STOMPP to test adherence packaging, MTM model in community setting

Poor medication adherence is a $300 billion problem that has resulted in increased emergency room visits, medication-related hospitalizations, and approximately 125,000 deaths annually in the United States. An ambitious new clinical study known as STOMPP is testing whether a hybrid pharmacy practice model using adherence packaging and/or medication therapy management (MTM) will have a positive impact on medication adherence. Community pharmacists will be part of the solution.

STOMPP (Study the Effect of a Hybrid Pharmacy Practice Model on Medication Adherence), which started enrolling patients last September, will assess clinical, humanistic (quality of life), and economic outcomes of up to 300 patients with metabolic syndrome and type 2 diabetes. The study is being conducted within an integrated delivery network that includes a physician’s practice, an endocrinology practice group, and a multi-site pharmacy, said lead investigator Sharrel Pinto, BS Pharm, DMM, MS, PhD.

“In this randomized control trial, we will compare this adherence pharmacy model [adherence medication packaging and MTM services] to other current practice models [pill bottles; pill bottles with MTM services] in terms of the impact on medication adherence. We are excited about this research and will present our interim findings later this year at the American Pharmacists Association meeting in San Diego,” said Pinto, division head and associate professor, Health Outcomes and Socioeconomic Sciences, and director, Center for Pharmaceutical Care and Outcomes Research, University of Toledo College of Pharmacy and Pharmaceutical Sciences, Toledo, Ohio.

An adherence pharmacy

Pinto recently published a white paper that provides guidance for pharmacists who want to develop and implement an adherence pharmacy. This pharmacy model delivers pharmacy services, including MTM, medication synchronization, and adherence packaging through scheduled appointments.

MTM in the adherence pharmacy embraces a comprehensive medication review, a personal medication record, and a medication action plan. The pharmacist can identify any potential or existing medication problems, refer the patient to a healthcare provider, and continue to follow the patient on chronic medications, said Pinto in her report, titled “Developing and implementing an adherence pharmacy.”

Complex medication regimens require patients to remember when to take each dose, and if they are taking multiple medications, some may have to be taken at different times during the day. Patients can forget to take their medications, forget to take them at specific times, or take too much or too little.

“What we want to do is make sure our patients know what it is they are taking, how they are taking it, and what to do if they miss a dose. The pharmacist can play a significant role in working with patients in order to simplify that regimen,” Pinto told Drug Topics.

Adherence medication packaging is not a new concept, having been used successfully in countries with universal health insurance such as Canada and Europe. It has been shown to increase medication adherence and treatment outcomes in the elderly. Patients refill their prescriptions on time more often and have improved health outcomes with daily-dose blister packaging, according to a 2008 U.S. study published in the Journal of the American Pharmacists Association.

“The big factor for the move toward adherence packaging [in the U.S.] is the new emphasis on healthcare reform, outcomes-based care, and improvement in quality of care for patients,” said Pinto. “We are starting to see independents and chains look at adherence packaging in a much different light than they have in the past.”

Blister packs

The RxMAP adherence packaging system being used in the STOMPP study is a customized calendar-style blister card that organizes oral solid tablets and capsules, including prescription medications, over-the-counter drugs, and vitamins/minerals. It also includes labels and instructions for as-needed medications that cannot be placed within the blister packaging. Each blister package can contain a 28-day supply of medication.

Because each blister package contains most of the patient’s medication, it is important to enroll patients in a medication synchronization program to ensure all of the medications are filled at the same time, Pinto wrote in the white paper.

“Once patients are enrolled at the [adherence pharmacy] and educated on the process, then the filling of their medication in the adherence packaging may begin,” Pinto stated.

Follow-up

To avoid any gaps in the patient’s care, refill reminders should be sent to the physician and the patient. The pharmacist or staff needs to call the patient a few days before the refill to ask about which medications are to be continued and included in the adherence packaging. If there are medication changes after the blister package has been dispensed to the patient, a procedure needs to be in place to reconcile the changes and correct the blister packaging.

For patients who have difficulty getting to the pharmacy, Pinto suggested providing a delivery or mail service. This offers a dual benefit - keeping the patient within your healthcare network or pharmacy and keeping patients adherent to their medications, Pinto said.

“Adherence packaging is a great resource, yet it will take some hard data or meaningful experiences for patients and payers to come to the realization themselves,” she said. “We are collecting evidence right now about the adherence packaging - to see what impact it has economically and from the pharmacy standpoint, how does that vary?”

A road map

For pharmacists who are interested in pursuing the adherence pharmacy model, Pinto suggested that they conduct a SWOT analysis, evaluating their strengths, weaknesses, opportunities, and threats - in other words, their readiness.

It is important to develop a roadmap, including an action plan that tracks who is doing what and when, she said. Pharmacists need to evaluate their staff’s acceptance of this model and level of expertise. All staff members must be trained in MTM, certified to perform MTM, and have experience with MTM.

“Once everyone is on board and trained in MTM, you can start talking to companies that offer adherence packaging solutions. You need to decide if you can invest in the machine [to fill the blister packaging] or if you are going to do it manually,” she said. “A SWOT analysis will help you create the next phases before you actually roll out the adherence pharmacy model.”

Reimbursement for MTM

Pharmacies are familiar with the reimbursement possibilities for MTM with Medicare Part D. However, employer groups, especially those that are self-insured, are open to the idea of MTM because many have had experience with disease management companies previously. These groups are able to understand the value of what pharmacists can offer in terms of MTM services, Pinto noted.

“I have been fortunate in working with employer groups over that last 10 years,” she said. “Working with employer groups opens up a whole window of opportunity. I know we are fighting for provider status and trying to get that reimbursement, but I feel that we have not even scratched the surface in this whole other area with employers [where 80% of Americans get their insurance].”

In 2005, Pinto began providing MTM services to employees in Lucas County, Ohio. She set up the program and demonstrated from their own data that there was a return on investment. At first physicians challenged this model, because they didn’t understand the role of pharmacists and considered these services a threat instead of a resource.

“We pharmacists need to educate folks that we really are a resource that is underutilized. We can really help and provide these services, especially as we move toward outcomes-based reimbursement,” she said.

“We can make the biggest impact by helping patients released from the hospital. This will help with some of the reimbursement challenges that healthcare systems are still facing,” Pinto said.

The STOMPP study will help to quantify the impact of medication adherence, she said.

The study is supported by Omnicell, a supplier of automation and business analytics software for medication and supply management. Omnicell also owns MTS Medication Technologies brand, including its medication adherence packaging solutions used in this study.