Successfully improved compliance is achieved through patient education, a practical treatment plan, and strategies to increase adherence.
According to the National Center for Health Statistics,1 an estimated 1.1 billion medications were provided or prescribed at ambulatory care visits in 1992. Respiratory drugs were the fourth most commonly prescribed medications overall. These numbers reflect an increasing trend over the period from 1980 to 1992 that correlates with the aging of the US population.
Unfortunately, the number of prescriptions written does not appear to correlate well with the number of medications actually taken. Some studies2,3 have shown that less than 50% of prescribed respiratory medications are ever used. In one large multicenter trial,4 renewal rates for inhaled corticosteroids have been shown to be as low as one prescription per year. A 2000 article in Chest5 describes a search of the scientific literature for studies assessing compliance with inhaled cortico-steroid prescriptions. This review revealed that patients took their inhaled medications as prescribed on only 20% to 73% of days. In addition, only 46% to 59% demonstrated efficient inhalation technique.
Serious problems develop when there is a gap between the level of patient compliance assumed by the treating physician and the level of compliance actually practiced by the patient. Nonadherence to asthma treatment regimens is a frequent cause of hospitalization,6 with physicians in emergency departments relying on reports from the patients on their medication use. The assumption is frequently made that a patient’s symptoms are not adequately controlled by the medications he or she is taking; therefore, the patient may be overtreated with powerful drugs when a lesser dose might have been effective. One institution conducted a survey7 revealing that 50% of the drugs taken by its elderly patients were being taken improperly. Another study8 attributed 25% of hospital admissions in the elderly population to medication misuse.
A new study published in the Archives of Internal Medicine9 examined the frequency and nature of the discrepancies between medications prescribed and actually taken in the outpatient clinic of an academic medical center in Boston. The investigators compared patients’ medical records with the actual medications that patients brought in and listed as an accurate representation of what they were taking. The study revealed that 276 (76%) of the 312 patients surveyed were not taking their medications as prescribed. Analysis revealed that 51% of these problems involved taking a medication that was not listed in the patient’s record, 29% of patients were not taking a medication that had been prescribed, and 20% of them showed a discrepancy in the dosage.
Investigations such as these demonstrate the need for a reliable method of measuring medication compliance. Using a system for tracking medication use can be beneficial both to the medical professional and to the patient. Keeping track of medications in a systematic way can assist the patient in remembering to take all doses that have been prescribed. This is especially true for a patient who may be taking multiple inhaled medications for a respiratory condition. The tools used in these monitoring efforts range from very simple to high tech.
A more specific tool is the daily patient diary. This is usually a paper form that the patient fills out on a daily basis, recording the medications taken as well as other parameters defined by the health care team. Joyce Massaros, RRT, is a respiratory therapist with the Heart & Lung Fitness Program, Beaufort Memorial Hospital, Beaufort, SC. She notes that a diary is given to each patient in the institution’s pulmonary rehabilitation and asthma education programs. She says, “Not only does this give us vital feedback on their symptoms, but it promotes patient adherence as well. When patients see that they have an improvement in their peak flow rates after using their inhalers, or when using their spacers, they are more motivated to follow their treatment plans.” The diary asks the patient to record peak flows before and after morning metered-dose inhaler (MDI) treatments, at midday, and at bedtime. In addition, patients record the number of puffs of each inhaler (as well as other medications) taken, symptoms experienced, and, in the case of asthma patients, what triggers might have led to an attack. Patients are also asked which symptoms led to the use of rescue medications. Massaros states, “Education and follow-up are very important to this process. The patient needs to understand the use and purpose of every medication, and the importance of monitoring their effectiveness.” Therapists must remain in contact with patients to ensure their adherence to their treatment plans.
Some clinics have set up telemonitoring systems to track medication compliance in their patients. Patients may be asked to call in daily to report symptoms and medication use. Alternatively, they may be contacted once a week by a therapist to report their data via telephone. Systems have also been developed that allow a patient to transmit his or her information to a central computer via telephone line using a small handheld device.
