Implementation of a Synergistic, Complementary Pharmacy Practice Model for an Advanced Heart Failure/Heart Transplant Program.

Study Objective: A pharmacy practice model for an Advanced Heart Failure (HF)/Transplant program was designed to address gaps in medication access, medication education and transitions of care (ToC). Activities specific to these initiatives performed by a four-member pharmacy team (3 pharmacists, 1 specialty technician) are described. Methods: Data were prospectively collected in 2020 for 284 admissions involving a high-risk cohort of advanced HF/transplant patients and a similar cohort seen in an ambulatory HF clinic. Interventions including medication reconciliation, e-prescribing, patient consultation and telephone call backs were performed daily to ensure medication access on discharge and as outpatients, comprehensive medication education on a continuum, and improved ToC. Metrics specific to these interventions and revenue reflecting outpatient prescription volume were quantified. Results: Standardized discharge medication education was provided to 97% of the cohort (n = 275). Of the 51 patients newly transplanted or receiving a left ventricular assist device, 100% had medication access on discharge and received follow-up telephone consultation within 48 hours. ToC was performed on admission (97%), pre-operatively (n = 51; 100%), post-operatively (n = 51; 100%) and on discharge (97%). Outpatient prescription volume increased 42% with net revenue increasing 157%. Conclusion: A pharmacy practice model involving an integrated 4-member team improved medication access and education and allowed for ToC at multiple points in the care process thereby improving medication safety. Collaboration between pharmacists and technicians working in inpatient, outpatient and specialty pharmacy settings is encouraged to provide complementary care to high-risk patients.

A Multidisciplinary Educational Approach to Anticoagulation Management for a Percutaneous Endovascular Mechanical Circulatory Support Device.

BACKGROUND: Anticoagulation (AC) management of the Impella varies considerably among treatment centers. Published data regarding the management of complications including heparin-induced thrombocytopenia, bleeding and thrombosis are limited. OBJECTIVE: A multidisciplinary team was assembled to 1) identify baseline knowledge of nurses and pharmacists involved in Impella anticoagulation management; 2) develop an educational tool specific to Impella anticoagulation; 3) reassess knowledge following implementation of the tool. METHODS: A team consisting of pharmacists, nurses and a physician developed surveys that were subsequently distributed to 28 nurses and 17 pharmacists. Survey questions measured knowledge in 4 areas of anticoagulation management: product selection, administration, monitoring and therapeutic recommendation. A pocket card containing flow diagrams for Impella anticoagulation management was developed. Following distribution of the card and education on its application, surveys were redistributed to measure the change in knowledge. RESULTS: The frequency (%) of correct answers for all survey questions for both pharmacists and nurses significantly increased from 38% to 84% (p < 0.00001) and 63% to 93% (p < 0.00001), respectively. Substantial increases in the frequency of correct answers in the majority of question categories were observed for both pharmacists and nurses postintervention. CONCLUSION AND RELEVANCE: Using a multidisciplinary approach, an institution-specific pocket card addressing the complexities of Impella anticoagulation was developed. Following dissemination of the card and education on its application, improved knowledge across the scope of Impella anticoagulation management was observed in both pharmacists and nurses.

Immunosuppression and Heart Transplantation.

Since the first human heart transplant in 1967, immense advancements have been made in the field of immunosuppression. This chapter provides an in-depth analysis of the use of immunosuppressive agents in heart transplant recipients. Evidence regarding maintenance immunosuppressive regimens, the efficacy of induction immunosuppression and corticosteroid weaning, as well as the use of distinct immunosuppression regimens within select patient populations is summarized. This chapter helps elucidate the data regarding contemporary protocols in cardiac transplantation.

Drug-Induced Liver Injury (DILI) With Micafungin: The Importance of Causality Assessment.

Background: Micafungin is increasingly used in the treatment and prevention of candidiasis in hospitalized patients. Limited data are available from which to assess the risk of drug-induced liver injury (DILI) with micafungin. No studies, to date, have applied a standardized causality assessment method to the study of micafungin-associated DILI. Objective: This study aimed to identify the frequency and clinical pattern of DILI in micafungin-treated patients as determined using 2 standardized causality assessment algorithms. Methods: A retrospective analysis was conducted of micafungin-treated patients at a single center between May 15, 2017, and May 15, 2018. DILI was defined on the basis of liver test elevations and the presence of associated signs and symptoms. The Roussel UClaf Causality Assessment Method (RUCAM) and the Naranjo algorithm were applied to each case. Results: A total of 99 patients were assessed; 52 were excluded, with a final sample of 47 evaluable patients. The definition of DILI was met in 9 (19%) patients, with a clinical pattern consistent with cholestatic injury in 7 of 9 (78%) patients. No cases were associated with jaundice. Agreement between the 2 causality assessment methods occurred in 4 of 9 (44%) cases. Application of the RUCAM algorithm led to the exclusion of 4 cases, resulting in a final reported prevalence of micafungin-associated DILI of 10.6%. Conclusion and Relevance: Asymptomatic DILI was identified in 10.6% of micafungin-treated patients. The choice of a causality assessment nomogram substantially influenced the determination of DILI prevalence. Compared with the Naranjo algorithm, the RUCAM algorithm is recommended as a more precise tool of assessing the relationship between drug exposure and DILI.

