Showing papers in "American Journal of Health-system Pharmacy in 2012"

ASHP national survey of pharmacy practice in hospital settings: dispensing and administration--2011.

Abstract: Purpose Results of the 2011 ASHP national survey of pharmacy practice in hospital settings that pertain to dispensing and administration are presented. Methods A stratified random sample of pharmacy directors at 1401 general and children’s medical-surgical hospitals in the United States were surveyed by mail. Results In this national probability sample survey, the response rate was 40.1%. Decentralization of the medication-use system continues, with 40% of hospitals using a decentralized system and 58% of hospitals planning to use a decentralized model in the future. Automated dispensing cabinets were used by 89% of hospitals, robots were used by 11%, carousels were used in 18%, and machine-readable coding was used in 34% of hospitals to verify doses before dispensing. Overall, 65% of hospitals had a United States Pharmacopeia chapter 797 compliant cleanroom for compounding sterile preparations. Medication administration records (MARs) have become increasingly computerized, with 67% of hospitals using electronic MARs. Bar-code-assisted medication administration was used in 50% of hospitals, and 68% of hospitals had smart infusion pumps. Health information is becoming more electronic, with 67% of hospitals having partially or completely implemented an electronic health record and 34% of hospitals having computerized prescriber order entry. The use of these technologies has substantially increased over the past year. The average number of full-time equivalent staff per 100 occupied beds averaged 17.5 for pharmacists and 15.0 for technicians. Directors of pharmacy reported declining vacancy rates for pharmacists. Conclusion Pharmacists continue to improve medication use at the dispensing and administration steps of the medication-use system. The adoption of new technology is changing the philosophy of medication distribution, and health information is rapidly becoming electronic.

Clinical and economic outcomes of a prospective antimicrobial stewardship program

Abstract: Purpose A pre–post analysis of an antimicrobial stewardship program (ASP) involving the use of data-mining software to prospectively identify cases for ASP intervention was conducted. Methods The investigators evaluated clinical outcomes and cost metrics before and after implementation of the ASP, which entailed daily physician review of summary reports on all adult inpatients receiving antimicrobial therapy. The primary outcome measures were annual antimicrobial expenditures and rates of infections due to common nosocomial pathogens; secondary outcome measures included patient survival and length of stay (LOS) in cases involving the indicator diagnoses of pneumonia and abdominal sepsis. Results Antimicrobial expenditures, which had increased by an average of 14.4% annually in the years preceding ASP implementation, decreased by 9.75% in the first year of the program and remained relatively stable in subsequent years, with overall cumulative cost savings estimated at $1.7 million. Rates of nosocomial infections involving Clostridium difficile , methicillin-resistant Staphylococcus aureus, and vancomycin-resistant enterococci all decreased after ASP implementation. A pre–post comparison of survival and LOS in patients with pneumonia ( n = 2186) or abdominal sepsis ( n = 225) showed no significant differences in those outcomes in either patient group, possibly due to the hospital’s initiation of other, concurrent infection-control programs during the study period. Conclusion A prospective collaborative ASP employed automated reports to efficiently identify key data for ASP review. After ASP implementation, antimicrobial expenditures and rates of nosocomial infections caused by resistant pathogens dropped without significant changes in patient survival, LOS, and readmissions for the two studied illness categories.

Newer oral anticoagulants: a review of laboratory monitoring options and reversal agents in the hemorrhagic patient.

Abstract: Purpose Available evidence on laboratory monitoring of coagulation assays and reversal strategies for the management of hemorrhagic events associated with the newer anticoagulants is reviewed. Summary While there are no published studies with dabigatran and prothrombinase-induced clotting time (PiCT) and no chromogenic assays available to measure the anticoagulant effects, thrombin time and activated partial thromboplastin time (aPTT ) may be used to detect the presence of dabigatran. Although ecarin clotting time is sensitive to elevated concentrations of dabigatran, only a small fraction of institutions have access to this assay. Rivaroxaban and apixaban prolong prothrombin time, dilute prothrombin time, aPTT, Heptest results, and PiCT to varying degrees, having the most- pronounced effects at higher concentrations. In contrast, the chromogenic antifactor Xa assay proved to be sensitive to lower amounts of rivaroxaban and apixaban with less variability. Despite the expectations with these newer anticoagulants, the associated risk of bleeding is significant, and there are insufficient data depicting treatment options in emergency situations. Until four-factor prothrombin complex concentrates (PCCs) become available in the United States, the obtainable options are activated PCC, three-factor PCCs, and recombinant factor VIIa. Conclusion Although there is currently no gold standard of measurement for any of the newer anticoagulants, the published literature enables practitioners to evaluate the efficacy and sensitivity of a majority of these assays. Prohemostatic agents can be used in instances of severe, life-threatening hemorrhagic complications.

