Browsing by Author "Ojewole, Elizabeth Bolanle."

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Adverse drug reactions associated with antiretroviral therapy in South Africa.
(2016) Birbal, Sumeshni.; Oosthuizen, Frasia.; Ojewole, Elizabeth Bolanle.
Abstract available in PDF file.
Awareness, attitudes, and experiences of patients taking antiretrovirals towards adverse drug reactions at a public health facility in KwaZulu-Natal.
(2020) Tlaila, Malebogo.; Ojewole, Elizabeth Bolanle.
Adverse drug reactions (ADRs) are undesirable side effects that occur even when a drug is administered at the proper dose and correctly for an appropriate indication. Given the high prevalence of Human Immuno-deficiency Virus (HIV) in South Africa, more than 3 million people are reported to be taking antiretrovirals (ARVs). Therefore, patients taking ARVs may also be taking other medicines due to other existing diseases such as diabetes, hypertension, and tuberculosis. The concurrent use of other medicines with ARVs may increase the potential of ADRs, snowballing to increased numbers of hospitalisations and contributing to mortality rates. The study investigated awareness, attitudes, and experiences of ADRs among patients taking ARVs. This was a descriptive cross-sectional study using a questionnaire that contained closeended questions to which patients responded. The study was conducted at a selected public hospital in KwaZulu-Natal. Questionnaires were available in both English and isiZulu and were hand delivered to patients. Ethical approval was obtained prior to commencement of this study. The participants were recruited by a random systematic selection by choosing every second participant. Both verbal and written consents were obtained before handing out questionnaires for participation. Statistical Package for Social Sciences (SPSS®) version of 25 was used to capture and analyse data. Categorical measurements were summarised using frequencies and proportions. Out of 200 questionnaires, a total of 174 patients responded, which delivered an 87% response rate. Of the 174 respondents, 55% (n=96) were females and 45% (n=78) were males. About 8% (n=13) of respondents were aware of ADRs, 55% (n=94) of drug–drug interactions and 12% (n=20) had reported ADRs. About 13% (n=22) respondents reported having hypertension, 7% (n=4) respondents reported diabetes and 1% (n=2) respondents reported tuberculosis. Almost 65% (n=114) respondents took the fixed drug combination, 17% (n=30) respondents took lamivudine and zidovudine combination, and 2.3% (n=4) respondents took ritonavir and atazanavir combinations. About 5% (n=8) respondents experienced vomiting, 1.7% (n=3) of respondents experienced diarrhoea and 1.1% (n=2) respondents experienced rashes. Most patients on ARVs and anti-TB medicines can experience reduced hearing or deafness, particularly in patients using medicines such as Kanamycin. Most medicines metabolised by CYP450, such as rifampicin and lopinavir/ritonavir combination, where rifampicin lowers ritonavir blood serum levels therefore requiring a boost of ritonavir. Patients should therefore be made aware of ADRs of ARVs, particularly those that may arise due to drug-drug interactions among the patients that have coexisting diseases. Patients should also be counselled to report ADRs, to obtain the ADR form, complete it and ensure they submit the ADR reports the healthcare professionals as well as the pharmacovigilance centre. The awareness of ADRs among patients taking ARVs could be improved by providing quality training and in-depth counselling of the patients during their visit to the hospital in order to ensure optimal therapy and patients safety.
Enhancing the buccal permeability potential of model ARV drugs : permeability and histo-morphological evaluations.
(2013) Rambharose, Sanjeev Kumar.; Govender, Thirumala.; Ojewole, Elizabeth Bolanle.
