Over the past several months, we have been looking at the NIOSH and OSHA regulations and how all pharmacies are under their federal authority. We have also incorporated some discussions on USP chapters <795>, <797>, and <800>, which are developed by the USP Compounding Pharmacy Expert Committee and are available if a state board of pharmacy decides to enforce them. A brief summary table shows this.

Copies of the related documents can be downloaded at:

EPA Standards
https://www.epa.gov/laws-regulations

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

OSHA Standards
https://www.osha.gov/SLTC/hazardousdrugs/controlling_occex_hazardous
drugs.html

Next week, we will begin our review of the Environmental Protection Agency standards.

News

NCPA: Analysis Blows Lid Off $8.5 Billion PBM Scam
A new report by one of the country's top pharmacy industry analysts shows how giant corporate middlemen are using "obscure" fees to scoop up billions in additional profits at the expense of patients and their neighborhood pharmacies. "It should be shocking to state and federal lawmakers and regulators that pharmacy benefit manager [PBM] corporations are using a government loophole to squeeze billions of dollars in fees from pharmacies, that those fees are driving up the cost of prescription drugs for patients, and that the sickest people in the country are subsidizing insurance premiums," said Doug Hoey, Pharmacist, MBA, NCPA CEO. The analysis, released by XIL Consulting, who advises some of the top players in the industry, concludes that PBMs are making enormous profits on so-called direct and indirect remuneration fees. PBMs impose the fees on pharmacies on a per-prescription basis. They're assessed sometimes months after the point of sale.
https://www.xilangconsulting.com/

Massachusetts - We Pay Only If It Works
If it works, we pay. If not, we get most - if not all - of our money back. MassHealth has directly negotiated with six drug manufacturers over the price of 12 drugs, which has saved the agency a net of $13 million.

• Gilead: Biktarvy, Genvoya, Odefsey, Descovy (to treat HIV)
• Indivior: Suboxone film (to treat opioid use disorder)
• AveXis (A Novartis subsidiary): Zolgensma (to treat spinal muscular atrophy)
• Asegua: Ledipasvir/Sofosbuvir, Sofosbuvir/Velpatasvir (to treat hepatitis C)
• Viiv: Triumeq, Juluca, Dovato (to treat HIV)
• AbbVie: Mayvret (to treat hepatitis C)

"We think it makes sense to pay for innovation for a drug that could really work. And we think the Commonwealth, with public dollars, should not pay for something if it doesn't do what it's advertised to do," said MassHealth director Dan Tsai.
https://www.wbur.org/commonhealth/2020/02/07/massachusetts-masshealth-zolgensma-cost-control

Did You Know ...

...that George Washington said the following?

"Labor to keep alive in your breast that little spark of celestial fire called conscience."

Tip of the Week

We also read that:

"Money dishonestly acquired is never worth its cost, while a good conscience never costs as much as it is worth." (Norris)

One wonders sometimes what has happened to the conscience of so many when it seems that in our society there are minimal limits placed on civility and one hears "lies" constantly presented in what we hear and see. From politicians to marketing of dietary supplements and even in the professions, it seems that almost anything can be said or done. It's hard to understand how some individuals can sleep at night.

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Looking Back

Cautious Rider
To her Reckless Dear,
Let's have less bull
And lots more steer!
     Burma-Shave