Joseph P. Vande Griend

Effects of Testosterone and Progressive Resistance Exercise in Healthy, Highly Functioning Older Men With Low-Normal Testosterone Levels

CONTEXT Aging in men is associated with reduced testosterone (T) levels and physiological changes leading to frailty, but the benefits of T supplementation are inconclusive. OBJECTIVE We studied the effects of T supplementation with and without progressive resistance training (PRT) on functional performance, strength, and body composition. DESIGN, SETTING, AND PARTICIPANTS We recruited 167 generally healthy community-dwelling older men (66 ± 5 years) with low-normal baseline total T levels (200-350 ng/dL). INTERVENTION Subjects were randomized to placebo or transdermal T gel [2 doses targeting either a lower (400-550 ng/dL) or higher (600-1000 ng/dL) T range] and to either PRT or no exercise for 12 months. MAIN OUTCOME MEASURE The primary outcome was functional performance, whereas secondary outcomes were strength and body composition. RESULTS A total of 143 men completed the study. At 12 months, total T was 528 ± 287 ng/dL in subjects receiving any T and 287 ± 65 ng/dL in the placebo group. In the PRT group, function and strength were not different between T- and placebo-treated subjects, despite greater improvements in fat mass (P = .04) and fat-free mass (P = .01) with T. In the non-PRT group, T did not improve function but improved fat mass (P = .005), fat-free mass (P = .03), and upper body strength (P = .03) compared with placebo. There were fewer cardiovascular events in the T-treated groups compared with placebo. CONCLUSIONS T supplementation was well tolerated and improved body composition but had no effect on functional performance. T supplementation improved upper body strength only in nonexercisers compared with placebo.

Patient-Level Medication Regimen Complexity Across Populations With Chronic Disease

BACKGROUND Expected treatment effectiveness from medications can be diminished due to suboptimal adherence. Medication nonadherence has been linked to pill burden from the quantity of medications; however, medication regimens with similar quantities of medications vary in complexity due to multiple dosage forms, frequency of dosing, and additional usage directions. Thus, a simple medication count ignores medication regimen complexity, especially as it pertains to a patient-level perspective that includes prescription and over-the-counter medications. A gap exists in the study of a patient-level medication regimen complexity metric across disease-specific populations. OBJECTIVE The goal of this study was to implement the quantitative Medication Regimen Complexity Index (MRCI) at the patient level in defined populations with chronic disease (geriatric depression, HIV, diabetes mellitus, and hypertension). Patient-level medication regimen complexity included all prescribed medications and over-the-counter medications documented in the electronic medication list. METHODS Using electronic medical records at the University of Colorado Hospital ambulatory clinics, we sampled 4 retrospective cohorts of adult patients in active care in 2011 with a qualifying medical diagnosis and prescribed disease-specific medication. Samples were randomly selected from all qualifying patients; de-identified information was coded using the MRCI. RESULTS Cohort-defining disease-specific prescription medications (eg, antidepressants for the depression-defined cohort) contributed <20% to the total patient-level complexity MRCI score; the MRCI score was dominated by complexity associated with all other prescription medications. Within disease-specific cohorts, MRCI scores differentiated patients with the highest and lowest medication counts, comorbidity counts, and the Charlson comorbidity index scores. For example, geriatric depression patients had a highest quartile mean MRCI score of 41 and a lowest quartile mean MRCI score of 13. Between disease-specific cohorts, high and low MRCI scores differed because each cohort had its own MRCI ranges. For example, highest quartile MRCI scores varied from a mean MRCI score of 41 (geriatric depression) to 30 (hypertension); lowest quartile scores ranged from a mean MRCI score of 7 (hypertension and HIV) to 13 (geriatric depression). CONCLUSIONS MRCI components of dosing frequency and prescribed medications outside of the cohort-defining disease medications contributed the most to the patient-level scores. Thus, chronic disease management programs may want to consider all medications that patients are taking and examine ways to reduce complexity, such as reducing multiple dosing frequencies when possible. MRCI scores differentiated high and low patient-level complexity measures, representing possible utility as a prospective tool to identify target patients for intervention. Future work includes simplifying the MRCI and enhancing the scores with medication risk factors, as well as explicitly linking to adherence and health services.