A lesson in clinical reasoning for the pharmacy preceptor.

PURPOSE: In this article, the pharmacy preceptor is introduced to the core components of the clinical reasoning process. Teaching strategies based on script theory and experiential educational theory are described to aid the pharmacy preceptor in facilitating the development of clinical reasoning in novice practitioners. SUMMARY: The development of clinical reasoning skills is essential for all healthcare providers. Clinical reasoning involves the integration of analytic and nonanalytic reasoning while minimizing the occurrence of cognitive error or bias. Such skills are needed to make diagnoses, formulate treatment plans, and solve clinical problems relating to all facets of healthcare. Teaching strategies by which to facilitate the development of clinical reasoning in physicians, nurses, and other healthcare providers have been described. To date, the topic of clinical reasoning has not been adequately addressed in the pharmacy education or practice literature. CONCLUSION: Clinical reasoning is fundamental to clinical pharmacy practice. Instruction and modeling of this process by preceptors facilitate the development of advanced practitioners.

Implementation of the systems approach to improve a pharmacist-managed vancomycin dosing service.

PURPOSE: Quality improvements achieved by applying the systems approach to assess the clinical effectiveness, operational efficiency, and financial feasibility of a pharmacist-managed vancomycin dosing service are described. SUMMARY: Faced with increased patient volumes and resource demands, the pharmacy department at Tufts Medical Center conducted an evaluation of its adult inpatient vancomycin dosing service using the systems approach, which emphasizes multidisciplinary assessment of system inputs, processes, and outcomes and consensus-building methods to identify needed changes and recommended action steps. A multidisciplinary committee composed of representatives of the medical center's pharmacy, internal medicine, infectious diseases, nursing, phlebotomy, and clinical laboratory services was assembled; in a series of three moderated monthly sessions, committee members deliberated and ultimately reached consensus on a list of action items. Relative to a concurrent intradepartmental assessment of the vancomycin dosing service based solely on pharmacist feedback, the systems approach identified a greater number and wider array of needed improvements in key program areas. Quality improvements implemented as a direct result of the systems-based analysis included a policy change authorizing pharmacists to order serum vancomycin determinations without physician cosignature and inclusion of a vancomycin dosing algorithm in the institutional antibiotic dosing guide. Future changes based on deliverable action items will result in a structured process to help direct program resources toward the patients most in need of pharmacist-managed vancomycin dosing services. CONCLUSION: The systems approach allowed for a comprehensive multidisciplinary evaluation of the service, as indicated by the identification of process improvements not identified by the department of pharmacy alone.

Bivalirudin for treatment of LVAD thrombosis: a case series.

Both platelet- and fibrin-rich thrombi have been described in patients with pump thrombosis associated with continuous flow left ventricular assist devices (LVADs). Bivalirudin is a direct thrombin inhibitor that also inhibits platelet adhesion. Compared to heparin, this hirudin analog is less immunogenic, binds to both free- and clot-bound fibrin, and has a lower risk of major bleeding. In a recently published algorithm on the step-wise approach to the diagnosis and management of LVAD thrombosis, direct thrombin inhibitors were included as a treatment option in the setting of persistent hemolysis, power spikes, and heart failure symptoms. Evidence to support the use of a direct thrombin inhibitor for LVAD thrombosis is limited and anecdotal. We describe the first case series to date of the use of bivalirudin as an alternative to heparin in six hemodynamically stable patients with a total of ten hospitalizations for HeartMate II LVAD thrombosis.

Prasugrel use in a patient allergic to clopidogrel: effect of a drug shortage on selection of dual antiplatelet therapy.

