This week, we will continue our comparison of the
- OSHA document "Controlling Occupational Exposure to Hazardous Drugs"
with
- USP <800> Hazardous Drugs-Handling in Healthcare Settings.
The OSHA requirements have already been in force for some time and already apply to all pharmacies handling hazardous drugs. These federal guidelines tend to be more reasonable for compliance by pharmacies.
This week, we will compare
- Section V: Prevention of Employee Exposure...(OSHA)
with
- Section 4. Responsibilities of Personnel Handling Hazardous Drugs of USP <800>...(USP)
Keep in mind that throughout this series it is interesting to note the "recommendations" and "should" terminology of the OSHA document vs the "must" or "shall" of the USP document for the same or similar items.
One needs to be aware that there is not a 1:1 correlation between the various sections in the OSHA document with the USP <800> document so the reader is encouraged to make some comparisons on their own. Also, a table is being developed for all the sections that will be posted on the CompoundingToday.com website in the future.
OSHA Document
V. PREVENTION OF EMPLOYEE EXPOSURE
- Hazardous Drug Safety and Health Plan
Where HDs are used in the workplace, sound practice dictates that employers develop a written Hazardous Drug Safety and Health Plan...Such a plan assists in:
- Protecting employees from health hazards associated with HDs, and
- Keeping exposures as low as reasonably achievable (ALARA).
Note: This section continues with more detail and includes:
"must" or "required" (7 times)
"should" (25 times)
USP <800> Document
- RESPONSIBILITIES OF PERSONNEL HANDLING HAZARDOUS DRUGS
Each entity must have a designated person who is qualified and trained to be responsible for developing and implementing appropriate procedures; overseeing entity compliance with this chapter and other applicable laws, regulations, and standards; ensuring competency of personnel; and ensuring environment control of the storage and compounding areas....
Note: This section continues with more detail and includes:
"must" or "responsible for" (4 times)
"should" (0 times)
Note: The OSHA document only refers to "employers" and does not require a "Designated Person"; it leaves that up to the pharmacy for how it is implemented.
More next week.
Loyd V. Allen, Jr., PhD, RPh
Editor-in-Chief
IJPC
Remington: The Science and Practice of Pharmacy Twenty-second edition
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