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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my.uitm.ir.727462024-05-29T09:28:29Z https://ir.uitm.edu.my/id/eprint/72746/ A qualitative review of off-label medication requests / Hazlinda Nazli Naem 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 NonPeerReviewed text en https://ir.uitm.edu.my/id/eprint/72746/1/72746.pdf A qualitative review of off-label medication requests / Hazlinda Nazli Naem. (2010) Degree thesis, thesis, Universiti Teknologi MARA (UiTM). |
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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 |
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Nazli Naem, Hazlinda |
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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 |
publishDate |
2010 |
url |
https://ir.uitm.edu.my/id/eprint/72746/1/72746.pdf https://ir.uitm.edu.my/id/eprint/72746/ |
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1800726665404350464 |
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13.18916 |