Treatment of heparin-induced thrombocytopenia before and after the implementation of a hemostatic and antithrombotic stewardship program.

In October 2013, we implemented a hemostatic and antithrombotic (HAT) stewardship program with the primary focus of ensuring appropriate use of intravenous direct thrombin inhibitors (DTI) in patients with heparin-induced thrombocytopenia (HIT). We sought to compare the duration and cost of DTI therapy for the management of HIT before and after implementation of the HAT stewardship program. Following institutional review board approval, we conducted a single center, retrospective chart review of all patients with a suspected diagnosis of HIT as assessed by an anti-heparin-PF4 enzyme-linked immunosorbent assay 6 months pre-HAT and post-HAT implementation. Patients were excluded if they were initiated on a DTI at an outside hospital, had a prior episode of HIT, or received mechanical circulatory support. Clinical characteristics, including demographics, comorbidities, medications, laboratory values, clinical and safety outcomes, length of stay, and mortality, were collected. A total of 592 patients were included; 333 patients were evaluated pre-HAT, while 259 patients were evaluated post-HAT. The mean duration of DTI treatment was significantly decreased in the post-HAT cohort (6.64 vs 5.17 days, p = 0.01), primarily driven by decreased duration of use for patients with suspected HIT (4.07 vs 2.86 days, p = 0.01). The HAT Stewardship program demonstrated a total decrease in annual costs associated with the diagnosis and management of HIT of $248,500. Our results indicate that the implementation of the HAT stewardship program had a significant impact on reducing the duration and costs of DTI therapy and the costs of laboratory evaluations in the management of HIT at our institution.

Implementation of a Hemostatic and Antithrombotic Stewardship program.

Hemostatic and antithrombotic (HAT) agents are high risk, high cost products. They require close monitoring and dose titration to adequately treat or prevent thrombosis while avoiding bleeding events. Incorporating the principles of inpatient anticoagulation management service into a stewardship program not only improves outcomes and decreases cost, but also improves transitions of care, exposes gaps in therapy management, and leads to the development of institution specific protocols and guidelines. We implemented a HAT Stewardship to provide real time clinical surveillance and management of these agents in an effort to optimize appropriate use, decrease serious adverse events, and minimize costs. The stewardship is staffed daily by an interdisciplinary team comprised of a pharmacist, hematology attending, and medical director. The stewardship focuses on (1) management of heparin-induced thrombocytopenia (HIT), (2) management of patients with Hemophilia A/B with inhibitors and acquired Factor VIII deficiency due to inhibitors, (3) oversight of anticoagulation in patients on extracorporeal membrane oxygenation and (4) assistance with anticoagulation management for patients with mechanical cardiac assist devices. Through implementation of this service, we have been able to demonstrate improved patient care and a positive economic impact exceeding the cost of this program by almost sixfold. Other centers should consider instituting a HAT Stewardship to maximize patient outcomes and minimize adverse events.

Effect of bar-code technology on the safety of medication administration.

BACKGROUND: Serious medication errors are common in hospitals and often occur during order transcription or administration of medication. To help prevent such errors, technology has been developed to verify medications by incorporating bar-code verification technology within an electronic medication-administration system (bar-code eMAR). METHODS: We conducted a before-and-after, quasi-experimental study in an academic medical center that was implementing the bar-code eMAR. We assessed rates of errors in order transcription and medication administration on units before and after implementation of the bar-code eMAR. Errors that involved early or late administration of medications were classified as timing errors and all others as nontiming errors. Two clinicians reviewed the errors to determine their potential to harm patients and classified those that could be harmful as potential adverse drug events. RESULTS: We observed 14,041 medication administrations and reviewed 3082 order transcriptions. Observers noted 776 nontiming errors in medication administration on units that did not use the bar-code eMAR (an 11.5% error rate) versus 495 such errors on units that did use it (a 6.8% error rate)--a 41.4% relative reduction in errors (P<0.001). The rate of potential adverse drug events (other than those associated with timing errors) fell from 3.1% without the use of the bar-code eMAR to 1.6% with its use, representing a 50.8% relative reduction (P<0.001). The rate of timing errors in medication administration fell by 27.3% (P<0.001), but the rate of potential adverse drug events associated with timing errors did not change significantly. Transcription errors occurred at a rate of 6.1% on units that did not use the bar-code eMAR but were completely eliminated on units that did use it. CONCLUSIONS: Use of the bar-code eMAR substantially reduced the rate of errors in order transcription and in medication administration as well as potential adverse drug events, although it did not eliminate such errors. Our data show that the bar-code eMAR is an important intervention to improve medication safety. (ClinicalTrials.gov number, NCT00243373.)

A safe practice standard for barcode technology.

OBJECTIVE: Safety advocates have identified barcode verification technology as an important tool to improve health-care practices. METHODS: We evaluated the evidence for the role of barcode technology in improving a wide range of medication safety outcomes across a broad range of settings. Important implementation issues were highlighted to guide standards for the safe adoption of barcode technology. RESULTS: Adverse drug events are common, occurring frequently in both inpatient and outpatient settings. Although approximately half of all preventable adverse drug events in inpatients result from medication errors arising from transcription, dispensing, and administration, these errors are far less likely to be caught than in any of the earlier stages of the medication use process and are therefore most amenable to improvement. When integrated with electronic medication administration records, barcode systems are associated with complete elimination of transcription errors. Furthermore, barcode-assisted dispensing systems are associated with 93% to 96% reductions in dispensing errors, and 85% reductions in potential adverse drug events in dispensing. Most studies have reported large and significant reductions in administration errors by up to 80% after implementation of barcode medication administration systems. Although most studies of barcode technology have been conducted in the adult inpatient setting, the limited data available also support their benefit in pediatric and outpatient settings. CONCLUSIONS: There is growing evidence for the efficacy of barcode solutions in improving overall medication safety. Standards for the implementation of barcode technology are proposed.

