James Jorgenson, MS, RPh, FASHP

Medications represent one of the fastest growing elements of healthcare expenses. This is due in part to increases in overall drug spend given to a combination of the introduction of a number of new drugs, greater use of specialty drugs for complex diseases, a lower than usual rate of patent expirations, and an overall increase in marketplace demand as a result of expanded coverage for a population that had previously been underemployed or chronically uninsured. Methods employed in the past to control the cost of medication therapy may no longer be adequate. A fresh look into how pharmacy benefit managers (PBMs) make money from their clients can help to negotiate more equitable oversight and distribution of the drug benefit.

According to the IMS Institute’s April 2015 report on US use and spending shifts for medicines, total costs for prescription drugs reached $373.9 billion in 2014.

 This represents a 13.1% change over 2013—the highest increase in medicines spend since 2001 when the rate of growth was 17% over the previous year.

Much of this increase can be attributed to a growth in the number of new medicines, which contributed an additional $20.3 billion to the 2014 spending. A large portion of the new medicines’ spend was attributed to specialty drugs (high-cost drugs used to treat complex conditions) which increased by 26.5%. This category of drugs now accounts for about a third of all medication spending, up from 23% just 5 years ago. Innovative new drugs for the treatment of hepatitis C, cancer, and multiple sclerosis were the largest cost drivers in the specialty drug category in 2014. For hepatitis C alone, over 161,000 patients started treatment in 2014—nearly 10 times more than in 2013; the use of new oral hepatitis C treatments accounted for $12.3 billion (60%) of the spending increase for new drugs. Other new medicines, including treatments for multiple sclerosis and cancer as well as non-specialty conditions such as diabetes, added $8.9 billion in new spending that year.

In addition to the impact of new medicines, patent expirations for brand name medicines occurred at the lowest level in 5 years. Cost reductions associated with generic drug introductions, which had been a consistent offset to rising brand name costs, contributed only $11.9 billion in savings. At the same time, overall price increases for medicines in 2014 hit double digits,

 as prices for brand, generic, and specialty drugs combined increased by 10.9%. By category, prices for brand name drugs rose 14.8%, specialty drug prices increased 9.7%, and generic medicines rose 4.9%.

All of these pricing trends happened on top of increased prescription utilization, largely as a result of new patients entering the insurance market. The uninsured rate in the United States also declined significantly in 2014, driven largely by the Affordable Care Act and an improving US economy. New state and federal health exchanges, as well as expanded Medicaid programs, caused increased beneficiary enrollments in October 2013 for coverage effective in January 2014, and by the close of 2014, the uninsured rate was reduced by 5.1%, adding 15.7 million people to the insured population. Concurrently, the US unemployment rate dropped 1.5%, and many of the 2.3 million newly employed were offered healthcare coverage by their employers. Medicare enrollment also increased as more baby boomers reached the age of eligibility; some of whom had been previously uninsured.

Pharmacy Benefit Management: Controlling the Cost Trend

Together, these factors have served to create a “perfect storm” affecting the trajectory of cost for prescription medicines. Patients, payers, and employers alike are feeling the impact of these rising costs and are looking for new strategies to help them to better manage their medicines spend. The collective concern is that methods employed in the past to control the cost of medicines may no longer be enough.

One of the staples for effective medication cost management has been the use of PBMs. From their inception in the early 1970s—when they were largely just claims processing entities&mdash;PBMs have evolved into very large and sophisticated operations, focusing on multiple elements of medication use. PBMs are now the de facto standard for administering prescription drug insurance benefits in the United States, as they have demonstrated the ability to reduce medication costs, provide pharmacy access on a national basis, and administer customized benefits that can meet the needs of a wide variety of clients in a very highly automated environment. Their core strategies for reducing prescription drug expenses include minimizing administrative overhead, obtaining discounts on drug cost, leveraging volume for reduced dispensing fees, and managing drug selection and utilization.

Now a multi-billion dollar industry, PBMs are also one of the most influential groups in the entire medicines supply chain. They have been successful in reducing medication cost by negotiating lower drug prices from pharmacies and rebates and other discounts from manufacturers, and they have been likewise successful in improving utilization of medicines by working with prescribers on drug selection and helping patients adhere to prescribed medication regimens to better manage their disease(s). Combined, this is a complex process that often is not fully understood by many self-funded employers using PBM services.

