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Background For beta-lactams, the parameter that best predicts bacterial killing is the length of time the antibiotic concentration exceeds the minimum inhibitory concentration (MIC). Studies have demonstrated improved outcomes with extended infusion (4-hour) piperacillin-tazobactam (P-TZ) compared with traditional immediate infusions. Objectives To describe how one institution made the conversion from immediate infusion of P-TZ to a 4-hour extended infusion utilizing an approved automatic therapeutic substitution, staff education, and smart pump technology, and to examine the impact of this conversion on patient length of stay and pharmacy costs. Methods With approval from the Pharmacy and Therapeutics (P&T), Antimicrobial Stewardship, and Medical Executive Committees, the decision was made to automatically convert all P-TZ orders to a standardized 4-hour infusion given every 8 to 12 hours depending on renal function. The medical records of all adult patients receiving P-TZ during 12 months pre implementation and 24 months post implementation of a 4-hour extended infusion of P-TZ were retrospectively analyzed for length of stay and mortality. The cost of P-TZ was also assessed during these time periods. Results With the help of smart pump technology, our institution successfully completed a conversion to 4-hour extended infusion P-TZ. Through this conversion, pharmacy expenditure of P-TZ was reduced by 38%; the total cost savings was $387,980.62 for the 24-month postintervention phase. Extended infusion P-TZ reduced hospital length of stay by 0.6 days ( P < .05), resulting in an additional cost savings of $1,689,480 for the 24-month postintervention phase. A conservative estimate of total cost savings to the hospital in the first 24 months, including the reduction in P-TZ expenditures, was $2,077,460.

The introduction of biosimilars represents an important mechanism by which health care organizations can manage the increasing expense of pharmaceuticals. While intended to occupy a position similar to that of generic versions of small-molecule medications, biosimilars will be governed by a unique regulatory mechanism, given the size, complexity, and variability of the originator biologic drugs. Therefore, the processes by which biosimilars will be evaluated for formulary inclusion and clinical use will be different as well. The biosimilar market is still in the early stages of development and requires further maturation. Therefore, pharmacists can seize the intervening time to assume leadership positions in preparing their organizations and clinical colleagues, including physicians, for the continued development of this new product class. Pharmacists must ensure that an appropriate clinical infrastructure is in place to allow for the safe and effective prescribing, administration, and monitoring of biosimilars. They must also be prepared to differentiate between state regulatory actions concerning biosimilars and the conflicting marketing messages that originator and biosimilar manufacturers are likely to issue. This article provides an introduction to the key formulary considerations required for biosimilar evaluation and use.

