The use of special approval medicines among pediatric patients in a tertiary care hospital: A reality check.
Non-formulary
Off-label
Pediatric
Special approval medicine
Unregistered
Journal
Exploratory research in clinical and social pharmacy
ISSN: 2667-2766
Titre abrégé: Explor Res Clin Soc Pharm
Pays: United States
ID NLM: 9918266300706676
Informations de publication
Date de publication:
Dec 2022
Dec 2022
Historique:
received:
19
06
2022
revised:
10
09
2022
accepted:
08
10
2022
entrez:
25
10
2022
pubmed:
26
10
2022
medline:
26
10
2022
Statut:
epublish
Résumé
Special approval medicines (SAMs) are medicines used with approval from the Director General of Health Malaysia when the therapeutic options within regulatory and formulary boundaries appear unsuitable or ineffective to treat the patients. To examine and characterize the use of SAMs among children in a Malaysian tertiary care hospital. The named-patient basis SAM application forms, cover letter, pharmacist review summary and patient monitoring forms available at the Pharmacy Department between 1st January 2019 and 31st December 2020 were reviewed. Unprocessed, unapproved and stock-basis applications were excluded. The outcome measures were categories, scope, off-label use and cost of SAM. Per-patient data were analyzed descriptively. Overall, 1010 patients (mean age of 8.7 ± 5.6 years) were involved in 328 SAMs applications. The most common SAMs pharmacological groups were nervous system ( The use of SAMs among children in this hospital involved unregistered, non-formulary medicines used to substitute the available alternatives in the formulary. A concerted effort is warranted in exploring supplementary mechanisms to enhance the medicine registration process and formulary system towards facilitating enhanced provision of treatment for children.
Sections du résumé
Background
UNASSIGNED
Special approval medicines (SAMs) are medicines used with approval from the Director General of Health Malaysia when the therapeutic options within regulatory and formulary boundaries appear unsuitable or ineffective to treat the patients.
Objectives
UNASSIGNED
To examine and characterize the use of SAMs among children in a Malaysian tertiary care hospital.
Methods
UNASSIGNED
The named-patient basis SAM application forms, cover letter, pharmacist review summary and patient monitoring forms available at the Pharmacy Department between 1st January 2019 and 31st December 2020 were reviewed. Unprocessed, unapproved and stock-basis applications were excluded. The outcome measures were categories, scope, off-label use and cost of SAM. Per-patient data were analyzed descriptively.
Results
UNASSIGNED
Overall, 1010 patients (mean age of 8.7 ± 5.6 years) were involved in 328 SAMs applications. The most common SAMs pharmacological groups were nervous system (
Conclusion
UNASSIGNED
The use of SAMs among children in this hospital involved unregistered, non-formulary medicines used to substitute the available alternatives in the formulary. A concerted effort is warranted in exploring supplementary mechanisms to enhance the medicine registration process and formulary system towards facilitating enhanced provision of treatment for children.
Identifiants
pubmed: 36281358
doi: 10.1016/j.rcsop.2022.100188
pii: S2667-2766(22)00087-7
pmc: PMC9587311
doi:
Types de publication
Journal Article
Langues
eng
Pagination
100188Informations de copyright
© 2022 The Authors.
Déclaration de conflit d'intérêts
The authors declare no competing interests.
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