PBM services are structured around the drug benefits designed by their clients. The benefit design determines which drugs are covered and the extent to which generics and preferred brand name (ie, formulary) drugs are mandated. Also, the benefit plan defines the co-payment structure that determines cost-sharing levels between the client and their employees or members. In addition to the benefit plan, PBMs work with clients to establish and maintain large retail pharmacy-based networks within certain geographic and access standards. They may also operate or contract with mail order pharmacies, Internet pharmacies, and specialty pharmacies to expand access. All of the participating pharmacies agree to discount their pricing in exchange for access to the PBM’s members.

PBMs provide their clients with a highly automated claims processing environment. Nearly all pharmacy claims are electronically adjudicated at the point of dispensing based on data entered in the pharmacy’s dispensing and billing system. The claims system receives the claim, checks the member’s eligibility and benefit design to determine coverage and cost sharing, calculates the pharmacy reimbursement, and performs a series of drug interaction checks across the member’s claims history (which may include multiple pharmacies). The pharmacist receives real-time messaging for all of these steps, typically within 1 to 2 seconds. PBMs receive a processing fee per claim for this service.

PBMs contract with pharmaceutical manufacturers of branded drugs to receive rebates and administrative fees, which are paid for with increases in market share and/or utilization of their products. It is common for PBMs to share the rebates with their clients, but retain 100% of the administrative fees. Those PBMs that operate mail order pharmacies may receive extra rebates or better pricing for specific drugs purchased through those pharmacies because they more directly control utilization of those products.

PBMs also provide significant clinical programs, which include:

 PBMs combine clinical evidence and product cost to define which drugs in each therapeutic class should be used as primary and secondary options within the benefit plan. Formulary programs are overseen by Pharmacy and Therapeutics Committees, either at a national level or a client/plan-specific level. These programs may also include prior authorization and step therapy protocols to ensure that drugs are used in a rational, proven progression and only for indications supported by evidence-based clinical literature.

 Within each formulary program, certain therapeutic classes include substitution recommendations or mandates to optimize the cost-effectiveness of drug therapy. Members and prescribers have options to request exceptions or overrides to the substitution program, including medical necessity protocols.

 PBM clinical pharmacists, nurses and case managers work with clients to identify and manage members at risk for suboptimal therapeutic outcomes based on poor adherence, adverse event rates, or lifestyle factors. These members are assigned to personalized care plans that engage them in their care and promote proper use of their medications.

PBMs may bundle these programs into their standard administrative fees or charge separate per member or per service fees.

Aligning PBM and Plan Objectives: The Transparent PBM Model

In the past several years, the question of how PBMs make their money has been consistently raised as organizations struggle to better address the rising costs of medicines. PBMs generate revenue in several ways; the most common and understandable method is by charging health plans adjudication and service fees for processing claims. They also gain revenue by selling prescription drugs through their own mail order pharmacies. Less visible and the primary source of client confusion, however, is revenue associated with pharmaceutical manufacturers and network pharmacies. As noted earlier, PBMs negotiate formulary and market share discounts with pharmaceutical manufacturers as incentives to use their drugs (in mail order pharmacies) or promote products on formularies. These can be paid as direct, on-invoice discounts (as with purchases) or off-invoice retrospective rebates. In both cases, discounts are generally calculated as a percentage of the drug’s wholesale price and can be 40% to 50% or higher.

Another major source of PBM revenue is derived from the difference between what the PBM reimburses the pharmacy for a drug and what it charges the health plan. The difference, commonly called “spread pricing,” can lead to substantial revenues for PBMs. Brand name drugs, including high-cost specialty products, can have a spread of 1% to 3%. Generics, which are reimbursed using fixed price schedules (known as Maximum Allowable Cost [MAC] lists), can have spreads of over 10%. Because spreads can be different across pharmacy networks, with each chain having different reimbursement rates and MAC lists, PBMs can create situations where clients have no idea if they are receiving the correct discounts and how significant the spread actually is. Given this lack of information, negotiating a PBM contract and trying to ensure that all parties have achieved an equitable deal that contributes to optimal control of medication costs can be very challenging.

