[MCOH-EH] : USP 800 - WOEMA advisory statement

[Ryan, Mary Gene - SJRMC]

# 2 for St. John's Regional Medical Center & St. John's Pleasant Valley Hospital


With HumanKindness,

Mary Gene Ryan, MPH, RN, COHN-S, CSP, FAAOHN
Employee Health and Workers' Compensation Supervisor

Dignity Health
St. John's Regional Medical Center 
St. John's Pleasant Valley Hospital
1600 North Rose Avenue
Oxnard, CA 93030
805.988.2789 (O)
805.377.4866 (M)
805.981.4431 (F)
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From: MCOH-EH [mailto:mcoh-eh-bounces+marygene.ryan=dignityhealth.org at mylist.net] On Behalf Of mcoh-eh-request at mylist.net
Sent: Wednesday, February 19, 2020 7:32 AM
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Subject: MCOH-EH Digest, Vol 255, Issue 43

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Today's Topics:

   1. Re:  USP 800 - WOEMA advisory statement (Seeburger, Sara)
   2.  Prolia (denosunab) PPE at the time of administration
      (Galaid Edward I)


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Message: 1
Date: Wed, 19 Feb 2020 15:28:46 +0000
From: "Seeburger, Sara" <SaraSeeburger at Centura.Org>
To: MCOH-EH <mcoh-eh at mylist.net>
Subject: Re: [MCOH-EH] USP 800 - WOEMA advisory statement
Message-ID:
	<CY4PR0601MB3682E02B9BD01AEFEFD61676B3100 at CY4PR0601MB3682.namprd06.prod.outlook.com>
	
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3, but thinking we may change to 2 after reading the guidance from WOEMA.

Thank you,


Sara Seeburger, BSN, RN, COHN-S
Director Occupational Health
Centura Health
9100 E. Mineral Circle
Centennial, Co

saraseeburger at centura.org<mailto:saraseeburger at centura.org>
Office: 303.765.6498 | Fax: 720.874.5955

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I'm on a mission to create a safe working environment for our associates!



From: MCOH-EH <mcoh-eh-bounces at mylist.net> On Behalf Of Leslie Thompson via MCOH-EH
Sent: Thursday, February 13, 2020 12:11 PM
To: MCOH-EH <mcoh-eh at mylist.net>
Cc: Leslie Thompson <Leslie.Thompson at sharp.com>
Subject: [MCOH-EH] USP 800 - WOEMA advisory statement

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I am taking the USP 800 advisory statement to our legal department for review.  Before doing so, I wanted to get a pulse check on where other organizations are on the medical surveillance issue.  I realize I am oversimplifying with the following categories and you may fall somewhere in between.  Please vote:

  1.  Not doing any medical surveillance
  2.  Doing limited medical surveillance to only those with specific verified exposure to hazardous drugs as suggested by WOEMA
  3.  Performing medical surveillance for employees with potential for exposure beyond what WOEMA recommends

I am happy to tabulate and share with the group.

p.s. I believe someone on this listserv already shared but in case you missed it, here is a link to the advisory statement from WOEMA https://urldefense.com/v3/__https://www.woema.org/wp-content/uploads/2014/03/WOEMA-USP800-approved-12-4-2019.pdf?x51975__;!!N0ZPjHdXCg!9gdNflIrWVnlmHY-gRgQa0mfZtjANFKz2mZl1fawSDkNTYy-wMkBrHXYjU9wG2Q4aiSfZg$ <https://urldefense.com/v3/__https://www.woema.org/wp-content/uploads/2014/03/WOEMA-USP800-approved-12-4-2019.pdf?x51975__;!!N0ZPjHdXCg!9gdNflIrWVnlmHY-gRgQa0mfZtjANFKz2mZl1fawSDkNTYy-wMkBrHXYjU9wG2Q4aiSfZg$ >

Leslie

Leslie Thompson, RN, MSN, ANP
Manager, Employee Occupational Health Department
Sharp HealthCare
8695 Spectrum Center Blvd
San Diego, CA  92123
leslie.thompson at sharp.com<mailto:leslie.thompson at sharp.com>
P: 858-499-5264 F:858-499-5317

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Message: 2
Date: Wed, 19 Feb 2020 15:32:17 +0000
From: Galaid Edward I <Edward.Galaid at rsfh.com>
To: "mcoh-eh at mylist.net" <mcoh-eh at mylist.net>,
	"Occ-Env-Med-L at listserv.unc.edu" <Occ-Env-Med-L at listserv.unc.edu>
Subject: [MCOH-EH] Prolia (denosunab) PPE at the time of
	administration
Message-ID:
	<BN8PR16MB30124991E31516490E55BF4F93100 at BN8PR16MB3012.namprd16.prod.outlook.com>
	
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My CMO just asked me about changes in PPE required to be worn when administering  Prolia. Has anyone heard anything about this?

For those who are interested, here's the tox profile off of the mfr's SDS:

Acute Toxicity: No information available
Skin corrosion/irritation: No information available
Serious eye damage/eye irritation: No information available
Respiratory or skin sensitization: No information available
Germ cell mutagenicity: No information available
Carcinogenicity: No information available
Reproductive toxicity: Even though this does not meet GHS classification, the following data is available: Prolia? exposure in cynomolgus monkeys by subcutaneous injection at 50 mg/kg from gestation day 20 to parturition resulted in increased fetal loss, stillbirths, and postnatal mortality, along with histological changes in infants. In general, the effects observed in mothers and infants were consistent with the pharmacological action of denosumab as a monoclonal antibody against RANKL and an inhibitor of osteoclastic bone resorption. No effects on male or female fertility have been observed.
STOT - single exposure: No information available
STOT - repeated exposure: Even though this does not meet GHS classification, the following data is available: Prolia? was administered to cynomolgus monkeys via subcutaneous injection once monthly for 1 year at doses of 1, 10 and 50 mg/kg and no adverse effects were observed. Denosumab produced rapid and sustained decreases in markers of bone turnover and increases in bone mineral density at doses >1 mg/kg, which were attributable to the pharmacologic activity of the monoclonal antibody.
Aspiration Hazard: No information available

Thanks

Ed Galaid

Edward I. Galaid, MD, MPH, FACOEM
ABIM, ABPM (OM)
Medical Director, Occupational Medicine
Roper Saint Francis Healthcare
Charleston, SC 29401
Member, ACOEM Task Group on Law Enforcement Officer Health
843-402-5053


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