USP<800> A Deeper Dive. Joe Cabaleiro R.Ph.

Transcription

1 USP<800> A Deeper Dive Joe Cabaleiro R.Ph. Consultant/Facilitator LP3 Network Inc. Consultant MEDISCA Network Inc. Senior Associate; Gates HealthCare Associates, Inc.

2 Disclosures Joe Cabaleiro is a consultant to both LP3 Network Inc. and MEDISCA Network Inc. and is a facilitator of LP3 Network Inc. s copyright program materials. 2

3 Disclosures Joe Cabaleiro declare(s) no conflicts of interest, real or apparent, and no financial interests in any company, product, or service mentioned in this program, including grants, employment, gifts, stock holdings, and honoraria. The American College of Apothecaries is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. 3

4 Copyright & Content Disclosure The material presented in this activity is Copyright LP3 Network Inc Material presented during this CE Activity reflects current literature on the subject and is presented without commercial bias, prejudice or influence. Additional material presented and any personal opinions on the part of the expert presenter will be notably specified. 4

5 Learning Objectives At the conclusion of this program, the participating pharmacist or technician will be able to: List the risks of exposure to hazardous drugs. Discuss the regulatory requirements for respiratory protection when working with HDs. Describe workflow changes that may be required when working with hazardous drugs. 5

6 What, me worry? There is lots of evidence that healthcare worker exposure to HDs is really, really bad! Cancers Miscarriages Impotency fects.html 6

7 The problem is Most HD toxicity is not acute Very difficult to link cause and effect except statistically. Exact cause is difficult to prove in a particular case. We could use more data No one is studying compounding pharmacies. Most of the data relates to antineoplastic drugs. 7

8 An Example - DES Ironically first used to reduce complications of pregnancy. Increases breast cancer risk in exposed women. Increases cancer risk in daughters of exposed women - DES Daughters. Increases risk of testicular abnormalities in sons of exposed women. May cause issues in the children of exposed sons and daughters. 8

9 Protecting Your Personnel Personnel Training PPE Engineering Controls Safe Handling 9

10 Written HD communication program addresses: Personnel Training List of HDs SDS Maintenance HD Labeling OSHA guide Resource: 10

11 The Written Program Three ways to develop one: Use your SOPs Use a template ms/files/samplehazchemcommprogram.rtf Write your own 11

12 Right to Know Requirement Hazard Determination SDS Receiving Transport Storage Dispensing Manipulation Decontamination & Cleaning Spills Training SOPs HD List SOP SDS Management SOP Receiving SOP: Where, garb, etc. Shipping, delivering SOPs Controlled Rm Temp, HDs for Sterile Packaging, Labeling Sterile and Non-Sterile Compounding Deactivation/decontamination/disinfection Spill kit use, training, maintenance SOPs addressing training/competency 12

13 The Hazardous Drug List Must be accurate and current. Update when you receive a new HD. Must be reviewed at least annually. Can be an electronic or paper document. The NIOSH hazardous drug list is not your hazardous drug list! Must be accessible to employees. Must be used to train employees. 13

14 Respiratory Protection For most purposes, N-95 mask is sufficient. Collects 95% of challenge aerosol N=Not resistant to oil R=Somewhat resistant to oil P=Oil Proof A surgical mask is not a replacement for a respirator. 14

15 N-95 Masks General protection when*: Compounding with HDs Cleanup of very small spills (<5ml) A surgical mask is not a replacement for a respirator. But an N-95 used in healthcare must have surgical mask properties. *Refer to table 5 in the NIOSH HD List for a more a more complete reference 15

16 Get the right kind of N-95! Surgical type is FDA approved for healthcare settings. Combines surgical mask & respirator. Exhalation valves not appropriate for sterile compounding. Cannot be re-used. Exhalation valve not appropriate for sterile. Suboptimal for non-sterile.

17 Sometimes you need full face protection! When there is a risk of splashing Cleaning ceilings Cleaning under BSC work trays Cleaning up large spills

18 A better approach! P-100 Filter Remember that P & that 100? With Multi Gas Cartridge

19 Respiratory PPE Requires Fit Testing Must verify that respirator fits each employee. Must be performed initially & annually. Must medically clear prior to fit testing: Lung conditions Heart conditions Asthma

20 OSHA Mandated Questionnaire document?p_table=standards&p_id=9783

21 Fit Testing Must be done by a qualified person. Can be done in-house. Various vendors provide online training & kits.

22 Eye Washes & Showers

23 Eye Washes & Showers Not just for NIOSH listed drugs. Injurious, caustic or corrosive Strong acids and strong bases No more than 10 seconds to reach. Plumbed eye wash must provide 0.4 gal/min for 15 minutes. A personal eye wash is not a substitute for a plumbed eye wash. Can be used to support a plumbed eyewash. 23

