Evaluation of a Pharmacist-Managed Diabetes Program in a Primary Care Setting Within an Integrated Health Care System.

BACKGROUND: Pharmacists have important roles in managing the therapy of patients with type 2 diabetes and improving patient care. Pharmacists titrate medications; reinforce patient education; and address care gaps, such as medication adherence, vaccinations, and overdue health screenings. Through these efforts and more, pharmacists help to improve patient care and achieve Healthcare Effectiveness Data and Information Set (HEDIS) measures. Thus, it is important to demonstrate improved health outcomes through pharmacist contributions to diabetes management, which can then provide an opportunity to expand the role of clinical pharmacists in other medical centers and practice settings within an integrated health care system. OBJECTIVE: To evaluate the effect of a pharmacist-managed program within a primary care setting by determining the percentage of patients who reached the HEDIS goal of hemoglobin A1c (A1c) < 8.0%, the time needed to reach this goal, and A1c reduction in patients with type 2 diabetes. METHODS: This retrospective cohort study identified patients aged 18-74 years who had uncontrolled A1c ≥ 8.0%. Patients in the Complete Care Program (CCP) had their diabetes therapy managed by a pharmacist and were propensity score matched to a comparison group of usual care (UC) patients. Multivariate regression analyses and a Cox proportional hazards model compared the change in A1c from baseline and the time to A1c goal between the 2 groups. RESULTS: There were no significant differences in baseline characteristics between the CCP and UC patients (n = 980 patients per group). CCP patients were significantly more likely to achieve the HEDIS goal of A1c < 8% at 3 months (OR = 2.44, 95% CI = 1.93-3.10, P < 0.0001) and at 6 months (OR = 1.32, 95% CI = 1.08-1.61, P = 0.007) compared with the UC patients. CCP patients also reached the A1c goal significantly faster: 3.4 months versus 4.6 months (P < 0.0001), even after controlling for covariates (HR = 1.24, 95% CI = 1.09-1.41, P = 0.001). Change in baseline A1c was -0.95% versus -0.54% (P < 0.0001) at 3 months and -1.19% versus -0.99% (P = 0.008) at 6 months for CCP versus UC patients, respectively. CONCLUSIONS: Type 2 diabetes therapy management by clinical pharmacists was associated with a greater percentage of patients achieving the HEDIS goal of A1c < 8.0%, reaching the A1c goal faster, and a greater A1c reduction from baseline at 3 and 6 months of follow-up compared with patients receiving usual care. DISCLOSURES: No funding was provided to support this research study. The authors report no potential conflicts of interest relevant to this article. All authors contributed to the study concept and design. Benedict and Spence performed data analysis and interpretation. The manuscript was written by Benedict, with assistance from Spence and Rashid. All authors reviewed and contributed to manuscript revisions. Spence is the guarantor of this work and, as such, had full access to all the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis. Parts of this study were presented at the AMCP Managed Care and Specialty Pharmacy Annual Meeting; San Francisco, California; April 19-22, 2016.

Treatment Patterns and Overall Survival Associated with First-Line Systemic Therapy for Patients with Advanced Non-Small Cell Lung Cancer.

