Drugstore Prescription Errors Lead to Illnesses, Deaths, & Lawsuits

(For other articles on pharmacy errors go to our Misfilled Prescriptions
Page.)

Can you trust the pharmacy that fills your prescriptions? Maybe not.

A number of cases from many states have shown that what the label says
may not be what the container holds. Drugstore Prescription Errors,
frequently called "misfills", are becoming more common for a number of
reasons. As a result, injuries, illness, and death have been caused by
the taking of harmful medication.

When a "misfill" occurs there are two related consequences: one is that
the patient does not take the correct medication needed to treat an
illness or condition; the second is that the patient takes a medication
that was not prescribed and is likely to be dangerous. Sadly, permanent
injury or death is sometimes the result.

In Florida, because of the huge elderly population, the pharmacy
business is booming with new drugstores opening virtually every week
on a new corner. This increase in prescription-filling puts stress upon
the filling process. Just the increasing volume of prescriptions being
filled at each drugstore raises the likelihood of a "misfill" occurring.

In one excellent article in the Bangor Daily News there is a litany of
misfilled prescriptions that should make you triple check every pill or
tablet. Excerpts from the article follow:

Bangor, ME - June 26, 1999 - Dennis Pinkham is no couch potato. According
to his wife, Janet, when he finishes work at the construction company
the couple owns in Kenduskeag, he busies himself with projects around
their home. So in the summer of 1995, when night after night he walked
through the door and collapsed on the sofa, often nauseated, she was
worried. Could his prescription for Zocor, a cholesterol-lowering drug,
somehow be making him ill, they wondered as days of malaise turned into
weeks. Not likely, it seemed, as he had been taking the medication for
some time, recently refilling the prescription.

But with suspicions raised, Janet Pinkham took the pills back to the Rite
Aid pharmacy on Broadway in Bangor. It was then she discovered that her
husband had been given the wrong drug and for weeks had been taking
Zestril, a drug that controls high blood pressure. To make matters
worse, Dennis Pinkham was already taking a medication to lower his
blood pressure.

The Pinkhams likely would have let the matter drop -- considering it a
rare mistake -- had they not gone to the same pharmacy two months later
to refill the Zocor.

"I couldn't believe it!" said Janet Pinkham. "They gave him the same
wrong prescription again." That's when the couple filed a complaint
with the state's Board of Commissioners of the Profession of Pharmacy,
the group responsible for policing pharmacists.

While this is an especially egregious example of a misfilled prescription,
such mistakes have been anything but rare in Maine this decade.

In June 1992 Sue Ellen Gerrish refilled a prescription for Premarin, an
estrogen replacement, at Brooks Pharmacy in Rockland. After experiencing
intense itching, she returned the medication to the pharmacy, where she
learned they had doubled the prescribed dose.

In October 1996, Bonnie Smart of Hartland had a prescription filled at
Rite Aid in Newport for desipramine, used for treating depression. After
taking the drug for two days, she was almost immobilized with
fatigue. Returning to the pharmacy, she was told she had been given an
anti-psychotic drug by mistake.

In September 1997, Sally Dobres refilled a prescription at Wal- Mart
in Augusta for 20-milligram tablets of Prozac, an anti- depression
medication. More than a month later, Dobres, whose symptoms of depression
and anxiety had increased, discovered that the pharmacist had given her
20-milligram doses of Prilosec, an ulcer medication.

In February of this year, a Knox County jury awarded Antoinette Walter
$550,000 in damages as a result of a misfilled prescription she was given
by Wal-Mart in Rockland in 1997. Walter, who had cancer, was prescribed
Lukeran but mistakenly given Alkeran, a stronger, more volatile version
of the drug. She suffered serious internal bleeding, nausea, vomiting,
rashes and bruising. Wal-Mart has appealed the case.

