Adverse drug reactions in paediatric in-patients in a South African tertiary hospital
| dc.contributor.advisor | Decloedt, Eric | en_ZA |
| dc.contributor.advisor | Rosenkranz, Bernd | en_ZA |
| dc.contributor.advisor | Kruger, Mariana | en_ZA |
| dc.contributor.author | Makiwane, Memela MacDonald | en_ZA |
| dc.contributor.other | Stellenbosch University. Faculty of Medicine and Health Sciences. Dept. of Medicine: Clinical Pharmacology. | en_ZA |
| dc.date.accessioned | 2017-11-22T13:52:54Z | |
| dc.date.accessioned | 2017-12-11T10:33:40Z | |
| dc.date.available | 2019-06-28T03:00:18Z | |
| dc.date.issued | 2017-12 | |
| dc.description | Thesis (MSc)--Stellenbosch University, 2017. | en_ZA |
| dc.description.abstract | 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. | en_ZA |
| dc.description.abstract | AFRIKAANSE OPSOMMING: Geen opsomming | af_ZA |
| dc.description.version | Masters | en_ZA |
| dc.embargo.terms | 2019-06-28 | |
| dc.format.extent | [72] leaves : illustrations (some color) | |
| dc.identifier.uri | http://hdl.handle.net/10019.1/102625 | |
| dc.language.iso | en | en_ZA |
| dc.publisher | Stellenbosch : Stellenbosch University | en_ZA |
| dc.rights.holder | Stellenbosch University | en_ZA |
| dc.subject | Off-label drug use -- Complications | en_ZA |
| dc.subject | Drugs -- Side effects | en_ZA |
| dc.subject | Children -- Drug use | en_ZA |
| dc.subject | Children -- Hospital care -- South Africa | en_ZA |
| dc.subject | Cancer in children -- Chemotherapy -- Complications | en_ZA |
| dc.title | Adverse drug reactions in paediatric in-patients in a South African tertiary hospital | en_ZA |
| dc.type | Thesis | en_ZA |
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