[MCOH-EH] hazardous drug administration

Dr Joe Fanucchi drjoe at meditrax.com
Fri Sep 8 23:07:40 PDT 2017


On 8/31/2017 1:59 PM, Angeli Mancuso wrote:
> I sincerely appreciate the input and perspectives from this group. I 
> have some follow up questions that I’m curious how others are handling:
> 1)For current employees, how are you getting folks into compliance 
> with this regulation?
------------------------------------------------------------------------

Colleagues,

After seeing a number of references to "Pharma 800 requirements" and 
"the new hazardous drug administration regulation." I made several 
inquiries to the NIOSH and OSHA folks at the AOHP Conference in Denver. 
None of them recognized the term "Pharma 800", and they were unable to 
find any references to that specific term online.

They were also puzzled by references to "USP 800 _regulations_" or "USP 
800 _ru__les_".

  * USP is a non-governmental agency which is not authorized to issue
    regulations, and which charges a fee to obtain a copy of their "best
    practices" recommendations. USP 797, and now 800(2016), provide the
    national professional standard for pharmacy processes to protect the
    safety and health of employees, not only patients. USP 800 addresses
    drug preparation, administration, disposal and spill management
    procedures that minimize worker and environmental exposure. It
    should be noted that these documents provide guidance from USP
    related to worker protection. However, they are _not_ OSHA regulations.
  * I was informed that although _OSHA has no explicit standard_, USP
    800 focuses explicitly on protecting workers from exposures to
    hazardous drugs. USP 797 and 800, then, represent "best practices"
    in healthcare that incorporate national consensus standards on
    infrastructure maintenance (ASTM).
  * Since 2008, the Oncology Nursing Society/American Society of
    Clinical Oncology
    <https://www.ons.org/practice-resources/standards-reports/chemotherapy>
    have developed a joint program with best practices and
    implementation guidance
    <https://www.ons.org/practice-resources/standards-reports/chemotherapy>
    now available without charge.

NIOSH has compiled an updated list of antineoplastic and other hazardous 
drugs (NIOSH List of Antineoplastic and Other Hazardous Drugs in 
Healthcare Settings, 2014 <https://www.cdc.gov/niosh/docs/2014-138/>).

Relevant OSHA regulations include:

  * 1910.1020
    <https://www.osha.gov/pls/oshaweb/owadisp.show_document?p_table=STANDARDS&p_id=10027>,
    Access to employee exposure and medical records. OSHA requires the
    reporting of employee exposure to hazardous medications, and allows
    access to these records by employees.
  * 1910.1200
    <https://www.osha.gov/pls/oshaweb/owadisp.show_document?p_table=STANDARDS&p_id=10099>,
    Hazard communication. Includes the coverage of drugs and
    pharmaceuticals in the non-manufacturing sector. Requires any drugs
    posing a health hazard (with the exception of those in solid, final
    form for direct administration to the patient, i.e., tablets or
    pills) be included on lists of hazardous chemicals to which
    employees are exposed. In compliance with this standard all
    personnel involved in any aspect of the handling of covered
    hazardous medications must receive information and training to
    appraise them of the hazards in the work area. [related topic page
    <https://www.osha.gov/dsg/hazcom/index.html>]
  * 1910.1450
    <https://www.osha.gov/pls/oshaweb/owadisp.show_document?p_table=STANDARDS&p_id=10106>,
    Occupational exposure to hazardous chemicals in laboratories
  * OSHA has also published a document Controlling Occupational Exposure
    to Hazardous Drugs
    <https://www.osha.gov/SLTC/hazardousdrugs/controlling_occex_hazardousdrugs.html#surveillance>.

Can any list members provide a specific reference to the origin of the 
term "Pharma 800" if it is something other than what the OSHA and NIOSH 
representatives described, or if the term refers to a specific set of 
regulations?

Your comments and recommendations are most welcome regarding the 
development and implementation of policies which will promote 
professionally-endorsed "best practices," but in the absence of specific 
regulations the MCOH-EH List's principal role may well be supporting the 
exchange of creative approaches to this issue.

Regards,

Joe Fanucchi

-- 
*Joe Fanucchi MD FACOEM*
President and Medical Director
MediTrax / OHS, Inc. <http://www.meditrax.com/>
o:925-820-7758
c:925-368-3367
<http://www.meditrax.com/>
/MediTrax software: Everything you need, at a fraction of the cost!/

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