24 Faucet Mount Eyewash

25 Pop Quiz! Compliance with everything we have talked about so far is required by A. July 1, 2018 because USP<800> says so. B. January 1, 2017 because CA BOP says so. C. Duh-never! -They are just a suggestion not a requirement. D. Today - They are current OSHA requirements. 25

26 Room Design Tips (Non-Sterile) Where are you going to wash your equipment? Are you transporting contaminated equipment through the pharmacy? Can other staff be exposed? How are you going to contain the mess? Do cleanup personnel have to be HD garbed? How about nearby staff? A sink on the contaminated side of the room has big benefits: Can wash all equipment/utensils right in the HD room! 26

27 Room Design Tips (Non-Sterile) Garbing and doffing are time consuming and expensive. I forgot the. I need more... While you are dressed up can you... We just got this stat order... The patient is here, can you pass me the... Consider a pass through! Materials and supplies can flow in and out without garbing and doffing. 27

28 Canopies & Thimbles Oh My! BSC Exhaust Air Room Air BSC Room Air 28

29 Canopies & Thimbles May allow you to convert an internally vented device to an externally vented one. Check if the manufacturer makes a thimble. May allow you to vent the PEC and the room with a single device. 29

30 Deactivation & Decontamination What PECs Work Surfaces Outside PECs Floors Walls, ceilings, shelves, refrigerator interiors etc. When Daily Between Different HDs Daily Weekly Monthly *More frequent D&D may be required in the case of spills, splashes, very active facilities etc. 30

31 How? Non-Sterile Typical Process Wipe all surfaces down. Repeat a second time. Repeat with a detergent solution. Maybe: Remove detergent residue with water. 31

32 How? Sterile Typical Process Wipe all surfaces down. Repeat a second time. If a sporicidal agent, a specific dwell time is required. Repeat with a disinfectant/detergent solution. Maybe: Remove detergent residue with sterile water. Repeat with SIPA for final disinfection. 32

33 Implications Time consuming. Expensive: Personnel PPE Deactivation/decontamination agents Wipes Time Managing workflow will be critical. 33

34 Managing Workflow BHRT capsules Rx: Deactivate/decontaminate/clean capsule machine & utensils. Deactivate/decontaminate PECs. DES capsules Rx: Deactivate/decontaminate/clean capsule machine & utensils. Deactivate/decontaminate PECs. Another BHRT capsule Rx: Repeat the process above. 34

35 A better workflow All BHRT capsules for the day: Deactivate/decontaminate/clean capsule machine & utensils. Deactivate/decontaminate PECs. All DES capsules for the day: Deactivate/decontaminate/clean capsule machine & utensils. Deactivate/decontaminate PECs. Bottom line: Grouping similar HDs to avoid deactivation/decontamination will save time and money. 35

36 Workflow extends to personnel in HD areas Every time personnel enter HD area: Gown, glove, mask, hairnet, booties, etc. Every time personnel leave HD area: Discard gowns, gloves, masks, hairnet, booties, etc. Gowns must be changed: Every 2-3 hours or per manufacturer s guidelines. Gloves must be changed: Every 30 minutes or per manufacturer s guidelines. Bottom line: Schedule HD compounding so personnel can be in the room at least 2-3 hours. Another reason that pass through is important! 36

37 Gloves Must be tested to ASTM D6978. ASTM D6978 only tests for permeability to certain antineoplastic drugs. Permeability to other HDs is an unknown. Be careful solvents like DMSO, alcohols & others increase permeability. Must be worn for handling all classes of HDs. 37

38 Residue or bulk chemo in vials Unused HD IVs P, U and Toxic D waste Sharps, glass etc. Any hard waste HD Waste Trace Contaminated Waste Soft waste Gloves, Gowns, etc 38

39 Think about Storage space for waste: Where is the pharmacy going to store HD waste? Scheduling will reduce waste & disposal expense. What is hazardous? In the workplace NIOSH, OSHA. When you discard EPA, State and Local Rules. Surprise: They are different! Best advice: Contact an expert waste disposal firm in your area. This is a very complex area! 39

40 Questions? 40

41 Need More Information? Joe Cabaleiro R.Ph. Consultant/Facilitator LP3 Network Inc. Consultant MEDISCA Network Inc. Senior Associate; Gates HealthCare Associates, Inc. 41