Ecallantide for treatment of acute attacks of hereditary angioedema

Abstract: Purpose The pharmacology, pharmacokinetics, efficacy, safety, dosage, administration, adverse effects, and place in therapy of ecallantide, a kallikrein inhibitor for the treatment of hereditary angioedema (HAE), are reviewed. Summary Ecallantide is the first member of the kallikrein inhibitor class approved for the treatment of acute attacks of HAE. Ecallantide works by binding to kallikrein, preventing the conversion of kininogen to bradykinin, which reduces vascular permeability, thus reducing the swelling associated with acute attacks of HAE. Ecallantide has been studied for the treatment of HAE in three Phase II studies and two Phase III studies. These studies were collectively known as the EDEMA (Evaluation of DX-88’s Effect in Mitigating Angioedema) studies. Phase III clinical trials found that ecallantide is superior to placebo in ameliorating patient symptoms associated with acute attacks of HAE at any anatomical site. Ecallantide has a favorable safety profile, with the most common adverse effects being gastrointestinal effects, headache, and injection site reactions. The most severe adverse effects of ecallantide are the risk of anaphylaxis and the possible development of antiecallantide antibodies. A risk evaluation and mitigation strategy program has been approved by the Food and Drug Administration to help ensure the safety and efficacy of ecallantide use. The recommended dose is 30 mg given as three separate subcutaneous injections. Conclusion Ecallantide is a novel agent approved for the treatment of acute attacks of HAE at any anatomical site. It is one of only three medications approved for this indication in the United States, presents a unique mechanism of action, and appears to be safe and effective when used for its labeled indication.

Projecting future drug expenditures--2012.

Abstract: Purpose Factors likely to influence drug expenditures, drug expenditure trends in 2010 and 2011, and projected drug expenditures for 2012 are discussed. Summary Data were analyzed to provide drug expenditure trends for total drug expenditures and the hospital and clinic sectors. Data were obtained from the IMS Health National Sales Perspectives database. From 2009 to 2010, total U.S. drug expenditures increased by 2.7%, with total spending rising from $299.2 billion to $307.5 billion. Drug expenditures in clinics grew by 6.0% from 2009 to 2010. Hospital drug expenditures increased at the moderate rate of 1.5% from 2009 to 2010; through the first nine months of 2011, hospital drug expenditures increased by only 0.3% compared with the same period in 2010. The dominant trend over the past several years is substantial moderation in expenditure growth for widely used drugs, primarily due to the ongoing introduction and wide use of generic versions of high-cost, frequently used medications. At the end of 2010, generic drugs accounted for 78% of all retail prescriptions dispensed. Another pattern is substantial increases in expenditures for specialized medications, particularly in the outpatient setting as growth in prescription drug expenditures for clinic-administered drugs consistently outpaces growth in total expenditures. Various factors are likely to influence drug expenditures in 2012, including drugs in development, the diffusion of new drugs, generic drugs, drug shortages, and biosimilars. Conclusion For 2012, we project a 3–5% increase in total drug expenditures across all settings, a 5–7% increase in expenditures for clinic-administered drugs, and a 0–2% increase in hospital drug expenditures.

Implementation of an antimicrobial stewardship program in a rural hospital

Abstract: Purpose The implementation of a pharmacy-directed antimicrobial stewardship (AMS) program involving the use of telemedicine technology is described. Summary Pursuant to a gap analysis of AMS services at a rural hospital where physician specialists in infectious diseases (ID) or pharmacists with advanced ID training were not available, a multidisciplinary team was formed to implement a stewardship program targeting six antimicrobials with a high potential for misuse. A key part of the program was the participation of a remotely located ID physician specialist in weekly case review teleconferences. An evaluation of the first 13 months of the initiative (May 2010–June 2011) indicated that pharmacist-initiated AMS interventions increased dramatically after program implementation, from a baseline average of 2.1 interventions per week to an average of 6.8 per week; the rate of antimicrobial streamlining increased from 44% to an average of 96%. Due to inconsistent documentation, an increase in the rate of physician–pharmacist agreement could not be demonstrated; however, anecdotal evidence suggested an increase in physician requests for case reviews by the AMS team and enhanced interdisciplinary collaboration. An analysis of 2010 purchasing data demonstrated a decrease in annual antibiotic costs of about 28% from 2009 levels (and a further decrease of about 51% in the first two quarters of 2011). The rate of nosocomial Clostridium difficile infection decreased from an average of 5.5 cases per 10,000 patient-days to an average of 1.6 cases per 10,000 patient-days. Conclusion Implementation of an AMS program at a rural hospital led to increases in pharmacist-recommended interventions and streamlining of antimicrobial therapy, as well as decreases in health care-associated C. difficile infections and antimicrobial purchasing costs.

Levocarnitine for valproic-acid-induced hyperammonemic encephalopathy

Abstract: Purpose The use of levocarnitine for the treatment of valproic-acid-induced hyperammonemic encephalopathy (VHE) is reviewed. Summary VHE is generally characterized by an acute onset of impaired consciousness, focal neurologic symptoms, and increased seizure frequency. The exact mechanism of VHE is unclear but relates to the accumulation of toxic valproic acid metabolites and elevated ammonia levels. Carnitine is an essential cofactor in the proper metabolism of valproic acid and ammonia elimination. A lack of carnitine is thought to contribute to hyperammonemia. Valproic acid is thought to increase renal metabolism of glutamate and may contribute to ammonia production. Levocarnitine, the active isomer of carnitine, has been used to treat VHE resulting from valproic acid overdose as well as usual dosages of valproic acid. A literature search of PubMed was conducted for all English-language articles published from 1948 to May 2011 regarding the use of levocarnitine for VHE. Search terms included levocarnitine , l-carnitine , valproic acid , and hyperammonemia encephalopathy . Although large, randomized controlled trials of levocarnitine treatment in VHE are lacking, levocarnitine has been shown to be generally safe and effective in retrospective trials and case reports. Overall, there is more literature supporting the use of levocarnitine in VHE associated with acute overdose than with short- or long-term treatment with usual dosages of valproic acid. No adverse events related to levocarnitine therapy were reported in any of the literature reviewed. Prospective trials are needed to further support the efficacy and safety of levocarnitine in the treatment of VHE. Conclusion Levocarnitine may be effective and appears to be safe in the treatment of VHE.

