Antibiotics stewardship: prevalence, nature, and factors associated with dispensing of antibiotics without prescription among community pharmacists in Nigeria

ABSTRACT

Background

Dispensing antibiotics without a prescription is common among community pharmacists in low- and middle-income countries despite its association with antibiotic resistance. This study describes the prevalence and nature of dispensing antibiotics without prescription among community pharmacists in Nigeria and its associated factors.

Method

A cross-sectional study was conducted among community pharmacists in Nigeria with a validated, online, self-administered questionnaire. Reliability was assessed with Cronbach’s alpha. Descriptive and inferential statistics were performed with SPSS Version 2023 at a 0.05% significance level.

Result

A total of 420 community pharmacists participated in the study. The Reliability result was 0.860, implying the data collection tool’s perfect internal consistency. Independent pharmacies represented 87.4% of the respondents, and most were in urban areas (71.4%). Most respondents (98.1%) dispensed antibiotics without prescription, with (84.2%) sometimes requesting laboratory investigations before dispensing antibiotics. Cephalosporin (74.8%), penicillin (70.2%), and quinolones (68.3%) were the major classes of antibiotics dispensed. The pharmacists’ confidence in their clinical skills (78.8%), ability of the antibiotics to cover a broader range of microorganisms (78.0%), inability of patients to access healthcare services in other places (67.3%), emergencies (58.3%), affordability (49.0%), patients’ demand (38.2%), absence of sanctions (34%), not getting prescriptions (33.1%), were the key deciding factors for the pharmacists to dispense antibiotics without prescription or substitute class of antibiotics. Factors like financial incentives, fear of losing clients, fear of expiry, competition from other pharmacies, and trust in patients’ self-diagnosis were low in driving decisions to dispense antibiotics without prescriptions.

Conclusion

Non-prescription dispensing of antibiotics is high among community pharmacists in Nigeria, and is related to various factors. A strategic approach, including mandatory health insurance schemes, prescription and dispensing policies, and enforcement of antimicrobial stewardship regulations by the Nigerian government, is necessary to improve ethical practice and address the irrational dispensing and use of antibiotics in Nigeria.

Background

Communicable and infectious diseases are major health problems in Nigeria (Muhammed et al., 2017). Access to medicines for Nigerians is a critical factor in national healthcare. There is a high prevalence of self-medication with prescription medicines, including antibiotics, and a lack of access to healthcare services due to financial constraints, and out-of-pocket health spending in Nigeria (Olanrewaju et al., 2024). The practice of self-medication and purchasing antibiotics without prescriptions, and the use of antibiotics for self-limiting infections, like upper respiratory tract infections, especially in low- and middle-income countries, play key roles in sub-therapeutic dosing and inappropriate use of antibiotics. These have become global public health concerns and have been implicated as significant factors contributing to the accelerated prevalence of Antimicrobial Resistance (AMR) (Aslam et al., 2018; Auta et al., 2019; Bell et al., 2014; Chokshi et al., 2019; Chukwu et al., 2022; Godman et al., 2020; Salam et al., 2023; Sono et al., 2023).

In 2019, Western sub-Saharan Africa had the highest AMR-attributed death rate (27.3 deaths per 100,000) across all age groups, compared to Australasia, with the lowest (6.5 deaths per 100,000) (Antimicrobial Resistance Collaborators, 2022). In the WHO African region, an estimated 1.05 million deaths were associated with antibiotic resistance, and 250,000 deaths were attributed to antibiotic resistance in 2019 (Antimicrobial Resistance Collaborators, 2024). Nigeria is number 19 of 204 countries with the highest age-standardized mortality rate per 100,000 population associated with AMR (Institute for Health Metrics and Evaluation, n.d.). In 2019, there were 64,500 deaths attributable to AMR and 263,400 deaths associated with AMR, making the number of AMR deaths in Nigeria higher than those from enteric infections, respiratory infections, tuberculosis, maternal and neonatal disorders, neglected tropical diseases, malaria, and cardiovascular diseases (Institute for Health Metrics and Evaluation, n.d.). The mortality, morbidity, prolonged hospitalisation, increased medical costs, and economic burden of microbial resistance have reached epidemic magnitudes and have been linked to serious global public health security threats (Chukwu et al., 2022; Friedman et al., 2016). The cost of antimicrobial resistance, economically and in terms of human health, is immense (Hofer, 2019). Though there is still a lack of studies on the economic burden of antimicrobial resistance from low-income economies and lower-middle-income economies, from a societal perspective and about primary care, a systematic review conducted from a healthcare or hospital perspective, in tertiary care settings reported that the attributable cost of resistant infection ranges from – US$2,371.4 to + US$29,289.1 per patient episode; the mean excess length of stay was 7.4 days, the odds ratios of mortality for resistant infection was 1.844, while readmission was 1.492 (Poudel et al., 2023). According to the Centers for Disease Control and Prevention (CDC), more than two million people in the United States become ill with antibiotic-resistant diseases every year, resulting in a minimum of 23,000 deaths (CDC, 2013). In Russia, Indonesia, and Brazil, 40–60% of infections are caused by resistant microorganisms, and this resistance is predicted to increase 4–7 times faster in these countries compared to other Organisation for Economic Co-operation and Development countries (Hofer, 2019).

