Development and validation of a performance-based palliative care assessment tool for student pharmacists.

INTRODUCTION: Integration of hospice and palliative care principles within pharmacy curricula is essential to fill the need of pharmacist training in this growing specialty. A formalized assessment tool to evaluate skill development does not exist for student pharmacists specific to palliative care. The objective of this study was to develop a valid and reliable, palliative care-focused, performance-based assessment tool for student pharmacists. METHODS: Eight academic palliative care (PC) pharmacists were recruited for the workgroup to perform domain development, validation, tool creation, and reliability testing for this performance-based assessment tool. Hospice and palliative care clinical pharmacist entrustable professional activities (EPAs) served as the framework. Content validity testing utilized content validity index and scale universal agreement (S-CVI/UA) to determine level of agreement for activities included in the tool. Student volunteers completed a standardized patient case and workgroup members served as raters during the reliability testing phase. Interrater reliability was measured through calculation of Fleiss Kappa scores for each activity. RESULTS: Out of 14 EPAs, nine were deemed "essential" to include in the tool. Thirty-four supporting activities for the nine essential EPAs were drafted. Two rounds of content validity testing were necessary to achieve S-CVI/UA of 0.9593. Consensus was reached from workgroup members for activities deemed necessary to include in the tool after questionnaire distribution utilizing a Fleiss Kappa cutoff >0.6. CONCLUSIONS: This validated tool will afford colleges and schools of pharmacy with PC curricula an opportunity to assess student achievement of PC-specific skills and evaluate curricular effectiveness.

Adverse pregnancy outcomes after in vitro fertilization due to undiagnosed urogenital tuberculosis and proposed screening algorithm for patients from tuberculosis-endemic countries.

Objective: To report 2 cases of adverse pregnancy outcomes due to delayed diagnosis of urogenital tuberculosis and propose a screening algorithm for patients from tuberculosis-endemic countries. Design: Case report. Setting: Academic medical center. Patients: Two patients with delayed diagnosis of urogenital tuberculosis leading to a fetal loss and a preterm delivery of an infant with congenital tuberculosis. Interventions: Endometrial biopsy, acid-fast bacilli culture of urine, and endometrium. Main outcome measures: Pregnancy outcomes. Results: Fetal loss at 19 weeks and preterm delivery of an infant with congenital tuberculosis before urogenital tuberculosis treatment. Conclusions: Patients who are at risk of urogenital tuberculosis should be screened in advance of infertility treatment to potentially prevent adverse pregnancy outcomes.

Comparison of Current Post-Graduate Pain Management and Palliative Care Pharmacy Residency Programs.

Post-graduate pharmacy residency training in pain management and palliative care is continuing to increase in availability. It is expected that there will be further expansion in the need for specialty trained pain and palliative care pharmacists as the population continues to age and prevalence of pain increases; however, descriptions of current post-graduate year 2 pain management and palliative care residencies are limited. The purpose of this survey is to collect program information and compare baseline characteristics of the currently available programs. Data collected included funding source, required and elective experiences, residency program director training, jobs held by residents upon completion of the program, and preceptor availability/training. Of the 15 respondents, baseline characteristics were variable. Outpatient chronic pain management was the most commonly selected required experience. Approximately 33% of residency program directors had completed a post-graduate year two residency in pain management and palliative care, and the majority of responding programs were funded by the Department of Veterans Affairs. The characteristics of responding programs illustrates the diversity of current post-graduate pain management and palliative care residency opportunities. The results of this survey help evaluate these opportunities and will provide valuable information as this specialty continues to progress.

Development of Entrustable Professional Activities for Specialist Hospice and Palliative Care Pharmacists.