Buccal delivery of antiretroviral (ARV) drugs may overcome disadvantages such as low bioavailability due to extensive first pass effects and gastrointestinal degradation associated with the oral route. However, the small mucosal surface area and low membrane permeability are challenges to buccal drug permeation. Identification of new permeation enhancers as well as new permeation enhancing strategies have been shown to overcome these limitations, thereby delivering adequate amounts of drug through the buccal mucosa. Polymeric excipients with previously reported mucoadhesive and controlled release properties could also possess additional buccal permeation enhancing effects and may therefore serve as multifunctional excipients in a buccal drug delivery system. Therefore the aims of this study were: 1) to identify and compare the buccal permeability potential of tenofovir (TNF) and didanosine (ddI). 2) to identify the buccal permeation effects of potential multifunctional excipients ie. carboxymethylcellulose (CMC), sodium alginate (SA), polyacrylic acid (PAA) and polyethylene glycol (PEG) for TNF and ddI, and 3) to identify the buccal permeation potential of saquinavir (SQV) and assess the effect of high-energy ball milling on its permeability. All in vitro permeation studies across porcine buccal mucosa were performed using vertical Franz diffusion cells with TNF, ddI and SQV being quantified using UV spectrophotometry at 262 nm, 250 nm and 239 nm respectively. The histomorphological evaluations were undertaken by light microscopy (LM) and Transmission Electron Microscopy (TEM). Ball milling of SQV samples for 1, 3, 15 and 30 hours was performed in a high-energy planetary mill. The integrity of the buccal mucosa was assessed by transepithelial electrical resistance (TEER) measurements using a Millicell ERS meter connected to a pair of chopstick electrodes. Both TNF and ddI were able to permeate the buccal mucosa in a concentration-dependent manner. A higher permeability was observed for ddI (Flux = 181.62 ± 23.62 μg/cm2h) as compared to TNF (Flux = 102.10 ± 19.80 μg/cm2h). The permeation of these drugs in the absence of enhancers was attributed to passive diffusion via the paracellular route with transcellular route being an additional possibility for ddI. The addition of PAA, SA, CMC and PEG increased the permeability of TNF whilst only PEG was able to increase the permeability of ddI. The effect of these polymeric excipients appeared to be dependent on their ionic charges as well as that of the respective drugs. Permeability enhancement ratios for ddI and TNF were 1.63 and 1.74 respectively with PEG (0.5 %w/v) and CMC (0.5 %w/v) respectively. A maximum enhancement ratio of 2.13 for TNF was achieved with 4 %w/v PEG. Furthermore PEG was identified as the optimal permeation enhancer for TNF and ddI. Histological investigations revealed no significant loss in cellular integrity for mucosa treated with either TNF or ddI alone or when coupled with PEG as an enhancer. The differences in histomorphological changes in response to TNF and ddI alone could support the greater permeation observed with ddI. The histological findings proved useful in assessing the effects of drug and enhancer on mucosal integrity and provided insight into permeation pathways across the mucosa. Selective polymeric excipients therefore provide an effective means to increase the penetration of ddI and TNF. Their previously reported mucoadhesive and controlled release properties coupled with their permeation enhancing effects shown in this study highlight their potential use as multifunctional excipients for the design of buccal drug delivery systems. SQV, a candidate for buccal drug delivery, is limited by its poor solubility. Therefore, Aim 3 identified the effects of high energy ball milling on the buccal permeability of SQV and compared it’s enhancing effect to the conventional use of common chemical enhancers together with unmilled SQV i.e. ethylenediaminetetraacetic acid (EDTA), sodium lauryl sulphate (SLS), PEG and beta cyclodextrin (ß-cyclodextrin). Unmilled SQV was able to permeate through the buccal mucosa with a flux of 3.99 ± 0.11μg/cm2h. Ball milling of SQV at all the time periods led to an increase in its permeability with optimal enhancement obtained at 15 hours with an enhancement ratio of 2.61. The enhanced permeability of the milled SQV samples was attributed to a contribution of various factors such as solubility, particle size, surface area, crystallinity, morphology and the formation of solid dispersions. The chemical permeation enhancers were also able to increase the permeability of unmilled SQV across the buccal mucosa, with SLS achieving the greatest enhancement ratio of 1.75. However, ball milling of SQV without any chemical permeation enhancers displayed to a greater enhancement ratio (2.61) as compared to the best permeation enhancer SLS at 0.5 %w/v (1.75). Histological investigations revealed no significant loss in cellular integrity for mucosa treated with either unmilled or milled SQV samples. The presence of larger intercellular spaces in the treated tissue suggests that SQV also uses the paracellular route of transport in combination with the transcellular route across the mucosa. High energy ball milling of SQV is therefore an effective approach for increasing buccal permeability when formulating SQV for a buccal delivery system, as compared to incorporating common chemical enhancers studied at 0.5% w/v for this purpose. The findings in this study will therefore contribute to formulation optimization strategies for the development of novel buccal delivery systems for ARV drugs, thereby optimising treatment of patients with HIV and AIDS.
