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Biomedical subjects

Craig A Pedersen

Publications and source records attributed to Craig A Pedersen.

At least 19 recordsLinked to original sources
PubMed2007

Interrater agreement with a standard scheme for classifying medication errors.

PURPOSE: The interrater agreement for and reliability of the National Coordinating Council for Medication Error Reporting and Prevention (NCC MERP) index for categorizing medication errors were determined. METHODS: A letter was sent by the U.S. Pharmacopeia to all 550 contacts in the MEDMARX system user database. Participants were asked to categorize 27 medication scenarios using the NCC MERP index and were randomly assigned to one of three tools (the index alone, a paper-based algorithm, or a computer-based algorithm) to assist in categorization. Because the NCC MERP index accounts for harm and cost, and because categories could be interpreted as substantially similar, study results were analyzed after the nine error categories were collapsed to six. The interrater agreement was measured using Cohen's kappa value. RESULTS: Of 119 positive responses, 101 completed surveys were returned for a response rate of 85%. There were no significant differences in baseline demographics among the three groups. The overall interrater agreement for the participants, regardless of group assignment, was substantial at 0.61 (95% confidence interval [CI], 0.41-0.81). There was no difference among the kappa values of the three study groups and the tools used to aid in medication error classification. When the index was condensed from nine categories to six, the interrater agreement increased with a kappa value of 0.74 (95% CI, 0.56-0.90). CONCLUSION: Overall interrater agreement for the NCC MERP index for categorizing medication errors was substantial. The tool provided to assist with categorization did not influence overall categorization. Further refining of the scale could improve the usefulness and validity of medication error categorization.

Adverse Drug Reaction Reporting Systems↗
PubMed2006

Impact of United States Pharmacopeia chapter 797: results of a national survey.

PURPOSE: The initial response of the pharmacy profession to United States Pharmacopeia (USP) chapter 797 and the current state of hospital pharmacy practice as it relates to implementing this chapter were studied. METHODS: A stratified random sample of 600 hospital pharmacy directors across the nation were surveyed by mail. RESULTS: A total of 251 surveys (41.8%) were returned. Larger hospitals (> or =200 staffed beds) were more likely than smaller hospitals (<200 staffed beds) to have read USP chapter 797 (80.0% versus 45.8%, respectively) and have a copy of the chapter (94.6% versus 78.0%, respectively). Overall, respondents felt that chapter 797 would negatively affect workload and pharmacy's ability to provide sterile preparations in a timely manner. Conversely, respondents replied that the new standard would have a positive effect on the quality of care provided by the hospital. Overall, 45.3% of respondents reported plans to build a clean-room, and 21.7% reported plans to obtain new equipment to comply with chapter 797. Furthermore, 42.3% of respondents had decreased the quantity of high-risk compounding. Respondents also reported that their pharmacy's budget had increased in order to comply with chapter 797. The most common requirements with which respondents were not willing to comply were validating the accuracy of automated compounding devices, sterilizing products and equipment before entering the cleanroom, rotating the type of disinfectants, and prohibiting use of cosmetics by staff. CONCLUSION: USP chapter 797 standards have influenced the compounding practices of hospital pharmacies nationwide, including a decrease in the compounding of high-risk preparations, an increase in budgetary allocations, and implementation of better quality assurance practices. Larger hospitals tended to implement more changes than did smaller hospitals, and there remains room for improvement overall.

Drug Compounding↗
PubMed2006

ASHP national survey of pharmacy practice in hospital settings: dispensing and administration--2005.

PURPOSE: Results of the 2005 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 1173 general and children's medical-surgical hospitals in the United States was surveyed by mail. RESULTS: The response rate was 43.5%. Most hospitals had a centralized drug distribution system; however, there is evidence of growth in decentralized models compared with data from 2002. Automated dispensing cabinets were used by 72% of hospitals and robots by 15%. The percentage of doses dispensed in unit dose form increased, as did the use of two-pharmacist checks for high-risk drugs and high-risk patient groups. However, the percentage of medication preparation and dispensing quality-improvement programs declined over the past six years. Medication administration records (MARs) have become increasingly computerized over the past six years. Consequently, the use of handwritten MARs has declined substantially. Technology implemented at the administration step of the medication-use process is continuing to grow. Bar-code technology was implemented by 9.4% of hospitals, and 32.2% of hospitals had smart infusion pumps. Pharmacy hours of operation were stable, with 30% of hospitals providing around-the-clock services. About 12% of hospitals are using off-site medication order review and entry after hours. Pharmacy staffing has steadily increased over the past three years; however, hospital pharmacies reported a 5.6% vacancy rate. CONCLUSION: Safe systems continue to be in place in most hospitals, but the adoption of new technology is changing the philosophy of medication distribution. Pharmacists are continuing to improve medication use at the dispensing and administration steps of the medication-use process.

Drug Compounding↗
PubMed2006

Improving the safety of medication administration using an interactive CD-ROM program.

