Pubdate: Wed, 28 Oct 2009
Source: Wall Street Journal (US)
Copyright: 2009 Dow Jones & Company, Inc.
Contact:  http://www.wsj.com/
Details: http://www.mapinc.org/media/487
Author: Amy Merrick

CASE SPURS PHARMACIES' FEARS OF LAWSUITS OVER DRUG ABUSE

When Patricia Copening, a petite, 35-year-old doctor's office 
receptionist, bought nearly 4,500 doses of prescription painkillers 
one year, alarm bells sounded at the Nevada controlled-substance task 
force. The state board sent letters to 14 pharmacies in the Las Vegas 
area warning that Ms. Copening could be abusing drugs.

On the afternoon of June 4, 2004 -- a year after the letters were 
sent -- Ms. Copening climbed into a gray Dodge Durango, veered onto 
U.S. 95 and was seen weaving erratically in and out of three-lane 
traffic, witnesses later said. She plowed into 21-year-old Gregory 
Sanchez Jr., a delivery-van driver who had pulled over to repair a 
flat tire on the highway's shoulder, killing him at the scene. She 
also hit Robert Martinez, 33, who had been helping Mr. Sanchez move 
packages out of his van. Mr. Martinez suffered a head injury, a 
broken right leg and other wounds. Ms. Copening wasn't injured.

A lawsuit filed by Mr. Martinez, his family and Mr. Sanchez's family, 
now pending before the Nevada Supreme Court, may be the first U.S. 
case to address whether pharmacies can be held liable when a customer 
causes a fatal car accident. The case, Sanchez vs. Wal-Mart Stores et 
al, asks whether drugstores must use information at their disposal to 
protect the public from potentially dangerous customers.

The Nevada case is part of a broader movement under way to place more 
responsibility for patients' prescription-drug use on pharmacies.

Abuse of prescription drugs has risen dramatically over the past two 
decades, along with a surge in the number of controlled-substance 
prescriptions being written.

In 2007, U.S. retail pharmacies dispensed nearly 180 million 
prescriptions for opiates, such as hydrocodone and oxycodone, up from 
about 40 million in 1991, according to congressional testimony last 
year from the National Institute on Drug Abuse.

At the same time, pharmacists have much more patient information at 
their disposal, thanks to pharmacy computer systems and a 
proliferation of state online prescription-tracking databases. The 
availability of patient information is only expected to increase as 
electronic health records are adopted by more and more doctors.

As a result, consumers, government officials and pharmacies 
themselves are increasingly asking what a pharmacy is legally and 
ethically obligated to do with this newly available information.

This week, the National Association of Boards of Pharmacy is 
convening a task force to discuss pharmacies' roles in 
prescription-tracking programs. Separately, the association is 
considering whether to develop new guidelines about pharmacists' 
responsibilities to the general public. The issue "is not even an 
area we'd thought about until recently," says Carmen Catizone, 
executive director of the group.

Prescription-tracking systems are operating in 33 states, with the 
goal of identifying potential addicts and referring them for 
treatment, or getting law enforcement involved if necessary. Most 
have been set up since 2002. Last month, California launched the 
largest such database, covering 7,500 pharmacies and 158,000 prescribers.

With such programs, "there's certified information coming across, and 
that's where pharmacies are struggling" to know exactly how to 
respond, Mr. Catizone says. Earlier this year, the association passed 
a nonbinding resolution urging pharmacists to help reduce the 
excessive use of controlled substances by their customers.

The pharmacy industry -- which includes big chains such as Wal-Mart 
Stores Inc., CVS Caremark Corp. and Walgreen Co., all parties in the 
Nevada case -- acknowledges the growing public pressure to curb 
prescription-drug abuse. At a recent conference of the National 
Association of Chain Drug Stores, conference materials called 
preventing prescription-drug abuse "the new focus in the war on 
drugs." It noted that "public and private initiatives are looking to 
the entire supply chain, including retail pharmacy, to be part of the 
solution."