BACKGROUND: A variety of regimens are used as first-line treatment in patients with advanced non-small cell lung cancer (NSCLC), which may include combination regimens and single agents, depending on histology, molecular profile, and performance status. OBJECTIVE: To describe the types of first-line therapies and compare overall survival between therapies used for patients with advanced NSCLC in an integrated health care system. METHODS: This retrospective cohort study included patients aged 18 years or older from Kaiser Permanente California with a diagnosis of stage IIIB/IV NSCLC. First systemic treatment date occurred from January 1, 2008, through September 30, 2013. Overall survival was measured as the number of months from initial treatment until death, end of enrollment, or September 30, 2014. Treatment regimens were categorized into 6 mutually exclusive groups: platinum doublets; pemetrexed-based, bevacizumab-based, and pemetrexed + bevacizumab-based combinations; singlets; and tyrosine-kinase inhibitors (TKIs). Survival was compared using Kaplan-Meier curves and adjusted Cox proportional hazard models. Subgroup analyses were performed by age group and by nonsquamous histology. RESULTS: Of 2,081 patients, approximately half (52.3%) received platinum doublets, followed by TKIs (19.0%), pemetrexed-based regimens (13.4%), bevacizumab-regimens (8.0%), singlets (5.5%), and pemetrexed + bevacizumab-based combinations (1.8%). Median survival was longest for pemetrexed + bevacizumab-based combinations (18.5 months), followed by bevacizumab-based regimens (14.5), TKIs (12.7), pemetrexed-based regimens (10.4), doublets (9.2), and singlets (5.3). There was a significantly reduced risk of mortality for pemetrexed + bevacizumab-based combinations (HR = 0.64; 95% CI = 0.42-0.94) and TKIs (HR = 0.83; 95% CI = 0.73-0.94) compared with doublets. Singlets were associated with an increased risk of mortality (HR = 1.50; 95% CI = 1.22-1.84). Subgroup analysis among patients aged 65 years and over found no significant differences among treatment groups, with the exception of singlets, which were associated with an increased risk of mortality compared with doublets (HR = 1.51; 95% CI = 1.20-1.90). Among patients under aged 65 years, pemetrexed + bevacizumab-based combinations (HR = 0.36; 95% CI = 0.21-0.64) and TKIs (HR = 0.76; 95% CI = 0.59-0.97) were associated with a reduced risk of mortality, and singlets were associated with an increased risk (HR = 1.85; 95% CI = 1.17-2.92). CONCLUSIONS: In this cohort of patients with advanced NSCLC, patients received a platinum agent with or without bevacizumab or pemetrexed, a TKI, or a single agent. Younger patients (aged < 65 years) receiving bevacizumab + pemetrexed-based combinations had a survival advantage over those receiving platinum doublets, and this finding merits further investigation. Younger patients receiving TKIs also had longer survival. Compared with platinum doublets, we found no survival advantage for older patients receiving bevacizumab or pemetrexed, which suggests that combination therapy of a platinum agent and taxane, such as carboplatin and paclitaxel, could be a reasonable option for older patients who are not candidates for targeted therapy. DISCLOSURES: No outside funding supported this study. Rashid has received past funding from Bristol-Myers Squibb, Astellas, Novartis, and Pfizer. No other authors report any potential financial conflicts of interest. Study concept and design were primarily contributed by Spence and Hui, with input from the other authors. Hui, Spence, and Rashid took the lead in data collection, and data interpretation was performed by Schottinger, Millares, and Spence, assisted by the other authors. The manuscript was written primarily by Spence, along with Chang, and revised by Spence, with input from the other authors.

The Risk of Pneumonia in Older Adults Using Nonbenzodiazepine Hypnotics.

