Treatment patterns in women with postmenopausal osteoporosis using abaloparatide: a real-world observational study.

Review of medical records from 173 women with osteoporosis who received abaloparatide treatment revealed that 96.0% had at least one visit for osteoporosis management and 55.5% had medication support group access. The most common reasons for discontinuing treatment were financial (31.2%) and tolerability (22.8%). Most patients (64.8%) completed treatment as prescribed. PURPOSE: Abaloparatide is approved for the treatment of women with postmenopausal osteoporosis at high risk for fracture. This study evaluated real-world treatment patterns for patients new to abaloparatide, regardless of osteoporosis treatment history. METHODS: Data for patients with ≥ 1 prescription for abaloparatide were collected retrospectively from six academic and clinical practice settings across the US. RESULTS: A total of 173 patients were enrolled (mean [SD] age, 69.8 [7.4] years). At the time of abaloparatide treatment initiation, 78.6% had received other osteoporosis medications. Mean (SD) time from discontinuation of osteoporosis medications prior to initiation of abaloparatide was 1.7 (3.2) years. Twenty-four months of follow-up data from the initiation date of abaloparatide was collected from 94.0% of patients and 6.0% of patients had 12-24 months of follow-up. During the follow-up period, 96.0% of patients had at least one visit for osteoporosis management and 55.5% had access to a medication support program. The median duration of therapy was 18.6 months and 105/162 (64.8%) completed abaloparatide treatment as prescribed. The most common reasons for treatment discontinuation were financial (31.2%) and tolerability (22.8%). Following completion of a course of treatment with abaloparatide, 82/162 (50.6%) patients transitioned to another osteoporosis medication. The median time between abaloparatide treatment course completion and the initiation of follow-on medication was 21 days. CONCLUSION: Most patients completed treatment with abaloparatide as prescribed, and over half continued with an antiresorptive agent. This favorable conduct may be the result of regular follow-up visits and accessibility to both medication and patient support services.

Medication Decision-making in Osteoporosis: Can We Explain Why Patients Do Not Take Their Osteoporosis Medications?

Patients at high risk of fracture often do not take medication for osteoporosis. Recent literature may give us some insights into why patients at high risk of fracture do not take medications for osteoporosis.

Validation of the Osteoporosis-Specific Morisky Medication Adherence Scale in long-term users of bisphosphonates.

PURPOSE: To examine the psychometric properties and validity of the 8-item Osteoporosis-Specific Morisky Medication Adherence Scale (OS-MMAS-8) in postmenopausal women prescribed bisphosphonates (BPs) for at least 15 months. METHODS: A random sample of women aged ≥55 years with osteoporosis prescribed daily or weekly BPs was identified. Pharmacy fill data were extracted to calculate the medication possession ratio (MPR). Eligible women were stratified by low (<0.50), medium (0.50-0.79), or high (≥0.80) MPR, with the a priori goal of recruiting 133 participants in each group. OS-MMAS-8 scores can range from 0 to 8 and were categorized as low (<6), medium (6 to <8), and high (8) adherence. Internal consistency reliability (Cronbach's alpha), test-retest reliability [intraclass correlation coefficients (ICCs)] and convergent validity (correlating OS-MMAS-8 with MPR and other self-reported measures) were assessed. RESULTS: A total of 400 women out of 449 respondents reported that they were still taking their BPs at the time of the survey and completed OS-MMAS-8. Overall, 38.5, 34.3, and 27.3% of participants had low, medium, and high OS-MMAS-8 scores, respectively. The mean (SD) MPRs according to OS-MMAS-8 scores (<6, 6 to <8 and 8) were 56.9 (22.6), 69.0 (24.9), and 76.7 (26.4), respectively. The correlation between OS-MMAS-8 and MPR was 0.36; p < 0.0001. Cronbach's alpha was 0.74, and the ICC was 0.83 (95% CI 0.76-0.88). CONCLUSIONS: OS-MMAS-8 has acceptable psychometric properties for assessing medication adherence in postmenopausal women prescribed therapy for osteoporosis. Additional studies are needed to investigate the psychometric properties of OS-MMAS-8 in other settings and populations.