FDA approves tofacitinib for rheumatoid arthritis.

Abstract: FDA on November 6 announced the approval of tofacitinib oral tablets as a second-line treatment for moderate-to-severe rheumatoid arthritis in adults. According to Pfizer, tofacitinib is the first FDA-approved inhibitor of Janus kinase a tyrosine-specific protein kinase that contributes to

Comparison of rates of reported adverse events associated with i.v. iron products in the United States

Abstract: Purpose An analysis of reported adverse events (AEs) among patients using i.v. iron products, including the newer agent ferumoxytol, is presented. Methods All AE reports to the Food and Drug Administration (FDA) citing iron sucrose, ferric gluconate, high- and low-molecular-weight iron dextran products, or ferumoxytol from October 2009 through June 2010 were evaluated. The rates of various classifications of reported AEs were calculated on a per-unit-sold basis and, for comparison of products supplied in different unit sizes, also in terms of 100-mg dose equivalents (DEq) of iron. Results A total of 197 reported AEs were identified (a cumulative rate of 14.1 AEs per million units sold). The rates of all AE classifications combined ranged from 5.25 to 746 per million units sold for iron sucrose and ferumoxytol, respectively; using the other method of calculation, the rates ranged from 5.24 per million DEq (iron sucrose) to 147 per million DEq (ferumoxytol). Relative to iron sucrose and sodium ferric gluconate, ferumoxytol was associated with significantly elevated risks of death (odds ratio [OR], 475 and 156, respectively; p < 0.0001), serious nonfatal AEs (OR, 263 and 121, respectively; p < 0.0001), and all evaluated AE classifications combined (OR, 142 and 109, respectively; p < 0.05). Conclusion Analysis of reports submitted to FDA revealed large differences among i.v. iron products in reported deaths, serious AEs, other major AEs, and other AEs. Iron sucrose and sodium ferric gluconate were associated with much lower rates of AEs per million units sold than iron dextran or ferumoxytol, which were associated with the highest rates of all reported AE classifications.

Reversal of dabigatran-induced bleeding with a prothrombin complex concentrate and fresh frozen plasma.

Abstract: Purpose The case of a patient for whom reversal of dabigatran-induced bleeding was performed with a prothrombin complex concentrate (PCC) and fresh frozen plasma (FFP) is reported. Summary An 85-year-old man arrived at the emergency department with complaints of generalized weakness, fatigue, and one episode of dark stool. The patient’s medical history included hypertension, heart failure, stage III chronic kidney disease, cerebrovascular accident, prostate cancer, gastritis, esophagitis, diverticulosis, and a bleeding gastrointestinal ulcer. Laboratory test results revealed acute liver failure, acute kidney injury, and anemia. He was diagnosed with hemorrhagic shock secondary to bleeding in his upper gastrointestinal tract. A reversal strategy was implemented using 16 units of FFP and 2000 units of a three-factor PCC. After administration of these agents, the patient’s hemoglobin concentration stabilized, and there were no further signs of overt bleeding, suggesting potential hemostasis. Confirmation of this reversal was not possible due to the effect of concomitant liver failure on the International Normalized Ratio and the activated partial thromboplastin time (aPTT), common variables used to measure coagulation. Conclusion Treatment with a PCC and FFP was administered to an 85-year-old man diagnosed with hemorrhagic shock secondary to bleeding in his upper gastrointestinal tract in an effort to reverse the anticoagulant effects of dabigatran. Although the patient’s hemoglobin levels stabilized and his aPTT values decreased after treatment, he died as a result of multiorgan failure.

Antidotes for toxicological emergencies: A practical review

Abstract: Purpose Appropriate therapies for commonly encountered poisonings, medication overdoses, and other toxicological emergencies are reviewed, with discussion of pharmacists’ role in ensuring their ready availability and proper use. Summary Poisoning is the second leading cause of injury-related morbidity and mortality in the United States, with more than 2.4 million toxic exposures reported each year. Recently published national consensus guidelines recommend that hospitals providing emergency care routinely stock 24 antidotes for a wide range of toxicities, including toxic-alcohol poisoning, exposure to cyanide and other industrial agents, and intentional or unintentional overdoses of prescription medications (e.g., calcium-channel blockers, β-blockers, digoxin, isoniazid). Pharmacists can help reduce morbidity and mortality due to poisonings and overdoses by (1) recognizing the signs and symptoms of various types of toxic exposure, (2) guiding emergency room staff on the appropriate use of antidotes and supportive therapies, (3) helping to ensure appropriate monitoring of patients for antidote response and adverse effects, and (4) managing the procurement and stocking of antidotes to ensure their timely availability. Conclusion Pharmacists can play a key role in reducing poisoning and overdose injuries and deaths by assisting in the early recognition of toxic exposures and guiding emergency personnel on the proper storage, selection, and use of antidotal therapies.

Teaching clinical problem solving: a preceptor's guide.

