10/2/15. Charles Logan, CPhT

Transcription

1 10/2/15 Discuss USP 797 importance of workflow in the sterile compounding area. Recognize the proper procedures to be followed when compounding sterile preparations. PPE Charles Logan, CPhT Cleaning the PEC October 4, 2015 Describe general quality control and assurance elements related to sterile preparations. PATIENT SAFETY USP 797 is the regulation that applies to healthcare institutions, pharmacies, and other facilities which compound sterile preparations. The purpose of the regulation is to prevent infection and contamination in patient using pharmaceutical compounding sterile preparations (CSPs). Less than 40% of hospital pharmacies reported that they meet or exceeded requirements of USP 797 Currently, 27 states require direct compliance with USP 797 and 21 states have established similar regulations Many state pharmacy boards have started aggressive inspection for USP 797 compliance, following deaths of 64 people in 2012 Facility Design Issues Compounding sterile preparations (also called IV additives, admixtures, and other related terms) is a common function in health- system pharmacy and must be completed with knowledge of the components used, precision using approved procedures, and an understanding of how CSPs will be used for the patient. Lack of environmental testing and certification USP requires air sampling be performed every 6 months Inadequate monitoring and documentation of storage temperatures Storage or device temperatures must be recorded daily Un- caulked ceiling tiles and floors Improper Cleaning and Disinfecting USP 797 requires regular cleaning Compounding areas must be cleaned even if not visibly soiled When commercially prepared products are unavailable or too expensive, admixtures must be compounded. Ø Common CSPs compounded by health- system pharmacies include the following: Injections- intravenous (IV), subcutaneous (SC), intramuscular (IM), intradermal (ID) Intermittent IVs (also called piggybacks) IV infusions Epidural injections and infusions Intrathecal injections and infusions Ophthalmic preparations Irrigations 1

2 10/2/15 v These areas must meet rigid tests of air quality and sterility, have specific air flow (positive pressure in an area used for mixing nonhazardous CSPs and negative pressure in an area used for mixing hazardous CSPs), and be free of bacterial or fungal contamination. v Sometimes a PEC must be placed in an area that does not meet the USP <797> requirements for a cleanroom or buffer area. (i.e. a pharmacy that does not have the space or resources to create a buffer and ante area or in a pharmacy satellite created to supplement a cleanroom). v In these situations, a PEC may be placed in a dedicated space outside of a buffer area called a segregated compounding area. v CSPs mixed in a segregated compounding area are limited to nonhazardous low risk preparations and administration must be started within 12 hours of mixing. The sterile compounding area is the location where admixtures are prepared. It must be used only for this purpose and include equipment that is calibrated and certified for proper use. Access to the area must be limited only to personnel defined in the health- system policy. The primary engineering control (PEC), informally called a hood, is the device in which the CSPs are mixed, and is the cleanest place in the sterile compounding area. All sterile compounding in a pharmacy must be performed in a PEC, which has two basic functions: To filter microbes and extraneous materials from the air To maintain a controlled airflow out of the PEC to prevent contaminated room air from entering the device The secondary engineering controls are often called the IV room or cleanroom. There are two portions of these secondary engineering controls: Ø The buffer area where the PEC resides Ø The ante area (a transition area between the general pharmacy area and the buffer area) where garbing and hand hygiene are performed Before entering the compounding area, compounding personnel must do the following: Remove outer garments Remove cosmetics (they may shed flakes and/or particles) Remove all visible piercings and jewelry (they may interfere with the fit of gloves or cuffs of gowns) Artificial nails cannot be worn. Natural nails must be kept neat and trimmed CDC recommends a limit of natural nails to ¼ inch in length. Eating, drinking, gum- chewing, and smoking are not permitted in the compounding area Aseptic Technique Garbing procedures Cleaning and Disinfecting of the Work Area Daily Cleaning Requirements Monthly Cleaning Requirements If compounding personnel have an active skin disorder, conjunctivitis, or a respiratory infection, they should not be permitted to prepare sterile compounding FUN FACT: Over 1 million skin cells are shed per hour which can contain contaminate organisms 2

