Candice L. Garwood

Diabetes Medications Related to an Increased Risk of Falls and Fall-Related Morbidity in the Elderly

Objective To review literature regarding the effect of diabetes medications as a contributing risk for falls and fall-related morbidity in elderly patients with type 2 diabetes. Data sources Primary literature was identified through PubMed MEDLINE (1966–November 2009) using the search terms elderly, aged, older adults, diabetes type 2, diabetes mellitus, falls, fractures, medication, hypoglycemia, and vitamin B12 deficiency. Each drug class and the individual agents within the classes were also included in the search. Additional references were obtained through review of references from articles obtained. Study selection and data extraction Clinical studies evaluating diabetes medications and their association with falls, as well as studies evaluating their association with the complications of falls, were considered for inclusion. Selection emphasis was placed on randomized studies evaluating diabetes medications and falls. Data synthesis There is no direct link between metformin and falls; however, an indirect association caused by neuropathy secondary to vitamin B12 deficiency may be of concern. Although hypoglycemia is a risk factor, to date, there are no trials specifically linking insulin secretagogues to falls. Insulin use has been demonstrated to increase the risk of falls in the elderly. Thiazolidinediones increase fracture risk and thus may worsen fall-related outcomes. There are no studies to date linking other agents to an increased risk of falls. Conclusions Special considerations should be made when treating elderly patients with diabetes. At this time, a patients functional level and risk factors for falls should weigh into decision-making regarding drug selection. The risk of falls and fall-related complications associated with diabetes medications should not be ignored.

Use of Anticoagulation in Elderly Patients with Atrial Fibrillation Who Are at Risk for Falls

OBJECTIVE: To evaluate data addressing use of anticoagulation in elderly patients with atrial fibrillation (AF), in particular those at risk of falls. DATA SOURCES: Primary literature was identified through PubMed MEDLINE (1966–December 2007) and EMBASE (1980–December 2007) using the search terms anticoagulation, warfarin, aspirin, elderly, falls, older persons, atrial fibrillation, bleeding, education, stroke, and use. Additional references were obtained through review of references from articles obtained. STUDY SELECTION AND DATA EXTRACTION: Clinical studies evaluating warfarin and aspirin efficacy in AF, as well as studies evaluating anticoagulation and falls, elderly patients, and bleeding were considered for inclusion. Selection emphasis was placed on randomized studies of AF and those evaluating anticoagulation and falls. DATA SYNTHESIS: Uncertainties over the optimal treatment for elderly patients with AF still exist. Variance in the guidelines is reflected in current practice, as some discrepancies are present. Warfarin is underprescribed in elderly patients, with only about 50% of eligible patients receiving therapy. Falls are most often cited as the reason for not using anticoagulants in an elderly patient. Three risk–benefit analyses have been performed, and all found that despite risks associated with warfarin, its benefits outweigh its risks even in patients who fall. Warfarin should be used rather than aspirin or no therapy in elderly patients at risk of falls. Anticoagulation education has been shown to reduce the risk of bleeding in the elderly and should be a vital part of warfarin management. CONCLUSIONS: The risk of falls alone should not automatically disqualify a person from being treated with warfarin. While falls should not dictate anticoagulant choice, assessment and management of fall risk should be an important part of anticoagulation management. Efforts should be made to minimize fall risk.

Quality of anticoagulation care in patients discharged from a pharmacist-managed anticoagulation clinic after stabilization of warfarin therapy.

Study Objective. To determine if transitioning patients from a pharmacist‐managed anticoagulation clinic after stabilization of warfarin therapy to physician‐managed care alters the quality of anticoagulation care.

An Objective Structured Clinical Examination to Assess Problem-Based Learning

Objectives. To compare pharmacy students’ performance on an objective structured clinical examination (OSCE) to their performance on a written examination for the assessment of problem-based learning (PBL); and to determine students’ and faculty members’ perceptions of OSCEs for PBL evaluations. Design. Four OSCEs were added to the written examination to assess 4 PBL cases in a third-year pharmacotherapy course. OSCE scores were compared to written examination scores. Faculty members evaluated student performance. Assessment. OSCE performance did not correlate with the written-examination scores. Most students (≥ 75%) agreed that OSCEs reflected their learning from PBL and measured knowledge, communication, and clinical skills. A majority of faculty members (≥75%) agreed that OSCEs should be part of PBL assessment. Conclusions. Addition of an OSCE to written examinations was valued and provided a more comprehensive assessment of the PBL experience.

