Iversen, Maura D. PT, DPT, SD, MPH1,2,5; Vora, Ruchita R. PT, MS3; Servi, Amber BA4; Solomon, Daniel H. MD, MS2,4,5
Osteoporosis is a chronic asymptomatic condition with high morbidity and mortality, whose sequelae are costly to manage.1 Osteoporosis is often a silent disease that becomes symptomatic after a fracture.2 In 2005, an estimated 2.1 million fractures were attributed to osteoporosis, resulting in health care costs of approximately $17 billion. By 2025, fracture rates are expected to rise to 3 million, and the corresponding increase in health care costs are expected to reach $25 billion.3
Research indicates that osteoporosis can be prevented by combining fall prevention techniques with effective and timely pharmacotherapy.4,5 Pharmacotherapy can reduce fracture incidence in at-risk patients by 40% to 50%.4–6 A systematic review and meta-analysis of randomized controlled trials of cyclic etidronate, alendronate, and risedronate indicate that bisphosphonates increase bone mineral density in the spine and hips in a dose-dependent manner, thus reducing the risk of vertebral fractures by 30% to 50%.5 Data indicate that vertebral fractures increase mortality, raise the risk of further fractures and deformity, and may cause pain.6 Hip fractures, which account for the greatest health care expenditures lead to high morbidity and mortality. The 1-year mortality from hip fracture is 1 in 5, and almost two-thirds of these patients never regain prefracture activity status.6 Vertebral fractures are fairly common and their adverse effects impact functional ability and independence and are often underestimated.
Although prevention strategies have been proven effective, less than half of the patients diagnosed with osteoporosis regularly take their medications, and of these, only half continue taking their medications after a year.1,7–9 Why are patients not adherent to their medications? One hypothesis relates to the asymptomatic nature of the disease. At-risk patients do not realize the importance of taking their medications until an adverse event occurs.10
In a review of studies reported in MEDLINE from 1975 to 2005 addressing adherence to bisphosphonate therapy, Gold et al11 found a variety of factors related to nonadherence. These factors included cost, adverse effects, dosing frequency, disease education, patient follow-up, and patient involvement in treatment decisions. However, few studies have examined patients' and physicians' perspectives about osteoporosis medication adherence. A European survey, conducted by a market research company, included 500 physicians (primary care physicians [PCPs] and rheumatologists). In addition, 502 women aged 60 years and older with postmenopausal osteoporosis, who had taken or were taking bisphosphonate therapy, were included. This study identified the gaps between patients' beliefs and physicians' perceptions of osteoporosis.2 This survey was conducted for women older than 60 years, and it is unclear how participants were surveyed, that is, via questionnaires, phone interviews, or face-to-face interviews.
The present study was undertaken by the Section of Clinical Sciences and the Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham & Women's Hospital, Boston, Massachusetts. It was performed at a Boston-based hospital affiliated with a large health care system, and the Pharmaceutical Assistance Contract for the Elderly, a Pennsylvania Department of Aging program. The present study aims to describe patients' and physicians' perspectives about osteoporosis medication adherence and compare and contrast these perspectives in an effort to delineate strategies to improve medication adherence.
Setting and Recruitment
To best understand the factors influencing adherence to osteoporosis medications, we recruited older adults (aged 65–85 years) and general medicine providers. Thirty-two patients diagnosed with osteoporosis and currently taking osteoporosis medications were recruited via advertisements in a tertiary hospital medical center newsletter. There were 22 patients from Boston and 10 from the Greater Boston area. Patients interested in the study contacted the research assistant, were screened for eligibility, and were provided with the details of study. Patients' eligibility included age of 65 to 85 years, diagnosis of osteoporosis (OP), willingness to participate in focus group, and experience taking an OP medication. Eleven physicians and 1 nurse practitioner were recruited via e-mail from the Division of General Medicine of various Boston-based hospitals affiliated with a large health care system. Provider eligibility included employment in one of the affiliated hospital's primary medicine practices, experience in treating patients with OP, and ability to prescribe an OP medication. Attendance at the focus group sessions implied informed consent. The protocol was approved by the institutional review board of the sponsoring institution.
