Learning Objectives Compounding Sterile Preparations 1. To - PDF document

10/4/2014 Learning Objectives Compounding Sterile Preparations 1. To challenge current practices in your sterile preparations areas by becoming aware of Learning from Past Mistakes to recent compounding errors in the USA that have resulted in morbidity and mortality. 2. To justify changes in your sterile preparation areas through understanding of key components of USP <797> and Federal and State enforcement authority. Prevent Future Ones – 3. To be able to state the key components of USP <797> 2004 and 2008 update that pertain to recent pharmaceutical compounding errors: 1. Personnel training requirements A Review of USP <797> 2. Facilities and engineering control requirements such as proper use, placement, and cleaning and disinfection of primary engineering controls – AND – proper utilization of secondary engineering controls 3. Cleaning and disinfecting principles and requirements 4. Principles of aseptic technique and airflow awareness Catherine Cone, PharmD, BCPS, PhC 5. Determination of beyond use dates versus expiration dates 6. Single use versus multiple use vials 7. High risk compounding 4. To know what reactions constitute physical and chemical incompatibilities 5. To be able to visually inspect compounded sterile products for physical and chemical incompatibilities 6. To know the key components of the QA programs required by USP <797> Headlines – Compounding Errors Where D id “We” Go Wrong? Make the News • 751 People Infected with Meningitis! 64 DEAD!! Should • Sterile Compounding Pharmacies: Pharmacists be Allowed to Compound? – Non-sterile to Sterile • 12 People Infected by Compounding Pharmacy – 11 Lose – Incorrect Doses Eye Sight Permanently • Contaminated Cardioplegia Solutions Linked to 5 – Aseptic Technique Hospitalizations and 3 Deaths – Single dose vials vs multiple dose vials • Medication Recalls at Two Compounding Pharmacies for “Floating P articles” and Suspected Eye Infections – Inadequate Facilities • 21 Polo Horses Dead Hours After Receiving Overdose from – Lack of standard operating procedures or Compounding Pharmacy procedures not followed • 9 People Die After Receiving Contaminated TPN’s – Lack of QA programs in place • IV solutions found to be 640% higher than strength listed – 3 people die Let’s Not Forget What Can We Do? • These incidents were preventable • Understand, follow, and implement protocols, policies and procedures on compounding sterile – Mother’s, Father’s, Sister’s and Brother’s, and Best products Friends….. Mourning the loss of their loved ones – People are dead and disabled because pharmacists • Train our students, technicians, and pharmacists and technicians didn’t follow standard procedures, on USP <797> and meticulous aseptic technique didn’t have appropriate training, or operated in sub - • Maintain our competence through continued standard conditions education and training • That is unacceptable • Update our facilities to meet or exceed USP • Recent survey showed that only 56% of hospitals <797> requirements surveyed had a USP <797> compliant clean room • Use common sense! If something doesn’t seem – How many pharmacies are not compliant in NM? right….it probably isn’t 1

10/4/2014 United States Pharmacopeia (USP) Chapter <797> - Purpose • History To describe practices and conditions to prevent – Founded in 1820 harm to individuals, including death to patients – Legislation in 1848 • Drug Import-Act made the USP the official compendium for the US that could result from: – Federal Food and Cosmetic Act in 1938 • Gave USP the authority and responsibility via the FDA for standards of 1. Non-sterility strength, quality, purity, packaging, and labeling • Technically they (FDA) can investigate and potentially charge offenses 2. Bacterial endotoxins if USP is not followed – However, they usually leave that to the states 3. Variability in intended strength of ingredients • Potentially relevant USP chapters include: <71> on sterility testing, <85> on endotoxins, <788> on particulate matter, <797> on compounding sterile products, <1075> on good compounding 4. Physical and chemical contaminants practices, <1116> on microbiological evaluation, <1191> on stability considerations, <823> on radiopharm, and the upcoming <800> on 5. Inappropriate quality of ingredients chemotherapy Main Sections of <797> Main Sections of <797> • Responsibilities of personnel • Quality control • Compounded Sterile Preparations (CSPs) risk • Automatic compounding devices for parenteral levels nutrition • Personnel training and evaluation • Checks and tests on finished products • Immediate use CSPs • Storage and beyond use dating • Single dose vs. multiple dose • Maintaining sterility, purity, and stability of • Hazardous drugs (USP <800> is the next dispensed and distributed CSPs • Patient training publication), radiopharmaceuticals, allergen extracts • Patient monitoring and adverse event reporting • Verification of CSPs • Quality assurance programs USP <797> 21 Dead Polo Horses Condensed into 4 main areas 1. Compounding personnel: responsibilities in implementation of USP <797> 2. Facilities 3. Compounding sterile preparations 4. Quality assurance programs 2

10/4/2014 Pharmacist Sent to Jail; Little Girls Compounding Personnel Loses Her Life • Must have adequate training including: – Didactic training on USP <797> requirements • Proof: Written examination must be completed at least once yearly for non-hazardous compounding; twice yearly with hazardous – Hands-on (skills development) Eric Cropp • Development of meticulous aseptic technique Emily • Proof: Personnel must pass once yearly (non-hazardous) gloved fingertip touch testing, Jerry media fill challenge testing, show competence in aseptic technique • Proof: Personnel must pass twice yearly (hazardous) gloved fingertip touch testing, media fill challenge testing, show competence in aseptic technique – Certified training through CNM for technicians – it’s the only technician training program that is currently certified in this state to my knowledge – At College of Pharmacy students use the American Society of Health System’s Pharmacy (ASHP) Compounding Sterile Preparations Video Guide and Workbook to Chapter <797> to learn didactic information • Student’s practice in a lab setting to develop compounding skills and aseptic technique prior to being allowed to compound at a patient care facility • What do these last two cases have in common? Student training is done over a 2 semester (2 X 16 weeks) period • Proof: Students must pass written USP <797> test, gloved fingertip touch test, and media fill challenge test (they cannot proceed to rotations without passing) Compounding Personnel Compounding Personnel • Basics of Aseptic Compounding – personnel – Personnel hygiene and garbing training should include: • Personnel must wash hands with warm water and anti- – Proper aseptic technique(s) septic from hands to elbow for 30 seconds – Understanding of Laminar Airflow Hood (LAFH) – Nail pick and gentle scrub operation termed Primary Engineering Controls (PEC) – Rinse and dry with lint free towel – Environmental controls termed Secondary – Humans shed 10 6 skin cells per hour Engineering Controls (SEC) » Severe scrubbing increases skin cell shed – Filling and checking intravenous (IV) orders – No artificial nails, make-up, piercings, outer-clothing, etc. • Correct therapy, correct dosing, calculations, accuracy of fill, should be worn in to the clean room areas ability to check for potential contamination or leaks, and labeling • Stress double checks prior to dispensing Compounding Personnel Compounding Personnel • The number one reason for virus/bacteria/ spores transfer to a patient is: TOUCH CONTAMINATION • To decrease touch contamination – Thorough washing, garbing, and sanitizing is mandatory – Aseptic technique must be perfected 3