Implementation of Debriefing Services for Pharmacy Residents in a 24-Hour, In-House Clinical Pharmacy On-Call Program: A Pilot Study.

Background: This clinical pharmacy on-call program (CPOP) is a 24-hour, in-house service provided by pharmacy residents. During shifts, challenging situations may arise, which may correlate with depression, anxiety, and stress. Objective: This pilot study aims to describe the implementation of a debriefing program and characterize mental health patterns of residents in the CPOP. Methods: A structured debriefing process was developed to provide support to residents in the CPOP. Over a 1-year period, twelve outgoing pharmacy residents and ten incoming pharmacy residents completed a modified Depression Anxiety Stress Scale (mDASS-21) questionnaire and received a stress perception score (SPS) during debriefing. Data from first and final on-call shifts were compared via a paired Wilcoxon signed-rank test. Residents were referred to an Employee Assistance Program (EAP) based on mDASS-21 and SPS results. Scores from final on-call shifts were compared between residency classes via a Wilcoxon rank sum test. Results: Following successful implementation, 106 debriefing sessions were completed. Pharmacy residents responded to a median number of 38 events per shift. Significant reductions in anxiety and stress scores were observed from the first and final on-call shifts. Six residents were referred to EAP. A lower incidence of depression, anxiety, and stress was observed in pharmacy residents who received debriefing compared to previous residents. Conclusion: The debriefing program provided emotional support to pharmacy residents participating in the CPOP. Implementation of debriefing demonstrated a reduction of anxiety and stress from the beginning to the end of the academic year and in comparison to the previous year.

A multicenter case series documenting Medicare Part D plan denials of immunosuppressant drug coverage for organ transplant recipients.

Medicare Part D plans make coverage decisions according to FDA-labeled indications and off-label uses endorsed by two CMS-recognized compendia. Patients who rely on Medicare Part D for immunosuppressive drug coverage are at risk for denied coverage when these medications are prescribed off-label. The purpose of this multicenter collaboration was to assemble a case series documenting situations where immunosuppressive therapies prescribed for transplant patients were denied by Medicare Part D prescription drug plans. This case series documents 66 instances in 39 patients where immunosuppressive drug claims were denied coverage due to off-label use not endorsed by the compendia. Patients were recipients of lung (n = 28, 72%), heart (n = 7, 18%), or liver (n = 4, 10%) transplants. Denied claims were for mycophenolate mofetil (n = 22, 33%), azathioprine (n = 18, 27%), sirolimus (n = 15, 23%), mycophenolate sodium (n = 5, 8%), everolimus (n = 5, 8%), and belatacept (n = 1, 1%). Most denials were upheld across all the levels of attempted appeal, including those escalated to a Medicare Administrative Law Judge. This case series demonstrates a critical flaw in the construct of the Medicare Prescription Drug Benefit. The currently referenced compendia are not up to date and do not reflect best practices in organ transplantation.

The Clinical Conundrum of Cannabis: Current Practices and Recommendations for Transplant Clinicians: An Opinion of the Immunology/Transplantation PRN of the American College of Clinical Pharmacy.

Cannabis, or marijuana, comprises many compounds with varying effects. It has become a treatment option for chronic diseases and debilitating symptoms, and evidence suggests that it has immunomodulatory and antiinflammatory properties. Transplant centers are more frequently facing issues about cannabis, as indications and legalization expand. As of February 2020, 33 states and the District of Columbia have legalized medical cannabis, and 14 have legalized recreational cannabis. Moreover, 8 states have passed legislation prohibiting the denial of transplant listing solely based on cannabis use. Studies demonstrate the potential for significant pharmacokinetic and pharmacodynamic interactions between cannabis and immunosuppression. Additionally, safety concerns include increased risk of myocardial infarction, ischemic stroke, tachyarrhythmias, malignancy, neurocognitive deficits, psychosis, other neuropsychiatric disorders, cannabis use disorder, respiratory symptoms, and infection. A recent retrospective database study found a negative association between documented cannabis use disorder and graft survival, but little additional evidence exists evaluating this relationship. In the absence of robust clinical data, transplant centers need a clear, reasoned, and systematic approach to cannabis. The results of our national survey, unfortunately, found little consensus among institutions. As both recreational and medicinal cannabis become more ubiquitous nationwide, transplant centers will need to develop comprehensive policies to address its use.