Of the 32 patients, 30 were women (28 whites, 2 blacks) and 2 were men (whites). Eleven participants were physicians, and 1 was a nurse practitioner. Of these, 7 were women (whites), 5 were men (3 whites and 2 Asians). The average experience of providers was 21 years, with a range from 7 years to 35 years.
The research team, which included a physical therapist, a physician, a nurse practitioner, and a health educator, developed the moderator guides for the focus groups. A researcher trained in focus group methodology served as the primary focus group moderator. Separate focus groups were conducted for patients and physicians. Each patient group had 6 to 8 subjects including men and women. Three focus groups were conducted for the patients and 3 were conducted for the physicians. Focus groups lasted 60 to 90 minutes and were conducted until thematic saturation was reached. Thematic saturation is reached when during focus groups no new themes are discovered. All focus group interviews were audiotaped and transcribed by a medical transcriptionist. Patients were provided with $25.00 remuneration, parking, and refreshments for their participation. Medical staff were provided lunch.
We collected basic demographic information on each participant. Once the focus groups were transcribed, they were read and coded by 3 separate coders, who were blinded to each other's results. The process of open data coding was used. Open coding is defined as the process of breaking down, examining, comparing, conceptualizing, and categorizing data.12 This process is used to identify themes emerging from group conversations. Each coder identified themes individually, then met to discuss and refine themes using a normative group process and settle discrepancies in coding. Once the themes were agreed upon, the coders returned to the transcript and selected quotes from the data to illustrate each theme.
Eight patient themes (Table 2) and 3 physician themes with subthemes (Table 3) emerged from the focus groups. Patient themes that were identified included the following: quality and value of doctor-patient relationship, satisfaction with clinic visits, greater trust in specialists than PCPs, self-image and personal dissatisfaction, medication confusion, psychological impact of disease, patient outlook on adherence, and sources of knowledge about medication.
Quality and Value of Provider-Patient Relationship and Impact on Adherence
Table 2-b. Patient T...Image Tools
Table 3-b. Provider ...Image Tools
This theme addresses the roles of the patient and provider in the provider-patient relationship, the value that the patient places on the doctor's words, and how the patient views the doctor's authority. Specifically, the theme includes whether the patient listens to and believes what the PCP tells him or her, follows directions without question, or responds to what the doctor has to say about his or her disease management.
Patients expressed positive and negative opinions about their provider-patient relationships and the role of the provider in disease management decisions. For instance, one female patient stated, “My primary care physician just recommended drug A, and I went along with his recommendation. Just purely on the strength of my relationship with him, I started it.” This statement illustrates the paternalistic approach to medical care13 with the patient following medical recommendations regardless of her opinion as to the value of the medication. Another patient added, “I have friends who don't follow what the doctor suggests in terms of medicine and it always surprises me. Why go to the doctor when you are not going to do what he says?” In these examples, the patient places a high value on the doctor as the authority in the medical decision making.
Satisfaction With Doctor Visits and Impact on Information Sharing About Medications
This theme describes patients' experiences during the clinic visits and their ability to discuss medical management and/or ask questions about their osteoporosis. Patients reported that their average visit length ranged from 7 to 15 minutes. Many patients reported feeling rushed during the visit and unable to bring up medication issues such as how to take their medications and the desire to receive written medication information from physicians. Patients also emphasized their need to have directions repeated as they had trouble understanding or recalling information. As one patient remarked, “When I couldn't swallow the pill, then I knew.... My doctor did not raise the issue of side effects and I didn't either. I read over the material that comes with the medication.” A few patients were very complimentary of their PCPs and appreciated the time that they shared together. For example, one patient noted, “My doctor uses 20 minutes, she gives me all the time I need (to understand my treatment).”
