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

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-lab...

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Main Author: Nazli Naem, Hazlinda
Format: Thesis
Language:English
Published: 2010
Online Access:https://ir.uitm.edu.my/id/eprint/72746/1/72746.pdf
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spelling my-uitm-ir.727462024-05-29T09:28:29Z A qualitative review of off-label medication requests / Hazlinda Nazli Naem 2010 Nazli Naem, Hazlinda 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. 2010 Thesis https://ir.uitm.edu.my/id/eprint/72746/ https://ir.uitm.edu.my/id/eprint/72746/1/72746.pdf text en public degree Universiti Teknologi MARA (UiTM) Faculty of Pharmacy Mohd Ali, Salmiah
institution Universiti Teknologi MARA
collection UiTM Institutional Repository
language English
advisor Mohd Ali, Salmiah
description 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.
format Thesis
qualification_level Bachelor degree
author Nazli Naem, Hazlinda
spellingShingle Nazli Naem, Hazlinda
A qualitative review of off-label medication requests / Hazlinda Nazli Naem
author_facet Nazli Naem, Hazlinda
author_sort Nazli Naem, Hazlinda
title A qualitative review of off-label medication requests / Hazlinda Nazli Naem
title_short A qualitative review of off-label medication requests / Hazlinda Nazli Naem
title_full A qualitative review of off-label medication requests / Hazlinda Nazli Naem
title_fullStr A qualitative review of off-label medication requests / Hazlinda Nazli Naem
title_full_unstemmed A qualitative review of off-label medication requests / Hazlinda Nazli Naem
title_sort qualitative review of off-label medication requests / hazlinda nazli naem
granting_institution Universiti Teknologi MARA (UiTM)
granting_department Faculty of Pharmacy
publishDate 2010
url https://ir.uitm.edu.my/id/eprint/72746/1/72746.pdf
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