BACKGROUND: Previous studies have shown an increased risk of pneumonia with benzodiazepines (BZD) and an increased risk of any infection with non-BZD hypnotics, but no analysis has specifically investigated the risk of pneumonia with non-BZD hypnotic use. OBJECTIVE: To evaluate the risk of pneumonia associated with non-BZD hypnotic use in the elderly. METHODS: This was a retrospective case-control study of members aged 65 years and older enrolled in an integrated health care system. Cases were identified as patients aged 65 years and older with a diagnosis of pneumonia from January 2011 to December 2012. Controls were matched in a 4:1 ratio to cases based on age, gender, and active enrollment. Non-BZD hypnotic exposure was evaluated for all cases and controls 1 year before the index date. Proximity of exposure to index date and duration of use were analyzed. Conditional logistic regression adjusted for covariates was performed. RESULTS: We identified 51,029 cases with pneumonia and matched 188,391 controls without pneumonia. Of the cases with pneumonia, 5.5% (2,790) of cases had exposure to a non-BZD hypnotic, compared with 3.4% (6,345) of controls. Non-BZD hypnotic exposure was associated with an increased risk of pneumonia (OR = 1.14; 95% CI = 1.08-1.20). When exposure was stratified by proximity to index date, only current exposure was associated with an increased risk of pneumonia (OR = 1.27; 95% CI = 1.18-1.36). Short-term exposure was associated with a relatively higher risk of pneumonia (OR = 1.57; 95% CI = 1.39-1.77) compared with long-term use (OR = 1.16; 95% CI = 1.06-1.25). CONCLUSIONS: Current use of non-BZD hypnotics in older adults is associated with an increased risk of pneumonia. The findings of this study provide additional support for reducing the use of non-BZD hypnotics in older adults and for pursuing safer alternatives for treating insomnia. DISCLOSURES: No outside funding supported this study. At the time of this study, Jung was a PGY2 resident in drug information at Kaiser Permanente Drug Information Services. All authors are employed by Kaiser Permanente and report no other potential financial conflicts of interest. Study concept and design were contributed by Jung, Spence, Lee, and Gibbs. Jung, Spence, and Hui were responsible for data collection, and data interpretation was performed by Jung and Spence, with assistance from Escasa, Lee, and Hui. The manuscript was primarily written by Jung, along with Spence and Escasa, and revised by Spence, Escasa, and Lee, along with the other authors.

Risk of Injury in Older Adults Using Gastrointestinal Antispasmodic and Anticholinergic Medications.

OBJECTIVES: To determine the risk of injury associated with gastrointestinal (GI) antispasmodic and anticholinergic use in elderly adults. DESIGN: Retrospective case-control study. SETTING: Integrated healthcare system. PARTICIPANTS: Healthcare system members aged 65 and older (N = 260,010; 54,152 cases, 205,858 controls). MEASUREMENTS: Cases were identified as individuals with an injury resulting in a hospitalization, emergency department, or urgent care visit (index date) from January 2009 through December 2010. Cases and controls were matched in a 1:4 ratio based on age and sex. GI antispasmodic and anticholinergic current and past exposure for cases and controls was evaluated. Individuals were classified as current users if the days' supply of the GI prescription overlapped the index date and past users if the days' supply ended more than 60 days before the index date. Duration of use for current users was analyzed for short- and long-term use. Conditional logistic regression produced adjusted odds ratios (ORs) with 95% confidence intervals (CIs). RESULTS: Of the total population, 1,068 (0.4%) had current exposure to a GI antispasmodic or anticholinergic (302 (0.6%) cases, 766 (0.4%) controls). Current users had a small but significantly greater risk of injury than nonusers (OR = 1.16, 95% CI = 1.01-1.34, P = .03). Past use was not significantly different from no use. Short-term users had a significantly greater risk of injury (OR = 1.31, 95% CI = 1.01-1.70, P = .04) than nonusers. Long-term use was associated with greater risk, but the difference was not statistically significant. CONCLUSION: Older adults using GI antispasmodic and anticholinergic drugs have greater risk of injury. These findings support recommendations to limit the prescribing of GI antispasmodics and anticholinergics in elderly adults.

Evaluation of an outpatient pharmacy clinical services program on adherence and clinical outcomes among patients with diabetes and/or coronary artery disease.