3 10/2/15 Step (such as bacteria, fungi, and parasites) or preventing contact with microorganisms Aseptic technique: is a set of specific practices and procedures performed under carefully controlled conditions with the goal of minimizing contamination by pathogens Procedures that the compounder must be aware of when preparing CSP s: workflow in the compounding area placement of products and devices in the PEC hand hygiene proper garbing procedures Different techniques are used with horizontal and vertical flow devices, isolators, and robotic devices What is the most common mechanism for CSP contamination? Ø The Technician Proper hand hygiene and garbing minimizes this risk Action 1 Wear clean appropriate attire Wear no cosmetics or jewelry (watches, rings, earrings, piercings, etc.) upon entry into the ante area Bring no food or drinks into the ante area or buffer areas Store no food or drinks in the ante area or buffer areas 2 The entrance to the ante area is considered the dirty side because hand hygiene and garbing has not yet taken place. - The dirty side of the ante area is where hair, face, and shoes need to be covered Don the following garb components (in any order) in the dirty side of the ante area: - Head and facial hair cover and ensure that all hair is covered. - Mask must cover bridge of nose down to include chin - Booties must be donned one at a time, placing the covered or designated shoe on the clean side of the line of demarcation, as appropriate Asepsis: is the state of being free from disease- causing contaminants 3 Step into the clean side of the ante area 4 Remove debris from under fingernails using running warm water and a nail cleaner. Perform hand hygiene procedure by wetting hands and forearms and washing using soap and warm water for at least 30 seconds Dry hands and forearms using a low- lint towel or hand dryer 5 Select the appropriate- sized gown and examine it for any holes, tears, or other defects Don gown, ensure full closure, and that it fits snugly around the neck and wrists 6 Disinfect hands again using a waterless alcohol- based surgical hand rub with persistent activity and allow hands to dry thoroughly before donning sterile gloves 7 Don appropriate- sized sterile powder- free gloves ensuring that there is a tight fit with no excess glove material at the fingertips Examine gloves to ensure there are no defects, holes, or tears Apply sterile alcohol to the gloves, and allow the gloves to dry 8 After garbing, enter the buffer area to prepare the CSPs Components (IV bags, vials of drugs, etc.) may be transferred from carts in the ante area to carts in the clean areas, placed in pass- throughs between the ante and buffer areas, or received in the buffer area by other means that preserve the aseptic practices 9 While engaging in sterile compounding activities, routinely disinfect gloves with sterile 70% isopropyl alcohol prior to work in the direct compounding area and after touching items or surfaces that may contaminate gloves Allow gloves to thoroughly dry before continuing 10 Remove personal protective equipment (PPE) on the clean side of the ante area 11 Remove gloves and perform hand hygiene 3

4 10/2/15 1. Remove debris from underneath fingernails with a nail cleaner and warm water. 2. Wash hands and forearms to the elbow for at least 30 seconds with non- Antimicrobial or antimicrobial soap and water. Hand washing should be vigorous and thorough. 3. Do not use antimicrobial scrub brushes on the skin, as they can damage the skin And increase shedding. 4. Completely dry the hands and forearms using lint- free disposable wipes or an electronic hand dryer. 5. Continue with garbing process Using a waterless alcohol- based surgical hand scrub to further cleanse the hands. Allow hands to dry prior to donning sterile gloves. 1. Remove face mask and gown. 2. Remove hairnet, facial hair cover and shoe covers. 3. Wash hands. 4. Remove remaining cleanroom garb. 5. Exit the cleanroom area. 4