Abstract: Purpose Instructional methods to help pharmacists succeed in their growing role in practice-based teaching are discussed, with an emphasis on techniques for fulfilling the four key preceptor roles. Summary The American Society of Health-System Pharmacists (ASHP) and other organizations advocate ongoing efforts to develop the teaching skills of clinician–educators serving as preceptors to pharmacy students and residents. The broad model of teaching clinical problem solving recommended by ASHP emphasizes the creative and flexible application of the four major preceptor roles: (1) direct instruction, (2) modeling, (3) coaching, and (4) facilitating. A variety of teaching methods used in the fields of medicine and nursing that can also be adopted by practice-based pharmacy educators are presented; in particular, the advantages and disadvantages of various case-presentation formats (e.g., One-Minute Preceptor, SNAPPS, patient-witnessed teaching, “Aunt Minnie,” “think-aloud”) are reviewed. Other topics discussed include the appropriate use of questioning as an educational tool, strategies for providing constructive feedback, teaching learners to self-evaluate their skills and progress, and integrating residents into teaching activities. Conclusion The ASHP-recommended approach to teaching clinical problem-solving skills can be applied within the educational frameworks provided by schools of pharmacy as well as pharmacy residency programs. A wide range of validated teaching strategies can be used to tailor learning experiences to individual learner needs while meeting overall program goals and objectives.

Hypertriglyceridemia-induced acute pancreatitis treated with insulin and heparin

Abstract: Purpose A case of hypertriglyceridemia-induced acute pancreatitis that was managed with insulin and heparin is reported. Summary A 39-year-old Hispanic man arrived at the emergency department with complaints of abdominal pain, nausea, and vomiting over one day. A computed tomography scan of the abdomen revealed peripancreatic inflammatory changes surrounding the tail of the pancreas, consistent with pancreatitis. Pertinent laboratory test values on admission were as follows: triglyceride concentration, 5366 mg/dL; total cholesterol concentration, 555 mg/dL; amylase concentration, 131 units/L; lipase concentration, 51 units/L; serum glucose concentration, 253 mg/dL; and serum sodium concentration, 128 mmol/L. The patient was diagnosed with hypertriglyceridemia-induced pancreatitis. On hospital day 1, the patient was given nothing by mouth and received a 1-L bolus dose of 0.9% sodium chloride injection, followed by a continuous infusion of 0.9% sodium chloride injection at a rate of 125 mL/hr. Subcutaneous heparin 5000 units every eight hours, sliding-scale regular insulin, and gemfibrozil 600 mg twice daily were initiated. On hospital day 2, the patient’s triglyceride concentration decreased to 2962 mg/dL, and his blood glucose concentration was 147 mg/dL. Subcutaneous insulin detemir 25 units daily was ordered, and sliding-scale insulin was continued. Due to continued elevated triglyceride levels, the patient was transitioned from subcutaneous insulin to an i.v. insulin infusion at 0.1 unit/kg/hr in addition to an infusion of 5% dextrose. On hospital day 5, the patient’s triglyceride concentration decreased to 717 mg/dL; the insulin–dextrose infusion was discontinued. The patient was discharged on hospital day 6. Conclusion A 39-year-old man with pancreatitis caused by severe hypertriglyceridemia was treated with a continuous insulin infusion and subcutaneous heparin.

Patient-centered medical home: Developing, expanding, and sustaining a role for pharmacists

Abstract: Purpose The development of a patient-centered medical home (PCMH) health care model and the role of pharmacists in PCMHs at the University of Michigan are described. Summary In 2009, Blue Cross Blue Shield of Michigan (BCBSM) provided financial incentives to physician groups to implement PCMH principles. A partnership was formed among the department of pharmacy, college of pharmacy, and faculty group practice at the University of Michigan Health System (UMHS) to integrate clinical pharmacists into the PCMH model at eight general medicine practices. The rationale was that PCMH pharmacists could assist in managing chronic conditions by substituting or augmenting physician care, help achieve quality indicators, and increase revenue by billing for their services. At the University of Michigan, PCMH pharmacists currently provide direct patient care services at eight general medicine health centers for patients with diabetes, hypertension, hyperlipidemia, and polypharmacy, which are billable using T codes, which are payable to UMHS by most BCBSM plans. In the first year, the number of PCMH pharmacist half-day clinics varied from one to six per health center, and the mean number of patients per half-day clinic ranged from 2.2 to 6. Pharmacists in four PCMHs made more medication changes per visit than the other four, particularly for patients with diabetes. Conclusion At the University of Michigan, PCMH pharmacists currently provide direct patient care services at eight general medicine health centers for patients with diabetes, hypertension, hyperlipidemia, and polypharmacy via referral from physicians.

Publication rates of abstracts presented by pharmacy residents at the Western States Conference.

Abstract: Purpose Investigators report the results of a study to determine the proportion of residency projects presented as abstracts at a regional residency conference that were subsequently published as full-length articles. Summary Using every third item listed in the abstract booklets from the Western States Conference for the years 1995, 2000, and 2005, a search of MEDLINE and EMBASE for journal citations indicating publication of the corresponding residency projects was conducted; the searches covered a period including and extending five years beyond the year of abstract presentation at the conference. Of the total of 270 abstracts evaluated, 17 were expanded to full-length articles and published within the search time frame. The average time to publication (mean ± S.D.) was 24 ± 10 months. The publication rates associated with abstracts presented at the 1995, 2000, and 2005 conferences were 4.2%, 5.2%, and 8.2%, respectively. All published articles appeared in peer-reviewed journals, with more than half (54.2%) in pharmacy journals. The majority of residency projects published were retrospective and prospective cohort studies. In most cases (58.8%), the resident was listed as the first author of the published journal article. Conclusion The overall publication rate of abstracts presented at a regional residency conference in 1995, 2000, and 2005 was 6.3%, with an increase in the rate over those years.

