherence, changes in therapy, complex medication regimens, polypharmacy and death of the patient (Alhomoud, 2020; Wang et al., 2021).
Leftover medicines are often stored in the home indefinitely and this may encourage their irrational use and disposal. They may either be stored in places which enhance their deterioration and yet be used, or they may be disposed of improperly via the sink, flushed down the toilet or tossed in the garbage (Michael et al., 2019). Direct risks of unsafe disposal such as inappropriate medicine sharing, childhood poisonings and diversion of medicines to illicit use have also been recognised and raised as environmental problems (Insani et al., 2021). When medications are disposed of as solid waste or into a wastewater disposal system, including sewerage or an on-site septic system, these medications enter the environment (Insani et al., 2021; Nassiri Koopaei and Abdollahi, 2017). The potential impact of pharmaceuticals disposed in water bodies via sewage plants and other sources is a concern in many low-income countries. In these countries, wastewater treatment facilities may not be designed to remove medications from the contaminated water due to the unmodernised water treatment system (Shukla et al., 2017; Zinn et al., 2018).
Pharmaceutical waste irrespective of whether it comes from, a hospital, clinic, pharmacy or private household cannot be disposed of like conventional waste and therefore requires special handling and disposal (Shukla et al., 2017; Societies and Federation, 2000). Methods used for the disposal of pharmaceutical waste include the sewer, landfills, incineration, encapsulation, inertisation and return to the manufacturer (Drugs and Medicines, 2000; Iosue, 2020). Landfills are preferred for the disposal of solid waste; however, engineered landfills are preferred since their architecture protects the aquifer. Sewers are suitable for the disposal of liquid pharmaceutical waste, while encapsulation and inertisation are appropriate for the disposal of antineoplastic and controlled drugs (Ejeromedoghene et al., 2021; Societies and Federation, 2000).
Studies conducted in Nigeria revealed that disposal of expired medications in pharmacies was through the National Agency for Food and Drug Administration and Control (NAFDAC), drug distributors and rubbish bins (Michael et al., 2019). In New Zealand, third-party contractors were the major route of disposal for expired solid dosage forms in community pharmacies surveyed, while most liquid dosage forms were disposed of in the sink (Tong et al., 2011).
In Ghana, there is literature on the disposal of health care waste from hospitals and expired, unwanted or unused medicines in households. These studies report that there is fair awareness on the handling and disposal of health care waste among health care professionals. Health care waste disposal materials are often found in private than public hospitals and incineration is the commonest method for the disposal of health care waste in hospitals (Adu et al., 2020; Odonkor and Mahami, 2020; Sasu et al., 2012). Furthermore, households often have leftover, unused and expired medicines at home, and these medicines are often disposed of inappropriately through the waste bin and buried in the ground (Aboagye and Kyei, 2014; Abruquah et al., 2014; Osei-djarbeng et al., 2015).
Attitudes of community pharmacies and their clients on the use and disposal of unwanted and leftover medicines are also scarcely documented. The objective of the study, therefore, was to determine how community pharmacies dispose of expired and unwanted medicines and also to determine the characteristics, uses and disposal of leftover medicines by clients who patronise the community pharmacy. The role of the community pharmacists in the assessment and disposal of unused and leftover medicines at home was also explored.
Methods
Study design and site
This cross-sectional study was conducted in six sub-metros in the Kumasi metropolis in the Ashanti region. The Ashanti region is the most populous region in Ghana. There are about 460 community pharmacies in the region with about 250 in the Kumasi metropolis. The study was conducted in two phases. The first phase of the study was the client survey conducted among clients who visited community pharmacies in the Amakom sub-metro in the Kumasi metropolis. The survey sought to determine the utilisation and disposal of leftover and unwanted medicines among clients who visited these pharmacies. It also explored the use of the community pharmacy as a place for the assessment and collection of unused medicines for disposal. The second phase was the pharmacy staff survey conducted in community pharmacies in six sub-metros in the Kumasi metropolis. The study’s objective was to find out how the pharmacies in the Kumasi metropolis disposed of unwanted and expired medicines and the challenges faced in the disposal process.
