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Abstract
Objective Antibiotic misuse includes using them to treat colds and influenza, obtaining them without a prescription, not finishing the prescribed course and sharing them with others. Although drug providers are well positioned to advise clients on proper stewardship practices, antibiotic misuse continues to rise in Ethiopia. It necessitates an understanding of why drug providers failed to limit such risky behaviours. This study aimed to explore drug providers’ perspectives on antibiotic misuse practices in eastern Ethiopia.
Setting The study was conducted in rural Haramaya district and Harar town, eastern Ethiopia.
Design and participants An exploratory qualitative study was undertaken between March and June 2023, among the 15 drug providers. In-depth interviews were conducted using pilot-tested, semistructured questions. The interviews were transcribed verbatim, translated into English and analysed thematically. The analyses considered the entire dataset and field notes.
Results The study identified self-medication pressures, non-prescribed dispensing motives, insufficient regulatory functions and a lack of specific antibiotic use policy as the key contributors to antibiotic misuse. We found previous usage experience, a desire to avoid extra costs and a lack of essential diagnostics and antibiotics in public institutions as the key drivers of non-prescribed antibiotic access from private drug suppliers. Non-prescribed antibiotic dispensing in pharmacies was driven by client satisfaction, financial gain, business survival and market competition from informal sellers. Antibiotic misuse in the setting has also been linked to traditional and ineffective dispensing audits, inadequate regulatory oversights and policy gaps.
Conclusion This study highlights profits and oversimplified access to antibiotics as the main motivations for their misuse. It also identifies the traditional antibiotic dispensing audit as an inefficient regulatory operation. Hence, enforcing specific antibiotic usage policy guidance that entails an automated practice audit, a responsible office and insurance coverage for persons with financial limitations can help optimise antibiotic use while reducing resistance consequences.
- anti-bacterial agents
- pharmacists
- qualitative research
- behavior
Data availability statement
All data relevant to the study are included in the article or uploaded as supplementary information.
This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.
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STRENGTHS AND LIMITATIONS OF THIS STUDY
This study applied the Phenomenology concept, with interviews conducted to collect rich participant experiences and viewpoints.
The exploratory qualitative study design enabled broad coverage, allowing for perspectives from a variety of practice contexts at various premises in both urban and rural settings.
Since all participants were selected purposefully, they may not be transferable to a larger community of drug providers.
Despite the use of probes and indirect questions as proxies for exploring other drug sellers’ practices, interviews may result in a professionally acceptable response.
Introduction
The global consumption of antibiotic medicines has increased by 46% since 2000,1 with more than 50% of the consumption being unnecessary.2 This increase in antibiotic consumption, together with their widespread misuse, has led to the rise in bacterial antimicrobial resistance,2–5 which was associated with around 5 million deaths in 2019 globally.6 Antibiotic misuse is the improper utilisation of these medicines, with potentially harmful health consequences associated with domains of the misuse, such as ‘using antibiotics to treat colds or flu; using antibiotics without a prescription or recommendation from a certified healthcare worker, or asking for antibiotics against a healthcare worker’s recommendation; not finishing a prescribed course of antibiotics; sharing antibiotics with others; and using leftover antibiotics’.7 Antibiotic misuse can be triggered by inefficient healthcare systems, in addition to time and financial constraints in most resource-limited countries.8 A literature reveals up to 93% of non-prescribed antibiotic use,9 with 45% of the use for children as non-prescribed uses.10 Other studies also show that the prevalence of antibiotic misuse is 69% in sub-Saharan Africa11 and 67.3% in Ethiopia.12–14 The majority of deaths associated with resistance has occurred in sub-Saharan Africa, including Ethiopia.3
Interplays of behaviours in the access interface are a usual challenge with the use of antibiotics in Ethiopia. Drug providers are well positioned to play a responsible role at the interface of transactions for prescribed antibiotic access.15 Nonetheless, non-prescribed antibiotic access has been widespread, with more than two-thirds resulting in a course discontinuation.16 In a formal healthcare system, the non-prescribed request for and subsequent dispense of antibiotic drugs is believed to pass through a provider-client counter. However, the Ethiopian medication directive prohibits the dispensing of antibiotics unless they are prescribed by an authorised healthcare worker.17 In this context, any act of antibiotic dispensation in response to self-medication requests is against the law. A meta-synthesis reveals that the primary reasons for dispensing antibiotics without a prescription are profit, client demand, weak regulatory enforcement and a provider’s negative attitude.18 Other studies further explain the drivers of antibiotic misuse by citing a lack of knowledge about antibiotics and their resistance risks, financial incentives to maximise medicine sales, limited access to formal healthcare, unanticipated consequences of antibiotic resistance, inadequate regulatory oversight and a lack of clear policy guidance.15 19–22 These studies portray the major actors linked with antibiotic misuse, but their account to this wrongdoing is debatable.23 24 Most previous studies investigated the primary drivers of antibiotic misuse, triangulating different actors.8 15 19–22 25 26 However, contextual knowledge of why drug providers failed to limit this improper antibiotic usage, despite their insights into these medicines and their resistance dangers, has been largely overlooked. Again, stewardship efforts aiming to prevent or reduce antibiotic misuse may not be targeted with this information of various actors due to the possible complexity of blame-shifting among stakeholders. Drug providers, particularly dispensers, should be the primary target due to their professionally privileged position at the interface of medicine transactions (ie, for both prescribed and non-prescribed access), because they have a defined retail profit markup by legislation for private business works,27 and because they have vowed to consider the welfare of humanity and to care for their profession’s ideals and commitments while providing service.28 The law also grants pharmacy personnel the exclusive right to sell drugs, including antibiotics.17 In this study, therefore, drug providers primarily refer to medicine dispensers (ie, pharmacy professionals), except for a few remote nurse participants who also serve as dispensers. In this regard, we examine any point of blame and perspective of drug providers in the transaction of dispensing antibiotics on self-medication requests despite their knowledge of these drugs as prescription only.
