A Multi-Site Qualitative Study Examining Pharmacy Student Perspectives on the Opioid Crisis.

Objective. To determine pharmacy students' perspectives regarding opioid use, the opioid crisis, and pharmacy education related to both topics.Methods. Students from each professional year at eight participating schools and colleges of pharmacy were invited to participate in focus groups and answer questions about their experiences with the opioid crisis. Faculty and/or staff moderated the focus groups and audio-recorded responses. Recordings were deidentified, transcribed, and analyzed.Results. One hundred fifty students participated in one of 29 focus groups conducted. Responses were categorized according to themes using consensual qualitative research (CQR) methodology. Sources impacting student views on the crisis included school, personal and work experience, and media. Perspective changes since starting school included increased knowledge and awareness and decreased bias/stigma.Conclusion. Conducting focus groups on the opioid crisis provided pharmacy schools with information on what student pharmacists are learning about the crisis, practices they see, and their recommendations to address the crisis. Pharmacy schools can better prepare students to combat the opioid crisis by providing them with training in opioid counseling, use of naloxone, and how to have difficult conversations with patients.

The substance use intervention team: A hospital-based intervention and outpatient clinic to improve care for patients with substance use disorders.

PURPOSE: In response to the opioid crisis, public health advocates urge hospitals to perform substance use disorder (SUD) screening, brief intervention, discharge planning with referral to treatment, and naloxone education. Universal screening makes specialized treatment available to all patients and decreases stigma around SUDs, allowing patients and providers to address SUDs during their hospitalization. Additionally, hospital and emergency department-initiated medications to treat SUD improve patient engagement with treatment and decrease opioid use, and use of medications for opioid use disorder after nonfatal overdoses decreases mortality. SUMMARY: A substance use intervention team (SUIT) service was established to offer universal screening and consultation by an interdisciplinary team at our urban academic medical center. The SUIT program provides inpatient consultation services as well as medical and behavioral clinic visits to transition patients to long-term treatment and is comprised of physicians, nurse practitioners, a clinical pharmacist, social workers, and a nurse. Successes attributed to enhanced medication use as a function of having a designated pharmacist as an integral member of the team are highlighted. Our medical center initiated screening efforts in tandem with its interdisciplinary team and clinic. The team attempts to start appropriately selected patients with SUD on medications for SUD while hospitalized. From January through December 2018, 87.2% of patients admitted to the hospital received initial SUD screening. Of the patients who screened positive, 1,400 received a brief intervention by a unit social worker; the SUIT service was consulted on 880 patients, and multiple medications for SUD were started during inpatient care. CONCLUSION: A screening, brief intervention, and referral to treatment service was successfully implemented in our hospital, with the SUIT program in place to provide interdisciplinary addiction care and initiate medications for SUD in appropriate patients.

Leveraging pharmacists to maintain and extend buprenorphine supply for opioid use disorder amid COVID-19 pandemic.

PURPOSE: Strategies for deploying clinical pharmacists to increase access to buprenorphine in inpatient, outpatient and transitional care, and community practice settings are described. SUMMARY: Access to medications for opioid use disorder (MOUD) is essential, but patients face many barriers when pursuing treatment and MOUD. The coronavirus disease 2019 (COVID-19) pandemic has compounded the opioid crisis and worsened outcomes by introducing new barriers to MOUD access. Many strategies to ensure continued access to MOUD have been described, but the role of leveraging pharmacists during the opioid/COVID-19 syndemic to improve medication access and outcomes remains underappreciated. Pharmacists, while both qualified and capable of liberalizing access to all forms of MOUD, may have the strongest impact by increasing access to buprenorphine. Herein, we present progressive strategies to maintain and extend buprenorphine access for patients with OUD through deployment of clinical pharmacists, particularly in the context of the COVID-19 pandemic, during which access may be further restricted. CONCLUSION: Leveraging pharmacists to extend access to MOUD, particularly buprenorphine, remains an underutilized strategy that should be implemented, particularly during the concurrent COVID-19 global pandemic.

Take-Home Naloxone Program Implementation: Lessons Learned From Seven Chicago-Area Hospitals.