Sample size and sampling
Inclusion criteria for the first phase of the study were clients who visited the five randomly selected community pharmacies within the Amakom sub-metro. Amakom sub-metro was purposively sampled because it is centrally located and easily accessible and has a very vibrant community. Two hundred clients (40 from each pharmacy) aged 18 years and above who were willing to be part of the study were selected by systematic sampling. The sample size (n) is calculated according to Cochran’s formula: n = z2 × p × (1 – p)/e2 (Singh and Masuku, 2014)
where z = 1.96 for a confidence level (α) of 95%, p = proportion (expressed as a decimal) and e = margin of error.
z = 1.96, p = 0.5, e = 0.0693
n = 1.962 × 0.5 × (1 − 0.5)/0.06932
n = 0.9604/0.0048 = 199.98
n ≈ 200
The five randomly selected pharmacies for the first phase of the study were not included in the second phase. The second phase of the study involved 120 community pharmacies, randomly selected from the six sub-metros in the Kumasi metropolis. Pharmacy staff (pharmacists, dispensing technicians and medicine counter assistants) who were on duty working in these pharmacies at the time of visit were purposively selected for a face-to-face interview.
Development and validation of survey instruments
In the first phase of the study, a semi-structured questionnaire was developed to capture data on the characteristics, sources, uses, expiry and disposal of leftover or unused medicines. Information used to draft the questionnaire was obtained from the literature. The questionnaire was developed in English and translated to Twi, the local dialect, to be used when needed. Data collectors went through training to ensure back-translating questions into English would have the same meaning as the original text. In the second phase of the study, a semi-structured questionnaire was designed to capture data on the methods of, and challenges encountered in the disposal of expired medicines. The two questionnaires were validated by an academic pharmacist and a community pharmacist. The academic pharmacist has a PhD in clinical pharmacy with more than 10 years of experience in conducting research and community pharmacy practice whiles the community pharmacist has a bachelor of pharmacy degree and 15 years of experience in community pharmacy practice. Questionnaires used for the study were piloted in a sub-district not included in the study population.
Data collection
Data for both the first and second phases of the study was collected over a period of 5 months, from July to November 2020. In the first phase, clients who visited the pharmacy between 10 am and 5 pm, and who consented to take part in the study were asked to bring any unused and leftover medicines to the pharmacy for an assessment. Leftover medicines were defined as unused medications at home whether opened or unopened. Demographic characteristics such as name, age, sex, educational background, household population and telephone number were documented. A date was then set for an interaction with the pharmacist, to be assisted by a fifth year Doctor of Pharmacy (Pharm D) student. During the interaction, a semi-structured questionnaire was used to collect data on the name, expiry date, source and prior disposal of unused or leftover medicines. The Pharm D student was responsible for reminding clients of the appointment and recording the names and expiry dates on the leftover medicines.
In the second phase of the study, the researcher approached staff working in the selected pharmacies, informed them of the objectives of the survey and sought their consent to be enrolled in the study. Pharmacy staff that consented to be part of the study were face-to-face interviewed guided by a structured questionnaire.
Data analysis
Data collected was checked for completeness, coding and keying and analysed using the Statistical Package for Social Sciences (SPSS v.244, SPSS, Inc.) and Microsoft excel according to frequency distributions and descriptive statistics. P values less than 0.05 were considered to be significant.
Ethical approval
Ethical clearance was sought from the Committee on Human Research Publication and Ethics, School of Medical Sciences, Kwame Nkrumah University of Science and Technology (CHRPE/AP/172/20). Participant information leaflets were administered to the respondents after which written consent was obtained from the participants who agreed to be part of the study. Participants were always assured of anonymity and confidentiality and voluntary participation in the study.
Results and discussion
Client survey
Demographic characteristics
Eighty-two of the respondents (41%) were males and 118 (59%) were females. The mean age was 39 ± 11.456. Forty-three respondents (21.5%) were uneducated, 51 (25.5%) had primary to junior high school, 46 (23%) had senior high school education and 60 (30%) had tertiary education. The mean family size was 3.8 ± 1.634
Availability and sources of leftover medicines
Of the 200 clients selected, 131 (65.5%) brought their unused or leftover medicines at home to the pharmacy to be assessed. The presence of leftover medicines or unused medicines among households is common. The prevalence of unused medicines among households in Riyadh Saudi Arabia, Northwestern Ethiopia, Malaysia and Tanzania is 89.5%, 70%, 84% and 96%, respectively (Marwa et al., 2021; Wajid et al., 2020; Wang et al., 2021; Yimenu et al., 2020). The mean number of medicines was 2.49 ± 1.094 (range 1–5). Reasons for the existence of leftover medicines in the home included: respondents stopped taking medicines when they felt better (97; 74%), adverse reactions experienced (8; 6.2%) and respondents skipped some days of taking their medicines (12; 9.2%). In addition, 9 (6.8%) were of the view that they were given an overdose and 5 (3.8%) had changes in their medicine regimen.