The drugstore chains contacted for this story declined to comment on 
the issue. The National Association of Chain Drug Stores also declined comment.

The chains are watching the Nevada case closely. Legally, it's one 
thing for a pharmacy to be held liable for hurting an individual 
customer by, say, filling a prescription with the wrong drug. But 
drugstores worry Sanchez could open them to broader and more 
ambiguous responsibility with significant consequences to the industry.

Some predict higher insurance costs and more expensive prescriptions, 
to absorb the costs of additional lawsuits. In court filings, 
Wal-Mart argued that pharmacies might decide not to stock certain 
regulated painkillers. Walgreen suggested that the judgment of 
pharmacists could be pitted against that of doctors, as pharmacists 
struggle to decide whether to refuse a prescription.

Michael Wall and L. Kristopher Rath, attorneys for Longs Drug, now 
owned by CVS Caremark, predicted a "tsunami of litigation" if the 
families prevail. Drugstores could be sued by their own customers if 
pharmacists refuse to fill valid prescriptions and customers are 
harmed, they said. Drugstores could also be sued by those who claim 
to be injured by a customer who purchased prescription drugs.

In their defense, the drugstore chains argue that they face a dilemma 
similar to that faced by bartenders in some states. Bartenders can be 
held liable for the acts of customers served too much alcohol. 
Similarly, doctors have been successfully sued by car-crash victims 
for failing to warn patients not to drive under the influence of 
certain medications.

Nevada was one of the first states to systematically share 
prescription information among doctors, pharmacists and 
law-enforcement officials when it set up a computer database to track 
potential drug abuse in 1997.

Under Nevada law, pharmacies must report their patients' 
controlled-substance prescription records each month. Staff members 
of the state's Prescription Controlled Substance Abuse Prevention 
Task Force filter that data for warning signs of abuse, such as 
purchasing drugs from multiple pharmacies. If a customer sets off 
enough red flags, the task force sends a form letter to the 
pharmacies the patient has visited.

"The focus of the task force is to get people into treatment and help 
them," says Larry Pinson, executive director of the state pharmacy 
board. "The primary option is for the pharmacist to speak with the patient."

But the law creating the task-force database isn't explicit about 
what pharmacies should do with the letters, he says.

In June 2003, the task force sent letters to the 14 pharmacies in the 
Las Vegas area, including Wal-Mart, Walgreen, CVS and others, warning 
them that Ms. Copening had purchased during the prior year 60 
prescriptions, or nearly 4,500 doses, of controlled substances. Most 
were for medications containing hydrocodone, a frequently abused narcotic.

"It is not the Task Force's intent to determine how you dispense 
prescriptions," the letter said. "Well-informed pharmacists can and 
will use their professional expertise to assist patients who may be 
abusing controlled substances."

In Ms. Copening's case, there's no documentation of any pharmacist 
making a note in her customer records about the task-force letter, 
counseling her about drug addiction or refusing to give her 
prescriptions. She continued to buy large quantities of hydrocodone, 
as well as Soma, a muscle relaxant, from numerous pharmacies, 
according to her prescription records, which are part of the lawsuit. 
The combination of the two drugs, which is said to produce a euphoria 
similar to that induced by heroin, is known locally as the "Las Vegas 
cocktail."

That June afternoon in 2004, Ms. Copening left the Las Vegas OB-GYN 
clinic where she worked as a receptionist. She drove a Durango owned 
by her employer, Richard M. Groom.

Witnesses reported later that Ms. Copening was driving haphazardly, 
jerking her steering wheel from side to side. She appeared to be 
either laughing to herself or having a seizure.

Around the same time, Mr. Sanchez got a flat tire. He pulled his 
silver Airborne Express van onto the shoulder of U.S. 95 and sent a 
text message to a dispatcher: "Yo my tire blew."

