Essential factors demonstrating readiness of primary care practices for clinical pharmacy services.

PURPOSE: The characteristics of primary care practices that are necessary to establish and maintain ambulatory care clinical pharmacy services were identified. METHODS: A focus group of 15 ambulatory care pharmacists in Western North Carolina developed a survey of 26 practice readiness statements pertaining to the development of clinical pharmacy services in primary care. National ambulatory care pharmacy experts were then surveyed using a modified Delphi model for consensus building to determine which items were essential. Four rounds of surveys were completed. After each round, statements were accepted as consensus, modified, or removed from the survey based on responses. Statements were deemed to have reached consensus when 80% of respondents were in agreement. RESULTS: A total of 6 statements reached agreement after 4 rounds of survey: (1) full integration into the team, (2) access to the electronic health record (EHR), (3) a physician or administrative champion, (4) appropriate equipment provided by the clinic, (5) a private room to see patients, and (6) a practice that is open to team-based care. CONCLUSION: An expert panel of ambulatory care pharmacists identified 6 factors that should be considered prior to establishing ambulatory care services in primary care practices. Of these, foundational elements included full integration into the care team, presence of a physician or administrative champion, and a practice that is ready for team-based care. Operational elements included access to the practice's EHR, equipment provided by the practice, and private space to see patients.

Development of a targeted naloxone coprescribing program in a primary care practice.

OBJECTIVES: To develop a targeted naloxone coprescribing program in a primary care practice. SETTING: Large academic family medicine practice in western North Carolina. PRACTICE DESCRIPTION: A robust pain management program was developed at this institution in 2012 which incorporated many of the recommendations later outlined in the 2016 Centers for Disease Control and Prevention (CDC) guidelines for prescribing opioids for chronic pain. The only guideline-recommended initiative that was not addressed involves providing naloxone to patients on chronic opioid therapy at high risk for opioid overdose. PRACTICE INNOVATION: Pharmacists embedded in this practice developed a targeted naloxone coprescribing program for patients who are on chronic opioid therapy and have doses of 50 mg or more morphine equivalents daily (MED), are taking benzodiazepines, have a history of substance use disorder, or have a history of overdose. EVALUATION: A retrospective chart review was conducted to determine the number of patients on chronic opioid therapy who meet the CDC guidelines for offering naloxone. RESULTS: A total of 1297 patients were identified, and 709 met the criteria for chronic opioid use. Nearly one-half (n = 350; 49.4%) of these patients met the criteria for naloxone, although only 3.4% had naloxone on their medication list. Doses of 50 mg or more MED was the primary reason for needing naloxone (n = 216; 61%) with concomitant benzodiazepine use as the second most likely reason (n = 130; 37.1%). For patients taking 50 mg or more MED, 37.5% were also on a benzodiazepine and 4.1% also had a history of substance use disorder. CONCLUSION: Pharmacists embedded in a primary care practice are well poised to develop a targeted naloxone coprescribing program to increase patients' access to naloxone.

Pharmacist managed diabetes and cardiovascular risk reduction clinic in kidney transplant recipients: bridging the gap in care transition.

The purpose was to assess the feasibility of a care transition intervention for kidney transplant recipients (KTRs) with diabetes. Results document improved quality indicators and reduced resource utilization. These findings imply that a care transition intervention for KTRs with diabetes is feasible and associated with improved patient outcomes.

Foot ulcer risk is lower in South-Asian and african-Caribbean compared with European diabetic patients in the U.K.: the North-West diabetes foot care study.

