Author + information
- aKidney and Hypertension Section, Joslin Diabetes Center, Harvard Medical School, Boston, Massachusetts
- bDepartment of Pharmacy Practice, MCPHS University, Boston, Massachusetts
- ↵∗Reprint requests and correspondence:
Dr. Larry A. Weinrauch, Harvard Medical School, 521 Mount Auburn Street, Suite 204, Watertown, Massachusetts 02472-4153.
Historically, partnerships among patient, pharmacist, and physician were sufficiently close that substantive discussion could generate quick and beneficial solutions. Over the past 4 decades, scientific advancement has led to increasing survival with decreased morbidity for several chronic illnesses. The ubiquitous patient with diabetes, chronic systolic heart failure, and atrial fibrillation in the 1970s would have received a sulfonylurea, digoxin, warfarin, and a diuretic. Today that patient might be taking 2 or more antidiabetic agents, a statin, angiotensin-converting enzyme inhibitor/angiotensin receptor blocker/angiotensin receptor-neprilysin inhibitor, beta-blocker, spironolactone, diuretics, either aspirin plus a new oral anticoagulant or warfarin, and perhaps digoxin. Such polypharmacy, although backed by scientific evidence for patients at highest risk, is a substrate for drug-drug interactions, patient nonadherence, and management confusion.
However, as pharmacies and insurers consolidate, the community is losing to wholesale economic considerations one of its most effective proponents for health care delivery and greatest partners with physicians in health care.
In this issue of the Journal, Tsuyuki et al. (1) of the RxEACH (Alberta Vascular Risk Reduction Community Pharmacy Project) report the results of 723 patients at 56 Canadian pharmacy clinics randomized to usual pharmacy care or an intervention by participating pharmacists focused on directing more intensive goal-directed therapy to reduce cardiovascular risk. The case-finding recruitment strategies required presence of peripheral, cardiac, or cerebrovascular disease, an estimated Framingham risk score >20%, and at least 1 of the following: blood pressure (BP) >140/90 or >130/80 mm Hg if diabetic, low-density lipoprotein cholesterol (LDL-C) >2.0 mmol/l (77 mg/dl), glycosylated hemoglobin (HbA1c) >7.0%, or current smoker. This is an enriched population for cardiovascular risk.
The authors hypothesized that pharmacist intervention (compared with usual care) would reduce cardiovascular risk score, LDL-C, HbA1c, systolic and diastolic BPs, and smoking at the end of a 3-month trial. The intervention was relatively simple: pharmacists communicated with treating physicians while advancing medications and altering diet when appropriate. Indeed, they did demonstrate improvement in these surrogate outcomes. The patients with diabetes dropped their baseline HbA1c of 8.6% to 7.6%, with 42% achieving an HbA1c of <7.0%, significantly better than the usual care group. This was accomplished in a very short period of time with monthly pharmacy visits.
That better management could be achieved with appropriate case finding and rigorous attention to goals should be a wake-up call. Whether such management must be delivered by physicians, pharmacists, nurse practitioners, or other facilitators (such as paramedics in Boston or specialized multilingual clinical trainees in India) (2,3) is less important than the observation that we are able to recruit or case find patients who might benefit from additional management and that better results are rapidly achievable.
The burden of medical therapy for hypertensive patients with diabetes looms large, especially for those with renal disease (4–7). Removing financial disincentives to adherence has not been demonstrated to improve outcomes for patients after myocardial infarction (8). Even among heart failure patients requiring implanted defibrillators, adherence to guidelines remains suboptimal (9). Adverse morbidity and mortality have been linked to nonadherence to guideline-directed therapy (10,11). The RxEACH study results demonstrated room for improvement of medical care in the trial population (1), hardly surprising given how many people are not currently achieving guideline targets for lipids, BP, smoking cessation, or glycemic management. Observations from this study should trigger analysis of potential public health benefits from additional studies of larger size and longer duration, if for no other reason than financial benefits to the community.
Although there is no reason to believe cooperative efforts would not be durable, longer studies will be required to delineate cost and risk, and assess follow-up. This study had other limitations; there was no documentation of care leading up to study participation (no run-in), and body mass index (BMI) was not followed throughout. While therapeutic inertia is occasionally blamed for failure to achieve goals, it cannot be invoked if the patient is not under active care. Additionally, data regarding potential therapeutic missteps are not available. To achieve such rapid reductions in glycemia, one must risk hypoglycemia; for hypertension therapy, one risks hypotension.