Implications for body weight extremes in solid organ transplantation.

The pharmacokinetic profiles of medications are altered in overweight and underweight patients, but few studies have described these differences in patients with body mass index extremes. As solid organ transplant programs expand their candidate selection criteria to accommodate a growing population of patients with weight extremes, it has become imperative to understand and evaluate the impact weight extremes have on the pharmacokinetics of life-sustaining immunosuppression in this population. This review will describe pharmacokinetic and dosing considerations for weight extremes in solid organ transplant recipients, including changes following bariatric surgeries, non-pharmacologic and pharmacologic management strategies for weight loss and gain, and potential drug-drug interactions with popular weight management products.

Accepting Hearts From Hepatitis C-Positive Donor: Can We Expand the Donor Pool?

BACKGROUND: Until recently, transplantation from hepatitis C-positive donors was relatively contraindicated as eradication of active hepatitis C previously required an interferon-based regimen that has been associated with rejection in solid organ transplantation. New interferon-free treatment regimens for hepatitis C have fewer adverse events and higher cure rates than interferon-based regimens. Interferon-free regimens have been shown to be safe in the liver transplantation literature, but little is known about the safety and efficacy of treatment in heart transplantation. CASE DESCRIPTION AND DISCUSSION: Here we report a case of successful eradication of hepatitis C with a non-interferon-based regimen using ledipasvir-sofosbuvir following combined orthotopic heart and liver transplantation. Based on the prevalence of hepatitis C in the general population, inclusion of hepatitis C-positive donors for heart transplantation can expand this component of the donor pool 3- to 6-fold. CONCLUSIONS: In carefully selected patients and recipients, inclusion of hepatitis C-positive donors may allow for expansion of the donor pool.

Automatic Errors: A Case Series on the Errors Inherent in Electronic Prescribing.

The adoption of electronic prescribing is on the rise, as it reduces medication errors compared to handwritten orders. The inadvertent dispensing of discontinued medications is a type of medication error that is less well described, but one that can lead to adverse events. Software for electronic prescriptions transmits orders for refills or new prescriptions, but not discontinuations, to the pharmacy. Medications that have been stopped are displayed only at the prescribing facility's electronic medical record (EMR). This report describes five cases in which the pharmacy dispensed electronically discontinued medications, two of which contributed to adverse outcomes.

Abuse-deterrent and tamper-resistant opioids: how valuable are novel formulations in thwarting non-medical use?

INTRODUCTION: In recent years, attention has been given to the development of abuse-deterrent and tamper-resistant opioid formulations in light of concern over the growing misuse and abuse of opioids prescribed for the treatment of chronic pain. AREAS COVERED: This critical review discusses abuse-deterrent and tamper-resistant formulations, which may help to overcome concerns of misuse in using opioids for pain management. The role and utility of these novel formulations in clinical practice are outlined, as well as the risks and benefits associated with formulations that are currently available or under development. EXPERT OPINION: Numerous concerns with the integration of these formulations into clinical practice remain, as no product is intended or capable of addressing all types of misuse or abuse. As a result, these formulations should not necessarily be considered preferred agents once available in clinical practice. Moreover, before initiating therapy with abuse-deterrent and tamper-resistant formulations, proper patient assessment to identify risk factors for misuse and abuse should be implemented and optimized. With screening and monitoring in place, it would then be sensible to consider these formulations in patients who appear to be at high risk of misuse, abuse and/or diversion.