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By Casey Christie / The Californian
BY KELLIE SCHMITT Californian staff writer email@example.com
Bakersfield's Faast Pharmacy has been charged with a breathtaking scope of pharmacy violations ranging from filling drugs on behalf of an illegitimate Internet site to reselling medications in short supply.
The citations by the California Pharmacy Board could have resulted in multimillion- dollar fines, although Faast's owner says the amount has been negotiated down sharply.
Lisa Faast doesn't operate the only pharmacy that has become involved with Internet sites.
Internet sales of prescription medications have "grown tremendously" in recent years, according to a 2011 article published in the journal Annals of Internal Medicine. Many of those online retailers sell controlled substances without an established physician-patient relationship, which may "partly account for the dramatic increase in U.S. prescription drug abuse since the early 1990s," the authors wrote.
The National Association of Boards of Pharmacy has looked at about 8,000 websites touting drug sales over the past five years and found 96 percent are illegal or rogue sites, an association spokesman said.
Fred Mayer, a longtime Marin County pharmacist who is now the head of a public health consumer pharmacy group, said prescriptions sold through these sites typically are forged or written by so-called "script doctors," physicians who never meet their patients.
"They make them fill out a little form, asking 'Are you allergic to anything?' and 'What other diseases do you have?'" he explained. "Then they prescribe them whatever they want."
The companies, which frequently are based outside the United States, often target independent pharmacies to fill those prescriptions since the financial opportunities are sometimes too enticing to turn down, said Carmen Catizone, executive director of the National Association of Boards of Pharmacy.
Catizone was not familiar with the allegations against Faast Pharmacy but noted that in general, independent pharmacies have been under increasing financial strain from the rogue websites and changes in health plan reimbursements.
"It seems like it's getting more and more difficult for some pharmacies to survive with lowering reimbursements and the big chains," Catizone said. "This is an avenue for them to survive and generate revenue."
Despite technology's advances, a relationship between the doctor and patient is still required, he added.
Even with telemedicine, there's a pre-existing relationship with a primary care doctor who refers the patient to faraway specialists. And health insurance companies that fill their patients' prescriptions online can do so appropriately because it's a closed system in which records are shared and monitored.
Pharmacies see cost pressures, demands from 'rogue' websites
The citations cover a wide range of alleged offenses, some of which are considered serious and involve the improper distribution of frequently abused prescription drugs. Others involve lesser lapses, such as failing to report information to a narcotics database and losing more than 1,000 painkiller pills.
Virginia Herold, the executive officer of the pharmacy board, said the number of citations, some of which include several distinct accusations, stands out: "I'll put it this way: we have 6,500 pharmacies in the state and most do not have three citations."
Faast has been issued three citations, two of which involved multiple allegations that are in the process of being settled, and a fourth citation as yet unresolved.
In that case, the board cited Faast -- as well as dozens of pharmacies statewide -- for selling drugs in short supply to a San Diego-based wholesaler. The wholesaler then distributed those medications to government hospitals and other health care facilities at "exceedingly high mark-ups," according to Herold.
Those accusations come at a time of severe nationwide prescription drug shortages, which on occasion have forced hospitals and other health care facilities to purchase dwindling supplies of essential medications at high mark-ups.
The majority of Faast's citations were rolled into one accusation with a $27 million fine attached, though pharmacy owner Lisa Marie Faast says she's negotiating a settlement that would reduce that penalty to $100,000 and end the case.
Faast, also the president of the Kern County Pharmacists Association, said she's never intentionally violated pharmacy laws and that the citations stem from conflicting interpretations of the industry's rapidly changing landscape.
But Herold countered that pharmacists are required to know the law, and the board publishes numerous newsletters and other documents on hot button issues such as working with websites.
In addition to those charges, the board cited Faast for:
* Dispensing 1,103 prescriptions to California patients through a website without a doctor's "good faith prior exam."
