Developing a Comprehensive Framework of Safeguarding Strategies to Address Anticipated Errors With Organizational High-Alert Medications.

Purpose: To describe the development of a comprehensive framework of safeguarding strategies to address observed/anticipated errors with organizational high-alert medications. Methods: Observed/anticipated errors were identified for organizational high-alert medications and medication classes based on a review of external literature and alerts as well as internal voluntary error reporting. Anticipated or frequently reported errors were categorized into common cause error types. Error reduction strategies to address each common cause error were identified in collaboration with medication safety specialists and specialty practice pharmacists. Results: The review of externally and internally reported errors identified 101 observed/anticipated common cause errors across the 19 high-alert medication classes (median 5 error types per medication class, interquartile range 3-6). Safeguarding strategies specific to high-alert medications were identified in the following domains: separate or sequestered storage; restricted ordering; active alerts; dispensing in patient-specific dosing, unit of use, or unit-dose packaging; dispensing from pharmacy only; auxiliary labeling; level of care restriction; required monitoring; independent double checks; certification/privileging of staff; specific guidelines for use/monitoring; and other/miscellaneous. Identification of the observed/anticipated errors and the associated safeguarding strategies facilitated the development of a comprehensive tool and visual framework for addressing common cause errors associated with organizational high-alert medications. Conclusion: A comprehensive framework of safeguarding strategies to address anticipated errors with organizational high-alert medications is proposed. Although individual safeguards are institution-specific, the framework can be leveraged by all hospitals in order to take inventory of error-reduction strategies and prospectively identify gaps to address common cause errors.

The potential for floral evolution in response to competing selection pressures following the loss of hawkmoth pollination in Ruellia humilis.

PREMISE: In the absence of hawkmoth pollinators, chasmogamous (CH) flowers of Ruellia humilis self-pollinate by two secondary mechanisms. Other floral visitors might exert selection on CH floral traits to restore outcrossing, but at the same time preferential predation of CH seeds generates selection to increase the allocation of resources to cleistogamous (CL) flowers. METHODS: To assess the potential for an evolutionary response to these competing selection pressures, we estimated additive genetic variances ( σ A 2 ${\sigma }_{{\rm{A}}}^{2}$ ) and covariances for 14 reproductive traits and three fitness components in a Missouri population lacking hawkmoth pollinators. RESULTS: We found significant σ A 2 ${\sigma }_{{\rm{A}}}^{2}$ for all 11 floral traits and two measures of resource allocation to CL flowers, indicating the potential for a short-term response to selection on most reproductive traits. Selection generated by seed predators is predicted to increase the percentage of CL flowers by 0.24% per generation, and mean stigma-anther separation is predicted to decrease as a correlated response, increasing the fraction of plants that engage in prior selfing. However, the initial response to this selection is opposed by strong directional dominance. CONCLUSIONS: The predicted evolutionary decrease in the number of CH flowers available for potential outcrossing, combined with the apparent preclusion of potential diurnal pollinators by the pollen-harvesting activities of sweat bees, suggest that 100% cleistogamy is the likely outcome of evolution in the absence of hawkmoths. However, rare mutations with large effects, such as delaying budbreak until after sunrise, could provide pathways for the restoration of outcrossing that are not reachable by gradual quantitative-genetic evolution.

Description of the role of pharmacist independent double checks during cognitive order verification of outpatient parenteral anti-cancer therapy.

INTRODUCTION: To describe pharmacist interventions as a result of an independent double check during cognitive order verification of outpatient parenteral anti-cancer therapy. METHODS: A single-center, retrospective analysis of all individual orders for outpatient, parenteral anti-cancer agents within a hematology/oncology infusion center during a 30 day period was conducted. The primary endpoint was error identification rates during first and second verification. Secondary endpoints included the type, frequency, and severity of errors identified during second verification using a modified National Coordinating Council for Medication Error Reporting and Prevention Index. RESULTS: A total of 1970 anti-cancer parenteral orders were screened, from which 1645 received an independent double check and were included. The number of errors identified during first and second verification were 30 (1.8%) and 10 (0.6%) respectively; second verification resulted in a 33.3% increase in corrected errors. The 10 errors identified during second verification included: four rate transcriptions to optimize pump interoperability, three rate and/or volume modifications, two dosage adjustments, and one treatment deferral due to toxicity. The severity was classified as Category A for four (40%), Category C for three (30%), and Category D for three (30%) errors. This correlated to a low capacity for harm for seven (70%) and a serious capacity for three (30%) errors. CONCLUSIONS: Second verification of outpatient, parenteral anti-cancer medication orders resulted in a 33.3% increase in corrected errors. Three errors detected during second verification were determined to have a serious capacity for harm, supporting the value of independent double checks during pharmacist cognitive order verification.