OBJECTIVE: To determine 1) foot ulcer rates for European, South-Asian, and African-Caribbean diabetic patients in the U.K and 2) the contribution of neuropathy and peripheral arterial disease (PAD) differences to altered ulcer risk between the groups. RESEARCH DESIGN AND METHODS: In this U.K. population-based study, we screened 15,692 type 1 and type 2 diabetic patients in the community health care setting for foot ulcers, foot deformities, neuropathy, and PAD plus other characteristics. In total, 13,409 were European (85.5%), 1,866 were South Asian (11.9%), and 371 were African Caribbean (2.4%). RESULTS: The age-adjusted prevalence of diabetic foot ulcers (past or present) for Europeans, South Asians, and African Caribbeans was 5.5, 1.8, and 2.7%, respectively (P < 0.0001). Asians and African Caribbeans had less neuropathy, PAD, and foot deformities than Europeans (P = 0.003). The unadjusted risk of ulcer (odds ratio [OR]) for Asians versus Europeans was 0.29 (95% CI 0.20-0.41) (P < 0.0001). PAD, neuropathy, foot deformities, and insulin use attenuated the age-adjusted OR from 0.32 to 0.52 (0.35-0.76) (P < 0.0001). African-Caribbean versus European ulcer risk in males was attenuated from 0.60 to 0.71 by vibration sensation. CONCLUSIONS: South Asians with diabetes in the U.K. have about one-third the risk of foot ulcers of Europeans. The lower levels of PAD, neuropathy, insulin usage, and foot deformities of the Asians account for approximately half of this reduced foot ulcer risk. Lower neuropathy is the main contributor to the reduced African-Caribbean ulcer rate, particularly in men. The reasons for these ethnic differences warrant further investigation.

Design and synthesis of highly potent and selective (2-arylcarbamoyl-phenoxy)-acetic acid inhibitors of aldose reductase for treatment of chronic diabetic complications.

Recent efforts to identify treatments for chronic diabetic complications have resulted in the discovery of a novel series of highly potent and selective (2-arylcarbamoyl-phenoxy)-acetic acid aldose reductase inhibitors. The compound class features a core template that utilizes an intramolecular hydrogen bond to position the key structural elements of the pharmacophore in a conformation, which promotes a high binding affinity. The lead candidate, example 40, 5-fluoro-2-(4-bromo-2-fluoro-benzylthiocarbamoyl)-phenoxyacetic acid, inhibits aldose reductase with an IC(50) of 30 nM, while being 1100 times less active against aldehyde reductase, a related enzyme involved in the detoxification of reactive aldehydes. In addition, example 40 lowers nerve sorbitol levels with an ED(50) of 31 mg/kg/d po in the 4-day STZ-induced diabetic rat model.

Muscle weakness and foot deformities in diabetes: relationship to neuropathy and foot ulceration in caucasian diabetic men.

OBJECTIVE: To examine the relationships among muscle weakness, foot deformities, and peroneal and tibial nerve conduction velocity in diabetic and nondiabetic men. RESEARCH DESIGN AND METHODS: A neuropathic and foot evaluation was undertaken in 10 nondiabetic control subjects (group C) and in 36 consecutive diabetic patients attending Diabetes Centre clinics, including 10 diabetic control subjects (group D), 15 diabetic neuropathic patients (group DN), and 11 diabetic patients with a history of ulceration (group DU). Neuropathy was defined as a peroneal motor nerve conduction <40 m/s. Muscle weakness was assessed in seven intrinsic and seven extrinsic muscles of the foot using a semiquantitative score (max score per muscle = 3). Foot deformities were assessed using a foot deformity score (max score = 3). A higher score indicated increased muscle weakness or more severe foot deformities. Muscle weakness and foot deformities were assessed without prior knowledge of patient and neuropathy status. RESULTS: Peroneal and tibial nerve conduction velocity were associated with weakness in muscles innervated by, respectively, the peroneal and tibial nerve (r = -0.70 and r = -0.51, P < 0.01) and foot deformities (r = -0.60 and r = -0.59, P < 0.001). The DN and DU groups had more weakness in intrinsic and extrinsic muscles compared with the C and D groups. Muscles innervated by the tibial nerve had a greater proportional muscle weakness than those innervated by the peroneal nerve in the DN and DU groups. The DN and DU patients had more foot deformities (median food deformity score [interquartile range]) (3 [2-3] and 2 [2-3]) compared with D and C patients (0 [0-0.75] and 0 [0-0]). CONCLUSIONS: Important relationships have been shown between motor nerve conduction deficit and muscle weakness; however, it is still not clear whether abnormal nerve function, leading to a decrease in muscle strength, could be responsible for the development of foot deformities.