* Filling 13 prescriptions from a Virginia doctor whose license had been surrendered. The Medical Board of Virginia charged the doctor with prescribing controlled substances to 14,000 patients over the Internet without a "good-faith prior exam."
* Failing to maintain drugs in a safe and secure matter; 1,408 tablets of Norco, commonly known by the brand name Vicodin, were unaccounted for.
* Failing to report 183 prescriptions of a controlled substance to a state database.
* Filling a prescription and mailing it to an Idaho resident without obtaining a license from the Idaho Board of Pharmacy.
* Refilling 120 tablets of Soma, a muscle relaxer, two times in a month without authorization.
* Selling and repacking drugs to a doctor for office use that wasn't properly labeled.
Along with licensing and promoting education among California pharmacists, the state board is also charged with investigating and disciplining pharmacies.
During the fiscal year 2010-11, the board issued 1,044 citations. There were 6,159 licensed pharmacies and 36,267 licensed pharmacists in California during that period.
'I DID IT OPENLY'
Lisa Faast, 33, remembers getting approached by an Internet outlet in 2008, about two years after she opened her Rosedale pharmacy. The company asked her to supply patients in remote areas of the country with various drugs, some as common as birth control medications and antibiotics. The state board's accusation, though, also details her supplying a number of commonly abused drugs such as muscle relaxers and non-narcotic painkillers.
To Faast, the arrangement seemed a win-win. After graduating from the University of the Pacific and working at Kmart's pharmacy in Wasco, the young entrepreneur was eagerly building her own business. She could expand her clientele while helping patients in rural locales nationwide get reasonably priced medications, she said.
Along with adding to her overall business, she'd receive $4 over ingredient cost for each prescription. She said she no longer remembers the Internet company's name or where the company was based. She does recall receiving electronic prescriptions from doctors for the 1,103 medications she filled for California patients.
She called those doctors to confirm the prescription and looked up their state medical board licenses. After that, she mailed them to various locations nationwide. She does not recall if the doctors and the patients were in the same state.
"I did it openly," she said. "If I thought I was doing something wrong, I wouldn't have done it. I thought I vetted this."
She knew a "good-faith examination" by a doctor was necessary as part of the prescription process. But Faast said she grew up in the technology age, learning about advances in areas such as telemedicine. In today's Internet age, she questioned whether that exam had to be in person or a patient's illness could be determined online.
Still, when a colleague warned her that working with Internet sites could be troublesome, Faast said she stopped the operation less than four months later -- well before the board started investigating her.
"I consider myself straight and narrow," she said. "I am very on the right side of the tracks."
Herold, the California board leader, said the law is clear: a physician/patient relationship is the key element, which was missing in this case.
DRUGS IN SHORT SUPPLY
The online sales and other complaints are in the process of being settled, Faast said.
Just last month, though, the board issued Faast the new citation involving Priority Pharmaceuticals, the San Diego-based wholesaler that specializes in hard-to-find drugs.
Faast and more than 50 other California pharmacies received citations for their interactions with Priority, according to Herold, the California board leader. Those pharmacies received extra money for supplying the drugs, which Priority then sold to hospitals and other health facilities for "exceedingly high mark-ups," Herold said.
Priority attorney John Cronin said the company did not engage in any "exorbitant" mark-ups, and that it has already submitted testimonials to the board from customers who believed the prices were reasonable. He also said the language of the statute itself proves those transactions were lawful, and that the pharmacy board has never given any indication or warning that they may object to this activity.
A pharmacy may furnish drugs to a wholesaler to alleviate a temporary shortage of a drug that could result in a denial of health care, according to the business and professions code.
But Herold said the crux of the issue involves the pharmacies buying drugs in short supply that they don't need simply because a profit can be made. Drug companies give pharmacies a careful allocation of these drugs so that no one can corner the market.