PURPOSE: A case illustrating multiple considerations in choosing safe and effective dual antiplatelet therapy for a patient with a history of clopidogrel allergy-including concerns relating to a national drug shortage-is described. SUMMARY: A 75-year-old woman required dual antiplatelet therapy (aspirin plus a thienopyridine) after a cardiac catheterization procedure; during a prior emergency department visit for acute coronary syndrome, she had experienced an allergic reaction within 24 hours of receiving dual therapy including clopidogrel. A team of pharmacy and allergy staff determined that challenging the patient with prasugrel was the best treatment option. Key considerations in the decision-making process included (1) concerns that an alternative thienopyridine, ticlopidine, might be unavailable for long-term outpatient use due to an ongoing national drug shortage, (2) the patient's concomitant use of metoprolol (cessation of ß-blocker use is recommended for four days before attempted clopidogrel desensitization), and (3) recent reports of the safe use of prasugrel in three patients with a history of clopidogrel allergy. In the case described here, prasugrel administration was effective and did not result in adverse effects; however, the risk of cross-reactivity of clopidogrel and ticlopidine or prasugrel remains largely unknown. The case highlights the importance of careful consideration of a number of patient- and drug-specific factors in the selection of the most appropriate antiplatelet dual therapy for patients with a history of allergic reactions to clopidogrel. CONCLUSION: A shortage of ticlopidine prompted the use of prasugrel in a clopidogrel-allergic patient requiring dual antiplatelet therapy. Prasugrel therapy was well tolerated, with no evidence of allergic reaction.

Assessment of the 4Ts pretest clinical scoring system as a predictor of heparin-induced thrombocytopenia.

STUDY OBJECTIVE: To evaluate the utility of the 4Ts clinical scoring system as a pretest probability method for the detection of heparin-induced thrombocytopenia (HIT). DESIGN: Prospective observational study. SETTING: Medical and surgical inpatients at a tertiary care medical center. PATIENTS: Eighty consecutive patients with suspicion of HIT who had a polyspecific enzyme-linked immunosorbent assay (ELISA) performed between December 1, 2008, and April 1, 2009, for detection of platelet factor 4 (PF4)-heparin antibodies. MEASUREMENTS AND MAIN RESULTS: The predictive value of the 4Ts scoring system as determined by using a standard laboratory marker of HIT--the ELISA--and the interrater reliability of the scoring system were assessed. Sixty-seven (84%) of the 80 patients had low clinical probability of HIT based on the calculated 4Ts score. The ELISA result was negative for PF4-heparin antibodies in 74 patients (93%). Based on the results of the ELISA, the negative predictive value of the 4Ts score was 91%. Each 4Ts score was calculated by two independent investigators and adjudicated by a third investigator when necessary. The interrater reliability of the scoring system was fair (Cohen κ coefficient 0.362, 95% confidence interval [CI] 0.222-0.502; weighted κ coefficient 0.554 (95% CI 0.441-0.667). Determination of the timing of HIT was associated with the largest number of discrepancies (16) between evaluators, followed by other causes of thrombocytopenia (15), degree of decline in platelet count (14), and the presence of thrombosis or other sequelae (2). CONCLUSION: A low 4Ts score supports a low probability of HIT based on the results of the polyspecific ELISA. Overall, the interrater reliability of the scoring system was fair. Components of the 4Ts scoring system need to be further clarified or modified in order to improve interrater reliability and thereby increase the clinical utility of this pretest probability model.

Vancomycin-induced leukocytoclastic vasculitis.

Vancomycin is well recognized as causing the nonallergic skin reaction known as red man syndrome; however, it is rarely suspected as causative in the setting of an immune-mediated skin reaction. We describe a 76-year-old Caucasian woman with a history of penicillin and sulfa allergies who was transferred to our medical center while receiving vancomycin for treatment of persistent methicillin-sensitive Staphylococcus aureus (MSSA) bacteremia. After admission, the patient's pacemaker was explanted; cultures from the pacemaker grew MSSA. Based on the culture data and her allergy to penicillin, vancomycin was continued. On day 4 of therapy, the patient developed a papular rash with small blisters on her distal upper extremities. Furosemide, which she was receiving intermittently to maintain fluid balance, was initially suspected as the likely cause. Furosemide was withheld; however, the rash worsened and spread to her neck and torso. Results of skin biopsy confirmed a severe leukocytoclastic, necrotizing small-cell vasculitis that met the criteria for a hypersensitivity vasculitis associated with drug therapy. Five days after discontinuation of vancomycin, the vasculitis was resolving and continued to resolve throughout the remainder of her hospitalization. Furosemide was readministered without worsening of the vasculitis. Use of the Naranjo adverse drug reaction probability scale indicated that the likelihood of vancomycin being the cause of the vasculitis was probable (score of 5). Clinicians should be aware of vancomycin as a potential cause of small-vessel vasculitis.

Predictors of mortality in patients with suspected propofol infusion syndrome.

