Influence at a higher level.
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OBJECTIVE: There is a worldwide concern about rational drug use, more specifically related to antimicrobial utilization. In developing countries, few resources are intended for monitoring on rational drug use. Moreover, there are limited data on the use of antimicrobial agents in hospitals. A study was carried out to describe patterns of use of antimicrobial agents over a 7-year period (1990 to 1996). METHODS: The study was conducted in a 690-bed tertiary care university hospital in Porto Alegre, Brazil. Hospital records were reviewed to identify inpatient antibiotics use. Results were expressed in defined daily dose per 100-beds/day. Cluster analysis was performed to determine the trends in use of individual agents. RESULTS: Antimicrobials use increased year after year, from 83.8 DDD per 100 beds-day in 1990 to 124.58 DDD per 100 beds-day in 1996. Penicillins were the drug group mostly used (39.6%), followed by cephalosporins (15.0%), aminoglycosides (14.4%), sulfonamides (12.8%), glycopeptides (3.6%), and lincosamides (3.1%). These groups were responsible for around 90% of all agents used. The use of antimicrobial agents was divided into thirteen groups based on cluster analysis. CONCLUSIONS: Antimicrobial use increased dramatically in the study period, and this increase was significantly higher when compared to other studies. When newer alternative agents became available in the hospital, the use of already existing drugs decreased and in some cases remained relatively stable. After implementing specific interventions, such as an effort for the correct use of cefoxitin, the expected changes in use were observed.
Target drug programs and medication use evaluations are activities that are undertaken to improve the correct use of drugs. These programs should focus on inappropriate drug use, drug use problems, optimizing use of drugs, and improving the level of patient care. To monitor the effects of the programs, several types of outcomes have been evaluated, such as economic and financial, clinical quality, quality of life, patient satisfaction, and collaborative practice. The methodology to classify and monitor drug use incorporates the classification system developed by the World Health Organization, which takes into account each drug's anatomic, therapeutic, and chemical classification. In order to avoid focusing only on drugs and drug costs in these programs, and to allow for monitoring the impact of the programs on clinical practice, linking drug data to patient data is stressed. Target drug programs improve the appropriate use of drugs, and by doing so, contribute to safe and rational use of drugs in society.
Practice guidelines and clinical pathways are increasingly being used as tools to enhance the quality of health care services and to manage costs better. This article reviews the role of guidelines and clinical pathways in health care as defined within the broader concept of practice policies. The factors that increase the effectiveness of practice policies are examined. These include the origin of development, dissemination technique, and implementation strategy. Policies that are internally developed and implemented with concurrent reminder systems are the most effective. Clinical pathways fit these criteria and are therefore highly effective policy types. The roles that pharmacists within health systems can undertake in policy development are described. These include writing the policy document, providing expert review, providing education, and most important, facilitating the desired outcomes by implementing pharmacy services that promote compliance with the guidelines. Examples of pharmacy-based guideline and pathway implementation from the Henry Ford Health System are described for inpatient anticoagulation, outpatient preferred drug formulary policy, and outpatient lipid therapy management.
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STUDY OBJECTIVE: To assess the lipid-lowering efficacy, safety, and costs of a large-scale statin formulary conversion program. DESIGN: Prospective, observational study. SETTING: Tertiary academic medical center. PATIENTS: A total of 980 patients consented to participate; 942 patients completed the study. INTERVENTION: Patients were converted from their current statin therapy to either cerivastatin 0.4 or 0.8 mg/day, or simvastatin 80 mg/day, using a conversion algorithm. MEASUREMENTS AND MAIN RESULTS: Efficacy and safety were evaluated at baseline and after 6 weeks of therapy; costs were also measured. Overall attainment of the National Cholesterol Education Program (NCEP) goal for low-density lipoprotein cholesterol (LDL) increased from 64.8% to 74.5% of patients (p<0.001); mean LDL decreased from 115+/-30 mg/dl to 106+/-25 mg/dl (p<0.001). Adverse events occurred in 3% of patients, and included myositis (0.6%) and increased hepatic transaminases (0.1%). Overall costs were reduced by $115/patient treatment-year. CONCLUSION: Statin therapeutic interchange can improve lipid control at reduced costs. The possibility of uncommon but potentially serious adverse effects suggests that these programs require appropriate monitoring.