Drug providers are participants in this study. Drug providers’ perspectives in the context of attributes related to antibiotic misuse are understudied in Ethiopia and elsewhere. We believe that investigating drug providers’ antibiotic dispensing experiences can address important themes in this gap and provide a fresh context for understanding how they manage the interplays of self-medication requests, profit gain, market competition, regulatory standards and practice culture in eastern Ethiopia. This study is relevant for eastern Ethiopia, where self-medication with antibiotics is more common,29 and access to these drugs comes from a number of sources. For most people in this area, trade is one of the livelihoods that form the foundation of the economy and the way of life. This province is also close to border areas where informal circulation of trade supplies, including drugs, is relatively accessible to the market. According to a study report, for instance, 44% of antibiotic access in resource-constrained nations comes via informal sources (ie, as part of shop items).30 In this study, we challenge the motives behind antibiotic misuse practices that are solely against providers’ professional duties, illustrating the complex interplays in which self-medication, profit gains, competition, and regulatory and policy issues are intertwined in the business survival strives of drug providers. Hence, this study aimed to explore drug providers’ perspectives on antibiotic misuse practices in eastern Ethiopia.
Methods
Study design and setting
A qualitative description was the design for this study,31 with an exploratory approach to understand the details of multiple perspectives on how drug providers deal with antibiotic misuse practices in the setting. With such an aim of gaining a thorough knowledge of participants’ experiences and viewpoints, a qualitative research design is appropriate.32 Interviews are the most appropriate data collection method for such qualitative research to capture participants’ voices and experiences in their own words.33 We used an interview guide designed to examine participants’ experiences and viewpoints based on the Phenomenology concept.34 The study also followed the Consolidated Criteria for Reporting Qualitative research (COREQ) (see COREQ checklist).35 Moreover, the study was designed to include participants from both urban (Harar) and rural (Haramaya) locations in eastern Ethiopia to capture different contexts.
Patient and public involvement
Our data collection tool was pilot-tested with in-depth interviews among the three drug providers recruited from the public to ensure that it is inclusive and complete. Two of these providers were from rural areas, while the remaining one was from an urban setting. They were recruited with the assistance of health extension workers. Each participant was informed about the study and requested to give written consent to an interview and audio recording. The interviews were then held in their chosen location and time. We identified practical issues with the interview guide, sessions and tactics while evaluating the audio-recorded data. This helped us identify cross-cultural language relevance and word ambiguity, indicating gaps in the clarity of some questions. We then revised our interview guide to ensure that appropriate questions are asked and that they do not make respondents uncomfortable or confused. Since the pilot tests were part of the methods used to prepare for actual data collection, they were excluded from the final analysis.
Participants and recruitment
Participants were drug providers of any gender from the chosen medicine supplying premises in Harar town and rural subdistricts of Haramaya. These premises included pharmacies, drug stores, health centres, hospitals and primary clinics (those entitled to provide drugs from a predefined emergency medicine list only that does not cover antibiotics,36 as noted in Ethiopia’s essential medicine list37). We identified all potentially eligible premises (based on an official list obtained from district health offices). We recruited the study participants through the support of the local health extension workers (ie, these are frontline personnel for providing basic health services, especially to rural communities with limited access to healthcare facilities otherwise38). They were non-participants but assisted us with a purposive sampling of experienced participants. Although we triangulated study participants from a variety of premises in urban and rural areas, the selection process was judgemental to yield information-rich participants.
