Unlicensed and Off-labelled Use of Medicines among Adult Patients in Intensive Care Unit, Universiti Kebangsaan Malaysia Medical Centre

NORAIDA MOHAMED SHAH, TUAN MAZLELAA TUAN MAHMOOD, LAU CHEE LAN, RAHA ABDUL RAHMAN

Abstract


The use of medicines in unlicensed and off-label manner for adults is less common with limited research compared to children. This research was carried out to characterise unlicensed and off-label use of medicines in adult intensive care patients of a hospital in Malaysia. Data on medications prescribed to patients were collected from the patients’ medical records and the unlicensed and off-label status for each medicine were determined. Forty nine (73.1%) and 20 (29.9%) patients from a total of 67 patients received at least one medicine in an unlicensed and off-label manner, respectively. The most common reason for off-label use of medicines was higher than the licensed dosing frequency (29.6%). The most common unlicensed and off-label medicine used was amlodipine tablet (5.8%) and IV metoclopromide (11.1%), respectively. Length of stay in the ICU was a significant predictor for unlicensed use of medicines (OR 1.219; 95% CI 1.022-1.456; p=0.028) and number of medication prescribed was a significant predictor for off-labelled use of medicines (OR 1.130; 95% CI 1.010-1.263; p=0.032). There was substantial prescribing of unlicensed medicines compared to off-label medicines in the adult ICU highlighting the need for more research to be carried out considering the critical condition of the patients.  


DOI : http://dx.doi.org./10.17576/JSKM-2019-1701-03



Keywords


Adults; Intensive Care Unit; Malaysia; Off-Label; Unlicensed

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