Dr.Gh.Hezareh Advisory Committee for Hospital Pharmacy
“Some problems are so complex that you have to be highly intelligent and well informed just to be undecided about them.” Dr. Laurence J. Peter
Enteral Parenteral Contamination o Chemistry, PH, Sterility, Pyrogenisity, Potency, Appearance, Particular Matter Sterility Compounded Sterile Preparations (CSP)
1. Intended Use o Product quality (“5 Rights”) Right Patient, Right Medication, Right Dose, Right Time and Right Route 2. “Protect the product” o Sterility of compounded sterile preparation (CSP) through various methods 3. “Protect the worker”
Preventing harm due to: 1. Microbial contamination 2. Excessive bacterial endotoxins 3. variability in the intended strength 4. Unintended chemical and physical contaminants 5. ingredients of inappropriate quality in compounded CSPs
Workers (the most common) o Contact o Skin, hair Air o Air conditioning Adjacent areas Internal production o Walls, ceiling, floor, instruments
Infection Air Emboli Allergy Incompatibility Particulate matters Pyrogens
Unable to eat or drink Lake of absorption Emergency Lake of appropriate non-parenteral form
Billions of compounded doses prepared annularly by pharmacists and other clinicians More than 40% of inpatients receive CSPs CSPs prepared under controlled conditions (pharmacists) and uncontrolled conditions (on the ward) by nurses and physicians 61% nurses malpractice
Primary Engineering Controls (PEC) Secondary Engineering Controls (SEC) Filtration Air Flow Exhaust Air Pressurization Containment
Laminar Air Flow Workbench Barrier Isolator Biologic Safety Cabinet (BSC)