James D. Scott

Guidelines for improving entry into and retention in care and antiretroviral adherence for persons with HIV: evidence-based recommendations from an International Association of Physicians in AIDS Care panel

DESCRIPTION After HIV diagnosis, timely entry into HIV medical care and retention in that care are essential to the provision of effective antiretroviral therapy (ART). Adherence to ART is among the key determinants of successful HIV treatment outcome and is essential to minimize the emergence of drug resistance. The International Association of Physicians in AIDS Care convened a panel to develop evidence-based recommendations to optimize entry into and retention in care and ART adherence for people with HIV. METHODS A systematic literature search was conducted to produce an evidence base restricted to randomized, controlled trials and observational studies with comparators that had at least 1 measured biological or behavioral end point. A total of 325 studies met the criteria. Two reviewers independently extracted and coded data from each study using a standardized data extraction form. Panel members drafted recommendations based on the body of evidence for each method or intervention and then graded the overall quality of the body of evidence and the strength for each recommendation. RECOMMENDATIONS Recommendations are provided for monitoring entry into and retention in care, interventions to improve entry and retention, and monitoring of and interventions to improve ART adherence. Recommendations cover ART strategies, adherence tools, education and counseling, and health system and service delivery interventions. In addition, they cover specific issues pertaining to pregnant women, incarcerated individuals, homeless and marginally housed individuals, and children and adolescents, as well as substance use and mental health disorders. Recommendations for future research in all areas are also provided.

Medication Therapy Management Services Provided by Student Pharmacists

Objectives. To evaluate the impact of student pharmacists delivering medication therapy management (MTM) services during an elective advanced pharmacy practice experience (APPE). Methods. Student pharmacists provided MTM services at community pharmacy APPE sites, documented their recommendations, and then made follow-up telephone calls to patients to determine the impact of the MTM provided. Students were surveyed about the MTM experience. Results. Forty-seven students provided MTM services to 509 patients over 2 years and identified 704 drug-related problems (average of 1.4 problems per patient). About 53% of patients relayed the recommendations to their physician and 205 (75%) physicians accepted the recommendations. Eighty-eight percent of patients reported feeling better about their medications after receiving MTM services. A majority of the students perceived their provision of MTM services as valuable to their patients. Conclusions. Providing MTM services to patients in a pharmacy practice setting allowed student pharmacists to apply skills learned in the doctor of pharmacy (PharmD) curriculum.

Placebo Practice Trials: A Tool to Assess and Improve Adherence Readiness

PURPOSE Antiretroviral therapy is being increasingly delayed until later stages of illness. Therefore, prior to prescribing HAART, providers are emphasizing the need for patients to be ready to adhere well to the treatment regimen. Unfortunately, providers are no better than chance at predicting a patients adherence, and there are no established methods for accurately assessing a patients adherence readiness. This pilot study assessed the utility of a series of up to five 1-week placebo practice trials accompanied by adherence counseling as a clinical tool to both assess and improve adherence readiness. METHOD Participants were not prescribed treatment until they demonstrated readiness, which was defined as 90+% adherence during a single practice trial. Once HAART was initiated, adherence to one selected antiretroviral was monitored for 4 weeks. Electronic monitoring caps were used to measure adherence. RESULTS Twenty men enrolled in the study at two HIV outpatient clinics in Southern California. Mean age was 33, 50% were non-White, 35% were employed, 30% had not completed high school, 15% were Spanish monolingual, and 30% had unstable housing. Nine participants achieved 90+% adherence in the first practice trial, with an additional 8 participants demonstrating readiness after two to four practice trials; two participants withdrew from the study because of intolerance of the restrictions related to the use of the caps; and one participant was removed from the study after no effort was given during two practice trials. Of the 17 participants who completed the program and demonstrated adherence readiness, 15 started on an antiretroviral regimen and 2 decided to defer treatment indefinitely. Of the 15 who started therapy, 13 (87%) achieved 90+% adherence during the first month of antiretroviral therapy. The samples mean adherence during the first 4 weeks of treatment was 93% (SD = 13). CONCLUSION These results suggest that once a patient is able to adhere well to a 1-week practice trial they are likely to adhere equally well to HAART. A larger controlled study is needed to further assess the effectiveness of practice trials as a clinical tool for both assessing and improving adherence readiness.