Current trends in immunosuppressive therapies for renal transplant recipients

Abstract: Purpose Current trends in immunosuppressive therapies for renal transplant recipients are reviewed. Summary The common premise for immunosuppressive therapies in renal transplantation is to use multiple agents to work on different immunologic targets. The use of a multidrug regimen allows for pharmacologic activity at several key steps in the T-cell replication process and lower dosages of each individual agent, thereby producing fewer drug-related toxicities. In general, there are three stages of clinical immunosuppression: induction therapy, maintenance therapy, and treatment of an established acute rejection episode. Only immunosuppressive therapies used for maintenance therapy are discussed in detail in this review. The most common maintenance immunosuppressive agents can be divided into five classes: (1) the calcineurin inhibitors (CNIs) (cyclosporine and tacrolimus), (2) costimulation blockers (belatacept), (3) mammalian target of rapamycin inhibitors (sirolimus and everolimus), (4) antiproliferatives (azathioprine and mycophenolic acid derivatives), and (5) corticosteroids. Immunosuppressive regimens vary among transplantation centers but most often include a CNI and an adjuvant agent, with or without corticosteroids. Selection of appropriate immunosuppressive regimens should be patient specific, taking into account the medications9 pharmacologic properties, adverse-event profile, and potential drug–drug interactions, as well as the patient9s preexisting diseases, risk of rejection, and medication regimen. Conclusion Advancements in transplant immunosuppression have resulted in a significant reduction in acute cellular rejection and a modest increase in long-term patient and graft survival. Because the optimal immunosuppression regimen is still unknown, immunosuppressant use should be influenced by institutional preference and tailored to the immunologic risk of the patient and adverse-effect profile of the drug.

Impact of a rapid peptide nucleic acid fluorescence in situ hybridization assay on treatment of Candida infections

Abstract: Purpose The impact of a rapid peptide nucleic acid fluorescence in situ hybridization (PNA FISH) assay with an antimicrobial stewardship intervention on the treatment of Candida infections was studied. Methods The utility of implementing the PNA FISH assay with an antimicrobial stewardship intervention in hospitalized patients with candidemia was evaluated by measuring the median time to Candida species identification, time to targeted therapy, and clinical outcomes, including time to culture clearance, hospital length of stay, and hospital mortality. Secondary objectives included determining the cost-effectiveness of the PNA FISH assay by assessing estimated antifungal drug costs (as average wholesale price) before (June 26, 2009–September 19, 2010) and after (September 20, 2010–June 13, 2011) test implementation and confirming test accuracy. For both groups, laboratory personnel notified the physician of the results of Gram's stain from blood culture. Results Time to targeted therapy significantly decreased after the implementation of the PNA FISH assay ( p = 0.0016). The postimplementation group had a higher rate of culture clearance ( p = 0.01). Median time to species identification was 0.2 day with the PNA FISH test versus 4 days with routine methods ( p < 0.001). Accounting for the cost of the test itself and the cases in which patients were switched to moreexpensive therapy on the basis of the test, we estimated that the PNA FISH test resulted in savings of approximately $415 per patient. Conclusion Implementing a PNA FISH test to identify Candida species from yeast-positive blood cultures in conjunction with a pharmacy-driven antimicrobial stewardship protocol decreased the time to targeted antifungal therapy and the time to culture clearance. Am J Health-Syst Pharm. 2012; 69:1910- 4

Quality of life and economic costs associated with postthrombotic syndrome.

Abstract: Purpose Published evidence on quality-of-life (QOL) outcomes and health care costs in patients with postthrombotic syndrome (PTS), a common and difficult-to-diagnose complication of venous thromboembolism (VTE), is reviewed. Summary Occurring in as many as 70% of patients with VTE, PTS remains a challenging and costly disorder, partly due to the lack of a standard diagnostic definition and varying classification systems. Searches of Medline and EMBASE identified 12 articles on humanistic and economic outcomes associated with PTS. The results of U.S. and international studies indicate that PTS is a key determinant of long-term QOL among patients with VTE. In one large study, 37% of patients with VTE developed PTS within two years of a diagnosis of deep venous thrombosis (DVT), and 4% developed severe PTS, with the occurrence of PTS linked to clinically relevant declines in measures of physical and mental health. Research indicates that the economic burden of PTS in the United States may be as high as $200 million annually. Recent progress in efforts to develop standard PTS terminology may facilitate the dissemination of clear consensus guidelines to assist in timely PTS detection and optimal care. Conclusion Appropriate measures to decrease PTS-related burdens may include the prevention of DVT, clear diagnostic criteria for PTS, and an education campaign aimed at increased standardization in the management of DVT. Gaps in the current understanding of the risk factors, diagnostic criteria, preventive strategies, and even treatment modalities for PTS hamper the ability of clinicians to employ measures that could reduce the occurrence of this disorder and the associated morbidity.

