In the United States, it has been estimated that 7.8% of the total population has diabetes. In 2007, the direct medical expenditures for diabetes were about $116 billion and the total direct and indirect costs were $174 billion, according to the CDC.1
Patients with diabetes often have 2 or more comorbidities, such as hypertension, hyperlipidemia, and obesity. Compelling evidence from well-designed clinical trials has demonstrated that control of blood pressure and blood glucose and cholesterol levels can dramatically reduce diabetes complications.2-4 This often requires the use of multiple medications: it is common for a patient with diabetes to take 10 or more prescription drugs.
An analysis by Rizza and colleagues5 shows that in a scenario where goals of diabetes therapy are achieved, medical cost saving could improve by 20%, or an estimated $325 billion, in 30 years. But despite the availability of a wide variety of glucose-lowering drugs and well-established treatment guidelines, current diabetes care is far from optimal. According to the Third National Health and Nutrition Examination Survey conducted from 1999 to 2002, only 50% of the patients with diabetes achieved a glycosylated hemoglobin A1c (HbA1c) goal of 7% or less, and 40% met blood pressure recommendations set by the American Diabetes Association.6 Adherence to prescribed medications can be challenging and costly, and problems with self-management of drug therapy can exacerbate the burden of disease.7
Medication nonadherence is a serious public health issue. According to the American Heart Association, 12% of Americans do not fill their prescriptions at all, 12% do not take their medicine after they get their prescription filled, 29% stop taking their medicine before it runs out, and 22% take less of their medication than is prescribed. In other words, only 25% of patients are taking their medication as prescribed.8
The rate of medication adherence is typically low in patients with chronic conditions, especially in patients with type 2 diabetes mellitus. A review of the literature by Cramer9 showed that patient adherence to treatment with oral hypoglycemic agents ranged from 36% to 93% and adherence to insulin therapy was 62% to 64%.
Consequences of nonadherence. Medication nonadherence accounts for more than 10% of all hospitalizations and 23% of all nursing home admissions each year.8 It is estimated that medication nonadherence costs the health care system approximately $100 billion a year.10
Ho and colleagues11 conducted a retrospective cohort study of 11,532 patients in the Kaiser Permanente of Colorado diabetes registry and found that the prevalence of medication nonadherence was 21.3%. Compared with adherent patients, nonadherent patients had higher systolic and diastolic blood pressure and HbA1c and low-density lipoprotein cholesterol levels. They also had higher rates of all-cause hospitalization and mortality.
A recently published systematic literature review by Salas and colleagues12 reported that low medication possession ratios in patients with diabetes mellitus were associated with higher health care costs. This review found that there were significant differences in the reported cost of medication nonadherence in patients with diabetes because of various methods used in estimating costs among studies. Some studies have shown that the cost of medication nonadherence in these patients can be up to $11,000 per year per patient.12,13
Factors affecting medication adherence. According to the World Health Organization, medication adherence is related to social and economic factors, the health care team and system, the characteristics of the disease, therapy-related factors, and patient-related factors.14 Solving the problems related to each of these factors is necessary in order to improve medication adherence.
Research on adherence has typically focused on barriers such as complex treatment regimens, frequent medication dosing, forgetfulness, adverse drug effects, lack of information, and depression. Financial barriers to medication adherence have not been addressed until recently. In a survey of Americans aged 50 and older, 25% said that they did not fill a prescription written by their doctor in the past 2 years. Cost was cited as the primary reason (40%). Some respondents wished to avoid drug adverse effects (11%); others responded that the drug would not help much (11%), they did not think they needed it (8%), and the drug did not help (6%).15
The number of nonelderly Americans who could not afford their prescription drugs grew from 24.4 million in 2003 to 36 million in 2007, according to the Center for Studying Health System Change.16
As the recession continues and the unemployment rate grows, the ranks of the uninsured are increasing. Recent data from the Census Bureau showed that the number of uninsured Americans has risen to 46.3 million in 2008—15.4% of the US population.17
The proportion of patients with employer-provided health care coverage who reported cost-related medication problems increased from 8.7% in 2003 to 10.7% in 2007.16 The underinsured have health insurance prescription coverage but face significant cost sharing that limits their access to needed drug treatment.