An algorithmic computerised order entry approach to assist in the prescribing of new therapeutic agents: case study of activated protein C at an academic medical centre.

BACKGROUND: Academic medical centres face the need to care for patients with complex medical conditions, educate physicians-in-training and conduct research, all with increasingly constrained budgets. The adoption of new therapeutic technology presents challenges and opportunities in each of these areas. Severe sepsis remains a major cause of morbidity and mortality, especially in tertiary-care facilities. Recombinant human activated protein C reduces mortality in patients with severe sepsis, but trial data indicate that the benefit of the drug is confined to the more seriously ill patients, while the risk of bleeding complications can be considerable. The cost of the drug is approximately USD 6000-8000 per treated patient. Integration of this product into routine care has produced unique challenges concerning clinical decision making, safety and cost. OBJECTIVES: To describe one hospital's multidisciplinary approach to the adoption of this new medication. METHODS: Before activated protein C was approved for use, Brigham and Women's Hospital (BWH) convened a working group to formulate clinical guidelines proactively. This new agent did not fit into an obvious therapeutic category but cut across multiple clinical disciplines requiring the involvement of several hospital departments in developing policy. As new data on efficacy emerged during the US FDA review of the drug, the working group had to devise a method for using the available information to assist clinical decision making while placing appropriate restrictions on the use of activated protein C. The goal was to make accurate information available to guide ordering physicians' decision making interactively, 24 hours a day. RESULTS: The committee developed a utilisation policy for activated protein C that provided guidance on patient selection, contraindications and risk stratification. Interactive computer-based order entry screens were developed to guide physicians through a complex set of clinical criteria to ensure appropriate evidence-based use. A careful review of contraindications is required as a second step. To risk stratify patients in accordance with the trial subset analyses and the FDA labelling guidelines, ordering physicians are guided in calculating an APACHE II (Acute Physiology and Chronic Health Evaluation) score for the patient. Physicians from several specialties are available for advice and consultation on patients with difficult or controversial conditions. Approximately two-thirds of completed orders passed the clinical algorithm; an additional 35% of patients did not meet the medication criteria but received the drug after the attending physician requested an override of the guidelines. CONCLUSION: The BWH approach to activated protein C used an innovative multidisciplinary approach and computer-assisted order entry to guide clinical use of a new agent with substantial clinical efficacy, risks and costs. This approach provides a model for strategies to deal with other new and complex medical technologies.

Impact of robotic antineoplastic preparation on safety, workflow, and costs.

PURPOSE: Antineoplastic preparation presents unique safety concerns and consumes significant pharmacy staff time and costs. Robotic antineoplastic and adjuvant medication compounding may provide incremental safety and efficiency advantages compared with standard pharmacy practices. METHODS: We conducted a direct observation trial in an academic medical center pharmacy to compare the effects of usual/manual antineoplastic and adjuvant drug preparation (baseline period) with robotic preparation (intervention period). The primary outcomes were serious medication errors and staff safety events with the potential for harm of patients and staff, respectively. Secondary outcomes included medication accuracy determined by gravimetric techniques, medication preparation time, and the costs of both ancillary materials used during drug preparation and personnel time. RESULTS: Among 1,421 and 972 observed medication preparations, we found nine (0.7%) and seven (0.7%) serious medication errors (P = .8) and 73 (5.1%) and 28 (2.9%) staff safety events (P = .007) in the baseline and intervention periods, respectively. Drugs failed accuracy measurements in 12.5% (23 of 184) and 0.9% (one of 110) of preparations in the baseline and intervention periods, respectively (P < .001). Mean drug preparation time increased by 47% when using the robot (P = .009). Labor costs were similar in both study periods, although the ancillary material costs decreased by 56% in the intervention period (P < .001). CONCLUSION: Although robotically prepared antineoplastic and adjuvant medications did not reduce serious medication errors, both staff safety and accuracy of medication preparation were improved significantly. Future studies are necessary to address the overall cost effectiveness of these robotic implementations.

Bariatric surgery pharmacy consultation service.

Bariatric surgical patients often need changes in formulation and dosages of their medications. The literature contains minimal information regarding pharmaceutical care and consultation services for the bariatric surgery patient. Complex medication regimens and safety concerns initiated a collaborative effort between surgeons and pharmacists to manage more effectively bariatric patients perioperatively. The consultation service included patient identification, pharmacy referral, pharmacist consultation with the patient, communication of recommendations with surgeons, follow-up, and documentation. There were 124 consultations performed from February 2, 2009 to December 1, 2010 with an average of 7.7 medications optimized per patient. Every patient required a minimum of one adjustment to their regimen. The surgeons approved 98% of these recommendations. Of recommendations provided, the majority focused on changing the formulation of the medication in some manner. The collaborative effort between surgeons and pharmacists effected changes in medication transitioning perioperatively and resulted in improved pharmaceutical care for this patient population.

Effect of bar-code technology on the incidence of medication dispensing errors and potential adverse drug events in a hospital pharmacy.

We performed a direct observation prepost study to evaluate the impact of barcode technology on medication dispensing errors and potential adverse drug events in the pharmacy of a tertiary-academic medical center. We found that barcode technology significantly reduced the rate of target dispensing errors leaving the pharmacy by 85%, from 0.37% to 0.06%. The rate of potential adverse drug events (ADEs) due to dispensing errors was also significantly reduced by 63%, from 0.19%to 0.069%. In a 735-bed hospital where 6 million doses of medications are dispensed per year, this technology is expected to prevent about 13,000 dispensing errors and 6,000 potential ADEs per year.