Performance of a vancomycin dosage regimen developed for obese patients

Abstract: Purpose An original and a revised vancomycin dosing protocol for obese patients were compared with respect to attainment of target serum trough vancomycin concentrations and the occurrence of nephrotoxicity. Methods The attainment of target vancomycin trough values (10–20 μg/mL) and nephrotoxicity were compared retrospectively between an original protocol (vancomycin 15 mg/kg i.v. every 8–12 hours), which had been associated with high troughs, and a revised protocol (10 mg/kg i.v. every 12 hours or 15 mg/kg every 24 hours). Patients were included if they were obese (weight ≥ 100 kg and total body weight ≥ 140% of ideal body weight), had normal renal function (creatinine clearance ≥ 60 mL/min), had received i.v. vancomycin for at least 48 hours, and had one evaluable vancomycin trough value. Nephrotoxicity was defined as an increase in serum creatinine concentration of 0.5 mg/dL or of 50% over baseline, whichever was greater. Results Seventy-four and 64 patients were stratified into groups that had been treated with the revised and original protocols, respectively. The mean ± S.D. maintenance dose was 19 ± 2 mg/kg/day with the revised protocol and 34 ± 7 mg/kg/day with the original protocol ( p < 0.001). Compared with the original protocol, the revised protocol resulted in a higher frequency of target troughs (59% versus 36%, p = 0.006) and below-target troughs (23% versus 9%, p = 0.033) and a lower frequency of above-target troughs (18% versus 55%, p < 0.001). Nephrotoxicity occurred in two patients in each group. Conclusion Compared with the original vancomycin protocol for obese patients, a revised vancomycin protocol using lower total daily doses improved the attainment of target trough concentrations, with minimal nephrotoxicity.

Factors used by pharmacy residency programs to select residents.

Abstract: Obtaining a pharmacy residency training position is becoming competitive as the number of applicants participating in the ASHP Resident Matching Program (RMP) exceeds the number of positions.[1][1]–[3][2] The competitive nature of the RMP impresses on applicants the need to thoroughly prepare for

Practical considerations for optimal transdermal drug delivery

Abstract: Purpose The properties of various transdermal drug delivery system (TDDS) products are reviewed, with safety recommendations and guidance on addressing questions frequently posed by patients and caregivers. Summary Drug delivery via a TDDS can offer many advantages over other methods of administration, but those benefits can be compromised by improper use or alteration of medication patches or a lack of awareness of the properties of different patch types (reservoir, matrix, drug-in-adhesive). To assess current TDDS technologies and recommended practices for safe and effective use of medication patches, a literature search for articles on commonly used TDDS products available in the United States was conducted; supplemental information was obtained from package inserts and through direct communication with manufacturers. In addition to recommendations on the site and duration of TDDS application and proper patch disposal, clinicians must consider (1) potential problems with cutting patches as a method of dosage adjustment, (2) safety concerns related to the electric conductivity of metal-containing patches, (3) appropriate strategies for managing patch adhesion failures, and (4) the advisability of writing on patches for medication safety or compliance reasons. Clinicians should also be prepared to counsel patients about TDDS-specific recommendations on the avoidance of sunlight and other external heat sources during the use of a medication patch. Conclusion Practical considerations related to transdermal drug delivery include the appropriateness of cutting patches, the implications of their containing metallic components, and whether they may be covered with tape or written on. Manufacturers of patches provide some useful information on these topics.

Schizophrenia and the immune system: Pathophysiology, prevention, and treatment

Abstract: Purpose Published evidence on established and theoretical connections between immune system dysfunction and schizophrenia is reviewed, with a discussion of developments in the search for immunologically-targeted treatments. Summary A growing body of evidence indicates that immunologic influences may play an important role in the etiology and course of schizophrenia. A literature search identified more than 100 articles pertaining to suspected immunologic influences on schizophrenia published over the past 15 years. Schizophrenia researchers have explored a wide range of potential immune system-related causal or contributory factors, including neurobiological and neuroanatomical disorders, genetic abnormalities, and environmental influences such as maternal perinatal infection. Efforts to establish an immunologic basis for schizophrenia and identify reliable immune markers continue to be hindered by sampling challenges and methodological problems. In aggregate, the available evidence indicates that at least some cases of schizophrenia have an immunologic component, suggesting that immune-focused prevention strategies (e.g., counseling of pregnant women to avoid immune stressors) and close monitoring of at-risk children are appropriate. While antipsychotics remain the standard treatments for schizophrenia, a variety of drugs with immunologic effects have been investigated as adjunctive therapies, with variable and sometimes conflicting results; these include the cyclooxygenase-2 inhibitor celecoxib, immune-modulating agents (e.g., azathioprine and various anticytokine agents such as atlizumab, anakinra, and tumor necrosis factor-α blockers), and an investigational anti-interferon-γ agent. Conclusion The published evidence indicates that immune system dysfunction related to genetic, environmental, and neurobiological influences may play a role in the etiology of schizophrenia in a subset of patients.

Pharmacy forecast 2013-2017: strategic planning advice for pharmacy departments in hospitals and health systems: executive summary of a trends report from the center for health-system pharmacy leadership, ASHP research and education foundation.