BACKGROUND: Poor medication adherence among patients with chronic diseases can result in complications and increased health care expenditures. An outpatient pharmacy clinical service (OPCS) program targeted nonadherent diabetes mellitus (DM) and/or coronary artery disease (CAD) patients with hemoglobin A1c (HbA1c) and/or low-density lipoprotein cholesterol (LDL-C) outside clinical goals. Pharmacists engaged identified patients with a face-to-face B-SMART consult, a consultation methodology to identify Barriers to medication adherence, work on Solutions to identified barriers, Motivate patients, recommend Adherence tools, reinforce the pharmacist-patient Relationship, and Triage if needed, to other services such as health education to improve outcomes.  OBJECTIVES: To (a) assess rates of medication adherence and clinical outcomes in the OPCS program compared with usual care in an integrated health care system and (b) estimate return-on-investment (ROI) from this intervention.  METHODS: This retrospective cohort study used data from the Kaiser Permanente Southern California region to identify patients who received OPCS consultations and usual care patients from March 2009 through December 2010, with 1 year of follow-up from the initial consult (index date). Four patients from usual care were matched to each patient in the OPCS program and were assigned the same index date as the matching OPCS patient. Additional selection criteria were applied after matching. All patients were required to have a medication possession ratio (MPR) of less than 0.80 for their diabetes or dyslipidemia oral medications 1 year prior to the index date, indicating lower adherence to the prescribed therapy. Diabetic patients or dyslipidemic patients had to have a HbA1c or LDL-C lab result outside of clinical goals prior to the index date to be included in the study, respectively. Adherence outcomes as well as clinical outcomes were measured 12 months after the index date using chi-square tests for differences in percentages and t-tests for differences in means. The ROI was based on a cost-avoidance model that compared the cost of the OPCS program with the cost savings gained through reduced hospitalizations and emergency department (ED) visits. The diabetes and dyslipidemia cohorts were combined for the ROI analysis. RESULTS: Demographic and clinical characteristics at baseline were similar between the OPCS group (n = 1,480) and usual care group (n = 1,477). Among patients with diabetes, a higher percentage in the OPCS group than in the usual care group were adherent with their diabetes medications (53.5% vs. 37.4%, P = 0.001). There was no significant difference in average MPR between groups. However, patients in the OPCS group had a greater increase in mean MPR (0.19 vs. 0.15, P = 0.024); were less likely to discontinue taking their diabetes medications (11.7% vs. 35.5%, P = 0.001); and were more likely to have a timely first fill after the index date (34.8% vs. 12.9%, P = 0.001). The average number of days to the first fill after the index date was significantly shorter for the OPCS group (79.3 vs. 156.3, P = 0.001). Regarding clinical outcomes, patients with diabetes in the OPCS group had a lower mean HbA1c (8.48 vs. 8.80, P = 0.024) and a greater reduction in HbA1c (-1.25 vs. -0.75, P = 0.001) than in the usual care group. They were also less likely to have an ED visit (1.67% vs. 4.21%, P = 0.040), but there was no significant difference in the percentage of patients with a hospital admission. Among patients with dyslipidemia, the mean MPR was significantly lower for the OPCS group than the usual care group (0.70 vs. 0.74, P = 0.003). There were no significant differences in the percentage of adherent patients or the change in mean MPR from baseline. However, the OPCS group was significantly less likely to discontinue dyslipidemia medications (21.1% vs. 35.4%, P less than 0.001) and more likely to have a timely fill (28.3% vs. 15.1%, P less than 0.001). The average days to first fill after the index date was 106.9 for the OPCS group, compared with 162.6 for the usual care group (P less than 0.001). The OPCS group had a lower mean LDL-C (105.1 vs. 110.4, P = 0.001) and a greater reduction in LDL-C (-30.5 vs. -22.4, P = 0.001) than the usual care group. There were no significant differences in the percentage of patients with an ED visit or a hospital admission. In terms of ROI, assuming that 58% of hospitalizations and 8.5% of ED visits incurred in the usual care group were avoidable, approximately $5.79 could be saved for every dollar spent on the OPCS program.  CONCLUSION: By engaging nonadherent patients to restart their DM or lipid medications during a face-to-face consult, the OPCS pharmacist was able to influence and improve medication adherence and clinical outcomes, particularly among patients with diabetes. A positive ROI was demonstrated.

Impact of a Medicare MTM program: evaluating clinical and economic outcomes.