"She used her ordering ability with a wholesaler to purchase drugs from a list she was given," Herold said. "She sold them not because she was trying to solve the shortage ... she did this to make money."
It may have been different, Herold acknowledged, if Faast had already had those drugs as extra inventory.
From Faast's perspective, though, she followed the law's provisions for when a pharmacy can sell to a wholesaler. She independently verified the drugs were indeed in short supply. Since she didn't need the medications for her patients, she accepted Priority's extra 10 percent "processing fee" and shipped them out.
The total order was for $2,134.52, according to the citation.
"It's not like I'm retiring to the Bahamas for selling eight orders to Priority," Faast said. "Isn't the whole point of a business to make a small profit?"
Faast said she never asked how much Priority would sell the medications for, saying that is part of supply and demand law.
"I don't believe in price controls," she said. "I'm a free market believer. The fact they made a profit on it, why am I getting in trouble?"
She said that she and other pharmacies are "fighting very hard" against this citation, and that she has sent letters to her local representatives as well as statewide organizations seeking help.
Pharmacy laws aside, though, experts say the citations bring up ethical issues intrinsic to the country's intensifying drug shortages. By engaging with a company the board accuses of driving up prices, those pharmacists got involved with an ethically compromising situation that could have ripple effects on patients in need, said Ramon Castellblanch, an associate professor in the health education department at San Francisco State University.
"This is price gouging to me -- you're obviously raising the prices of medicine and making it less available," he said. "Some customer at the other end is going to have to deal with that. What if you don't have the money?"
Faast also asserted that many additional charges were insignificant, explaining some, such as forgetting to report controlled substances to the state database, were simple oversights.
As for the Virginia doctor who surrendered his license after accusations of filling thousands of Internet prescriptions without a good-faith exam, Faast said she probably vetted him once and didn't recheck his license after he lost it.
She says she did properly label the prescriptions that she then distributed to a plastic surgeon's office for patient use after surgery. She's not sure what happened with the Idaho patient. And she attributed the missing painkillers -- as well as the refills for the muscle relaxer -- to theft by a former employee whom she fired and reported the incident to the police.
OTHER LOCAL PHARMACISTS
Faast isn't the only local pharmacy grappling with these issues. Some, though, make a decision to steer clear of Internet sites as well as turning around and selling in-demand medications to secondary wholesalers.
A wholesaler also approached Brian Komoto of Komoto Pharmacy about supplying a list of drugs in short supply, offering him 10 percent over cost. He didn't even bother to look at the list to see if he had access to any.
"How do I know you're being truthful to the industry in how you're going to resell the product I give you?" he said.
He applies that same skepticism to Internet retailers.
"It's viewed in the industry to stay away from that type of thing," Komoto said. "When you don't know it's going to be safe for your patient, you're at risk."
Pat Person, a Bakersfield pharmacist and the president-elect of the California Pharmacists Association, said he had a similar response when an Internet outlet asked him to dispense medications for it.
"That sounds fishy," he said. "Internet Pharmacy is an oxymoron. We don't want to be associated with them."
But Person acknowledged that he may be more savvy about the new Internet trends since he's so heavily involved in the state pharmacy association.
As prescription drug abuse soars, the field is bound to face even more challenges, Person said.
"The profession of pharmacy is moving toward a lot of gray," he said. "Pharmacists aren't good at working in the gray. We're good at black and white."
As for Faast herself, she says she's doing her part to make sure other pharmacies don't fall into a gray area, calling up colleagues who may engage with an Internet company to warn of the perils. She's focusing on her community service in Bakersfield, such as giving free vitamins to the community, donating flu shots and giving free backpacks to children in need.
She said she hopes her business will survive this, and she will emerge as a stronger pharmacist. Now, she said she asks more questions, and consults colleagues for second opinions more often.
"This whole experience has made me more aware of things," she said. "I had to fight for my right to stay in my profession. It's made me more tenacious to keep that right."
Lois Henry contributed to this report.