Abstract: In this time of economic uncertainty and turmoil in health care, it would be unthinkable for a hospital or health system not to plan for the future. The same can be said for the components of health care institutions, including the pharmacy department. From the perspective of the pharmacy

Analyzing methods for improved management of workflow in an outpatient pharmacy setting

Abstract: Purpose The results of a workflow analysis at a large central outpatient pharmacy are reported, with theoretical modeling of potential efficiencies attainable through workflow enhancements. Summary In keeping with concepts of “lean health care,” a time–motion analysis was conducted at a central outpatient pharmacy that dispenses an average of 250 prescriptions per day. Through direct observation over an eight-week period, pharmacists’ dispensing-oriented activities were categorized as either value-added (i.e., centered on direct pharmacist–patient contact and, hence, providing increased value to the patient) or non-value-added. The workflow analysis suggested opportunities to derive more value from pharmacists’ time by shifting their efforts away from non-value-added activities (i.e., technical dispensing functions) toward value-added activities: engagement of patients on entry into the pharmacy, pharmacist order verification, and patient counseling. The theoretical application of two models of enhanced workflow indicated that model A (expansion of pharmacy technicians’ standard duties to include prescription preparation, stock-container retrieval, and prescription processing) could reduce pharmacists’ non-value-added time by about 55%, or more than six minutes per prescription, with an even greater (74%) potential reduction offered by model B (technician performance of checkout procedures in addition to expanded standard duties). Although the research site was atypical in its high staffing level relative to prescription volume, the findings suggest that similar workflow enhancements might be applicable in a range of community practice settings. Conclusion Through analysis of existing workflow in an outpatient pharmacy, opportunities to optimize the use of value-added pharmacist time in the dispensing process were identified.

Eribulin mesylate: a novel halichondrin B analogue for the treatment of metastatic breast cancer.

Abstract: Purpose The pharmacology, pharmacokinetics, clinical efficacy, safety, and administration of eribulin in patients with metastatic breast cancer are reviewed. Summary Classical chemotherapeutic agents for breast cancer have dominated treatment regimens even in the era of targeted therapy. Disease progression through these agents is often due to the development of resistance or lack of efficacy with these agents. Recently, a new nontaxane agent, eribulin mesylate, was approved for the treatment of metastatic breast cancer in patients who have received at least two prior chemotherapeutic agents. Eribulin is a member of a new class of synthetic cytotoxic agents derived from the Japanese sea sponge Halichondria okadai . Eribulin differs from other antimicrotubule agents in that it can bind to the microtubule cap and inhibit tubulin polymerization, leading to microtubule arrest. In Phase II clinical trials, eribulin demonstrated activity in extensively pretreated patients who had previously received an anthracycline, taxane, and capecitabine and had shown disease progression within the last six months of treatment. In a pivotal Phase III clinical trial of heavily pre-treated patients, patients who received eribulin versus the physician’s treatment of choice showed a significant increase in overall and progression-free survival. Eribulin has a manageable adverse-effect profile, consisting mainly of neutropenia and fatigue. Eribulin has been associated with a low incidence of peripheral neuropathy. Conclusion Eribulin, a novel synthetic antimicrotubule agent that binds to the vinca domain of tubulin and inhibits the polymerization of tubulin, offers a new treatment option for metastatic breast cancer or locally advanced breast cancer.

Fidaxomicin: A novel macrocyclic antibiotic for the treatment of Clostridium difficile infection

Abstract: Purpose The pharmacology, clinical efficacy, safety, dosage and administration, and place in therapy of fidaxomicin for the treatment of Clostridium difficile infection (CDI) are reviewed. Summary Fidaxomicin, a macrocyclic antibiotic, has a narrow spectrum of activity against gram-positive anaerobes and is bactericidal against C. difficile . It has no activity against gram-negative bacteria. Fidaxomicin has minimal activity against Bacteroides species, which may be advantageous in maintaining colonization resistance and protecting the gastrointestinal tract from colonization by C. difficile . The minimum inhibitory concentration for 90% of organisms for fidaxomicin against C. difficile ranged from 0.0078 to 2 μg/mL in in vitro studies. After oral administration, fecal concentrations are detected and are directly proportional to the dose administered. Fidaxomicin resistance in vivo has not been reported. In clinical trials, fidaxomicin has been shown to be noninferior to vancomycin in the management of mild-to-moderately severe CDI. The adverse-effect profile of fidaxomicin is comparable to that of vancomycin. The recommended dosage for treatment of CDI is fidaxomicin 200 mg orally twice daily for 10 days. Fidaxomicin should be considered for patients who previously received treatment with metronidazole or vancomycin for CDI and who are diagnosed with recurrent CDI in which a non-NAP1/BI/027 strain is isolated. At institutions where strain typing is not available, fidaxomicin may be considered in patients with recurrent CDI who have not responded to treatment with the regimen used for the first episode of CDI. Conclusion Fidaxomicin is a well-tolerated agent for the treatment of CDI and has been shown to be noninferior to vancomycin in the management of mild-to-moderately severe CDI.