Despite consensus recommendations from the American College of Emergency Physicians (ACEP), the Centers for Disease Control and Prevention, and the surgeon general to dispense naloxone to discharged ED patients at risk for opioid overdose, there remain numerous logistic, financial, and administrative barriers to implementing "take-home naloxone" programs at individual hospitals. This article describes the recent collective experience of 7 Chicago-area hospitals in implementing take-home naloxone programs. We highlight key barriers, such as hesitancy from hospital administrators, lack of familiarity with relevant rules and regulations in regard to medication dispensing, and inability to secure a supply of naloxone for dispensing. We also highlight common facilitators of success, such as early identification of a "C-suite" champion and the formation of a multidisciplinary team of program leaders. Finally, we provide recommendations that will assist emergency departments planning to implement their own take-home naloxone programs and will inform policymakers of specific needs that may facilitate dissemination of naloxone to the public.

Management of Breakthrough Pain in Hospitalized Older Adults.

OBJECTIVE: The appropriateness of analgesic administrations based on pain score and medication order in older adults during hospitalization was evaluated. SETTING: As-needed analgesic administrations for geriatric patients on hospitalist general medicine services at a large-university-affiliated medical center from January 1 to March 31, 2015, were included. PRACTICE DESCRIPTION: The hospital is a level one trauma center with more than 500 beds serving an area of more than 500,000 people, 12% of whom are 65 years of age or older. At our institution, breakthrough pain is treated with as-needed analgesic medications based on pain scores specified by the ordering provider. Medication should be given according to which order contains the patient-reported severity of pain. PRACTICE INNOVATION: This is an institutional review board-approved retrospective chart review of 430 analgesic medication administrations in hospitalized older adults. MAIN OUTCOME MEASUREMENTS: Incidence of appropriate medication administration based on pain score report and active medication orders. RESULTS: As-needed analgesic medications were given appropriately 44% of the time based on patient-reported pain score and active medication order. An active medication order was missing to treat the pain score reported by the patient 29% of the time. Out of 430 analgesic administrations, improvement in pain occurred 26% of the time. Pain was reassessed one hour after administration for almost 33% of the orders. Of those, 73% showed an improvement in pain score. CONCLUSION: Our results demonstrate a large discrepancy for hospitalized older adults in what medication is administered compared with what is ordered for as-needed pain treatment. Missing orders contributed to almost one third of inappropriate medication administrations.

Methadone, Buprenorphine, and Naltrexone for the Treatment of Opioid Use Disorder in Pregnant Women.

Pregnant women with opioid use disorder can be treated with methadone, buprenorphine, or naltrexone to reduce opioid use and improve retention to treatment. In this review, we compare the pregnancy outcomes of methadone, buprenorphine, and naltrexone in clinical trials and discuss the potential behavioral and developmental effects of these agents seen in offspring in animal studies. Important clinical considerations in the management of opioid use disorder in pregnant women and their infants are also discussed. Outside of pregnancy, buprenorphine is used in combination with naloxone to reduce opioid abuse and diversion. During pregnancy, however, the use of buprenorphine as a single agent is preferred to prevent prenatal naloxone exposure. Both methadone and buprenorphine are widely used to treat opioid use disorder; however, compared with methadone, buprenorphine is associated with shorter treatment duration, less medication needed to treat neonatal abstinence syndrome (NAS) symptoms, and shorter hospitalizations for neonates. Despite being the standard of care, medication-assisted treatment with methadone or buprenorphine is still underused, making it apparent that more options are necessary. Naltrexone is not a first-line treatment primarily because both detoxification and an opioid-free period are required. More research is needed to determine naltrexone safety and benefits in pregnant women. Animal studies suggest that changes in pain sensitivity, developmental processes, and behavioral responses may occur in children born to mothers receiving methadone, buprenorphine, or naltrexone and is an area that warrants future studies.

Medication-indication knowledge bases: a systematic review and critical appraisal.

