Creative thinking required to help patients adhere to drug regimens

Clinicians should work with the patient and caregivers to determine how recommended drug therapy regimens will fit with the patient’s lifestyle.

Issue: May 2008

None of the numerous medications available to prescribing clinicians and directly to children and their caregivers will be effective if they are not used.

In a busy pediatric office practice or a busy pharmacy, making an accurate diagnosis, choosing a medication most likely to be effective for the patient, and dispensing the medication to the patient/caregiver may appear to be sufficient. However, if that specific medication, as effective as it potentially may be for the patient, is not taken, it will not be effective.

Edward A. Bell

Adherence is defined as the extent to which a person’s behavior — taking a medication, following a diet, and/or executing lifestyle changes — corresponds with agreed recommendations from a health care provider. Some may use the term “compliance.” However, many prefer the term adherence, as adherence emphasizes the patient’s/caregiver’s role as a partner in the treatment and decision-making process.

Some believe “compliance” implies more of a one-way process (ie, clinician dictates the treatment regimen and the patient must comply). Related to the definition of adherence is what extent of adherence defines this term. Must a patient take 100% of prescribed doses to be considered adherent? Should adherence be defined by the clinical outcome of the patient; ie, whatever adherence rate is needed to control the patient’s disorder for which the drug is used? An adherence rate of 80% or more is frequently used in published clinical studies to define adherence.

Why non-adherence occurs

It is difficult to describe the prevalence of non-adherence, as many factors are important to consider. A difficulty with assessing the frequency of non-adherence is how to measure adherence, as there is no gold standard for measurement. The various published studies that have measured adherence have found a wide variety of adherence rates, depending upon the age group, disease state and demographic group, among other factors. However, review articles often use 50% as a broad, summary estimate of pediatric adherence with drug therapies.

The reasons why patients are non-adherent to our drug therapy recommendations are numerous. These include forgetfulness, concern over drug adverse effects, misunderstanding of the correct use of the drug, health literacy factors, economic factors, lack of appreciation/realization of the drug’s benefits or therapeutic effect, cultural factors, family/social factors (eg, disorganized home environment, different caregivers), or regimen factors (ie, frequency of dosing). Factors specific to pediatrics include administration difficulties, such as liquid medication taste, inherent problems with drug administration to infants or young children, reliance upon a parent or caregiver, and dosing at school or day care. Some experts believe forgetfulness may be the most common reason for non-adherence.

The potential for increased morbidity/mortality of the disease does not always equate to greater adherence. Studies have documented high non-adherence with such serious disorders as pediatric cancers, organ transplantation, and cystic fibrosis. Determining why a patient is non-adherent is an important means to increasing adherence.

Assessing adherence

What is the best means to determine if a patient is receiving the medication the clinician has prescribed? Although several methods can be used, no one method is the best for all patients, and there is no gold standard for adherence measurement. Perhaps the most commonly employed method by clinicians is self-reporting by the patient or caregiver. Although this method may be inherently inaccurate, clinicians can employ certain techniques that may improve its reliability. Experts recommend using open-ended (eg, “What difficulties do you have in taking your medicines?” “How often do you forget to take your medicine?” “How many doses did you forget or not take this past week?”) vs. closed-ended questions (“Are you taking your medicines?”) when assessing adherence. Asking these questions or discussing adherence in a warm, empathic, and nonjudgmental manner is likely to be more effective. Use of a nonjudgmental manner, acknowledging that medication adherence can be difficult, and explaining that adherence is a mutual goal and effort may enhance the patient’s willingness to admit non-adherence and reasons for its existence. There is some evidence by published studies that physicians are not able to accurately assess adherence. One study found that pediatricians over estimated adherence to antibiotic regimens for acute otitis media of their patients and poorly predicted adherence. Another study concluded that pediatricians were no better than chance at predicting which of their patients were adherent.