The WHO Access, Watch, and Reserve (AWaRe) classification and guidance for antibiotics was established to balance stewardship and appropriate access to antibiotics. It advocates that ‘Access antibiotics’ should constitute 70% of antibiotics dispensed across sectors (United Nations, 2024). Between 2000 and 2015, there was a 90.9% increase in global per-capita consumption of ‘Watch antibiotics’, compared with a 26.2% increase in ‘Access antibiotics’. This rapid increase in ‘Watch antibiotics’ consumption shows the challenges in antibiotic stewardship, especially in low- and middle-income countries. The community consumption of antibiotics is approximately 85–95% of total antibiotics consumption in countries with available data (Duffy et al., 2018), especially with the increasing use of ‘Watch antibiotics’ in low- and middle-income countries (Klein et al., 2021).

One major factor associated with antibiotic self-medication and antibiotic resistance is the inappropriate dispensing and selling of antibiotics without a physician’s prescription, which is a common practice in different parts of the world, especially in low-income and middle-income countries such as Nigeria (Akande-Sholabi et al., 2023; Oga-Omenka et al., 2023). In Nigeria, dispensing antibiotics without prescriptions is common among community pharmacists despite their knowledge of antibiotic stewardship/resistance and regulations prohibiting the act (Abubakar & Tangiisuran, 2020; Akande-Sholabi et al., 2023; Olutuase, 2019). Several studies have identified factors associated with this practice, including patient demand, lack of enforcement of existing regulations, economic incentives, and intention to maintain customer loyalty (Belachew et al., 2021; Roque et al., 2015; Zawahir et al., 2019). In Akwa Ibom state, south-south Nigeria, 68% of pharmacists recommended an antibiotic for common cold, and the most frequently dispensed included azithromycin (43%), amoxicillin/clavulanic acid (24%), and sulphamethoxazole/trimethoprim (20%), while 72% recommended at least one antibiotic for acute diarrhea, with metronidazole (82%) as the most frequently dispensed agent (Akpan et al., 2021). In this regard, some scholars have expressed doubts about the role of pharmacists as healthcare providers and have seen pharmacists as retailers and business people rather than healthcare providers (Akinyandenu & Akinyandenu, 2014). Many similar studies in Nigeria have focused on knowledge, perception, and practices of non-prescription antibiotic dispensing among community pharmacists in Nigeria and have proffered probable solutions for changes in practice (Abubakar & Tangiisuran, 2020; Akande-Sholabi et al., 2023; Akinyandenu & Akinyandenu, 2014; Chukwu et al., 2021; Folorunso et al., 2020; Olutuase, 2019; Ugwu et al., 2023). However, to the researchers’ knowledge, no factors have been investigated that are associated with this undesirable practice. Understanding community pharmacists’ underlying factors and challenges is essential to developing effective and targeted interventions to curb the undesirable practices and mitigate the associated health risks. Therefore, this study investigated the prevalence and nature of dispensing antibiotics without prescription among community pharmacists in Nigeria and its associated factors, as well as proffered recommendations to address the menace.

Methods

Study area

The study area is the Federal Republic of Nigeria, located on the western coast of Africa. It has diverse geography, climates, and languages. Nigeria is comprised of 36 states, and the Federal Capital Territory, with a total area of 923,769 Km², and Lagos State being the most populous city (National Bureau of Statistics, 2017).

Study population

The study population is 4840 community/retail pharmacies registered in Nigeria as of December 31, 2023 (Pharmacy Council of Nigeria, 2023).

Study design

The study is a cross-sectional quantitative study among community pharmacists in all the states of Nigeria.

Sample size determination

The sample size was calculated using the Fisher’s formula.

$$N=Z^2\mathrm{PQ}/D^2$$

Where Z = a constant which is 1.96 at a 95% confidence interval

P = estimated prevalence of worldwide non-prescription antibiotics dispensing in community pharmacies = 63.4% (0.634) (Li et al., 2023).

$$Q=1-P$$

D = absolute precision or sampling error tolerated  = 5%

$$={\displaystyle \frac{{1.96}^2\times 0.634\times 0.366}{{0.05}^2}={\displaystyle \frac{0.867}{0.0025}=346.8=347}}$$

Hence, a minimum sample size of 347 community pharmacists is necessary for the study.

Sampling techniques

We conducted a descriptive, cross-sectional, internet-based survey using a self-administered questionnaire among community pharmacists across all states of Nigeria and the Federal Capital Territory. We used online platforms (WhatsApp and Telegram platforms) to recruit community pharmacists through their respective state leaders. We shared the link to the validated online questionnaire on Google form with the community pharmacy leaders and requested them to share it on their various community pharmacy-based platforms and allow participants to complete the survey voluntarily. Also, the research team members individually broadcasted WhatsApp messages to community pharmacists through our contacts. We continued periodic reminders as long as the data collection period lasted.

Inclusion criteria

Full-time pharmacists, pharmacist directors, and superintendent pharmacists practicing in community pharmacies in Nigeria who consented to participate were included in the study.

Exclusion criteria

Pharmacy graduates undergoing internship training programmes, National Youth Corps Pharmacists, and part-time pharmacists working in community pharmacies, were excluded from the study. The survey tool did not provide for this set of pharmacists.

