Tackling Hypertension With Pharmacists in Tow

Henry R. Black, MD


March 14, 2016

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Editor's Note:
Henry R. Black, MD, interviews Barry L. Carter, PharmD, a professor in the Department of Pharmacy Practice and Science at the University of Iowa College of Pharmacy, on the role of pharmacists in group practice management of patients with hypertension and other cardiovascular risk factors.

Henry R. Black, MD: Hi. I'm Dr Henry Black. I'm an adjunct professor of medicine at the New York University (NYU) Langone School of Medicine. I'm here today with my friend and colleague, Dr Barry Carter. Barry?

Barry L. Carter, PharmD: Thank you, Henry. I'm Barry Carter. I'm a professor in the College of Pharmacy at the University of Iowa and also the Department of Family Medicine in the College of Medicine at the University of Iowa.

Dr Black: I'd like to go over a couple of things that you've done in the research part of hypertension. We go back a long way, but [your recent research uses] cluster randomization.[1] Could you review that study for us and tell us what the findings were?

Dr Carter: Sure, I'd be happy to, Henry. I do have to acknowledge that you are the individual who got me so actively involved in the American Society of Hypertension and the American Heart Association's Council for High Blood Pressure Research. That has been immensely helpful to me.

With regard to our research in behavioral-based intervention, particularly having a pharmacist embedded in a primary care office: When we do behavioral-type research where [we're] intervening at both the physician level as well as the patient level, it's very important (in order to avoid contamination) to randomize an entire office to either the intervention or the usual caregiver. That's what we've done in about four of our trials.

In that regard, an office is then randomized to either a control or the intervention arm. That is what we mean when we talk about cluster-randomized trials. Our interventions involve a pharmacist embedded in the primary care office—who works with physicians perhaps for long periods of time—but who has not necessarily done the blood pressure-based intervention that we've done in our trials.

Integrating Pharmacists Into Primary Care Offices

Dr Black: Do you think that would work in just about any office, or only in offices where physicians, nurses, and nurse practitioners would accept a pharmacist? Do you ever get any pushback on that? What I would imagine is people would be very grateful to have someone who is aware of what drugs and drug interactions might be.

Dr Carter: That's a good question. In fact, I've practiced in family medicine for the first 12 years of my career as a clinical pharmacist and have visited almost all of the offices that we have done studies in, which now are over 50 offices around the country. Of course, the cultures vary at the individual offices. But I can tell you that when a pharmacist is newly placed in an office, it usually takes about 6 months for everybody to get comfortable with each other, develop trust, and have physicians and other members of the staff understand what it is the pharmacist is able to do (or perhaps not able to do) and where they can best assist with the management of chronic medical conditions. Then, they become an integrated member of the team.

Obviously, the longer those relationships occur, the greater the depth of complexity of what those teams can do. But usually, about 6 months is an average period of time where that level of trust begins to get pretty strong.

Dr Black: What do you think a pharmacist can and can't—or shouldn't—do?

Dr Carter: That's also a very good question. If we think about it again in primary care—not necessarily a specialty office, but in primary care—we kind of usually think of the physician as the leader of the team delegating responsibility to various team members for certain aspects of care management.

Again, depending on the office, depending on the individual physician's desires and those kinds of things, those roles can differ. They can be anything from assisting with, as you said, trying to overcome drug/drug interactions or adverse drug reactions, as well as trying to improve medication adherence all the way up to complete approval to choose the medication, order the medication, adjust doses, and even order laboratory tests. It depends on the office. It depends on the team and the relationships in those offices. But there's a wide variety of things a pharmacist can do.

What I can tell you the pharmacist should not do, and probably doesn't do in almost any office, is diagnose or deal with patients who have suspected secondary hypertension. Resistant hypertension is a bit different, as long as secondary hypertension has been ruled out. But the pharmacists are not going to be in the capacity to diagnose or do much physical assessment, [except] maybe some minor things, [such as] looking at ankle edema from a calcium-channel blocker. When you're talking about diagnoses, that's outside the realm of what a typical pharmacist would do. Those kinds of things are for other team members, or certainly for the physician to do.

Dr Black: Do the pharmacists interact directly with the patients, or indirectly?

Dr Carter: Mostly directly. All of our studies have included pharmacists embedded in the office. In the case where a physician either refers a patient to the pharmacist or requests that a patient be referred to the pharmacist, [then] the pharmacist will usually schedule the patient or go in the patient room, do an assessment, try to determine history, and try to determine the reasons for poor blood pressure control. They'll do a medication history and history of nonprescription drugs, including herbal therapies that perhaps could elevate blood pressure—such things as ephedra.