FDA drug safety communications: a narrative review and clinical considerations for older adults.

BACKGROUND The US Food and Drug Administration (FDA) has new regulatory authorities intended to enhance drug safety monitoring in the postmarketing period. This has resulted in an increase in communication from the FDA in recent years about the safety profile of certain drugs. It is important to stay abreast of the current literature on drug risks to effectively communicate these risks to patients, other health care providers, and the general public. OBJECTIVE To summarize 4 new FDA drug safety communications by describing the evidence supporting the risks and the clinical implications for older adults. METHODS The FDA Web site was reviewed for new drug safety communications from May 2011 to April 2012 that would be relevant to older adults. Approved labeling for each drug or class was obtained from the manufacturer, and PubMed was searched for primary literature that supported the drug safety concern. RESULTS FDA drug safety communications for 4 drugs were chosen because of the potential clinical importance in older adults. A warning for citalopram was made because of potential problems with QT prolongation in patients taking less than 40 mg per day. The evidence suggests minor changes in QT interval. Given the flat dose-response curve in treating depression with citalopram, the new 20-mg/d maximum dose in older adults is sensible. Another warning was made for proton pump inhibitors (PPIs) and an increased risk of Clostridium difficile infection. A dose-response relationship was found for this drug risk. With C. difficile infections on the rise in older adults, along with other safety risks of PPI therapy, PPIs should only be used in older adults indicated for therapy for the shortest duration possible. In addition, a warning about dabigatran was made. There is strong evidence from a large clinical trial, as well as case reports, of increased bleeding risk in older adults taking dabigatran, especially in older adults with decreased renal function. This medication should be used with caution in older adults. Finally, several warnings were made about statins. Routine periodic monitoring of liver enzymes does not appear to be effective in detecting or preventing serious liver injury from statin use; thus, liver enzymes are no longer recommended to be routinely monitored. Statin-induced cognitive changes are rare, and insufficient evidence is currently available to establish causality. Statins appear to moderately increase the risk of developing diabetes (versus placebo), and regular screening for diabetes should be considered, especially for patients taking high-dose statins and patients with multiple risk factors for diabetes. CONCLUSION FDA drug safety communications incorporate complex methodologies that investigate the risks (and relative benefits) of medication therapy. Clinicians caring for older adults need to be aware of the most current evidence behind these drug risks to effectively communicate with and care for their patients.

Histamine-1 receptor antagonism for treatment of insomnia

OBJECTIVES To evaluate the literature regarding the use of histamine-1 (H(1)) receptor antagonists and to describe their role in the treatment of insomnia in adult patients, including the elderly. DATA SOURCES Literature was identified via PubMed and Medline through April 1, 2012, using the search terms insomnia and sleep, each individually combined with histamine antagonist, tricyclic antidepressant, trazodone, mirtazapine, doxepin, amitriptyline, nortriptyline, trimipramine, doxylamine, diphenhydramine, and antihistamine. STUDY SELECTION AND DATA EXTRACTION Data included randomized double-blind trials that statistically evaluated H(1) receptor antagonist treatment in patients with insomnia compared with a placebo control or Food and Drug Administration-approved insomnia treatment. Trials selected evaluated sleep latency, wake after sleep onset, total sleep time, number of awakenings, and/or sleep efficiency in a subjective or objective manner. A total of 65 trials were evaluated, and 16 met inclusion criteria. DATA SYNTHESIS With the exception of low-dose doxepin (Silenor-Somaxon), trials evaluating the clinical effectiveness of H(1) receptor antagonists show mixed results and are limited by sample size and generalizability. Large, randomized, appropriately controlled trials are lacking, making it difficult to define the safety and efficacy of these agents. In contrast, low-dose doxepin has been shown to provide consistent sleep benefit compared with placebo. CONCLUSION Over-the-counter antihistamines may have a role for short-term insomnia treatment in younger adults, but tolerance develops rapidly. Mirtazapine should not be used solely for the treatment of insomnia. Sedating antidepressants can be considered after failure of first-line insomnia treatments. Patients taking these agents chronically should be evaluated for continued efficacy and potential harm. Low-dose doxepin may have a unique role in the treatment of insomnia in elderly patients given its tolerability, documented efficacy, and lack of important adverse effects.