Experiences of Implanon NXT® users at public health facilities in South Africa.
(2018) Prosad, Shimona.; Ojewole, Elizabeth Bolanle.
Background and aim: Implanon NXT® was introduced in South Africa (SA) in the public health sector in February 2014. There exist concerns with premature Implanon NXT® user discontinuation in SA however, the true extent remains unknown due to delayed monitoring systems and limited empirical data. This study aimed to evaluate the experiences of Implanon NXT® among users in the public health sector in SA. Methods: A retrospective study was conducted and entailed analysis of secondary data attained from the National Department of Health Pharmacovigilance Centre for Public Health Programmes using reports submitted from 1 April 2015 to 11 September 2017. A total of 3743 cases were extracted and analysed using SPSS®. Tests of association were performed using demographics, adverse drug reactions and discontinuation variables. Chi square test and Mann Whitney U-Test were performed to test differences between Gauteng and KwaZulu-Natal (KZN). Results: The 20-24-year olds were the most frequent Implanon NXT® users (25.70%; 962/3743). Of the 36.57% (1369/3743) cases which reported adverse drug reactions (ADRs), menorrhagia (52.01%;712/1369), headache (20.45%;280/1369) and dizziness (11.18%;153/1369) were the most frequent ADRs. Discontinuation was reported by 63.56% (2379/3743) of case reports and premature discontinuation was reported by 81.1% (1210/1492). The common reasons for discontinuation were menorrhagia (34.27%;728/2124), expiry (29.57%;628/2124) and headache (10.26%;218/2124). Overall, ADRs were found to be the main reason for discontinuation (83.99%; 1784/2124). Pregnancies reported with Implanon NXT® occurred in 4.97% (68/1369) of case reports and efavirenz-based therapy was suspected to be associated with pregnancy in Implanon NXT® users (p<0.001). The common ADRs and reasons for discontinuation of Implanon NXT® reported in Gauteng was consistent with the national data while drug interaction and pregnancy were commonly reported in KZN. Premature discontinuation of Implanon NXT® was higher in Gauteng (82.6%, 252/305) than KZN (76.7%, 23/30). Conclusion: Young women were frequent users of Implanon NXT® . Menorrhagia was the predominantly reported ADR among all the users. A high frequency of discontinuation was identified, and ADRs were mainly responsible for discontinuation. The frequency of failure was small and efavirenz was suspected to be associated. The experiences of Implanon NXT® users differed between KZN and Gauteng which emphasizes tailored strategies need to be considered. Users’ counselling, adverse drug reaction treatment and management, monitoring and evaluation are recommended to address high discontinuation in SA.
Exploring the buccal delivery potential of an antiretroviral drug.
Ojewole, Elizabeth Bolanle.; Govender, Thirumala.