Greater Trust in Specialists Than Primary Care Physicians
Many patients seemed to believe in and trust specialists, such as endocrinologists or rheumatologists, more than their primary care physician when the issue was osteoporosis management. Patients shared their doubts about the primary care providers' knowledge of osteoporosis. As one patient commented, “I was on drug A and had to take it 3 times a week. The pharmacy gave me the directions, which were different, so I told my doctor. My doctor didn't say anything about (the discrepancy) when I told him. He said that it was fine.” Another added, “What's good about going to an endocrinologist is that when I had bone density screenings, we went over them and he showed me where getting off drug A would be advantageous (since drug A is not a lifetime drug and is effective for 5–10 years after it is first started). The primary care doctor really needs this knowledge.”
Self-image and Personal Dissatisfaction
Patients were concerned about having chronic age-related illness such as osteoporosis. They expressed concerns about their ability to move around, work, and socialize. Many patients, regardless of gender, expressed concerns about loss of height and developing a hump in their spine. For example, a woman remarked, “I never realized I had the hump..... I said oh my God, when did it come? Slowly I'm sure. It's too late now to correct that, but maybe I can help it from getting worse [with medication].”
Patients expressed uncertainty about how to take their medications. Most patients did not understand why they were taking a certain osteoporosis medication and could not describe how it worked or how to tell whether it was working. As one patient reported, “I was on drug A after a fall when I broke a couple of vertebrae. But the bone studies didn't improve after that.” In reference to discussion with the provider about medication instructions, one patient stated, “They (the PCPs) don't tell you much. It's printed on your prescription. It's always printed there and you should be aware of it.”
Psychological Impact of Disease and Adherence
Some patients reported feeling depressed and helpless after being diagnosed with osteoporosis, whereas others accepted the diagnosis and worked around the pain. Many patients modified their lifestyles. One patient shared, “When you get [osteoporosis], you get discouraged and you really don't want to hear it. It's not easy to be consistent (with drugs and exercises) and have structure in your life, and you have to have that.” Another patient, talking about how osteoporosis has affected her life, said, “Two years ago I woke up one morning and couldn't walk. I collapsed on the floor. My poor hip went.... So I had a big operation and it made me realize that if I could just walk again and be able to take care of my home [I would take my medication regularly]... This disease has changed my life.”
Patient Outlook on Adherence
This theme addresses factors that deter patients or present barriers to adherence and the factors that patients believed helped them adhere to their medication. Side effects of medications were a primary reason for lack of adherence and were not always shared with providers. As one patient stated, “I had taken drug A for 5 years but I stopped it because it destroyed my esophagus.” Another patient added, “I became non-compliant for a long period of time when I was having strange symptoms... I gave up everything, all my medications, because I began to suspect them all... I made a complete list of all my medications; I began reading the fine print [to figure out] which one was causing the symptoms.”
Other factors, such as the method of administration and medication instructions, were difficult for patients to remember. As one patient stated, “I have a terrible time remembering drug A because you have to punch one out (of the foil). And I totally forget. Then I have to remember not to lie down [after I take it].” Other patients incorporated strategies to overcome these barriers. For instance, regarding medication cost, a patient shared “a little trick” with Medicare B: “Anything that was not generic, I asked the doctor to switch to a generic ... So everything is at a minimum price, very inexpensive.”
Others developed strategies to consistently take their medication. As one patient noted, “I take my (osteoporosis medication) on Sunday. Every Sunday, because you can sit down for an hour and read the paper and then have breakfast.” Another patient added, “I like a newsletter (about medications), because what you read you remember. What you hear dissipates. You actually can refer back (to it) off and on, if you have it there.” A third patient added, “It would be easier if you get one of those pill compartments.” These shared strategies provoked a great deal of interchange among subjects. Most patients had a preferred strategy to use.
Source of Knowledge About Medication
Patients reported that they obtained information about osteoporosis and its treatments from sources other than their PCP. For example, one patient remarked, “I started it (my osteoporosis medication) when I read about the program in the communication booklet from the hospital's senior newsletter.” Another got her knowledge from the label that she read on the pill bottle: “I do not take drug A although I was told to, because when I read the label it said if you have difficulty swallowing, do not take it.”