The pharmacy board, which licenses pharmacists and investigates citizen
complaints, has received about 75 complaints of misfilled prescriptions
in the 1990s. Most of the complaints were resolved by the board warning,
reprimanding or fining pharmacists anywhere from $50 to $750.

More than a dozen lawsuits alleging injury due to misfills also have
been filed in Maine courts since 1994 against four national drug retail
chains doing business in the state.

Most mistakes, however, simply go unreported, according to research
studies.

But it is the state's largest chain-owned drugstore, Rite Aid, that
is involved in the greatest number of misfill complaints -- an amount
disproportionately higher than its competitors based on its share of
business in the state.

Since the beginning of 1994, 46 complaints about misfilled prescriptions
have been filed with the pharmacy board, 40 of which were verified. Out
of those 40, 25 were against Rite Aid pharmacists, or almost 63 percent.

In addition, Rite Aid has been sued eight times in state and federal
court for prescription errors since 1994, while the other five largest
national drug chain stores in Maine -- Brooks, Shop 'n Save, Wal-Mart,
Osco Drug and CVS -- have faced a combined total of five suits during
the same period.

A nationwide shortage of pharmacists -- especially acute in Maine --
has created heavy workloads. Relatively low unemployment has made it
difficult to hire and retain pharmacy technicians, who regularly fill
routine prescriptions. Moreover, the market for new prescription drugs
has mushroomed, adding to the workload in all pharmacies.

Theresa Bonsey of Hermon has been a pharmacist since 1981, working both in
institutional settings, such as Central Maine Medical Center in Lewiston,
and in retail stores, such as Brooks Drug and Shop 'n Save. She has
been a pharmacist at Eastern Maine Medical Center's inpatient pharmacy
for almost three years. One of only a few pharmacists willing to be
quoted for this article, Bonsey vows she will never go back to the
pressure-cooker atmosphere of retail pharmacy.

"Retail pharmacists are paid more, but there is more expected out of
them," Bonsey said. That can mean working 12 hours without getting time
to eat or use a bathroom, dealing with a queue of demanding customers
and spending hours on the phone with insurance companies.

"If you don't get a lull, where you can regroup and eat
something...clearly you're not fresh and clearly you're not going to
make good decisions -- you're going to miss things."

Managed care has steadily cut into pharmacy profit margins by paying
flat reimbursement fees per prescription rather than basing payment on a
percentage of the prescription charge. Hence, there is pressure to "get
the numbers up" in retail pharmacies because a profit is only possible
with volume, Bonsey said.

In a 1998 complaint involving a Rite Aid store in Yarmouth, the
pharmacist, Michael Butts, admitted that he had made a dispensing error
and apologized.

In a letter to the board he wrote: "I have rectified the situation
that affected my professional performance by selecting not to be a Rite
Aid employee."

"Working for Rite Aid was the worst experience of my professional
career. The district managers continued to cut the pharmacy technician
hours to levels that were unacceptable. I would work for 12 to 14 hours
with little or no help without the privilege of eating or going to
the bathroom.

"I am very vocal about Rite Aid's treatment of employees and {its}
disrespect for the pharmacy profession."

In another case from 1996, Harold Litchfield went to a Portland Rite
Aid and received a prescription for haloperidol, an anti- psychotic
medication, instead of furosemide, which is used for high blood pressure
and other conditions. According to Litchfield's complaint, he became
"deathly ill."

In responding to the complaint, Stephen Pelletier, the pharmacist in
charge, wrote that on the day he made the mistake he had worked from 8:30
a.m. to 9 p.m. -- 12 1/2 hours -- and filled 192 prescriptions. Pelletier
attributed the mistake to long hours with little help.

"On the day I filled the 192 prescriptions it is highly likely that a
mistake could be made," Pelletier wrote. "I don't believe any pharmacist
and even laypersons with some knowledge of the routine of daily pharmacy
practice ... would not agree with me that the qualified {pharmacy}
technician time in this case was far from acceptable."

