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President's Letter - November 2019

Monday, November 25, 2019  
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As we enter the holiday season, it is important to be appreciative of the things we may be taking for granted. For hospital pharmacists, we focus on getting prescribers, patients, and nurses to view medications as the precious resource they are and to use them judiciously. 

Years of drug shortages have made us fearful of product availability. Budget pressures and group purchasing contracts often lead us to purchase the lowest cost product available to our health system. It may be that pharmacists are taking drug quality for granted.

Janet Woodcock, M.D., Director, Center for Drug Evaluation and Research wrote:

“You might not always shop based solely on the lowest price. For instance, if you highly value your time, you may choose a car from a manufacturer with a great reputation for reliability, even though similar cars cost a bit less. Choices based on what you value are common in everyday life. But, unfortunately, when it comes to prescription medications, buyers may not have that option. And in the view of the U.S. Food and Drug Administration, this lack of transparency is contributing to ongoing drug shortages, a critical health care issue that reduces treatment options, limits access to medications, and can threaten the well-being of patients in need of important therapies."

Dr. Woodcock goes on to speak about the lack of a quality rating system, as a result, purchasers of pharmaceuticals do not have the knowledge regarding which manufacturers have mature quality systems in place. While she does not cite America’s addiction to cheap drugs, she does imply that the more appropriate course would be to purchase products from reliable sources, even if it costs a little extra.

But there is a problem with medications in America. Pick up a dish, a child’s toy or piece of clothing, it will tell you what country it was made in. Drug manufacturers assert that locations for manufacturing active pharmaceutical ingredients (API) and producing finished dosage forms are proprietary due to business relationships and contracts. The FDA permits this lack of transparency.

An inter-agency Drug Shortage Task Force was convened by the FDA at the request of Congress in 2018. The task force found that “Quality-control problems at manufacturing facilities were responsible for more than half of recent drug shortages.”

I did not appreciate the scope of drug quality manufacturing issues until I read the book “Bottle of Lies: The Inside Story of the Generic Drug Boom,” by Katherine Eban; published in May of this year. The book provided me a more global trade view of pharmaceutical manufacturing and the evil of data manipulation and corporate greed. At first, I did not want to believe what I read and the book brought about a wave of emotions, mainly shock, anger, and heartbreak. It did not take long to identify the references that supported pieces of her storyline. Concerns about medication quality are hard for me to stop thinking about especially with the news highlighting contamination being detected in common generics. As Pharmacists, we advocate for safe use of medications, but we are now charged with adding a new layer...making sure the medications themselves are safe!

For the holiday season, I recommend you treat yourself to this book which may make you start thinking about medications differently!

Christine Roussel, PharmD, BCOP 
PSHP President 

 


Other Resources:

  • "Drug inequality: Allowable variations and illegal underperformance in off-patent drugs"
    • http://safemedicinescoalition.org/resources/wp_drug_inequality.pdf
  • "Generic Drug Manufacturer Ranbaxy Pleads Guilty and Agrees to Pay $500 Million to Resolve False Claims Allegations, cGMP Violations and False Statements to the FDA"
    • https://www.justice.gov/opa/pr/generic-drug-manufacturer-ranbaxy-pleads-guilty-and-agrees-pay-500-million-resolve-false
 

more Calendar

12/9/2019
2019 Pennsylvania Reception at ASHP Midyear Clinical Meeting!

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