Implementation of a Clinical Pharmacy Specialist-Managed Telephonic Hospital Discharge Follow-Up Program in a Patient-Centered Medical Home

The objectives of this retrospective study were to examine the feasibility and characteristics that define successful implementation of a Clinical Pharmacy Specialist (CPS) telephonic hospital discharge follow-up quality improvement initiative, as well as the impact of this initiative. Adult patients who were discharged from a safety-net hospital between July 1, 2010 and June 30, 2011 and who were part of a patient-centered medical home were included in this quality improvement initiative. CPSs attempted to contact 470 patients; of those, 207 received the intervention and 263 did not. Patients in the contacted group were more likely to attend a hospital discharge follow-up appointment (66.2% vs. 44.5%, P<0.01) and had lower rates of 30-day readmission (22 vs. 52, P<0.01) compared to those who were not contacted. Institutions should consider allocating resources for pharmacist-managed posthospital discharge follow-up services because of the potential for positive clinical and financial impact.

Patient-level Medication Regimen Complexity in Older Adults With Depression

PURPOSE Polypharmacy and medication adherence are well known challenges facing older adults. Medication regimen complexity increases the demands of self-care in the home. Some medication regimens may be more complex than others, especially when dosage form, frequency of dosing, and additional usage directions are included in complexity along with the number of medications In older adults with depression, it is unknown what features of their medications most influence their medication regimen complexity. METHODS A sample cohort of 100 adults ≥65 years old with a diagnosis of depression was randomly selected from electronic medical records (EMR) in ambulatory clinics at the University of Colorado (CU) and University of San Diego (SD). Demographic, medical history, and medication-related information was extracted from the EMR. Complexity was determined using the Medication Regimen Complexity Index (MRCI). IRB approval was obtained. FINDINGS The cohort mean age was 74.3 years (SD) and 79.7 years (CU). The mean unweighted Charlson comorbidity index for 1.0 (SD) and 1.8 (CU). The mean number of medications was 7.1 and 8.0, with 1.1 and 1.2 depression meds, 5.4 and 4.3 non-depression prescription meds, and 0.6 and 2.4 OTC meds for the SD and CU cohorts, respectively. 66% of SD adults and 70% of CU adults took six or more meds. Individual MRCI scores were on average 17.62 (SD) and 19.36 (CU). Dosing frequency contributed to 57-58% of the MRCI score, with patients facing an average of 7-8 unique dosing frequencies in their regimen. In both cohorts, there was an average of 3 additional directions added to the regimens to clarify dosing. IMPLICATIONS As expected, in our older adult cohorts with depression the majority of patients took multiple medications. Using a standardized instrument, we characterized the regimen complexity and found that it was increasingly complex due to numerous dosing forms, frequencies and additional directions for use. Patient-level medication regimen complexity should go beyond depression medication to encompass the patients entire regimen for opportunities to reduce complexity and improve ease of self-care.

Prioritization of Patients for Comprehensive Medication Review By a Clinical Pharmacist in Family Medicine

Background: This pilot study describes and evaluates the clinical pharmacy priority (CP2) score. We hypothesize that patients with high CP2 scores are more likely to receive a medication recommendation after comprehensive medication review (CMR) than patients with lower scores. Prioritization of patients for CMR by a clinical pharmacist in family medicine could enhance the provision of interprofessional care within the patient-centered medical home. Methods: The CP2 score was developed collaboratively by the research team and is derived from 11 patient-specific factors extracted from the electronic health record. To evaluate the utility of the score, CMR was performed prospectively by a clinical pharmacist for patients with appointments between October 1 and December 31, 2012, at 2 University of Colorado family medicine clinics. Results: CMR was performed for 1107 patient appointments. Of these, 101 were identified as having received a medication recommendation from the clinical pharmacist. For patients with a CP2 score of 0 to 2, 2 of 588 charts (0.3%) reviewed received a recommendation (level 1). The proportion increased to 37 of 358 (10.3%) for scores of 3 to 7 (level 2), 40 of 119 (33.6%) for scores of 8 to 10 (level 3), and 22 of 42 (52.4%) for scores of ≥11 (level 4). Compared with CP2 scores in level 1, patient appointments were more likely to receive a medication recommendation after CMR in level 2 (relative risk [RR], 30.4; 95% confidence interval [CI], 7.4–125.3), in level 3 (RR, 98.8; 95% CI, 24.2–403.3), and in level 4 (RR, 154; 95% CI, 37.5–632.8). Conclusions: Patients with higher CP2 scores were more likely to receive a medication recommendation after CMR by a clinical pharmacist than patients with lower scores. The CP2 score could be used by clinical pharmacists in family medicine to enhance the efficient and effective delivery of interprofessional care.

