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

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