Disclaimer for Compliance with USP an Assessment …

1 Practical Strategies for Compliance with USP <800>: Performing an Assessment of Risk 21th Annual ASHP Conference for Pharmacy Leaders Disclaimer Patricia Kienle is a member of the USP Compounding Expert Committee, but this presentation is not endorsed by or affiliated with USP. Practical Strategies for Compliance with USP <800>: Performing an Assessment of Risk Patricia C. Kienle, RPh, MPA, FASHP. Director, Accreditation and Medication Safety Cardinal Health Innovative Delivery Solutions Laflin, Pennsylvania Objectives Preparation Cite the document that defines hazardous drugs Read Assessment of Risk section from USP <800>. Identify the drugs and dosage forms eligible for an Assessment of Risk Review niosh 2016 hazardous drug list for the drugs and dosage forms Design an Assessment of Risk to be used at your organization you handle at your system List the facility and monitoring elements for Compliance with USP <800>. Prioritize gaps in Compliance that need to be addressed within your organization 2016 American Society of Health-System Pharmacists 1 of 14.

2 Practical Strategies for Compliance with USP <800>: Performing an Assessment of Risk 21th Annual ASHP Conference for Pharmacy Leaders Why <800>? Enforceability of <800>. <800> hazardous Drugs Handling in Healthcare settings protects <800> will become federally enforceable Patients on July 1, 2018. Personnel States may place <800> into state Environment regulations It adds to does not replace <795> and <797> on Nonsterile and State Board of Pharmacy Sterile Compounding Other state agencies First enforceable standard that protects healthcare personnel from risk of hazardous drugs Photo courtesy of USP. Compounding Compendium Genesis of USP <800> niosh Occupational Exposure Information 165/pdfs/2004 2016 American Society of Health-System Pharmacists 2 of 14. Practical Strategies for Compliance with USP <800>: Performing an Assessment of Risk 21th Annual ASHP Conference for Pharmacy Leaders niosh hazardous drug Information Major Components of <800>. Facilities hazardous drug list Work practices Containment of HDs Technique to limit exposure Decontamination of areas exposed to HDs Assessment of Risk Monitoring Personnel Facilities <800> Storage and Compounding Requirements Two Design Options for Sterile Compounding Cleanroom suite Separate room with fixed walls Vented to the outside Positive pressure ISO 7 anteroom opening into negative pressure ISO 7 buffer room with biological safety cabinet (BSC) or compounding aseptic containment isolator (CACI).

3 Minimum Requirements Containment Segregated Compounding Area Separate space with BSC or CACI. Negative pressure Appropriate number of air changes per Limited to 12 hour beyond use date (BUD). ( wc negative to adjacent hour space) NOTE: Not currently allowed by <797>. NOTE: Low Volume Exemption is no longer allowed 2016 American Society of Health-System Pharmacists 3 of 14. Practical Strategies for Compliance with USP <800>: Performing an Assessment of Risk 21th Annual ASHP Conference for Pharmacy Leaders Design for Nonsterile Compounding hazardous Drugs Primary Engineering Control Carcinogen Containment Ventilated Enclosure ( powder hood ) Genotoxin Secondary Engineering Control Teratogen Room that is separate from non hazardous drugs, and is under negative Reproductive toxin pressure, vented to the outside, and has the appropriate number of air changes per hour (ACPH) Organ toxicity at low dose in humans or animals Occasional nonsterile compounding can be done in the sterile New drugs that mimic existing HDs in structure or toxicity compounding area; details are in <800>.

4 Original reference: ASHP Guidelines on Handling hazardous Drugs, 1990. niosh List of hazardous Drugs What's the Assessment of Risk All About? Antineoplastics USP <800> establishes the Non antineoplastics containment strategies and work Reproductive only hazards practices best known to control hazardous drug contamination Engineering controls Protective equipment Work practices 161/pdfs/2016 2016 American Society of Health-System Pharmacists 4 of 14. Practical Strategies for Compliance with USP <800>: Performing an Assessment of Risk 21th Annual ASHP Conference for Pharmacy Leaders Ideal Situation Your Options Handle every drugs in every dosage form on the niosh list with all the containment strategies and work practices identified in <800> Handle every drug and dosage form on the niosh list with all the precautions and work practices listed in <800>. Is that possible in every case? Is that practical in every case? Perform an Assessment of Risk for some dosage forms of some drugs on the list HD Life Cycle in Your Organization Personnel to Consider Receiving Receive Dispose Transport Pharmacy technicians Pharmacists Transport Administer Nursing Procedural personnel Surgical Services Store Mix Emergency Department Obstetrics 2016 American Society of Health-System Pharmacists 5 of 14.

5 Practical Strategies for Compliance with USP <800>: Performing an Assessment of Risk 21th Annual ASHP Conference for Pharmacy Leaders Your hazardous drug List Required Assessment of Risk Elements 1. Review the niosh list of hazardous drugs drug 2. Identify the drugs and dosage forms you handle Dosage form 3. Perform an Assessment of Risk Risk of exposure 4. Document review of the list annually Packaging Manipulation Documentation of alternative containment strategies and/or work practices Review annually and document Your HD List Consider Require ALL containment strategies Alternative containment strategies drug , dosage form, and packaging detailed in <800> can be considered and implemented Where manipulation occurs and by whom Active Pharmaceutical Ingredient Antineoplastics you only need to Life cycle of the HD throughout your organization (API) of any HD on the list count or package Antineoplastics that require Non antineoplastics manipulation Dosage forms that don't fit your Reproductive only hazards Assessment of Risk 2016 American Society of Health-System Pharmacists 6 of 14.