OBJECTIVE: Medication-indication information is a key part of the information needed for providing decision support for and promoting appropriate use of medications. However, this information is not readily available to end users, and a lot of the resources only contain this information in unstructured form (free text). A number of public knowledge bases (KBs) containing structured medication-indication information have been developed over the years, but a direct comparison of these resources has not yet been conducted. MATERIAL AND METHODS: We conducted a systematic review of the literature to identify all medication-indication KBs and critically appraised these resources in terms of their scope as well as their support for complex indication information. RESULTS: We identified 7 KBs containing medication-indication data. They notably differed from each other in terms of their scope, coverage for on- or off-label indications, source of information, and choice of terminologies for representing the knowledge. The majority of KBs had issues with granularity of the indications as well as with representing duration of therapy, primary choice of treatment, and comedications or comorbidities. DISCUSSION AND CONCLUSION: This is the first study directly comparing public KBs of medication indications. We identified several gaps in the existing resources, which can motivate future research.

Theoretical pharmacokinetic drug alterations in pediatric celiac disease.

INTRODUCTION: The incidence of pediatric celiac disease has risen and many of these children will receive medications at some time in their life. However, the absorption of drugs in pediatric patients with celiac disease has never been studied. The few studies that do exist have only been performed in adults and indicate that drug concentrations can be altered for some drugs. It is also noteworthy that few researchers have conducted studies to determine if the distribution, metabolism, and excretion of drugs are altered in celiac disease. AREAS COVERED: The pharmacokinetics of drugs greatly differ between children and adults. Combined with the pathophysiological changes known to occur with celiac disease, there is compelling evidence to support that drug exposure in pediatric celiac disease may be altered. Relevant characteristics of celiac disease that may affect drug disposition include intestinal atrophy, hypoalbuminemia, reduced CYP3A enzymes, and thyroid dysfunction. EXPERT OPINION: The safety and efficacy of drug dosing in children with celiac disease can be enhanced with additional pharmacokinetic studies of commonly prescribed drugs in this population. Ideally, these studies should include drugs that have high bioavailability, are highly protein bound, undergo extensive CYP3A enzyme metabolism, and/or have a narrow therapeutic range.

Overview of current and alternative therapies for idiopathic membranous nephropathy.

Membranous nephropathy is one of the leading causes of nephrotic syndrome in adults, which is characterized by edema, hypoalbuminemia, hyperlipidemia, lipiduria, and proteinuria. Determination of idiopathic membranous nephropathy (IMN) disease progression risk is important for guiding initial therapy, with immunosuppressive therapy being reserved for high-risk patients. Because IMN may spontaneously remit in approximately 30% of patients, it is important to carefully select which patients should begin immunosuppressive therapy so as to maximize clinical benefit while limiting toxicity. An observation period of at least 6 months with conservative management that includes the use of angiotensin-converting enzyme inhibitors or angiotensin receptor blockers is recommended. Initial treatment in high-risk IMN is a 6-month course of alternating steroids and alkylating agents. Calcineurin inhibitors (CNIs) represent an alternative first-line therapeutic option for high-risk patients who refuse treatment with steroid or alkylating agent therapy or for whom these treatments are contraindicated. Additional options are essential for patients with IMN who fail to adequately respond to initial therapies or who cannot use recommended therapies due to contraindications or intolerance, risks associated with repetitive dosing with alkylating agents, or potential exacerbation of impaired renal function with CNIs. While evidence for the use of alternative therapies in IMN is modest at best, our review summarizes the available literature for rituximab, mycophenolate mofetil, adrenocorticotropic hormone, intravenous immunoglobulin, and azathioprine. Rituximab has generally demonstrated beneficial outcomes with limited toxicity. Evidence supports a role for mycophenolate mofetil, although the evidence is of low quality and limited duration. Results from ongoing studies are required before adrenocorticotropic hormone can be recommended as therapy for treatment-resistant patients. Intravenous immunoglobulin and azathioprine are unlikely to have a role in IMN. With the advent of new tools and biomarkers measuring disease activity combined with new data regarding possible treatment options, the management and prognosis of IMN are likely to improve.

Bleeding incidence and real-life prescribing practices with dabigatran use in an acute care setting.