Provider themes were focused on structural barriers to care, provider beliefs about patient nonadherence, and strategies to enhance patients' adherence to medications.
Structural Barriers to Care
Providers reported that structural barriers shaped health care practices around information sharing. These providers felt that they had little or no control over the clinic visit length, staffing, medical record systems, communication among doctors, and insurance plans. Providers felt that these barriers impaired their ability to provide effective patient care and played a large role in patient dissatisfaction. Providers felt that they alone could not do everything they wished to do, such as make new medication lists and problem lists, because of staffing issues. A physician stated, “With the ideal (unlimited) staffing you could have someone before the visit call up and say, ‘before you see the doctor, I want to get the medication list up to date. Tell me the pills you are taking and how you are taking them.’” Another physician said, “We should have enough staff do that and to be able to get the patient back (to the clinic).”
Another issue raised was the shortcomings of the medical records system and/or the inadequate use of this system by doctors. One provider remarked, “The biggest problem I see is I spend a lot of time cleaning out medication lists on the system. So someone is coming in with 12 things and you ask, what are you taking, and they are taking one of them.” Providers recognized that more complex medication regimens lead to more medication adherence problems. Other providers used the electronic medication system regularly to ensure that patients were taking their medications and to keep the list updated. For instance, a physician reported as follows: “I always go over (the medication list)...every time I see them, and you know it's on the list, and they (the patient) says, ‘Oh I forgot.’ A lot of people say they just forget... So [I do] some counseling right then.”
Length of Visit Time
Providers and patients felt that the visit time was not enough to address all the patients' concerns. Though a longer visit time would be ideal, many felt that it was not possible given their patient load. Many providers expressed their belief that issues that patients wish to discuss are not serious enough to require immediate medical intervention. As one provider said, “If you have 7 minutes, or you have 14 minutes, you still have 74 active problems. You just can't sit there and talk to them in all honesty about a lot if issues you'd like to. You just don't have the time.”
Medical insurance was seen as a major factor influencing adherence. Patients taking osteoporosis medications are old and have Medicare as their primary insurance. Providers felt that the insurance system was complicated and confused them as much as it confused their patients. As one provider shared, “With the new Medicare, honestly, I don't know anymore who's got what.” Another provider offered, “I think the seniors right now are so befuddled by Medicare D that people who were very reliable, now are like ‘Oh my Gosh, this is so big!’ I think it has been a detriment.”
Some physicians commented upon the difficulties coordinating medication regimens and the apparent lack of communication between providers treating the same patient. As one provider stated, “I had a patient ask me that day if I could find a medication that a urologist she had seen had wanted to put her on 4 years before. We spent 10 minutes going through the chart. It wasn't there in the note, and it was lost forever. I ended up e-mailing the doctor and this took a lot of time.” Another doctor responded, “The thing that would be very helpful is to get all the specialists to put their medications on the medication list.”
Physician Beliefs About Patient Adherence
This theme contains the provider's beliefs and perspective about the reasons for patients' nonadherence to osteoporosis medications. One of the factors widely accepted by these providers for nonadherence was the cost. Providers observed that because of cost of long-standing medications not covered by the insurance companies, patients stop taking medications, stop going for refills, or alter the dosage and frequency without consulting the doctor. A physician remarked, “We are seeing an increase in noncompliance that has to do with patients not being able to afford their medications.” Another added, “And the other thing patients do, for cost issues, is split the doses. Their dose is 40 mg, but they are taking 20 instead for approximately a month.”
In some focus groups, providers vocalized experiences from their practice, stating that patients sometimes did not know why they were taking a certain medication. They believed that patients need knowledge to comply, and they should have information about their condition and the drugs they are taking, to ensure adherence to medications. A physician recounting a patient experience said, “[The patient] had hypothyroidism and supposedly started on medications and then never took it. So she came back with real significant (symptoms) so I said, ‘what happened?’ She didn't think it was important.” Another physician commenting on adherence to medications for chronic nonsymptomatic illnesses said, “Another big issue is when people aren't feeling symptoms, they don't take the medications. Compliance is terrible because people feel well.”