CONTEXT: Entrustable professional activities (EPAs) translate competencies into explicit, practical terms that clearly state the expected roles and responsibilities of clinicians who have achieved proficiency and expertise in a field. EPAs are defined for Hospice and Palliative Medicine physicians but not for other members of Hospice and Palliative Care (HAPC) interprofessional teams, including pharmacists. OBJECTIVES: The objective of this study was to develop EPAs for HAPC pharmacists. METHODS: An 11-member workgroup of HAPC pharmacists was convened to develop candidate EPAs using nominal group and modified-Delphi methods. Content validity index was used as a measure of consensus, defined a priori at ≥ 60%. Vetting occurred via intra- and interprofessional stakeholder reactor groups and a national survey of HAPC pharmacists. RESULTS: Following an iterative process of workgroup and stakeholder consensus-building, 15 HAPC pharmacist EPAs were developed. Among the workgroup, all 15 EPAs reached ≥ 70% consensus, indicating appropriate internal validity. In a national survey of 185 HAPC pharmacists with a 20% response rate, 13 EPAs were rated by most respondents as "essential" and 2 were rated by most respondents as "important but not essential." Respondents indicated the 15 EPA set represented the core professional activities of HAPC pharmacists well (median rating of 5 on a Likert-like scale, IQR 1). CONCLUSION: Fifteen consensus EPAs describe essential activities of HAPC pharmacists in direct patient care, leadership, education, and scholarship. These EPAs will further guide pharmacist training programs, HAPC services seeking to incorporate a specialized pharmacist on the team, and currently practicing HAPC pharmacists.

Multicentered Evaluation of Palliative Care Pharmacists' Interventions and Outcomes in California.

Introduction: The palliative care (PC) pharmacist's role within PC teams is increasingly recognized with favorable outcomes being reported. Methods: Retrospective study evaluated hospitalized adults seen by PC pharmacists, as part of PC consultation team at three California institutions. The primary objective was to categorize pharmacists' interventions. Secondary end points included length from admission to PC pharmacist involvement and symptom improvement following pharmacist intervention. Results: Data were collected for a total of 557 patients. Over the study period, the PC pharmacists provided 1466 medication recommendations and 2545 nonsymptom-based interventions. Average length of stay (LOS) was 15.6 days with mean time to PC service referral of 3.6 days. PC pharmacist consult occurred after a mean of 4.3 days after PC team consulted. LOS was significantly lower if seen by PC pharmacist within 72 hours of PC consultation, 12.3 days versus 24.5 days (p < 0.001), as well as when serving as lead clinician 9.3 days versus 15.5 days (p < 0.001). Achievement of severity goal was significantly higher at 24 and 72 hours assessment periods when received a medication recommendation for pain, dyspnea, anxiety, and constipation. Conclusion: PC pharmacists provide substantial transdisciplinary interventions. Significantly decreased LOS was found when PC pharmacist was involved within 72 hours of initial PC consultation and when served as lead clinician. Improved symptom goal attainment was demonstrated for pain, dyspnea, anxiety, and constipation. In summary, integration of a PC pharmacist on a PC team can be relied upon to provide patient-centered, transdisciplinary care and enhance symptom management.

Severe ovarian hyperstimulation syndrome associated with long-acting GnRH agonist in oncofertility patients.

PURPOSE: To report three cases of severe ovarian hyperstimulation syndrome (OHSS) among oncofertility patients receiving a long-acting GnRH agonist for ovarian suppression after controlled ovarian hyperstimulation (COH) with a GnRH antagonist protocol METHODS: Chart abstraction was completed for three patients at a single academic medical center. Patients included were undergoing fertility preservation prior to gonadotoxic chemotherapy. All patients underwent COH with GnRH antagonist protocol and embryo cryopreservation immediately followed by ovarian suppression with long-acting GnRH agonist. Main outcome measure was development of OHSS. RESULTS: Despite using GnRH agonist trigger and freezing all embryos, patients developed ascites, intermittent hyponatremia and hemoconcentration consistent with severe early-onset OHSS after receiving long-acting GnRH agonist immediately following oocyte retrieval for ovarian preservation. CONCLUSIONS: Risk of severe OHSS may be increased when a long-acting GnRH agonist is used for ovarian suppression immediately following oocyte retrieval. A delay in initiating long-acting GnRH agonist after oocyte retrieval in patients at high risk for developing OHSS should be considered.

Patterns of heroin use following index prescription opioid exposure.