In-depth interviews
This study draws on data collected through semistructured, face-to-face, in-depth interviews with fifteen participants. Interviews are viewed as prominent data collection methods in qualitative research33 and are the most appropriate techniques to incorporate the voices and experiences of participants in their own words. A pilot-tested interview guide was employed to conduct interviews. In line with the characteristics of semistructured interviews,39 we used open-ended questions to allow the interviewer and participants to diverge freely in any way to pursue responses in more detail. The interview guide addressed major topics such as drug providers’ experiences with drug source, antibiotic dispensing, client counters, practice culture and regulatory challenges (see online supplemental file 1).
Supplemental material
Data collection
The first author (DE), who is a pharmacist himself, has conducted the data collection for this research. The first author’s insider status as a pharmacy professional was an obvious assistance in recruiting the study participants and establishing rapport and trust in the interview process. He visited each participant before the interviews to establish relationships and choose locations, dates and times that were convenient for them. Prior to each interview, we received written informed consent from all participants. The interviews were then undertaken at times suitable for participants at their workplaces. In addition to taking field notes, each interview was audiotaped. The interviews began with general background questions before proceeding to professional experience, including antibiotic dispensation practices. Next, participants were encouraged to discuss openly on issues related to the sources of medicines, perspectives on antibiotic dispensation and context of antibiotic access and use practices in the setting. Participants were also invited to discuss how other dispensers view antibiotic misuse practices in context of duties of the profession with antibiotic usage in the setting. During the interviews, we asked probing questions to learn more about the cases and practices. Individual interviews lasted an average of 60 min. We undertook the in-depth interviews between March and June 2023. Data saturation determined the sufficiency of in-depth interviews. Participation in the study was fully voluntary, and participants were not reimbursed. No participants refused to participate.
Data management and analysis
Our analysis was informed by a thematic method. It is a flexible tool for adapting to qualitative research aiming to generate themes.40 The thematic approach is the most appropriate analysis method for semistructured interviews. Using this method, qualitative researchers can construct a coding framework that leads to an organised structure of themes generated inductively or deductively.41 The several steps inherent in the thematic approach also help researchers to demonstrate details on how they identify, analyse, organise, describe and report themes found within a dataset,40 enabling readers to judge the trustworthiness of the research process. So, the thematic method was identified to be helpful for a transparent discussion of perspectives on how drug providers deal with antibiotic misuse.42 43 In this sense, we hired a multilingual researcher to transcribe all audio recordings verbatim. Next, the first author reviewed each transcript against audio-recorded data to ensure accuracy and completeness. Additionally, the other authors evaluated and confirmed all transcripts against audio recordings. Moreover, another multilingual researcher translated all source language transcripts into English. The first author then cross-checked the transcripts against the source language, as transcripts in both languages must be accurate, complete and systematic. Finally, random samples of five transcripts were returned to participants for comment and correction before the coding process began.
Following verification of sampled transcripts from participants, we imported all transcripts into ATLAS.ti V.7.5.744 to store and facilitate the coding and analysis processes by two authors (DE and FAK). We followed the steps of the thematic analysis as recommended by Braun and Clarke.40 Initially, we read and reread the interview transcripts repeatedly to identify and recognise patterns, categories and themes in participants’ antibiotic dispensing practices. Next, we assessed the entire dataset and field notes to capture the main theme of the data to generate initial codes. These codes were broad and based on inductively derived ideas. As the analysis progressed, the coding became more focused since we identified the specific themes regarding the participants’ antibiotic dispensing experiences, one concerning the issue of antibiotic misuse practices. We identified potential main themes and subthemes by grouping codes of similar ideas together. We then checked the alignment of the identified themes and subthemes with each code and the entire dataset. Afterwards, we defined and named these themes while generating the overall scope of the analysis findings framed in a coding tree (figure 1). Finally, we produced the study report by selecting descriptive or compelling extracts as quotes and linking these quotes to the description of the findings anonymously.
A coding tree for qualitative analysis of participant responses, eastern Ethiopia, 2023.
Ethics approval
Participants gave written informed consent to participate in the study before the interviews began (see online supplemental file 2). Quotes were presented anonymously using participant age and sex.
Supplemental material
Reflexivity
The research team included DE (a PhD student at the time of the study who was in charge of data collection), FAK, GD and LO (PhD and experienced researchers with several years of expertise in public health). Recognising that these attributes may influence data interpretation, quotations were used to increase trustworthiness, and each member reviewed the analysis to challenge any interpretation based on preconceptions rather than data. The research project was also peer reviewed by colleagues.
Results
The ages of the study participants ranged from their 20s to 50s. Most of the participants were males. There was considerable diversity in their work experience, which ranged between 2 and 40 years. Most participants were owners of the premises where they work. Furthermore, there was variation in educational level that ranged between a College Diploma and a Master’s Degree (table 1).
Sociodemographic characteristics of participants, eastern Ethiopia, 2023
We identified a variety of viewpoints from drug providers on antibiotic misuse practices. These perspectives were organised into three main themes: drivers of antibiotic self-medication, motivations for non-prescribed antibiotic dispenses and inadequate regulatory control and a lack of clear antibiotic use policy. Additionally, 12 minor themes have been identified to describe the main themes in the context of healthcare operations, drug sales, professional duties and regulatory issues (see online supplemental table 1).