A university hospital formulary change that was designed to reduce the use of the third-generation cephalosporins ceftazidime and cefotaxime and replace them with the so-called "fourth-generation" cephalosporin cefepime was evaluated. A retrospective review of antibiotic use and antimicrobial resistance during two 6-month periods before and after the formulary change was performed. All hospital patients with vancomycin-resistant Enterococcus (VRE), ceftazidime-resistant Klebsiella pneumoniae (CRKP), methicillin-resistant Staphylococcus aureus (MRSA), piperacillin-resistant Pseudomonas aeruginosa (PRPA), and ceftazidime-resistant P. aeruginosa (CRPA) infections were included in the study Ceftazidime use decreased from 9600 g to 99 g, and cefotaxime use decreased from 6314 g to 732 g, which represented a combined decrease of 89%. Use of cefepime increased from 0 g to 5396 g. Infections from CRKP decreased from 13% to 3%, PRPA infections decreased from 22% to 14%, and CRPA infections decreased from 25% to 15% (p<0.05 for all). Infections from MRSA dropped insignificantly, and VRE infections increased significantly. Substituting cefepime for ceftazidime and cefotaxime while reducing the overall use of cephalosporins appears to decrease rates of CRKP, PRPA, and CRPA.
INTRODUCTION: Formulary decisions regarding a given drug class are often made in the absence of patient outcome and/or sophisticated pharmacoeconomic data. Analyses that consider factors beyond simple acquisition costs may be useful in such situations. For example, the cost implications of using manufacturers' recommendations for dosing in patients with renal dysfunction may be important, depending on the distribution of various levels of renal function within a patient population. METHODS: Using four 1000-patient populations representing different renal function distributions and a fifth population of our medical center's distribution, we determined the costs of therapy for intravenous and oral levofloxacin, gatifloxacin, and moxifloxacin for a 10-day course of therapy for community-acquired pneumonia. Costs considered were average wholesale prices (AWPs), 50% of AWP, or same daily price, plus intravenous dose preparation and administration costs when applicable. Costs for each renal function distribution were examined for significant differences with an analysis-of-variance test. Also, costs of failing to adjust dosing regimens for decreased renal function were determined. RESULTS: Differences in fluoroquinolone costs (AWP, 50% AWP, or when matched as the same daily price) among the populations were found. When considering same daily prices, differences among populations ranged from about 35,000 dollars with intravenous gatifloxacin to more than 51,000 dollars for intravenous levofloxacin (all fluoroquinolones, p>0.05). Within a population, differences in costs among the intravenous fluoroquinolones ranged from 47,000-99,000 dollars. Rank orders of the drugs and population costs of therapy were affected by the pricing structure used and varied by the specific population and drug. Differences among the fluoroquinolones or populations were much smaller (<2100 dollars) when considering oral regimens. Costs potentially incurred by failing to adjust dosing for renal function were substantial. CONCLUSION: Formulary decisions can be facilitated by considering factors such as patient characteristics and related dosing in addition to simple acquisition costs. In our example, consideration of the distribution of renal function within a given patient population and related dosing for these fluoroquinolones revealed potentially important differences within the class.
STUDY OBJECTIVE: To evaluate the effects on efficacy and safety of a formulary change from granulocyte colony-stimulating factor (G-CSF) to granulocyte-macrophage CSF (GM-CSF). DESIGN: Retrospective chart review. SETTING: Single-center academic institution. PATIENTS: Fifty-six patients aged 18 years or older with breast cancer, lung cancer, melanoma, Hodgkin's lymphoma, or non-Hodgkin's lymphoma who developed neutropenia within 4 weeks after treatment with myelosuppressive chemotherapy and who had been given five or more doses of CSF as primary or secondary prophylaxis from January 1995-March 2002. Twenty-nine patients treated before January 2000 were given G-CSF; after the formulary change in January 2000, 27 patients were primarily given GM-CSF. MEASUREMENTS AND MAIN RESULTS: The primary efficacy end point was time to an absolute neutrophil count of 1.5x10(3)/mm3 or greater after treatment with CSF. Second and third efficacy end points, respectively, were frequency of febrile neutropenia and effect of CSF treatment on schedule and dose intensity of subsequent chemotherapy cycles. Primary and secondary safety end points, respectively, were frequency of adverse events and use of resources used to manage these events. The time to neutrophil recovery was similar with G-CSF and GM-CSF. Febrile neutropenia was more common in the patients given GM-CSF. Chemotherapy dose delays also were more common in patients treated with GM-CSF, as was the frequency of fever. Use of resources (platelet and red blood cell transfusions, intravenous antibiotics, and hospitalizations) was greater in the patients treated with GM-CSF. CONCLUSION: The formulary change to GM-CSF was associated with a higher frequency of febrile neutropenia, resultant chemotherapy dose delays, more adverse events, and greater use of resources to manage the adverse events. These results suggest that G-CSF and GM-CSF are not therapeutically equivalent, with G-CSF having a superior safety and efficacy profile for the prevention of chemotherapy-induced neutropenic events.