Data collection and data collection tools

Data collection commenced in April 2024 and ended in June 2024. The questionnaire was drafted following a comprehensive review of previous and similar studies with validated data collection tools (Abdelrahman et al., 2022; Abubakar & Tangiisuran, 2020; Akande-Sholabi et al., 2023; Akpan et al., 2021; Auta et al., 2019; Badger-Emeka et al., 2018; Belachew et al., 2021; Roque et al., 2015; Zawahir et al., 2019). The research team drafted the questionnaire and shared it with eight pharmacists with pharmacy and public health expertise who possess at least a PhD in pharmacy or public health. Four of the experts have conducted and published community-based studies on antibiotic stewardship and antimicrobial resistance in Nigeria. They reviewed the contents to ensure that the questions were comprehensive, clear, coherent, unambiguous, user-friendly, unbiased, related to the study objectives, and fully represented the concept being measured. Thereafter, we piloted the study among 20 pharmacists who were not involved in the study, and the questionnaire was revised based on the comments from the pilot study. We used Cronbach’s alpha coefficient to measure the questionnaire’s internal consistency.

The introduction page provided a concise overview of the background, the survey’s purpose, directions for completing the questionnaire, and a statement on informed consent. The questionnaire was divided into four (4) sections, consisting of seventeen (17) questions. The first section contained eight (8) questions on socio-demography, while the second section consisted of three (3) questions on the nature and prevalence of non-prescription antibiotic dispensing. Section four (4) asked questions on the factors associated with the practice, one of which was a 5-Likert scale question. In contrast, the last section was an open-ended question that sought recommendations to encourage the proper practice. The questionnaire was designed not to permit multiple completion by a respondent and was developed in English language, which is the official language for education, training, and practice in Nigeria.

The questionnaire was hosted online on Google Forms. The access link was shared on community pharmacists’ online platforms, WhatsApp and Telegram groups and individual numbers by the research team and through the various state leads of the Association of Community Pharmacists of Nigeria.

Data analysis

Reliability was assessed with Cronbach’s alpha. Descriptive and inferential statistics were performed with SPSS version 2023 at 0.05% significance.

The collected data was imported and cleaned in Microsoft Excel before being exported to SPSS Version 23. Descriptive statistics were used to summarise the sociodemographic data, classes of antibiotics dispensed and reasons for dispensing antibiotics without prescription. Chi-square was used to test the association between the socio-demographic characteristics of participants and their non-prescription antibiotics dispensing. Recommendations for improved practice were summarised in tests.

Limitation

The survey did not consider situations where relatives and friends make calls to physicians and get recommendations for antibiotics, without a valid prescription, as ethical dispensing.

Only 20 community pharmacists participated in the pretesting of the survey tool. We could not achieve retrieval of pretesting responses from a minimum of 10% (35 participants) of the sample size. The pharmacists indicated their preference to make their ‘voices heard’ through the data collection and publication of the study rather than participating in the pretesting that would not be included in the data for publication. However, this was not expected to compromise the integrity of the study due to the rigour demonstrated in validating the survey tool.

Findings from this study could not be interpreted concerning the AWaRe classification for the dispensed antibiotics, as the data collection instrument did not collect antibiotics dispensed as individual antibiotics. Instead, it was collected as antibiotic classes.

A study design involving simulated clients would have been a more effective method to assess the extent of non-prescription dispensing of antibiotics than a self-completed data collection method to overcome biases associated with self-completion of questionnaires and increase the validity of study findings. However, this was not feasible due to the enormous cost of conducting such a nationwide survey.

Informed consent

Being an online survey, informed consent was obtained from all participants using a question at the beginning of the questionnaire – ‘Do you wish to participate in the study?’. This was included after giving a brief description of the study. Respondents could freely decline or withdraw from the study without any adverse effect.

Ethical approval/ consideration

The ethical approval for the study titled ‘Notification of Executive Approval of Protocol’ was obtained from the Oyo State Hospital Management Board Ethics Committee, Reference Number: NHREC/OYOSHRIEC/10/11/22.

Results

The respondents consisted of 420 community pharmacists. The Cronbach’s alpha assessment result was 0.860, implying a perfect internal consistency of the data collection tool.

Table 1 shows that more than half of the respondents are males (55.8%), a large proportion (43.4%) are more than 40 years, 61.3% have completed at least a Bachelor of Pharmacy degree, about 36.8% have worked in the community pharmacy practice for less than five years, majority work in independent pharmacy outlets (87.4%) and predominantly practice in the South West (54.4%), followed by the South-South (19.8%) and the South East (8.4) regions of Nigeria.

Table 1.

Demographics characteristics of study participants.

S/N	Variables		N (%)
1.	Age	18–29 yrs.	112 (26.7)
		30–40 yrs.	125 (29.8)
		Above 40 yrs	182 (43.4)
2.	Gender	Male	234 (55.8)
		Female	185 (44.2)
3.	Work experience in community pharmacy practice	Less than 5 yrs.	154 (36.8)
		5–10 yrs.	103 (24.6)
		Above 10 yrs.	162 (38.7)
4.	Highest educational qualification	B. Pharm.	257 (61.3)
		Pharm. D	22 (5.3)
		Masters	89 (21.2)
		FPC Pharm.	37 (8.8)
		PhD	14 (3.3)
5.	Position	Pharmacist Director	218 (52.0)
		Superintendent Pharmacists	108 (25.8)
		Full Time Pharmacist	93 (22.2)
6.	Type of pharmacy	Chain Pharmacy	53 (12.6)
		Independent Pharmacy	366 (87.4)
7.	Location of pharmacy	Urban	299 (71.4)
		Semi-urban	98 (23.4)
		Rural	22 (5.3)
8.	Region of practice	South West	228 (54.4)
		South-South	83 (19.8)
		South East	35 (8.4)
		North Central	24 (5.7)
		North East	15 (3.6)
		North West	9 (2.1)
		Abuja	25 (6.0)

B. Pharm. = Bachelors of Pharmacy; Pharm. D = Doctor of Pharmacy; FPC Pharm. = Fellow of West African Postgraduate College of Pharmacy.