Rite Aid allowed no more than 30 hours of pharmacy technician time per
week for this pharmacy, Pelletier wrote. The technician had worked six
hours on the day the error was made, only half as much as Pelletier.

Pelletier was reprimanded by the board.

In a 1996 misfill case at a Bucksport Rite Aid, Verle Henry received
a refill prescription for Dilantin, used to treat irregular heartbeat,
epilepsy and other conditions. Instead of getting his usual 100-milligram
dose, he received 30-milligram capsules. Henry's wife, Mary, wrote in
the pharmacy board complaint that her husband came into the house one
day feeling faint, ready to pass out. Upon closer investigation, she
found the prescription error.

In his written response to the Henrys' complaint, the pharmacist,
Harold Logan, who was subsequently censured and fined $100 by the board,
suggested that "the tremendous amount of stress and pressure and constant
interruptions that we pharmacists are constantly exposed to" contributed
to the error.

"It was also at this time that I got two new girls as techs," Logan
wrote. "They didn't have any experience or training. They were expected
to receive this under fire.

"It is becoming more and more difficult to fill prescriptions with the
demands of ... an employer that has to cut corners in order to continue
to make a profit."

In responding to a misfill complaint in 1998, Paul Charltray, a pharmacist
at Rite Aid in Falmouth, wrote that the error was "most likely due to
lack of help, lack of qualified help, volume, constant distraction of
two phone lines and company programs piled on top." He said he did not
believe anything would be done to improve conditions at the pharmacy
and notified the board that he had left Rite Aid and taken a job at an
independent pharmacy.

It's hard to know how many misfills are found by customers but never
reported to the pharmacy board.

In October 1996, a jury in York, S.C., awarded $16 million to the parents
of 7-year-old who suffered brain damage as the result of a misfill by
a Rite Aid pharmacist in 1995. Instead of receiving a prescription for
Ritalin, which controls hyperactivity, Gabrielle Hundley got Glynase,
a drug given to diabetics to reduce sugar levels in the blood. Gabrielle
was left mildly retarded as a result.

A circuit judge subsequently refused to grant Rite Aid's request for
a new trial or a reduction of the $16 million award. The company has
appealed the case to the South Carolina Supreme Court.

Days after the jury award in October, Rite Aid announced that it
was selling more than 200 of its stores in North Carolina and South
Carolina. In turn, the company bought a string of pharmacy outlets on the
West Coast called Thrifty PayLess. According to consent orders between
Rite Aid and pharmacy boards in Oregon and Washington, the new ownership
led to misfill problems.

Don Williams, director of the Washington Pharmacy Board, said the board
noticed in the latter half of 1998 that it was receiving many more
complaints about the 145 Thrifty PayLess stores under Rite Aid ownership
than it had under the previous ownership. In 1996 the board received 32
complaints about the chain. In 1998 the number increased to 80, mostly
concerning misfilled and mislabeled prescriptions.

In February, the Washington Pharmacy Board reached an agreement with Rite
Aid in which the company paid $10,000 in penalties and $40,000 to the
Washington State Department of Health to be used for health education. As
part of the consent agreement, Rite Aid, which admitted no wrongdoing,
is required to review its written policies, procedures and personnel
training practices. The company is required to report that information
to the board.

"The reason we issued discipline to the corporation in this matter
was that there seemed to be an organizational problem," said Williams,
referring to the boom in complaints under Rite Aid ownership. He said it
is unusual for any state pharmacy board to take action against corporate
owners because boards usually limit oversight to individual pharmacists.

Rite Aid ran into similar problems with its Thrifty PayLess stores in
Oregon at about the same time. The Oregon Board of Pharmacy in 1998
also noticed an increase in citizen complaints about the drugstores,
many concerning misfills.

"It might be the case that a single pharmacist makes a mistake, but many
pharmacists from the same company making mistakes -- that needs to be
looked at closer," said Gary Schnable, the pharmacy board compliance
director.