OBJECTIVES: Since dabigatran's emergence in the United States market for use in preventing stroke and systemic embolism in nonvalvular atrial fibrillation, the Food and Drug Administration has issued two safety alerts for serious bleeding events. The postmarketing findings, along with anecdotal clinician concerns, prompted this drug utilization evaluation for dabigatran. SETTING: We included all adult patients administered dabigatran from January 1, 2011, to December 31, 2011, while admitted to a large university-affiliated medical center. PRACTICE DESCRIPTION: Dabigatran is available on formulary with a dosing and monitoring policy developed by a multidisciplinary subcommittee of the formulary and therapeutics committee. PRACTICE INNOVATION: This is an institutional review board-approved retrospective chart review of 172 patients administered dabigatran during hospitalization. MAIN OUTCOME MEASUREMENT: Incidence of gastrointestinal bleeds and minor bleeds with the use of dabigatran. RESULTS: The incidence of gastrointestinal bleeds in our study was 2.3% and minor bleeds was 2.3%. Doses outside of the manufacturer's recommendations were not associated with overt bleeds while in the hospital. CONCLUSION: Our results demonstrate that the incidence of bleeds experienced with dabigatran was relatively low despite the reports received by FDA.

Advances in pediatric celiac disease.

PURPOSE OF REVIEW: To summarize the recent advances in celiac disease in children. RECENT FINDINGS: New clues to the pathogenesis of celiac disease continue to emerge that may implicate the role of microbiome changes, antirotavirus VP7 antibodies, and the Parkinson's disease seven gene in celiac disease. Updated guidelines in pediatrics no longer support biopsies in all patients with celiac disease who have been identified by serology, clinical signs, and genetics. Serology screening of total immunoglobulin A in all patients may not be necessary in select patients. Prevalence and additional diseases associated with celiac disease continue to be elucidated. SUMMARY: Our knowledge of celiac disease continues to grow with increasing evidence of the pathogenesis, genetics, diagnosis, and risk factors of the disease. Major changes have been made with respect to the guidelines for pediatric celiac disease, and potential improvements to simplify the algorithms for diagnosis and elimination of unessential testing have been proposed by new studies.

Olmesartan and drug-induced enteropathy.

In three case histories, patients' sprue-like symptoms improved when olmesartan (Benicar) therapy was withheld.

New oral anticoagulants for atrial fibrillation: are they worth the risk?

Atrial fibrillation (AF) is the most common cardiac arrhythmia in the U.S. Anticoagulation is recommended for stroke prevention in AF patients with intermediate-to-high stroke risk (i.e., patients with a CHADS2 score of 1 or greater). Warfarin was previously the only option for oral anticoagulation in these patients, but three new oral anticoagulants have become available as alternatives for warfarin in patients with nonvalvular AF. The advantages of the newer agents include a rapid onset, predictable pharmacokinetics, and no need for routine anticoagulation monitoring. Dabigatran (Pradaxa) and apixaban (Eliquis) have demonstrated improved efficacy compared with warfarin. Rivaroxaban (Xarelto) was non-inferior to warfarin for stroke prevention in AF. Apixaban demonstrated a reduced incidence of major bleeding compared with warfarin and a reduction in all-cause mortality. Limitations to the use of the new oral anticoagulants include the lack of a reversal agent; an inability to use the therapies in specific patient populations (such as those with severe renal or hepatic impairment); limited experience with drug-drug and drug-disease interactions; and a lack of available coagulation tests to quantify their effects. Although the newer agents have higher acquisition costs, the benefits of cost savings may be derived from the potential for decreasing the incidence of hemorrhagic stroke and intracranial bleeding and reducing the need for anticoagulation monitoring. Benefits and risks should be carefully weighed before these agents are prescribed for patients presenting with new-onset AF.

Developing a formal representation for medication appropriateness criteria.

Inappropriate medications use (IMU) is a serious issue of global concern that leads to a waste of resources and potentially harms the patients. IMU can usually be identified by extracting information about the patient's conditions and treatments, and comparing them with "medication appropriateness criteria". To enable automation of these criteria, we developed a formal representation for them, which we called Objective Medication Appropriateness Criteria (OMAC). OMAC represents four aspects of the criteria: trigger, rules, action and metadata. Our evaluation showed that OMAC can completely represent explicitly defined medication appropriateness criteria using links to external knowledge sources. OMAC is the first formal representation for medication appropriateness criteria, and will enable development of structured rules for appropriate use of medications that can be implemented using standards for clinical decision support.

