Pharmacists will participate more in patient care in years to come

Provider status legislation still high on the lists of pharmacy groups

With a new year unfolding, Drug Utilization Review (DUR) takes this opportunity to look ahead at pharmacy practice, regulation, and the continued battle for pharmacists to receive provider status. To help, DUR asked representatives from the American Society of Health-System Pharmacists (ASHP) in Bethesda, MD, and the American Pharmaceutical Association (APhA) in Washington, DC, for their thoughts. Here is what they said.

Pharmacy practice

Pharmacists will continue to have a more active role in patient care in a variety of settings, says David Witmer, PharmD, director of ASHP’s professional practice and scientific affairs division. "As more pharmacists complete residency training and as more pharmacists graduate with PharmD degrees, you’ll see increased interest and increased activity in those areas. Is that going to mean there will be more pressures to look at the system of health care and how we use pharmacists, how we use technicians and technology? Sure."

Witmer expects that a number of pharmacists who have graduated with bachelor of science degrees will seek some additional degree. That may or may not be the PharmD degree, however. "You will see pharmacists continuing to pursue master’s degrees and PhDs and other degrees to further their career. What direction they will go in their post-graduate education would really depend on their career interest."

More pharmacists with PharmD degrees will pursue advanced degrees, as well, he continues. "As long as we have pharmacists, we are going to have pharmacists who want to better themselves and further their education. I don’t think that is going to change. What will change is the number of baccalaureate graduates in the work force over time."

Witmer also expects an increase in the emphasis on appropriate education and training of pharmacy technicians and increased credentialing of those technicians through the technician certification exam. That will lead to more well-defined roles for technicians in a variety of settings and will enable pharmacists to apply their time more effectively in other patient care activities, he says.

Other trends may stay in the forefront in the near future, Witmer says. These include:

Popular prescription drugs shifting to over-the-counter (OTC) status.

The debate about switching prescription drug products to OTC status will continue, Witmer predicts. "That will have some impact in terms of patient care and in terms of pharmacists having to address how those drugs will be used, what their formulary status will be, and how patients will get their OTC medications for a number of different disease states."

"Claritin moving OTC is going to be a significant shift, and Prilosec is on track to move over as well," says Susan Winckler, RPh, JD, vice president of policy and communications and staff counsel for APhA. However, she adds, the reality is that all health care is what could be called "self-care," because it ultimately depends on what the patient chooses to do. "Certainly the increasing availability of over-the-counter medications presents another opportunity for pharmacists to make the best use of those over-the-counter medications."

New advice coming out on handling cytotoxic drugs.

"There is some emerging research about transferring devices and protections from various types of biological safety cabinets," Witmer says. "That will begin to have impact in the next year on people thinking about how they set up their program and how they prepare those drugs in various work settings."

Regulation

The biggest challenge in the first quarter of 2003 will be making sure everyone is ready for compliance with the final federal privacy regulation in mid-April, Winckler says. The privacy regulation is mandated under the Health Insurance Portability and Accountability Act of 1996 (HIPAA).

"That requires folks to be taking a look at how they deal with their information, developing privacy practices, developing information that communicates those privacy practices to their patients, and then tracking all that information, as well," she says.

The portion of the rule that addresses distributing notice of privacy practices and then documenting that patients have received it is difficult because it’s not standard practice today, she says. However, it’s still better than what could have been. "[That section] is far superior to the prior written consent requirement. It’s superior for patients because they won’t have this disruption to their care, and obviously superior for the care providers because they can actually focus on caring for their patients rather than chasing a paper requirement that may not have yielded much benefit."

Winckler expects the HIPAA security and electronic signature standards to be released soon, but providers should have a greater implementation period for these standards than for the privacy rules, which were released in August and had an implementation date of April.

Regulation may be forthcoming on the issue of pharmacist compounding, as well, Witmer says. "There will be some potential challenges or changes to either state board of regulations or FDA [U.S. Food and Drug Administration] policies that could affect how pharmacists practice in the coming year."

In June, the Foodand Drug Administration (FDA) issued a compliance policy guide for FDA staff and industry regarding pharmacy compounding. (To see the report, go to www.fda.gov/ora/compliance_ref/cpg/cpgdrg/cpg460-200.html.)

Efforts to address compounding on the state level can be of benefit if they are done well, Winckler says. The challenge is that the FDA regulates manufacturing, not compounding. "We have to work out some middle ground there. We certainly don’t want to protect the folks who are manufacturing under the guise of compounding. We hope the FDA identifies them without sweeping the whole profession and the activity we call compounding’ under that umbrella of activity."

Another issue Winckler expects to undergo intense debate in the near future is the effort to speed the availability of generic drugs. A Senate bill passed in July 2001 is dead because the House failed to act on it. An administration plan is moving forward, but the question remains as to whether the plan is strong enough.

"That will likely be debated between the generic manufacturers and the brand-name manufacturers," Winckler says. "From the pharmacists’ perspectives, [the question is] how do we make sure there is protection for the brand-name companies so we will continue to have innovative medications, but still get rid of some of the so-called loopholes that have really challenged the system? Obviously, pharmacists want their patients to have access to good-quality generics."

The battle will continue over a Medicare prescription drug discount plan, as well. A hearing was scheduled for late January on whether the Bush administration has the regulatory authority to conduct this program.

Provider status

Some of the biggest challenges are going to come not in the form of government regulation, but in government’s role as a payer and the regulations that result, Winckler says. In Medicare, there continues to be an effort to add a Medicare benefit that will pay pharmacists for their services.

Securing provider status for pharmacists under the Social Security Act has been a major effort for ASHP, Witmer says. "We think that is important because, particularly in ambulatory care settings, pharmacists just aren’t on the same par as other types of providers who are providing the same kind of services but are able to bill for them."

When pharmacists are finally recognized, there will be significant impact on how pharmacists bill for their services and even on what kinds of services they can provide in what kinds of settings, Witmer adds. "It’s not that they aren’t trained to do that now, but they will be in a better economic position to justify their role in their services and obtain reimbursement for their services."