Clinical Pharmacology

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This division was known as Pharmacology until 27 June 2013.

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Browsing Clinical Pharmacology by browse.metadata.advisor "Decloedt, Eric"

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    Adverse drug reactions in paediatric in-patients in a South African tertiary hospital
    (Stellenbosch : Stellenbosch University, 2017-12) Makiwane, Memela MacDonald; Decloedt, Eric; Rosenkranz, Bernd; Kruger, Mariana; Stellenbosch University. Faculty of Medicine and Health Sciences. Dept. of Medicine: Clinical Pharmacology.
    ENGLISH SUMMARY: Purpose: Paediatric patients have more adverse drug reaction (ADR) rates than adults due to off-label use of medicines and the prevalence data of ADRs in Sub-Saharan African children is limited. The aim was to describe the prevalence and nature of ADRs in paediatric (≤ 16 years old) in-patients at a tertiary hospital in South Africa. Methods: We conducted a prospective study of paediatric in-patients to identify suspected ADRs. Children had to be admitted for at least 24 hours during the 3-month study period (1 December 2015 to 29 February 2016). The data collected included age, sex, diagnosis and medicines received. We assessed causality using the 10-question Naranjo probability scale and classified severity using the Hartwig severity scale. Results: We found that 18.4% (52/282) of patients had 61 ADRs. The median age of patients with ADRs was 1.4 years (interquartile range (IQR): 0.5 – 5.3 years). ADR was the reason for admission in a third of the patients (31%; 16/52). Paediatric oncology patients suffered the majority of the ADRs (56.5%; 13/23), followed by HIV-infected patients on antiretroviral therapy (ART) (42.9%; 9/21) and tuberculosis (TB) patients (17.5%; 7/40). HIV-TB coinfected patients also experienced a high 30.8% (4/13) rate of ADRs. The majority of the ADRs were moderate 45.9% (28/61), while 42.6% (26/61) were mild, and 11.5% severe ADRs (7/61). These ADRs range from severe neutropaenia 4.9% (3/61) and drug induced liver injury (DILI) 4.9% (3/61) to mild cutaneous rashes 13.1% (8/61). There were no fatal ADRs, while 13.1% (8/61) ADRs were considered life threatening; 27.9% (17/61) necessitated and/or prolonged hospitalisation and 31.1% (19/61) resulted in persistent or significant disability or incapacity. Thirty eight percent of ADRs (23/61) were predictable. Paediatric oncology patients on chemotherapy were 7 times more likely to have ADR(s) than other patient groups [OR 7.3 (3.0 – 17.9), p < 0.01]. More ADRs were associated with chemotherapy 44.3% (27/61) and antimicrobials 42.6% (26/61), while the other miscellaneous medicine classes were associated with 34.4% (21/61) of the recorded ADRs. Conclusion: The prevalence of ADRs was 18.4% and in 31% the ADR was the reason for admission. The ADRs in paediatric oncology patients were expected, but of note nearly half the HIV-infected patients (43%) suffered an ADR.
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    Evaluation of the effectiveness of dose individualisation to achieve therapeutic vancomycin concentrations
    (Stellenbosch : Stellenbosch University, 2017-12-05) Abulfathi, Ahmed Aliyu; Decloedt, Eric; Stellenbosch University. Faculty of Medicine and Health Sciences. Dept. of Biomedical Sciences. Dept. of Medicine. Division of Clinical Pharmacology.
    ENGLISH ABSTRACT: Background The glycopeptide antibiotic vancomycin is used for treatment of methicillin resistant Gram positive cocci. Adequate vancomycin plasma concentrations are related to bacterial cure. However, inter- and intra-patient variability make it difficult to achieve therapeutic vancomycin concentrations. The primary objective of this study was to determine the effectiveness of using computerised therapeutic drug monitoring (TDM) to assist in achieving therapeutic vancomycin concentrations at a tertiary hospital in South Africa. Method This was a 2-period study consisting of a retrospective 1-month observational period followed by a prospective 1-month period where computerised TDM was implemented as an intervention to assist with vancomycin dose individualisation. Prescribers were provided with guidelines on vancomycin dosing and TDM results during both study periods. During the prospective period, all vancomycin TDM results were followed by dose individualisation using computerised TDM. In addition, the area under the-concentration-time curve over minimum inhibitory concentration (AUC/MIC) was calculated to ensure a ratio of ≥400. Results The retrospective study included 77 patients with 292 vancomycin concentrations: 69% (53/77) adult and 31% (24/77) paediatric patients. The prospective study included 80 patients with 217 vancomycin concentrations measured: 69% (55/80) adult and 31% (25/80) paediatric patients. Less vancomycin TDM data were requested during the prospective period with a median (interquartile range) of 2 (1-3) samples per patient compared with 3 (1- 5) during the retrospective period. The odds ratio of achieving therapeutic trough concentrations was 3.63 (95% confidence interval (CI): 1.81 - 7.3) in the prospective period when TDM-adjusted vancomycin dosing and correct TDM procedures were applied. The use of computerised TDM in patients on continuous infusion resulted in 26% improvement in achieving therapeutic vancomycin concentrations in the prospective period (odds ratio 2.96; 95% CI: 1.19 - 7.36). In the prospective period, AUC0-24 was 400 mg·h/L or above in 71% of occasions. Conclusion The correct use of computerised TDM results in a higher frequency of therapeutic vancomycin concentrations in a middle income setting. Trough vancomycin concentrations alone correlate poorly with AUC0-24. Achieving therapeutic vancomycin concentration may strengthen antibiotic stewardship and save on TDM resources.