OBJECTIVE: This study examined the means of obtainment, indication, and prescriber of an index opioid in self-reporting heroin users. DESIGN: Cross-sectional, observational study. SETTING: A survey was submitted by participants in the United States with current or past heroin use. PARTICIPANTS: Three hundred twenty-three participants greater than 18 years of age completed the survey. MAIN OUTCOME MEASURE: Participants were surveyed regarding prescription opioid use prior to heroin initiation and spe-cifically how they were obtained. Surveys were comprehensive in nature, divulging information including which opioid(s) was/were used, how they were obtained, by which prescriber (if prescribed), and if there was a diagnosis for chronic pain. RESULTS: Roughly 47 percent of participants reported using prescription opioids prior to heroin. The most commonly used prescription opioid prior to heroin initiation was oxycodone (92.5 percent). The most common acquisition of opioids was through the prescribing of a physician, which occurred in roughly 63 percent of cases. These prescriptions were obtained most often from primary care physicians and emergency departments. Only 34 percent of participants reported being diagnosed with a chronic pain condition prior to using heroin. CONCLUSIONS: This study further supports the role that prescription opioids play in the transition to heroin use. It suggests that oxycodone is the most common prescription opioid used prior to heroin initiation. Additionally, it reports descriptive information as to how and where prescription opioids are obtained.

Palliative and end of life care content within common pharmacy textbooks.

INTRODUCTION: This study compared the end-of-life care (EOLC) content in pharmacy-related textbooks to textbooks evaluated in a comparable 2003 study. METHODS: Six common pharmacy-related textbooks were reviewed for content relating to EOLC. Five of the textbooks were the newest editions of the same texts reviewed in a similar 2003 study, and one focused primarily on clinical ethics, a topic that was underrepresented in the previous study. The six texts were searched for a list of 33 keywords or phrases pertaining to EOLC. Entries containing any of these 33 keywords were assigned a domain and scored using a simple scoring system of one if minimally helpful content was present or two if helpful content was present. The total number of entries and their average scores were compared to the results of the previous study. RESULTS: The average number of entries per textbook was 154, which represents an increase from the 110.1 average number of entries in the 2003 study. However, one of the textbooks had a total of 470 entries alone. Of a total number of 78 possible domains, 40 had either zero or one entries. The average ratings for each book ranged from 0.5 to 1.6, whereas they ranged from 0.9 to 1.6 in 2003. Four of six books in this study had average rating of less than 0.9. CONCLUSION: Although certain texts have made strides to include more EOLC content, overall, EOLC content in pharmacy textbooks may still be improved.

Interstitial Cystitis: An Update on the Disease Process and Treatment.

Interstitial cystitis (IC) is a chronic pain disorder of the bladder that is often underdiagnosed and mistreated. The difficulties in diagnosis stem from numerous theories regarding pathophysiology and etiology, including the breakdown of the glycosaminoglycan (GAG) layer, altered permeability of the urothelium, uroinflammation, and neural up-regulation. Dysfunction of the bladder increases the struggle for proper treatment and continues to prove difficult for health care providers to correctly diagnose and manage IC. If diagnosed and/or managed inappropriately, IC may contribute to increased symptom burden and decreased quality of life with respect to activities of daily living. When evaluating a patient's clinical presentation in combination with predefined risk factors, a health care provider can better establish a true diagnosis of IC, which, in turn, leads to better management of IC-associated symptoms. This review will help health care providers better understand the disease process by discussing pathophysiology, pain pathways, and common symptoms of IC, with the goal of better aiding them in the proper diagnosis and treatment of patients with IC.

Persistent Post-Mastectomy Pain: Risk Factors and Current Approaches to Treatment.

Persistent Post-Mastectomy Pain (PPMP) is a common condition that can follow surgeries for breast cancer, the most common cancer in women. Because of the frequency of PPMP and its potential severity, it has received increasing research attention. This manuscript reviews the recent research literature, beginning with a brief history and then relevant medical, surgical, demographic, and psychosocial risk factors. Subsequently, social, psychological, and functional sequelae that have been linked to PPMPS are considered, as is research on current pharmacological, psychological, and rehabilitative approaches to treatment. The review concludes with a discussion of directions for future research and treatment that might reduce the incidence and impact of PPMP on breast cancer survivors. PERSPECTIVE: This article describes current research literature involving mechanisms, risks, and treatments related to persistent post-mastectomy pain. Implications of research findings also are discussed for pre- and post-surgical approaches to pain management, current treatments, and promising research directions.

Ten Tips Palliative Care Pharmacists Want the Palliative Care Team to Know When Caring for Patients.

