Did you ever wonder why some drugs:

• can be compounded with minimal formulation work?
• require extensive research and development for a formulation?
• require various solvents/cosolvents in a formulation?
• are coated onto sugar nonpareil pellets?
• require a small particle size and others don't?
• require a large particle size and others don't?
• cannot be given orally without manipulation?
• are quite water soluble but are not very well-absorbed?
• are poorly water soluble but are well-absorbed?
• are minimally affected by the presence of excipients?
• are significantly affected by the presence of excipients?
• qualify for a BCS waiver and others don't?
• are affected by meals and others are not?
• are difficult to formulate and others are not?

Starting next week, we will begin a series on the Biopharmaceutical Classification System (BCS) as it relates to compounding. The BCS is a scientific framework for classifying drug substances that is based on the drug's aqueous solubility and intestinal permeability. The objective is to be able to predict the in vivo pharmacokinetic performances of drugs from solubility and permeability data.

Next week, we will look at the basics of the BCS system and begin our discussions on how it can be used in compounding.

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

Connecticut Targeting PBM "Clawbacks"
Connecticut has a new law taking effect in January that will close a drug price loophole that's been the subject of more than a dozen U.S. lawsuits taking aim at a practice by PBMs called pharmacy clawbacks.

Clawbacks occur when a patient picks up a drug at the pharmacy and pays the co-payment set by their PBM, the co-payment of which is actually more than the actual cash cost of the drug. The PBM ultimately pockets the difference. Patients mostly never realize there's a cheaper cash price because of clauses in contracts between pharmacies and PBMs that bar the drugstore from telling people there's a cheaper way to pay.

Connecticut is joining Louisiana, Georgia, North Dakota, and Maine, all of which have also passed legislation aimed at stopping the clawbacks. Other states have introduced legislation related to clawbacks, which have prompted at least 16 lawsuits since October.
https://www.bloomberg.com/news/articles/2017-07-11/pharmacy-clawbacks-targeted-in-latest-state-law-aimed-at-pbms

EpiPen Price and PBMs
A new class-action lawsuit challenging the price of EpiPens is targeting not the drug's manufacturer but three PBMs and the industry's rebate practices. The lawsuit alleges that CVS Health, Express Scripts, and Prime Therapeutics practice price gouging; this includes a more than 500% increase in EpiPen's price from 2007 to 2016 by demanding increased rebates from manufacturers in exchange for favorable placement on their formularies.

Drug companies have incentives to raise prices, according to the lawsuit, in order to give larger rebates to the PBMs who then pocket significant revenues and don't pass the savings along to patients.
http://www.daytondailynews.com/news/local/epipen-lawsuit-targets-drug-price-middlemen/X1MX7GpTfd1fWOHOaSVU6J/

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Did You Know ...

�that many use the word "optimism" in the sense of "expecting a favorable outcome"?

Tip of the Week

"Optimism" grows from:

• Faith in the rightness of the natural order of things
• Confidence in our own abilities
• Acceptance of blending good and bad in the world and in ourselves
• Consciously choosing to focus on the good in our lives
• Gratitude for the blessings that come our way

[From Cowboy Values-Recapturing What America Once Stood For (James P. Owen)]

Looking Back

It took years,
To perfect for you,
A brushless cream,
That's greaseless too.
     Burma Shave