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PHILADELPHIA -- One way of looping remote pharmacists into the primary care clinician workflow successfully boosted statin initiation in the cluster-randomized SUPER LIPID trial.

Researchers devised an intervention of asynchronous automated orders, a centralized approach using pharmacists to discuss and prescribe statins without a doctor's visit. This led to most orders cosigned (73.7%) and a referral to a centralized pharmacy initiated, after which the most frequent outcomes were a patient starting a target-dose statin (28%) or a patient declining the statin (19%).

The proportion of individuals who were ultimately prescribed any statin reached 31.6% out of all eligible patients, a significant improvement over usual care's 15.2% (OR 2.22, 95% CI 1.47-3.37). Similarly, there was an increase in prescriptions of appropriate-dose statins (24.8% vs 7.7%, OR 6.79, 95% CI 4.00-11.53), reported Alexander Fanaroff, MD, MHS, of University of Pennsylvania, Philadelphia, at the American Heart Association (AHA) annual meeting.

"A centralized asynchronous model could be an effective adjunct to visit-based clinical interactions in increasing statin prescribing for high-risk patients," Fanaroff told the audience.

Based on SUPER LIPID, the tested pharmacist-led approach produced an increase in statin prescribing that was much larger than other approaches in previous trials.

"A centralized approach removes the key barrier in that a patient has to have a visit with the doctor to be prescribed a statin. Many less engaged patients either do not visit the doctor, or when they do, may not be amenable to discussing a statin. Patient visits are also short in duration and sometimes not everything that needs to be discussed can be addressed," commented Mitesh Patel, MD, MBA, of Ascension Health in St. Louis.

"I really liked that the pharmacists were able to prescribe statin therapy instead of simply recommending it to the physician. I think this is a key aspect of why this intervention was successful, because it removed that additional opportunity for clinical inertia," said Dave Dixon, PharmD, of Virginia Commonwealth University in Richmond, who was not involved with the study.

Statins are a key preventive medication due to their ability to lower LDL cholesterol, a major risk factor in cardiovascular disease. Despite the backing of robust science and widespread adoption in clinical guidelines, statins remain under-prescribed in the population -- clinical inertia being an often-cited barrier to implementing these usually well-tolerated and cheap medications.

Recent CDC estimates suggest statins are used only in that could benefit from lipid lowering.

"New, innovative, and scalable approaches to increase statin utilization could have a significant impact on improving population health," Patel told MedPage Today.

Session discussant Benjamin Scirica, MD, MPH, of Brigham and Women's Hospital and Harvard Medical School in Boston, discussed how implementation strategies range in resource intensity -- at the low end are interventions like patient and provider education, whereas remote and in-person management clinics represent higher-cost strategies.

"In general, you get what you pay for. Lower-cost solutions will not result in meaningful changes in care," Scirica said.

Indeed, the strategy of automated statin orders sent to a central pharmacy would have to overcome several financial and logistical barriers in the real world. "Sustainability is a potential barrier since pharmacists cannot directly bill for their clinical services," Dixon cautioned.

While most U.S. states legally allow the pharmacist prescriptive authority in collaboration with physicians, they are often not recognized by payors as clinicians. As such, pharmacists are limited to incident billing attached to claims by a physician or advanced practice clinician.

Dixon suggested that "improvement in the achievement of performance measures related to statin initiation in select populations, such as those with diabetes, can increase health system revenue and offset the cost of pharmacists."

"Another barrier is that not all health systems or medical offices have pharmacists, but there is an opportunity for collaboration with community-based pharmacists to help identify patients eligible for statin therapy," Dixon added.

Scirica noted that the SUPER LIPID investigators remained unable to get statins to the majority of eligible patients, indicating more work needs to be done.

SUPER LIPID had 11 primary care practices in the Lancaster, Pennsylvania, area randomized to usual care (n=975) or automatic orders entered for referral to a pharmacist for statin initiation, independent of in-person visit (n=975).

The SUPER LIPID investigators had eligible patients identified via electronic health record (EHR) algorithms as being assigned a primary care provider and not being prescribed a high- or moderate-intensity statin despite having an indication for one. Exclusion criteria included a documented intolerance of statins, severe kidney disease, PCSK9 inhibitor use, and those who were pregnant or breast-feeding or in hospice.

In a parallel stepped-wedged trial with 16 primary care providers participating, investigators tested another strategy of integrating centralized pharmacy services into lipid management, comprising interruptive pop-up EHR notifications during patient encounters with recommendations to refer patients to a centralized pharmacy for consideration of statin initiation.

The intervention ultimately showed a modest effect on statin prescriptions (OR 1.43, 95% CI 1.02-2.00) and no effect on appropriate-dose statin prescriptions in primary care (OR 1.47, 95% CI 0.85-1.47). Each provider had seen the notification approximately 12 times per month.

Downstream of both automated ordering and EHR pop-up strategies, the pharmacists participating in SUPER LIPID receiving a referral for statin consideration reviewed the patient's chart. Unless people had contraindications for statins or had declined statins recently, pharmacists called each patient, discussed initiation of statins, and prescribed one if the patient agreed.

Fanaroff acknowledged that the visit-based trial did not reach its enrollment goal and suffered from baseline imbalances between groups (due to randomization at the level of practice and physician). No data were collected on statin adherence and long-term cardiovascular outcomes in either study.

And although tested in a population that was relatively representative of women, the interventions still need to be assessed in underrepresented minority populations, Dixon said.

"Both approaches have the potential to be scalable in other settings and for other populations," Patel said. "Future research should focus on implementing the approach at broader scale to evaluate its impact and to understand barriers and opportunities to scale the approach further."

Correction: The article had erroneously stated that Ascension Health was located in Philadelphia. The correct city is St. Louis.

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