As a result of the board's investigation, Rite Aid, which admitted no
wrongdoing, entered into a consent agreement with the board in March. It
agreed to pay $19,000 in penalties, reimburse the board $20,500 for
expenses and give $20,000 to the Oregon State University College of
Pharmacy for education. As part of the agreement's 12- point action
plan to improve the performance of the drug outlets, the pharmacy board
will assign all future complaints regarding Thrifty PayLess to a single
board inspector.

Misfill studies

A study published in 1995 by American Pharmacy, a scholarly journal,
found that 100 prescription orders dispensed in metropolitan areas in
New Jersey, New York and Florida yielded 24 prescription errors, such as
wrong drug, wrong strength, wrong quantity or wrong label. Four of those
errors would have had serious ill effects if taken. The study concluded
that the problem of dispensing errors required "immediate attention."

Two other studies in 1995 and 1996 found that the average range of
prescription errors to be 3 to 5 percent. Other studies estimate that
between 0.87 percent and 1.5 percent of those misfills are potentially
injurious to patients. Given that an estimated 2.8 billion prescriptions
were filled in America in 1998, that means between 1 million and 2
million prescriptions had the potential to harm.

There is no simple answer to why dispensing errors are made.

An article in the Medical Sciences Bulletin in 1997 pointed out that
some mistakes are made because too many drugs have nearly identical
names. For example: Levoxine vs. Lanoxin, Eldepryl vs. enalapril, quinine
vs. quinidine. Prescriptions also use drug suffixes, like SR or XL,
whose presence or absence can alter the prescription.

Anthony Grasha, a psychology professor at the University of Cincinnati
who has conducted industry-sponsored studies on pharmacy misfills, has
documented 17 factors associated with pharmacists who make prescription
errors. Some of those are conflicts with a supervisor, co-workers or
family members; frustration with the task of filling prescriptions;
problems with the physical environment of the pharmacy; and drinking
too much caffeine.

But corporate management has also come under scrutiny for its part in
misfills. According to a March 1996 article in the American Journal of
Health-Systems Pharmacy, the Alabama Supreme Court affirmed a $250,000
jury verdict against a corporation based on a plaintiff's allegation
that the company had insufficient controls over how prescriptions were
filled at its pharmacies.

The article concluded, "This case departs from precedent because it
considers the possibility that a pharmacist may be caught in circumstances
that predispose him or her to error (for example, inadequate support
personnel, outdated technologies, poor lighting, or some deficiency
in the physical layout), so that a pharmacy can be characterized as an
accident waiting to happen."

In particular, the correlation between pharmacy workload and dispensing
errors has been of special interest -- and debate -- this decade.

In 1994, the National Association of Boards of Pharmacy established
the Task Force to Study Pharmacists' Workload. The task force issued
a request for proposals for a research project looking into workload
issues. The project, however, never was funded.

In a report last year, the task force wrote that there is still "little
data available regarding the effect of various environmental, sensory,
staffing and prescription filling and dispensing procedures. Without
reliable data of this kind, NABP and the state boards of pharmacy are
unable to make appropriate and valid decisions about the effects of
workload systems on medication errors."

Still, after reviewing existing research on misfills, the task force
concluded that "workload conditions in the pharmacy are a problem that
impact the public health and safety." The task force noted that a number
of other factors are involved, such as lighting, temperature, physical
layout, staffing, working with insurance companies and advising patients
on over-the-counter medications.

The National Association of Boards of Pharmacy advocates that state
boards establish continuous quality improvement programs (CQI), which are
intended to encourage pharmacists and pharmacies to report medication
errors in a way that will allow the boards to determine which factors
are most likely to contribute to the problem.

In February, Florida became the first state to implement CQI. Pharmacies
will be required to keep a record of any reports or allegations of
misfills, and a CQI committee will analyze the errors quarterly. According
to John Taylor, the Florida board's executive director, CQI will allow
the board to look at the system, not the individual.