Table 2 shows the general behaviour of pharmacists when dispensing antibiotics without prescriptions and how often they request laboratory investigations (culture and sensitivity tests) before dispensing antibiotics. A large proportion sometimes (62.3%) and always (35.8%) engage in this unethical practice, totalling 98.1% of respondents. The majority (84.2%) sometimes request laboratory investigations before dispensing antibiotics. About 31.3% of the respondents rarely substitute antibiotic molecules, while 42.1% sometimes did.

Table 2.

Participants’ behaviour on the dispensing of antibiotics without prescription.

S/N	Variables		N (%)
1.	How often do you dispense antibiotics without a prescription?	Always	150 (35.8)
		Sometimes	261 (62.3)
		Never	8 (1.9)
2.	How often do you request laboratory investigation before dispensing antibiotics to patients?	Always	52 (12.4)
		Sometimes	353 (84.2)
		Never	14 (3.3)
3.	Are there cases where you substitute the antibiotic molecule (not brand) for patients that visit your premises with prescription?	Always	10 (2.4)
		Often	45(10.7)
		Sometimes	110 (42.1)
		Rarely	131 (31.3)
		Never	57 (13.6)

In Figure 1, cephalosporins, penicillins, and quinolones took the lead, with more than 300 respondents agreeing always to dispense without prescriptions. The least dispensed were carbapenems, nitroimidazoles, and aminoglycosides.

Figure 1.

Different classes of antibiotics dispensed without prescription.

The most common reasons community pharmacists dispense antibiotics without prescriptions are represented in Figure 2. Emergencies and not getting prescriptions in their pharmacies were the primary reasons, while trust in patients’ self-diagnosis and economic considerations were the least important.

Figure 2.

Most common reasons for dispensing antibiotics without prescription.

Many factors influenced the choice of antibiotics dispensed without prescriptions, as shown in Figure 3. The ability of the antibiotics to cover a wider range of microorganisms (broad spectrum for suspected infection) was a key deciding factor for 78% of pharmacists, followed by the affordability of medicines (49%). The pharmacists did not always consider the desire to improve sales and many other factors.

Figure 3.

Factors that inform the choice of antibiotics dispensed without prescription.

Figure 4 represents the various reasons for antibiotic molecule substitution among the pharmacists in this study. Economic considerations such as prices of the medicines (where patients cannot afford the prescribed drugs) determine the class of antibiotics for the substitution. Other times, the pharmacists, by their clinical judgment (where interaction with patients suggests that substitution will bring a better outcome), decide which class of antibiotics will give the best outcomes. History of severe adverse drug reactions and side effects by the patient and unavailability of the prescribed medicine in the pharmacy were other factors.

Figure 4.

Reasons for antibiotic class substitution.

Table 3 below represents factors that influence and how they influence participants’ decision to dispense antibiotics without a prescription. The pharmacists’ confidence in their clinical skills and the inability of patients to access healthcare services in other places were very influential in making the pharmacists dispense antibiotics without prescription. Also, syndromic management of sexually transmitted infections according to guidelines, ethical considerations, and the purchasing power of the patient were critical factors in dispensing antibiotics without prescription. Factors like patients’ demand, absence of sanctions, competition from other pharmacies, fear of losing clients, financial incentives, and fear of expiry were low in driving decisions to dispense antibiotics without prescriptions.

Table 3.

Factors that are influential in the participants’ decision to dispense antibiotics without a prescription.

S/N	Variables	N (%)
		Not Influential	Somewhat Influential	Moderately Influential	Influential	Very Influential
1.	Patient's demand or preference (insisting on getting antibiotics)	184 (43.9)	75 (17.9)	88 (21.0)	34 (8.1)	38 (9.1)
2.	Confidence in personal clinical judgment	39 (9.3)	50 (11.9)	116 (27.7)	91 (21.7)	123 (29.4)
3.	Inability of patients to access healthcare services (e.g. clinics and hospitals)	62 (14.8)	75 (17.9)	138 (32.9)	79 (18.9)	65 (15.5)
4.	Patients’ lack of access to health insurance	114 (27.2)	74 (17.7)	107 (25.5)	62 (14.8)	62 (14.8)
5.	No sanctions for dispensing without prescriptions	215 (51.3)	62 (14.8)	79 (18.9)	25 (6.0)	38 (9.1)
6.	Opportunity to carry out the syndromic management of STI which we have been empowered by policy to do	88 (21.0)	102 (24.3)	98 (23.4)	60 (14.3)	71 (16.9)
7.	Competition from other pharmacies	275 (65.6)	66 (15.8)	45 (10.7)	18 (4.3)	15 (3.6)
8.	Fear of losing clients	253 (60.4)	72 (17.4)	50 (11.9)	28 (6.7)	15 (3.6)
9.	Ethical considerations and professional responsibility	40 (9.5)	65 (15.5)	137 (32.2)	77 (18.4)	102 (24.3)
10.	If I do not dispense it, they will get it from illegal medicine stores that stock antibiotics	170 (40.6)	74 (17.7)	90 (21.5)	34 (8.1)	51 (12.2)
11.	Patient's prior experience with the antibiotic	139 (33.2)	113 (27.0)	93 (22.2)	33 (7.1)	41 (9.8)
12.	Financial incentives	210 (50.1)	87 (20.8)	78 (18.6)	30 (7.2)	14 (3.3)
13.	Patients’ socioeconomic factors (not having enough money to visit the hospital)	57 (13.6)	80 (19.1)	143 (34.1)	84 (20.0)	55 (13.1)
14.	Patients feel hospital services are more expensive	95 (22.7)	90 (21.5)	121 (28.9)	62 (14.8)	51 (12.2)
15.	Antibiotics will expire if I do not get prescriptions	265 (63.2)	61 (14.6)	55 (13.1)	21 (5.0)	17 (4.1)

