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 rules".

• 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 have developed a joint program with best practices and implementation guidance 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).

Relevant OSHA regulations include:

• 1910.1020, 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, 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]
• 1910.1450, Occupational exposure to hazardous chemicals in laboratories
• OSHA has also published a document Controlling Occupational Exposure to Hazardous Drugs.
  

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

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Joe Fanucchi MD FACOEM
President and Medical Director
MediTrax / OHS, Inc.
o:925-820-7758
c:925-368-3367

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