Susan J. Skledar

Use of Lipid Emulsion to Reverse Local Anesthetic–Induced Toxicity

Objective: To evaluate the use of lipid emulsion for reversal of local anesthetic–induced toxicity. Data Sources: Literature was accessed through PubMed and OVID (1966–May 2007) using the search terms lipid emulsion and local anesthetic. Reference lists were consulted to identify additional publications. Study Selection and Data Extraction: All articles published in English were evaluated for inclusion. Publications describing the use of lipid emulsion for reversal of local anesthetic in either humans or animals were included. Data Synthesis: It has been suggested that lipid emulsion (Intralipid) may reverse local anesthetic toxicity by extracting lipophilic local anesthetics from aqueous plasma or tissues or by counteracting local anesthetic inhibition of myocardial fatty acid oxygenation. Studies in rats and dogs have shown that lipid emulsion is effective in resuscitating animals who are asystolic after the administration of intravenous bupivacaine. Three case reports support the use of lipid emulsion to reverse systemic toxicity, including seizures, electrocardiogram abnormalities, and cardiac arrest, resulting from the administration of levobupivacaine, ropivacaine, bupivacaine, or mepivacaine. The regimens used in these cases consisted of bolus doses of 1,2–2 mL/kg followed by continuous infusions of 0.25–0.5 mL/kg/min. All of the patients recovered fully with no neurologic sequelae. Conclusions: Literature describing animal studies and human case reports suggests that lipid emulsion is effective in the reversal of local anesthetic toxicity. The potential risks of administering the relatively high doses of this agent are uncertain, and the optimal dose has not been established. In light of these uncertainties, it is appropriate to administer lipid emulsion only after advanced cardiac life support has failed and prior to cardiopulmonary bypass

Increasing pneumococcal vaccination rates among hospitalized patients.

OBJECTIVE To increase the proportion of inpatients vaccinated against pneumococcal infection. DESIGN Pre- and post-intervention study. SETTING University medical center-affiliated, suburban community teaching hospital. PATIENTS Unvaccinated inpatients 65 years and older and those 2 to 64 years old who had chronic medical conditions predisposing them to invasive pneumococcal infection. INTERVENTION The nursing staff screened newly admitted patients for eligibility based on age, diagnosis, or medications from a computer-generated admissions list and placed a pre-printed order form for the pneumococcal polysaccharide vaccine (PPV) on the charts of eligible patients. Following the physicians order, the nursing staff administered the PPV and recorded it Ongoing quality improvements including admission vaccination screening and computer-based record keeping were initiated to identify unvaccinated eligible patients and track vaccination status. RESULTS Efforts resulted in rates of in-hospital vaccination ranging from 3.1% to 7.9% (mean, 5.2% +/- 1.7% [standard deviation]) and significant improvements in the assessment of previous vaccination status, reaching 54% of eligible patients after 1 year. Ascertainment of a previous vaccination increased significantly following the initiation of the use of admission forms that specifically assessed vaccination status and a system to permanently record vaccination status in an electronic medical record (P < .05). CONCLUSION Concerted efforts using electronic medical records significantly improved the assessment and documentation of inpatient vaccination status. Greater improvement of the rates of in-hospital vaccination will require healthcare system-wide efforts such as a standing order policy for vaccinating all eligible patients. Standing orders for inpatient immunization supported by effective assessment and tracking systems have the potential to raise vaccination rates to the goals of Healthy People 2010.

Designing a Strategy to Promote Safe, Innovative Off-Label Use of Medications:

Innovative off-label medication use (defined as prescribing with reasonable rationale for use, but insufficient evidence to allay safety, efficacy, and cost-effectiveness concerns, yet is not clinical research) is common practice and provides challenges to ensuring high-quality health care and patient safety. This article describes a strategy to promote policy and standardization of innovative off-label medication use, ensure oversight of patient safety, and prospectively assess efficacy. A multidisciplinary group developed a policy and process to regulate innovative off-label medication use that standardizes formulary review, maximizes peer expertise input, and minimizes institution liability by evaluating the effectiveness of use, promoting evidence-based practices, and ensuring ethical obligations to patients and society. This strategy has been implemented through institutional staff structure. The review process balances benefits/risks for biologically plausible therapy that lacks rigorous data support. The authors’ strategy illustrates collaboration that enables a priori consideration for innovative off-label medication use while providing safety surveillance and outcomes monitoring.

Overcoming barriers to establishing an inpatient vaccination program for pneumococcus using standing orders.

