At the recent Quality Compounding Summit, one of my first slides stated the following:

Pharmacy is very regulated!
Pharmacy compounding is even more regulated!!
Pharmacy compounding of sterile preparations is even more regulated!!!
Pharmacy compounding using hazardous drugs is even more regulated!!!!

Let’s add one more:

Pharmacy compounding of nuclear pharmaceuticals is even more regulated!!!!!

Despite being one of the most regulated professions in the world, we constantly hear or read the media making untrue statements that “Pharmacy is an unregulated profession and needs more federal oversight�! Their lack of knowledge and the misinformation they broadcast is unfair and casts a shadow on an honorable and proud profession that provides great services for the public.

Over the next few weeks, we will look at the following regulations governing and affecting our practice:

• NIOSH
• OSHA
• EPA
• State Boards of Pharmacy
• DEA
• FDA
• NRC
• Others

Yes, we are “very� regulated in what we do to serve the public. Maybe it’s time to place a few regulations regarding the truth on the media! “Freedom of the Press� does not give them license to lie and spread their ignorance. Maybe it should be changed to and limited to “Freedom of the Press for the Truth.� It seems that the media is the unregulated group here in our society.

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

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News

NABP Receives FDA Funding to Develop Data-Sharing System for Improved Oversight of Compounding Pharmacies
The National Association of Boards of Pharmacy® (NABP®) announced it has been awarded funding from the FDA to create a data system to assist with the collection, management, and sharing of information regarding compounding pharmacies in the U.S. The system will provide boards of pharmacy with a tool to report interstate compounding pharmacy information to the state boards of pharmacy and the FDA. The platform will enable the boards of pharmacy to prioritize their resources to address the compounding pharmacies that pose the highest risk to patients. Upon completion, the project will reduce risks to patients by fostering better and more targeted oversight of compounding pharmacies.

Visit nabp.pharmacy to learn more.
NOTE: (This is at least the third entity provided by your tax dollars for the FDA to gather information on compounding.)

THC Products May Play a Role in Outbreak of Lung Injury Associated with E-cigarette Use, or Vaping
The latest findings suggest THC products play a role in the outbreak. Most of the people (77%) in this outbreak reported using THC-containing products, or both THC-containing products and nicotine-containing products, according to a report published in the CDC’s Morbidity and Mortality Weekly Report (MMWR). According to CDC’s report including 514 patients; they reported:

• About 77% reported using THC-containing products, with or without nicotine-containing products; 36% reported exclusive use of THC-containing products; and
• 16% reported exclusive use of nicotine-containing products.

As of September 24, 2019, 805 confirmed and probable cases of lung injury associated with e-cigarette product use, or vaping, have been reported to CDC by 46 states and the U.S. Virgin Islands. Those cases included 12 deaths in 10 states. More than two-thirds of patients are male; median age of cases is 23 years and about 62% of patients aged 18-34 years.
https://www.cdc.gov/media/releases/2019/p0927-thc-vaping.html

Vaping Illnesses Top 1,000, CDC Reports (Just in today)
According to data released by CDC on Thursday, hundreds more people in the U.S. have been sickened by a mysterious vaping-related lung disease, and the death toll has risen to 19. The agency said 1,080 cases have been reported, up from the 805 reported a week ago. Vaping-related injuries have now been reported in almost every state. Most patients had a history of vaping products containing THC, the psychoactive ingredient in marijuana. Most are male and young, with 80% of patients under 35 and more than one-third under 21. Cases have occurred in 48 states and the U.S. Virgin Islands. According to Anne Schuchat, MD, principal deputy director of CDC, the new case count reflects an increase of 275 in just the past week. About one-half of the 275 were hospitalized in the past 2 weeks, and the rest were older cases whose link to vaping was just recognized.
(New York Times [10/04/19)] Grady, Denise)
(APhA Pharmacy Today, October 4, 2019)

Pathology of Vaping-Associated Lung Injury
Despite the accumulating data on the clinical and imaging features of vaping-associated lung injury, its pathology is poorly understood. The authors reviewed lung biopsies from 17 patients (13 men; median age, 35 years [range, 19–67]), all of whom had a history of vaping (71% with marijuana or cannabis oils) and were clinically suspected to have vaping-associated lung injury. Presentation was acute or subacute in all cases, with bilateral pulmonary opacities; all but two patients presented in 2019. In all cases, histopathological findings showed patterns of acute lung injury, including acute fibrinous pneumonitis, diffuse alveolar damage, or organizing pneumonia, usually bronchiolocentric and accompanied by bronchiolitis.
https://www.nejm.org/doi/full/10.1056/NEJMc1913069?query=main_nav_lg

Did You Know ...

…that George Washington said the following?

“It is better to offer no excuse than a bad one.�

Tip of the Week

A very successful college football team has the following above the door where they exit to go onto the playing field. “No Excuses.�

Most pharmacists practice our profession honorably and very seriously as we know what can happen if a mistake is made. If one thinks about it, we can harm more people in a day than many can in years. This is why it is regulated with oversight to protect our patients and our personnel.

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Looking Back

1880 A.D.
Straight razor and
Shaving Soap.
1930 A.D.
Safety razor and
     Burma-Shave