OBJECTIVES: To assess the impact of a Medicare Medication Therapy Management (MTM) program in a large integrated health plan on patient mortality, hospitalization and emergency department (ED) utilization, and daily prescription costs. STUDY DESIGN: Retrospective matched cohort study. METHODS: Patients who received MTM services between 2006 and 2010 were matched to control patients who were enrolled in Medicare but did not receive MTM services. They were matched in a 1:4 ratio based on age, gender, geographic location, and prospective diagnostic-cost-group (DxCG) risk score. Multivariate regressions were used to analyze the outcomes. Subgroup analyses were conducted for patients enrolled in 2010 because the Centers for Medicare & Medicaid Services lowered the drug-cost threshold for MTM eligibility and changed from opt-in to optout participation. RESULTS: We identified 34,532 members who received MTM services and 138,128 control members. The MTM group was found to have a significantly reduced mortality (hazard ratio 0.86, 95% confidence interval [CI], 0.84-0.88; P <.001), lower odds for hospitalization (odds ratio [OR] = 0.97, 95% CI, 0.94-0.99; P = .018), higher odds for emergency department visits (OR = 1.17, 95% CI, 1.14-1.20; P <.001), and no differences in change in daily medication costs when compared to the matched group. The subgroup analysis of the 2010 cohort found similar results with better outcomes than the overall cohort. CONCLUSIONS: Medicare MTM services resulted in lower mortality and odds for hospitalization for enrolled patients compared with matched controls. This study observed an increase in ED visits and no differences in change in daily medication costs in MTM services.

Risk of injury associated with skeletal muscle relaxant use in older adults.

BACKGROUND: The use of skeletal muscle relaxants (SMRs) among older adults is associated with sedation and confusion, which may lead to an increased risk of falls and injuries. SMRs continue to be used among older adults, although they are on the Beers list as drugs to avoid in the elderly. OBJECTIVE: To investigate the relationship between SMR use and subsequent risk of injury. METHODS: This was a retrospective case-control study of members aged 65 years or older enrolled in an integrated health care system. Cases were defined as patients with a documented injury resulting in either a hospitalization or an emergency department or urgent care visit from January 2009 through December 2010. Cases were matched to controls in a 1:4 ratio by age and sex. Patients had to be enrolled and alive on the date of an injury (index date). SMR exposure for all cases and controls was evaluated within 60 days prior to the index date. Conditional logistic regression adjusted for covariates was performed, with risk estimates presented as odds ratios with 95% confidence intervals. RESULTS: From a base population of 322,806 older adults, we identified 27,974 cases of injury and 104,303 matched controls. Among the cases, 365 (1.30%) used an SMR; among the controls, 801 (0.77%) used an SMR in the 60 days prior to the index date. After adjustment for demographic and clinical covariates, risk of injury was significantly increased for patients using an SMR compared to no use (OR 1.32, 95% CI 1.16-1.50; p < 0.001). Carisoprodol was associated with an increased risk of injury (OR 1.73, 95% CI 1.04-2.88; p = 0.036), as were methocarbamol (OR 1.42, 95% CI 1.16-1.75; p = 0.001) and cyclobenzaprine (OR 1.22, 95% CI 1.02-1.45; p = 0.029). CONCLUSIONS: Older adults using SMRs have an increased risk of injury. These findings provide evidence to support current recommendations to avoid the use of SMRs in elderly patients.

Evaluation of clinical and safety outcomes associated with conversion from brand-name to generic tacrolimus in transplant recipients enrolled in an integrated health care system.