5 10/2/15 When leaving the compounding area during a shift, if departmental policy allows, the exterior gown may be removed and hung in the anteroom Gowns may be reused only if it has been used solely for nonhazardous CSPs and is not visibly soiled It is important to distinguish between cleaning and disinfecting. Cleaning removes visible solids or soiling before disinfecting After cleaning, disinfecting removes microbial contamination It may be hung inside- out and reused for that shift only Gloves, masks, shoe and hair covers cannot be reused once they have left the compounding area. Clean surfaces by removing loose material and any residue from spills. For water- soluble residue, use sterile water to clean the surface. Ø Don t forget to repeat all hand hygiene before entering the compounding area! After cleaning, wipe the surface with 70% isopropyl alcohol or a similar residue- free disinfecting agent. A disinfecting agent must be used in the PEC (the most critical work surface!) Then allow to dry before compounding Daily Cleaning: PECs should be cleaned and disinfected at the following times: At the beginning of each shift Before each batch At least every 30 minutes during compounding When surfaces are visibly soiled When surface contamination is known or suspected When cleaning and disinfecting, ensure that you clean all work surfaces, including the sides and IV bar DO NOT Wet the HEPA Filter You should clean the hood from A. Back to Front B. Front to Back The PEC should be cleaned from back to front, to ensure that the clean surfaces are not contaminated. Counters and other easy- to- clean surfaces. Cleaning should be done carefully with minimal movement so air quality is not compromised Trash should be removed daily or when full. Floors in the buffer area, ante area, and segregated compounding area must be mopped daily with a germicidal agent (not while compounding). Mops, wipes, sponges, and other cleaning materials must be low- shedding and dedicated for use only in the sterile compounding area. Ideally, all cleaning materials are disposable and discarded after one use. Remember! Cleaning starts with the cleanest area and moves toward the dirtiest. Clean and disinfect buffer and ante area shelves. Empty storage shelving in the buffer and ante areas of all supplies for cleaning and disinfecting. 5

6 10/2/15 Working in the PEC Beyond- Use Dates Be aware of particle generators before entering the hood. Examples: Paper and Cardboard Boxes Machines General principles that apply to all PECs include the In- Process and Final Checks of CPS following: Never obstruct the direct airflow of first air to critical sites. Never touch any critical site. Aseptic manipulation should be performed at least 6 inches inside the PEC. Keep air vents clear when placing or moving objects. BUDs are a function of the drug s stability and the sterility limits as defined by USP <797>. Manufacturer s expiration dates (part of the FDA approved labeling), represent the timeframe which an unopened product can be expected to remain within limits of labeled strength, relative to storage temperature of the product. The manufacturer s expiration dates (specific to the Stability can be determined from manufacturer s labeling information, such as in the package insert, peer- reviewed articles and references, the Handbook on Injectable Drugs,7 Extended Stability for Parenteral Drugs,8 and King Guide to Parenteral Admixtures. Each pharmacy should have an up- to- date reference chart noting stability of commonly mixed CSPs. Sterility limits are defined by USP <797>, are based on the complexity of the preparation (low, medium, or high risk) and the temperature under which it is stored after compounding. Unless sterility is tested for the CSP (or for the specific batch of CSPs), the BUD cannot exceed the times listed in the slides. The shorter time between stability and sterility limits must be used to determine the BUD of the CSP. unopened product) differ from the BUDs, which must be determined once the product is manipulated into a CSP. Puncturing a vial, moving a product from refrigerated to room temperature, and other manipulations alter the length of time the vial or CSP can be used. Compounded entirely under ISO class 5 air. The compounding involves only transfer, measuring, and mixing with closed packaging systems. Manipulations are limited to aseptically opening ampules, penetrating stoppers on vials with sterile needles and syringes, and transferring sterile liquids in sterile syringes to sterile devices or packages. The compounding involves only transfer and mixing manipulations using not more than 3 commercially manufactured sterile packages and not more than 2 entries into any 1 sterile container or package. 6