NICU patients are at particularly high risk of harm and even death from medical error. In one NICU, a process change was undertaken to minimize the risk of errors resulting in the intravenous (IV) administration of enteral formulas and oral medications. In addition, a double-check system for medication doses was introduced to reduce the likelihood of medication errors. The previous practice was to deliver enteral formulas via syringe pump using TV syringes and tubing and to dispense medications in bulk bottles, drawing up patient-specific doses at the bedside. Converting to oral syringe delivery of medications and enteral formulas utilizing enteral-only tubing eliminated the necessity for Luer-Lok IV tubing and syringes, thereby reducing the potential for wrong-route error. Converting from dispensing medications in bulk to a unit-dose system permitted establishment of a double-check system in which doses are first checked by a pharmacist and then checked by the nurse before they are administered. This article describes the planning, implementation, and postimplementation process required to make this change in practice a success.
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PURPOSE: The distribution, content, timeliness, use, and influence of pharmacoeconomic assessments (PEAs) of drugs in New Zealand public hospitals were examined. METHODS: In April 2005, a questionnaire-based, cross-sectional survey was sent to chief pharmacists at all 29 New Zealand hospitals employing a pharmacist. The questionnaire asked pharmacists about the use and influence of PEAs in their hospitals' formulary decision-making process. Answers were given using a scale of 1 to 6, with 1 being the most positive response. RESULTS: Of the 29 surveys mailed, 24 (83%) were completed. Data on 12 PEAs were analyzed. Assessments were seen and summaries read in most hospitals (median, 77% and 65%, respectively). Full documents were read in fewer hospitals (35%). In general, the PEAs were considered moderately easy to understand, provided a concise summary, and contained adequate detail of the methodology. Of the 24 respondent hospitals, 21 had assessment processes for new medicines; hence, a total of 252 hospital evaluations of Pharmaceutical Management Agency (PHARMAC)-assessed drugs were possible. A total of 132 possible evaluations (52%) were undertaken. More evaluations (106 [42%]) took place before PHARMAC's PEAs were distributed and fewer (26 [10%]) after distribution. Where used, the PEAs appeared to have a modest effect on hospital decisions. CONCLUSION: The provision of 12 PEAS by PHARMAC to hospitals in New Zealand had only a modest influence on their formulary decision-making process, mostly due to the lack of timeliness of the PEAs. The timely delivery of centrally developed PEAs may be essential to generating a greater effect on the formulary decisions at a wider level.
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Pharmacy and Therapeutics (P&T) committees undertake policy, regulatory and educational activities to promote rational use of medicines in their institutions with the aim of improving the quality of health and economic outcomes at these institutions. Formulary management is an important part of the P&T committees' activities and making drug choices is one of the committees' most difficult tasks. The 3 types of information most commonly identified by P&T committees as necessary for making drug choices are effectiveness, safety and cost data; usually in this order of importance. There is some evidence, however, that safety data are not considered by all committees when they make decisions about adding a new drug to a formulary. The role of adverse drug reaction (ADR) data in formulary decision-making (for registered drugs) occurs at several levels. First, ADR data obtained from pre-marketing studies of the drug are important and enable the committee to make an assessment of the risk of toxicity that should be anticipated for the drug. However, the limited nature of this information makes an absolute assessment impossible. Secondly, comparative safety information is necessary when deciding the place in therapy of a particular drug. Weighing up the comparative risks and benefits is a complex task which is a routine activity for most P&T committees whatever level of sophistication is applied. Thirdly, ADR data are an important ingredient of any economic assessment considered by a P&T committee. Calculation of the costs and consequences associated with the adverse effects of treatment demand careful assessment. Finally, aggregated adverse drug event reports which collate not only the consequences of adverse drug reactions but also medication incidents (medication errors) and which have been reported locally can be a useful quality assurance process for a P&T committee. This information will contribute to the identification of drugs for deletion from the formulary and less commonly in making decisions about additions to the formulary. As formulary management forms only part of a P&T committee's work, so the committee's interest in ADR is broader than the use of these data in making drug choices. The P&T committee may also be involved in promoting ADR reporting to either a central database or primary carers. Although often of limited availability, ADR information has an important role in the formulary management process of P&T committees.
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