OBJECTIVES: To identify predictors of mortality in patients with suspected propofol infusion syndrome and to develop a simple scoring system to identify patients with suspected propofol infusion syndrome who are most at risk of death. DESIGN: Retrospective, database analysis. SETTING: MEDWATCH system. PARTICIPANTS: Reports (1989-2005) where propofol was associated with > or = 1 of 24 published propofol infusion syndrome clinical manifestations. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: After comparison of demographic and clinical manifestations between survivors and nonsurvivors, a multivariate logistic regression model was built through a stepwise selection process and then used to develop a simplified mortality scoring system. Of 1139 patients with suspected propofol infusion syndrome, 342 (30%) were fatal. Death was more likely if patients were < or = 18 yrs (odds ratio [95% confidence interval], 2.3 [1.7-3.2]), male (1.3 [1.1-1.7]), received a vasopressor (1.8 [1.3-2.5)]), or had the following clinical manifestations: cardiac (3.8 [2.88-4.91]), metabolic acidosis (3.7 [2.7-5.0]), renal failure (1.9 [1.4-2.6]), hypotension (1.8 [1.3-2.3]), rhabdomyolysis (1.8 [1.3-2.3]), or dyslipidemia (2.0 [1.2-3.4]). The multivariable modeling process found that cardiac symptoms, rhabdomyolosis, hypotension, metabolic acidosis, renal failure, and age each affected survival, although significant interactions existed between some of these factors. Based on the combination of the presence or absence of the six factors in the multivariate model, a propofol infusion syndrome mortality risk score of 0 to 4 resulted in a predicted %/observed % mortality for each score of 0 (10%/10%), 1 (24%/24%), 2 (47%/44%), 3 (72%/81%), and 4 (89%/83%). CONCLUSIONS: A number of characteristics are independently associated with higher mortality in patients with suspected propofol infusion syndrome, only some of which are currently reflected in the package insert. Further research should focus on prospectively evaluating the mortality scoring system in patients with suspected propofol infusion syndrome.

Nonbloody, red stools from coadministration of cefdinir and iron-supplemented infant formulas.

Cefdinir is an extended-spectrum, third-generation cephalosporin that may be used for treatment of acute otitis media in patients allergic to penicillin. When administered with iron-containing products, including infant formulas, cefdinir or one of its metabolites may bind to ferric ions, forming a nonabsorbable complex that imparts a reddish color to the stool. We describe a 9-month-old infant with failure to thrive and acute otitis media who developed an erythematous maculopapular rash during treatment with amoxicillin-clavulanate. His antibiotic therapy was changed to cefdinir. Five days into a 10-day course of therapy, the infant's mother brought him to the pediatric clinic and reported the appearance of red stools. He had no associated gastrointestinal symptoms (vomiting, abdominal pain, or diarrhea). His hematocrit and hemoglobin level were normal, and Clostridium difficile antigen studies and tests for species of Shigella, Salmonella, and Camphylobacter as well as ova and parasites were all negative. Cefdinir was discontinued, and his stools returned to normal within 48 hours. Three weeks later, he again received cefdinir for recurrent otitis media. Red stools reappeared 48 hours later, were determined to be guaiac negative, and resolved within hours of drug discontinuation. During both occurrences of red stools, the infant had been breastfed and was receiving supplemental feedings with an iron-containing infant formula. In the product labeling of cefdinir, this adverse event is described as a consequence of the drug-drug interaction; however, it is not listed in the adverse drug reaction section of the labeling. As such, one may miss the association between cefdinir and reddish stools when investigating this event as a potential adverse reaction to cefdinir. When using the Naranjo adverse drug reaction probability scale to assess causality in our patient's case, this adverse drug reaction was determined as highly probable. As this infant had been breastfed, the use of a supplemental iron-containing infant formula was not identified as a potential contributing factor until the second occurrence of red stools. Health care professionals should review the entire product labeling, including the drug-drug interaction section, when investigating a potential adverse drug reaction. With the recent approval of generic formulations of cefdinir, clinicians should be aware of this drug-drug interaction with iron-containing products to prevent unnecessary alarm by parents and caregivers, as well as costly medical evaluations for gastrointestinal bleeding.

An advanced pharmacy practice experience in academia.

OBJECTIVES: To create an advanced pharmacy practice experience (APPE) that would encourage students to consider a career in academia. DESIGN: A 6-week, 6-credit elective APPE was created that offered students the opportunity to observe and participate in activities consistent with a full-time faculty appointment. ASSESSMENT: A 9-question survey instrument was administered to 27 students who completed the APPE between 2000 and 2004 to determine the impact of the APPE on the student's career choice. Sixteen (59%) of the 27 students returned the completed survey instrument. Ten of the 16 respondents noted that the APPE had influenced their pursuit of a position with a teaching component. CONCLUSION: Offering APPEs in academia may encourage students to incorporate teaching and scholarship into their career plans.