Psychometric properties of the osteoporosis assessment questionnaire (OPAQ) 2.0: results from the multiple outcomes of raloxifene evaluation (MORE) study.

BACKGROUND: We explored psychometric properties of the Osteoporosis Assessment Questionnaire 2.0 in terms of reliability, validity, and responsiveness with generic, clinical, demographic, and preference-based data collected from a population of postmenopausal women with osteoporosis. METHODS: The Multiple Outcomes of Raloxifene Evaluation study was a randomized, placebo-controlled, multinational clinical trial evaluating efficacy and safety of raloxifene. The Osteoporosis Assessment Questionnaire 2.0, a generic quality of life measure (Nottingham Health Profile), and a preference-based measure (Health Utilities Index) were administered at baseline and annually. Psychometric properties of the 14 Osteoporosis Assessment Questionnaire 2.0 domains were evaluated by standard statistical techniques. RESULTS: This study included a subset of 1477 women from the Multiple Outcomes of Raloxifene Evaluation study population completing the questionnaires. Mean (standard deviation) age was 68.4 (6.8) years. Prevalent vertebral fractures were found in 70% (n =1038) of women. Internal consistency was >0.7 in 9 Osteoporosis Assessment Questionnaire 2.0 domains. Correlations were moderate and significant for similar Osteoporosis Assessment Questionnaire 2.0 domain scores, Nottingham Health Profile domains, and Health Utilities Index scores. All but 2 Osteoporosis Assessment Questionnaire 2.0 domains distinguished between patients with or without prevalent vertebral fractures and detected worsening with increased number of vertebral fractures. Women with ≥ 1 incident vertebral fracture generally had a greater worsening in Osteoporosis Assessment Questionnaire 2.0 scores (excluding social activity and support of family and friends) from baseline to study endpoint compared with women without incident vertebral fractures. CONCLUSIONS: Most domains in the Osteoporosis Assessment Questionnaire 2.0 demonstrated robust psychometric properties; however, several domains not showing these criteria may need to be reassessed and removed for a potentially shorter and validated version of the Osteoporosis Assessment Questionnaire.

Use of health-related quality of life measures to predict health utility in postmenopausal osteoporotic women: results from the Multiple Outcomes of Raloxifene Evaluation study.

BACKGROUND: The aim of this study is to examine the associations between health utility (HU), health-related quality of life (HRQoL), and patient characteristics in postmenopausal osteoporotic (PMO) women. METHODS: Baseline data from a subsample of 1,245 participants of the Multiple Outcomes of Raloxifene Evaluation study, a randomized, placebo-controlled, multinational clinical trial to evaluate the safety and efficacy of raloxifene, were analyzed. The study cohort included 694 participants from non-European Union (non-EU) countries and 551 participants from EU countries. All participants with complete baseline HU and HRQoL assessments were included in the following analyses: 1) HU (HUI or EQ-5D) and HRQoL (QualEFFO or OPAQ and NHP) associations; 2) HU variability explained by HRQoL domains; and 3) the percentage of HU variability explained by statistically significant (p < 0.05) HRQoL domains, after adjusting for baseline characteristics. RESULTS: Several domains were significantly associated with HU scores. HU variance was well explained (41% to 61%) by 4 to 6 (p < 0.05) significant HRQoL domains. After controlling for baseline characteristics, 48% to 64% of the HU variance was well explained by 5 to 7 significant (p < 0.05) HRQoL domains. Additional trend analyses detected statistically significant decreases in HRQoL and HU scores with an increased number of vertebral and non-vertebral fractures. CONCLUSIONS: Both disease-targeted and generic HRQoL domains were well correlated with HU. A large percentage (48% to 64%) of the HU variance was explained by HRQoL, after adjusting for baseline characteristics. Both disease-targeted and generic HRQoL measures were significant predictors of HU. HRQoL and HU scores decreased with increased vertebral and non-vertebral fractures.

Psychometric properties of the Osteoporosis-specific Morisky Medication Adherence Scale in postmenopausal women with osteoporosis newly treated with bisphosphonates.