Recently, the PBM industry has been responding to requests for greater openness and access to information with a new model: the fully transparent PBM. In this model, the client is charged only a negotiated service or administrative fee—usually per claim or per member. The PBM discloses and provides the client with the full extent of all negotiated pharmacy and manufacturer discounts. According to the Pharmaceutical Strategies Group, this new PBM model is designed to: simplify the PBM procurement process; leverage more value from the PBM/supplier relationship; reduce or eliminate the potential for perverse incentives to increase costs (eg, pushing higher cost brand drugs to obtain rebates); obtain better information to facilitate better plan coverage and management decisions; and reduce the overall cost of the PBM relationship.

While the fully transparent PBM model has the potential to significantly reduce pharmacy benefit costs, comparing the new model to a traditional model can be confusing in itself. Using a traditional PBM Request for Proposal when considering a PBM change rarely provides for an effective evaluation or comparison of the new model. In essence, when making the base financial comparison, organizations need to understand and compare the elements mentioned in the 

to ensure that their overall PBM costs will be reduced.

The pricing analysis should also be accompanied by an evaluation of how drug mix could change under each management model based on each vendor’s formulary, pharmacy network accessibility, clinical program strategy, and medication therapy management initiatives. As noted by Snook and Filipek in their white paper, the ultimate question that a plan sponsor needs to answer is: How much does the pharmacy benefit cost and can that be effectively reduced? This answer is more complicated than just considering PBM fees, prescription prices, spreads, and rebates; it also has to do with the long-term benefits and costs associated with improving patient health, increasing medication adherence, and other factors.

At the end of the day, it is apparent that alternative strategies must be deployed to address the rising cost of medicines. While traditional PBM models have been successful in the past, we should definitely not consider a “one size fits all” approach for the future. With the emergence of new PBM models using pass-through pricing versus traditional lock-in pricing, there are now alternatives that could help with further cost reductions for the pharmacy benefit. The key to better management of the pharmacy benefit is a complete understanding of what a plan is actually buying from a PBM. Whether incorporating a traditional lock-in approach or a pass-through arrangement, both can be transparent as long as the revenue sources are disclosed and understood and a high degree of communication exists between the PBM and its client. In either case, the key to reducing drug costs for a plan sponsor is transparency, and organizations evaluating their PBM programs should work to fully understand their options and to ensure an equitable “apples to apples” comparison in any PBM analysis.

Articles

With continued increases in the US drug spend, the evolution of fully transparent PBM programs has introduced an alternative approach to traditional PBM structures aimed at enhanced utilization and cost control.

Is PBM Transparency an Answer to Controlling Rising Drug Costs?

Not long ago specialty pharmaceuticals were missing from everyone’s radar and vocabulary. Then, suddenly, they burst on the scene. Based on their high cost and increasing use, the reaction has mimicked that of the astronauts who said, “Houston, we have a problem!” The concern about specialty pharmaceuticals, the common strategies used to manage these important products, and how those strategies can be enhanced are the focus of this paper.

The rising cost of specialty pharmaceuticals continues to cause concern. Over the last 5 years, the cost increases for these agents have averaged 16%.

 Express Scripts reported: “Looking at pharmacy benefi ts alone, 17.6% of total 2011 pharmacy costs among Express Scripts plan sponsors were for specialty medications.”

Although many factors are contributing to this increase, more than half of it is due to increasing unit cost. For the multiple sclerosis agents, the increased cost per year has averaged more than 20% for the past 4 years. However, the real growth in specialty drug costs is hidden, as roughly 47% of overall specialty medication costs are billed under medical benefits.

A recent Specialty Pharmacy Times article titled “Eight mega trends shaping the future of specialty pharmacy” cited the following trends

There is increased drug spending and trend within this category.

There will be more industry consolidation because of patent expiration for small molecule products.

At least 700 new drugs are in the specialty pipeline.

Expectation is for more targeted, tailored, and personalized medicine.

Legislative and regulatory developments will continue to shape the future.

More than 40 biosimilar compounds are in development.

The industry issued 86 copay cards in 2009 and 300 in 2011.