Supplemental material
Theme 1: drivers of antibiotic self-medication
Previous use experience
Most participants discussed how previous use experience has assisted clients in identifying certain antibiotics they typically request with names. They repeatedly mentioned to unfettered access to these medications in their argument to explain and justify clients’ past antibiotic misuse behaviours. Outdated antibiotics, such as ampicillin and tetracycline, have been cited as the most commonly used antibiotics for self-medication in the past years. Some participants also argued that clients’ specific knowledge of antibiotics is strongly linked to their previous excessive use. As a participant pointed out:
[Many clients] know the names of antibiotics. They know [or come to the pharmacy and ask for] outdated antibiotics like tetracycline […]. This exposure shows their access from the very previous. […] these things show that the use of antibiotics without prescriptions does not start now. I think it existed in the past as well. (A male ages 30–40 years old)
Poverty and the intention to avoid extra costs
Most participants have repeatedly highlighted the financial hardship of clients and their intention to avoid expenses associated with consultations and unnecessary laboratory testing as the reason for their antibiotic misuse. For instance, ‘poverty is the root cause of requesting or dispensing antibiotics without a prescription,’ according to a participant (a female aged 50–60 years old). Another participant (a male aged 30–40 years old) recounted an incident in which a client with a cough was required to have a complete blood count test, incurring extra cost. He critiqued such unnecessary expenses, claiming that they drive clients to choose direct presentation of symptoms at pharmacies to obtain antibiotics. Other participants echoed concerns about these additional charges of prescribers, which are normally required before receiving prescriptions, prompting clients to opt for self-medication with antibiotics to avoid unnecessary expenses.
Lack of necessary tests at health centres
Some participants stated that antibiotic prescriptions at health centres are primarily based on a history of illness presentation and that necessary tests are not performed. They stressed that a failure to perform necessary tests can undermine the quality of care, prompting clients to resort to self-medication with antibiotics. A participant, for example, discussed a sequential trial of giving different antibiotics to a patient to assess their therapeutic benefits rather than performing the necessary testing before prescribing these medications, stating:
Initially, we give drugs such as amoxicillin or doxycycline. If the patient does not improve on these antibiotics, we shift the treatment to ceftriaxone at a third step. If the patient did not experience a cure with ceftriaxone taken for seven days, we refer the patient to a hospital. (A female aged 20–30 years old)
Unavailability of antibiotics in public institutions
The majority of participants stated that the lack of most antibiotics in public hospitals and health centre pharmacies discouraged clients from visiting prescribers. All participants from public health institutions reiterated the common shortage of popular antibiotics, citing it as a likely driver for clients’ self-medication practices from the available sources. For instance, a participant pointed out that the usual shortage of antibiotics at formal drug sources forces clients to consider alternative options, such as kiosks. He stated:
The first pressure is a lack of antibiotic supply at public facilities, such as health centers, hospitals, and so on. […] they [clients] opt to go to kiosks because of a lack of medicines [antibiotics] they may need for treatments. (A male aged 20–30 years old)
Proxy prescription
Many participants have cited neighbours and family members as usual sources of proxy information for clients’ antibiotic self-medication behaviours. A participant (a male aged 20–30 years old) claimed that clients ‘self-prescribe mainly based on the information they get from family members or neighbors’. Participants also criticised healthcare workers for suggesting antibiotics to clients over the phone or on pieces of paper. They criticised healthcare workers for recommending antibiotics to family members, relatives, or friends without a legitimate diagnosis or authorisation to do so.
