ADHERENCE TO MEDICATION REGIMENS BY PATIENTS has always been, and continues to be, an area of great concern to the health care community.

Nonadherence to drug therapy can result in an alteration of the risk/benefit ratio, and can literally be a matter of life and death. The impact of noncompliance is staggering in terms of both health care outcomes and cost. It is estimated that the cost of nonadherence in the United States totaled $337 billion in 20131.

Up to 30% of prescriptions are never filled,2 and poor compliance has been linked to increased mortality and hospitalization across various disease states.

Consider these statistics:
  • nonadherence causes ~30% to 50% of treatment failures and 125,000 deaths annually2
  • medication is not continued as prescribed in approximately 50% of cases2
  • medication rates of compliance drop off after 6 months2
  • only 51% of Americans treated for hypertension are compliant with their therapy2
  • 25% to 50% of patients discontinue statins within one year2
Even for those prescriptions that are filled, the patients are often noncompliant with prescriber directions by missing doses, taking the incorrect dose, not following instructions, such as taking the medication with or without food, and failing to complete the prescribed days of therapy.

There are a host of dynamics that influence a patient’s lack of commitment to adherence, including simply forgetting to take the medication, disease states that have no symptoms, such as hypertension, cost, and side effects, to name a few. Those patients treated for multiple conditions, for which they are often prescribed concomitant medications with varying intervals throughout the day, can face additional complications in adhering to instructions.

What is Adherence?
There is often confusion between the terms that float about regarding adherence. It is important to understand exactly what “Medication Adherence” is.

The CDC2 uses the following definitions:
  • Medication adherence: The patient’s conformance with provider recommendation with respect to timing, dosage and frequency of medication taken during the prescribed duration.
  • Compliance: Patient’s passive following of provider’s orders.
  • Persistence: Duration of the time patient takes medication, from initiation to discontinuation of therapy. 
Additional buzzwords around this topic include abandonment, which applies when the patient fails to fill a prescription, or prematurely discontinues therapy. Another term used by manufacturers is “time to fill,” which refers to the period from the time the provider prescribes the medication to the start of therapy.

Time to fill is comprised of several segments that need to be fully defined and understood in order to accurately depict the prescription journey.

How is Adherence Measured?
The standard for measuring adherence includes Medication Possession Ratio (MPR) and Portion of Days Covered (PDC).
  • Medication Possession Ratio is defined as the sum of the days’ supply for a given period of time dispensed to a patient, divided by the number of days in the time period.
  • Portion of Days Covered is defined as the number of days covered in a given period of time, divided by the number of days in the time period. 
PCD is a bit more accurate in measuring adherence, in that it removes the potential for dispensing overlap. Utilization Review Accreditation Commission (URAC), the gold standard for specialty pharmacy accreditation, uses PCD for their credentialing measure of adherence.

What are the Drivers of Non Adherence?
This is a complex, multifaceted issue and there is no single definitive reason. There are a myriad of factors that can impact the level of adherence to drug therapy. As noted earlier, this may include patients forgetting to take their medications, skipping doses, taking an incorrect dose, not following directions on how to take the medications, side effects, and cost and coordination with concomitant therapies. One or more of this host of dynamics, none easily solved, can cause non adherence.

Impact of Non Adherence
According to the 2015 Express Scripts International drug trend report, 37.7% of drug spending was represented by specialty medications, with that number expected to increase to 50% by 2018.Specialty drug spend is expected to reach $1.7 trillion by 2030.3

The critical importance of medication adherence is especially true for certain disease states and conditions where noncompliance can lead to resistance, tissue rejection, and even morbidity. These include HIV, post transplant, and oncology patients. Adherence via taking medications every day prevents HIV from multiplying, which reduces the risk that the disease will mutate and produce drug-resistant HIV. Missing doses of transplant medications can cause tissue rejection.

According to a study of 418 oncology patients, 10% stopped taking their medications, 7% never filled their prescription, and 9% did not regularly fill their prescription.4 Given the impact of nonadherence for cancer patients, the outcome can be dire.

Enter Specialty Pharmacy
There is no doubt that specialty pharmacies have, and will continue, to play a major role with regards to facilitating a continuum of care for patients dealing with complex disease states and accompanying challenging therapies. Specialty pharmacies and the highly educated health care professionals at these pharmacies sit at the epicenter of patient care coordination.

Health plans are increasingly requiring the use of specialty pharmacies to ensure their patients are receiving care from specialty-trained clinicians to optimize clinical outcomes. United Health Group research demonstrated that specialty pharmacies and coordinated medical services resulted in a total cost savings of about 13% for cancer and transplant services, as well as an increase in compliance for patients with cancer, multiple sclerosis, and rheumatoid arthritis.5

There are countless studies documenting that specialty pharmacies consistently outperform retail pharmacies with respect to adherence metrics. The results for one such study for hepatitis C treatment determined:
  • Study patients who exclusively used a specialty pharmacy had a 60% higher likelihood of achieving optimum adherence compared with retail pharmacy users.6
  • Average regimen adherence was 8.6% higher for specialty pharmacy patients than for retail pharmacy patients.6
  • Specialty pharmacy services (eg, disease-specific and drug-specific patient counseling, patient training on proper drug self-administration, identifying and treating side effects, assistance with administrative issues) may overcome barriers to adherence in hepatitis C patients.
One large-scale study was conducted to compare compliance and persistence results between all products in a specialty class across the retail and specialty channels. Insights confirmed that specialty pharmacies consistently outperform not only retail pharmacies, but also traditional mail order in medication possession ratio.7

Drilling down to specific specialty therapies, a major specialty pharmacy reports the following adherence rates.3
  • multiple sclerosis: 95.33%
  • rheumatoid arthritis: 94.65%
  • HIV: 97%
  • Crohn’s disease: 95.68% 
Specialty Pharmacy Accreditation and Compliance
While there is no current industrywide accepted definition for a specialty pharmacy, specialty pharmacy accreditation has become a must-have versus a nice-to-have. Any pharmacy that puts forth the rigorous effort to gain accreditation can distinguish itself as a provider of specialty services. Accreditation bodies, such as URAC, have specific standards of focus, including customer service, communications and disclosure, specialty drug management, pharmacy operations, and patient management.