The higher the patient cost for these drugs, the poorer the adherence and the higher the cost for medical, laboratory, and facility use.

article. First, the literature reveals little concern about and little to no publication on the inappropriate use of these agents (surely there is some). Second, because of the complexity of billing for these agents, organizations may be leaving a signifi cant amount of revenue on the table.

The 2 basic approaches for controlling the use of these agents are management strategies and clinical strategies.

Most payers under the pharmacy benefi t have turned to traditional techniques used by pharmacy benefit management companies for managing conventional drugs, like tinkering with the benefi t design, using formulary restrictions, and requiring the use of specialty pharmacies. However, specialty pharmaceuticals are not conventional agents.

Specialty drugs raise complex cost, access, and administrative issues for payers, and do not fit nicely into traditional benefit design structures. Thus, there is inconsistency among payers in coverage, access, and reimbursement. Should specialty pharmaceuticals be placed in the pharmacy or the medical benefit, and how much member cost sharing should be applied?

 Currently, 83% of employers place drugs under the pharmacy benefit.

Increasing the member share of payment for specialty drugs and limiting patients to a 30-day supply have been key management strategies for controlling use.

Specialty drugs fall into 2 distinct categories based on the site and method of administration: those that can be admin istered by either the patient or caregiver and those that require a healthcare professional to administer them in a physician’s office, infusion center, outpatient hospital department, or home. Most payers include self-administered injectables in the pharmacy benefit. There is a large difference in the average monthly cost to a payer for a self-administered injectable compared with the cost for other prescription drugs. For example, self-administered injectables often cost more than $1500 a month, compared with an average of $18 a month for generic drugs and an average of $88 a m onth for brand name drugs.

Formulary Design, Restrictions, and Management 

Two formulary strategies work better than others— listing preferred agents and strict prior approval. About 83% of employers use prior approval for these agents under the pharmacy benefit, but only 37% use prior approval under the medical benefit.

 A moderately effective approach is using step therapy—starting with the most cost-effective and safest drug therapy before progressing to other more costly or risky therapies. Other strategies include restricting quantities, dose, and duration of therapy.

Many health plans require some specialty drugs to be channeled through specialty pharmacy providers. About 72% of employers use a formulary and contracted specialty pharmacy network.

 The most common services provided by specialty pharmacies include direct distribution of drugs to patients and physicians, coordination of reimbursement and eligibility, all-day access to a healthcare professional, and appropriate drug use.

To solve a complex problem, wise proponents seek agreement on the problem before discussing possible solutions.9(p51) From reading the medical literature and listening to the media, one would think the problem is high cost. That is part of the problem, as is a continuing march toward developing more of these agents. However, the other part of the equation is that many patients need these agents and benefit from them. Therefore, the real problem is how to strike a balance between patient access to these agents and controlling inappropriate use.

One study found that “Increased cost sharing for specialty drugs will not reduce their use, but will transfer a greater share of their costs to patients.”

 Therefore, “Care management should focus on making sure that patients who will most likely benefit receive them. Once such patients are identified, it makes little economic sense to limit coverage.”

 However, for many payers, few care management activities have been used, especially if specialty pharmaceuticals are covered under the medical benefit.

 For example, while most specialty pharmacies offer some therapy management service for specific disease categories, fewer than one-third (30%) of payers report using these programs.

 It appears that the patientcentered approaches that health plans reportedly seek to improve adherence and limit unwarran ted use can reap benefits in the form of improved patient outcomes. However, methods to identify inappropriate use and waste are seldom being used.

 Perhaps this is because the incentives are nonexistent or misaligned.

Major clinical strategies for controlling the use of specialty pharmaceuticals include patient-centered management by pharmacists, use of clinical guidelines, performing medication use evaluations (MUEs), and integrating the entire medication use of specialty pharmaceuticals into a single organization structure.

Patient-Centered Management by Pharmacists

URAC (an independent, nonprofit accreditation agency formerly known as the Utilization Review Accreditation Commission) standards for specialty pharmacy accreditation cover a broad range of services, but patient-centered management is the most important standard to fulfill.