In Table 4 below, dispensing without prescription was higher among pharmacists with more than five years of working experience than younger colleagues. Likewise, in chain pharmacy outlets, dispensing without prescription was higher among pharmacists than in independent pharmacies. Other slight differences exist in the location, region of practice, and position held, although there was no significant association at p < 0.05.

Table 4.

Chi-Square association between ‘How often the participants dispense antibiotics without a prescription’ and their socio-demographic variables.

S/N	Demographic Variables		How often do you dispense antibiotics without a prescription?			P- Value
			Always N (%)	Sometimes N (%)	Never N (%)
1.	Age	18–29 yrs.	41 (36.6)	69 (61.6)	2 (1.8)	0.357
		30–40 yrs.	46 (36.8)	79 (63.2)	0 (0.0)
		Greater than 40	63 (34.6)	113 (62.1)	6 (3.3)
2.	Gender	Male	82 (35.0)	148 (63.2)	4 (1.7)	0.872
		Female	68 (36.8)	113 (61.1)	4 (2.2)
3.	Work experience in community pharmacy practice	Less than 5 yrs.	56 (36.4)	96 (36.8)	2 (1.3)	0.722
		5–10 yrs.	36 (35.0)	66 (64.1)	1 (1.0)
		Above 10 yrs.	58 (35.8)	99 (61.1)	5 (3.1)
4.	Highest educational qualification	B. Pharm.	89 (34.6)	163 (63.4)	5 (1.9)	0.832
		Pharm. D	7 (31.8)	15 (68.2)	0 (0.0)
		Masters	34 (38.2)	52 (58.4)	3 (3.4)
		FPC Pharm.	16 (43.2)	21 (56.8)	0 (0.0)
		PhD	4 (28.6)	10 (71.4)	0 (0.0)
5.	Position	Pharmacist Director	80 (36.7)	133 (61.0)	5 (2.3)	0.945
		Superintendent Pharmacist	37 (34.3)	69 (63.9)	2 (1.9)
		Full Time Pharmacist	33 (35.5)	59 (63.4)	1 (1.1)
6.	Type of pharmacy	Chain Pharmacy	17 (32.1)	36 (67.9)	0 (0.0)	0.427
		Independent Pharmacy	133 (36.3)	225 (61.5)	8 (2.2)
7.	Location of pharmacy	Urban	110 (36.8)	184 (61.5)	5 (1.7)	0.804
		Semi-urban	34 (34.7)	62 (63.3)	2 (2.0)
		Rural	6 (27.3)	15 (68.2)	1 (4.5)
8.	Region of practice	South West	83 (36.4)	142 (62.3)	3 (1.3)	0.829
		South South	27 (32.5)	54 (65.1)	2 (1.6)
		South East	15 (42.9)	20 (57.1)	0 (0.0)
		North Central	6 (25.0)	17 (70.8)	1 (4.2)
		North East	5 (33.3)	9 (60.0)	1 (6.7)
		North West	3 (33.3)	6 (66.7)	0 (0.0)
		Abuja	11 (44.0)	13 (52.0)	1 (4.0)

Table 5 below shows that the type of pharmacy outlet (p = 0.024) and region of pharmacy practice (p = 0.042) are significantly associated with requesting laboratory investigation before dispensing antibiotics to patients at p < 0.05. The southwest and south-south regions of the country took the lead in always requesting laboratory investigations before dispensing antibiotics. Chain pharmacies showed a similar pattern compared to independent pharmacies.

Table 5.

Chi-Square association between ‘How often the participants request laboratory investigation before dispensing antibiotics’ and their socio-demographic variables.