As palliative care (PC) moves upstream in the course of serious illness and the development of drugs and their indications rapidly expand, PC providers must understand common drug indications and adverse effects to ensure safe and effective prescribing. Pharmacists, experts in the nuances of medication management, are valuable resources and colleagues for PC providers. This article will offer PC providers 10 useful clinical pharmacy tips that PC pharmacists think all PC providers should know for safe and effective symptom management. Close collaboration with or addition of a trained pharmacist to your PC team can improve clinical care for all PC patients.

Multicentered Study Evaluating Pharmacy Students' Perception of Palliative Care and Clinical Reasoning Using Script Concordance Testing.

INTRODUCTION: As the role of the pharmacist on the transdisciplinary palliative care team grows, the need for adequate instruction on palliative care and clinical reasoning skills in schools of pharmacy grows accordingly. METHODS: This study evaluates second- and third-year pharmacy students from 6 accredited schools of pharmacy that participated in surveys before and after the delivery of a didactic palliative care elective. The survey collected student demographics, perceptions of the importance of and student skill level in palliative care topics. The script concordance test (SCT) was used to assess clinical decision-making skills on patient cases. Student scores on the SCT were compared to those of a reference panel of experts. RESULTS: A total of 89 students completed the pre-/postsurveys and were included in data analysis. There was no statistically significant difference in student perceived importance of palliative care skills before and after the elective. Students from all 6 institutions showed significant increase in confidence in their palliative care skills at the end of the course. There was also a significant improvement across all institutions in clinical reasoning skills in most of the SCT questions used to assess these skills. CONCLUSIONS: Students choosing an elective in palliative care likely do so because they already have an understanding of the importance of these topics in their future practice settings. Delivery of a palliative care elective in the pharmacy curriculum significantly increases both student confidence in their palliative care skills and their clinical reasoning skills in these areas.

Differences in the Association between Depression and Opioid Misuse in Chronic Low Back Pain versus Chronic Pain at Other Locations.

Patients with chronic pain and depression are more likely to develop opioid abuse compared to patients without depression. It is not known if this association differs by pain location. We compared the strength of association between depression and opioid misuse in patients with chronic low back pain (CLBP) vs. chronic pain of other location (CPOL). Chart abstracted data was obtained from 166 patients seeking care in a family medicine clinic. Depression was measured by the PHQ-9 and opioid misuse was measured using the Current Opioid Misuse Measure. Pain severity and interference questions came from the Brief Pain Inventory. Cross-tabulations were computed to measure the association between depression and opioid misuse stratified on pain location. Exploratory logistic regression modeled the association between depression and opioid misuse after adjusting for pain location and pain severity and interference. Depression was significantly associated with opioid misuse in CPOL but not in CLBP. Regression results indicate pain interference partly accounts for the depression-opioid misuse association. These preliminary results from a small patient sample suggest depression may co-occur with opioid misuse more often in CPOL than in CLBP. Further research is needed to compare this comorbidity in specific pain diagnoses such as arthritis, fibromyalgia and CLBP.

Global Transcriptome Abnormalities of the Eutopic Endometrium From Women With Adenomyosis.

OBJECTIVE: Adenomyosis is a clinical disorder defined by the presence of endometrial glands and stroma within the myometrium, the pathogenesis of which is poorly understood. We postulate that dysregulation of genes and pathways in eutopic endometrium may predispose to ectopic implantation. No study, to our knowledge, has examined the global transcriptome of isolated eutopic endometrium from women with clinically significant adenomyosis. DESIGN: Laboratory-based study with full institutional review board approval and consents. MATERIAL AND METHODS: Endometrial sampling was performed on hysterectomy specimens (proliferative phase) from symptomatic women with pathologically confirmed diffuse adenomyosis (n = 3). Controls (n = 5) were normo-ovulatory patients without adenomyosis. All patients were free from leiomyoma, endometriosis, and hormonal exposures. Isolated purified total RNA was subjected to microarray analysis using the Gene 1.0 ST Affymetrix platform. Data were analyzed with GeneSpring and Ingenuity Pathway analysis. Validation of several genes was undertaken by quantitative real-time reverse transcriptase polymerase chain reaction. RESULTS: Comparison of transcriptomes of proliferative endometrium from women with and without adenomyosis revealed 140 upregulated and 884 downregulated genes in samples from women with adenomyosis compared to controls. Highly differentially expressed genes include those involved in regulation of apoptosis, steroid hormone responsiveness, and proteins involved in extracellular matrix remodeling as well as microRNAs of unknown significance. Affected canonical pathways included eukaryotic initiation factor 2 signaling, oxidative phosphorylation, mitochondrial dysfunction, estrogen receptor signaling, and mammalian target of rapamycin signaling. CONCLUSION: The eutopic endometrium in patients with adenomyosis has fundamental abnormalities that may predispose to invasion and survival beyond the myometrial interface.