To the Editor: The recent article, “Bupivacaine Liposomal Versus Bupivacaine: Comparative Review,” by Noviasky et al [Hosp Pharm. 2014;49(6):539-543] is a valiant effort to review this topic. However, the authors have made a critical oversight in their attempt to interpret analgesic efficacy based solely on pain intensity. As per Schmidt’s study,1 analgesic efficacy must be evaluated using not only the pain intensity score, but also other outcome measures such as the postsurgical consumption of rescue medication, subject-reported results from validated outcomes instruments such as the Brief Pain Inventory (BPI), and subject satisfaction with postsurgical analgesia (to name just a few). If one were to study pain intensity scores alone, it would be incorrectly assumed that the analgesic effects of liposomal bupivacaine would last for only 12 to 24 hours. When combined with the other outcome measures, such as the use of postsurgical opioid rescue medications and assessments of patient functionality and satisfaction, it was clear that the analgesic effect lasted throughout the 72-hour study period. Although the pain scores normalized within the first day, they did so because the placebo patients were receiving statistically significantly more narcotic rescue pain medication than the liposomal bupivacaine patients (of course, it would be unethical to study a patient’s pain response without rescue medication being available). Other outcome metrics, such as patient satisfaction and quality of life measures from the BPI, also showed statistically significant advantages to liposomal bupivacaine throughout the entire 72-hour period – not just the first 12 to 24 hours. Most of the data presented in the Noviasky article comes from studies used in the submission to the US Food and Drug Administration (FDA) for approval of liposomal bupivacaine (Exparel; bupivacaine liposome injectable suspension). Subsequent studies such as the Improve trials for colorectal surgery and the orthopedic data presented at the most recent American Academy for Orthopedic Surgery (AAOS) were completely ignored and unaddressed. In the first Improve trial, Cohen2 demonstrated that a liposomal bupivacaine–based multimodal regimen resulted in statistically significantly less opioid consumption, lower hospital costs, and a shorter length of stay than a standard opioid-based analgesic regimen for postsurgical pain in patients undergoing open colectomy compared to his institution’s standard of care (opioid-based patient-controlled analgesia [PCA]). These results have been replicated in several other trials and surgical models (Marcet,3 Candiotti4). In fact, a very recent pooled analysis of these similarly designed studies by Cohen et al5 showed statistically significant reductions in postsurgical opioid consumption, reductions in hospital median length of stay by 1.4 days, and reductions in mean per-patient hospitalization costs by $2,455. This decrease by 60% of total narcotic consumption was accompanied by a 67% reduction in opioidrelated adverse events. Turning to the orthopedic study at the March 2014 meeting of the AAOS, Barrington and Emerson6 compared their last 1,000 total joint arthroplasties (TJA) without liposomal bupivacaine to their first 1,000 TJAs with liposomal bupivacaine; their study demonstrated pain relief for 72 hours compared to bupivacaine HCl, which lasted only 6 to 8 hours, as well as a decreased number of falls (from 10 to 2) and a savings of $1,246 per patient. The value of liposomal bupivacaine as an analgesic adjuvant must be considered as a multidimensional concept, including efficacy, safety, and pharmacoeconomics. Because liposomal bupivacaine typically affects the pharmacy budget, pharmacy directors tend to focus on that feature while not observing the hospitalwide savings that may be achieved. As a former hospital pharmacy director for many years, I know this only too well. But while working in the group purchasing organization industry, I realized that by integrating quality measures and patient outcomes with pharmacy data, a better, fuller evaluation is realized.7 In June 2010, the American Society of Health-System Pharmacists (ASHP) and Society of Hospital Medicine (SHM) reported on survey results8 in which directors of pharmacy or members of ASHP’s Pharmacy Practice Managers Section reported that only 13% of formulary system decisions made by their Pharmacy and Therapeutics (P&T) Committees in hospitals were influenced by pharmacoeconomic methods, even though 87% of respondents felt that pharmacoeconomic methods should be used. Additionally, more than 9 out of 10 survey respondents reported having pharmacoeconomic analysis available during their most recent P&T Committee discussion, but only 26% rated the available information as extremely helpful and 71% desired additional pharmacoeconomic information. Hospital pharmacy departments are not financial silos, and perhaps now is the time for hospital pharmacists to again embrace this joint SHM/ASHP statement. Given that liposomal bupivacaine provides pain relief and patient satisfaction over several days while still improving hospital pharmacoeconomics (despite pharmacy budgets being impacted), why aren’t we as pharmacists leading the charge to this therapeutic victory?

Purpose The purpose of this study was to determine the current perceptions of drug information practice and training. Methods Electronic surveys were sent to 417 pharmacists who likely would have drug information responsibilities. The survey collected information regarding job responsibilities, perceived importance of each responsibility to drug information practice, type of postgraduate training received to prepare for responsibilities, and perceived adequacy of training. Results There were 206 survey respondents. The most frequently cited primary job responsibilities were providing instruction to students and staff, operating drug information centers, and responding to drug information queries. Most respondents felt that educational instruction, pharmacy and therapeutics (P&T) committee support, and responding to drug information questions were very important to drug information practice. On-the-job experience was cited as the most frequent source of training. Of the respondents, 46% reported completion of a pharmacy practice residency and 40% reported completion of a drug information specialty residency, with 14% completing both. Fifteen percent of respondents had no postgraduate training. Most respondents felt prepared for current job responsibilities after postgraduate training, with the exceptions of information systems support, pharmacoeconomic evaluations, and clinical outcomes research. Conclusion Despite earlier recommendations, drug information job responsibilities within the study sample have changed little over the past decade. Respondents felt that most of their job responsibilities are important to drug information practice and that postgraduate training adequately prepared them for most of these responsibilities. However, only 40% of respondents received specialized training in drug information practice.

The Director's Forum series is written and edited by Michael Sanborn and Robert Weber and is designed to guide pharmacy leaders in establishing patient-centered services in hospitals and health systems. Another specific goal of this column is to address many of the key challenges that pharmacy directors face today, while providing information to foster growth in pharmacy leadership and patient safety. This month's Forum focuses on the Pharmacy and Therapeutics Committee and discusses essential functions and ways to maximize committee effectiveness.