Whilst antiretroviral drugs (ARVs) have significantly improved treatment of Human Immunodeficiency Virus infection and Acquired Immune Deficiency Syndrome (HIV and AIDS), several limitations exist with their oral route of administration. Several orally administered ARVs such as, didanosine, saquinavir, tenofovir and zidovudine are associated with low and erratic bioavailability due to extensive first pass effect (FPE) as well as gastrointestinal (GI) acids and enzymatic degradation. Moreover, the half-life for several ARV drugs is short, which requires frequent administration of doses leading to systemic side effects and decreased patient compliance. Alternative routes of administration, such as buccal, rectal and vaginal, are widely investigated in the literature. Buccal delivery of drugs may therefore overcome the above limitations by bypassing FPE and GI degradation, thus improving bioavailability. Furthermore, drug absorption following buccal administration is not influenced by the potential variations in the gastric emptying rate or the presence of food. However, drug absorption can be limited by low buccal permeability due to the epithelial lining the mucosa. Identifying optimal novel enhancers is paramount to designing and developing drugs as buccal delivery systems. In an attempt to explore the potential of the buccal mucosal route for the delivery of an ARV drug using didanosine (ddI) as a model drug, the aims of this study were to: 1] investigate the permeability properties of ddI across the buccal mucosa route in order to determine its suitability for development as a buccal delivery system, 2] determine the effects of novel permeation enhancers, i.e. aloe vera gel (AVgel), oleic acid (OA) and its novel synthesized oleodendrimer derivatives, on the buccal permeability of ddI, and 3] to find out (through histomorphological evaluation) whether ddI and the novel enhancers, i.e. AV gel and novel OA derivatives have any toxic effects on the buccal mucosa. The buccal mucosa was harvested from pigs, and all the excess connective tissue was surgically removed. In vitro buccal permeation experiments were undertaken using modified vertical Franz diffusion cells, with phosphate buffered saline pH 7.4 (PBS) at 37 °C. ddI was quantified at 250 nm using a validated UV spectrophotometric method. The histomorphological evaluations were undertaken using light microscopy (LM) and transmission electron microscopy (TEM). ddI permeated through the buccal mucosa and its permeability was concentration-dependent. A linear relationship (R² = 0.9557) between the concentrations and flux indicated passive diffusion as the mechanism of drug transport. AVgel, at concentrations of 0.25 to 2 %w/v, significantly enhanced ddI flux (p<0.05), with permeability enhancement ratios from 5.09 (0.25 %w/v) to 11.78 (2 %w/v), but decreased permeability at 4 and 6 %w/v. OA and its derivatives, i.e. ester (OA1E), the dicarboxylic acid (OA1A), the bicephalous dianionic surfactant (OA1ANa) and their parent compound, OA, all enhanced the buccal permeability of ddI. OA, OA1E, OA1A and OA1ANa at 1 %w/w all showed potential, with enhancement ratios (ER) of 1.29, 1.33, 1.01 and 1.72 respectively. OA1ANa at 1 %w/w demonstrated the highest flux (80.30 ± 10.37 μg cm ˉ².hr), permeability coefficient (4.01 ± 0.57 x 10 ˉ³ cm hrˉ¹) and enhancement ratio (1.72). The highest flux for ddI (144.00 ± 53.54 μg cm ˉ².hr) was reported with OA1ANa at 2 %w/w, which displayed an ER of 3.09 more than that with ddI alone (p=0.0014). At equivalent concentrations, OA1ANa (ER=3.09) had a significantly higher permeation enhancing effect than its parent OA (ER=1.54). Histomorphological studies showed that ddI did not have any adverse effects on the buccal mucosae. Ultrastructural analysis of the buccal mucosae treated with phosphate buffer saline pH 7.4 (PBS), ddI/PBS and ddI/PBS/AVgel 0.5 %w/v showed cells with normal plasmalemma, well-developed cristae and nuclei with regular nuclear envelopes. However, cells from 1, 2 and 6 %w/v AVgel-treated mucosae showed irregular nuclear outlines, increased intercellular spacing and plasmalemma crenulations. AVgel enhanced the buccal permeation of ddI and 0.05 %w/v was identified as a potentially safe and effective concentration for developing and optimizing buccal delivery systems. OA1ANa at all concentrations, except 6.0 %w/w had no adverse effects on the mucosae. OA1ANa at 2 %w/w was identified as a potentially safe concentration, and the optimal novel OA derivative that can widen the pool of fatty acid derivatives as chemical permeation enhancers for buccal drug delivery. The cellular changes, such as vacuoles formation and increased intercellular spaces, were attributed to the buccal permeation enhancing effects of AVgel and OA1ANa. The results in this study confirmed the potential of buccal delivery of ddI, identified permeability parameters of ddI across the buccal mucosa and its permeability enhancement by both AVgel and OA derivatives as novel permeation enhancers. The study showed that both OA1ANa at 2 %w/w and AVgel at 0.5 %w/v, or lower concentrations, can be used as buccal permeation enhancers to develop and optimize novel buccal delivery systems for ddI to improve ARV therapy. The novel enhancers are recommended for selection as buccal permeation enhancers, to design and optimize ddI buccal delivery systems, and application to other ARV drugs for improved therapy.