Prepubertal Gynecomastia Due to Indirect Exposure to Nonformulary Bioidentical Hormonal Replacement Therapy: A Case Report.

BACKGROUND: Gynecomastia is a disorder of the endocrine system characterized by an abnormal presence of a palpable unilateral or bilateral enlargement and proliferation of glandular ductal benign breast tissue in male individuals. This case discusses the medical implications of an unregulated, indirect exposure to nonformulary, bioidentical hormone replacement therapy in male children. CASE: An 8-year-old boy presented with prepubertal gynecomastia secondary to estrogen exposure from maternal use of bioidentical hormonal replacement therapy (the Wiley protocol). We review the literature on prepubertal gynecomastia secondary to exogenous estrogen exposure, evaluation, clinical surveillance of the pubertal development, and relevant short- and long-term implications. CONCLUSION: Indirect exposure to nonformulary hormonal replacement in our case report was an etiologic factor in the development of prepubertal gynecomastia. This novel estrogen exposure source has important implications in the differential diagnosis of prepubertal gynecomastia and potential adverse effects secondary to precocious hormonal exposure.

Opioid Medication Practices Observed in Chronic Pain Patients Presenting for All-Causes to Emergency Departments: Prevalence and Impact on Health Care Outcomes.

BACKGROUND: Chronic pain is a significant health problem that affects an estimated 100 million American adults (aged ≥ 18 years). Chronic pain affects more individuals than heart disease, stroke, diabetes, and cancer combined. Chronic pain sufferers cost up to $635 billion annually in medical treatment and lost productivity. Opioids are commonly used to treat chronic pain, but their metabolic interactions with concurrently prescribed medications for concomitant disease burdens can affect potency and efficacy of pain therapy. Additionally, misuse of short-acting opioids (SAOs) for chronic pain versus breakthrough pain can create gaps in pain relief. These potentially suboptimal prescribing practices may contribute to the high economic impact associated with chronic pain.  OBJECTIVE: To examine the prevalence of suboptimal opioid therapy and the associated health care costs resulting from these prescribing practices in real-world patients presenting for all-causes to the emergency department (ED).  METHODS: This retrospective observational database cohort analysis used the linked Premier-Optum database and included patients with ED visits from 2006 to 2010 having ≥ 60 days supply of opioids in the 75 days prior to the visit. Suboptimal prescribing practices were identified as patients with (a) drug-drug exposures (DDEs), defined as cytochrome P-450 (CYP-450)-metabolized opioids prescribed concurrently with CYP-450 inhibitors or inducers and/or (b) monotherapy with SAOs. Comorbid conditions and principal diagnoses were documented. Readmission rates to the ED and hospital within 72 hours as well as ≤ 30, ≤ 45, ≤ 60, and ≤ 90 days were computed. Total costs for health care were calculated, and reimbursement rates were normalized using 2011 Medicare severity diagnosis-related group (MS-DRG) and CPT-4 information. Nonparametric bootstrapping to adjust for patient comorbidities was applied to cost data. RESULTS: Of the 9,214 patients identified with chronic pain, potentially suboptimal medication practices prior to the index ED visit were found for 8,539 (92.6%) patients. These appeared to be corrected in 345 (4.0%) patients before leaving the ED. Of 675 (7.3%) patients without prior DDE or exclusive use of SAOs, 345 (51.1%) patients were discharged with one of these. Of the 8,352 patients who left the ED with DDE or exclusive use of SAOs, 1,525 (18.3%) left with a DDE without exclusive SAO use; 4,812 (57.6%) left with both DDE and exclusive SAO use; and 2,015 (24.1%) left with only exclusive SAO use. Only 862 (9.3%) patients from the entire cohort left the ED without DDE or exclusive SAO use. Patients identified with suboptimal opioid use were aged 50 ± 13.5 years and were predominantly female (64.0%). Hypertension (44.0%), fluid and electrolyte disorders (32.7%), chronic pulmonary disease (22.8%), depression (19.6%), diabetes without chronic complications (16.2%), and drug abuse (15.6%) were the most prevalent comorbid conditions identified. The most prevalent principal diagnoses involved symptoms and signs of ill-defined conditions (36.5%), injury and poisoning (18.2%), and diseases of the musculoskeletal system (13.2%). The majority of revisits to the ED and hospital admissions occurred within 72 hours (73.6%) of the index visit and within 30 days (70%), respectively. When adjusted total costs were compared for all patients whose opioid use included DDE versus those without, a significantly greater cost (P less than 0.05) was observed at every time period except ≤ 72 hours. Respective mean increases in costs were $581, $689, $773, and $1,275 at 30, 45, 60, and 90 days. Exclusive SAO use with or without DDE resulted in a significant increase (P less than 0.05) in mean costs at all times: $214 at 72 hours; $836 at 30 days; $1,023 at 45 days; $1,022 at 60 days; and $1,536 at 90 days.  CONCLUSIONS: This study identified potentially suboptimal opioid prescribing practices in a real-world population presenting for all-causes to the ED. The observed rate of ED revisits and inpatient admissions in these patients was associated with increased health care costs. These findings suggest that the ED has the future potential to serve as an ideal setting to identify and correct such practices, thereby improving patient care and reducing resource use and beneficiary costs.