The increasing popularity of Internet communication has opened another avenue for tracking patient well-being and medication adherence. Massaros explains, “Our patient diary form is available to patients on the hospital’s Web page. They are able to fill out their diaries and email them to us. We ask them to do this at 3-month intervals for follow-up, as well as any time their symptoms flare.”
Other systems are available that allow patients to keep online diaries that are reviewed by disease-management specialists. Any signs of problems can be dealt with early by notifying the physician and patient. Overuse and underuse of medications can be addressed. One Internet-based monitoring system allows the physician or therapist to view the patient’s diaries and summary information directly online. This helps the clinician fine-tune patients’ treatment regimens for maximum effectiveness. A recent study10 demonstrated that asthma patients were able to complete the Internet protocol with no difficulty, even when they had no previous computer background. In addition, 87% were strongly interested in using Internet asthma monitoring in the future.
LIMITATIONS OF SELF-REPORTING
There is one major limitation shared by all of these monitoring methods: they rely on the patient to self-report medication use. Research data have indicated that these self-reports tend to be unreliable. A study by van Grunsven et al11 compared patient diaries with dry-powder inhalers (DPIs) returned for refills. Whereas the diaries indicated more than 95% compliance with the prescribed medication, the actual DPI use rate indicated a mean overall individual compliance rate of 72%.
A study12 of 161 children with mild asthma compared daily diary cards with remaining doses in their DPIs over a period of 14 weeks. Results showed a mean compliance of 93% according to the diaries, compared with 77% compliance measured using the remaining doses. A study13 of 55 low-income, urban children showed only a 44% compliance rate with prescriptions for MDI anti-inflammatory agents, indicated by canister weight at follow-up visits, compared with a much higher rate in patient diaries. Those figures tend to indicate that there are factors at play other than simple forgetfulness—such as cultural health beliefs, psychological problems, or socioeconomic factors related to medication cost—that interfere with prescription adherence.
Such studies highlight the need for more reliable methods of compliance monitoring. Efforts have focused on the development and testing of devices that would electronically monitor the doses taken of any given medication. The increasing sophistication of very small microchips has made it possible to design devices for this purpose.
One early design capitalized on the pill-minder function. A small microchip imbedded in a pill box could be set to beep when a pill dose was due. It also recorded when the pill box was opened and closed. Information from the microchip could then be downloaded to a computer to give the clinician and patient a graphic representation of when doses had been taken and skipped. Results from the University of Lausanne, Switzerland,14 indicated that up to 50% of treatment failures for hypertension might be due to unrecognized lapses by patients in taking their antihypertensive medication. The study indicated that while some patients skipped doses because of adverse effects of the medications, many patients simply forgot doses, and they expressed surprise when shown the results of monitoring.
Over the past several years, manufacturers have been working on producing a device that would attach to a patient’s MDI and record each actuation. This information could then be viewed by the physician and patient alike. One such device used thermistor actuation with a microprocessor that dispensed inhaled medication and recorded the date and time of each canister activation. The patient was able to track the number of inhaler puffs taken at each prescribed interval. At regular intervals, the clinician was able to observe both the total number of puffs taken of the designated inhaler and the number of puffs taken each day. Several versions of this device have been tested. Some studies have shown that the data collected have not always given an accurate accounting of patient use. One study performed at the University of Florida, Gainesville15 tested several units for 7 days, actuating them one, two, four, or eight times twice daily. An equal number of inhalers were tested the same way through the normal actuator. The weight of all the canisters and the voltage of the device’s batteries were checked at the end of the 7-day trial. The data retrieved from the devices were then compared with the information manually recorded with each discharge. Although the loss in canister weight was the same in all canisters used, the accuracy of the monitoring devices in recording actuations ranged from 50% to 100%. The most frequent cause of data loss appeared to be a dead battery in the unit, although there were other mechanical problems noted as well. These difficulties gave the appearance of missed doses. The investigators concluded that the units were not sufficiently reliable to monitor patient adherence accurately.
