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CVS promotes its store-brand over-the-counter drugs as economical alternatives to national brands. Also referred to as "private label" drugs, CVS-brand products are twice as profitable for the company as sales of national brands, but questions are now arising about the quality of these medications.

Ranbaxy Laboratories, the company which manufactures many of CVS's private label products, has been slammed by the Food and Drug Administration for improperly testing the quality of its drugs. According to the International Herald Tribune,

"In one instance, company officials refrigerated drugs then indicated they had been stored at room temperature. At other times the company lied about the number and frequency of safety tests conducted."

This is not the first time the FDA has cited problems with Ranbaxy's product quality. In June 2006, FDA inspectors issued the company a warning letter on its stability testing practices at a Ranbaxy factory, and in 2007, the company had to recall 73 million anti-seizure tablets produced at that same facility. In July 2008, the Justice Department accused Ranbaxy of "systematic fraudulent conduct, including submissions by Ranbaxy to the FDA that contain false and fabricated information about stability and bioequivalence, failure to timely report the distribution of drugs that were out of specification ("OOS"), and attempts to conceal violations of current Good Manufacturing Practices (cGMP) regulations from the FDA."

With so many citations of fraud and misconduct, it's no small wonder that the FDA has refused to review new medication submissions from Ranbaxy. With its customers' health on the line, why has CVS refused to cut ties with this untrustworthy company?

FDA halts review of drugs from Ranbaxy plant [International Herald Tribune]


State pharmacy boards across the country help hold pharmacies to a high standard of patient care. Board duties vary from state to state, but they typically "license pharmacies and pharmacists, set training standards, oversee pharmacy inspections and hold disciplinary proceedings for alleged safety violations." With so much influence over the pharmacy industry, state boards are a critical part of ensuring patient safety. But according to a recent report from USA Today, the presence of representatives of major retail pharmacy chains on these boards may give rise to a range of potential conflicts of interest. 

Nationally, the report states, nearly one quarter of pharmacy board panelists work for a major retail pharmacy chain. As panelists, pharmacy chain employees have the power toshape regulations that favor their employers. It's not surprising then that, according to Daniel Hussar, a pharmacy professor at Philadelphia's University of the Sciences and editor of the Pharmacist Activist newsletter,"chains aggressively seek as much representation on the boards as they possibly can." CVS currently has 21 employees on pharmacy boards in 15 states, the highest number of representatives from any one company. Walgreens, CVS's competitor, also has 21 employees on state boards.

Board members are required to obey conflict of interest regulations. But because these rules may be too narrow to catch all potential conflicts, such conflicts sometimes arise:

In June 2005, Florida's pharmacy board held a disciplinary hearing for Tonya Pearson, a Walgreens pharmacist in Jacksonville. She was accused of failing to catch a dosage-instruction error on a methadone prescription.... Gail Merrell, the Walgreens pharmacist who chaired the panel, said her employment would not "affect my ability to render judgment," a hearing tape shows. Albert Garcia, a board member who also worked for Walgreens, made a similar statement.

As the panel deliberated penalties, board member Eric Alvarez, a pharmacist not affiliated with Walgreens, made a motion to impose the $10,000 maximum state fine.... But the motion failed for lack of a seconding vote. Merrell, saying she disagreed with the maximum penalty, proposed a $500 fine.
The article also notes that many pharmacy boards are already having trouble enforcing regulations, even without conflicts of interest. A dearth of resources in some states has made store inspections infrequent, leaving many pharmacies unmonitored.  This may be a major problem for CVS shoppers, since regulators in multiple states have found the company's pharmacists working at unsafe speeds and selling expired products on its shelves.

What impact do you think pharmacy employees have on state regulation? Do you think panelists should be independent, or is industry experience a valuable resources?

Chains' Ties Run Deep on Pharmacy Boards [USA Today]


WCNC's story on speed-related pharmacy mistakes in North Carolina isn't the first time those mistakes have made news.  In February, TV station KFOR filed this story of Cameron Brewer, an Oklahoma City, OK., resident who filled a prescription at his local CVS back in February:


Cameron was prescribed antibiotics, but the CVS pharmacist on duty gave him a bottle of heart medication and anti-psychotics, both meant for other patients. CVS's corporate policies that encourage pharmacists to work faster can lead to mistakes like this one. As Cameron says in the video, the pharmacist who incorrectly filled his prescription "said, 'You know, I was doing three things at once.'"

Cameron luckily avoided serious injury, but filling a prescription incorrectly can be a life-threatening mistake. CVS didn't comment on how fast its Oklahoma City pharmacists were working that day, but it did give Cameron a $25 gift certificate for its potentially devastating mistake.

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