Some providers brought up issues about communication and accuracy of patient reports. Are the patients actually taking their medications? Physicians had almost no way of knowing for sure. A doctor observed, “With some of those more silent, asymptomatic conditions, it is a harder issue to trust or to know when someone is lying to you.”
The providers believed that side effects were a fairly common reason for patients to discontinue medications. More often than not, the providers were not informed about these changes. For instance, a doctor remarked, “People having side effects stop the medicine and then come back to see you 4 months later,” whereas another added, “Our educated patients, they read the fine print and they see the nausea, dizziness, and you have a problem. They will not take the medication because they think they can do natural treatments and sometimes they need to be persuaded (to take their osteoporosis medications).”
Outside sources of knowledge were believed to influence patients. This is knowledge that patients gain from other sources like media, friends, family, pharmacists, and so forth, which affects their decisions of taking drugs, treating their ailments, and sometimes lead patients to place less value on the doctors' decision. One doctor commented, “They are getting all this information from the media... You shouldn't be taking this... Everything that comes out of the news people listen to and then call their doctor and say, ‘should I be taking this?’ And [they] start doubting whether they should be on it.” Another doctor expressed, “I always talk about adverse effects and yet patients get their adverse effects info from Women's Day, Oprah Winfrey, the person sitting next to them at the beauty parlor or the bar, their grandmother, their nephew. The doctor is one voice among 12 others that have equal weight in whether they should take that medicine.”
This theme addresses strategies and solutions suggested by providers to help encourage better patient adherence to osteoporosis medications.
Providers suggested the use of pill boxes which patients could fill once a week. One provider suggested “cards with pill boxes for geriatric patients, (since) cognition isn't there to remember their medications,” whereas another added, “I think a pill box is a good way to make sure that the medications can be tracked, and what [the patients] have taken.”
This is another tool suggested by the physicians. A PCP suggested, “PCPs could give the patient a miniaturized laminated medication book with updates at every visit.” Another physician talking about the drawback of a pocket-sized list commented, “It's a trade off of how much (information) you can put on it, so that you can put in into a wallet or a pocket book.”
Longitudinal medical records list
The longitudinal medical records (LMR) is a system of ambulatory electronic medical records that most hospitals and health care facilities maintain.14 With LMR, providers can maintain patient records electronically, enhance data access, and reduce time in nondirect care–related activities.14 In addition, providers can easily share data with other clinicians across the facility.14 Providers felt that LMR was a convenient tool to enhance communication among providers. Providers suggested modifying the LMR system to list medications, their frequency, and dosage, which could be printed and given to patients at each visit. One doctor talking about convenience of LMR said, “Everything has to be in LMR, or it's a pain in the neck. It is to put something in LMR, click, save or forward and say set this person up for an appointment to check on this.” Another stated, “On occasion I have printed out the LMR medication list and given to the patient. It says take 1 p.o.q.d. It would be good to have something in LMR, to translate the medication list into English in a printable format.” The physicians felt that this was doable.
Providers felt that they were overburdened and hence not able to spend quality time with patients. They attributed this to clinics being short staffed and suggested having a medical assistant or help from nurses to deal with minor patient problems, so that patients are prepared with their major concerns when they actually see the PCP. This would enable the nurse to go over their medication lists and would give patients an opportunity to voice their concerns. A physician suggested, “Someone [other than us] needs to screens the patients, and go over their current med list.” Another added, “Some patients cannot read so the medical assistant can spend more time and figure out which (drug) is which.” Providers disapproved of insurance companies calling their patients to check whether they are taking their medication or refilling their prescription. A physician commented, “I would rather that they put their resources to be spent towards a geriatric nurse who can maybe do drug compliance, maybe bring in patients over 80 once a year with all their medications and try and do some teaching.”
There have been numerous studies conducted by insurance providers and independent researchers, examining patient adherence with osteoporosis medications and evaluating the effectiveness versus side effects of bisphosphonates and various other therapies available for managing osteoporosis. In the past, there have been studies examining patient outlook on adherence, but the unique aspect of this study is that it is the first to identify and compare physicians' and patients' perspectives about osteoporosis and the factors believed to be responsible for poor adherence to osteoporosis medications.