Prospective Study of Topical Testosterone Gel (AndroGel) Versus Intramuscular Testosterone in Testosterone-Deficient HIV-Infected Men

Abstract Purpose: Testosterone replacement therapy via deep intramuscular injections causes extraphysiologic variations in serum testosterone concentrations. A topical transdermal testosterone gel formulation (AndroGel®) provides sustained physiologic concentrations of serum testosterone. The objective of this open-label switch study was to compare pharmacokinetics, safety, tolerability, and efficacy of delivery of daily testosterone gel versus intramuscular testosterone injection every 1 or 2 weeks in hypogonadal human immunodeficiency virus (HIV)-infected men. Method: Patients received intramuscular testosterone (100-200 mg/wk) for 8 weeks, then switched to daily topical testosterone gel (5-10 g gel/day) for 8 weeks. Study endpoints included free serum testosterone concentrations and quality-of-life scores. Results: Thirty patients (average age, 45 years) were recruited; 24 completed the study. Mean peak free testosterone concentrations with intramuscular testosterone and testosterone gel were 42 pg/mL and 23 pg/mL, respectively, and mean peaktrough fluctuations in free testosterone were 26.7 ± 12.8 pg/mL and 2.7 ± 10.7 pg/mL, respectively (p < .001). Quality-of-life scores indicated more improved physical and emotional well-being with gel versus intramuscular testosterone. No significant changes in laboratory parameters or lean body mass were noted. Conclusion: Daily testosterone gel produced stable testosterone concentrations and improved quality of life compared with intermittent intramuscular testosterone injections.

Serious Renal Impairment Occurs Rarely with Use of Tenofovir DF

Abstract Purpose: The purpose of this study was to evaluate the short-term effects (up to 6 months) of tenofovir disoproxil fumarate (DF) use on renal function in patients being treated for HIV-1 infection. Method: The charts of 447 HIV-1-infected patients who received at least three months of tenofovir DF treatment were reviewed. Data collected included demographics, concurrent antiretrovirals, other concurrent medications, CD4 counts and HIV-1 viral loads, and serum creatinine values while on tenofovir DF. Data collection was truncated at 6 months. Results: Baseline serum creatinine (SCr) was 1.0 mg/dL, with a calculated creatinine clearance (CLCr) of 95.2 mL/min (using the Cockroft-Gault equation). There was no significant change in SCr or CLCr at 12 weeks (1.1 mg/dL and 92.7 mL/min, respectively) or 24 weeks (1.1 mg/dL and 92.9 mL/min, respectively). All three patients with grade 2 increases in SCr had other medical reasons for an increased SCr (one patient each had indinavir-associated nephrolithiasis, lactic acidosis, and pancreatitis). No patients experienced any complications from these increases in SCr. Conclusion: Increases in SCr and CLCr within the first 6 months of tenofovir DF therapy were rare. Although no clinical nephrotoxicity was observed, continued observation of renal function is warranted in patients predisposed to renal impairment.

Overview of a co-curricular professional development program in a college of pharmacy

The goal of a professional program at a school or college of pharmacy is to produce competent and professional pharmacy practitioners. In 2009, The American College of Clinical Pharmacy published a white paper to assist in the teaching of professionalism in schools/colleges of pharmacy to include traits such as responsibility, commitment to excellence, respect for others, honesty and integrity, and care with compassion. In February 2015, the Accreditation Council for Pharmacy Education released their updated accreditation standards (Standards 2016) which introduced the concept of co-curricular activities (Standard 12.3): experiences that complement, augment, and/or advance what is learned in the formal didactic and experiential curriculum. This article details the Professional Development Curriculum at Western University of Health Sciences (WesternU) College of Pharmacy as a potential educational model that promotes professionalism through mandating co-curricular activities for student pharmacists.