Preventability of adverse drug events involving multiple drugs using publicly available clinical decision support tools

Abstract: Purpose The results of a retrospective evaluation of the frequency and preventability of adverse drug events (ADEs) involving multiple drugs among hospital inpatients are reported. Methods Data collected in a previous cohort study of 180 actual ADEs and 552 potential ADEs (PADEs) at six community hospitals in Massachusetts were analyzed to determine the frequency and types of multiple-drug ADEs and the extent to which the ADEs might have been prevented using publicly available clinical decision-support (CDS) knowledge bases. None of the hospitals had a computerized prescriber-order-entry system at the time of data collection (January 2005–August 2006). Results A total of 17 ADEs (rate, 1.4 per 100 admissions) and 146 PADEs (rate, 12.2 per 100 admissions) involving multiple drugs were identified. The documented events were related to drug duplication ( n = 126), drug–drug interaction ( n = 21), additive effects ( n = 14), and therapeutic duplication ( n = 7) or a combination of those factors. The majority of actual ADEs were due to drug–drug interactions, most commonly involving opioids, benzodiazepines, or cardiac medications; about 75% of the PADEs involved excessive drug doses resulting from order duplication or the prescribing of combination drugs with overlapping ingredients, usually products containing acetaminophen and an opioid. It was determined that 5 (29.4%) of the ADEs and 131 (89.7%) of the PADEs could have been detected through the use of the evaluated CDS tools. Conclusion A substantial number of actual ADEs and PADEs in the community hospital setting may be preventable through the use of publicly available CDS knowledge bases.

Implementation of targeted interventions to decrease antiretroviral-related errors in hospitalized patients.

Abstract: Purpose The implementation and effectiveness of targeted interventions aimed at decreasing the frequency of antiretroviral-related errors in hospitalized patients with human immunodeficiency virus (HIV) are described. Summary A prospective investigation conducted at the University of North Carolina Hospitals revealed a high rate of antiretroviral-related errors occurring on admission to the hospital and throughout a patient’s hospital stay. The high frequency of errors emphasized the need for targeted interventions aimed at preventing these errors and quickly identifying and resolving errors that do occur. Several interventions aimed at decreasing this error rate were instituted, including the addition of computer alerts for incorrect doses and drug interactions to the pharmacy order-entry system, distribution of an educational pocket-sized card among the staff, addition of commercially available combination antiretroviral products to the hospital formulary, updates of the computerized prescriber-order-entry (CPOE) system to include common dosage defaults, involvement of the infectious diseases consultation service to evaluate prescribed regimens of newly admitted patients with HIV, and daily review of newly initiated anti-retroviral regimens by a clinical pharmacist trained in HIV care. A follow-up analysis was conducted after these interventions were implemented to evaluate their effectiveness. Of the 78 patients identified during the postintervention analysis, 12 (15%) had at least one error in their initial drug regimen versus 49 patients (72%) in the preintervention study ( p < 0.001). Conclusion Antiretroviral medication error rates decreased after the implementation of targeted interventions that included distributing an educational pocket-sized card, adding alerts to the pharmacy order- entry system, incorporating default dosages into the CPOE system, and adding combination antiretrovirals to the formulary.

Apixaban: a novel oral inhibitor of factor Xa.

Abstract: Purpose The pharmacology, pharmacokinetics, efficacy, and safety of apixaban are reviewed. Summary Apixaban is an oral, direct, selective factor Xa inhibitor with a rapid onset of action. It has a plasma elimination half-life of 12 hours and has been administered in a twice-daily dosing regimen in clinical trials without the need for anticoagulation monitoring or dosage adjustment. Apixaban has multiple elimination pathways, and its pharmacokinetics is not substantially altered by patient age, sex, race, or ethnicity. The results of three Phase III trials indicated that apixaban was similar to or more effective than enoxaparin for preventing venous thromboembolism (VTE) in patients undergoing total hip or knee replacement, with similar or lower rates of bleeding. Two Phase III trials found that apixaban was more effective for stroke prevention than either aspirin or warfarin in patients with atrial fibrillation (AF), with a similar (versus aspirin) or improved (versus warfarin) safety profile. A Phase III trial evaluating apixaban plus antiplatelet monotherapy or dual-antiplatelet therapy in patients with acute coronary syndrome ended early due to clear evidence of a clinically important increase in bleeding among patients randomized to apixaban without any meaningful reduction in ischemic events. The adverse-event profiles for apixaban and comparators have been similar in studies conducted to date. Conclusion Apixaban, a new anticoagulant, appears to offer an efficacy and safety profile comparable with that of enoxaparin for preventing VTE after orthopedic surgery, with the advantage of oral administration. In patients with AF, apixaban is more effective than either warfarin or aspirin for stroke prevention, with an acceptable safety profile.

Development of a residency interviewing preparatory seminar.

Abstract: Purpose The development of a residency interviewing preparatory seminar (RIPS) is described. Summary The RIPS elective at Nova Southeastern University College of Pharmacy was designed to assist pharmacy students during their last professional year in preparing for the residency application process. The learning objectives of the course focused on improving students’ interviewing and presentation skills, professionalism, and developing their curriculum vitae (CV) and personal statement. Course and instructor evaluations and demographic data collected via anonymous surveys were used to ascertain students’ perspectives about the course. The class was purposely scheduled to begin in October and end in November, right before the ASHP Midyear Clinical Meeting in early December. Due to limited faculty availability on the scheduled evenings and the desire to provide tailored, in-depth feedback, enrollment was limited. The RIPS was an intensive eight-week elective completed by 10 fourth-year pharmacy students. The course began with an overview of the residency application process, and students submitted their CVs and personal statements to faculty mentors for critique. To simulate residency interview components, students completed several timed activities in class and participated in mock interviews. Students stated that the course improved their application materials, interview skills, and confidence in their ability to obtain a residency. Overall, 78% of RIPS participants matched with a residency program. Conclusion The RIPS elective was successful in improving residency candidate confidence at the ASHP Midyear Clinical Meeting. Students reported that the course was helpful and improved their confidence and ability to interview.