 The URAC standards include several medication management requirements that say there should be:

• Strategies and interventions to optimize appropriate therapeutic outcomes for patients through improved medication use based on available information.

• Support for patient advocacy and empowerment to self-administer drugs.

• Initial assessment of appropriate and/or inappropriate drugs.

• Education concerning side effects, drug interactions, food/drug interactions, and safe disposal and other safety precautions such as handling, as well as coordinated development of a care/service plan.

• Monitoring and promotion of medication adherence.

• Effort to minimize the incidence of adverse events.

• Effort to optimize therapeutic outcomes by promoting continuity of care during all patient care transitions and facilitation of collaboration among all the patient’s healthcare providers.

• Self-management and effective use of available clinical and educational resources related to individual patients’ medications.

• Counseling and education related to medication.

• Monitoring for side effects and contraindications.

• Reconciliation, such as for multiple medications.

Strategies for controlling use of specialty pharmaceuticals should focus on situations where these agents are used inappropriately and on improvement of the complex billing process.

Enhancing the Strategy for Specialty Pharmaceuticals

Former US Surgeon General C. Everett Koop is often credited with stating that “Drugs don’t work in patients who don’t take them.” The unfortunate truth is that people often do not have their prescriptions filled, or do not pick up their medication at the pharmacy. The further reality is that nearly half of those who do pick up their prescriptions do not take their medication as prescribed. When asked, patients offer various reasons for not following through properly with their prescriptions. These behaviors should make us pause and consider the burden that we must share to cover the cost and human suffering that can result through unnecessary morbidity and mortality.

The rates of and reasons for medication-taking (or-avoidance) behavior have been studied extensively. The term 

 is used to describe the extent to which a person’s behavior (by taking medication, following diets, or performing lifestyle changes) coincides with medical or health advice. This can be contrasted with 

, which means a passive acceptance of a patient’s physician’s orders regardless of the patient’s involvement in that process. Another term, 

, refers to the act of continuing treatment for the prescribed duration. Rarely used in the literature, persistence often appears in pharmaceutical industry statistics when measuring prescription refill rates.

The question of how to measure adherence properly has challenged researchers for some time. The complexity of this issue prevents the developing of a “gold” standard. There are direct methods to verify proper ingestion of medications, such as: observing therapy participation, measuring the medicine or metabolite in the blood, or measuring a biological marker in the blood. Indirect methods are less specifi c and rely on patients completing self-reports, questionnaires, or patient diaries. Other indirect measurements use pill counts, prescription refi lls, electronic medication monitors, and assessment of the patient’s clinical response by measuring physiological markers (eg, heart rate in patients taking beta-blockers).

No matter how it is measured and quantifi ed, medication adherence, irrespective of disease, prognosis, or setting, is expected in only 50% to 70% of all patients.

 For example, despite strong evidence proving the benefits of statin therapy for lowering lipid levels in the primary and secondary prevention of acute coronary events, most patients do not adhere to these medication regimens. In a recent study, only half of all patients continued to take statins prescribed for them after 6 months, and only 30% to 40% continue to take them at the end of the fi rst year.

, medication adherence rates for the fi rst year of therapeutic intervention are reported for several common chronic diseases in the United States.

Reasons cited for nonadherence can be thought of as qualitative or quantitative in nature. In the United States, patients not fi lling their prescription happens 30.5% of the time for paper, phone, or fax prescriptions, and 23.5% for e-prescriptions.

Even when prescriptions make it to the pharmacy, 3.7% of traditional prescriptions, and 5.3% of e-prescriptions, are not picked up by the patient.

 These are quantitative results of nonadherence. A qualitative distinction would be whether the nonadherence was intended or unintended. Examples of unintentional nonadherence include forgetting to take the medication or misunderstanding how to carry out a specifi c regimen. Not filling a prescription because the cost is considered prohibitive is intentional nonadherence.

No matter the reason, there is consensus that nonadherence is higher with regimens for chronic versus acute diseases. Rapoff found that “Global estimates are that about one-third of patients fail to fi nish a course of medications for acute illnesses, while adherence averages between 50% and 55% for chronic disease regimens.”