OBJECTIVES To identify and classify barriers to establishing a standing orders program (SOP) for adult pneumococcal vaccination in acute care inpatient facilities and to provide recommendations for overcoming these roadblocks. Vaccination rates in hospitals with SOPs are generally higher than those in hospitals that require individual physician orders. The array of solutions drawn from our experience in different hospital settings should permit many types of facilities to anticipate and overcome barriers, allowing a smoother transition from initiation to successful implementation of an inpatient pneumococcal vaccination SOP. DESIGN Descriptive study of barriers and solutions encountered during implementation of a pneumococcal vaccination SOP in three hospitals of the University of Pittsburgh Medical Center Health System (UPMC) and in the scientific literature. SETTING As of 2004, two UPMC tertiary-care hospitals and one UPMC community hospital had incorporated SOPs into existing physician order-driven programs for inpatient vaccination with pneumococcal polysaccharide vaccine. RESULTS Barriers were identified at each step of implementation and categorized as patient related, provider related, or institutional. Based on a process of continual review and revision of our programs in response to encountered barriers, steps were taken to overcome these impediments. CONCLUSIONS A strong commitment by key individuals in the facilitys administration including a physician champion; ongoing, persistent efforts to educate and train staff; and close monitoring of the vaccination rate were essential for successful implementation of a SOP for pneumococcal vaccination of eligible inpatients. Legal statutes and evaluations of external hospital-rating associations regarding the effectiveness of the vaccination program were major motivating factors in its success.

Promethazine Adverse Events after Implementation of a Medication Shortage Interchange

BACKGROUND: Prochlorperazine and droperidol were commonly used antiemetics at the University of Pittsburgh Medical Center– Presbyterian Hospital until a shortage of prochlorperazine occurred and a black box warning was added to droperidol prescribing information. Subsequently, promethazine was selected as the approved intravenous antiemetic for therapeutic interchange in December 2001. Promethazine use and adverse drug events (ADEs) were investigated following review of a serious ADE that identified promethazine use as a probable contributing factor. OBJECTIVE: To illustrate ADEs associated with promethazine and characterize high-risk patients. METHODS: An ADE database analysis identified promethazine ADEs reported from 2000 to 2003. Promethazine utilization and ADEs were compared with those of other antiemetics during the pre- and post-interchange periods. RESULTS: Promethazine utilization increased significantly during the post-interchange period compared with all other antiemetics (p < 0.001). Promethazine ADEs increased from one event during the pre-interchange period to 13 events during the post-interchange period. Causality assessment using the Naranjo algorithm ranged from possible to probable. The promethazine ADE rate per 10 000 doses was significantly higher than the combined ADE rate for all other antiemetics (p < 0.001; incident rate ratio [IRR] 4.32). Elderly patients (aged ≥65 y) experienced more promethazine ADEs than younger patients (p = 0.005; IRR 4.68). Concurrent use of opioids and/or sedating drugs contributed to promethazine ADEs in 11 of 14 (78.6%) patients. CONCLUSIONS: Geriatric status is a significant risk factor for promethazine ADEs. Concomitant use of sedating drugs may further increase the risk for ADEs. Therapeutic interchange programs should be monitored for both ADEs and utilization.

Eliminating postoperative nausea and vomiting in outpatient surgery with multimodal strategies including low doses of nonsedating, off-patent antiemetics: is "zero tolerance" achievable?

For ondansetron, dexamethasone, and droperidol (when used for prophylaxis), each is estimated to reduce risk of postoperative nausea and/or vomiting (PONV) by approximately 25%. Current consensus guidelines denote that patients with 0–1 risk factors still have a 10–20% risk of encountering PONV, but do not yet advocate routine prophylaxis for all patients with 10–20% risk. In ambulatory surgery, however, multimodal prophylaxis has gained favor, and our previously published experience with routine prophylaxis has yielded PONV rates below 10%. We now propose a “zero-tolerance” antiemetic algorithm for outpatients that involves routine prophylaxis by first avoiding volatile agents and opioids to the extent possible, using locoregional anesthesia, multimodal analgesia, and low doses of three nonsedating off-patent antiemetics. Routine oral administration (immediately on arrival to the ambulatory surgery suite) of perphenazine 8 mg (antidopaminergic) or cyclizine 50 mg (antihistamine), is followed by dexamethasone 4 mg i.v. after anesthesia induction (dexamethasone is avoided in diabetic patients). At the end of surgery, ondansetron (4 mg i.v., now off-patent) is added. Rescue therapy consists of avoiding unnecessary repeat doses of drugs acting by the same mechanism: haloperidol 2 mg i.v. (antidopaminergic) is prescribed for patients pretreated with cyclizine or promethazine 6.25 mg i.v. (antihistamine) for patients having been pretreated with perphenazine. If available, a consultation for therapeutic acupuncture procedure is ordered. Our approach toward “zero tolerance” of PONV emphasizes liberal identification of and prophylaxis against common risks.

United States medical practice summary: innovative off-label medication use.

