Feature Story

Pharmacy face-off over patient testing

April 2000
Karen Southwick

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 protocol.
• 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 the results.

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 the CDC.

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.

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 long-range implications."

The Georgia Association of Pathologists and Medical Association of Georgia enlisted their national organizations in opposing HB 1234.

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 doses—pharmacists 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.