Potentially serious health outcomes can result from nonadherence to prescribed medications, such as therapeutic failure, unnecessary hospitalization, and even death. This is borne out in the fi ndings from many studies:

• Chaudry and McDermott determined that poor adherence to immunosuppressive drugs can be linked to heart, kidney, and liver transplant failures.

• A meta-analysis of 21 studies sought to discover the relationship between nonadherence and mortality.

 The defi nitions for good and poor adherence were used from each individual study. When compared with poor adherence, good adherence was associated with lower mortality. The authors concluded that “good adherence to drug therapy is associated with positive health outcomes.”

• The National Consumers League estimates there are 125,000 deaths per year from medication noncompliance.

• The relationship of treatment adherence to mortality after myocardial infarction was investigated in 2175 patients.

75% of prescribed medication) were 2.6 times more likely than good adherers to die within a year of follow-up.

• In a recent population-based study, the importance of being on the correct medication after myocardial infarction was shown.

 Among statin users, the risk of mortality was greatest for low adherers and was intermediary for intermediate adherers compared with the highadherence members of the study.

The cost of medication nonadherence for all patients (adult and pediatric) in the United States is estimated to be $100 billion every year.

The National Consumers League states that the resulting cost for avoidable healthcare due to medication noncompliance is $290 billion each year.

 Also, the cost to the consumer of medication was found to be inversely related to adherence.

 In one study, it was discovered that patients whose average monthly statin prescription copayment equaled or exceeded $20 were more than 4 times as likely to stop statin therapy as those patients who paid less than $10.

A study to evaluate the relationship between medication adherence, hospitalization risk, and healthcare cost revealed that for diabetes and hypercholesterolemia a high medication adherence was associated with lower disease-related medical costs.

A significant part of the cost of nonadherence is from hospitalization and readmission rates. Hospital admission rates for patients with diabetes, hypertension, hypercholesterolemia, and congestive heart failure and having high medication adherence were significantly lower than for patients with these diseases who had low medication adherence. For heart failure patients, nonadherence to a medical regimen is a worrisome consequence, since the 1-year mortality in the Medicare population approaches 40%.

It is also the most common readmission diagnosis in the Medicare population.

For those suffering from mental health diagnoses, nonadherence to prescribed therapeutic regimens also results in higher rates of hospitalization. In a study of patients with schizophrenia, irregular users of their medication had signifi cantly higher rates of hospitalization (42% vs 20%), more hospital days (16 days vs 4 days), and higher hospital costs ($3992 vs $1048).

In another study of patients who were previously hospitalized for treatment of bipolar disorder, those who were adherent to their antipsychotic medication at least 75% of the time had a lower risk of all-cause rehospitalization and mental health—related rehospitalization.

What Can We Do to Improve Medication Adherence?

To improve adherence to prescribed regimens, one must understand the reasons for nonadherence. The explanations people give for not following through with their prescribed regimens vary widely. For some it is a matter of forgetting to take medications or not knowing exactly when or how they are to be taken. Some medications make swallowing pills diffi cult. Side effects that come with many medications can make people feel worse, wondering if they need to take them. Sadly, there are growing segments of the population that do not f ll their prescriptions because of the cost. Some will try to make prescriptions last twice as long by cutting the pillsin half.

Methods to improve adherence fall into 4 general categories: patient education, behavioral interventions, improved dosing and dosing schedules, and improved communication between prescribers and patients.

 These interventions include oral education (by physicians, nurses, or pharmacists), audiovisual education, written education, telephone education, mailed education, and e-mailed education.

 These include skill building by healthcare professionals, providing rewards, pill counting, calendars, pill boxes, mail reminders, telephone reminders, and e-mail reminders.

A meta-analysis of trials of interventions to improve medication adherence reviewed 61 studies.

 Each intervention was counted as a separate study resulting in 95 cohorts totaling 9604 subjects receiving an intervention, and 9318 subjects who served as controls. Behavioral interventions accounted for 41 cohorts, educational interventions for 22 cohorts, and combined interventions for 32 cohorts. Overall, adherence for all interventions increased adherence from 4% to 11%. The effect sizes for the interventions were: education 0.11, behavior 0.07, and combined 0.08. When stratifying the combined intervention group by behavior intervention, mail reminders had the largest impact. Thus, interventions targeting behavior changes or using a combination of methods was determined to work best.