Rising prescription drug costs and less generous drug coverage are likely to be contributing to the increase in unmet prescription drug needs among the underinsured. According to the latest National Health Expenditure data from the Center for Medicare & Medicaid Services, more health care dollars are being spent on medications. Growth in prescription drug spending is projected to outpace spending growth in hospital care and doctor/clinical services.18
A report released by Medco Health Solutions, Inc, found diabetes medications are now the most powerful driver of drug spending growth. A growing diabetes epidemic and introduction of new treatment options could drive diabetes drug costs by 70% within 3 years.19 With an increase in pharmacy spending, health plans increase cost sharing with enrollees by raising copayments and coinsurance.
Health plans have also created a fourth tier for high-priced drugs, and enrollees pay a percentage of the cost of drugs. Goldman and colleagues20 found that a 10% increase in cost sharing would result in a 2% to 6% decrease in prescription drug spending. Higher cost sharing is associated with decreased medication adherence and increased use of medical services in patients who have diabetes.
Cost-Related Medication Nonadherence
When faced with financial hardship, people with significant medication expenses will alter behaviors in attempts to save money. They may let prescriptions go unfilled or skip doses or take smaller doses to make the prescription last longer. In a national survey of 875 older adults with diabetes, 19% reported cutting back on use of their medications because of cost, 11% reported cutting back on their diabetes medications, and 7% reported cutting back on their diabetes medications at least once a month. In order to pay for their medications, 20% reported forgoing food and other essentials, 14% increased credit card debt, and 10% borrowed money from family or friends.21
Lack of physician-patient communication. Patients who have problems affording their medications do not always tell their health care providers. In a national survey of 660 older adults with chronic illness, 67% of respondents never told their doctors in advance that they are planning to take less medication or not fill a prescription because of the cost and 35% never discussed the issue of cost at all. Of those who did not talk to their doctors, 66% reported that their doctors did not ask about a patient’s ability to pay for medication, 58% did not think their health care providers could help, and 46% were too embarrassed to discuss this issue.22
Physicians often do not communicate with patients about drug costs. In a survey of 519 physicians, only one-third reported that they knew how much patients are spending out-of-pocket for prescriptions. The most commonly cited barriers to discussion with patients about out-of-pocket costs are insufficient time, concern over possible patient discomfort, and lack of habit.23 Another barrier is that physicians are unfamiliar with the cost of medications they commonly prescribe. A survey of physicians found that 68% of respondents underestimated the correct price range for all drugs. They reported that regular access to information on prescription drug costs would help them prescribe more cost-effectively.24
Identifying patients and intervening. Specific factors have been identified that may lead a health care provider to ask patients if they will have difficulty with medication costs. If a patient expresses concerns about medication costs, is a racial or ethnic minority, takes 7 or more prescription medications, or has no prescription coverage, his or her provider may be more likely to inquire about difficulty with paying for treatments.25
Several studies suggest that patients are selective about the medications they forgo. Patients with different clinical characteristics and socioeconomic backgrounds respond to medication cost problems differently. Table 1 lists the patients at greatest risk for cost-related medication nonadherence. Interventions to improve cost-related medication nonadherence are described in Table 2.
Detecting Cost-Related Nonadherence
There are many ways to measure medication adherence. To maximize accuracy in the clinical setting, a combination of prescription refills rate and patient interview is a practical approach. When interviewing patients, use the following techniques:
• Ask an open-ended question about the patient’s medication habits. Example: “Tell me how you are taking your medications.”
• Create a non-judgmental environment in which the patient feels safe admitting to nonadherence. Example: “You are taking a lot of medicines. It is hard for anyone to keep them straight. Not only that, they can be expensive.”
• Explain that it is important for health care providers to get accurate information about patient medication adherence to make appropriate treatment decisions. Example: “Your blood sugar is still high. But before you get more medicine, let’s make sure there isn’t a problem taking the medicine that you’ve already been taking. Taking too much isn’t good either.”
• Ask about medication adherence last. Example: “Have you cut back on any of your medications because of cost?”
Strategies to Assist Patients With Problems Paying for Their Medications
Once cost-related medication nonadherence is identified, health care providers should take steps to make sure their patients get the medications they need. There are multiple cost-cutting strategies available, which may be remembered using the acronym GOT HELP (Table 3).