Data are limited regarding how academic medical centers (AMCs) deal with medication use that represents a departure from product labeling; has reasonable rationale for use, but insufficient evidence to allay safety, efficacy, and cost-effectiveness concerns; yet is not clinical research (defined as innovative off-label medication use). This report describes national trends in management of innovative off-label medication use. A cross-sectional survey of US AMCs was conducted. Survey questionnaires were directed to drug information centers or pharmacy directors. Of 469 AMCs contacted, 104 responded (22%). Fifty-nine AMCs identified innovative off-label use as a challenge. Only 18 AMCs developed strategies to address this issue: 12 requiring initial reviews and 8 requiring clinical monitoring. Sixty-five AMCs indicated interest in data sharing of clinical outcomes for innovative off-label protocol(s). Innovative off-label medication use is a widely recognized challenge; however, few prospectively active AMC responses exist. The authors suggest development of systematic structured approaches within and across AMCs.

Core Competencies for Research Training in the Clinical Pharmaceutical Sciences

Objective. To identify and apply core competencies for training students enrolled in the clinical pharmaceutical scientist PhD training program at the University of Pittsburgh School of Pharmacy. Design. Faculty members reached consensus on the required core competencies for the program and mapped them to curricular and experiential requirements. Assessment. A rubric was created based on core competencies spanning 8 major categories of proficiency, and competencies of clinical versus traditional PhD training were delineated. A retrospective evaluation of the written comprehensive examinations of 12 former students was conducted using the rubric. Students scored above satisfactory in 11 out of 14 comprehensive examination metrics, with a mean score greater than 3.8 on a 5-point scale. Conclusions. The core competencies identified will provide an essential foundation for informed decision-making and assessment of PhD training in the clinical pharmaceutical sciences.

Training and recruiting future pharmacists through a hospital-based student internship program

PURPOSE A hospital-based pharmacy internship program is described. SUMMARY The University of Pittsburgh Medical Center (UPMC) is a 19-hospital partnership affiliated with the University of Pittsburgh Schools of the Health Sciences, serving over 4 million patients per year through its community and teaching hospitals, community care programs, and managed care insurance product. UPMC created a structured pharmacy internship program that provides students with the skills to prepare them for future employment in a hospital or institutional pharmacy setting and creates a hiring and benefits infrastructure focused on student retention after graduation. During the first year of the internship, the training for the student pharmacist focuses on hands-on learning in hospital pharmacy operations. Subsequent years provide the opportunity to learn from pharmacists in a variety of practice sites, training side by side and working on a project with a pharmacist in a specialty area of the students choice. A pathway of sequential job classifications with increasing salary and the advantage of accruing years of service with UPMC was established through administrative approval. Additional financial incentives offer encouragement for students to accept pharmacist positions at UPMC after graduation. Since the internships inception in 2004, eight interns have completed the program. Of these, four are employed by UPMC as hospital pharmacists, and another is completing a postgraduate year 1 residency at UPMC. CONCLUSION A four-year, structured pharmacy internship program at UPMC provided students with early experience in hospital pharmacy practice and resulted in successful training and retention of the interns as pharmacists at UPMC.

The impact of hospital pharmacist and technician teams on medication-process quality and nurse satisfaction

Purpose This project deployed pharmacist and technician teams on patient care units to improve (1) the quality of the medication process and (2) nurse satisfaction with pharmacy services. Methods An interdisciplinary team developed a decentralized pharmacy model, establishing complimentary roles for pharmacists and technicians based on their current roles, expected roles, and published evidence. A trained nurse or pharmacist observed the medication process before and after implementing the service model; nurses were surveyed for satisfaction with pharmacy services. Statistical analysis of changes in order-processing times and nurse satisfaction were determined using an independent samples t-test (CI = 0.95, P < 0.05). Results Two processes were significantly improved before after implementing the decentralized model (PRE vs POST): (1) order entry time, PRE 24.4 ± 18.1 min (Mean ± SD) vs POST 12.1 ± 10.5 min, P = 0.001; (2) order delivery time, PRE 50.5 ± 18.9 min vs POST 27.5 ± 15.2 min, P = 0.048. Nursing satisfaction significantly improved after implementation of the decentralized model, specifically in perception of quality, PRE (Median score = 3) vs POST (Median score = 4), P = 0.04, timely delivery of STAT and routine medications PRE (Median score = 2) vs POST (Median Score = 4, P = 0.00, pharmacy as an asset to patient care PRE (Median score = 3) vs POST (Median Score = 5), P = 0.04, and effective pharmacy and nursing communication PRE (Median score = 2) vs POST (Median Score = 4), P = 0.04. Pharmacists increased their medication safety interventions and documentation almost five-fold. Conclusions Pharmacist-technician teams on the patient care units improved service and nurse satisfaction and may be a useful method for decentralizing pharmacy services in hospitals that do not have satellites.