As the US opioid epidemic continues to soar, physicians have been held criminally responsible for patients’ overdose deaths. Now, it appears pharmacists are also criminally liable.
That’s the opinion of pharmacy law experts who have watched the crisis unfold during the past decade.
Keith Yoshizuka, PharmD, JD, assistant dean for administration at the Touro University College of Pharmacy, Vallejo, California, notes, for example, that in 2015, a California physician, Lisa Tseng, MD, was convicted of second-degree murder for the overdose deaths of three patients. She was later sentenced to 30 years to life in prison.
“I don’t think it’s too large of a leap to expect a pharmacist to face criminal liability in the event that one or several of the patients overdose on medications that were filled by that pharmacy,” Dr Yoshizuka told Medscape Medical News. “I can see the district attorney going after that pharmacy or the pharmacist for second-degree murder for, basically, recklessness — criminal negligence. But demonstrating that liability is still not clear-cut,” he added.
[Pull quote: “I don’t think it’s too large of a leap to expect a pharmacist to face criminal liability in the event that one or several of the patients overdose on medications that were filled by that pharmacy.”]
I don’t think it’s too large of a leap to expect a pharmacist to face criminal liability in the event that one or several of the patients overdose on medications that were filled by that pharmacy.
Brian Gallagher, RPh, JD, associate professor at the Marshall University School of Pharmacy, Huntington, West Virginia, agreed.
“It’s not illegal to dispense a controlled substance to someone who is an addict who has legitimate pain,” Dr Gallagher told Medscape Medical News. “It’s a very, very gray area — it’s very subjective” for a pharmacist who is trying to decide whether a prescription should be dispensed, he said.
It’s not illegal to dispense a controlled substance to someone who is an addict who has legitimate pain. It’s a very, very gray area — it’s very subjective.
That’s true despite state and federal regulations that guide pharmacists in the dispensing of controlled substances. In 1971, the Drug Enforcement Administration (DEA) established the doctrine of corresponding responsibility, according to which a prescription for a controlled substance must be issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his or her professional practice. The responsibility for the proper prescribing and dispensing of controlled substances falls upon the prescribing practitioner, and a corresponding responsibility rests with the pharmacist who fills the prescription.
The DEA has also warned pharmacists to address or resolve “red flags,” such as cash payments for controlled substances or patients who come to a pharmacy for a prescription but who live far away, before dispensing.
“Corresponding responsibility is perhaps one of the most commonly misunderstood and/or unknown concepts found in DEA’s regulations,” writes DEA compliance attorney Larry Cote in a 2013 blog post. “And yet, enforcement actions against pharmacies are most frequently initiated when a pharmacist fails to exercise his/her corresponding responsibility,” he adds.
And yet, enforcement actions against pharmacies are most frequently initiated when a pharmacist fails to exercise his/her corresponding responsibility.
Lost Licenses, Businesses, Careers
Some pharmacists in California seem not to be heeding the call to mind their corresponding responsibility or do their best to address red flags. Or perhaps they are just too harried — or don’t have the right tools ― to weed out inappropriate or illegal prescriptions.
But judging by the rising number of investigations and disciplinary actions relating to controlled substances by the California Pharmacy Board, more often, pharmacists are paying the price in lost licenses, pharmacies, and careers.
The board fired a significant warning shot in 2013 when, after a long investigation that uncovered multiple failures to address red flags, it revoked the licenses of Pacifica Pharmacy and its pharmacist, Thang Q. Tran. An appeal was rejected.
The decision was considered precedential because it contained “a significant legal or policy determination of general application that is likely to recur,” according to the board.
Others, such as a long-time owner of a pharmacy in the Los Angeles area, believe the board is going too far. That pharmacist says he chose to give up his license — and sell his business ― rather than fight the board any further after an investigation that lasted a year. The inquiry started in 2011, when the family of a young man who died in 2010 of an opioid overdose initiated a complaint with the board.
The prescribing physician — who eventually became an addict — took his own life before a medical board investigation had been completed. The pharmacy board conducted an on-site inspection of the pharmacy in 2013, and in a subsequent report, said that between 2008 and 2010, the pharmacist had filled more than 4500 controlled substance prescriptions from the doctor but failed to call him to verify any of them. The report also cited numerous failures to address red flags, such as filling prescriptions too early and making unauthorized refills.
The pharmacy provided lengthy explanations to the board to justify its practices and hired an attorney to represent it and its pharmacists during conferences with the board and an administrative law judge.
The pharmacy also paid for a forensics expert, who provided the coroner’s records that showed that although the young man died from oxycodone intoxication, he had numerous other substances in his system, including MDMA (ecstasy) and metabolites of marijuana.
The pharmacist lost the case and chose not to spend more money on an appeal. The store paid a $35,000 fine, and the pharmacist paid a $7500 fine. Liability insurance covered some of the attorney’s fees, but nothing else.
