Pharmacy face-off over patient testing
Pharmacists and pathologists, who have seen many of their
traditional functions commoditized by competition and cost-cutting,
are increasingly at odds over pharmacists’ efforts to expand their
scope of practice.
In several states, pharmacists are backing legislation that would
allow them to perform certain laboratory tests like glucose and
cholesterol without state laboratory licensure or regulation. Such
testing is part of a campaign by pharmacy groups to get pharmacists
involved more directly in patient care.
"In a managed care environment where physicians don’t have the
time to spend, patients need somebody who is seeing them more frequently
and monitoring them consistently," says Mitch Rothholz, a spokesman
for the American Pharmaceutical Association in Washington, which
represents pharmacists. As nurses and physician assistants have
done in some states, pharmacists can work with doctors in monitoring
and modifying treatment, he asserts.
A White Paper issued last August by three national pharmacy groups,
including the pharmaceutical association, said in addition to dispensing
medication, pharmacists "also have the additional challenge, as
integral members of the health care team, to educate, monitor and
care for patients."
As evidence, the White Paper cited:
- Pharmacists’ contributions in managing conditions related to
high cholesterol, diabetes, and asthma. For example, in Mississippi
the state Medicaid agency implemented a new benefit for pharmacy
services in patient education and monitoring.
- As of early 1999, 24 states allow collaborative practice agreements
in which physicians delegate patient management responsibilities
to pharmacists, which can include refilling medications to modifying
or initiating a patient’s medication according to an approved
- The credentialing group for pharmacists has established standards
for certifying pharmacists in disease state management related
to lipid management, anticoagulation, diabetes, and asthma.
Although medical groups such as the CAP and the American Medical
Association do not necessarily oppose these efforts, they are
wary of pharmacist attempts to move into physician practice
areas like prescribing drugs or administering tests and interpreting
At its fall 1999 meeting, the CAP House of Delegates adopted
a resolution to assess the extent of pharmacists performing
laboratory tests and to make recommendations that state governments
could use in defining the "practice limits of pharmacists."
State pathology societies could disseminate the recommendations
to appropriate government officials.
Pharmacists marching in Georgia
The hottest battle between pharmacists and pathologists is in Georgia.
Last year, the state legislature passed, and Gov. Roy Barnes signed,
a law (SB 100) that permits pharmacists to perform "capillary blood
tests" and interpret the results "as a means to screen for or monitor
disease risk factors and facilitate patient education." The pharmacist
must report test results to the patient’s "physician of choice."
This year, a related measure, HB 1234, would exempt pharmacists
performing these tests from licensure by the Georgia Department
of Human Resources. While the attempt to repeal last year’s law
has not yet been successful, physician groups did succeed in getting
HB 1234 amended so that pharmacists may perform only over-the-counter
tests without licensing. Those are CLIA-waived tests that a patient
can perform at home.
Nonetheless, pathologists are outraged.
"In the state of Georgia, even people who cut hair have to get
licensed and inspected," says Wesley Simms, MD, past president of
the Georgia Association of Pathologists and a member of the Medical
Association of Georgia’s Council on Legislation.
"The pharmacists are saying that having a pharmacist license is
enough to do lab tests," adds Dr. Simms, associate director of clinical
laboratories at John D. Archbold Memorial Hospital in Thomas-ville,
Ga. "It’s the same thing as saying, ’I’m a licensed pathologist,
so I can open a funeral home.’"
The Georgia pathologists passed a resolution unanimously seeking
to overturn the capillary blood test law, but the Medical Association
of Georgia has done little to move that along, Dr. Simms says. Now,
HB 1234 is key. "Pharmacists are looking for a law that would lower
standards," he says.
Capillary blood testing is so vague that it could apply to many
types of tests, including complex ones, adds David Booker, MD, president
of the Georgia Association of Pathologists and based at St. Joseph
Hospital in Augusta, Ga. "If [pharmacists] can order blood tests
and interpret the results, it’s very close to practicing medicine."
Pharmacists "aren’t trained to do testing," he adds. And if they’re
going to do it, "they should be subject to the same standards that
we are for the protection of the public." Dr. Booker even objects
to pharmacists performing over-the-counter tests because patients
will place more faith in the results than they would if they had
done the test themselves.
"There’s a big difference between the patient taking responsibility
for doing a test and a health professional doing it," he adds. In
the latter situation, "the public will assume that the pharmacist
is properly trained and regulated." In his own laboratory, Dr. Booker
notes, "people know the state comes in and inspects us. It makes
no sense that people who are less qualified than we are to perform
tests should be exempt."
Dr. Booker emphasizes that the expansion of pharmacy is not viewed
as a threat to pathology. What pharmacists are doing, he says, will
compete with physician office laboratories, not with hospital-based
pathologists. "Pathologists are not speaking up to protect their
income," he says. "We’re speaking up to protect quality of testing
and patient care."