Theme 2: motivations for non-prescribed antibiotic dispenses
Focus solely on profit
Most participants have consistently highlighted that the key motivation for non-prescribed antibiotic dispensing by pharmacy/drug store owners is profit. They cited profit-driven practices by pharmacy owners, such as handing over sales of drugs, notably antibiotics, to family members who are not health workers. They constantly blamed such premise owners for worsening antibiotic misuse because their family members lacked the necessary qualifications for dispensing medications, including antibiotics. This plan to continue operating the business by unskilled persons was mentioned to undermine the professionalism required by law. For instance, a participant pointed out:
Many drug sellers [in towns] are descendants of the owners. These individuals are untrained but work with the experience they gained from their families. Such sellers focus on profit harvesting only and do not generally follow drug dispensing regulations. (A male aged 30–40 years old)
Participants further discussed on sellers’ profit intent that involved antibiotic misuse despite their professional responsibility to protect public health. They believed that refusing to dispense antibiotics without a prescription could result in a shift of profit to less scrupulous sellers who are willing to engage in this practice, as a participant said:
Denying the dispensing of antibiotics without a prescription would double the profit of a nearby pharmacy that routinely does so. (A male aged 20–30 years old)
The majority of participants also attributed antibiotic misuse, such as dispensing fewer dosages than needed, exclusively to their profit-driven commercial approach. According to a participant (a male aged 20–30 years old), ‘a totally accepted practice in the community is receiving fewer antibiotic doses than needed over the other [more doses than needed]’. His viewpoint suggests that clients often receive fewer antibiotic doses in the setting, yet these habits go uncontested by dispensers. Instead, they focused on the consequences of refusing to sell antibiotics without a prescription. A participant recounted:
If you refuse to give them [clients] antibiotics, they become aggressive and intend to obtain them from other premises with confidence. (A female aged 50–60 years old)
A participant further attributed giving broad-spectrum and multiple antibiotics at private pharmacies and clinics to antibiotic misuse, reiterating a profit-driven commercial mindset. Such practices were unnecessary, in her opinion, yet persisted in increasing the earnings of private sellers, as stated:
There are instances in which clients access third-generation antibiotics from private premises despite the availability of the first-choice antibiotics. […] giving ceftriaxone injection to a patient with an illness in which amoxicillin is effective is unnecessary. The sellers [at private premises] also dispense multiple antibiotics of similar indication for their profit only. (A female aged 20–30 years old)
A desire for client satisfaction
Participants consistently discussed the misuse associated with dispensing higher generation and broad-spectrum antibiotics to satisfy clients’ desire for rapid effect. However, this satisfaction claim has been recognised as instrumental solely to business bondages with the clients because the medicines that clients need are costly and have a higher risk of resistance. They contended that the underlying motive is a competitive drive for profit, irrespective of restrictions on selling such drugs at some levels of premises. A participant said:
Drug sellers usually compete to satisfy their clients. They hold many [broad-spectrum] antibiotic drugs, like ceftriaxone […]. Clinic providers also sell [such] antibiotics, but I do not know their source for these medicines. (A male aged 30–40 years old)
Survival in business
The majority of participants consistently linked sellers’ desire to remain in business to antibiotic misuse practices in the setting. They justified this survival intent in the business by noting the antibiotic market dominance and the high cost of living as typical reasons for continuing to dispense these drugs without prescriptions. With antibiotic sales that can reach up to 60% of the medicines dispensed, most participants regarded antibiotic trades as the ideal market item to stay in the business. They believed that competing with the business without selling antibiotics was impossible because these drugs had the highest transaction volume. According to a participant (a male aged 30–40 years old), ‘antibiotics constitute more than 60% of the selling’. Although antibiotics were discussed to constitute more than half of all medicines issued by providers, only a few types, including amoxicillin, ceftriaxone, amoxicillin-clavulanate, azithromycin, ciprofloxacin, doxycycline, cotrimoxazole, metronidazole and ampicillin, were mentioned to explain this dominance.
Most participants working in private premises reiterated that their failure to meet regulatory standards regarding antibiotic dispensing practices was due to high living costs. They attributed uneven conformity to the suggestion of regulations, which is likely to cause economic hardship on their business if they are the only providers waiting for prescriptions to sell antibiotics. A participant gave his elaboration to this view, stating:
It will create a critical economic hardship for your business if you only follow the regulations. […] it creates a situation in which you sell nothing. If you wait for prescriptions that come rarely, it is a problem. You cannot pay for the liability of the house rent. […] you cannot afford a family’s living expenses. (A male aged 50–60 years old)
Market competition from informal drug sellers
Although informal premises are not authorised to sell drugs, most participants have repeatedly blamed unrestricted sales from unlicensed sources on worsening non-prescribed antibiotic access in rural areas. This access option from informal premises, such as kiosks, has been consistently criticised for undermining the business of licensed sellers. A participant, for example, pointed out:
Clients have a more common experience of receiving antibiotics from informal premises like kiosks […]. We usually hear information from clients about the option of getting such medicines from kiosks. (A male aged 30–40 years old)
His comment suggests that unrestricted access to antibiotics from kiosks has added options for clients to their choice of drug access sources. There was a strong contest among participants regarding selling antibiotics at kiosks in the same way that anyone can sell other shop items. A participant (a male aged 30–40 years old), for example, offered his critique of similar ways of selling antibiotics and other trade items at kiosks. His account illustrated that the situation has deteriorated to the point that these essential drugs are being viewed as mere commodities (ie, subjected to the same commercial handling as other trade items).
