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).
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).
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 Outdated antibiotics, such as ampicillin and tetracycline, have been cited as the most commonly used antibiotics for self-medication in the past years.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 They know [or come to the pharmacy and ask for] outdated antibiotics like tetracycline […].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.
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