Workload regulation

Despite the national board's advocacy of CQI, the idea of specifically
regulating pharmacy workload in order to reduce misfills is alive
and well.

North Carolina became the first state to regulate pharmacists' hours
earlier this year. Spurred on by a complaint of a misfill dispensed by
a pharmacist who had worked a 16-hour shift in 1997, the North Carolina
Pharmacy Board's proposed a rule that would prohibit pharmacists from
working more than 12 continuous hours per day. Pharmacists who work
more than six continuous hours would get a 30- minute meal break and a
15-minute break.

"Twelve hours is a common shift," said David Work, executive director
of the North Carolina pharmacy board. "But 16 hours is over the top."

However, the Rules Review Commission, an independent agency in North
Carolina, rejected the workplace regulations, saying that the pharmacy
board has no authority to set such rules. The pharmacy board is seeking
a judicial review of the commission's decision, Work said.

In late 1995, 27 Maine pharmacists -- 10 from Rite Aid -- submitted a
petition to the Maine Board of Pharmacy asking that the board establish
a regulation limiting pharmacists to a maximum 12- hour workday. The
board voted to deny the petition, noting the "potentially controversial
nature and far-reaching effect of such a rule."

Theresa Bonsey, who was working at Shop 'n Save at the time, signed the
petition. "I think they should allow at least two 20- minute breaks away
from the pharmacy area for a pharmacist in a 12- hour day -- minimum,"
she said. "If you've gone without even a 20- minute chance to regroup,
go to the bathroom and eat something, how can you possibly be functioning
at a level where you're able to think and analyze and approach someone
in a good way?"

Despite its rejection of the petition, the board has remained interested
in the subject of workload.

Catherine Longley, commissioner of the Maine Department of Professional
and Financial Regulation, which oversees the pharmacy board, formed a
seven-member review group last fall to consider changes to the Maine
Pharmacy Act during this year's legislative session.

One of the issues up for discussion was pharmacy workload.

In an August letter to the legislative analyst working with the review
group, the state pharmacy board said it "feels there is a need to regulate
certain aspects of pharmacy staffing within Maine pharmacies to assure
the availability of adequate trained personnel to meet the specific
volume needs of each outlet."

Christina Valar Breen, who is Longley's assistant and acted as her
designee on the task force, said there are many pharmacists who see
workload as a problem and would like to see something done. But the
workload issue was eventually dropped because it was too contentious
and threatened to scuttle a draft bill by the review group, she said.

"The discussion started turning into a labor-relations debate," said
Valar Breen. "The task force couldn't see how we could come up with
legislative action to address it."

In general, pharmacy companies oppose such restrictions. "Workload,
in and of itself, is not a significant factor in misfills," said Carr
for Rite Aid.

A bill passed this legislative session authorizes a second phase of
the task force. Anne Head, director of the Office of Licensing and
Registration, which administers the pharmacy board, said the task force
will likely look at workplace regulation by the pharmacy board or by
new law.

"It's important to consider because the only purpose of this board is
to protect the public from unsafe pharmacy practices," Head said. "It
seems to me that the public protection mission of this board is broad
enough to include the change in pharmacy practice that we're seeing
across the country, where corporate entities tend to dominate the retail
pharmacy service."

Bernard "Bill" Miller, who owns and operates Miller Drug in Bangor, the
state's largest independent drugstore, acknowledges that the pharmacist
shortage has caused some problems in adequate staffing for the state's
pharmacies, but he said he does not believe regulation of store workload
would work. "It can't be a numbers game -- it has to be common sense,"
he said, noting that the time it takes to prepare any given prescription
varies widely. "We don't need to be legislated."

Miller said it is a pharmacist's professional obligation not to tolerate
working conditions that promote mistakes. "You have a professional
responsibility to quit if the chain doesn't let you do the work
professionally," he said.




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