This week, we will discuss the applicable NIOSH Tables of interest and note that NIOSH may be easier to be compliant with than USP standards, especially when looking at Table 5!

Step #1: Prepare your own list of Hazardous Drugs (HDs) using Tables 1-3 as your guide.

• Check with your state board of pharmacy to see which tables they will be enforcing. Some may only be interested in Table 1, the Antineoplastic Drugs, which are the most serious (most have MSHGs); Tables 2 and 3 may be handled differently.
• Regarding Table 3, reassignment of personnel may be an alternative method of handling these drugs with potential reproductive issues and use only personnel (male or female) not planning on any pregnancies or not of child-bearing age, etc.

Step #2: Utilize Table 5 for personal protective equipment and engineering controls for working with hazardous drugs in healthcare settings. This Table lists the following column headers:

By checking the requirements for the specific formulation (e.g., tablet, capsule, liquid, injection, topical), the requirements are listed and are much briefer than USP Chapter <800> and are enforceable. There is much more “flexibility� in meeting these standards, which are provided in 3 simple pages, as compared to the strict 19-page, single-spaced document in the USP.

Table 5 has some important footnotes, as follows:

*This NIOSH guidance applies to drugs in Tables 1-3.

†For nonsterile preparations, a ventilated engineering control such as a fume hood or Class I BSC or a HEPA-filtered enclosure (such as a powder hood) is sufficient if the control device exhaust is HEPA-filtered or appropriately exhausted to the outside of the building. It is recommended that these activities be carried out in a control device, but it is recognized that under some circumstances, it is not possible. If the activity is performed in a ventilated engineering control that is used for sterile intravenous preparations, a thorough cleaning is required following the activity.

Bottom Line: NIOSH seems more reasonable than USP Chapter <800> to comply with.

Next, we will complete our briefing of the NIOSH Document by looking at enforcement priorities, etc.

Reference:
https://www.cdc.gov/niosh/docs/2016-161/pdfs/2016-161.pdf?id=10.26616/NIOSHPUB2016161

Loyd V. Allen, Jr., PhD, RPh
Editor-in-Chief
International Journal of Pharmaceutical Compounding
Remington: The Science and Practice of Pharmacy Twenty-second edition

News

Iowa Pharmacies Dwindle, Multiple Counties Left in ‘Prescription Drug Desert’
An estimated nine Iowa counties are currently only served by a single outpatient pharmacy, according to the Iowa Health Professions Tracking Center. The Iowa Board of Pharmacy says 40 pharmacies across the state have closed in the last two years. "Trying to reverse that trend is going to be difficult," said Andrew Funk, executive director of the Iowa Board of Pharmacy. Funk said a big factor hurting small pharmacies is the fee system run by Pharmacy Benefit Managers (PBMs). “Essentially, the PBMs say, ‘This is how we’ll reimburse you – take it or leave it,’" Funk said. Members of the Iowa Pharmacy Association question PBMs’ billions of dollars in profits, and their ability to operate their own competing pharmacies.
https://www.kcci.com/article/as-pharmacies-dwindle-10-iowa-counties-left-in-prescription-drug-desert/29504116

What are People Vaping? Study Links e-liquids to Some Lung Inflammation
A new study suggests that vaping e-liquids, specifically those containing propylene glycol and glycerin, may lead to some inflammation in the lungs — but more research is needed to determine just how much inflammation may occur over a prolonged period of time. The study, published in the journal Cancer Prevention Research, found that in people who had never smoked, after using e-cigarettes just twice daily for a month, levels of propylene glycol in their system was linked with changes in inflammatory cell counts in their lungs, although the magnitude of changes was small.
https://www.cnn.com/2019/10/16/health/vaping-e-liquids-lung-inflammation-study/index.html

Did You Know ...

…that George Washington said the following?

“99% of failures come from people who make excuses�!

Along the same lines, Franklin stated the following.

“He that is good for making excuses, is seldom good for anything else.�

Tip of the Week

Making excuses can result from a lack of willingness to accept responsibility. We all want to accept responsibility for something “good� that is done, but it takes courage to accept responsibility for an error or a mistake that is made. I read recently that there can be Six Pillars that can improve the ethical quality of our decisions and the character of our lives. They include:

• Trustworthiness,
• Respect,
• Responsibility,
• Fairness,
• Caring, and
• Citizenship.

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Looking Back

These signs we
Gladly dedicate,
To men who’ve had
No date of late!
     Burma-Shave