Why do some studies only give a beyond-use date (BUD) of 30 days when according to the published study there is still almost 100% of the initial concentration of the drug present?

Stability studies are designed to be carried out in an experiment that has a defined time length, generally, 30, 60, 90, 120, or 180 days; there are some exceptions, but these times are common. When conducting a study, one may not always know the predicted time period for which the drug is stable in the specific formulation or packaging and storage conditions. Consequently, at the end of the study when the last samples are obtained and analyzed, there may still be 95%, 97%, or even 99% of the intact drug remaining. However, since the study was only conducted for a certain number of days, that is the BUD the investigators will generally assign to the preparation.

For example, using a study with an assigned BUD of 30 days, it is also of interest that occasionally phrases such as "A beyond-use date of:

• 30 days
• up to 30 days
• at least 30 days"

As we saw in the Newsletter two weeks ago, one of the USP official compounded monographs has a BUD of up to one year. The routinely discussed 6 months maximum is arbitrary, as many compounded preparations will be stable for longer time periods. For now, it is best to adhere to the published BUDs unless there is other supporting documentation. The USP <795> Beyond-Use Date section also states that these procedures are "recommendations" the compounding pharmacist should consider.

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

Purdue Pharma's Sackler Family Directed and Covered up Opioid Sales Tactics
After facing years of investigations and legal proceedings over its marketing for OxyContin, Purdue Pharma is on the receiving end of an amended complaint laying out a detailed account of the alleged role the company's founding family played in the state's opioid crisis–and the lengths its members went to cover their tracks.
https://www.fiercepharma.com/pharma/sackler-family-directed-purdue-s-sales-tactics-for-dangerous-opioid-massachusetts-ag-says

Walmart Drops CVS Pharmacy Coverage
Walmart is no longer honoring prescription drug coverage from CVS Health, leaving large numbers of Walmart customers searching for a new pharmacist and amplifying concerns about the growing market power of the CVS empire. Walmart confirmed its exit from CVS Caremark after CVS refused the retail giant's demand for larger reimbursements for the prescription drugs it dispenses.
https://www.washingtonpost.com/business/economy/walmart-drops-cvs-pharmacy-coverage-in-price-dispute/2019/01/15/36c933e8-18f9-11e9-9ebf-c5fed1b7a081_story.html

Rising Drug Prices Straining Hospitals Forcing Budget Cuts
Increasing costs of prescription drugs have strained hospital budgets and operations, forcing health systems to cut costs by reducing staff. Between 2015 and 2017, hospital drug spending increased by 18.5 percent, a rate far exceeding medical inflation for the period. "We are in the midst of a prescription drug spending crisis that threatens patient access to care and hospitals' and health systems' ability to provide the highest quality of care," said Rick Pollack, chief executive officer of the American Hospital Association.
https://www.bloomberg.com/news/articles/2019-01-15/rising-drug-prices-said-to-strain-hospitals-force-budget-cuts

Pet Opioid Prescriptions Have Soared; But Who's Really Using the Drugs?
A new study has uncovered a 41 percent increase in opioids prescribed for pets over a 10-year period, but only a 13 percent bump in the number of pet hospital visits. The prescription spike could have been driven by the complex care offered at a veterinary hospital, or it might also mean all those prescriptions didn't go to Fido and Fluffy.
http://www.philly.com/health/opioids-pets-veterinary-medicine-abuse-20190111.html

$21 Million Paid to 2012 Meningitis Outbreak Victims
The Massachusetts Attorney General has distributed more than $21.125 million to more than 600 victims of the 2012 fungal meningitis outbreak from a $40 million allocation provided under a grant from the U.S. Justice Department. The funding was provided by the federal agency under a program established to give assistance to crime victims.
https://www.tennessean.com/story/news/2019/01/11/meningitis-outbreak-victim-payouts/2547877002/

Did You Know ...

�that pharmacists used to be "the MOST trusted profession"? Now the top 5 appear to be firefighters, teachers, doctors/nurses, postal workers, and the armed forces.

Tip of the Week

What happened to pharmacists? It may involve the negative impact of escalating drug prices (which goes back to the pharmaceutical manufacturers; practicing pharmacists often have trouble even making a reasonable profit on some commercial drugs due to PBMs, etc.) and the appearance that pharmacists are the cause of it because of their exposure and high visibility to the public. Also, some pharmacists have made the news "big-time" due to their criminal activities in compounding resulting in patient deaths and a few even charging exorbitant prices for some compounded drug preparations ($5,000 to $10,000 for a single prescription)! It may also involve "skirting the law" and not following the laws, regulations, and standards under which we practice. Anyway, our reputation (pharmacists) has been tarnished, but, hopefully, it will be regained.

To round out the list, the LEAST trusted professions include attorneys, journalists, and politicians.

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Looking Back

A little rhyming,
Jokes aside,
Don't be content,
Until you've tried
     Burma Shave