S/N	Demographic Variables		How often do you dispense antibiotics without a prescription?			P- Value
			Always N (%)	Sometimes N (%)	Never N (%)
1.	Age	18–29 yrs.	41 (36.6)	69 (61.6)	2 (1.8)	0.357
		30–40 yrs.	46 (36.8)	79 (63.2)	0 (0.0)
		Greater than 40	63 (34.6)	113 (62.1)	6 (3.3)
2.	Gender	Male	82 (35.0)	148 (63.2)	4 (1.7)	0.872
		Female	68 (36.8)	113 (61.1)	4 (2.2)
3.	Work Experience in Community Pharmacy Practice	Less than 5 yrs.	56 (36.4)	96 (36.8)	2 (1.3)	0.722
		5–10 yrs.	36 (35.0)	66 (64.1)	1 (1.0)
		Above 10 yrs.	58 (35.8)	99 (61.1)	5 (3.1)
4.	Highest Educational Qualification	B. Pharm.	89 (34.6)	163 (63.4)	5 (1.9)	0.832
		Pharm. D	7 (31.8)	15 (68.2)	0 (0.0)
		Masters	34 (38.2)	52 (58.4)	3 (3.4)
		FPC Pharm.	16 (43.2)	21 (56.8)	0 (0.0)
		PhD	4 (28.6)	10 (71.4)	0 (0.0)
5.	Position	Pharmacist Director	80 (36.7)	133 (61.0)	5 (2.3)	0.945
		Superintendent Pharmacist	37 (34.3)	69 (63.9)	2 (1.9)
		Full Time Pharmacist	33 (35.5)	59 (63.4)	1 (1.1)
6.	Type of Pharmacy	Chain Pharmacy	17 (32.1)	36 (67.9)	0 (0.0)	0.427
		Independent Pharmacy	133 (36.3)	225 (61.5)	8 (2.2)
7.	Location of Pharmacy	Urban	110 (36.8)	184 (61.5)	5 (1.7)	0.804
		Semi-urban	34 (34.7)	62 (63.3)	2 (2.0)
		Rural	6 (27.3)	15 (68.2)	1 (4.5)
8.	Region of Practice	South West	83 (36.4)	142 (62.3)	3 (1.3)	0.829
		South-South	27 (32.5)	54 (65.1)	2 (1.6)
		South East	15 (42.9)	20 (57.1)	0 (0.0)
		North Central	6 (25.0)	17 (70.8)	1 (4.2)
		North East	5 (33.3)	9 (60.0)	1 (6.7)
		North West	3 (33.3)	6 (66.7)	0 (0.0)
		Abuja	11 (44.0)	13 (52.0)	1 (4.0)

** Values show a significant difference at p = 0.05.

In Table 6, class substitution of antibiotics was highest in rural and semi-urban areas compared to urban areas. Regions of practice, type of pharmacy, educational qualification, age, and gender of participants did not significantly correlate with the practice of antibiotic class substitution among the participants.

Table 6.

Chi-Square association between ‘Cases where participants substitute the antibiotic molecule for patients with prescription’ and their socio-demographic variables.

S/N	Demographic Variables		Are there cases where you substitute the antibiotic molecule (not brand) for patients that visit your premises with prescription?					P- Value
			Always N (%)	Often N (%)	Sometimes N (%)	Rarely N (%)	Never N (%)
1.	Age	18–29 yrs.	4 (4.0)	16 (16.2)	28 (28.3)	36 (36.4)	15 (15.2)	0.07
		30–40 yrs.	6 (5.8)	16 (15.5)	27 (26.2)	36 (35.0)	18 (17.5)
		Greater than 40	0 (0.0)	13 (8.6)	55 (36.4)	59 (39.1)	24 (15.9)
2.	Gender	Male	6 (3.2)	28 (14.8)	62 (32.8)	69 (36.5)	24 (12.7)	0.296
		Female	4 (2.4)	17 (10.4)	48 (29.3)	62 (37.8)	33 (20.1)
3.	Work experience in community pharmacy practice	Less than 5 yrs.	6 (4.6)	20 (15.3)	42 (32.1)	45 (34.4)	18 (13.7)	0.586
		5–10 yrs.	3 (3.3)	12 (13.3)	27 (30.0)	33 (36.7)	15 (16.7)
		Above 10 yrs.	1 (0.8)	13 (9.8)	41 (31.1)	53 (40.2)	24 (18.2)
4.	Highest educational qualification	B. Pharm.	7 (3.2)	34 (15.3)	66 (29.7)	80 (36.0)	35 (15.8)	0.479
		Pharm. D	1 (5.0)	3 (15.0)	3 (15.0)	10 (50.0)	3 (15.0)
		Masters	2 (2.8)	8 (11.3)	24 (33.8)	24 (33.8)	13 (18.3)
		FPC Pharm.	0 (0.0)	0 (0.0)	10 (35.7)	13 (46.4)	5 (17.9)
		PhD	0 (0.0)	0 (0.0)	7 (58.3)	4 (33.3)	1 (1.8)
5.	Position	Pharmacist Director	3 (1.7)	21 (11.9)	55 (31.1)	71 (40.1)	27 (15.3)	0.663
		Superintendent Pharmacist	4 (4.3)	12 (13.0)	24 (26.1)	34 (37.0)	18 (19.6)
		Full Time Pharmacist	3 (3.6)	12 (14.3)	31 (36.9)	26 (31.0)	12 (14.3)
6.	Type of pharmacy	Chain Pharmacy	1 (2.1)	6 (12.8)	16 (34.0)	17 (36.2)	7 (14.9)	0.989
		Independent Pharmacy	9 (2.9)	39 (12.7)	94 (30.7)	114 (37.3)	50 (16.3)
7.	Location of pharmacy	Urban	6 (2.3)	30 (11.6)	87 (33.7)	95 (36.8)	40 (15.5)	0.032**
		Semi-urban	2 (2.5)	10 (12.5)	19 (23.8)	34 (42.5)	15 (18.8)
		Rural	2 (13.3)	5 (33.3)	4 (26.7)	2 (13.3)	2 (13.3)
8.	Region of practice	South West	3 (1.4)	26 (12.6)	73 (35.3)	67 (32.4)	38 (18.4)	0.099
		South-South	2 (3.3)	7 (11.5)	11 (18.0)	31 (50.8)	10 (16.4)
		South East	1 (4.0)	6 (24.0)	5 (20.0)	11 (44.0)	2 (8.0)
		North Central	0 (0.0)	1 (5.6)	8 (44.4)	9 (50.0)	0 (0.0)
		North East	1 (9.1)	1 (9.1)	2 (18.2)	5 (45.5)	2 (18.2)
		North West	1 (11.1)	0 (0.0)	4 (44.4)	3 (33.3)	1 (11.1)
		Abuja	2 (9.1)	4 (18.2)	7 (31.8)	5 (22.7)	4 (18.2)