A subsequent study at National Jewish Medical and Research Center,16 Denver, tested 24 of the devices at 8-hour intervals for 8 days. At the conclusion of the study, the researchers rated only 42% of the devices as reliable, and all of those devices still underestimated MDI actuation. There were seizure-pattern bursts of activity believed to be due to damaged thermistors, and there were four cases of dead batteries. Therefore, the investigators did not recommend the device for use in clinical or research settings.
Another device has been extensively tested for reliability and ease of patient use. This small device, shaped something like a champagne cork, fits over the end of the MDI to be monitored. The rubber gripping cup fits over most MDIs manufactured in the United States and can be transferred from one inhaler to another. Other inhalers can be used with a spacer containing an actuator. This device is pressure activated, so that it records a puff each time the patient presses down to actuate the MDI. A beep sounds when the puff is recorded. In addition, the device chimes three times to alert a patient that only 20 puffs remain in the inhaler. This MDI monitor records the doses taken each day, the total doses taken in 30 days, and the number of doses remaining in the canister. It resets each day at midnight to start recording again for the following day. The device is available through several health equipment suppliers and is priced at less than $35.
A study at the University of California, Los Angeles (UCLA) Medical Center17 tested this device and compared it with the thermistor device. The investigators tested the three functions (daily total actuations, number of doses remaining, and total actuations in 30 days) in three separate studies. In the first, laboratory personnel actuated the device several times in succession on 3 consecutive days. In the second, clinic personnel carried the MDI with the device attached for 4 weeks and followed a three-times-daily protocol to test the device. For 2 weeks of the study the other device was tested in the same way. In the third study, patients had both devices attached to their routinely used MDIs for 4 weeks. It was found that the small, generally available devices were accurate 99% of the time, and agreed with self-reports at a 97% rate. The second study showed similar results, although the alternative device only agreed with these results 90% to 93% of the time. In study number three, using actual patients rather than clinic personnel, the agreement with patient self-reports was only 85%, and concurrence between the two devices was only 76%. Still, the study concluded that the small device available to the general public provided an accurate measure of MDI use for clinicians, researchers, and patients.
Grace Ibrahim, RRT, is a staff research associate at the UCLA Lung Research Center who participated in the study of this device. She reports, “The patients liked using it, for the most part. It helped them keep track of how much medication they had actually taken during the course of the day. This was especially helpful to the chronic obstructive pulmonary disease patients who might be taking several different MDIs at the same time, and could lose track of the puffs taken. This helped them keep from overdosing or underdosing on their medications.”
Ibrahim notes that there were still some problems in using the MDI monitors. She says, “Some patients found that they were bulky and disliked having to carry something larger around.” In addition, she relates that users encountered a problem with some of the units. “When some of the units are dropped, the screens go blank. They can be reset, but the accumulated data are lost, which is a problem for researchers,” she says. The team also found that some of the patients would waste doses by activating their MDIs several times before coming to the research laboratory to avoid the appearance of medication underuse. This same tendency to dump medication doses was noted in another study in London18 in which patient diary cards showed good compliance, but the electronic compliance monitor showed inappropriate or erratic use of rescue MDIs.
It is apparent that efforts must be made by everyone in the clinical setting to devise means of improving patient medication compliance. It is also evident that this effort must be multifactorial. Key to the success of improving compliance is establishing a positive relationship between the patient and the therapy staff.4 The relationship should be expanded to allow significant patient education and to produce strategies that improve adherence. The therapist can help to identify issues that might inhibit good compliance, such as medication cost, side effects, and fitting the dosing schedule to the patient’s work or school schedule. The number of medications or doses required might be reduced by working with the patient’s physician. Electronic monitoring could play a significant role in helping both the patient and the clinician to track MDI use. Taking time with the patient to address their concerns is a very important part of developing an effective treatment plan.
One new electronic MDI-monitoring device takes a more global disease-management approach to compliance monitoring. When attached to the patient’s inhaler, it records the time and date of each actuation, whether the device was shaken as instructed, and whether the inhalation was appropriately timed to get the best deposition of the medication. This device also coordinates with one that measures peak flow and forced expiratory volume in 1 second for the patient. These recordings can then be downloaded into a program that graphs pulmonary function and medication use, helping the clinician tailor the patient’s care better. New studies will evaluate the effectiveness of this approach to patient compliance.
