Alleged violations could shutter pharmacy

01/15/2020

The West Marin Pharmacy, an essential resource for many residents on the coast, is in hot water. The California State Board of Pharmacy has made a series of accusations of clerical and procedural misconduct against the business, and has recommended revoking or suspending the license of pharmacist and co-owner Zsusanna Biran.

After the state office of the attorney general, which provides legal representation for the board, investigates the case, Ms. Biran’s attorney, Natalia Mazina, said it is possible the parties could settle. Otherwise, Ms. Mazina said the case will go before the state office of administrative hearings.

A letter sent in November by Anne Sodergren, the interim executive director of the pharmacy board, details accusations that resulted from inspections in September 2018 and February 2019.

Board spokesman Bob Dávila said his agency typically visits a pharmacy every four years, but that it also does so in response to complaints. Ms. Biran, who co-owns the business with her husband, Jason Yoon, told the Light that she was aware of three recent complaints sent to the board. One customer claimed to have been given slow-release morphine instead of fast-release, another said medication she received was past its labeled expiration date, and another claimed his medication was a placebo.

The citation released after the state board’s first inspection, in 2018, revealed several issues. These included that the pharmacy lacked proper signage, offered medication pick-up on Sundays without a licensed pharmacist on duty, and made several types of hormonal drugs in-house without equipment compliant with the board’s most recent regulations. 

In response, Ms. Biran paid $6,000 in fines. She told the Light that she remedied the offending practices.

But an inspector came back mere months later. In addition to listing the complaints about the morphine and the past-due expiration date, the inspector made six additional accusations. Ms. Biran said the inspector spent a full day in the pharmacy, combing through the roughly 300 medications hanging on racks for pick-up.

First, the inspector cited a discrepancy between the pharmacy’s database of medications and what she found in the store. Ms. Biran told the Light that one possible explanation was clerical error in data entry. It is very easy to enter the wrong size bottle, for instance, which throws off a pill count by the thousands, she said.

Second, the pharmacy was taking back unused pills from customers for disposal, according to the board’s complaint. But in order to do so, pharmacies are required to be licensed as reverse distributors or possess a locked kiosk, neither of which is the case at West Marin Pharmacy.  

The inspector also found pills from separate manufacturers in the same bottle, while the law requires separate bottles; noted one bottle for blood pressure medication missing five pills; and found a pain medication missing a required identification number. Lastly, the pharmacy wasn’t up-to-date with two record-keeping practices: a self-assessment and a log of medications made in-house.

In her November letter, Ms. Sodergren recommended disciplinary action. She asked the office of administrative hearings to consider closing the business, and proposed either suspending the company’s permit for operations and Ms. Biran’s pharmacy license for five years, or else revoking them both. Ms. Sodergren recommended that Mr. Yoon also be prohibited from operating the business.

Speaking with the Light last week, Ms. Biran said she was surprised to receive the letter, believing the second inspection had gone smoothly and that the issues had been resolved when she corrected course and paid fines in 2018. She received the letter several days before Thanksgiving and scrambled to find a lawyer.

Following Ms. Mazina’s advice, Ms. Biran declined to respond to the board’s specific accusations, but she did say she had never had such troubles during her more than 40 years of practicing pharmacy. She bought the practice—where a similar business has operated out of the same space since it was built in 1954—13 years ago.

Ms. Biran, who grew up in Hungary before her family moved to Connecticut when she was 14, completed a five-year pharmacy program at the University of Connecticut straight out of high school. She never owned her own business but managed others on the East Coast and, after moving to California in 1980, in the South Bay.

She retired in 2005, but fate would have it that she was not finished with pharmacy. After learning the Point Reyes Station business was for sale, and falling in love with West Marin, Ms. Biran and Mr. Yoon bought the pharmacy in 2007.

The business has proved difficult to keep afloat, however. In letters to the Light over the years, Ms. Biran has described the obstacles she faces as a small business.

In her most recent letter to the editor, she described how customer co-pays do not always cover the cost of the medication for the pharmacy. There are also “clawbacks,” when pharmacy benefit managers—which interface between health insurers and distributors—instruct a pharmacy to collect a copay above the cost of the medication and then come back months later for the excess amount.  

A third challenge she described are fees charged by private insurance companies for unclaimed medications. These issues are moot for larger companies that own both pharmacies and insurance providers, such as CVS. “What is the difference between dinosaurs and independently owned pharmacies like West Marin Pharmacy? Dinosaurs are already extinct,” Ms. Biran wrote.

Her commitment to keeping the doors open in any way she can, despite the challenges, is clear. “Because of the housing shortage, I’ve personally housed at my own expense several employees who work at the pharmacy,” she wrote in her recent letter. 

She also voiced interest in exploring a cooperative model to help with her financial woes. 

It’s an idea Ms. Biran floated in the Light back in 2015, after a lawsuit caused additional strain. As a result of the settlement agreement, the pharmacy forked over $46,000 to three former employees to compensate for daily breaks they alleged the pharmacy had not given them. “It certainly places a financial burden,” Ms. Biran said of the lawsuit at the time. “And emotional, spiritual. It’s a heartbreak.”

As the only pharmacy in West Marin, the closure of the business would have a significant impact. 

Steve Siegel, the C.E.O. of the Coastal Health Alliance, said the nonprofit had an interest in keeping a local pharmacy. “It’s most important to us for acute issues, for medicines that people need right away,” he said. Although he said many patients fill their prescriptions outside West Marin, he added, “I think people want to go to the pharmacy, like any local service they can, in order to sustain it.”

Laughty Nixdorf, a lifelong resident of Point Reyes Station and a mother of three, expressed interest in supporting a cooperative model. “I’d prefer to support a small, local shop than a big CVS store, and that’s a common a sentiment in the community,” she said. 

Marnie Jackson, a Nicasio resident who sells beauty products in the shop, said about Ms. Biran in particular: “She’s a great member of our community and she does everything she can. She’s more than a typical pharmacist: she knows more about Eastern medicine, and that’s certainly appreciated here. She thinks about the whole body, asking questions like, ‘What is your stress level?’”