6 Practical Strategies for Compliance with USP <800>: Performing an Assessment of Risk 21th Annual ASHP Conference for Pharmacy Leaders What drug and dosage forms present the biggest So What Happens with . questions related to including them in an API. Assessment of Risk? Antineoplastics that must be compounded Antineoplastics that must be repackaged Antineoplastic dosage form dispensed intact Antineoplastic oral dosage form that must be crushed Non antineoplastics or reproductive hazards that your committee feels should not be entity exempt Oral agents on Tables 2 and 3. Injectable agents on Tables 2 and 3 that are dispensed intact Injectable agents on Tables 2 and 3 that must be compounded .. Assessment of Risk Worksheet API of Any HD on the niosh List Active Pharmaceutical Ingredient of any antineoplastic, non . antineoplastic, or reproductive hazard No option must treat with all the containment strategies and work practices in <800>. 2016 American Society of Health-System Pharmacists 7 of 14.

7 Practical Strategies for Compliance with USP <800>: Performing an Assessment of Risk 21th Annual ASHP Conference for Pharmacy Leaders Antineoplastic Agents Antineoplastic Agents If any manipulation is required For antineoplastic agents that only require counting or packaging Drawing methotrexate from a vial Methotrexate tablets Crushing tablets or opening capsules to make a suspension Conventionally manufactured fluorouracil cream Splitting tablets You can consider these dosage forms in your Assessment of Risk But . No option must treat with all the containment strategies and work This was intended for outpatient pharmacies practices in <800>. Oral Antineoplastics Packaging Oral HDs = Nonsterile Compounding Transport into negative buffer room for storage of intact bottle Best: use a powder hood Once a table is needed, package the entire bottle at once, using the Acceptable: <800> allows use of same facilities and precautions you do with parenterals BSC/CACI for occasional nonsterile Pack each UD into individual sealed bag compounding No sterile compounding can occur during this No concurrent sterile compounding Total clean of C PEC before resuming Once it is packaged, it is a finished dosage form, so can be transported sterile compounding to the regular storage area and stored in a yellow lidded bin Photo courtesy of Labconco 2016 American Society of Health-System Pharmacists 8 of 14.

8 Practical Strategies for Compliance with USP <800>: Performing an Assessment of Risk 21th Annual ASHP Conference for Pharmacy Leaders HDs Other Than Antineoplastic Agents Can I establish a policy stating that all meds/dosage forms in Tables 2 and 3 are entity Non antineoplastics exempt? Reproductive only hazards A. Yes All can be considered for your Assessment of Risk B. No But some are concerning Approach to Assessment of Risk Consider for Non Injectables The niosh list has links and information concerning why the drug is on Purchase unit dose from manufacturer the list Wipe off to remove potential HD residue Look at that information, and evaluate it based on your circumstances Purchase bulk and package into unit dose or unit of use Some are situational hazards Use BSC and garb if you have that available Hazards in third trimester Antineoplastics Others Decontaminate counting tray and spatula 2016 American Society of Health-System Pharmacists 9 of 14. Practical Strategies for Compliance with USP <800>: Performing an Assessment of Risk 21th Annual ASHP Conference for Pharmacy Leaders Consider for Injectables Do you use CSTDs for drugs in Tables 2 and 3?

9 Separate BSC for Table 2 and 3 meds Could also be used for occasional use for non . sterile compounding A. Yes Closed System drug Transfer Devices (CSTDs) must be used for parenteral B. No antineoplastics when the dosage form C. We don't use CSTDs yet allows Should be used for compounding Photo courtesy of BD. HD Life Cycle in Your Organization Assessment of Risk Requirements If you exempt specific drugs and dosage forms in your entity, you must Receive Dispose identify the alternative containment strategies and/or work practices Determine how you will document this Spreadsheet? Transport Administer Separate form for each dosage form? Store Mix 2016 American Society of Health-System Pharmacists 10 of 14. Practical Strategies for Compliance with USP <800>: Performing an Assessment of Risk 21th Annual ASHP Conference for Pharmacy Leaders Receiving Receiving What HDs will be handled with all precautions and which will be Antineoplastics to negative pressure exempted for some or all elements based on your Assessment of Risk?

10 Others (as you determine) to negative pressure Antineoplastics injectables Ones that will have alternative strategies identify and document the Antineoplastics non injectables strategy Table 2 and 3 meds Identify as HD. Need to identify specific to drug and dosage form those agents that Wipe off will be handled differently and identify strategies in Assessment of Risk drug Storage If Oral HDs are Stored in Buffer Room Identify as HDs Maintain a list of those agents stored there Store in yellow, lidded bins Develop policy and procedure concerning who can package them Clearly note what must be done if Where they will be packaged manipulation of the dose is required Detailed procedure noting containment strategies Use only manual packaging system Photo courtesy of Medi Dose 2016 American Society of Health-System Pharmacists 11 of 14. Practical Strategies for Compliance with USP <800>: Performing an Assessment of Risk 21th Annual ASHP Conference for Pharmacy Leaders Unit dose methotrexate is on backorder.