Computerized provider order entry (CPOE) offers the opportunity to enhance communication to prescribers regarding the actions of the Pharmacy and Therapeutics (P&T) Committee. This includes formulary decisions, cost-containment strategies, and medication safety initiatives. In a system of paperbased orders, it can be challenging for prescribers to know what drugs are on formulary or are restricted to certain specialty services. Much of the responsibility for contacting the prescribers regarding nonformulary choices and restrictions lies with the pharmacist processing the order. CPOE allows for this information to be presented to the prescriber at the time of ordering and provides alternative agents when available. This article presents examples of the use of CPOE to implement P&T actions at Vanderbilt Children’s Hospital (VCH).

The University HealthSystem Consortium (UHC) Pharmacy Council Medication Management/Quality Improvement Committee has revised their template for drugs being researched for formulary inclusion. The new template incorporates controls aimed at reducing preventable patient injuries by assessing the safety risks of medications before they are added to an institution's drug formulary. Implementing this proactive strategy will improve the ability of Pharmacy and Therapeutics Committees to balance the benefits and risks of adding new drugs to the formulary. Key elements for the successful implementation of the UHC safety-focused strategy are discussed.

This article describes a pharmacy-managed, intravenous (IV) to enteral proton-pump inhibitor (PPI) program at a 377-bed tertiary care, teaching community hospital. IV pantoprazole was not restricted by indication, service, or patient location. Pharmacy converted any eligible patient prescribed an IV PPI to either pantoprazole tablets or lansoprazole capsules, packets, or enteral suspension according to protocol. Over a four-month evaluation period, 113 patients (mean age of 66 years) were prescribed IV PPIs for primarily suspected or documented GI bleeding. Gastroenterology specialists initiated 85% of IV PPI therapy. The most common dosage of IV PPI was 40 mg, once or twice daily with a median duration of 3 to 4 days. Continuous infusion IV PPI therapy was used for only two patients, both with GI bleeding. IV pantoprazole was converted to an enteral PPI in 73 of 113 patients in dosages of pantoprazole 40 mg or lansoprazole 30 or 60 mg administered once (32%) or twice (68%) daily. Pharmacists initiated 34% of the conversions. The total PPI expenditure was $6200 during the evaluation period. Daily acquisition cost savings, based on nominal pricing, ranged from approximately $5 to $25. Initial evaluation of the conversion program resulted in protocol revision and education of the medical staff, in an effort to minimize days of IV PPI use and encourage transition to enteral therapy. The protocol conversion dosage of lansoprazole 60 mg twice daily was changed to 30 mg twice daily and enteral pantoprazole tablets were deleted from the protocol (all IV PPI is converted to lansoprazole, 30 mg twice daily). Although IV pantoprazole remained on the hospital formulary, the medical staff were educated about the relative effectiveness of IV and enteral PPI therapy and the use of histamine-2 receptor antagonists for various indications. Prescribers of IV pantoprazole are now required to document the rationale for use. The Pharmacy and Therapeutics Committee will continue to explore the role IV PPI therapy, based on efficacy, safety, and cost.

Therapeutic interchange (TI), a formulary management process, is used by health care systems to help contain medication costs. A scientifically defensible and pharmacoeconomically beneficial TI program adheres to rigorous criteria enforced by an institution's Pharmacy and Therapeutics Committee. In situations where adherence to essential criteria is not mandated, TI may not produce the intended clinical and economic outcomes, and in practice may have legal implications. Appropriate application of TI has been described within the position statements of certain health care organizations and associations. Due to the high cost and frequent use of low-molecular-weight heparins (LMWHs), health care institutions have identified this pharmacologic class as a potential target for TI. Currently, the application of the TI process to LMWHs is questionable. This paper reviews the TI process and explores its controversial role in the formulary management of LMWHs.

PurposePharmacists and physicians were educated regarding updated guidelines on phytonadione indications, dosing, and routes of administration. Study objectives were to evaluate the use of phytonadione in a community hospital, educate pharmacists and physicians about phytonadione use, and assess the value of education in terms of patient outcomes.MethodsBaseline and follow-up data on phytonadione indications, dosages, and routes of administration were collected. Pretests and post-tests were administered before and after an education session. A Pharmacy and Therapeutics newsletter article highlighting the appropriate use of phytonadione was published.ResultsThe baseline and follow-up medication use evaluations (MUEs) revealed that 53% and 62% of patients had an appropriate indication for phytonadione, respectively (P = 0.181). Among patients with an appropriate indication, 44% were administered an appropriate dose in the baseline group and 46% in the follow-up (P = 0.876). The baseline MUE revealed that 20% of phytonadione routes of administration were appropriate; 18% were considered appropriate in the follow-up (P = 0.842). Pharmacists' knowledge showed improvement after education efforts, with the mean score improving from 57% to 93.4% from pretest to post-test (P < 0.05) and the median score changing from 50% to 100%.ConclusionImproving pharmacists' knowledge is beneficial and necessary; however, it was not enough to change practice in this study. Additional steps must be taken to encourage routine application of the knowledge.