Several objective measures of adherence can be used, including dosage count, blood level measurement, laboratory value measurement, blood glucose meters, diaries and dosage administration recording, or refill rates. Clinical studies frequently use dosage counts or dosage diaries as a measure of adherence. Although these measures can be accurate in some circumstances, they may also have disadvantages. A savvy patient or caregiver may discard tablets prior to a scheduled appointment or become more adherent several days prior to an appointment if a blood level is to be taken. Refill rates may be affected by use of more than one pharmacy or physician for a source of the drug. As no one method of measuring adherence is best, use of a combination of methods is likely to be more accurate. Use of objective measures should be employed when possible.

Increasing adherence

Numerous methods can be employed in an attempt to increase a patient’s adherence with drug therapy. No single method, however, has been shown to be more effective than another.

The published literature is relatively weak on studies in the pediatric population on methods to increase medication adherence. Most studies have been conducted in adults and largely have found that various methods can have a small but positive effect to increase adherence. It is helpful to determine why non-adherence is occurring. Non-adherence because of missed doses may be improved by changing to a drug that is dosed only once or twice daily. Studies have shown dosing regimens more often than twice daily are difficult for patients and caregivers. Dosing more often than twice daily often requires dosing at school, and surveys of caregivers have suggested that this is difficult. Thus, use of drug regimens with once or twice daily dosing are more likely to be taken as prescribed.

A frequently discussed aspect of measures to increase medication adherence in literature reviews is the establishment and maintenance of a good, open relationship with the patient. Use of a nonthreatening and nonjudgmental manner in determining the extent and reasons for non-adherence is more likely to be helpful. Clinicians should work with the patient and caregivers to determine how recommended drug therapy regimens will fit with the patient’s lifestyle. Modifications to drug therapy regimens may be necessary to adapt a best fit to the patient’s lifestyle. Patients and caregivers should be questioned about actual or perceived difficulties in adhering to medication regimens. Additional methods to increase adherence that may be used include behavioral modifications and using reminders like pill boxes, calendars or linking the dose with a personal habit such as eating or teeth brushing. A frequently used class of drugs in the treatment of asthma, inhaled corticosteroids, are often dosed twice daily and can be linked with twice-daily teeth brushing. Inhaled corticosteroid products can be used just before teeth brushing, and mouth rinsing serves an additional benefit of rinsing drug out of the mouth, reducing the potential for swallowing and increased systemic adverse effects.

Education on the disease state and prescribed drugs can be helpful, although clinicians should keep in mind that patients and caregivers typically forget much of an education session soon after. Studies have shown that 50% or less of an education session is typically recalled soon after. Short, repeated educational sessions may be best. Educational sessions should include provision of verbal and written instructions when possible. As drug adverse effects are a common concern of patients and caregivers, it may be helpful to specifically discuss this and strive to seek out concerns of the patient. For example, a patient’s fear of steroids may significantly reduce adherence to an inhaled corticosteroid product for asthma.

For more information:

Edward Bell, PharmD, BCPS, is a Professor of Pharmacy Practice at Drake University College of Pharmacy, Blank Children’s Hospital in Des Moines, Iowa.

Butz A. Evidence-based practice: what is the evidence for medication adherence in children? J Pediatr Health Care. 2006;20:338-341.

Finney J, et al. The overestimation of adherence to pediatric medical regimens. Children’s Health Care. 1993;22:297-304.

Gardiner P, Dvorkin L. Promoting medication adherence in children. Amer Fami Physician. 2006;74:793-8.

Lask B. Motivating children and adolescents to improve adherence. J Pediatr. 2003;143:430-3.

Matsui D. Current issues in pediatric medication adherence. Pediatric Drugs. 2007;9:283-8

Peterson AM, Takiya L, Finley R. Meta-analysis of trials of interventions to improve medication adherence. Amer J Health System Pharm. 2003;60:657-65.

Winnick S, Lucas DO, Hartman AL, Toll D. How do you improve compliance? Pediatrics. 2005;115:e718-e724.