Formulation and evaluation of mucoadhesive polymeric films for buccal delivery of didanosine.
(2013) Jones, Elsabé.; Govender, Thirumala.; Ojewole, Elizabeth Bolanle.
The development of new chemical entities, novel drug delivery systems and alternative routes to deliver antiretrovirals (ARVs) are being explored to overcome the numerous limitations associated with HIV & AIDS drug therapy. Drug delivery via the buccal route has recently emerged as a promising alternative to delivery via the oral route. Drugs can directly enter the systemic circulation, bypass gastrointestinal degradation and first-pass hepatic metabolism, thereby increasing bioavailability. Although buccal permeation investigations with ARV drug solutions have confirmed their trans-buccal delivery potential, studies on their formulation into delivery systems are lacking. Rapid drug degradation of didanosine (DDI) in the gastrointestinal tract due to acid hydrolysis, together with the need for repetitive dosing, its short half-life, low oral bioavailability and dose-related toxicity, make DDI a suitable model ARV drug for buccal delivery. The aim of this study was therefore to design, evaluate and optimize the preparation of novel polymeric films for buccal delivery of DDI as a model ARV drug. Multipolymeric monolayered films (MMFs) with drugs and polymers of opposing solubilities will offer several advantages for the controlled release delivery of DDI via the buccal route. The first aim of this study was therefore to prepare DDI loaded films with polymers of opposing solubilities and to undertake extensive physico-chemical/mechanical and molecular modelling characterisations. MMFs were prepared via a simplified solvent casting/evaporation method and characterised in terms of drug content uniformity, in vitro drug release, in vitro permeation, histomorphology, mucoadhesivity, mechanical properties and surface pH. Uniform drug content (91–105 %) with low variability was obtained for all films. Co-blending of DDI, Hydroxypropyl methylcellulose (HPMC) and Eudragit®RS 100 (EUD) (1:1:10) was required to achieve controlled drug release. The buccal permeability potential of DDI from the MMFs was successfully demonstrated with a permeability coefficient of 0.72 ± 0.14 × 10−2cm/h and a steady state flux of 71.63 ± 13.54 μg/cm2h. Films had acceptable mucoadhesivity (2184 mN), mechanical strength (0.698 N/mm2) and surface pH (6.63). The co-blending-co-plasticization technique for preparation of MMFs containing EUD and HPMC was justified via static lattice molecular mechanics simulations (SLAS). The mechanism inherent to the mucoadhesive and drug release profile performance of the MMFs was also elucidated via SLAS wherein a close corroboration among the in vitro–in silico (IVIS) data was observed. These extensive physico-mechanical and molecular atomistic studies confirmed the use of MMFs containing DDI, HPMC and EUD as a buccal delivery system. A large portion of ARV limitations are related to inadequate drug concentrations reaching the site of action and low oral bioavailability. Recent developments in the field of buccal drug delivery show an increased interest towards nano-enabled drug delivery. The advantages of buccal drug delivery can be combined with that of the nanoparticulate delivery systems to provide a superior delivery system in terms of enhanced bioavailability and drug targeting. The second aim of the study was therefore to design, evaluate and optimize the preparation of novel nano-enabled polymeric films for buccal delivery of DDI as a model ARV drug. Solid lipid nanoparticles (SLNs) were prepared via a hot homogenization technique followed by ultrasonication and were characterized in terms of size, surface charge, morphology and drug entrapment efficiency (EE). Optimal parameters for preparation of the DDI loaded SLNs were identified before preparing and comparing the physico-mechanical properties of nano-enabled multipolymeric monolayered films (MMFs) to conventionally prepared MMFs. Glyceryl tripalmitate in combination with Poloxamer 188 as a surfactant was identified as being most suitable for preparation of DDI-loaded SLNs. Optimized particles exhibited a desired particle size (201 nm), polydispersity index (0.168), zeta potential (-18.8 mV) and formulation pH (5.5). Conventional and SLN entrapped MMFs were prepared via solvent casting/evaporation using EUD and HPMC in combination and characterised in terms of drug content, drug release, permeation, mucoadhesion and mechanical properties. Drug release from the nano-enabled films was higher, with 56 % released in the 1st hour as opposed to 20 % for the conventionally loaded MMFs. DDI was released from the buccal film and permeated across the mucosa as evidenced by steady state ix flux values of 71.63 ± 13.54 μg/cm2h and 74.39 ± 15.95 μg/cm2h, for the conventional and nano-enabled MMFs, respectively. SLNs did not adversely affect the flux and confirms the potential of DDI being delivered via the buccal route using nano-enabled MMFs. Conventional MMFs exhibited higher mucoadhesion (1425.00 ± 77.15 mN) and mechanical strength (0.6976 ± 0.064 N/mm2) than nano-enabled MMFs (914.33 ± 68.09 mN and 0.4930 ± 0.003 N/mm2). These physico-mechanical studies confirm the potential use of nano-enabled MMFs containing DDI-loaded SLNs as a buccal delivery system and serves as a platform for future formulation optimisation studies. These results confirm the feasibility of preparing films for buccal delivery of DDI as a model ARV drug that may ultimately lead to optimized drug therapy for HIV & AIDS patients.
