To date, in previous issues of this newsletter, we have covered the following aspects of OSHA:

     Background and Priorities
     Inspection Process
     Results and Appeals
     General Information and Permissible Exposure Limits
     Controlling Occupational Exposure to Hazardous Drugs (Table of Contents)

This week, we will begin a comparison of the OSHA document "Controlling Occupational Exposure to Hazardous Drugs (see the table of contents in last week's Newsletter) with USP <800> Hazardous Drugs-Handling in Healthcare Settings. Both chapters reference each other, so it will be interesting to compare one that is inherently enforceable (OSHA document) with one that is enforceable only when adopted by an enforcing agency (State Boards of Pharmacy).

A brief review of the OSHA document shows the very liberal use of the word "should" (used over 300 times) as compared to "must" (less than 50 times). In fact, in some places the OSHA document states "should," but USP <800> states "must" on the same topic.

More next week.

News

FDA Clears First Nasal Spray for Cluster Seizures in Kids
The FDA has approved diazepam nasal spray (VALTOCO, Neurelis) in patients with epilepsy aged 6 and older for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity such as seizure clusters and acute repetitive seizures that are distinct from a patient's usual seizure pattern. VALTOCO is a proprietary formulation of diazepam incorporating a proprietary transmucosal absorption enhancer. It's the first nasal spray approved by the FDA as a rescue treatment for people with epilepsy aged 6 and older. VALTOCO is a ready-to-use nasal spray device available in 5-mg, 7.5-mg, and 10-mg strengths. The inactive ingredients in VALTOCO nasal spray include benzyl alcohol (10.5 mg per 0.1 mL), dehydrated alcohol, n-dodecyl beta-D-maltoside, and vitamin E. It is a clear, pale amber liquid.
https://www.medscape.com/viewarticle/923774
Note: Another compounded preparation - now a manufactured product.

Review of Purchases of Unapproved Medications by the Veterans Health Administration
Many drugs that were marketed prior to 1962 but lack FDA approval are commonly prescribed and dispensed in the U.S. These "unapproved medications" are widely purchased and used in health care today. In fact, the Veterans Health Administration, in FY 2016, purchased 3,299 different unapproved products. The largest expenditure was for sodium hyaluronate injection at $24.5 million but also included medications such as morphine injection, hydromorphone injection, calcium chloride injection, sodium fluoride dental, hydrocortisone rectal, phenazopyridine, barium sulfate liquid, and many others.

Am J Health-Syst Pharm. 2019; 76 (23): 1934-1943.
Note: Unapproved drugs, including compounded preparations, make up a significant percentage of drugs used today.

Study Finds that New FDA Drug Approvals Require Less Rigorous Evidence
An ongoing push to speed new medicines to patients has led to the growth of new FDA programs with relaxed evidence standards for approving drugs, according to an analysis from researchers at Harvard Medical School and Brigham and Women's Hospital. The findings mean patients and their doctors may not fully understand the risks and benefits of taking the latest medicines, especially when the majority of newly approved drugs offer "extremely modest benefits" over existing therapies, corresponding author Jonathan J. Darrow said in an interview.

"There's nothing inherently wrong with faster approval of drugs. It has to do with the approval of the drugs on the basis of less evidence - or really less certainty," said Darrow, who is part of Harvard's Program on Regulation, Therapeutics, and Law. "We're talking about an erosion in the amount or quality of the evidence."
https://news.bloomberglaw.com/pharma-and-life-sciences/fda-drug-approvals-require-less-rigorous-evidence-study-finds

Did You Know ...

...that winter is the time of year when it gets later earlier?

Tip of the Week

Do you prefer "standard time" or "daylight savings time"? Daylight saving time (DST), (United States and Canada) and summer time (United Kingdom, European Union, and others), is the practice of advancing clocks during summer months. One way to look at it is there is one 23-hour day in late winter or early spring and one 25-hour day in the fall. DST was introduced in 1895; the German Empire and Austria-Hungary organized the first nationwide implementation starting on April 30, 1916. Many countries have used it at various times since then. DST is generally not observed near the equator, where sunrise and sunset times do not vary enough to justify it. Some countries observe it only in some regions. For example, parts of Australia observe it, while other parts do not. Only a minority of the world's population uses DST; Asia and Africa generally do not observe it.

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Looking Back

Are you an
Even tempered guy?
Mad all the time?
Better try
     Burma-Shave