Prospective Study of a Novel Risk Stratification Process for Opioid-Related Harm Reduction in Cancer Patients Seen in an Outpatient Palliative Care Clinic.

Background: Oncologists and palliative specialists prescribe opioids for millions of cancer patients despite limited research on effective screening and mitigation strategies to reduce risk of opioid-related harm in that population. Objective: To evaluate the efficacy of a novel opioid risk stratification process for predicting significant aberrant behaviors (SABs) related to prescribed opioid medications. Design and Setting/Subjects: This is a prospective, longitudinal study of 319 consecutive patients referred to an outpatient palliative care clinic between 2010 and 2012, a period during which prescription opioid-related deaths began to increase in the United States. Measures: Patients completed a psychodiagnostic/substance use risk assessment with a licensed clinical psychologist or social worker at the initial palliative clinic visit. Patients were assigned to Low-, Moderate-, or High-Risk groups based on predetermined stratification criteria and were managed via an opioid harm reduction approach. The primary dependent measure was the presence of at least one SAB after the initial visit. Results: Eighteen percent of patients (n = 56) demonstrated at least one major aberrant behavior. Odds of future aberrant behavior was 15 times greater in the High-Risk versus the Low-Risk category. Five risk factors significantly enhanced our risk model: age 18 to 45 years, job instability, history of bipolar diagnosis, history of substance abuse, and theft. Conclusion: Our risk stratification process provides a useful model for predicting those at greatest risk of future aberrant behaviors and most in need of comanagement. We recommend additional studies to test our proposed streamlined risk stratification tool.

Pharmacogenomics of sickle cell disease: steps toward personalized medicine.

Sickle cell disease (SCD) is a monogenetic disease but has a wide range of phenotypic expressions. Some of these differences in phenotype can be explained by genetic polymorphisms in the human globin gene. These polymorphisms can result in different responses to typical treatment, sometimes leading to inadequate therapeutics. Research is revealing more polymorphisms, and therefore, new targets for intervention to improve outcomes in SCD. This area of pharmacogenomics is continuing to develop. We provide a brief review of the current literature on pharmacogenomics in SCD and possible targets for intervention.

Diltiazem for the management of malignancy-associated perineal pain and tenesmus.

BACKGROUND: Perineal pain is a frequent complaint of patients with advanced cancer (colorectal, genitourinary, prostate), and often quite difficult to manage with significant impact on quality of life. Calcium channel blockers (CCBs) are potent inhibitors of intestinal smooth muscle contraction and have been shown to impact tone and motility of the gastrointestinal tract. As such, they have been used in various pain syndromes of the lower gastrointestinal tract, such as chronic anal fissure, to promote healing and improve pain. Here we describe two cases using oral diltiazem for malignancy-associated perineal pain and tenesmus. DISCUSSION: The first case describes an elderly male with advanced urothelial cancer post surgical resection and chemoradiation who suffered from rectal pain described as "sitting on a football" despite nerve blocks and oral opioids. He experienced dramatic improvement in pain scores and daily requirements of oral analgesics after starting oral diltiazem. The second case describes a middle-aged female with rectal cancer post surgical resection and chemoradiation who suffered from quality-of-life-limiting rectal pain and pressure despite oral opioids. She experienced dramatic improvement in the "pressure-type" pain after adding oral diltiazem. CONCLUSION: Based on our experience with these two cases, we propose oral diltiazem for use as an adjunct therapy for management of chronic malignancy-associated perineal pain, specifically with characteristics of pressure-type pain and tenesmus.