Regulatory Compliance and Associated Quality of Amoxicillin in Drug Retail Outlets of Southwestern Ethiopia

Figures & data

Table 1 Background of the Dispensers and Drug Retail Outlets (n=42)

Variables		Frequency	Percentages
Is a drug outlet licenced and valid?	Yes	42	100
	No	0	0
Owner of the drug retail outlet	Professional dispenser	26	61.9
	Nonprofessional dispenser	16	38.1
Service year of the drug retail outlets	<10 years	19	45.2
	>10 years	23	54.8
Estimated income generation per month in Ethiopian birr	<5000 Ethiopian birr	19	45.2
	>5000 Ethiopian birr	23	54.8
Status of the dispenser working in the drug retail outlets	Certified dispenser	39	92.9
	Noncertified dispenser	3	7.1
Experience of dispenser	<10 years	22	52.4
	>10 years	20	47.6
Compliant regarding licensing requirements for drug retail outlets	Yes	12	28.6
	No	30	71.4
Do you have training regarding good storage practice?	Yes	18	42.9
	No	24	57.1

Figure 1 The criteria/cutoff limit of the overall computed mean.

Figure 2 Status of regulatory compliance of drug retail outlets.

Table 2 Association Between Independent Variable and Outcome Variables

Variables		Frequency	Compliance of Status of the Drug Retail Outlets		p-value
			Compliant	Noncompliant
Owner of the drug retail outlet	Professional dispenser	26	18	8	0.026*
	Nonprofessional dispenser	16	5	11
Service year of the drug retail outlets	<10 years	22	14	8	0.344
	>10 years	20	9	11
Estimated income generation per month in Ethiopian Birr	<5000 Ethiopian birr	19	14	5	0.033*
	>5000 Ethiopian birr	23	9	14
Status of the dispenser working in the drug retail outlets	Certified dispenser	39	22	17	0.581
	Noncertified dispenser	3	1	2
Experience of dispenser	<10 years	22	16	6	0.029*
	>10 years	20	7	13
Compliant regarding licensing requirements for drug retail outlets	Yes	12	4	8	0.098
	No	20	19	11
Training regarding good storage practice?	Yes	18	6	12	0.028*
	No	24	17	7

Note: *Statistically significant at p-value <0.05.

Table 3 Results of Quantity of API Capsules of Amoxicillin Samples (n=20) from Drug Retail Outlets

Parameters	Samples Obtained from Outlets that Complied to Regulatory Requirements				Samples Obtained from Outlets Did Not Comply to Regulatory Requirements
	2021-004-001-C		2021-004-002-C	2021-004-003-C	2021-004-004-NC	2021-004-005- NC	2021-004-006- NC
Assay 1 (%lc)	97.0		96.2	97.9	98.2	92.6	95.8
Assay 2 (%lc)	97.3		96.1	98.0	97.8	93.0	95.7
Mean (%lc)	97.2		96.1	97.9	98.0	92.8	95.7
Independent unequal variance t-test
Mean of S1		97.2			98.0
Mean of S2		96.1			92.8
Mean of S3		97.9			95.7

Notes: p-value >0.05. In sample codes C and NC indicate that sample is obtained from compliant and noncompliant drug retail outlets respectively; S1, S2, S3 are sample 1, sample 2, and sample 3, respectively.

Table 4 Cumulative Dissolution Data of Amoxicillin Release at 60 Minutes from the Samples Obtained from Selected Drug Retail Outlets Jimma, Ethiopia

Parameters	Samples Obtained from Outlets that Complied to Regulatory Requirements				Samples Obtained from Outlets Did Not Comply to Regulatory Requirements
	2021-004-001-C		2021-004-002-C	2021-004-003-C	2021-004-004-NC	2021-004-005-NC	2021-004-006- NC
%DR1	104.04		97.92	99.14	96.08	99.75	98.53
%DR2	99.75		102.20	104.04	99.14	100.98	96.69
%DR3	101.59		99.75	100.37	99.75	102.82	97.92
Mean	101.80		99.96	101.18	98.32	101.18	97.71
Independent unequal variance t-test
Mean of %DR of S1		101.80			98.32
Mean of %DR of S2		99.96			101.18
Mean of %DR of S3		101.18			97.71

Notes: p-value >0.05. In sample codes C and NC indicates that sample is obtained from compliant and noncompliant drug retail outlets respectively. DR of S1, DR of S2, DR of S3 are drug release of percentage sample 1, sample 2, and sample 3, respectively.

Figure 3 Calibration curve of amoxicillin reference standard in phosphate buffer at maximum wave length of 272 nm.