Mr. Martinez, his co-worker, parked his own van behind Mr. Sanchez's 
vehicle, and the two men started moving freight out of the disabled 
vehicle. Ms. Copening swerved off the road and hit them both. Mr. 
Sanchez died at the scene. The coroner discovered tire tracks across 
his lower back. Mr. Martinez suffered multiple injuries and was taken 
to the hospital.

In Ms. Copening's car, police found prescription bottles and loose 
pills, 167 in total, of hydrocodone, Soma and other drugs. Police 
reports said Ms. Copening appeared confused. She took off her 
low-heeled sandals and tried to walk barefoot in a straight line, 
following a patrol officer's directions, but struggled to keep her 
balance. When police asked, she couldn't remember the name of one of 
her two children.

She claimed she had taken only medicine for a migraine headache that 
day; a blood test detected hydrocodone. She was charged with reckless 
driving, driving while intoxicated and being involved in a fatal accident.

Ms. Copening pleaded guilty to two counts of reckless driving and 
served nine months in jail. Through a spokeswoman, she and her 
attorney declined to comment. The state revoked the license of Dr. 
Groom's business partner, Doyle S. Steele, the doctor who wrote most 
of Ms. Copening's prescriptions. A few months after the accident, the 
Sanchez and Martinez families sued Ms. Copening and the doctors.

After the task-force records came to light in pretrial discovery, 
lawyers for Messrs. Sanchez and Martinez added seven pharmacy-chain 
owners -- including Wal-Mart, Walgreen, CVS Caremark and Rite Aid 
Corp. -- and one independent drugstore as defendants.

Individual pharmacists have been successfully prosecuted for 
knowingly filling controlled-substance prescriptions that weren't 
issued for legitimate medical needs. In guidelines to pharmacists, 
the federal Drug Enforcement Administration says: "The pharmacist who 
deliberately looks the other way when there is reason to believe that 
the purported prescription had not been issued for a legitimate 
medical purpose, may be prosecuted...." Pharmacies have said that the 
guidelines leave open questions about what practices are unacceptable.

In general, courts have found that doctors owe greater duties to 
patients when issuing prescriptions than pharmacists do when filling them.

But recent court decisions have expanded pharmacists' responsibility. 
In 1994, the Indiana Supreme Court ruled in Hooks SuperRx Inc. vs. 
McLaughlin that a pharmacy had a duty to stop dispensing painkillers 
to a patient who was refilling a prescription faster than normally 
would be appropriate.

In the Nevada case, Clark County district court Judge Douglas W. 
Herndon dismissed the pharmacies from the suit, noting that the 
Nevada law creating the task force doesn't specify what action, if 
any, is required by the pharmacies.

The families appealed to the state Supreme Court, which heard oral 
arguments in March.

Lawyers for the pharmacies argue that, while drugstores may choose 
not to sell drugs to a customer, they had no legal obligation to turn 
away Ms. Copening or to protect the general public from her actions.

In a statement, Walgreen said: "While we're sympathetic to those 
injured in Ms. Copening's car accident, we agree with the district 
judge's decision that our pharmacists fulfilled their legal duties." 
Similarly, Wal-Mart said, "This is a deep personal tragedy for the 
families involved." Because the court hasn't issued its decision, "we 
don't believe it's appropriate to say more at this time," the company said.

CVS Caremark, Rite Aid and Albertson's Inc., the parent company of 
Sav-On Drug, all declined to comment on the case. The parent company 
of Lam's Pharmacy, a Las Vegas drugstore, declined to comment.

Some regulators say that even if the drugstore chains are absolved of 
any legal responsibility in the Nevada case, their pharmacists still 
had ethical duties to respond to the task-force report. "That 
requirement is still there professionally, if not legally," says 
William Winsley, executive director of the Ohio Board of Pharmacy, 
which isn't involved in the Nevada case.

The Nevada Supreme Court is expected to issue its opinion by the end 
of the year. 
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MAP posted-by: Richard Lake