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

Imraan Joosub was born in South Africa and graduated as a pharmacist from the University of Western Cape. He then obtained a Master’s degree from the University of Kwa Zulu Natal and holds several diplomas in Research, Medication Safety, and Arabic Language. Imraan has been working in the field of Hospital Pharmacy for almost 30 years. He currently works as a hospital pharmacy Supervisor and researcher employed at the Ministry of National Guard Health Affairs in Saudi Arabia. He has been published as an author and co-author in several highly regarded peer-review journals. His research interests include: Sterile and non-sterile compounding, technical specifications of aseptic compounding rooms, total parenteral nutrition, automated parental compounders, pharmaco-economic analyses, pharmacy automation, and medication safety. Imraan has been invited as a speaker to more than 30 International conferences and symposiums, and has travelled to more than 28 countries. He has served as the committee Chairperson to evaluate technical specifications of IV clean rooms, technical advisor to evaluate pharmacy automation projects (100 million Saudi Riyals), member of the tender committee of medicines (1 billion Saudi riyals), and member of the Saudi Medication Safety Committee ensuring safety of medicine at the Ministry of National Guard Health Affairs in Saudi Arabia. Imraan is the Chief Editor of the “Compounding manual for extemporaneous compounding for the Ministry of the National Guard Health Affairs”. The first evidence-based manual for non-sterile compounding in the Middle East (2017) following USP<795> guidance. He is also the co-founder of a free online pharmacy resource for extemporaneous compounding: “extemporaneous.info website”. Imraan has received more than 20 awards and recognitions for his roles and valuable contributions during his career. He has received a National Patient Safety Award by the Saudi Patient Safety Center for developing standards of non-sterile compounding and improving patient safety for Saudi Arabian Hospitals. Imraan has been recognized by the CEO Ministry of National Guard Health Affairs, for completions of the Tender bid for the Ministry.