For the patient
The Georgia Pharmacy Association retorts that pharmacist involvement
in disease monitoring and screening will improve patient care. "It’s
a nationwide movement," says Oren "Buddy" Harden, executive vice
president of the association.
As an example of the good that pharmacists can do, he cites a
recent survey by the Centers for Disease Control and Prevention
that shows most patients with a history of peptic ulcer disease
were unaware that a bacterial infection caused most ulcers and were
not seeing a physician. Pharmacist intervention in encouraging patients
to adhere to antibiotic therapy improves outcomes, according to
Similar surveys sponsored by the American Pharmaceutical Association,
or APhA, have demonstrated that pharmacists can help patients with
high cholesterol and diabetes better manage their conditions. "This
is not something that will cause a problem to pathologists," Harden
says. "We want patients to understand they have a problem and need
to see a physician."
Under the new Georgia law, pharmacists expect only to perform
fingerstick tests for high cholesterol, glucose, and H. pylori,
although that could expand as more of these kinds of tests come
on the market.
"We’re not talking rocket science," Harden adds. "We’re talking
about simple tests to help patients find out if they have a problem
or to monitor the course of their disease." He says pharmacists
in Georgia want to perform only CLIA-waived tests "that the government
has decided" don’t require a licensed operator.
Rothholz, of the APhA, says the majority of tests conducted by
pharmacist laboratories are CLIA-waived and that oversight is provided
by state pharmacy or health department boards as well as by the
Food and Drug Administration through an equipment review. "There
are standard FDA procedures you have to go through to certify equipment
is testing properly," he says.
The only tests pharmacists are doing, Rothholz maintains, are
those that can be handled appropriately outside a clinical laboratory.
"When they need more sophisticated tests," he says, "they work with
labs. Pathologists should look at this as an opportunity to collaborate
and expand their services."
As for keeping information on tests, Harden says pharmacists are
accustomed to maintaining databases on drug prescriptions and interactions,
so adding blood test results and reporting them to physicians is
not a problem. "They holler about quality of care," he says of pharmacist
opponents. "This increases quality of care and positive outcomes."
Pharmacist testing will send new patients to physicians, not take
business away, Harden believes. "We’re helping physicians identify
patients who they otherwise might never see," he adds. In many cases,
Harden predicts, physicians might order confirmatory or followup
tests, further increasing the market. "The real winner in this is
the patient," he says.
Physician group maneuvering
Pathologists were caught off guard by last year’s bill to allow pharmacists
to perform capillary blood tests, says James Lyle, executive director
of the Georgia Association of Pathologists and president of Health
Care Consultants of America in Augusta. One reason, he asserts, is
that the Medical Association of Georgia (MAG), which handles lobbying
on most physician issues, crafted a compromise with pharmacists in
which the latter would oppose a bill to allow optometrist prescribing
in exchange for MAG’s support of SB 100.
Despite that, the MAG
House of Delegates joined the Georgia pathologists in passing a
resolution calling for the repeal of the original bill. "There has
been little or no success with that," Lyle reports. "I don’t believe
there’s any support to repeal SB 100."
As for the new bill to exempt pharmacists from licensure, HB 1234,
at press time it had passed the Senate and was headed to Georgia’s
governor, as amended to limit the pharmacist exemption to only over-the-counter
tests. Physician groups considered the amendment a partial victory.
"Pharmacists will only be able to perform tests that can be done
in the home," Lyle notes. "The bill is better with the amendment,
although there’s still concern by physicians."
The Medical Association of Georgia originally did not oppose SB
100 because pharmacists insisted it would apply only to three tests:
diabetes, cholesterol, and H. pylori, according to Paul Shanor,
MAG’s executive director. With the emergence of HB 1234, MAG became
concerned about the possible expansion of testing and "we started
to oppose this," he adds.
Legislators cannot understand why a fingerstick blood test available
to the public without licensing shouldn’t also be available to a
pharmacist to perform, Shanor notes. "Right now it may not be that
big a problem, but as more home tests come out, the scope will expand."
He does see one advantage in having pharmacists perform the testing:
Pharmacists are required to submit the results to a physician, while
patients who perform self-tests are not. "What’s happening is that
pharmacists are giving up their traditional role of dispensing medication
and trying to become screening-diagnosticians."
Rather than a knee-jerk reaction, "all of us in the health care
field have to be very careful about which changes to support or
oppose," Shanor cautions. "We’re willing to support efforts done
in the right way, but we’re going to look very carefully for the
The Georgia Association of Pathologists and Medical Association
of Georgia enlisted their national organizations in opposing HB
In a Feb. 8 letter sent to the chair of the Georgia House Health
and Ecology Committee, CAP President Paul Bachner, MD, stated that
HB 1234 "would exempt [pharmacists] from requirements established
to ensure quality laboratory testing for the protection of patients.