Some participants also consistently discussed antibiotic misuse in the setting by citing the usual market shares of informal drugs, including antibiotics, as contraband items. They argued that antibiotic misuse has continued to rise among formal sellers due to a desire to compensate for business gains, which was a way for them to backfire on the unrestricted sales of antibiotics at reduced prices via informal routes. For example, a participant pointed out:
There are medicine sources other than wholesalers, especially those entered as contraband. When the prices of medicines [antibiotics] obtained from wholesalers are high, some sellers get the contraband products at cheaper prices. They can sell these medicines without a prescription as they do not have legal invoices. (A male aged 20–30 years old)
Moreover, participants argued that there was a high propensity for unrestricted access to antibiotics via informal routes during times of shortages from formal providers. In their account, they noted the usual supply shortage of some popular antibiotics (eg, amoxicillin and ceftriaxone) from formal suppliers, which has resulted in their widespread distribution by informal sellers. According to a participant:
There are repeated shortages of antibiotics […]. There are instances we lack supply of amoxicillin from formal suppliers […]. In such cases, supplies from contraband sources get much more opportunity to largely circulate it in the market. Other antibiotics like ceftriaxone also experience shortages. (A male aged 20–30 years old)
Theme 3: inadequate regulatory control and a lack of clear antibiotic use policy
The thief and the police game
All participants explained a sample antibiotic dispensing audit as part of the usual procedure for practice control by the regulatory authorities. This cross-checking approach remained traditional and attempted to audit as if the number of a sampled antibiotic medicine obtained via invoice corresponded with the amount sold via prescription. In their view, this audit approach to antibiotic dispensing was both confusing and ineffective in identifying gaps. They questioned its practicality, citing the time required to conduct an effective audit. With this, a participant pointed out:
With the current practice, the regulatory team tries to balance a sample of antibiotic drug you purchased against the amount dispensed via prescription for that specific antibiotic. This approach is tiresome, time-consuming, and costly. […], for example, assume we purchased 1000 units of amoxicillin and 200 units of this drug remained. The authorities would try to track 800 units of the drug from a prescription review, starting from our past purchase date. (A male aged 30–40 years old)
Participants further contended that effective auditing of a seller’s dispensing practice for a single antibiotic medicine does not guarantee the real practice of dispensing all antibiotics. They argued that the existing practice of antibiotic dispensing audit is prone to mislead because the sellers can openly deny holding the sampled antibiotic medicine; as a participant discussed:
If we hear that the regulatory authorities have started patrolling for supervision, we call each other and prepare to wait for them. When they come to your pharmacy and ask whether you hold some antibiotics, you deny the availability of the antibiotics they wanted to check. (A male aged 30–40 years old)
Participants also indicated sellers’ wrong assumptions regarding antibiotic dispensing, which was associated with the impracticality of conducting a sample antibiotic dispensing audit. They cited a widely held thought that giving antibiotics without a prescription is formal if it is done behind the scenes and away from the observation of regulatory authorities. They contended views of such irrational drug sellers for their intention to just follow the regulatory standards during visits of authorities, resuming their usual practice of giving antibiotics without a prescription after the supervision was complete. According to a participant:
The practice is just like the Thief and the Police game. When the authorities do active visits, the drug sellers do not dispense antibiotics without a prescription. When there is no supervision, they sell it as usual without a prescription. (A male aged 30–40 years old)
Participants further referenced the antibiotic misuse game, which entailed dispensing antibiotics obtained from informal sources without prescriptions. In their accounts, they repeatedly criticised such sellers’ intent to conceal the true practices from the eyes of authorities alone, implying a lack of concern for the public welfare. As a participant pointed out:
The sellers usually dispense the antibiotics procured through invoice via prescription while dispensing antibiotics from other sources without prescription. The regulatory authorities might assume a good antibiotic drug dispensing practice if they get prescription evidence for all selling. However, they would miss control of antibiotics obtained from informal sources as these are optional parallel to the formal ones. (A male aged 20–30 years old)
Inadequate regulatory control
Some participants linked antibiotic misuse to weak and infrequent regulatory control by authorities. They repeatedly referenced a lack of effective supervision for premises located away from main roads and in rural areas. They stressed that there was a mismatch between the work required and the amount of duty assumed by the regulatory officials. A participant, for example, stated:
They [regulatory authorities] do not usually visit pharmacies away from the main roads as they are not convenient [understaffed] to do this. It means that they do not control premises found in rural settings. (A male aged 20–30 years old)
Participants further linked a lack of explicit punishments for antibiotic dispensing without prescription to a weak regulatory function, despite the pervasive misuse. They condemned the degree of the punishment for dispensing antibiotics without a prescription, stating that it was merely a warning. A participant, for example, contested the warning as a meaningless penalty because he believed that it was insufficiently educative to correct the deep-rooted antibiotic misuse practices that extended to premises not authorised for selling medicines, pointing out:
I can say that there is no penalty. There would not have been selling of antibiotics without a prescription if there were equivalent penalties for wrong practices. The maximum penalty I have ever experienced is suspending the business for a month, which is senseless. (A male aged 30–40 years old)
Lack of clear policy support
Some participants consistently asserted that the widespread antibiotic misuse practice in the setting was prompted by a lack of clear policy and government attention. They condemned the government for paying no or little attention to these drugs, despite the necessity for multisector coordination for the rational use of antibiotics, which must be led by the government. A participant, for instance, referenced the active role that government policy has played in controlling the use of narcotic and psychotropic medications, stating:
The narcotic and psychotropic medications are well-controlled because they have a good policy focus. Giving similar attention to antibiotics […] can improve their use. (A male aged 30–40 years old)
Discussion
The study explored the clients’ convenience for self-medication, sellers’ financial interests, and policy and regulatory gaps as the primary drivers of antibiotic misuse practices in eastern Ethiopia. In this sense, providers’ commercial assumptions have driven non-prescribed antibiotic dispensing at pharmacies. In addition, clients’ financial limitations have led to unfettered access to antibiotics from informal suppliers, with even fewer dosages being used.
