This week, we will complete our discussion on the role of NIOSH and, as mentioned last week, NIOSH is more amenable for compliance than USP's very strict standards. Following NIOSH, we will look at OSHA and its relationship to pharmaceutical compounding.

The following are statements direct from the document, NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings, 2016.

I. General Approach to Handling Hazardous Drugs:

"…no single approach can cover the diverse potential occupational exposures to the drugs. All listed drugs are considered hazardous, but safe-handling precautions can vary with the activity and the formulation of the drug."

"Although all hazardous drugs should be handled according to recommended procedures, especially if they must be prepared aseptically, some populations of workers may not be at reproductive risk from handling drugs in Group 3. These include workers who are excluded from the susceptible populations for specific reasons such as age or infertility."

"No attempt has been made to perform risk assessments on each drug or to propose exposure limits. NIOSH has provided guidance for personal protective equipment and ventilated engineering controls for some of the various scenarios in which a drug may be handled in healthcare settings (Table 5). This guidance does not cover all possible situations but provides general recommendations for the typical handling situations in healthcare."

(Editor's note: For USP Chapter <800>, since there are no "defined exposure limits to HDs," the HDs tend to all be dumped into the same category requiring maximum preventive measures be implemented. This approach is NOT science based and does not seem rational, as a pharmacy doing only a few compounded HDs a day or week is definitely NOT the same as a pharmacy doing a hundred or more compounded HDs per day. Whereas larger hospitals can bear the extreme financial burden, as can a few large independent compounders, most cannot and will not, and then we have the issue of lack of access to needed medications by patients! This must be addressed if we care at all for our patients! Also, there are OSHA "permissible exposure limits (PELs)" for hundreds and hundreds of chemicals; the same should be applied to drugs. I was always taught to "match the tools with the job…you don't need a bulldozer to plant a small flower bed!" We definitely need appropriate standards, but they must match the situation, and it appears NIOSH standards accommodate this more appropriately.)

Who Enforces NIOSH Standards?
NIOSH is not a regulatory agency; it is a division of the CDC. NIOSH is responsible for conducting research and making recommendations for the prevention of work-related injury and illness. Although NIOSH is generally characterized as a non-regulatory agency, guidance and recommendations issued by NIOSH are often used by other agencies responsible for developing and enforcing workplace safety and health regulations.

https://www.cdc.gov/niosh/regulations.html and 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

FDA Issues Report on Causes and Potential Solutions to Drug Shortages
An FDA task force commissioned a team of FDA economists and researchers to study 163 drugs that went into shortage from 2013 to 2017, comparing them with similar products that did not go into shortage. The report states that the number of ongoing drug shortages has been increasing. Drug shortages were more likely to be relatively low-priced and financially unattractive drugs, and were more likely to be sterile injectables. Prices rarely rose after shortages began, and during shortages, production typically did not sufficiently increase enough to restore supply to pre-shortage levels. Additionally, a number of manufacturers said they had discontinued the production of drugs prior to a shortage for commercial reasons, such as a loss of profitability.
https://www.fda.gov/news-events/press-announcements/statement-fdas-new-report-regarding-root-causes-and-potential-solutions-drug-shortages

FDA Committee Recommends Withdrawing Makena (Hydroxyprogesterone Caproate) from the Market
An FDA advisory committee has recommended that the standard treatment to prevent women from having another preterm birth, hydroxyprogesterone caproate (Makena-AMAG Pharmaceuticals), be withdrawn from the market. The agency approved the treatment contingent upon completing a follow-up study. That study found that the weekly synthetic progestin injections did not decrease recurrent preterm births in women who took it versus a placebo. The advisory committee's recommendation is not binding but will be considered, along with testimony from a hearing, when FDA makes its decision.
https://www.wsj.com/articles/fda-committee-recommends-withdrawing-treatment-to-prevent-preterm-births-from-market-11572387799

Recalled Baby Powder Does Not Contain Asbestos
Johnson & Johnson did not find asbestos in multiple tests of a bottle of baby powder that FDA said contained trace amounts of the carcinogen. J&J had recalled 33,000 bottles of the product earlier this month after the FDA said it discovered evidence of chrysotile asbestos in a bottle bought from an online retailer. J&J said 15 new tests of that very bottle came up clean, and that another 48 tests of samples from the recalled lot, conducted by two third-party labs, reached the same conclusion. Three samples did initially test positive for asbestos, but after an investigation by the lab the contamination was found to be coming from a portable air-conditioner in the room. "This finding underscores the importance of investigating any positive test result," the company said, adding that "even when careful safeguards are followed, asbestos contamination may be introduced during sample division, storage, preparation, and analysis."
https://www.nytimes.com/2019/10/29/business/johnson-baby-powder-asbestos.html

Did You Know ...

…that Marilyn Monroe said the following?

"Someone said to me, ‘If fifty percent of the experts in Hollywood said you had no talent and should give up, what would you do?' My answer was then and still is, ‘If a hundred percent told me that, all one hundred percent would be wrong'."

Tip of the Week

Paid "talking heads," consultants, and experts have ruined the lives of many young people and even adults. Many have an ax to grind, an agenda to promote and are very opinionated and sometimes not very well educated…so they put themselves on pedestals and put up a big front…but years later you may see how poorly they handled their own lives! If you find yourself in a similar situation, be yourself, study hard, and use your God-given talents to the best of your ability and prove them wrong!

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Looking Back

"Shaving brush"
Was like old Rover,
When he died,
He died all over!
     Burma-Shave