BACKGROUND: Poor adherence to oral osteoporosis medications is common. Strategies for improving adherence begin with identification of the problem. The 8-item Morisky Medication Adherence Scale for self-reported adherence to antihypertensive medications was modified for assessing adherence to oral osteoporosis medications. An evaluation of the measurement properties of the Osteoporosis-Specific Morisky Medication Adherence Scale (OS-MMAS) was needed. OBJECTIVE: To examine the psychometric properties of the OS-MMAS in women with postmenopausal osteoporosis. METHODS: Five hundred women aged 55 years and older with osteoporosis who were newly prescribed daily or weekly oral bisphosphonates between May 15, 2010, and August 15, 2010, were randomly selected from Kaiser Permanente Southern California, a large integrated health care delivery system, and mailed a self-administered survey that included the 8-item OS-MMAS, Self-Efficacy for Appropriate Medication Use Scale (SEAMS), Beliefs about Medicines Questionnaire (BMQ), Treatment Satisfaction Questionnaire for Medication (TSQM), Gastrointestinal Symptom Rating Scale (GSRS), and 12-item Short-Form Health Survey (SF-12v2). OS-MMAS scores can range from 0 to 8, with higher scores indicating better medication adherence. Internal consistency reliability was evaluated using Cronbach α coefficient. Test-retest reliability was assessed using intraclass correlation coefficients (ICCs) in a subset of 102 participants. Construct validity was assessed using confirmatory factor analysis and correlations between OS-MMAS and related measures. RESULTS: Of 197 participants, 150 reported that they were still taking their bisphosphonate at the time of the survey and completed the OS-MMAS. Overall, 30.7%, 32.7%, and 36.7% had low, medium, and high OS-MMAS scores (<6, 6 to <8, and 8, respectively). Cronbach α was 0.82 and the ICC was 0.77. Convergent validity was supported by significant correlations with SEAMS, BMQ necessity, and TSQM scores. In confirmatory factor analysis, a single-factor scale was supported. CONCLUSIONS: The OS-MMAS showed strong psychometric properties with good reliability and construct validity and may provide a valuable assessment of self-reported medication adherence in women newly prescribed oral osteoporosis medications.

A Qualitative Study to Assess US Patient Preferences between new Transdermal System and Injectable Anabolic Therapies for Osteoporosis Treatment.

US patients with osteoporosis included in three focus groups identified efficacy, safety, cost, and convenience as important attributes of treatment when choosing between anabolic therapies with high stated preference for the solid Microstructured Transdermal System. OBJECTIVE: The current study evaluated patient perspective and relative importance of treatment attributes of in-home daily self-administration of abaloparatide-solid Microstructured Transdermal System (sMTS) compared with other anabolic agents (i.e. in-home daily subcutaneous self-injections, and monthly subcutaneous injections at doctor office) among a group of US patients with osteoporosis. METHODS: The current study included systematic literature reviews, experts' consultation and three online patients focus groups (n=27), including patients ≥50 years of age at high risk for fracture. Nominal Group Technique was used by asking patients to (1) Individually identify characteristics that would be important for them when choosing between anabolic treatments, (2) Share ideas and discuss perspectives with other patients, (3) Review additional attributes generated from a systematic literature review, (4) Select and rank individually the 7 most important characteristics from the list and (5) Report their acceptability and stated preference ranking between the three treatment options. RESULTS: Twenty women and 7 men with a mean age of 65 (range 51-85 years) participated in the focus groups. Twenty-four treatment characteristics were identified through focus groups and literature review. Efficacy, safety, out-of-pocket costs, strength of evidence and the option to self-administer were ranked as the most important attributes. The majority of patients stated preference for a daily sMTS if prescribed by their doctor. CONCLUSIONS: This study revealed that efficacy, safety, costs, and convenience are important attributes of osteoporosis treatment for US patients at high risk for fractures when choosing between anabolic therapies, with a high stated preference for sMTS.

Keepers of the House: A documentary.