Self-medication was accounted as the most convenient way to antibiotic use in the area. It is the acquisition and consumption of medications without the formal evaluation and recommendation of a physician for any diagnosis or treatment.45 Despite the potential risks of misdiagnoses, overdoses, prolonged periods of usage, interactions and polypharmacy,46 self-medication with a non-prescription drug empowers people towards freedom in deciding how to manage their minor illnesses.45 Although assumed positive for non-prescription medicines,47 self-medication with antibiotics is a claim to reclassify these medications from prescription-only to over-the-counter drugs. Despite evidence of public trust in a few drug providers,48 a non-prescribed request for and dispense of antibiotics is a misuse, and it is against the directive recommendation of use because these medications are prescription only. Beyond this purely administrative account, the antibiotic misuse practice via self-medications can be argued reasonably in terms of its high propensity to cause adverse health outcomes or drug resistance.49 For instance, misusing antibiotics at the provider-client counter misses their correct indications, and it is a potential exposure to trigger superinfection, resistance, delay in infection treatment and adverse drug effects.50 51 With this wrong habit of antibiotic access through self-medication,52 drug providers are expected to play a frontline stewardship role by denying non-prescribed antibiotic usage and providing patients with counselling and education about the issue.51 In fact, possible client contexts for choosing antibiotic self-medication may include the distance to healthcare facilities, longer waiting times for services and additional fees associated with the healthcare system for diagnoses and prescriptions.15 Nonetheless, such oversimplified and convenient antibiotic misuse practices can result in the loss of these vital medicines through resistance development.53 With our knowledge of a well-placed role as the guardians of appropriate antibiotic utilisation,54 55 we argue the drug providers’ failure to do so is a lack of professional responsibility.28
Informal sales of antibiotics by non-professional sellers can invite a non-prescribed dispense by formal dispensers, and this was argued as instrumental for market competition. This antibiotic use from unlicensed sellers remains an alternative source of healthcare,56 57 especially among rural people of resource-constrained nations.57 Since these informal drug suppliers’ sales have mostly remained unnoticed by public health agencies, it is a challenge for regulatory authorities to engage with them and reduce antibiotic misuse.58 With this context of unauthorised dispense as a hidden antibiotic sale from the eyes of regulatory authorities, which has been explained repeatedly as a practice game for profitability, it is illogical for the formal drug providers to blame and opt for competing with the informal suppliers. Despite such tendencies of competitive markets in areas of numerous drug sources,25 59 it is believed that the formal dispensing of antibiotics must align with the directive suggestion that ensures a professional duty of advocating stewardship approaches.54 Otherwise, the focus on operating the business for profit gains alone can endanger the effectiveness of antibiotics,60 particularly with the present context of competing interests on cards of the market dominance and popularity of these medicines.61
Profit maximisation has been a repeat argument of formal providers with the continued practice of antibiotic misuse.62 Despite a known retail profit markup with the selling of medicines,27 the financial incentive to harvest the profit in an increasingly competitive market is still challenging to the rational use of antibiotics.19 22 63 Although the drug providers recognise the risks associated with antibiotic use,64 they have a self-concept to externalise the misuse practices to other main actors in the usage transactions, and they do not bear ownership of the problem.42 Alongside the popularity and market dominance of antibiotics in our setting of high prevalence of infections,65 drug providers usually attempt to ensure their survival in the business via the sales of these drugs.53 However, an inefficient functional driver linked to weak regulation and the profit intentions of providers were the main grounds for antibiotic misuse for survival in the business.22 Contrary to the assertion that poverty drives antibiotic misuse, evidence suggests a complex link between poverty and antibiotic misuse.66 A common antibiotic misuse practice among least deprived individuals contradicts this claim irrespective of some domains of poverty, like inefficient healthcare systems and financial constraints, which facilitate the business-led misuse practice by sellers.8
Amidst competing interests and covert practices in antibiotic sales, a lack of clear policy support stands out as the main reason for compromise to the regulatory functions against antibiotic misuse. Policy guidance is necessary for enforcing accountabilities and ensuring the appropriateness of the practices.62 Recognising the key actors in antibiotic transactions is integral to translating policy into action.67 An explicit policy account can address sellers’ concerns about profit and survival in the market, motivating them towards a responsible practice with optimal regulatory compliance.68 With an antibiotic policy, insurance for antibiotic treatment can also be offered, solving the issue of clients utilising fewer dosages due to financial limitations.43 Securing such equitable access to antibiotics as a component of healthcare system resilience and effectiveness requires explicit policy support for financing and resources.69 The policy account for recognition and response to disparities can also ensure an equitable future for accessibility to antibiotics irrespective of where they are used.70 Despite a global plan for universal access to safe and quality-assured medicines, including antibiotics, by 2030,71 72 substantial efforts towards realising this goal have yet to materialise.