In another recent case, two Santa Barbara pharmacists agreed to surrender their licenses and pay a $15,000 fee to cover the costs of a board investigation that determined that they had ignored red flags with patients who had received prescriptions for controlled substances from a local physician who had come to be known as the “Candyman.” The doctor, Julio Diaz, MD, was convicted in 2015 of 79 felony counts and received 27 years in federal prison.
The California Board of Pharmacy expects pharmacists to “use their judgment,” said Virginia Herold, executive officer of the board. For every prescription, “they are to evaluate and make sure it is the right drug for the patient,” she told Medscape Medical News.
Errors are not unexpected, and “unless it is a grossly negligent error, we will cite and fine,” she said.
Errors are not unexpected, and unless it is a grossly negligent error, we will cite and fine.
Growing Scrutiny
The number of investigations “has gone up over time,” said Herold. She attributed it in part to the board’s broadening responsibilities — the board regulates 33 types of licenses covering 45,000 pharmacists, more than 72,000 pharmacy technicians, more than 6800 intern pharmacists, and more than 3000 designated representatives.
The board has 49 investigators — up from 15 about 2 decades ago.
Dr Yoshizuka, who has consulted for the board, said that it is conservative in choosing investigations. “They won’t pursue something unless they are pretty sure they are going to win,” he said. “In order for them to get to a point where they are actually suspending or revoking someone’s license, there has to be a lot of evidence.”
As a consumer advocate who has worked for the board for almost 3 decades, Herold sees her agency’s mandate as primarily focused on consumer protection. That is accomplished through enforcement of corresponding responsibility, she said.
A family whose loved one has suffered because of a prescription overdose or error “would want us to discipline that pharmacist that committed that error,” said Herold.
Pharmacists also have been under growing scrutiny in West Virginia, a state that has been among the hardest hit by the opioid epidemic. The liability pendulum swung against the state’s physicians and pharmacists in 2015, but it has recently taken a swing back toward the middle.
That year, West Virginia had the highest rate of drug overdose death in the United States, at 41.5 per 100,000, according to the Centers for Disease Control and Prevention.
The same year, the state’s Supreme Court ruled that substance abusers could sue prescribers and pharmacists who supplied medications ― even if the patients acknowledged engaging in illegal activities, such as misleading doctors and pharmacists, engaging in doctor shopping, and ingesting the medications in amounts greater than prescribed, said Dr Gallagher.
Fearing a tide of suits, the state legislature soon came up with a response, introducing and passing a bill prohibiting anyone engaged in illegal activities from suing doctors or pharmacists. The bill was approved by the governor in early 2016.
West Virginia has tried to provide some support for pharmacists through another recently approved bill that was signed by Governor Jim Justice on April 26. Marshall University had a hand in crafting the legislation, said Dr Gallagher, who in addition to his pharmacy experience previously served 8 years in the state legislature.
For instance, Senate Bill 333 requires that overdoses — not just overdose deaths — be reported to the prescription drug monitoring program (PDMP). Emergency department visits for overdoses “are a much bigger and better indicator that this person has a substance abuse problem,” said Dr Gallagher. Pharmacists can check the PDMP, which means “they’ll have a real idea, rather than just red flags,” said Dr Gallagher.
The law also gives the Board of Pharmacy the authority to require designated “drugs of concern” to be reported to the PDMP.
Any time a controlled substance is prescribed or dispensed, the physician or pharmacist must record a long list of items of information, including who picked up the prescription and whether it was paid for in cash or by other means. If a prescriber dispenses a controlled substance directly to a patient, it can only be enough to cover 72 hours of treatment. The Board of Pharmacy will enact rules to determine where the reporting will occur.
The West Virginia Board of Medicine will also now be required to report more quickly and publicly on disciplinary actions.
How to Spot Red Flags
Pharmacists are still vulnerable, said Dr Gallagher, adding that malpractice insurance won’t likely cover litigation costs if an opioid or other controlled substance was illegally dispensed.
The first line of protection is to ask questions. Although it may be hard to deny a patient a prescription — especially if it’s a first visit — a pattern of ignoring red flags will attract scrutiny,
The first line of protection is to ask questions, said Dr Yoshizuka. Although it may be hard to deny a patient a prescription — especially if it’s a first visit — a pattern of ignoring red flags will attract scrutiny, he said.
Asking questions and checking PDMPs are time-consuming tasks. But Dr Gallagher noted that “a lot of pharmacies get themselves into trouble because they say, ‘I don’t have time to do all of this.’ “
Not knowing how to spot red flags means getting more training, Dr Gallagher and Dr Yoshizuka agreed. “Everyone has a responsibility in trying to end this,” said Dr Gallagher, adding, “You shouldn’t have a pharmacy license if you don’t know there’s an opioid epidemic.”
And the fight to end the epidemic is a major battle, with many casualties, including people who legitimately need pain medications, as well as physicians and pharmacists who aren’t sure of, or ignore, their corresponding responsibility.
“It’s unfortunate, but people everywhere are getting hit by the shrapnel of this,” said Dr Gallagher.
Dr Yoshizuka has consulted for the California Board of Pharmacy and has been an expert witness for the Drug Enforcement Administration. Dr Gallagher has disclosed no relevant financial relationships.
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