Investigating patients' knowledge and use of the patient information leaflet regarding their warfarin therapy.
(2016) Hutheram, Karmishtha.; Ojewole, Elizabeth Bolanle.
Background: Warfarin is the gold standard drug of choice to manage thrombotic disorders, but may interact with certain foods and drugs, resulting in unwanted adverse effects. The use of patient information leaflet (PIL) as a standardized educational material is essential to ensuring optimal therapy. The aim of the study was to determine patient’s knowledge and use of PIL regarding their Warfarin therapy. Methods: A descriptive cross-sectional survey design required respondents to complete an anonymous questionnaire survey over 18 weeks. Responses were captured and analyzed using STATA version 13. Results: 34 patients responded in this study, of whom 56% (n=19) were males and 73.5% (n=25) had been on Warfarin treatment for less than 10 years. Only 50% (n=17/34) had knowledge of the PIL, 91% (n=31) knew about the International Normalized Ratio (INR) and 97% (n=33) understood its importance. While 76.5% (n=26) had knowledge of other drugs and foods that interact with Warfarin, and 70.5% (n=24) knew that consuming leafy green vegetables could reduce its effectiveness, only 58.8 % (n=20) understood the effect of alcohol on Warfarin. 91% (n=31) scored above 50% on the Oral Anticoagulant Knowledge (OAK) Test, with a moderate negative correlation between this and the respondent’s age (Spearman correlation = -0.27). Conclusion: INR testing and its importance in Warfarin therapy appeared to be known by most respondents, their lack of knowledge about PIL, as well as drug, alcohol and food interactions with Warfarin highlights the need for education and counseling to reinforce their knowledge and use of PIL.
Investigating the administration of medication in a private healthcare facility: identifying the most common medication administration error.
(2015) Selagan, Nirvana.; Suleman, Fatima.; Ojewole, Elizabeth Bolanle.
Background: Medication errors are an ongoing global problem for which there is limited South African data. Most medication errors have been shown to occur during the prescribing and administration of medication, with medication administration errors being the type of medication error least likely to be caught before reaching the patient. A study was conducted in one ward in a South African private healthcare facility to investigate the administration of medication in order to identify the most common medication administration error. The potentially serious effects of medication administration errors for the patient, as well as limited South African data on the topic show the significance of this study. Aim: Identification of the most common medication administration error in the selected ward. Method: Medication administration was observed over 16 consecutive days in one ward in a private healthcare facility in KwaZulu-Natal, South Africa. Allowing medication errors to occur for observation was considered unethical. Observer intervened in cases of potential errors before the error reached the patient. These potential errors were counted as near-misses. Nurses who administered medication in the ward also filled out a questionnaire to obtain their views on medication administration errors. Sampling was by convenience for both elements of the study. Results: A near-miss rate of 10.65% (n=56) including wrong time near-misses. The most common type of near-miss was wrong dose (33.93%, n=20). Discussion/Conclusion: The most common type of near-miss was wrong dose mainly due to ineffective communication between members of the healthcare team, which provides direction for educational efforts to improve system safety and thereby reduce near-miss rate. Recommendations: A bigger study involving more sites is required. Improved communication is required especially between pharmacists and nurses administering medication by communicating changes on prescriptions to nurses and providing medication information.
