#1 THINGS YOU NEED TO KNOW Go Live Date Christina Coleman Kim, - PDF document

10/4/18 USP <800> THE TOP 10 #1 THINGS YOU NEED TO KNOW Go Live Date Christina Coleman Kim, PharmD University of New Mexico Hospitals Christina Kim 2 GO LIVE INFORMATION • DECEMBER 1, 2019 • New Mexico Board of Pharmacy is currently re- #2 writing Title 16, Chapter 19, Part 30 (Compounding of Non-Sterile Pharmaceuticals) and Part 36 (Compounded Sterile Preparations) to include USP <800> regulations Introduction and Scope • What does this mean for hazardous compounding in New Mexico facilities? • We have approximately 14 months to bring our facilities into compliance with the new regulations • The New Mexico Board of Pharmacy will require compliance and will be inspecting for compliance as of December 1, 2019. • Get it done early because you’ll have a lot of people to reach out to! Christina Kim 3 Christina Kim 4 INTRODUCTION AND SCOPE • WHAT ARE WE DISCUSSING? • Handling Hazardous Drugs (HDs) #3 • WHY ARE WE DISCUSSING HANDLING HAZARDOUS DRUGS? Designated Person • To create standards for handling because we care about patient safety, employee safety and protecting the environment • WHO IS AFFECTED? • Anyone and any institution that handles HD preparations • SHARE WHAT WE HAVE AT UNMH Christina Kim 5 Christina Kim 6 1

10/4/18 DESIGNATED PERSON TO MANAGE THE PROGRAM #4 • RESPONSIBILITIES OF DESIGNATED PERSON • Qualified and trained • Oversee compliance with USP <800> as well as other applicable laws and regulations LIST OF HAZARDOUS • Competency of personnel • Environmental control of storage and compounding areas DRUGS • Oversight of facility including testing and monitoring • Maintaining documentation • DOES THE “DESIGNATED PERSON” HAVE TO DO EVERYTHING? • No, form an interdisciplinary team consisting of nurses, pharmacists, pharmacy technicians, physicians, veterinarians, safety personnel, environmental services personnel, etc. Christina Kim 7 Christina Kim 8 LIST OF HAZARDOUS DRUGS ASSESSMENT OF RISK • ENTITY MUST CREATE AND MAINTAIN A LIST OF HDs • IT IS ADVISEABLE TO PERFORM AN ASSESSMENT OF RISK • A list of HDs is maintained by The National Institute for (AOR) OF ALL DRUGS ON YOUR HAZARDOUS DRUG LIST Occupational Safety and Health (NIOSH) • Why? Provides for alternative containment strategies and • Group 1: Antineoplastic Drugs which may pose a reproductive work practices. risk for susceptible populations • HDs on the NIOSH List that must follow containment • Group 2: Non-antineoplastic drugs that meet one or more of requirements of USP <800> regardless of AOR include the NIOSH criteria for a hazardous drug and may also pose a • Any HD API reproductive risk for susceptible populations • Any antineoplastic requiring manipulation • Group 3: Drugs that pose a reproductive risk to both men and • Alternative containment strategies and work practices are women who are actively trying to conceive and women who allowed for drugs on the NIOSH list if an AOR is completed are breast feeding • Final dosage forms of compounded HD preparations • NIOSH 2016 List plus a proposed addition list for 2018 • Conventionally manufactured HD products that do • Practice-specific assessment of HDs which is evaluated yearly or not require any further manipulation whenever a new agent is added to the formulary • Perform an assessment of risk of the drugs on your list to determine how to handle HDs Christina Kim 9 Christina Kim 10 Step 1: Create an Algorithm ASSESSMENT OF RISK • Present it to your group and discuss NIOSH Table 2 or is carcinogenic, genotoxic, or organ toxic (per criteria in NIOSH guidelines) • Pick what factors are important and come • TOPICS TO INCLUDE IN THE AOR: up with a consistent set of rules 1. Type of HD • You could try to evaluate each drug and Injectable Solution, Topical Tablet, Capsule 2. Dosage form (Every form of every drug on the NIOSH list) each form one-by-one 3. Risk of exposure • After you include all of the forms of each drug you are looking at a list 300 lines 4. Packaging Requires manipulation sucRequires Requires drawing from ampule or vial? Requires manipulation such as mixing? manipulation such as crushing or splitting long! tablets or opening capsules? 5. Manipulation • That’s too much for a group discussion 6. Administration (PPE) • Dividing and conquering list-by-list can Yes: Yes: Yes: lead to inconsistency Storage: Standard Storage: Standard Storage: Standard Hood: C-PEC Hood: C-PEC Hood: C-PEC • Pharmacy garb: Full PPE Pharmacy garb: Full PPE EXAMPLES Pharmacy garb: Full PPE Hand Delivery non-chemo Hand Delivery non-chemo Hand delivery non-chemo Nursing Garb: Chemo gloves Nursing Garb: Chemo gloves 1. Final dosage form of compounded antineoplastics (An Nursing Garb: Chemo gloves AOR may reveal the need for less restrictive storage requirements) 2. Finasteride (crushing tablets on the floor) (An AOR may If not, then it's in its final dosage form If not, then it's in its final dosage form Storage: Pyxis Storage: Pyxis No, in final dosage form: Hood: N/A Hood: N/A reveal the need for more restrictive requirements.) Storage: Pyxis Pharmacy garb: N/A Pharmacy garb: N/A Hood: N/A Delivery: OK to tube Delivery: OK to tube Pharmacy garb: N/A Nursing garb: Chemo gloves Nursing garb: Chemo gloves Delivery: OK to tube Nursing Garb: Chemo gloves Christina Kim 11 Christina Kim 12 2