Our study has several strengths and limitations. It is among the pioneer studies from the insider viewpoint on drug providers’ dispensing experiences, including proxy exploration of antibiotic dispensing practices by other health workers. Previous research conducted in Ethiopia focused on clients’ antibiotic self-medication practices.12–14 16 29 These studies overlooked drug providers’ perspectives related to antibiotic misuse practices. They also missed an insider look at why the drug providers failed to limit improper ways of antibiotic access and usage, despite their insight of antibiotic resistance risk connected with the practice of their inappropriate use. In this regard, our study was notably broad in scope, allowing for perspectives from a variety of contexts on antibiotic accessibility and use in both urban and rural settings. The exploratory nature of our study aided in gaining a contextual understanding of the factors driving antibiotic misuse practices in the setting. This study is limited by the fact that purposeful sampling was used to acquire rich data from a diverse group of participants; yet, a detailed description of the context, methods and results provided can ensure rigour, facilitating the evaluation of credibility and transferability.73 74 Besides, interviews may be prone to acceptable responses to what participants assume is the correct answer rather than their genuine feelings. However, this desirability was mitigated by using open-ended interview questions that were carefully crafted to avoid leading questions. We also used probes and indirect questions to learn more about how other sellers dispense antibiotics. Furthermore, we considered the full dataset for analysis and reporting. Some domains of the practices reported by participants were a proxy exploration of clients’ behaviours, which examined the approach they follow in their intent to get antibiotic medicines. In addition, the study looked at other health workers’ practices as a proxy. These indirect investigations into clients’ and other health workers’ perspectives on their antibiotic practices lacked a direct confirmation for validation purposes. Despite these limitations, the findings of this study contribute to the body of contextual knowledge about the drivers of antibiotic misuse practices, allowing for a focused response that help to preserve these medications from the hazards of resistance. The study also sheds light on antibiotic misuse by exploring limited formal access to medicines and healthcare systems in remote and underprivileged locations like rural Ethiopia, where clients often obtain antibiotics without a prescription, even from informal sources. Hence, enforcing policy guidance that ensures antibiotic accessibility from formal providers through prescription recommendations and raising public awareness about where to seek healthcare can optimise proper antibiotic usage while reducing the likelihood of resistance.
Conclusion
This study found that profit earnings and the convenience of oversimplified access to medicines were the primary drivers of antibiotic misuse practices in eastern Ethiopia. The study underscored client self-medication pressures, seller business intents, and regulatory and policy gaps on these accounts. Another aspect explored by this study was an ambiguity in conducting the antibiotic dispensing audit, a traditional approach that essentially missed the unlicensed drug sellers. In this regard, enforcing specific antibiotic usage policy guidance, such as an automated dispensing audit, a responsible office, explicit malpractice penalties and antibiotic treatment insurance for people with financial constraints, can help reduce antibiotic misuse and the resulting resistance. Regular public awareness efforts through scheduled media can also help educate them on the necessity of prescribed access to antibiotics from reliable sources.
Data availability statement
All data relevant to the study are included in the article or uploaded as supplementary information.
Ethics statements
Patient consent for publication
Ethics approval
The study was approved by the Institutional Health Research Ethics Review Committee of Haramaya University (with a reference number of IHRERC/007/2023). Participants gave informed consent to participate in the study before taking part.
Acknowledgments
The authors would like to thank all participants for their willingness and active participation in our research. We also thank the Covidence organisation for the 2022 global scholarship award to the first author that helped him acquire the academic skills and resources required for this study.
References
Supplementary materials
Supplementary Data
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Footnotes
X @Dumessa Edessa @Dumessa2
Contributors DE carried out the concept development, participated in study design, data acquisition and analysis, and drafted the manuscript. FAK, GD and LO participated in the study design, data acquisition and analysis, and reviewed the manuscript. All authors read and approved the final manuscript. DE is responsible for the overall content as guarantor.
Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.
Competing interests None declared.
Patient and public involvement Patients and/or the public were involved in the design, or conduct, or reporting or dissemination plans of this research. Refer to the Methods section for further details.
Provenance and peer review Not commissioned; externally peer reviewed.
Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.