Patient management criteria are built around the patient and based on the best available science and clinical practice. Comprehensive standards for accreditation include a focus on individualized patient services and interventions to optimize therapeutic outcomes through appropriate medication use.

Effective communication protocols, monitoring and promotion of medication adherence, development of care, service plans, and education related to medication are all elements of accreditation. The health care professionals at these accredited specialty pharmacies are highly qualified and best positioned to support adherence to specialty products.

Methods
Given the multitude of dynamics that influence adherence, it is no surprise the solution to optimizing compliance requires a multifaceted approach. Effective communication is the cornerstone of building a results-driven adherence plan. Regardless of the site of service, the need to educate, remind, and coach patients and caregivers is of critical importance. Traditional strategies, such as refill reminders, medication counseling, simplifying dosing regimens, and customized packaging, do improve outcomes.

The use of digital tools, such as e-mail, text messages, and video training are playing an expanded role in supporting the larger compliance plan. Customized patient services programs, coupled with actionable intelligence from data reporting, are crucial to support adherence goals. In some specialty therapies, there may be an opportunity to introduce a targeted clinical intervention, based on the product profile, to anticipate a patient falling off therapy.

For example, if the product has a side effect that could be exacerbated by a dosing titration schedule, this could be an opportunity to head off any compliance issues with a proactive clinical intervention above and beyond the pharmacy’s standard of care. There are a number of medication adherence tools, including the Morisky Medication Adherence Scale (MMAS), used as a predictor of noncompliance. Any adherence program should be customized, by patient, as a one-size fits all approach may not provide meaningful results.

Conclusion
There is no single solution leading to adherence nirvana. Medication adherence is a complex issue that demands a herculean effort. The one constant in this challenge is the specialty pharmacy. Study after study confirm that adherence results are consistently higher when using a specialty pharmacy. Highly skilled health care professionals practicing at specialty pharmacies are most often the best equipped to provide comprehensive therapy management to maximize clinical outcomes.

They have a holistic view of the patient’s entire medical and therapeutic status, including concomitant therapies, medical history, allergies, comorbid conditions, and are best positioned to assess, recognize, and intervene if they see compliance trouble brewing. The consistent patient-management protocols, disease-specific care plans, and specialized clinical teams at specialty pharmacies combine to create a formidable force to mitigate barriers to adherence, while positively impacting clinical outcomes and maximizing the benefits of specialty therapies.

The views expressed in this article are the opinions of the author and not of Mallinckrodt Pharmaceuticals.

References
1. The Express Scripts 2015 Drug Trend Report. http://lab.express-scripts.com/lab/drug-trend-report. Accessed May June 2, 2016
2. CMS. Medication Adherence. https://www.cdc.gov/primarycare/materials/medication/docs/medication-adherence-01ccd.pdf. Accessed June 2, 2016
3. Martin Sipkoff. Improved Adherence Highlights Specialty Pharmacy Potential. Managed Care: October 2009. http://www.managedcaremag.com/archives/2009/10/improved-adherence-highlights-specialty-pharmacy%E2%80%99s-potential. Accessed June 2, 2016
4. Kelly Matthews. Improving Medication Adherence for Oncology Patients Through High-Tech Interventions. Specialty Pharmacy Times: June 2015. http://www.specialtypharmacytimes.com/publications/specialty-pharmacy-times/2015/june-2015/improving-medication-adherence-for-oncology-patients-through-high-tech-interventions. Accessed June 2, 2016
5. The Growth of Specialty Pharmacy. UnitedHealth Center for Health Reform & Modernization. Issue Brief April 2014. http://www.unitedhealthgroup.com/~/media/uhg/pdf/2014/unh-the-growth-of-specialty-pharmacy.ashx. Accessed June 2, 2016
6. Jay Visaria, and Sharon Glave Frazee. Role of Pharmacy Channel in Adherence to Hepatitis C Regimens. February 2013. http://www.ajpb.com/journals/ajpb/2013/AJPB_JanFeb2013/Role-of-Pharmacy-Channel-in-Adherence-to-Hepatitis-C-Regimens. Accessed June 5, 2016
7. Understanding and Improving Adherence for Specialty Products. IMS Intelligence Applied. http://adhereforhealth.org/wp-content/uploads/pdf/Understanding_Improving_Adherence_Specialty_Products_IMS_Health.pdf. Accessed June 3, 2016

About the Author
MARYANN DOWD, RPH, has over 30 years of experience in the health care sector spanning retail/specialty pharmacy, biotechnology, and management consulting. Maryann specializes in channel optimization, providing strategic and tactical insight into the specialty pharmacy service model. She has held various leadership roles at Biogen Idec, Pricewaterhouse Coopers, and EMD Serono. She has provided thought leadership in the management of multi-sponsored risk evaluation and mitigation strategies programs and led an innovative limited distribution track and trace program designed to mitigate diversion and counterfeiting of high-target biologics. Maryann practiced pharmacy at CVS Health in Massachusetts after graduating from Massachusetts College of Pharmacy. She is a member of the editorial board of Specialty Pharmacy Times.