Comparative roles of microvascular and nerve function in foot ulceration in type 2 diabetes.

OBJECTIVE: To determine the relative roles of different modalities of sensory nerve function (large and small fiber) and the role of microvascular dysfunction in foot ulceration in type 2 diabetic subjects. RESEARCH DESIGN AND METHODS: A total of 20 control subjects and 18 type 2 diabetic subjects with foot ulceration and 20 without were studied. None of the subjects had clinical features of peripheral vascular disease. The Computer-Aided Sensory Evaluator IV (CASE IV) was used to determine vibration detection threshold (VDT), cold detection threshold (CDT), warm detection threshold (WDT), and heat pain onset threshold (HPO). Vibration perception threshold (VPT) was also assessed by a neurothesiometer. Microvascular function (maximum hyperemia to skin heating to 44 degrees C) was assessed using laser Doppler flowmetry (mean maximum hyperemia using laser Doppler flowmeter [LDF(max)]), laser Doppler imaging (mean maximum hyperemia using laser Doppler imager [LDI(max)]), and skin oxygenation with transcutaneous oxygen tension (TcpO(2)). RESULTS: VPT, VDT, CDT, and HPO were all significantly higher in individuals with ulceration than in those without (VPT and VDT: P < 0.0001) (CDT and HPO: P = 0.01). LDF(max), LDI(max), and TcpO(2) were significantly lower in the two diabetic groups than in the control subjects, but there was no difference between individuals with and without ulceration. Univariate logistic regression analysis revealed similar odds ratios for foot ulceration for VDT, CDT, HPO, and VPT (OR 1.97 [95% CI 1.30-2.98], 1.58 [1.20-2.08], 2.30 [1.21-4.37], and 1.24 [1.08-1.42], respectively). None of the microvascular parameters yielded significant odds ratios for ulceration. CONCLUSIONS: This study found that there was no additional value in measuring small-fiber function with the CASE IV over measuring vibration by either CASE IV or the inexpensive neurothesiometer in discriminating between individuals with and without ulceration. Furthermore, none of the tests of microvascular function including the TcpO(2) were able to discriminate between individuals with and without ulceration, suggesting that such tests may not be of benefit in identifying subjects at greater risk of foot ulceration.

Can motor nerve conduction velocity predict foot problems in diabetic subjects over a 6-year outcome period?

OBJECTIVE: This study examined motor nerve conduction velocity (MNCV) and other peripheral nerve and vascular tests as predictors for foot ulceration, amputation, and mortality in diabetes over a 6-year follow-up period. RESEARCH DESIGN AND METHODS: We recruited 169 diabetic subjects (without significant peripheral vascular disease with an ankle brachial pressure index [ABPI] >/=0.75) for the study and separated them into groups (to ensure diversity of nerve function). The control group consisted of 22 nondiabetic people. At baseline, all subjects underwent assessment of MNCV; vibration, pressure, and temperature perception thresholds; peripheral vascular function; and other diabetes assessments. RESULTS: Over the 6-year outcome period, 37.3% of the diabetic subjects developed at least one new ulcer, 11.2% had a lower-limb amputation (LLA) (minor or major), and 18.3% died. Using multivariate Cox's regression analysis (RR [95% CI] and removing previous ulcers as a confounding variable, MNCV was found to be the best predictor of new ulceration (0.90 [0.84-0.96], P = 0.001) and the best predictors of amputation were pressure perception threshold (PPT) (5.18 [1.96-13.68], P = 0.001) and medial arterial calcification (2.88 [1.13-7.35], P = 0.027). Creatinine (1.01 [1.00-1.01], P < 0.001), MNCV (0.84 [0.73-0.97], P = 0.016), and skin oxygen levels (14.32 [3.04-67.52], P = 0.001) were the best predictors of mortality. CONCLUSIONS: This study shows that MNCV, which is often assessed in clinical trials of neuropathy, can predict foot ulceration and death in diabetes. In addition, tests of PPT and medial arterial calcification can be used in the clinic to predict LLA in diabetic subjects.