Each month, subscribers to The Formulary® Monograph Service receive five to six well-documented monographs on drugs that are newly released or are in late Phase III trials. The monographs are targeted to your Pharmacy and Therapeutics Committee. Subscribers also receive monthly one-page summary monographs on the agents that are useful for agendas and pharmacy/nursing in-services. A comprehensive target drug utilization evaluation (DUE) is also provided each month. The monographs are published in printed form and on diskettes that allow customization. Subscribers to the The Formulary Monograph Service also receive access to a pharmacy bulletin board, The Formulary Information Exchange (The F.I.X.). All topics pertinent to clinical and hospital pharmacy are discussed on The F.I.X. Through the cooperation of The Formulary, Hospital Pharmacy publishes selected reviews in this column. If you would like information about The Formulary Monograph Service or The F.I.X., call The Formulary at 800-322-4349. The September 2002 Formulary monograph topics are ziprasidone mesylate for injection; lanthanum carbonate, artesunate rectal capsules, ZD1839, and memantine. The DUE is on ziprasidone.

Each month, subscribers to The Formulary® Monograph Service receive five to six well-documented monographs on drugs that are newly released or are in late Phase III trials. The monographs are targeted to your Pharmacy and Therapeutics Committee. Subscribers also receive monthly one-page summary monographs on the agents that are useful for agendas and pharmacy/nursing in-services. A comprehensive target drug utilization evaluation (DUE) is also provided each month. The monographs are published in printed form and on diskettes that allow customization. Subscribers to the The Formulary Monograph Service also receive access to a pharmacy bulletin board, The Formulary Information Exchange (The F.I.X). All topics pertinent to clinical and hospital pharmacy are discussed on The F.I.X. Through the cooperation of The Formulary, Hospital Pharmacy publishes selected reviews in this column. If you would like information about The Formulary Monograph Service or The F.I.X., call The Formulary at 800-322-4349. The December 2001 Formulary monograph topics are budesonide modified-release capsules, tenofovir disoproxil fumarate, pegfilgrastim, fulvestrant, and etonogestrol/ethinyl estradiol vaginal ring. The DUE is on budesonide modified-release capsules.

Each month, subscribers to The Formulary® Monograph Service receive five to six researched monographs on drugs that are newly released or are in late Phase III trials. The monographs are targeted to your Pharmacy and Therapeutics Committee. Subscribers also receive monthly one-page summary monographs on the agents that are useful for agendas and pharmacy/nursing in-services. A comprehensive target drug utilization evaluation (DUE) is also provided each month. The monographs are published in printed form and on diskettes that allow customization. Subscribers to the The Formulary Monograph Service also receive access to a pharmacy bulletin board called The Formulary Information Exchange (The F.I.X). All topics pertinent to clinical pharmacy are discussed on The F.I.X. Through the cooperation of The Formulary, Hospital Pharmacy publishes selected reviews in this column. If you would like information about The Formulary Monograph Service or The F.I.X., call The Formulary at 800-322-4349. The April 2001 Formulary monographsare on caspofungin, peginterferon alfa-2b, ziprasidone, 90Y ibritumomab tiuxe-tan, and Abarelix depot. The DUE is on caspofungin.

Each month, subscribers to The Formulary® Monograph Service receive five to six researched monographs on drugs that are newly released or are in late Phase III trials. The monographs are targeted to your Pharmacy and Therapeutics Committee. Subscribers also receive monthly one-page summary monographs on the agents that are useful for agendas and pharmacy/nursing in-services. A comprehensive target drug utilization evaluation (DUE) is also provided each month. The monographs are published in printed form and on diskettes that allow customization. Subscribers to the The Formulary Monograph Service also receive access to a pharmacy bulletin board called The Formulary Information Exchange (The F.I.X). All topics pertinent to clinical pharmacy are discussed on The F.I.X. Through the cooperation of The Formulary, Hospital Pharmacy publishes selected reviews in this column. If you would like information about The Formulary Monograph Service or The F.I.X., call The Formulary at 800-322-4349. The December 2000 Formulary monographs are budesonide inhalation suspension, arsenic trioxide, sodium phosphate, ziprasidone, and unoprostone. The DUE is on budesonide inhalation suspension.