BACKGROUND: Our documentary, Keepers of the House, highlights ways that hospital housekeepers, typically unnoticed care team members, provide emotional support for patients and their families. This film addresses a gap in education by emphasizing the importance of valuing and reflecting on the unique lived experiences of others. APPROACH: We created this documentary to expose students to the experiences and perceptions of hospital housekeepers. A focus group with six hospital housekeepers informed an interview script for the film's creation. Nine additional housekeepers were then interviewed, which developed into a 15-min documentary. Healthcare students and educators from five disciplines viewed the documentary during their institution's Medical Education Day. EVALUATION: To expose students and educators to housekeepers' experiences, we designed our post-viewing survey to address whether the housekeepers' stories impacted their understanding of the role and value of these workers. Viewers were surprised by the depth and breadth of patient-housekeeper interactions, the trauma housekeepers experienced from patient loss and the pride housekeepers take in their work. The stories that touched the viewers varied but centred on connections between housekeepers and patients. Lessons learned focused on recognizing the contributions of unseen team members. IMPLICATIONS: This innovative documentary amplifies the perspectives of voices rarely heard in healthcare. We aim to use this film, alongside its associated learning session, in education and grand round settings to foster discussion around empathy, valuing underrecognised team members and applying these insights in practice. This work can be disseminated to other institutions, further amplifying underrepresented narratives in healthcare.

Development, reliability, and validity of a new Preference and Satisfaction Questionnaire.

OBJECTIVES: Existing questionnaires that assess preference and/or satisfaction with postmenopausal bone loss treatments were reviewed and determined to be inadequate for the assessment of an oral pill versus a subcutaneous injection. The Preference and Satisfaction Questionnaire (PSQ) was developed to assess preference, satisfaction, and bother with a weekly oral tablet versus a once every 6 months subcutaneous injection for treatment of postmenopausal bone loss. METHODS: Questions were developed based on literature review and expert input. Content validity of the PSQ in this patient population was assessed among current or previous bisphosphonate users in group interviews, and item comprehension and readability were also evaluated. Reliability, validity, and structure of the questionnaire were assessed in two phase 3 randomized clinical trials. RESULTS: Twenty-four women participated in cognitive interviews and found the PSQ understandable and acceptable. Subsequently, 1583 trial participants took the PSQ. Interitem correlations, ranging from 0.50 to 0.97 for preference items, 0.85 to 0.94 for pill-satisfaction items, and 0.84 to 0.92 for injection-satisfaction items, and a well-fitting confirmatory factor analysis (root mean square error of approximation 0.04, nonnormed fit index 0.99, and root mean square residual 0.08) supported the structure of the instrument. Cronbach's alpha reliability values for pill satisfaction, injection satisfaction, pill bother, and injection bother were 0.93, 0.89, 0.82, and 0.61, respectively. Discriminative validity was indicated with better satisfaction and bother scores being related to adherence and the absence of adverse events. CONCLUSIONS: The PSQ is a valid and reliable measure and may be a valuable tool to assess patient preference and satisfaction with a weekly oral tablet and 6-month subcutaneous injection for postmenopausal bone loss.

Growing up with sickle cell disease: a pilot study of a transition program for adolescents with sickle cell disease.

We implemented the Duke Sickle Cell Disease (SCD) Transition Program for adolescents with SCD and investigated the knowledge about SCD; concerns and emotions about transitioning; and the initial impact of the Transition Program. Thirty-three adolescents participated in the initial study. Gaps in knowledge included ethnicities affected by SCD and inheritance of SCD. Adolescents were primarily concerned about transferring to a new medical team. There was a mix of both positive and negative emotions that varied over time. Overall, we have identified educational gaps and concerns and emotions about transitioning, which we will address through the Duke SCD Transition Program.

Abaloparatide Real-World Patient Experience Study.