3. Improved Dosing and Dosing Schedule Interventions: 

These include dosing changes, reducing medication burden, dosage schedule changes, and packaging changes.

Greater dosing frequency and regimen complexity are associated with poorer adherence.

Once-daily dosing was studied among a group of patients taking antiretroviral therapy.

 The participants on oncedaily regimens were half as likely to miss a dose during the 4 days before being interviewed about adherence.

 The Medication Regimen Complexity Index (MRCI) is used to track regimen attributes. Making simple dosing and dosing schedules and reducing medication burden improves adherence. There are more advantages to using fixed-dose combinations of antihypertensives (one being, they improve adherence) than disadvantages.

Using fixed-dose combinations of any antihypertensive agent has been shown to produce significantly higher adherence than using individual agents.

 However, these fixed combinations cannot be used for titration.

 A Cochrane review sought to discover if reminder packaging improved adherence to self-administered long-term medications.

 Data from 6 intervention groups in 4 clinical trials were analyzed. The use of reminder packaging resulted in patients showing a significant decrease in diastolic blood pressure and glycated hemoglobin levels, but had no effect on systolic blood pressure in the same group.

4. Improved Provider/Patient Communication Interventions:

 Several physician behavioral factors have been identifi ed with the problem of medication adherence: prescribing complex regimens, communication barriers, not taking the time to explain why the medication is needed and the importance of taking it, and ineffective communication of information about adverse effects. Inadequate communications between physicians, hospitalists, primary care physicians, and consultants also contribute to medication errors and potentially avoidable hospital readmissions. It has been found that on hospital discharge direct communication between hospitalists and primary care physicians occurred in less than 20% of hospitalizations, and discharge summaries were available at less than 34% of fi rst post-discharge physician offi ce visits.

A study sought to determine whether pharmacists giving advice to patients upon starting a new medicine for a chronic condition would improve adherence.

 It was found that nonadherence was lower in the intervention group compared with the control group (9% vs 16%). In a follow-up study of this patient population, it was discovered that the number of patients reporting medication problems was signifi cantly lower in the intervention group compared with the control group, and that the intervention group was less costly (£187.7 vs £282.8, or US$294.69 vs US$444.00).

Sokol and colleagues evaluated the impact of medication adherence on healthcare utilization and cost for 4 chronic conditions that are major drivers of drug spending. In this study they examined the records of 132,277 patients younger than 65 years with a diagnosis of diabetes, hypertension, hypercholesterolemia, or congestive heart failure.

 For diabetes and hypercholesterolemia, a high level of medication adherence was associated with lower diseaserelated medical costs. For all 4 conditions, patients who maintained 80% to 100% medication adherence were significantly less likely to be hospitalized compared with patients with lower levels of adherence. For diabetes, hypertension, and hypercholesterol emia, high levels of adherence with condition-specifi c drugs were associated with lower medical costs across all of the patients’ treated conditions. For all 4 conditions, all-cause hospitalization rates were lowest for patients who had the highest medication adherence.

The rate of nonadherence to taking medications as prescribed is estimated to be 30% to 50% in the United States. Poor medication adherence is correlated with poorer patient outcomes and 125,000 deaths yearly. Nonadherence is responsible for more than one-third of medication-related hospitalizations that add as much as $290 billion to the cost of healthcare each year. Despite these numbers, interventions to improve adherence have had only modest success.

Research evidence shows that interventions targeting behavior changes or using a combination of methods work best. Single interventions that have shown some success include those that reduce the number of daily doses of medications, use motivational strategies, package medications into special containers (eg, pill boxes, blister packs), provide more convenient care, educate patients, or involve monitoring and feedback. As the US healthcare system attempts to move from a volume-based curve to one that is value-based with the emphasis on improved quality and reduced cost, medication adherence presents an opportunity to address both elements. It also presents a significant opportunity for pharmacists as the “medication therapy experts” on the healthcare team to take a leading role in improving medication adherence.

While studies have identified multiple causes for medication nonadherence, interventions have been largely unsuccessful. Opportunity exists to improve adherence and positively impact healthcare
quality and costs.