Reasons cited for the existence of leftover or unused medicines among our respondents are similar to other reasons reported in studies conducted among households in Ghana (Aboagye and Kyei, 2014; Abruquah et al., 2014; Osei-djarbeng et al., 2015). Furthermore, a review that included 25 related studies on disposal of unused medicine in different countries showed that non-adherence to medication, change in medication and death were the common reasons for the existence of leftover medicines (Makki et al., 2019). Non-adherence to medication is a pharmaceutical care problem often documented among patients who are on medications, especially patients with chronic diseases; however, when a concordant approach is used in counselling patients, their views on and feelings about medicines could be adequately discussed and non-adherence to medicines could be reduced. Medicines management schemes could also be initiated in health care centres to address the existence of leftover medicines at home due to changes in the medication regimen. These schemes could encourage patients with chronic diseases to bring along their medicines when they visit the hospital so that when there are changes in regimen, unwanted medicines may be kept by the hospital for further use if the quality of the medicine is good. In the United Kingdom, several medicines management schemes have been initiated using patients own drugs and studies have shown that these schemes reduce wastage and prevent duplication of therapy and other medication errors (Lummis et al., 2006).
Sources of these leftover medicines were community pharmacies (80; 61.1%), hospitals (28; 21.4%) and drug peddlers (18; 13.7%), and 5 (3.8%) were from other sources such as siblings, friends and neighbours. These sources of leftover medicines cited by our respondents are similar to sources reported by authors in Ghana who have studied the disposal of leftover medicines among households (Aboagye and Kyei, 2014; Osei-djarbeng et al., 2015). In Ghana, community pharmacies are one of the commonest sources for obtaining medicines because over-the-counter medicines are often dispensed without prescriptions, opening hours are convenient and the pharmacist can prescribe medicines for the treatment of illness of common occurrence like malaria. There was no significant relationship among sex, educational level and the number of leftover medicines. However, there was an association between the number of leftover medicines at home and family size (p = 0.002) (Table 1). Other studies have also shown that several factors are associated with the existence of left medicines at home. A study conducted by Wang et al. (2021) in Malaysia showed that the highly educated, people who paid for their medicines and patients with acute illness were likely to have unused medicines at home. In Northwestern Ethiopia, a study among 507 households revealed that the existence of unused medicines was associated with marital status and monthly income (Yimenu et al., 2020).
Number of leftover medicines and demographic characteristics.
Classes, quality and uses of leftover medicines
Two hundred and eighty leftover medicines were found. These included analgesics (102; 36.4%), antibiotics (50; 17.9%), antacids (22; 7.9%), cough preparations (20; 7.1%), multivitamins (18; 6.4%) herbal preparations (15; 5.4%), haematinics (14; 5%), anti-malarials (11; 3.9%) and other medicines (28; 10%) (Table 2). Several studies in both the developed and developing countries have shown that classes of leftover medicines or unwanted medicines at home include analgesics, antibiotics and nutritional supplements and vitamins (Ayele and Mamu, 2018; Insani et al., 2021; Kahsay et al., 2020; Wajid et al., 2020; Yimenu et al., 2020). Analgesics are often the commonest leftover medicines at home probably because they are usually the first-line treatment options in the home for health conditions which present with fever and headaches. Antibiotics were also part of the leftover medicines, and this may imply that treatment is often not adhered to and could lead to antibiotic resistance. Less than 5% of leftover medicines in our study were antimalarial, and this can be attributed to the fact that the course of these medicines is 3 days and hence compliance may not be difficult.
Classes of leftover medicines.