Despite the availability of various osteoporosis treatments, adherence remains suboptimal. One contributing factor may be patient experience with therapy. This US, multicenter, combined retrospective chart review and patient questionnaire study included postmenopausal women at high risk for fracture and is the first study to describe real-world patient experience with abaloparatide (ABL) injection. Eight geographically diverse secondary care sites in the United States participated (n = 193). Mean ± SD age was 67.4 ±8.62 years. Most patients (86%) were satisfied with the ABL regimen, especially with ease of preparation (82%), ease of storage (87%), and storage convenience (89%), an attribute 83% of the patients thought was important. The majority of patients reported complete satisfaction with the ABL regimen allowing for their ability to conduct daily activities (85%) and convenience to fit into their daily schedule (84%). All reported taking ABL as directed, by injection in the lower abdomen, and 83% of patients reported medium or high adherence. Patients were satisfied with the needle size (76% completely satisfied), and 93% reported never deliberately missing a dose. Although injecting medication (18%) and higher out-of-pocket costs (17%) were deemed the most bothersome attributes, the majority (69%) noted their healthcare team understands how osteoporosis impacts their lives. In multivariable analyses, ease of preparation (OR = 2.62; 95% CI, 1.01-6.81; p = 0.048) and fracture history (OR = 1.72; 95% CI, 1.03-2.86; p = 0.037) were significantly associated with overall satisfaction. Ease of preparation was a predictor of higher satisfaction with treatment convenience (coefficient = 13.60; 95% CI, 8.08-19.12; p = 0.00). Remembering to take the medication was a significant predictor of self-reported adherence (OR = 16.66; 95% CI, 3.30-84.24; p = 0.001). In conclusion, the majority of patients were satisfied with ABL and found it convenient/easy to prepare and store. High self-reported adherence may be associated with positive patient experience including ease of use and adequate support from healthcare providers. © 2020 The Authors. JBMR Plus published by Wiley Periodicals LLC. on behalf of American Society for Bone and Mineral Research.

Compliance and persistence with osteoporosis medications: a critical review of the literature.

It is widely acknowledged that compliance and persistence with oral osteoporosis medications, particularly with bisphosphonates, is poor. Several excellent reviews have been written on compliance and persistence with osteoporosis medications and have discussed improvements seen with extended dosing intervals. This review begins with studies on extended dosing intervals to examine the limitations of administrative claims data. It also looks at compliance and persistence across multiple medical conditions, examining the importance of prescription fulfillment, intentional choice, causation and possible interventions.

Influence of Caretakers' Health Literacy on Delays to Traumatic Brain Injury Care in Uganda.

Background: Traumatic brain injury (TBI) is a life-altering condition, and delays to care can significantly impact outcomes. In Uganda, where nurse shortages are prevalent, patients' family members are the primary caretakers of these patients and play an important role in ensuring patients' access to timely care. However, caretakers often have little or no knowledge of appropriate patient care. Caretakers' ability to navigate the healthcare system and find and use health information to support their patients can impact delays in seeking, reaching, and receiving care. Objectives: This study seeks to determine the factors that impact TBI patient caretakers' health literacy and examine how these factors influence delays in care. Methods: This study was carried out in the Mulago National Referral Hospital neurosurgical ward, where 27 adult caretakers were interviewed using semi-structured, in-depth, qualitative interviews. "The Three Delay Framework" was utilized to understand participants' experiences in seeking, reaching, and receiving care for TBI patients. Thematic content analysis and manual coding was used to analyze interview transcripts and identify overarching themes in participant responses. Findings: The main health literacy themes identified were Extrinsic, Intrinsic and Health System Factors. Nine sub-themes were identified: Government Support, Community Support, Financial Burdens, Lack of Medical Resources, Access to Health Information, Physician Support, Emotional Challenges, Navigational Skills, and Understanding of Health Information. These components were found to influence the delays to care to varying degrees. Financial Burdens, Government Support, Emotional Challenges, Physician Support and Lack of Medical Resources were recurring factors across the three delays. Conclusion: The health literacy factors identified in this study influence caretakers' functional health literacy and delays to care in a co-dependent manner. A better understanding of how these factors impact patient outcomes is necessary for the development of interventions targeted at improving a caretaker's ability to maneuver the healthcare system and support patients in resource-poor settings.

Compliance and persistence with osteoporosis therapies.

The US Food and Drug Administration has approved a diverse group of effective osteoporosis therapies. However, these therapies obviously only work when patients with osteoporosis take them. Data from retrospective observational databases have shown poor compliance and persistence with all osteoporosis drugs, particularly oral bisphosphonate therapy. Patients on weekly therapies are more compliant and persistent than those on daily dosing. Data have also shown decreased fracture risk, decreased health care utilization, and lower costs in compliant and persistent patients.