Patient-Centered Tools for Medication Information Search.

Recent research focused on online health information seeking highlights a heavy reliance on general-purpose search engines. However, current general-purpose search interfaces do not necessarily provide adequate support for non-experts in identifying suitable sources of health information. Popular search engines have recently introduced search tools in their user interfaces for a range of topics. In this work, we explore how such tools can support non-expert, patient-centered health information search. Scoping the current work to medication-related search, we report on findings from a formative study focused on the design of patient-centered, medication-information search tools. Our study included qualitative interviews with patients, family members, and domain experts, as well as observations of their use of Remedy, a technology probe embodying a set of search tools. Post-operative cardiothoracic surgery patients and their visiting family members used the tools to find information about their hospital medications and were interviewed before and after their use. Domain experts conducted similar search tasks and provided qualitative feedback on their preferences and recommendations for designing these tools. Findings from our study suggest the importance of four valuation principles underlying our tools: credibility, readability, consumer perspective, and topical relevance.

Drug absorption in celiac disease.

PURPOSE: Published evidence on established and theorized effects of celiac disease on drug absorption and pharmacokinetics is reviewed. SUMMARY: Patients with celiac disease develop a variety of gastric disorders requiring oral medications, but the impact of damage to intestinal villi and other celiac disease sequelae on drug absorption remains poorly understood. A review of the pertinent literature (English-language articles on research in adults published during the period 1970-August 2012) identified several reports of altered drug absorption mechanisms in patients with celiac disease, including accelerated or delayed gastric emptying, increased permeability of jejunal mucosa, changes in intraluminal pH, decreased intestinal surface area, and reduced intestinal cytochrome P-450 enzymes. A small number of published studies suggest that celiac disease may be associated with altered drug absorption, resulting in higher serum concentrations of propranolol, lower peak concentrations of acetaminophen and practolol, higher dosing requirements with levothyroxine, impaired or delayed absorption of certain antibiotics, and other pharmacokinetic effects with a potential impact on medication efficacy and toxicity. However, these studies involved very small patient samples and were poorly controlled, with some yielding contradictory results. More and larger pharmacokinetic studies in patients with celiac disease-especially studies of drugs that are dosed empirically or are not amenable to dosage adjustment according to vital signs or laboratory values-are needed. CONCLUSION: Given the sometimes conflicting data on drug absorption in the context of celiac disease, cautious medication selection, dosage adjustment, and monitoring for efficacy and potential adverse effects are advised.

Role of interleukin-1 inhibitors in the management of gout.

Interleukin-1 (IL-1) inhibitors potentially have a role as antiinflammatory agents in refractory gout or for patients who are unable to tolerate conventional therapy, such as nonsteroidal antiinflammatory drugs (NSAIDs), colchicine, or glucocorticoids, for acute attacks. Additionally, IL-1 inhibitors may also help patients with polyarticular and tophaceous gout by making them less vulnerable to breakthrough attacks during initiation of chronic urate-lowering treatment, the mainstay of gout therapy. Because evidence highlights the role of proinflammatory cytokine IL-1 in the inflammation process during an acute gouty attack, IL-1 inhibitors are used to modulate the pathogenesis of a variety of autoinflammatory diseases, providing support for its potential role in the inflammatory process of gout. After NSAIDs, colchicine, and steroids, IL-1 inhibitors are beneficial as fourth-line therapy for acute gout attacks due to their high cost and limited clinical experience. The IL-1 inhibitors used in gout are anakinra, canakinumab, and rilonacept. Based on published evidence, anakinra has limited support in the form of anecdotal case reports to justify its use for treating gout. Canakinumab's toxic profile in clinical trials precludes its use in treating patients for gout, and rilonacept shows promise with a few well-designed studies to support its use in gout patients initiating urate-lowering treatment. When combined with current traditional therapies, these newer agents present clinicians and patients with more potential treatment options in the difficult-to-treat gout population.