Reasons given for keeping leftover medicines cited by our respondents were that they will be used by the respondents themselves or family members (including children) who experienced similar symptoms for which these medicines were prescribed. In a study by Insani et al. (2020) among 497 respondents, unused medicines were kept at home till expiry, given to friends and family who were not well or donated to the hospital (Insani et al., 2020). The uses of leftover medicines at home may often encourage self-medication and delay in seeking appropriate health care from health care facilities. Sixty (21.4%) of the leftover medicines had expired and its use could lead to reduced efficacy of the drug.
Disposal of leftover medicines
Seventy respondents (53.4%) were aware of the expiry dates of their expired medicines, while 61 (46.5) respondents were not aware. Regarding the time of disposal of leftover medicines, 56 (42.7%) of the respondents would dispose of these medicines when expired and 43 respondents (32.8%) did not know when they would dispose of these medicines. Thirteen (9.9%) would never dispose them off, and 19 (14.6%) would dispose them after they had kept them for a long time. Such disposal would be through the general-purpose bin (58; 77.0%), pouring them down the sink (11; 14.3%), via the toilet (4; 6.1%) and dumping in the gutter (2; 2.6%). These improper disposal practices witnessed in our study have been reported in several studies on the disposal of leftover and expired medicines among the households (Azmi Hassali and Shakeel, 2020; Begum et al., 2021; Kahsay et al., 2020; Kassahun and Tesfaye, 2020; Marwa et al., 2021; Osei-djarbeng et al., 2015; Wang et al., 2021). Furthermore, a review by Makki et al. (2019) reported that unwanted and expired medicines are often disposed of through the garbage trash, toilets, sink and given to relatives and friends.
Seventy-eight (60%) of respondents were willing to periodically visit the pharmacy to interact with the staff on their unwanted medicines. About one-third (35%) of pharmacy, clients were willing to allow the pharmacist to dispose of their unwanted/expired medicines, so the community pharmacy could be an ideal place for the collection of pharmaceutical waste from clients for onward disposal by the FDA. However, there will be a need for policies to back such services in the community pharmacy. In some developed countries such as Australia, medicines are sent back to pharmacies or the sources from which they were obtained to be processed, if necessary, and disposed of properly to prevent any harmful effects on human life as well as the environment (Bettington et al., 2018). In the United States, drug take-back programmes for unwanted over-the-counter medicines and prescriptions medicines have been initiated in some states to enable their proper disposal (Kinrys et al., 2018). These programmes are often offered by pharmacies.
Pharmacies and staff survey
Fifty-four (45%) of the facilities were retail-only pharmacies, 55 (44.2%) operated both as retail and wholesale and 13 (10.83%) were wholesale only. Of the 120 respondents, 76 (63.3%) were Dispensing Technologists, 30 (25%) were Pharmacists and 14 (11.7%) Medicine-Counter-Assistants. All 120 respondents agreed that they generated expired drugs often. The common method for the disposal of expired solid, liquid and injectable formulations cited by respondents were the general-purpose bin, while expired and unwanted prescription-only medicines (POMs) were mainly through the drain (Table 3). In a similar study, in Nigeria, solid dosage forms were disposed of through the rubbish bin, drug distributors and NAFDAC (National Agency for Drug Administration and Control), while liquid dosage forms were disposed of in the sink (Michael et al., 2019). Improper disposal methods among community pharmacies have also been retorted in Libya and Iraq (Albaroodi, 2019; Atia, 2021). However, in Saudi Arabia, 70% of 360 pharmacies surveyed return unused expired medicines to the pharmaceutical distributor (Alghadeer and Al-Arifi, 2021).
Methods for the disposal of medicines cited by pharmacy staff.
OTC: over-the-counter; POM: prescription-only medicine.
When medicines are dumped in the garbage, there is the risk of accidental poisoning and/or abuse since they can be picked up from the garbage by children, pets, homeless people and drug abusers. Furthermore, since waste is also dumped at landfills, these medicines make their way to the groundwater supply. Drinking water contaminated with antibiotics may foster the spread of antibiotic resistance among microorganisms. Medicines which are poured down the sink and toilets all end up in various water bodies and drainage systems and finally end up being used by people. In countries all over the world, traces of medicines and other pharmaceuticals have been found in national water supplies since water treatment facilities and domestic sewage systems are not specifically designed to remove pharmaceuticals from circulation (Ruhoy and Daughton, 2007). Although using the sink to dispose of medicines prevents people from accidentally taking the medications, it may result in inadvertent contamination which is believed to cause adverse effects such as death or delayed development of many aquatic species. Moreover, there is concern and the potential for humans to be also affected by this inadvertent environmental contamination by these pharmaceuticals.