Osteoporosis prevention and management: an evidence-based review.

Evidence-based guidelines that have been prepared by many professional organizations aimed at assisting the clinician in the initial evaluation of postmenopausal women who should be considered for bone mineral density evaluation by dual-energy x-ray absorptiometry; history, physical examination, and laboratory testing in those women being considered for pharmacologic intervention; and monitoring and management of women for whom therapy is prescribed are discussed.

Descriptive analysis of concomitant prescription medication patterns from 1999 to 2004 among US women receiving daily or weekly oral bisphosphonate therapy.

BACKGROUND: To improve medication-taking behavior, it is important to identify factors that may contribute to suboptimal compliance and persistence with osteoporosis medications. OBJECTIVE: The purpose of this descriptive analysis was to identify concurrent prescription medication use (number and type) among women receiving daily or weekly oral bisphosphonate therapy. METHODS: Patient prescription data were collected from November 1999 to June 2004 from a US patient claims database accessed through Wolters Kluwer Health (formerly NDC Health), which represents >65 million patients annually. Women aged >or=50 years who were receiving daily or weekly oral bisphosphonate medication during the study months were included. Concomitant medications were defined based on >or=14 days of prescription supply in the same month as bisphosphonate therapy. Data were examined to determine the frequency with which certain drugs and drug classes were prescribed concomitantly with bisphosphonates. Each study month was treated independently to assess concomitant medication use. RESULTS: Over the study period, the number of female bisphosphonate recipients in the database increased from 78,909 to 250,286. At the end of the study, 16.2%, 12.2%, 8.7%, and 19.1% of bisphosphonate recipients were prescribed 3, 4, 5, or >or=6 concomitant medications, respectively. The most commonly prescribed concomitant drug classes were cholesterol reducers, diuretics, beta-blockers, calcium channel blockers, synthetic thyroid hormones, angiotensin-converting enzyme inhibitors, systemic analgesics/anti-inflammatory drugs, and antispasmodics/antisecretory drugs. From July 2001 until the end of the study, the number of concomitant medications was higher for women receiving daily bisphosphonates than for those receiving weekly bisphosphonates, 4.16 versus 3.77 as of June 2004. In addition, the mean number of concomitant medications prescribed increased with age: in the aged 50 to 64 years cohort, the aged 65 to 74 years cohort, and the aged >or=75 years cohort, the mean number was 3.09, 3.62, and 3.97, respectively, as of June 2004. CONCLUSION: This analysis suggests that women prescribed bisphosphonates have a high medication burden, with the majority of patients (56%) taking >or=3 concomitant prescription medications.

Reduced fracture rates observed only in patients with proper persistence and compliance with bisphosphonate therapies.

Numerous studies have analyzed data from administrative claims databases to determine persistence and compliance with bisphosphonate therapy for osteoporosis; several of these studies have also examined how persistence and compliance with therapy affect fracture outcomes. All of the studies included in this review demonstrated that patients who were persistent or compliant with therapy had a decreased risk of fracture. None, however, adequately addressed the question of what level of persistence or compliance is necessary to obtain a reduced risk of fracture. There is agreement among studies that compliance and persistence rates are suboptimal for all osteoporosis treatments. Measures to improve persistence and compliance with osteoporosis medications are needed if patients are to achieve the full clinical benefit of treatment.

An evaluation of patient preferences for osteoporosis medication attributes: results from the PREFER-US study.

