A qualitative review of off-label medication requests / Hazlinda Nazli Naem

• Main Author: Nazli Naem, Hazlinda
• Format: Thesis
• Language: English
• Published: 2010
• Online Access: https://ir.uitm.edu.my/id/eprint/72746/1/72746.pdf; https://ir.uitm.edu.my/id/eprint/72746/

The aim and objective of the study is to review the request for off-label use made to the Pharmaceutical Services Division, Ministry of Health Malaysia. A total of 125 requests for off-label use of medications were made from January to December 2009. The three most common drugs requested for off-label use was Tigecycline 50mg Injection (n=34; 27.2%), N-Acetylcysteine 600mg Tablet (n=12; 96%) and Mycophenolate mofetil 250mg and 500mg Capsule (n=ll; 8.8%). The most common indications for which drugs were requested for offlabel use were multidrug-resistant Acinetobacter baunamii infection (n=34; 27.2%), prevention of contrast-induced nephrotoxicity (n=12; 9.6%) and systemic lupus erythematous and idiopathic pulmonary arterial hypertension (n=9; 7.2%). The major therapeutic subgroups were antibacterials for systemic use (n=34; 27.2%), antineoplastic agents (n=30; 2.4%) and immunosuppressants (n=17; 13.6%). 59.2% of requests (n=74) did not state the reason for request (n=74; 59.2%). 40 requests (32%) were because of the alternative listed in the drug formulary was not effective. Patients also developed side effects with alternative (n=9; 7.2%) and there was no alternative in the drug formulary (n=2; 1.6%). Only 23 requests (18.4%) included scientific papers. Types of study design of scientific papers submitted included case-report with level of evidence 4 (n=6; 26.1%) cohort study with level of evidence 2b (n=4; 17.4%), case-control with level of evidence 3b and case-series with level of evidence 4 (n=l; 4.3%). The findings from this study are expected to highlight the pressing need for more evidencebased use of off-label use of medications.