Bottom Line on Compliance Packaging

As innovative patient care models are tested and put into practice, new studies show the value of compliance-prompting designs.
Packaging that promotes compliance will receive increased attention as governments and private insurers seek to ensure patient safety and reduce healthcare costs.
Studies have shown, for example, that achieving high adherence levels in typically low-compliance therapies such as diabetes, cholesterol, and high blood pressure can reduce healthcare costs by 40 to 50%.
 
Packaging can be an important part of a solution that includes caregiver support and intervention, but adherence and persistence with medications requires patient buy-in, presenters said at the Healthcare Compliance Packaging Council’s (HCPC) recent symposium, RxAdherence 2011.
 
Patients themselves have the most influence on whether they stay on their medications, though doctors and pharmacists may command their trust, and caregivers and family members can help, according to a survey of professionals reported at the conference.
 
Packaging can support patient engagement with and commitment to therapy if it helps account for
therapy-specific hurdles to regimen compliance. With compliance solutions tailored to specific therapy needs, manufacturers and packagers can be involved “in the larger healthcare conversation,” said

 
Vernon Schabert, Ph.D, senior principal, HEOR, IMS Consulting Group.
Intervention tactics or patient characteristics that predict increased success need to be identified.
“Don’t assume that getting a prescription implies awareness, buy in, or commitment to adherence,” said Schabert, who described the Toviaz package as a good example of “an entire health management program” built on the package for a drug in which patience persistence has a distinctive profile.
 
The priorities of patients were identified by the National Consumers League (NCL) which just launched the nationwide “Script Your Future” campaign to promote adherence (www.ScriptYourFuture.org). The multimedia National Medication Adherence Campaign focuses on diabetes, cardiovascular disease, and respiratory diseases “where there are effective medications and compliance is way below what it should be,” said Larry Bostian, NCL vice president, at the HCPC event.
 
In national research, to be repeated mid-way through the initial three-year campaign, NCL found that patients have three priorities: They want to know what will happen if they don’t take the medicine, they are concerned about the impact of their condition on their families; and they want to feel empowered.
 
In another session, a six-hospital healthcare organization with integrated services that span nursing homes and home care, Meridian Health (www.meridianhealth.com), focused on patient behavior and needs in developing its iMPak Health program for chronic care out-patient management.
 
ENGAGING OUT-PATIENTS
iMPak Health has just begun to engage patients with easy-to-use e-diaries and “smart” home care cards that easily integrate into patients’ daily lives, said Sandra Elliott, director, consumer technology and service development, Meridian Health.
“When it comes to medication, compliance alone doesn’t tell a physician whether the treatment is working as intended. What is just as important is their daily response to the medication. The design of the tools to track compliance and a patient’s response to the medication is critical. The key question is always: Will people use [the home-based device]?” Elliott said.
 
In the program’s development, the healthcare provider identified four core characteristics required of the devices for success; ease-of-use, low price, scalability, and not interruptive of daily routines. It partnered with Cypak for chip and communication infrastructure and Stora Enso for the packaging.
As patients track and log in their progress, the diaries are a physical reminder of key symptoms, promoting awareness. The subjective historical recall is translated to trended, actionable date-and-time-stamped data that helps doctors understand whether treatment plans are working.
 
“Patients want to know whether the doctor is going to use the information, so you have to make sure clinicians are involved in the development of the core tool as well as the reporting of the data,” Elliott said.
Patients see the devices as convenient, nonintimidating tools that are empowering and promote self-awareness, save time, and significantly enhance the quality of interaction with the doctor, she said.
 
The program has expanded over two and half years through the development of five journals for symptom tracking of conditions such as stress, sleep disorder, weight management, and pain. Pain management patients are using Stora Enso’s Memori card to rate and rerate their pain and overall distress.
 
“Pain is one of the main reasons people go to see a doctor. All pain is not the same, and it is extremely subjective. It is considered by healthcare professionals as the ‘fifth’ vital sign, and major safety concerns are rapidly rising with patient misuse of opioids, which is leading to more and more emergency room visits,” Elliott said.
 
Is there an opportunity for “smart” blisters containing product?
“The dispensing systems in the United States are not really set up well for what maximally can be done with compliance packaging—such as blister packs that allow you to track when the seal has been broken as well as the position of the medication,” Elliott says. “The best short term options for maximizing packaging and data collection may lie with branded medications in particular for which there may be side effects and it is especially important to take them on time every day.
 
“As an interim solution, packaging with ‘connected’ or wireless inserts that prompt reminders and data collection on compliance can also track data on symptoms associated with the medication or even the condition. You are enhancing awareness of potential side effects of great importance as well as tracking compliance,” she adds.
 
Compliance packaging studies aim to prove return to pharmaceutical financial departments. In addition, package choices need to conform to the product manager’s vision for the brand and goals for market-competitiveness.
 
“You make a packaging change because it is important to the health and viability of the brand over time. What is the goal of the product—you have to make a cogent argument, with analytics to support it,” said Christine Coyne, senior product director, Endo Pharmaceuticals, during a panel discussion at RxAdherence.
 
Studies need to prove clinically meaningful results to healthcare payers who are focused on patient outcomes.
As unit-dose packaging frees pharmacists for patient counseling, pharmacies have established differentiating medication management services and have realized upticks in dispensing fees and store traffic from higher refill rates.
 
DRIVING REFILLS
Recent large-scale retrospective studies of refill rates by Catalent and MWV Healthcare show substantial impact when compliance packaging is used instead of vials (See Viewpoint from Catalent, p. 22). Ted Lithgow, president and chief science officer, MWV Healthcare, reported on an MWV study of 3.1 million patients that compared traditional vials with MWV’s Shellpak, showing substantial impact on refill rates when patients were switched to the Shellpak.
 
“We have strong data showing [compliance packaging] impacts persistence as well as adherence, and also data showing the patients did exceedingly well with multiple interventions,” Lithgow said at RxAdherence.
“We know that multiple interventions do the best job of helping patients adhere. They have a synergistic effect that we have found through our work with Walmart and other retailers that can dramatically improve patient adherence,” Lithgow says.
 
“These kind of multi-intervention strategies have been discussed in the literature for a long time,” he adds.
The Walmart study was a base line study in that no other interventions—such as pharmacist and patient education or store point-of-purchase materials—were used. MWV, for example, found in patient interviews that only about half recognized there was a calendar on the back of the package, and that additional pharmacy instruction. and counseling will drive even better compliance, Lithgow says.
 
“Our intent is to develop a range of data sets that encompass a range of different interventions, all working together to help patients use medications properly and develop better medicine-taking behavior,” he says.
Programs for evaluating cost control and improving quality of care established in the healthcare reform act create incentives for adherence strategies, said Tom Hubbard, senior program director, the National Network for Health Innovation.
 
The reform emphasizes improving drug regimens, as pay-for-performance models tie doctors’ fees to quality goals. Valued-based insurance design (VBID) reduces cost barriers for patients via co-pay and deductible incentives. Packaging and reminder technologies will be emphasized, as technology and “high-touch” strategies address patient behavior, with a transition to patient-centered care.
Underlying reform is a national strategy for healthcare improvement in which comprehensive quality measurements will be developed to support safer care, coordinated care, and person- and family-centered care. 
 
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