** Values show a significant difference at p = 0.05.

Discussion

This study examined the non-prescription antibiotic dispensing prevalence, nature, and associated factors among community pharmacists in Nigeria and found that dispensing antibiotics without prescription among community pharmacists in Nigeria has grown to an alarming proportion, raising serious concerns about associated factors and threat to public health. The pharmacists always and often dispensed antibiotics without a prescription and recourse to complete laboratory investigations. This finding is similar to a study in Tanzania that employed the ‘mystery client’ technique and reported widespread and rampant (88.2%) sales of antibiotics without prescription (Ndaki et al., 2021), and a similar study in Southern Nigeria that found a high rate of inappropriate antibiotics dispensing among community pharmacists (Akpan et al., 2021) but is contrary to findings in another study conducted in Northern Nigeria in which a far lower number of community pharmacists (39%) dispense antibiotics without prescription (Abubakar & Tangiisuran, 2020). Also, on the contrary, a similar study conducted in the Federal Capital Territory of Nigeria reported that community pharmacists often or always dispensed antimicrobials with prescriptions (Ugwu et al., 2023). Disparities in these findings may be associated with the fact that the previous Nigerian studies surveyed only two states. In contrast, the present study cut across the entire country and is therefore more representative of non-prescription antibiotic dispensing and their associated factors.

The most common antibiotics dispensed without prescription by the respondents were Cephalosporin, penicillin, and quinolones. This is similar to findings from other studies where ampicillin, amoxicillin, ciprofloxacin (quinolone), and metronidazole were the most common antibiotics dispensed without prescription (Nabeel et al., 2024), and 100% of them were available over the counter without prescriptions (Tor-Anyiin et al., 2020). Penicillin and quinolones are notorious for their good efficacy in upper respiratory tract infections, typhoid, and respiratory tract infections, making their indiscriminate use without prescriptions and laboratory investigations very easy (Kumar et al., 2022). The antibiotic class substitution was also a key issue in this study as more than half of the pharmacists often and or sometimes engage in it due to the prices of the medicines and pharmacists’ clinical judgment. Similar reasons were reported in another study where class substitution was usually driven by price and availability factors, dosage differences, and the need for a better therapeutic outcome (Alsufyani et al., 2023).

The major reasons advanced by the participants of this study for dispensing antibiotics without prescriptions include emergencies and not getting prescriptions in their pharmacies. This is contrary to findings from systematic research where significant reasons for antibiotics dispensing without a prescription were reported as insufficient controls over antibiotics sales, laws enforcement and policies on antibiotics dispensing, and a lack of pharmacists in community pharmacies (Batista et al., 2020; Marković-Peković et al., 2017). The pharmacists’ confidence in their clinical skills, ethical considerations, and professional responsibility, patients’ socio-economic factors, the inability of patients to access healthcare services in other places, patients’ lack of access to health insurance, syndromic management of sexually transmitted diseases according to guidelines and the purchasing power of the patient were very influential in making the pharmacists dispense antibiotics without prescription. Some of these influential factors are related to reasons reported by studies that included financial costs associated with the drugs and convenience, and inexistent law enforcement as reasons for distributing and purchasing antibiotics without prescription (Abdelrahman et al., 2022; Kakati et al., 2023; Nabeel et al., 2024). This contradicts a report from another study that suggests that pharmacists do not have adequate knowledge of the rational use of antibiotics (Abubakar & Tangiisuran, 2020).

Irrational use of antibiotics has been reported in many developing countries, including Eritrea, Nigeria, Pakistan, etc., and the primary driving force, as is also highlighted in this study, is weak regulation and policies (Akinyandenu & Akinyandenu, 2014). In Nigeria and many other developing nations, pressure from patients can aggregate the issue as open drug markets and patent medicine dealers who are poorly regulated create a scenario where the pharmacist must dispense or allow the patient to find alternative sources (Abdelrahman et al., 2022). This is also the case with findings from this study, where some respondents reported that if they do not dispense antibiotics without a prescription, the clients will purchase them from other sources, such as the illegal medicines stores that stock antibiotics.