They'll do an assessment. Is the problem adherence? Is the problem a suboptimal regimen?

Then, they will try to come up with some recommendations both to the patient and the physician. Again, depending on the relationship, the pharmacists may be in an office where they have the authority to just go ahead in the electronic medical record (EMR) and order a change in meds. Or they may have to confer with the physician and get a recommendation, and the physician then enacts the recommendation should they agree with it. But to answer your question: Yes—by and large, these are face-to-face interactions with the patient.

We have found (as you have found) that the number one reason for the lack of blood pressure control is clinical inertia or suboptimal medication regimens. If the pharmacist is adjusting therapy, things like that, many times if they've made a med initiation on a face-to-face visit, they can certainly do some modest titrations over the phone for a reliable patient. But most of the interventions, particularly the ones studied in the literature, have been face-to-face.

Following on the CAPTION Trial

Dr Black: Tell me about the study that you did, and what the results were.

Dr Carter: We finished the CAPTION trial and published the main results in 2013.[2] That particular trial was not designed to look at whether pharmacy-based intervention—pharmacists embedded in doctor's offices—was effective.

Prior research (a lot of systematic reviews and meta-analyses) already suggested that that type of intervention is effective.[3] But most of the trials that have been done have been done in one or two offices under ideal conditions—what we would call an "efficacy trial." What we wanted to determine was whether this type of a model would be implemented and adopted in a large number of very diverse offices when the practitioners are bombarded with all the other things that happen day-to-day in a typical office practice. It's more of an effectiveness trial than an efficacy trial. We wanted to determine whether the model would be implemented.[1]

The other thing that CAPTION assessed was, if a pharmacist intervention is discontinued, does the effect on the blood pressure remain or does it deteriorate? There aren't a lot of studies that have looked at that, so we want to look at what happens when the pharmacist intervention is discontinued.

The third thing that we want to look at is, there's not a lot of literature (certainly when we started the CAPTION trial) looking at whether this intervention is as effective in underrepresented minorities. We wanted to power the study with sufficient numbers of underrepresented minorities to test that.

We identified 32 medical offices around the country from San Diego to Boston that all had a pharmacist already embedded in the office. We developed a network of medical offices that had high numbers of African Americans and Hispanic persons primarily, such that by the end of the trial, we had a 53% minority population in our trial. Two thirds of the minorities were African American, and one third Hispanic.

That trial had three arms. The first arm was a 9-month pharmacist intervention arm that was then shut off. The second arm was identical to the first arm for the first 9 months, but it was continued for a full 24 months. (The pharmacists just kept working with the patient for a full 2 years.) The third arm was usual care.

These offices are very diverse. We had offices from a couple percent minorities to 100% minorities. We had offices with very large numbers of patients who had low income. We had about 25% of the patients in the trial who either had Medicaid or self-pay/no insurance. We ended up with larger diversity in our offices than we had anticipated.

When you do a cluster-randomized trial—in contrast with an individual randomized trial, where the patient is randomized—you're worried as much about the variability between offices as you are between patients. We had a lot of variability.

Our primary endpoint was blood pressure control at 9 months. It did not reach statistical significance for that primary endpoint. It was better in the intervention group, but the P value was 0.055, so just barely missed.

With regard to blood pressure reduction, mean blood pressure was 6 mm Hg better in the intervention group. For our primary endpoint at 9 months, we combined the two intervention groups because they were identical for the first 9 months. That was the main priority plan of analysis.

The blood pressure in the intervention group was 6 mm Hg lower for systolic blood pressure. Of note, it was 6.4 mm Hg lower in the minority subjects. It appeared that at least the extent of blood pressure reduction was just as good in minority patients.

The other thing I need to mention is that all of these patients on entry had uncontrolled blood pressure. Anecdotally, we know from the providers and the personnel in the offices that many of these patients had either never had blood pressure control, or for long periods of time had been uncontrolled. If we think about a typical office nowadays, where blood pressure control is upward of 70% or 75%—that is, 25% of people are not controlled or who are difficult to control—[then] it's not surprising that our control rates were a little bit lower than we expected. But overall, my interpretation was the outcomes were positive.

Bringing on a Pharmacist: Cost Considerations

Dr Black: Two things occur to me. One is the question of jealousy [of having access to a pharmacist]. The other is a question of cost. How much is the cost for an office to add a pharmacist if it doesn't have one, or to get a full-time pharmacist rather than a part-time pharmacist? How much more does a person there improve [compared with] just having access to a phone or the Internet?