To the Editor: Heparin is an indirect anticoagulant. The majority of its anticoagulation effect is due to the binding of heparin to antithrombin, which in turn inactivates coagulation factors IIa and Xa.1 Only one-third of heparin molecules administered to a patient have any anticoagulant effect, and the variance in chain length contributes to whether it binds to antithrombin over factor Xa.1 Shorter molecules bind to factor Xa, which contributes to the difference in anti-factor Xa units and activated partial thromboplastin time (aPTT) measurements in vivo.1 This activity is particularly useful in patients with or at increased risk for a venous thromboembolism (VTE) or patients with coronary heart disease.1,2 In practice, there are multiple ways to determine therapeutic aPTT levels in patients on heparin therapy. The tests currently available for measuring the extent of coagulation with heparin include aPTT or antifactor Xa (anti-Xa) level assays or a direct measurement of heparin concentration using protamine titration. Anti-Xa assays are associated with lower rates of variability in comparison to aPTT levels, and many institutions have begun to transition from the traditional aPTT laboratory tests to the newer anti-Xa assays.3 Variations in results between each facility are found with the commercially available reagents that are used to perform each test.1,2 Due to the variations, each laboratory is required to calibrate their tests on a regular basis against plasma heparin concentrations for accurate utilization of the tests in therapy.1,2 According to the Chest 2012 guidelines for antithrombotic therapy and prevention of thrombosis, standard practices for heparin use require individualized dose adjustments based on monitoring of aPTT levels.2 Monitoring coagulation in patients on heparin is necessary for adequate therapy and safety, as subtherapeutic levels increase the risk for the patient to acquire a clot and supratherapeutic levels increase the risk for the patient to develop a bleed.2 Any heparin order sets for continuous intravenous infusion should be facility-specific and incorporate the most recent therapeutic aPTT levels. This is necessary due to the variation between labs regarding the therapeutic reference range. Heparin rate adjustments and bolus dosing are adjusted according to an institution-specific protocol or a practitioner’s order with appropriate aPTT reference ranges. Order sets also serve as reminders to health care providers involved in the care of patients on heparin therapy to ensure that all aspects of heparin therapy are being monitored. Key elements to incorporate in these facility protocols include the required labs to be drawn (ie, CBC, aPTT), how often to draw them, algorithms for determining bolus and maintenance heparin doses, and parameters for which a physician should be notified. All reference lab values in any protocol/order sets should be updated with the periodic recalibration of the lab tests, as even a 1% error can lead to a much larger problem.4 Once these data are available to the laboratory, communication to the appropriate departments, such as pharmacy and any physician groups, is of the utmost importance. Sharing this information allows for all hospital order sets/protocols to be updated, resulting in patients receiving a heparin infusion with the most current and accurate aPTT reference ranges. Collaboration is key in order to provide excellent patient care, and any breakdown can lead to negative outcomes.5 If order sets are not updated with the scheduled recalibration of lab tests, patients can be under- or overdosed with heparin. Risks of underdosing include potentially fatal events such as the formation or promulgation of clots, whereas overdosing can lead to serious bleeding events. Although the adjustments of these numbers may not seem significant from one year to the next, cumulative changes may be drastic. The accuracy of an order set/protocol directly impacts the decisions a health care provider makes, which is why interprofessional communication and collaboration is essential for exceptional patient care and outcomes. For example, a patient may have a therapeutic aPTT range, but if the protocol has not been updated, adjustments may be made to the heparin infusion rate when it is not needed. At our facility, the following steps have worked well for interdisciplinary collaboration. Once the lab aPTT values have been updated, a communication is made to the pharmacy department and the appropriate committees, such as the Deep Vein Thrombosis Prevention Committee, Pharmacy and Therapeutics (P&T) Committee, or Forms Committee, overseeing the heparin infusion protocol. After the notification has been made, the committees review the new aPTT therapeutic values and approve the change on the protocol/order sets accordingly. If the committee is not scheduled to meet, a vote via e-mail or a brief meeting is called to approve or deny the changes so as not to delay appropriate therapy to patients. At the next meeting, the topic may then be formally introduced. Once the appropriate committees have approved the updated laboratory data, all documents with older data are revised. Utilizing an interdisciplinary approach for implementing changes to our hospital protocol or procedure has resulted in better patient care by providing accurate order sets. By having processes in place for increased collaboration between lab and pharmacy departments, the pharmacy department will know when the lab has updated the aPTT therapeutic range for patient care optimization. Each facility may wish to review their current practice to determine whether it is appropriate or whether a change needs to be made.