Further, the CAP believes that the interpretation of laboratory
tests is the practice of medicine, for which pharmacists are also
not licensed . . . The CAP believes all test procedures should be
subject to a documented quality control program including participation
in approved proficiency testing programs."
The American Medical Association, too, submitted a letter, via
its state association. Signed by Erin E. Ryan, a legislative attorney
with the AMA’s Division of State Legislation, the letter said HB
1234, "in effect, allows pharmacists to practice medicine . . .
and takes from physicians the ability to ensure that the services
performed by pharmacists are rendered safely and effectively by
removing state oversight of laboratories used by pharmacists."
Ryan’s letter said other AMA concerns are how to ensure the quality
of laboratory work in an unregulated laboratory and appropriate
followup care by physicians. "There is no need to remove the existing
safeguard that pharmacists who perform capillary blood tests and
interpret the results are, at a minimum, required to comply with
state laboratory regulation and requirements," Ryan wrote.
Battles in other states
The CAP’s House of Delegates resolution was actually touched off
by an attempt last year in Texas to allow pharmacists to perform
tests such as urine creatinine, urine albumin, hemoglobin A1c, cholesterol,
triglycerides, and others as part of a demonstration project.
The project, sponsored by the Texas Department of Health and Human
Services, was aimed at enlisting pharmacists in disease management
for Medicaid patients. The Texas Society of Pathologists and Texas
Medical Association succeeded in getting the state to limit pharmacists
to fingerstick glucose testing ordered by a physician.
"We had concerns about the quality of laboratory testing being
done by nonaccredited labs," says David Henkes, MD, past president
of the Texas Society of Pathologists.
In his own practice, Dr. Henkes has been involved for years with
point-of-care testing at a number of hospitals, and he has witnessed
the adverse effects on patient care when untrained people are permitted
to perform the tests. "Fortunately, there was no major consequence
to the patient in most of the scenarios," he says, "but the events
had the potential for major quality care issues.
"They aren’t accustomed to lab testing and don’t understand good
lab practice," he adds.
The same thing could occur with pharmacists, says Dr. Henkes,
medical director for laboratory and pathology services at Christus
Santa Rosa Health Care, San Antonio. For instance, pharmacists may
not recognize valid test results or realize when a retest is needed.
Echoing his colleagues in Georgia, he says, "This is about the quality
of patient care."
The Texas Medical Association and the Texas Pharmacy Association
negotiated amicably to work out a compromise, emphasizes Alfred
Gilchrist, legislative director of the TMA in Austin. "This is a
pilot project to determine whether a community pharmacist can enhance
patient outcome," he says.
Physicians were concerned that pharmacists would immediately advise
patients of test results without reporting back to the physician,
he says. And pathologists did not want testing performed by other
than an accredited laboratory.
Gilchrist believes the compromise, which limits testing to glucose
and requires physician approval of how the patient will be advised,
is a reasonable one. "TMA would not have signed off on it without
approval of the state pathology society," he adds.
Assuming the Health Care Financing Administration approves the
project, it will run for three years. "I know pharmacists and physicians
are fighting in legislatures across the country," says Gilchrist,
"but pharmacy and medicine are going to be far more effective if
we work together."
In Tennessee, a bill recently introduced in the House by pharmacist-legislator
Shelby Rhinehart would allow pharmacists to perform any laboratory
tests ordered by a physician as well as any CLIA-waived tests. The
proposal, HB 2378, would also exempt pharmacists from licensure
under the rules of the Tennessee Medical Laboratory Board.
David Yates, MD, a CAP state issue adviser in private practice
in Nash-ville, says he is not opposed to pharmacists doing a few
waived tests such as glucose (using an over-the-counter device)
and perhaps cholesterol when ordered by a physician. "It’s pointless
to try to regulate those," he says, because some of the waived tests
can be done by the patient at home. What he objects to is pharmacists
performing other laboratory tests ordered by a physician, especially
with no laboratory license required. The bill tries to give pharmacists
"the same latitude as physicians, though they do not have equivalent
training," he says.
At a legislative allied health subcommittee hearing Dr. Yates
attended March 7, the pharmacists made it clear they want to "manage
patients" with lipid and coagulation disorders and diabetes based
on the results of the tests, Dr. Yates reports. "That means adjusting
insulin doses, changing Coumadin dosespharmacists aren’t trained
to do that," he says.
The Tennessee Medical Association also has concerns about the
bill, according to Scott Smith, director of government affairs.
"It’s a patient safety issue," he says. "The state Department of
Health has got some interest in this because [pharmacists] are trying
to bring themselves out from under the licensing rules."
The debate over scope of practice expansion for nonphysicians
is not going to wane soon. Like pharmacists, other health care professionals,
including op-tom-et-rists, psychologists, physician assistants,
and nurses, are seeking to expand their spheres by moving into areas
traditionally reserved for physicians.
Sums up Dr. Henkes: "Scope of practice is going to be medicine’s
next big battle."
Karen Southwick is a freelance writer in San Francisco.