STUDY OBJECTIVE: To evaluate clinical and safety outcomes among transplant recipients whose tacrolimus was converted from the brand-name formulation to a generic formulation. DESIGN: Retrospective analysis. DATA SOURCE: Clinical databases and electronic records from a large, integrated health care system in California. PATIENTS: A total of 234 clinically stable, adult transplant recipients (renal, liver, and heart) whose tacrolimus was converted from the brand-name formulation to a generic formulation between October 1, 2010, and December 31, 2010, according to a physician-approved protocol. MEASUREMENTS AND MAIN RESULTS: For each patient, pre- and postconversion tacrolimus trough concentrations and serum creatinine concentrations were analyzed. Data were also collected on the percentage of patients who required dosage titration, drug cost savings, and rates of reversion to brand-name tacrolimus, biopsy-proved acute allograft rejections, and mortality. No significant differences were noted in mean ± SD pre- and postconversion tacrolimus trough levels (6.74 ± 1.61 vs 6.96 ± 2.31 ng/ml, p=0.137) or serum creatinine concentrations (1.33 ± 0.48 vs 1.36 ± 0.82 mg/dl, p=0.302). The mean ± SD percent change in tacrolimus trough concentration was 5.63 ± 32.95%. Thirty-six patients (15.4%) required dosage titration. Six patients (2.6%) reverted back to brand-name tacrolimus. No deaths or acute rejections occurred. Use of the generic product saved each patient an average of $45/month in drug acquisition cost and $26/prescription copayment. CONCLUSION: Clinical experience as well as research data show that use of generic tacrolimus results in trough concentrations that are comparable to the brand-name drug. Given the lack of adverse events reported and the cost savings recognized, conversion from brand-name tacrolimus to generic tacrolimus should be encouraged. Since dosage titration may be required, close therapeutic drug monitoring is recommended.

Evaluation of a pharmacist-managed amiodarone monitoring program.

BACKGROUND: Because of the potential for serious adverse effects, patients treated with amiodarone must be carefully screened and routinely monitored for potential liver, thyroid, and pulmonary toxicity. However, laboratory and pulmonary monitoring rates have been found to be substantially lower than recommended in guidelines, including those of the North American Society of Pacing and Electrophysiology (NASPE, 2007). OBJECTIVE: To (a) assess rates of laboratory monitoring of liver, thyroid, and pulmonary function and adverse events in a pharmacist-managed amiodarone monitoring program compared with usual care in an integrated health care system and (b) estimate return on investment (ROI) from this intervention. METHODS: This retrospective cohort study used clinic and enrollment data to identify those patients in the pharmacist-managed program and usual care who received at least 100 days of amiodarone therapy with the first prescription for amiodarone (index) from June 1, 2007, through May 31, 2009 (index date). Laboratory test monitoring was recorded at baseline (up to 6 months before the index date), from 1-6 months after the index date, 7-12 months after the index date, and at any time during the year (months 1-12). Alanine aminotransferase (ALT) was evaluated for liver function. Thyroid-stimulating hormone (TSH) and, for patients with abnormal TSH ( less than 0.4 micro international units [uIU] per mL or greater than 4.0 uIU per mL), free thyroxine (T4) were evaluated for thyroid function. Rates of pulmonary function testing (PFT) were measured by the diffusion capacity of carbon monoxide tests (DLCO) and annual chest x-rays (CXR); electrocardiograms were not counted. Monitoring rates were compared using Pearson chi-square tests, and logistic regression was used to compare the odds of testing (ALT, TSH, T4, CXR, PFT) between the 2 groups at any time during the year after the index date. Concomitant uses of amiodarone with high-dose statins and of amiodarone with digoxin were compared using Pearson chi-square tests. Hospitalizations and emergency room (ER) visits during the 12-month follow-up period were counted for (a) interstitial lung disease; (b) rhabdomyolysis for patients who received amiodarone with high-dose statins (either lovastatin greater than 40 mg per day or greater than 20 mg per day of simvastatin or atorvastatin); and (c) for patients with abnormal digoxin, ALT, TSH, or T4 levels, if the hospitalization occurred within 2 days of the abnormal laboratory value. RESULTS: There were 2,292 patients who received at least 100 days of amiodarone therapy and met the other inclusion criteria, of whom 181 patients (7.9%) were in the pharmacist-managed group and 2,111 received usual care. There were 90 (49.7%) new amiodarone users in the pharmacist-managed group and 990 (46.9%) in usual care. The 2 groups had similar demographic characteristics except race, with more whites and fewer African Americans, Asians, and Hispanics in usual care. Laboratory monitoring rates for ALT, TSH, and T4 were significantly higher in the pharmacist-managed group than usual care at the first and second 6 months and at baseline for ALT and TSH but not T4. Baseline CXR rates were significantly higher for the pharmacist-managed group than usual care (59.1% vs. 49.3%; P=0.011). Few patients in either group received PFT tests at baseline, 6.6% versus 3.6% (P=0.042). After controlling for covariates (age, gender, race, new vs. continuing use, and comorbidities), pharmacist-managed patients were significantly more likely to have at least 1 ALT test within the year after the index prescription (odds ratio [OR]=3.13, 95% CI=1.12-8.71), as well as a TSH test (OR=8.13, 95% CI=3.27-20.21) and T4 (OR=2.51, 95% CI=1.67-3.75). PFTs were also more likely to be given to these patients (OR=5.89, 95% CI=3.86-8.99). A higher percentage of patients in the pharmacist-managed group than in usual care were taking a high-dose statin during the 12-month follow-up period (47.5% vs. 36.2%, P=0.003), but of those patients, a greater proportion were switched to another statin (14.0% [n=12] vs. 7.5% [n=57], P=0.037) or a lower dose (9.3% [n=8] vs. 3.9% [n=30], P=0.022). Six patients in the usual care group (0.79% of patients on high-dose statins) developed rhabdomyolysis, and 5 (0.24% of all patients in usual care) had an admission for interstitial lung disease. The proportions of patients using amiodarone and digoxin concomitantly were similar in the 2 groups (35.9% vs. 31.3%, P=0.197). Among patients with abnormal laboratory results for ALT, TSH, and T4, or digoxin, there were 2 all-cause hospitalizations and 1 ER visit in the pharmacist-managed group and 34 all-cause hospitalizations and 18 ER visits in the usual care group during the follow-up year. Assuming that all hospitalizations and ER visits incurred in the usual care group were avoid- able, approximately $2.14 could be saved for every dollar spent on the pharmacist-managed amiodarone monitoring program. CONCLUSIONS: Pharmacist management of patients treated with amiodarone was associated with improved monitoring of recommended laboratory tests and PFTs.