Prescription pattern monitoring of outpatient pediatric patients.
(2019) Tsegay, Zerisenay.; Oosthuizen, Frasia.; Ojewole, Elizabeth Bolanle.
Prescribing for paediatric patients can be challenging for prescribers as children are especially vulnerable to harmful effects of drugs due to differences in pharmacokinetics and pharmacodynamics as well as the limited availability of licensed drugs in their appropriate dosage forms. The World Health Organisation has estimated that over 50% of drugs globally are prescribed inappropriately. Prescription pattern monitoring studies (PPMS) are tools for assessing the prescribing, dispensing and administering of drugs. They help in explaining the extent and profile of drug use, trends, and quality of drugs and compliance of prescribing with standard treatment guidelines (STGs) and essential medicines list (EML). Regular assessment of prescribing practice and evaluation for compliance in reference with treatment guidelines is crucial in promoting rational drug use and identifying problems related to drug therapy. This study was therefore conducted to monitor the prescription patterns in paediatric outpatients and to determine the level of compliance of prescribed treatments against the South African 2017 paediatric STGs/EML at a public sector tertiary hospital located in KwaZulu-Natal, South Africa. Methods This was a retrospective descriptive study, based on systematic sampling of paediatric patient files visiting the outpatient department. Paediatric outpatient files containing prescriptions dated between June 1, 2016 and May 30, 2017 were used. A systematic sampling technique was used to minimize bias in the selection process and to ensure equal representation of samples. Data regarding patient demographic characteristics, diagnosis and disease condition as well as details of the treatments prescribed (drug name, dose, dosage form, frequency and duration of treatment) were extracted from patient files and captured using MS Excel 2016. The data were analysed using the following statistical packages; the Statistical Package for Social Sciences® (SPSS®) version 25 and Minitab® version 18. Compliance was determined using the loose criteria model, a method adopted from a report by the Ministry of Health and Social Services of Namibia and the Systems for Improved Access to Pharmaceuticals and Services (SIAPS). Where applicable, associations were carried out and a p-value ˂ 0.05 was estimated as statistically significant. Results A total of 327 patient files were evaluated, of which 193 (59.02%) were for male patients and 134 (40.98%) female patients. The total number of drugs prescribed was 845 constituted by 29 drug groups, of which antibiotics 155/845 (18.34%), emollients 118/845 (13.96%) and analgesics 117/845 (13.85%) were most predominantly prescribed. Of the 155 antibiotics, penicillins 55/155 (35.48%), penicillins combined with beta-lactamase inhibitors 40/155 (25.81%) and cephalosporins 39/155 (25.16%) were most commonly used. The percentage of encounters with antibiotics was 35.47% and the average number of drugs per prescription was 2.58. Out of the overall 845 drugs prescribed, 354 (41.89%) were generic drugs prescribed from the paediatric EML while 491 (58.11%) were non-generic drugs prescribed using trade names. Out of the total of 419 disease conditions assessed, 134 disease conditions were identified as most commonly diagnosed. Majority of the patients 100/134 (74.63%) did not have comorbidities, while 34/134 (25.37%) had co-occurring conditions ranging from 2 - 4 diseases. Male patients 19/34 (55.88%) presented slightly higher number of comorbidities compared to female patients 15/34 (44.12%). In order to determine compliance, disease conditions which were not listed in the 2017 paediatric STGs were excluded, resulting in 275 disease conditions. Treatments prescribed for 219/275 (79.64%) disease conditions were in accordance with the South African paediatric STGs, while treatments prescribed for 56/275 (20.36%) disease conditions did not comply with the STG recommendations. Conclusion There was a high level of antibiotic prescribing among the paediatric outpatients, and penicillins were the most often prescribed. The average number of drugs per prescription identified in this study was higher than that recommended by the World Health Organization. Overall, majority of the treatments prescribed conformed with the recommendations of the South African 2017 paediatric STGs, however extent of generic prescribing was low. There is a need for training of prescribers and healthcare professionals, especially regarding generic prescribing in order to promote appropriate use of drugs and overall patient safety.