10/4/18 USP <800> THE TOP 10 THINGS YOU NEED TO KNOW Christina Coleman Kim, PharmD University of New Mexico Hospitals #1 Go Live Date Christina Kim 2 1
10/4/18 GO LIVE INFORMATION • DECEMBER 1, 2019 • New Mexico Board of Pharmacy is currently re- writing Title 16, Chapter 19, Part 30 (Compounding of Non-Sterile Pharmaceuticals) and Part 36 (Compounded Sterile Preparations) to include USP <800> regulations • 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 #2 Introduction and Scope Christina Kim 4 2
10/4/18 INTRODUCTION AND SCOPE • WHAT ARE WE DISCUSSING? • Handling Hazardous Drugs (HDs) • WHY ARE WE DISCUSSING HANDLING HAZARDOUS DRUGS? • 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 #3 Designated Person Christina Kim 6 3
10/4/18 DESIGNATED PERSON TO MANAGE THE PROGRAM • RESPONSIBILITIES OF DESIGNATED PERSON • Qualified and trained • Oversee compliance with USP <800> as well as other applicable laws and regulations • Competency of personnel • Environmental control of storage and compounding areas • 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 #4 LIST OF HAZARDOUS DRUGS Christina Kim 8 4
10/4/18 LIST OF HAZARDOUS DRUGS • ENTITY MUST CREATE AND MAINTAIN A LIST OF HDs • A list of HDs is maintained by The National Institute for Occupational Safety and Health (NIOSH) • Group 1: Antineoplastic Drugs which may pose a reproductive risk for susceptible populations • Group 2: Non-antineoplastic drugs that meet one or more of the NIOSH criteria for a hazardous drug and may also pose a reproductive risk for susceptible populations • Group 3: Drugs that pose a reproductive risk to both men and women who are actively trying to conceive and women who are breast feeding • NIOSH 2016 List plus a proposed addition list for 2018 • Practice-specific assessment of HDs which is evaluated yearly or 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 ASSESSMENT OF RISK • IT IS ADVISEABLE TO PERFORM AN ASSESSMENT OF RISK (AOR) OF ALL DRUGS ON YOUR HAZARDOUS DRUG LIST • Why? Provides for alternative containment strategies and work practices. • HDs on the NIOSH List that must follow containment requirements of USP <800> regardless of AOR include • Any HD API • Any antineoplastic requiring manipulation • Alternative containment strategies and work practices are allowed for drugs on the NIOSH list if an AOR is completed • Final dosage forms of compounded HD preparations • Conventionally manufactured HD products that do not require any further manipulation Christina Kim 10 5
10/4/18 ASSESSMENT OF RISK • TOPICS TO INCLUDE IN THE AOR: 1. Type of HD 2. Dosage form (Every form of every drug on the NIOSH list) 3. Risk of exposure 4. Packaging 5. Manipulation 6. Administration (PPE) • EXAMPLES 1. Final dosage form of compounded antineoplastics (An AOR may reveal the need for less restrictive storage requirements) 2. Finasteride (crushing tablets on the floor) (An AOR may reveal the need for more restrictive requirements.) Christina Kim 11 Step 1: Create an Algorithm • 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 up with a consistent set of rules • You could try to evaluate each drug and Injectable Solution, Topical Tablet, Capsule each form one-by-one • After you include all of the forms of each drug you are looking at a list 300 lines Requires manipulation sucRequires Requires drawing from ampule or vial? Requires manipulation such as mixing? manipulation such as crushing or splitting tablets or opening capsules? long! • That’s too much for a group discussion • Dividing and conquering list-by-list can Yes: Yes: lead to inconsistency Yes: Storage: Standard Storage: Standard Storage: Standard Hood: C-PEC Hood: C-PEC Hood: C-PEC Pharmacy garb: Full PPE Pharmacy garb: Full PPE Pharmacy garb: Full PPE Hand Delivery non-chemo Hand Delivery non-chemo Hand delivery non-chemo Nursing Garb: Chemo gloves Nursing Garb: Chemo gloves Nursing Garb: Chemo gloves 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 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 12 6
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