The data indicate that patients had a fair idea about the pathology involved in osteoporosis, and they obtained information from their doctors, friends, families, articles, and newsletters. The patients were open to trying different methods to enhance adherence to their medications, but they seemed dissatisfied with their PCP's knowledge about osteoporosis as compared with a specialist. Most patients also indicated that they were not instructed adequately about the medications by their providers. Patients preferred written information, in addition to spoken information, to help them remember the information shared. Written information could be referred to often and at their own convenience. These patients also seemed open to new treatments for osteoporosis and were interested in learning about advances in treatments.
As compared with the patients, the provider group expressed concerns regarding the structural barriers with medical infrastructure such as staffing, LMR, lack of communication between doctors, and various insurance programs. They suggested strategies like increasing patient knowledge, providing pocket lists and calendars, and having medical assistants or nurses help with patient screening and with geriatric patients having problems reading or understanding the method and frequency of taking their drugs.
Providers reported that they believed that their patients trusted and listened to specialists more than PCPs and recognized that patients gathered knowledge about osteoporosis from other outside sources. They reported that factors affecting patient adherence included drug side effects, cost, lack of knowledge about osteoporosis and benefits of treatment, and inability of the doctors to track patient adherence to therapy. Thus, certain factors such as education and knowledge about osteoporosis, side effects, and lack of doctor-patient communication surfaced as common factors affecting adherence across doctor and patient groups. Interestingly, patients identified more issues that were provider focused, specifically identifying the provider-patient relationship as a component impacting adherence, whereas provider suggestions remained patient and system focused.
A common area of concern emerging from patient and provider focus groups was dissatisfaction with the length of visits. Patients felt that the average 7- to 15-minute visit was not long enough for them to talk to their doctor about all their problems, and providers believed that they could not satisfactorily address all patient concerns during the limited time frame. Another theme that emerged as common was the amount of trust that patients placed in specialists. Patients believed that their PCPs did not have enough knowledge about osteoporosis and did not instruct them adequately about medications and treatment options available. The providers felt that patients placed more trust in the specialists and did not heed what the PCPs said. Both the patients and the doctors identified certain common factors for nonadherence of patients to their osteoporosis medications. They included the high cost of long-term medications, stopping medications because of side effects, and lack of patient knowledge about the medication.
Patients and physicians provided similar suggestions for enhancing patient adherence to medications such as using pillboxes, pocket lists, and calendars and distributing newsletters and detailed instructions of how and when to take medications. This study was conducted using patients and providers from a metropolitan area and from a few large hospitals. Thus, the result may not be applicable to all patients with osteoporosis. Although this study focused on providers who prescribed medications in the hospital-based medical practices, the information gleaned from these providers and patients may be useful for all members of the health care team. For example, limited time during medical visits was identified as a key factor impacting patient knowledge and thus, adherence to medications. Expanding the role of other health care providers (physical therapists, occupational therapists, etc) in educating patients about how to take medications; medication side effects and benefits; and exercise and supplements, perhaps using a central patient brochure, may improve medication compliance, increase physical activity, and enhance health outcomes. As each specialty has its unique approach to patient education and professional content, the variety of modes of information delivery and emphasis used by each profession may be more effective than single-specialty approaches. Physical therapists can assist in addressing impairments such as changes in posture (excessive kyphosis or hump), and in doing so, they can indirectly impact the psychosocial consequences of the disease.
The results of this study helped to inform the development of a multimodal intervention designed to elicit attitudes, beliefs, and barriers about OP medication adherence and to address system-based issues raised during the focus group. The intervention incorporates newsletters from patient-valued sources, personal counseling using motivational interviewing, and educational materials based on issues raised by patients during the focus groups. The intervention is being tested using a large cluster randomized controlled trial designed to improve adherence to osteoporosis medications and to examine cost-effectiveness of alternative strategies.