OBJECTIVE: To evaluate preferences for eight medication attributes that women may consider when evaluating prescription osteoporosis medications. RESEARCH DESIGN AND METHODS: The eligible sample consisted of women aged 50 years or older who responded to the 2003 or 2004 Internet-based National Health and Wellness Survey as being diagnosed with osteoporosis, considering themselves at risk, or having a family history of osteoporosis. In this Internet survey (the PREFER survey), respondents were asked to: (1) force-rank order the eight attributes from one to eight according to their preferences and (2) separately rate the importance of each attribute on a Likert-type scale from 1 (extremely unimportant) to 7 (extremely important). RESULTS: We collected 999 responses across 3 days from a sample of 3368 women and stopped compiling responses after achieving sample size targets. Drug effectiveness (e.g., ability to reduce the risk of fractures) was force ranked as the No. 1 preferred osteoporosis medication attribute by 37% of the sample. Side effects were force ranked as the No. 1 preferred medication attribute by 36% of the sample. Dosing frequency, dosing procedure, and formulation (i.e., how the drug is taken) were each force ranked as No. 1 by 2% or less of the sample. Drug effectiveness had the highest percentage of 'extremely important' responses (59%) followed by drug interactions (53%). Drug effectiveness was the highest-rated attribute (mean [S.D.] = 6.1 [1.6], median = 7), while dosing frequency was the lowest-rated attribute (mean [S.D.] = 4.7 [1.8], median = 5). CONCLUSIONS: In our sample of women with a diagnosis of osteoporosis or at risk for osteoporosis, drug effectiveness was the most highly ranked and rated of eight osteoporosis medication attributes. Side effects and drug interactions were also highly ranked and rated. Healthcare providers should consider incorporating patient preferences for key medication attributes into their therapeutic decision-making processes.

Initial experience with teriparatide in the United States.

Teriparatide has been commercially available in the United States (US) for over 3 years. This summary spans the early experience with this therapy. As of December 31, 2005, over 235 000 patients had filled a prescription for teriparatide world-wide. Data collected from July to December 2004, from 15,000 retail pharmacies in the US, indicated that the mean age of patients was 67.5 years, and more recent data collected from January through October 2005 indicated that 90% of patients were female. According to market research conducted with prescribing physicians from February through March of 2005, it is estimated that over 80% of patients receiving prescriptions for teriparatide had already experienced one or more prior fractures. Since teriparatide is administered subcutaneously, it is important that patients receive training on the use of the teriparatide injection device (i.e., the pen device). Educational programs are available for those who have been prescribed teriparatide therapy. Patients may also contact a customer care program regarding a variety of topics, including pen device use. Based on patient feedback, design changes have been implemented in the pen device to facilitate optimal use. Updates have also been made to the prescribing information to reflect the post-marketing surveillance experience. Adverse experiences reported to date have been consistent with the current product label and with cumulative teriparatide clinical trial experience. As of December 31, 2005 no reports of pathology-confirmed osteosarcoma have been received for individuals who have been treated with teriparatide, either with the commercially available drug or in clinical trials. We are unaware of any reports of osteosarcoma in association with other preparations of teriparatide, or other peptides of parathyroid hormone, either in the setting of clinical trials or from marketed drug experience.

Medication adherence: a challenge for patients with postmenopausal osteoporosis and other chronic illnesses.

OBJECTIVE: To define medication adherence and describe the limitations of various assessment methods, reasons for nonadherence to medications used to manage chronic illness, the impact of nonadherence to osteoporosis medications, and strategies for improving medication adherence. BACKGROUND: Medication nonadherence is a major public health problem that adversely affects patient outcomes and increases health care utilization and costs. Postmenopausal osteoporosis is a chronic disease, and adherence to drug therapy used to manage the disease is as much of a challenge as it is in other chronic diseases. SUMMARY: Medication adherence reflects both compliance and persistence. Direct assessment methods (e.g., observation, laboratory serum drug assays) are more accurate than indirect methods, but they are more costly and often impractical. Indirect methods include patient self-report and the use of prescription refill records, pill counts, and electronic monitoring devices. Medication adherence in patients with postmenopausal osteoporosis or other chronic illnesses is less than optimal. Adverse effects, financial constraints, mis-communication with the prescriber, and a perception that medications are unnecessary are among the possible reasons for medication nonadherence. Unintentional nonadherence is a passive process, often simply forgetting, and intentional nonadherence is an active process involving a deliberate choice, often based on adverse effects or a perceived lack of benefit. CONCLUSIONS: Nonadherence to osteoporosis medications can adversely affect patient outcomes and increase health care utilization and costs. An individualized approach to improving medication adherence based on patient preferences and readiness to change is needed.