7 10/2/15 All low risk level CSP conditions apply. Non- sterile ingredients are incorporated or a non- Multiple individual doses of sterile products are combined to prepare a CSP that will be administered to multiple patients or one patient multiple times. The compounding process includes complex aseptic manipulations sterile device is used. Sterile ingredients, devices, and mixtures are exposed to air quality inferior to ISO 5 air. other than single volume transfer. Using more than 3 commercially manufactured packages of sterile product, or more than 2 entries into any 1 sterile package or container. Non- sterile preparations are exposed for not more than 6 hours before being sterilized. Compounding typically lasts for a long duration (i.e. manual TPN). Intended to protect personnel, preparations, and environment Includes proper practices from receiving to disposal of hazardous drugs Will include both non- sterile (currently USP 795) and sterile products and preparations Standards will apply to all personnel who compound hazardous drugs and places where these drugs are prepared, stored, transported, and administered Ø Achieving and maintaining asepsis in the preparation of CSPs is a multi- step process. It involves Ø proper gowning and gloving Ø practicing proper hand washing technique Ø cleaning the laminar airflow hood thoroughly aseptically Ø practicing aseptic technique when making the CSP Ø It should be our goal to maintain the highest level of asepsis for CSPs while they are in our sphere of influence! 1.) Murdaugh LB, Staff AS. Competence Assessment Tools for Health- System Pharmacies. 5th Edition ) Davis K, Sparks J. Getting Started in Aseptic Com- pounding Video Training Program. Bethesda, MD: American Society of Health- System Pharmacists; ) American Society of Health- System Pharmacists (ASHP). Basics of Aseptic Compounding Technique Video Training Program. Bethesda, MD: American Society of Health- System Pharmacists; ) Kienle PC. Compounding Sterile Preparations: ASHP s Video Guide to Chapter <797> and Companion Guide. Bethesda, MD: American Society of Health- System Pharmacists; ) The United States Pharmacopeial Convention (USPC). General Chapter <797>: Pharmaceutical compounding sterile preparations. In: The United States Pharmaco- peia, 37th rev. ed., and the National Formulary, 32nd ed. Rockville, MD; ) American Society of Health- System Pharmacists (ASHP). ASHP guidelines on compounding sterile preparations. Am J Health- Syst Pharm. 2014;71(2): www. ashp.org/doclibrary/bestpractices/prepgdlcsp.aspx. Accessed December 7, ) Centers for Disease Control and Prevention. Guide- line for hand hygiene in health- care settings. MMWR. 2002;51(RR16): Accessed December 7, ) American Society of Health- System Pharmacists (ASHP). Handbook on Injectable Drugs. 18th ed. Bethesda, MD: ASHP; ) Bing CD, Nowobilski- Vasilios A. Extended Stability for Parenteral Drugs. 5th ed. Bethesda, MD: American Society of Health- System Pharmacists; ) King Guide to Parenteral Admixtures. Napa, CA: King Guide Publications Inc; ) Halvorsen D. State of Pharmacy Compounding. Pharmacy Purchasing & Products. April 2015; 12(4): S6- S17 12.) Kastango, E. The Top Ten Things You Need To Know About USP 797. Infusion. May/June ) Kastango, E. The Top 10 Gaps in USP Chapter <797> Compliance. Pharmacy Purchasing & Products. Sept

8 10/2/15 Which two areas comprise the cleanroom? A.) Ante area and segregated compounding area B.) Buffer area and segregated compounding area C.) Segregated compounding area and unclassified space D.) Ante area and buffer area The cleanroom consists of the ante area and the buffer area. When CSP contamination occurs, it is usually from. A.) Contaminated single- dose containers B.) Touch contamination C.) Cardboard containers D.) Contaminated garb Touch contamination by personnel is the most frequent reason for CSP contamination True or False: Personnel mixing CSPs are prohibited from wearing artificial nails or extenders. TRUE: Artificial nails or extenders cannot be worn when compounding CSPs because they are an infection risk. You have mixed a batch of antibiotics that will be refrigerated. The stability of the drug is 14 days under refrigeration. What is the maximum BUD allowed by USP <797>? A.) 24 hours B.) 48 hours C.) 9 days D.) 14 days USP <797> requires use of the shorter of the stability and sterility limits. Although the drug may be stable for 14 days because a batch is a medium- risk compound, the limit is 9 days. THANK YOU! Questions? 8