Syndromic management of sexually transmitted infections has robust guidelines for implementation that require the use of a specific combination of antibiotics to treat the condition without full details on the causative organism. Respondents in this study have relied on this guideline to dispense antibiotics without prescription. Medicine shortage and unaffordability are major drivers of antibiotics class substitution in this study. Class substitution was significantly correlated with the pharmacists in this study, as more practice was reported in rural areas than in urban or semi-urban areas. Ndaki et al. (2021) reported higher practices of dispensing antibiotics without prescription in rural areas than urban areas. This is not surprising as residents of rural areas may not be able to afford the brand of prescribed antibiotics and community pharmacists may use their clinical judgment to substitute affordable brands or generics. While substitution of drugs may seem logical, especially in closely related classes, continuity and adverse effects, including dangers of antimicrobial resistance due to slight differences in sensitivities, are major concerns. Any potential failure from class substitution will likely enhance resistance and a sequel of economic impact, thus setting up a negative feedback loop (Miljković et al., 2020). Therefore, the government and regulatory agencies must effectively address medicine shortages and costs to ensure round-the-clock availability and reduce class substitution of antimicrobials.

In this study, pharmacists with more years of experience practice antibiotic dispensing without prescriptions more than those with lower experience. This contradicts findings by Nabeel et al. (2024) in which younger pharmacists with less than 5 years of experience engage in poor practice than more experienced pharmacists. Reasons cited in the later study included the lack of continuing education to bring older pharmacists to trends in pharmaceutical care and the dangers of antimicrobial resistance. Lack of continuing education was also cited in a Spanish study among pharmacists (Vazquez-Lago et al., 2017). In the present study, our findings might also be associated with higher confidence among pharmacists with more years of experience in their clinical expertise, leading to disregard for prescriptions. However, in their study, Kumar et al. (2022) did not report any significant increase in knowledge about antibiotic use among pharmacists with more years of practice. Also, the region of pharmacy practice had a substantial impact on dispensing without prescription and laboratory investigations. The southwestern and south-south regions of Nigeria, consisting of states like Lagos, Ogun, Delta, Edo, and Port Harcourt, had the highest practices of always requesting laboratory investigations before dispensing antibiotics. However, they did not significantly differ from other regions in the sale of antibiotics without prescriptions. Lagos state has the highest number of pharmacists and pharmacies as the economic hub of Nigeria (Pharmacy Council of Nigeria, 2023). This correlates well with urban settlement and lesser practices of indiscriminate dispensing of antibiotics. However, a study by Chukwu et al. (2021) among six select states in Nigeria still pitched Lagos with the highest irrational use (prescription and dispensing combined) of antibiotics.

Over-the-counter antimicrobial dispensing is fuelling the emergence and spread of antimicrobial resistance. There is a need for an active and effective engagement of community pharmacists in antibiotic stewardship programmes to reverse the current antimicrobial use trends in low- and middle-income countries, including Nigeria (Oga-Omenka et al., 2023).

Ensuring appropriate antibiotic use is essential for maintaining the efficacy of existing antibiotics and for population’s overall health and well-being. Though the WHO AWaRe antibiotic classification and guidance has yet to be incorporated in the Nigerian Essential Medicines List (EML) and Standard Treatment Guideline (STG), processes have advanced for its inclusion in the ongoing review by the Federal Ministry of Health. The reviewed EML and STG are expected to become national antibiotic stewardship tools (Sharland et al., 2019). Further studies are recommended to investigate the non-prescription dispensing of antibiotics with the AWaRe antibiotic classification and guidance for individual antibiotics, build on the increasing use of the AWaRe system across countries and develop quality indicators to improve appropriate antibiotic use.

The Nigerian government, in collaboration with the Pharmacy Council of Nigeria, Association of Community Pharmacists of Nigeria, National Agency for Food Administration and Control, and other health stakeholders, through its One Health AMR National Action Plan 2.0 (2024–2028), is making efforts to develop a national system for reporting of Antimicrobial consumption data at all levels, including public and private hospitals and community pharmacists, and also to educate the public against irrational requests for antimicrobials. The education of the public aligns with reports that self-purchasing antibiotics – especially for self-limiting viral infections is a key driver of AMR in LMICs/African countries (Godman et al., 2020; Sono et al., 2023). Also, the AMR plan seeks to develop an antimicrobial/stewardship policy and support the enforcement of policy around antimicrobial procurement, distribution, prescription, sale, dispensing, and use in human and animal health (NCDC, 2024). In addition, the pharmacy profession at the regulatory and association levels included courses on antibiotic stewardship and antimicrobial resistance at the graduate and postgraduate university curricula, other research institutions, and continuing professional development programmes for pharmacists.

Though the total elimination of dispensing of antibiotics without a prescription may be difficult in Africa, especially in rural areas where community pharmacists may be the only available healthcare professionals, the strategic multisectoral coordination and dedicated sector-specific approaches that the Nigerian government is implementing will effectively reduce the undesirable practice of non-prescription of antimicrobials and address the evolving challenges posed by AMR across the country.

Conclusion

This study assessed critical issues in the prevalence and nature of non-prescription antibiotic dispensing among community pharmacists in Nigeria. It has unravelled some undocumented factors associated with the widely reported dispensing of antibiotics without prescription among community pharmacists in Nigeria. This undesirable practice is high among community pharmacists. It is related to factors such as emergencies, not getting prescriptions, medication costs, confidence in their clinical skills, inadequate access of the public to other healthcare providers in rural areas, and opportunity to practice syndromic management of sexually transmitted infections. Respondents recommended more strategic approaches, such as mandatory national and community-based health insurance schemes, institution of prescription and dispensing policy, and enforcement of extant regulations regarding antimicrobial stewardship by the Nigerian government, to improve ethical practice, ensure health equity, and address the irrational dispensing and use of antibiotics in Nigeria.

Disclosure statement

No potential conflict of interest was reported by the author(s).