A year in review: new drugs for older adults in 2011.

BACKGROUND New drugs approved by the Food and Drug Administration (FDA) may offer tremendous clinical advances by providing health care providers with new treatment strategies. However, additional care must be taken for safe and effective use of these new agents by older adults. OBJECTIVE Our objective was to identify FDA-approved medications in 2011 most likely to be prescribed to older adults, and to describe medication characteristics that may require special attention in this population. METHODS The FDA Web site was reviewed for new drug approvals from January through December 2011. Approved labeling for each drug was obtained from the manufacturers Web site and PubMed was searched for primary literature published between 1967 and 2012. RESULTS Rivaroxaban, an oral factor Xa inhibitor, is approved for once-daily use in treatment of nonvalvular atrial fibrillation and deep vein thrombosis prophylaxis after replacement of a hip or knee. Drug interactions and renal function must be considered when prescribing this drug to older adults. Fidaxomicin is an oral anti-infective approved for the treatment of Clostridium difficile-associated diarrhea. It has minimal oral absorption or side effects, no relevant drug interactions, but a very high cost. It is a treatment option after failure of oral metronidazole and oral vancomycin. Roflumilast is a selective inhibitor of phosphodiesterase 4 and is approved to reduce the risk of chronic obstructive pulmonary disease (COPD) exacerbations in patients with severe COPD and a history of exacerbations. It is recommended as a second or alternative choice combined with a long-acting bronchodilator in patients at high risk for hospitalization. Indacaterol is an inhaled long-acting β-agonist approved for COPD maintenance. It is administered once daily, which may improve adherence in older adults compared with currently available twice-daily agents. CONCLUSIONS Four new drugs approved in 2011 applicable to the geriatric population are presented. Clinicians must consider the available evidence, cost, drug-drug interactions, renal function, pharmacokinetic/pharmacodynamic differences, and patient preferences when considering prescribing these agents to older adults.

Effect of an Advanced Pharmacy Practice Experience on Medication Therapy Management Services in a Centralized Retail Pharmacy Program

BACKGROUND Medication therapy management (MTM) delivery is increasingly important in managed care. Successful delivery positively affects patient health and improves Centers for Medicare & Medicaid Services star ratings, a measure of health plan quality. As MTM services continue to grow, there is an increased need for efficient and effective care models. The primary objectives of this project were to describe the delivery of MTM services by fourth-year Advanced Pharmacy Practice Experience (APPE) students in a centralized retail pharmacy system and to evaluate and quantify the clinical and financial contributions of the students. The secondary objective was to describe the engagement needed to complete comprehensive medication reviews (CMRs) and targeted interventions. PROGRAM DESCRIPTION From May 2015 to December 2015, thirty-five APPE students from the University of Colorado Skaggs School of Pharmacy provided MTM services at Albertsons Companies using the OutcomesMTM and Mirixa platforms. Students delivered patient care services by phone at the central office and provided face-to-face visits at pharmacies in the region. With implementation of the MTM APPE in 2015, the team consisted of 2 MTM pharmacists and pharmacy students, as compared with 1 MTM pharmacist in 2014. The number of CMRs and targeted interventions completed and the estimated additional revenue generated during the 2015 time period were compared with those completed from May through December 2014. The patient and provider engagement needed to complete the CMRs and targeted interventions was summarized. OBSERVATIONS 125 CMRs and 1,918 targeted interventions were billed in 2015, compared with 13 CMRs and 767 targeted interventions in 2014. An estimated

Assessment of blood pressure in patients with hypertension aged 60–79 years before and after the publication of the 2014 Eighth Joint National Committee report

16,575-