News

Differences in "Strength Expression" on Product Labels of Compounders and Conventional Manufacturers May Lead to Dosing Errors
The FDA has received reports of dosing errors and confusion with the labeled-strength expression for certain compounded injectable products. Conventional manufacturers label their injectable products with the strength per total volume as the primary and prominent expression of strength on the label, whereas some compounders label their injectable products differently. Two case reports are presented.
https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/
PharmacyCompounding/ucm621769.htm

The FDA Announces Compounding Research Projects
The FDA has announced an agreement with the National Academies of Science, Engineering & Medicine (NASEM), and expanded agreements with the University of Maryland and Johns Hopkins University Centers for Regulatory Science and Innovation (CERSIs). These institutions will conduct research to help inform the public and the agency's policies regarding compounded drugs.

NASEM will conduct two studies.

• The first will examine the clinical utility of treating patients with compounded bioidentical hormone replacement therapy (BHRT) products.
• The second study will examine available evidence of the safety and effectiveness of multi-ingredient compounded topical pain creams.

The agency also expanded two previously announced research collaborations with UMD and JHU CERSIs to gather and analyze important information for developing the list of bulk drug substances, or APIs, that may be used in compounding by outsourcing facilities.
https://www.fda.gov/Drugs/DrugSafety/ucm621776.htm

Proposed Law Would Make Some Medicine Bottles Adult Proof
Michigan's health officials are worried that their opioid crisis is pushing for a state law that would require a lock on certain prescription bottles to prevent pill pilfering.

The bill would mandate that all prescriptions of opioids and certain other addictive drugs be dispensed in locking prescription vials rather than merely child-resistant ones.

To open them, people would have to enter a numeric code before screwing off the cap. The idea is to keep other people from sneaking small amounts of pills from someone else's prescription without getting noticed. https://www.hollandsentinel.com/news/20180924/proposed-law-would-make-some-medicine-bottles-adult-proof

Did You Know ...

...this? Just an observation: Many pharmacists in significant positions, including organizational offices and committee positions, do not take their responsibilities seriously or spend the necessary time to do them correctly and completely for the betterment of pharmacy.

Tip of the Week

It has always been quite apparent that some of those seeking leadership positions in pharmacy at the local, state, and national level are doing it for the prestige and recognition of occupying a position of leadership. They enjoy the travel, staying in nice hotels, and eating a lot of free meals. However, are they really serious about their responsibilities? Many (and I hope most) are, but some are not.

I have been involved in hundreds of national and state committee meetings, and it is quite apparent that:

• Some of the members don't even read the assigned materials and, therefore, are not prepared to discuss or vote on them
• Some of the leadership are not prepared to conduct discussions in the meetings
• Some of the leadership are not prepared to even participate in discussions in the meetings

However, that's what happens when good, sincere, dedicated pharmacists sit back and "let others do it!"

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Looking Back

Around the curve,
Likety-split,
It's a beautiful car,
Wasn't it?
     Burma Shave