Questioning patients carefully about their ability to use the medications prescribed for them will go a long way toward improving compliance. N
Peggy Walker, RRT, is the Western Regional Liaison Representative for the Asthma and Allergy Support Center, Los Angeles, Calif, which facilitates physician-directed asthma monitoring and education utilizing interactive Internet technology.
1. Nelson CR, Knapp DE. Medication therapy in ambulatory medical care. National Ambulatory Medical Care Survey and National Hospital Ambulatory Medical Care Survey: 1992 summary. In: Advance Data. No. 253. Hyattsville, Md: National Center for Health Statistics; 1994:1-46.
2. Lan DM, Sherman MS, Polansky M. Guidelines and realities of asthma management; the Philadelphia story. Arch Intern Med. 1997;157:1193-1200.
3. Bender B, Milgrom H, Rand C. Nonadherence in asthmatic patients: is there a solution to the problem? Ann Allergy Asthma Immunol. 1997;79:177-186.
4. Milgrom H, Bender BG. Factors affecting compliance and safety. In: Program and Abstracts of the 1999 Annual Meeting of the American College of Allergy, Asthma, and Immunology. Chicago: ACAAI; 1999.
5. Cochrane MG, Bala MV, Downs KE, et al. Inhaled corticosteroids for asthma therapy: patient compliance, devices, and inhalation technique. Chest. 2000;117:542-550.
6. Weinstein AG. Asthma treatment and noncompliance. Del Med J. 2000;72:209-213.
7. Darnell JC, Murray MD, Martz BL, et al. Medication use by ambulatory elderly: an in-home survey. J Am Geriatr Soc. 1986;34:1-4.
8. Col N, Fanale JE, Kronholm P. The role of medication non-compliance and adverse drug reactions in hospitalizations of the elderly. Arch Intern Med. 1990;150:841-845.
9. Bedell SE, Jabbour S, Goldberg R, et al. Discrepancies in the use of medications: their extent and predictors in an outpatient practice. Arch Intern Med. 2000;160:2129-2134.
10. Finklestein J, Cabrera MR, Hripesak G. Internet-based home asthma telemonitoring: can patients handle the technology? Chest. 2000;117:148-155.
11. van Grunsven PM, van Schayek CP, van Deuveren M, et al. Compliance during long-term treatment with fluticasone propionate in subjects with early signs of asthma or chronic obstructive pulmonary disease (COPD): results of the Detection, Intervention, and Monitoring Program of COPD and Asthma (DIMCA) Study. J Asthma. 2000;37:225-234.
12. Jonasson G, Carlsen KH, Sodal A, et al. Patient compliance in a clinical trial with inhaled budesonide in children with mild asthma. Eur Respir J. 1999;14:150-154.
13. Celano M, Geller RJ, Phillips KM, et al. Treatment adherence among low-income children with asthma. J Pediatr Psychol. 1998;23:345-349.
14. Stephenson J. Noncompliance may cause half of antihypertensive drug “failures.” JAMA. 1999;282:4.
15. Brueckner JW, Marshek P, Sherman J, et al. Reliability of the Medtrac MDI Chronolog. J Allergy Clin Immunol. 1997;100:488-491.
16. Wamboldt FS, Bender BG, O’Connor SL, et al. Reliability of the model MC-311 MDI Chronolog. J Allergy Clin Immunol. 1999;104:53-57.
17. Simmons MS, Nides MA, Kleerup EC, et al. Validation of the Doser, a new device for monitoring metered dose inhaler use. J Allergy Clin Immunol. 1998;102:409-413.
18. Hamid S, Kumaradevan J, Cochrane G. Single center open study to compare patient recording of PRN salbutamol use on a daily diary card with actual use as recoded by the MDI compliance monitor. Respir Med. 1998; 92:1188-1190.