On the awareness of the proper disposal of expired pharmaceutical products, 51 respondents (55%) cited landfill sites, 16 (16.7%) indicated that the waste should be flushed and 8 (8.3%) indicated incineration. In a similar study in Iraq, proper disposal methods cited by community pharmacists were incineration and returning the drug to the manufacturer or distributor (Albaroodi, 2019). Ninety-six respondents (80%) were aware that the Food and Drugs Authority (FDA), Ghana is the agency responsible for the disposal of pharmaceutical waste in the country. Cost of disposal of expired medicines, lack of enforcement of legislation and education on the proper disposal of expired pharmaceutical products were cited as barriers to effective disposal. To overcome these barriers, 114 respondents (95%) indicated that there was a need for a funded scheme for proper disposal of expired pharmaceutical products in the country. When further asked who should fund such a scheme 82 respondents (72.3%) suggested the FDA, 15 (13.3%) suggested pharmaceutical companies and 8 (6.7%) suggested all health facilities in the country. In Ghana, the FDA is legally mandated to dispose of pharmaceutical waste. Most of the pharmacy staff interviewed knew this although they were not adhering to this directive because they had to pay each time for this service. To overcome the challenges faced with the proper disposal of pharmaceutical waste all pharmaceutical outlets could pay a yearly fee to the FDA so that they could dispose of their pharmaceutical waste any time of the year without making out-of-pocket payments.
Conclusion
Improper disposal methods were used by clients in the disposal of leftover and unwanted medicines. There is a need for public health campaigns to create awareness on the proper disposal and the consequences of improper disposal of unwanted medicines. These educational campaigns could be implemented by the community pharmacies as part of their corporate social responsibilities to ensure the safe disposal of unwanted medicines. A high proportion of pharmacy clients brought their leftover medicines to be assessed by the pharmacist, indicating that the Ghanaian community pharmacy may also be an acceptable place for the assessment and collection of leftover medicines and onward disposal of expired medicines if appropriate measures are put in place. However, for this programme to succeed in Ghana, it must be properly advertised, and pharmacy staff would have to be educated on safe disposal practices since our study showed that the community pharmacy staff had a fair knowledge of proper disposal methods. Continuous educational programmes should be periodically organised to expose them to current methods in the proper disposal of medicines.
Footnotes
Acknowledgements
The authors wish to acknowledge the respondents who had time to interact with the study personnel. Also, the research assistants who helped in data collection and analysis, respectively.
Author contributions
MO-A, AFAM and FO-D conceptualised and designed the study, supervised and coordinated data collection. They also drafted the initial manuscript, reviewed and revised the manuscript, and approved the final manuscript as submitted. MO-A and AFAM designed the tools used for data collection, supervised data collection, made input into the study design and revised the manuscript as submitted. MO-A and AFAM collected data, analysed the data, and provided inputs to the manuscript and approved the final manuscript as being submitted. All authors approved the final manuscript and agreed to be accountable for all aspects of the work before it was finally submitted.
Availability of data and materials
The data collected for the study which have been analysed and presented are available at the corresponding authors’ institution and is available upon formal request.
Consent to participate
Participants were given detailed participant information leaflets that contained the purpose of the study, the investigators, and the potential risks and benefits of the study. However, the voluntariness to participate was key in the process. Participants who agreed to participate were then made to sign the informed consent document to affirm their willingness to participate. Participants were assured of anonymity and confidentiality at all times and that participation in the study was voluntary
Declaration of conflicting interests
The authors declared no potential conflicts of interest with respect to the research, authorship and/or publication of this article.
Ethical approval
Ethical clearance was sought from the Committee on Human Research Publication and Ethics, School of Medical Sciences, Kwame Nkrumah University of Science and Technology (CHRPE/AP/172/20).
Funding
The authors received no financial support for the research, authorship and/or publication of this article.