Generic drugs. In recent years, use of generic medications has increased because of increased use of tiered formularies, policies promoting generic substitution, and the availability of the $4 generic prescriptions programs. Despite the cost savings generated by the use of generic prescriptions, studies have shown that patients have multiple concerns about the safety and effectiveness of generic medications.
In a survey conducted by Consumer Reports in 2009, nearly half of the respondents reported having reservations about generic drugs. Twenty-seven percent of respondents believed that adverse effects of generic medications are different from those of brand-name drugs, 22% thought generics are not as effective, 18% thought that generics do not meet the same federal standards, and 16% said they are not as safe.26
Results of the Flint Study showed that diabetic patients also have negative beliefs about generic medications. In this study, almost 800 diabetic patients from an economically distressed region were surveyed. Table 4 shows the results of this study in regard to generic medications.27 Misconception about generic drugs can lead to medication underuse, which, in turn, results in poor health outcomes. This would negate the cost saving benefit of generic medications. Physicians and diabetes educators have the ability to address patients’ concerns and provide reliable information about generic medications. Insurers should assist health care providers in promoting adherence to therapy with generic medications.
Over-the-counter (OTC) drug substitution. Recently approved OTC drugs include loratadine(Drug information on loratadine), cetirizine, omeprazole(Drug information on omeprazole), and orlistat(Drug information on orlistat). Prices for generic OTC versions are lower than those for both generic and brand-named prescription drugs.
Therapeutic alternatives. If a brand-name drug has no generic equivalent, generic therapeutic alternatives may be available. Health care providers should consider evidence-based medicine when determining whether a therapeutic alternative within the same class or another class will be appropriate.
Helpful resources. Refer the patient to a social worker or help the patient access government and community programs. Although the recession and state budget deficits have affected many government and community programs, the patient may also be referred to Patient Assistance Programs (PAPs) from pharmaceutical companies. These programs are created to assist low-income patients with no prescription drug coverage. Each pharmaceutical company has its own application process that requires the participation of the physician.
Most PAPs provide a 3-month supply of specific medications. It may take from 4 to 6 weeks for the drug to arrive. Most applications need to be resubmitted every 3 months. The paperwork can be overwhelming, and the coordination of applications can be labor-intensive. Therefore, PAPs are best used for drugs that have no generic or therapeutic alternatives.
Explore $4 prescriptions. In the fall of 2006, Walmart announced a program offering various generic prescription drugs at a cost of $4 for a 30-day supply. Soon after, other chain pharmacies launched similar programs. The $4 generic prescription programs are now available at several stores, including Walmart, Target, Kroger, Giant Eagle, Ralphs, and Fred Meyer stores. To stay competitive, Meijer and Publix are now offering free 14-day antibiotics. Although it is advantageous to use the $4 generic prescription drug program, patients should be advised not to price shop—continuity of care should be considered.
Lowering prescription number. Health care providers should regularly review a patient’s list of medications and discontinue any nonessential or ineffective drugs. Such a practice helps decrease out-of-pocket cost, and polypharmacy, which can also contribute to medication nonadherence, may be avoided.
Pill-splitting. Some brand-name drugs in higher-dose pills cost the same as lower-dose pills. The physician can prescribe a higher dose and tell the patient to split the tablet for a lower dose. To make the practice safe, use of a pill-splitter is recommended, and pills should only be split if they are scored. Pills should not be split if they have a hard coating or are extended-release or continuous-release tablets.
Medication costs pose a very real barrier to medication adherence in patients with diabetes. Interventions that reduce rates of cost-related medication nonadherence can achieve substantial reductions in diabetes morbidity and mortality. Significant cost savings to the health care system may be achieved.
Prescribers and diabetes educators have the opportunity and ability to reduce cost-related medication nonadherence and thereby improve quality of care for patients with diabetes. They can identify patients at risk for cost-related medication nonadherence and initiate strategies to reduce these costs. Health care providers may find GOT HELP to be a helpful reminder of various drug cost reduction strategies.
Insurers and PBMs should consider a change in their approach to managing drug costs. Strategies to reduce short-term costs, such as increased cost sharing, do not add value in the long run if medication nonadherence is increased and health outcomes worsen. Insurers and PBMs should also cooperate with health care providers to ensure that patients receive the most cost-effective treatments. Health care providers should be given information on drug costs.
Insurers and PBMs can also assist health care providers in identifying nonadherence by providing prescription refill data. Patient health improves when providers and payers work together.
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