Virtual Conference
Pharma Conference 2022

Imraan Joosub

Madinah Al-Monowarrah, Kingdom of Saudi Arabia

Title: Extemporaneous compounding of oral liquid dosage forms - practices at tertiary care institutions in Saudi Arabia

Abstract

Background: Pharmacists rely heavily on reference material to extemporaneously compound medicines, on the assumption that such references are backed by evidence. Despite guidance by regulatory authorities, extemporaneous compounding for individual patients has traditionally not been prohibited, nor has it been closely regulated. 

Objective: Investigators sought to assess the adequacy of the evidence and recommend changes for the master formulae (MFs) used in the extemporaneous compounding manual at five Ministry of National Guard Health Affairs (MNGHA) tertiary care institutions in Saudi Arabia. 

Method: A descriptive cross-sectional study of all extemporaneous oral liquid dosage forms (n=75) was conducted. Investigators sought to establish if the current list of compounded oral liquid dosage forms are-: registered commercially, backed by a stability study or follow the SFDA guidance on assigning beyond-use-dates. A literature review of stability studies, tertiary references and package inserts were used to verify the MFs. Findings of each MF were tabulated and compared to stability studies. 

Results: It was found that 28 (37.3%) of oral liquid dosage forms were registered by a regulatory authority, 8 (10.7%) of MFs could not be traced to a stability study, while 3 (4%) MFs used BUDs. The taskforce approved 15 (20%) of the MFs without changes, while 42 (56%) of MFs had to be revised. 

Conclusion: This review found that although a wealth of resources on compounding oral liquid dosage forms exists, pharmacies can only rely on a fraction of these. The majority (80%) of the current MFs used in MNGHA institutions were rejected, due to inappropriate compounding practices and inaccuracies.

Biography

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