Longitudinal study of new and prevalent use of self-monitoring of blood glucose.

OBJECTIVE: We sought to assess longitudinal association between self-monitoring of blood glucose (SMBG) and glycemic control in diabetic patients from an integrated health plan (Kaiser Permanente Northern California). RESEARCH DESIGN AND METHODS: Longitudinal analyses of glycemic control among 1) 16,091 patients initiating SMBG (new-user cohort) and 2) 15,347 ongoing users of SMBG (prevalent-user cohort). SMBG frequency was based on pharmacy use (number of blood glucose test strips dispensed), and glycemic control was based on HbA(1c) (A1C). In the new-user cohort, ANCOVA models (pre- and posttest design) were used to assess the effect of initiating SMBG. In the prevalent-user cohort, repeated-measure, mixed-effects models with random-intercept and time-dependent covariates were used to assess changes in SMBG and A1C. All models were stratified by therapy (no medications, oral agents only, or insulin) and adjusted for baseline A1C, sociodemographics, insulin injection frequency, comorbidity index, medication adherence, smoking status, health care use, and provider specialty. RESULTS: Greater SMBG practice frequency among new users was associated with a graded decrease in A1C (relative to nonusers) regardless of diabetes therapy (P < 0.0001). Changes in SMBG frequency among prevalent users were associated with an inverse graded change in A1C only among pharmacologically treated patients (P < 0.0001). CONCLUSIONS: These observational findings are consistent with short-term benefits of initiating SMBG practice for all patients but continuing benefits only for pharmacologically treated patients. Differences in effectiveness between new versus prevalent users of SMBG have implications for guideline development and interpretation of observational outcomes data.