Dr Carter: I'll answer the question of having the pharmacist there. We did do a cost-effectiveness analysis that was published in journal Hypertension.[4] It suggested that it was a little over $200 per patient over the course of the 9 months. That cost was direct time with the patient that didn't include reviewing the chart beforehand or documenting in the chart afterward. The cost to manage a typical population of these patients could fairly easily be done with a half-time pharmacist managing a population in a given office on a half-time basis.

Most of these offices have the pharmacist anywhere from about 70% to 100% of the time, so it's very feasible to do that. Some offices that I'm aware of—not necessarily in our study—share a pharmacist if they're geographically close.

We're doing two National Heart, Lung, and Blood Institute (NHLBI)-sponsored studies[5,6] that are looking at a centralized cardiovascular risk service broader than just hypertension—it's diabetes, it's post-myocardial infarction (MI), it's stroke—to see whether centralized pharmacists in my research unit can work with private doctors who don't have the resources to hire their own pharmacists in an attempt to improve guideline adherence. For example, the patient needs to be on aspirin or a beta-blocker if he or she is having problems with adherence. The pharmacist works via telephone and the Web.

One of those studies[6] we're doing in six intervention offices in the state of Iowa [and] six control offices; we have remote EMR access to all of those private doctors' offices. The pharmacist oftentimes just makes a recommendation directly into the EMR, which makes it very convenient for the physician [unlike in] the old days, when we had to fax recommendations to the doctor.

We are working on some strategies for what we would call "resource-poor environments." Certainly in the Midwest, the vast majority of doctors' offices are solo practices or two or three doctors. Those places could not afford a pharmacist. We're looking at strategies that might assist them.

We have also done (in fact, back in the days when I was in Chicago and before) studies where physicians can partner with community pharmacists. The research there is also very positive. That's a little bit outside the scope of our cluster-randomized trial, but clearly, doctors do partner with community-based pharmacists and refer patients or work together in a sort of virtual team. They're not necessarily located side-by-side. But that can be a very effective strategy as well.

Training Pharmacists for Cardiovascular Disease Intervention

Dr Black: I think we can easily imagine that if doctors get rewarded for good blood pressure control data, [then] having someone to help and get you 6 mm Hg more can make a real difference in how things work out. What's your advice to practices, or to pharmacists? How much more training do they need? Should they specialize in cardiovascular disease, or be more general?

Dr Carter: I can tell you [that] the studies that we've done, including the CAPTION trial, 95% of the pharmacists (actually in CAPTION, 100% of the pharmacists) had a doctor or pharmacy degree, which is a minimum 6-year degree in pharmacy; many of our graduates now have a BS plus 4 years in pharmacy school. In addition, 95% had a postdoctoral residency or fellowship.

Pharmacy is moving toward the point where for a pharmacist to do these types of activities, they need a minimum of a 1-year residency. Now we have specialized residencies in ambulatory care wherein they focus on chronic disease management in primary care settings. That is going to become the standard.

Most of our pharmacists now are board-certified in either one of two areas. They can be board-certified in pharmacotherapy, which is a board-certification process that's been going on since 1991 that gives some degree of comfort that they are well versed in drug therapy. The second one is the board certification in ambulatory care, which is a little bit more focused on the things that a primary care practice would involve.

Clearly, board certification for pharmacists is becoming the standard to do these kinds of services, not a requirement. But a lot of health systems, when we start talking about the Affordable Care Act and accountable care organizations, are going to expect certain levels of standards. These are the kinds of things that you can use as a yardstick.

The final thing is, the American Society of Hypertension for many years has had a hypertension specialist. They've had the hypertension specialty exam for physicians. They've just [last fall announced] a certification process for nurses, pharmacists, and physician assistants. In fact, I'm going to be taking that exam, as well the intervention pharmacists working with me on those two studies. We're all going to take that exam.

For blood pressure management, and those kinds of things where a pharmacist is managing lots and lots of patients or if they're in a Veterans Administration Hospital health system and they're in the hypertension clinic, I think they ought to get that kind of a certification.

Dr Black: I'm happy to hear that. I think it's very important that we all work together.

Barry, I want to thank you for your time. Thank you for your inspiration over the years. I always look forward to your work, and it's been a pleasure. Thank you very much.

Dr Carter: Thank you very much, Henry. Appreciate it.

Disclosures: Barry L. Carter, PharmD, has disclosed the following relevant financial relationships:
Received research grant from: National Institutes of Health


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