Another major limitation: investigators may have recruited a patient cohort that has escaped careful follow-up. This will need to be addressed in future studies. It would also be important to know in more detail the interventions, including medications used, and the extent of hypoglycemia or other drug treatment-related problems. Improvement in BP, lipids, and glycemia may certainly be related to weight loss. A successful weight management or bariatric surgical program targeting obese 60-year-olds (BMI in this study was >33 kg/m2) would be anticipated to replicate these findings (albeit with higher costs and risks). No medication dosages are available in the current presentation, meaning some therapeutic changes may be undetected yet responsible for a major portion of the findings. Notwithstanding, the investigators were able to recruit a high-risk group and improve care facilitated by pharmacists.
Limited information was provided on remuneration or other barriers to the intervention. The authors noted compensation for pharmacist care was covered under a program available in Alberta; in the United States, pharmacists are excluded as providers in the Social Security Act, thus limiting program implementation and preventing widespread compensation for services provided in collaborative care programs. Individual states establish provider status or expand scope of practice in numerous ways; thus, applicability of these observations may vary by geography. This study suggested at least short-term benefits for integrating community pharmacists into a collaborative care initiative, but for most patients to benefit from more extensive risk reduction, pharmacists would need to be designated “providers” by federal regulations.
The average high-risk patient encounters the physician far less often than the pharmacist. In our aging population, the patients at risk for drug-drug interaction, medication confusion, or nonadherence may also be limited by visual or other handicaps, such as hearing deficits or inability to open containers. The loss of the community pharmacist may remove measures of safety and coaching from these patients.
Physicians often use “lack of training” as an excuse to prevent expansion of the pharmacist’s scope of practice, but pharmacy school curricula and standards for accreditation have evolved into comprehensive medication management and collaborative care in all health care settings (12). Although design of these programs may vary significantly, each emphasizes the patient-centered care process with essential components of collaboration, communication, and documentation (13). However, cost of pharmacist care cannot be balanced by revenue through traditional reimbursement. Some institutional programs have promoted pharmacist services as cost-containment measures, integrating them into patient-centered medical homes and recovering costs by preventing drug-drug interactions and errors, and acting synergistically with clinicians to decrease adverse outcomes.
This study highlighted use of a provincial remuneration program by community pharmacists to determine whether cardiovascular risks could be lowered in a relatively homogeneous population. The extent to which such studies apply to areas with multiple languages is unclear. Long-term evaluation and outcome trials regarding collaboration with community pharmacists incorporating various reimbursement models may provide additional evidence as to whether pharmacy services should be included within the Social Security Act.
Another important issue to consider in expanding this model: currently, there appears to be no standard process by which information available to the physician is fed back to the pharmacist. Not knowing who is responsible for disseminating the information and how patient privacy will be protected during such communications may be major implementation limitations.
As with many important observations, more questions must be answered and studies done to relate short-term benefits to long-term outcomes.
↵∗ Editorials published in the Journal of the American College of Cardiology reflect the views of the authors and do not necessarily represent the views of JACC or the American College of Cardiology.
Dr. Segal has served on the advisory board for Lilly USA, LLC. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- American College of Cardiology Foundation
- Tsuyuki R.T.,
- Al Hamarneh Y.N.,
- Jones C.A.,
- Hemmelgarn B.R.
- Kirkman M.S.,
- Rowan-Martin M.T.,
- Levin R.,
- et al.
- Weinrauch L.A.,
- D’Elia J.,
- Finn P.V.,
- et al.
- Weinrauch L.A.,
- Bayliss G.,
- Segal A.R.,
- et al.
- Roth G.A.,
- Poole J.E.,
- Zaha R.,
- et al.
- Herttua K.,
- Martikainen P.,
- Batty D.G.,
- Kivimäk M.
- Smith S.C. Jr..
- ↵Accreditation Council for Pharmacy Education. Accreditation standards and key elements for the professional program in pharmacy leading to the doctor of pharmacy degree, “Standards 2016”. Available at: https://www.acpe-accredit.org/standards/. Accessed April 3, 2016.
- ↵Joint Commission of Pharmacy Practitioners. Pharmacists’ patient care process. Available at: https://www.pharmacist.com/sites/default/files/files/PatientCareProcess.pdf. Accessed April 4, 2016.