Birth of a healthy child after preimplantation genetic screening of embryos from sperm of a man with non-mosaic Down syndrome.

PURPOSE: The purpose of this study is to present a case of healthy infant born after intracytoplasmic sperm injection-in vitro fertilization (ICSI-IVF) with preimplantation genetic screening (PGS) using sperm from a man with non-mosaic trisomy 21 and a literature review. MATERIALS AND METHODS: A 26-year-old euploid female and 29-year-old male with non-mosaic trisomy 21 and male factor undergoing ICSI-IVF treatment for primary infertility with embryo biopsy for PGS with comprehensive chromosomal screening (CCS) presented to the Infertility Clinic at Highland Hospital, the Alameda County Medical Center, California, with 6-year history of primary infertility. The outcome measure is a live birth of a healthy child and ploidy status of biopsied blastocysts. RESULTS: Egg retrieval yielded 33 oocytes, 29 of which underwent ICSI with ejaculated sperm. Twenty-eight 2PN zygotes were cultured, and 13 blastocysts underwent trophectoderm biopsy and vitrification 5 or 6 days after retrieval. CCS analysis revealed that 12 out of 13 (92 %) of blastocysts were euploid and one was a complex abnormal mosaic. Transfer of two grade I hatching blastocysts resulted in a singleton pregnancy with normal prenatal genetic screening and delivery of a healthy male infant at 41 weeks via primary cesarean section for non-reassuring fetal status. CONCLUSION: This is the first report of a live birth of a healthy child after ICSI-IVF with PGS using ejaculated sperm from a man with non-mosaic trisomy 21 and male factor infertility.

Common questions about chronic low back pain.

More than 30% of U.S. adults report having experienced low back pain within the preceding three months. Although most low back pain is nonspecific and self-limiting, a subset of patients develop chronic low back pain, defined as persistent symptoms for longer than three months. Low back pain is categorized as nonspecific low back pain without radiculopathy, low back pain with radicular symptoms, or secondary low back pain with a spinal cause. Imaging should be reserved for patients with red flags for cauda equina syndrome, recent trauma, risk of infection, or when warranted before treatment (e.g., surgical, interventional). Prompt recognition of cauda equina syndrome is critical. Patient education should be combined with evidence-guided pharmacologic therapy. Goals of therapy include reducing the severity of pain symptoms, pain interference, and disability, as well as maximizing activity. Validated tools such as the Oswestry Disability Index can help assess symptom severity and functional change in patients with chronic low back pain. Epidural steroid injections do not improve pain or disability in patients with spinal stenosis. Spinal manipulation therapy produces small benefits for up to six months. Because long-term data are lacking for spinal surgery, patient education about realistic outcome expectations is essential.