Clinical Pharmacists as Key Members of the Patient-Centered Medical Home: An Opinion Statement of the Ambulatory Care Practice and Research Network of the American College of Clinical Pharmacy

The American College of Clinical Pharmacy (ACCP) Ambulatory Care Practice Research Network (PRN) considers the role of clinical pharmacists to be fundamental to the success of the Patient‐Centered Medical Home (PCMH) model. Within the PCMH, pharmacists can improve the health of populations by participating in activities that optimize medication management. Multiple published articles support clinical pharmacist involvement in the PCMH with regard to promotion of team‐based care, enhanced access, care coordination, and improved quality and safety of care. A survey of clinical pharmacist members of ACCP who operate in such a model depict a variety of activities, with some members pioneering new and innovative ways to practice clinical pharmacy. Although this is a significant opportunity for pharmacists in the primary care setting, a unified vision of pharmacy services is needed. It is our hope that with continued efforts focused on obtaining national provider status, clinical pharmacy can use the PCMH model to solidify the future of primary care pharmacy. The following is an opinion statement of the ACCP Ambulatory Care PRN regarding the vital role of clinical pharmacists in the PCMH.

Successful use of fondaparinux in a patient with a mechanical heart valve replacement and a history of heparin-induced thrombocytopenia

The development of heparin-induced thrombocytopenia (HIT) is an antibody-mediated clinicopathologic syndrome. The resultant thrombocytopenia and thrombosis can be severe and life-threatening. Fondaparinux is a parenteral factor Xa inhibitor used for venous thromboembolism prevention and treatment. Fondaparinux has minimal affinity for platelet factor 4, making it an alternative agent to unfractionated heparin (UFH) and low-molecular weight heparin (LMWH) and a plausible consideration for patients with a history of HIT. The use of fondaparinux in patients with mechanical heart valve replacement and a history of HIT has never been discussed in the literature. We report on the case of a patient with a mechanical aortic heart valve replacement and a history of HIT who was successfully bridged postoperatively with fondaparinux. While there is currently no literature to support the use of fondaparinux in patients with mechanical heart valves, this drug may offer an option for management of such patients who cannot use heparin products. However, further clinical investigations are warranted to confirm both the safety and efficacy of this agent in the mechanical heart valve population.

The effect of cognitive impairment in the elderly on the initial and long-term stability of warfarin therapy.

AbstractBackground: Despite guidelines that clearly outline the benefits of warfarin, it remains underutilized. Various reasons are associated with the underuse of warfarin; however, cognitive impairment (CI) has been identified as one of the most common causes for not electing to anticoagulate elderly patients with atrial fibrillation. Nevertheless, there are limited data on warfarin use in such patients; therefore, we investigated anticoagulation stability in patients with and without CI. Objectives: Our objectives were to (i) examine if mild to moderate CI delayed the time required to achieve initial therapeutic anticoagulation; (ii) determine if mild to moderate CI was associated with long-term anticoagulation instability; and (iii) assess if initial anticoagulation problems predicted long-term anticoagulation instability. Methods: A retrospective study in a pharmacist-managed anticoagulation clinic was conducted in community-dwelling patients ≥60 years of age on warfarin therapy with a target international normalized ratio (INR) of 2.0–3.0. Our study included 57 patients; 20 were initiated on warfarin and 54 were analysed for long-term anticoagulation stability. Age, ethnicity, gender, warfarin indication, co-morbidities and caregiver involvement were recorded. We defined CI as having a Mini-Mental State Examination (MMSE) score of ≤26. To evaluate initial anticoagulation stability between groups, we analysed (i) number of clinic visits and days to achieve therapeutic INR; and (ii) minor and major adverse events upon initiation of warfarin. To evaluate long-term anticoagulation stability, we analysed (i) time in therapeutic range (TTR); (ii) the percentage of clinic visits with a reported dose mishap and the frequency of out-of-range INRs resulting from dose mishaps; and (iii) parameters associated with the intensity of clinic management: weekly warfarin dose changes, transient dose adjustments, any dose manipulation and the length of time between clinic visits. Results: We found no difference in the number (mean±SD) of visits (control = 5.8±4.3, CI = 4.6±2.4; p = 0.44) or days (control = 51.6±45.7, CI = 35.8±30.5; p = 0.36) required to achieve initial therapeutic anticoagulation. No adverse effects were reported in either group. In terms of long-term stability, TTR (mean±SD) was similar for both groups (control = 65±20% vs CI = 61±16%; p = 0.36). Although the proportion of dose mishaps did not differ (control = 74 in 705 visits, CI = 86 in 691 visits; p = 0.18), dose mishaps resulted in a greater frequency of out-of-range INRs for patients with CI (p = 0.01). There were no differences in clinic management measures between groups (p = not statistically significant [NS] for all). Finally, we found no correlation between the time to reach initial anticoagulation stability and long-term stability for either group (p = NS for all). Conclusion: We found mild to moderate CI neither delayed the time required to achieve therapeutic anticoagulation, nor decreased anticoagulation stability versus patients with normal cognitive function. Additionally, CI did not require more intensive clinic management. CI should not necessarily be a barrier to the use of warfarin anticoagulation in elderly patients attending an anticoagulation clinic.

Drug-Related-Problem Outcomes and Program Satisfaction from a Comprehensive Brown Bag Medication Review

To classify and quantify drug‐related problems (DRPs), determine acceptance of DRP recommendations, and assess medication review satisfaction.

Increased Thyroid‐Stimulating Hormone Levels Associated with Concomitant Administration of Levothyroxine and Raloxifene

A 47‐year‐old Caucasian woman had a 3.5‐year history of primary hypothyroidism treated with levothyroxine. Her levothyroxine dosage of 0.05 mg/day had been stable for the past 15 months. She was then prescribed raloxifene for prevention of osteoporosis secondary to early menopause. During the next 30 months, her levothyroxine dosage had to be gradually increased. The patient had been taking levothyroxine and raloxifene at the same time each day on an empty stomach. During the months of her levothyroxine dosage changes, however, she separated administration of levothyroxine and raloxifene by 12 hours; the patient then became hyperthyroid. Eventually, her levothyroxine needs decreased, and she returned to the same levothyroxine dosage she had taken before separating administration of the two drugs. These findings suggest that raloxifene decreased the absorption of levothyroxine when the two agents were coadministered. Assessment of causality using the Naranjo adverse drug reaction probability scale resulted in a possible association for this adverse event. Another published case report provides findings similar to our patients experience. The possibility of a malabsorption interaction between levothyroxine and raloxifene is significant, as hypothyroidism is common among postmenopausal women—the same population that is the target of osteoporosis therapy with agents such as raloxifene. The mechanism by which raloxifene decreases levothyroxine absorption is unknown. Further investigation of this potential interaction is warranted. Until then, clinicians should be alert to the potential for an interaction between raloxifene and levothyroxine.

Striking a Balance Between the Risks and Benefits of Anticoagulation Bridge Therapy in Patients with Atrial Fibrillation: Clinical Updates and Remaining Controversies

Long‐term anticoagulation with a vitamin K antagonist (VKA) or the new agent dabigatran is recommended to decrease stroke risk in patients with atrial fibrillation. When patients with atrial fibrillation undergo initiation or interruption of VKA therapy, or experience an isolated subtherapeutic international normalized ratio (INR), bridge therapy with a parenteral anticoagulant may be considered. To describe the literature for anticoagulation bridge therapy in patients with atrial fibrillation, we conducted a MEDLINE search (1966–February 2011) of the English‐language literature to identify related studies. Ongoing clinical trials were identified through a search of the ClinicalTrials.gov registry. Major national and international guidelines were gathered and evaluated. Additional literature was obtained through review of relevant references of the identified articles. Bridging is not supported by guidelines or clinical trials for patients starting VKA therapy for atrial fibrillation. A subtherapeutic INR value during long‐term VKA therapy may be associated with increased thromboembolic events, but the benefit of bridging has not been demonstrated. When VKA therapy is interrupted for procedures, retrospective and cohort data suggest that the decision to bridge should be based on a patients thromboembolic and bleeding risks associated with the procedure. Typically, it is recommended to use bridge therapy in patients with atrial fibrillation at high risk for thromboembolism, but the benefit of bridging is less clear in patients at low risk. Not all procedures necessitate anticoagulation interruption. Recent trials suggest that VKAs can be continued when patients are undergoing cardiac device procedures and some types of radiofrequency ablation. Several clinical trials are ongoing that will provide more definitive guidance for perioperative anticoagulation management of patients with atrial fibrillation. Patients taking dabigatran are unlikely to require bridge therapy because of a predictable anticoagulant effect and rapid onset of action. However, evidence for optimal perioperative management of dabigatran is needed.