PURPOSE: The impact of an interactive CD-ROM program on the rate of medication administration errors made by nurses was studied. METHODS: This randomized, controlled, nonblinded study was conducted at three community hospitals. Study participants included 30 registered nurses who had at least one year of nursing experience in acute care and who worked on medical or medical-surgical units. Nurses were randomized to an intervention group that completed an interactive CD-ROM program on safe medication practices or to a control group. Direct observation was used to determine the baseline (preintervention) and postintervention error rates for both study and control groups. Three categories of errors were defined: deviation from safe administration practices (core 1), preparation and administration errors (core 2), and deviations from prescribed therapy (core 3). An error rate was calculated for each nurse, and the error rates for the study and control groups were based on the average error rate for the nurses in each group. RESULTS: The majority of errors made were core 1 errors. The nurse-level data showed a significant decrease in core 1 error rates between baseline and postintervention periods. Core 2 error rates were higher in the postintervention period, but the increase was not significant. Very few core 3 errors were made by either group during either period. CONCLUSION: An interactive CD-ROM enabled nurses to apply the information learned to identify errors in medication administration and improved adherence to safe medication administration practices.

Adult↗
PubMed2006

Optimal timing of ampicillin administration to pregnant women for establishing bactericidal levels in the prophylaxis of Group B Streptococcus.

OBJECTIVE: The purpose of this study was to determine the time necessary to achieve and maintain bactericidal concentrations of ampicillin in the cord blood. STUDY DESIGN: This was a prospective study in which women scheduled for an elective cesarean section were given intravenous ampicillin before the procedure. Cord and simultaneous maternal blood samples were collected at the time of delivery. Serum ampicillin levels were analyzed by high-performance liquid chromatography. RESULTS: The ratio of cord blood to maternal serum ampicillin concentration was found to increase over time in a linear fashion. There was no correlation between maternal body mass index (22.3 to 48.3 kg/m2) and ampicillin cord blood concentrations. All cord serum samples far exceeded minimal bactericidal concentrations reported for Group B Streptococcus (0.25 to 2.0 microg/mL), even at 338 minutes following administration. CONCLUSION: Bactericidal levels of ampicillin in the cord blood are rapidly achieved within 30 minutes of administration of ampicillin to the mother. The increase in the ratio of cord to maternal serum ampicillin levels is directly related to time, suggesting a decrease in the clearance of ampicillin in the newborns as compared to the mothers. The cord blood ampicillin concentration exceeds the maternal concentration and both continue to be above the minimal bactericidal concentrations at 5.6 hours after administration. No relationship was observed between the maternal body mass index and ratio of cord to maternal serum concentrations of ampicillin.

Adult↗
PubMed2006

Provision of risk management and risk assessment information: the role of the pharmacist.

BACKGROUND: There exists a need to conceptualize and understand the roles that pharmacists serve to help convince others such as patients, prescribers, and payers to value their contributions and to plan for the roles they could serve in the future within the health care system. OBJECTIVE: The purpose of this study was to (1) describe and track differences in pharmacists' and patients' views about the pharmacist's and physician's role in medication risk management and risk assessment in 1995, 1998, 2001, and 2004, and (2) describe associations between selected demographic variables and reported opinions about the pharmacist's role using data from 2004. METHODS: Brushwood's Risk Management/Risk Assessment Framework was used as a conceptual guide for developing 2 risk management and 2 risk assessment scenarios. For each scenario, study participants were asked to select the level of responsibility shared by physicians and pharmacists in addressing the drug therapy problem. Data were collected in 1995, 1998, 2001, and 2004 using random samples of pharmacists and patients as study subjects. Descriptive statistics and logistic regression analysis were used for analyzing the data. RESULTS: The results showed that pharmacists view their role as providing risk management information to patients and may view this role as adding value to patient care above and beyond a level that can be provided by a physician alone. In 2004, pharmacists started to view the risk assessment scenarios as being more their responsibility as well. Patients, on the other hand, consistently viewed their physician as having primary responsibility for their health care in all of the scenarios we studied. CONCLUSIONS: Pharmacists view their role as one that adds unique value to a patient's health through their provision of medication risk management and some types of risk assessment. However, patients do not yet view the pharmacist as the primary provider of either medication risk management or risk assessment information.

Attitude of Health Personnel↗
PubMed2005

Utility of an online medication-error-reporting system.

PURPOSE: The utility of an online medication-error-reporting program was evaluated. METHODS: A survey regarding the utility of Medmarx was developed and mailed to 550 hospitals and health systems that used the medication-error-reporting program. Primary contact persons were identified and asked to gather and report the necessary information to adequately characterize medication-error reporting in their institution before and after implementing the Medmarx system. Potential respondents were contacted four times during the survey period by the United States Pharmacopeia. RESULTS: Of the 550 surveys sent, 200 were returned and 25 were undeliverable, resulting in a response rate of 38%. The average number of medication errors reported internally increased twofold after the adoption of the Medmarx system. Pharmacy departments were most often reported as responsible for medication-safety oversight activities after Medmarx implementation. Most facilities (94%) generated reports from the medication-error database, and 75% used this information to identify 7.0+/-8.1 opportunities to improve their medication-use system annually. Most respondents believed that Medmarx played an integral role in preparing their facility for Joint Commission accreditation surveys (65%), provided a tool for root-cause analysis (71%), and helped identify problems in the medication-use process (85%). The annual costs of the subscription and staff time required to use the system was estimated to be 16,756 dollars+/-21,108 dollars. Sixty-six percent of users were satisfied with the impact the system has had on improving the medication-use process. CONCLUSION: Implementation of the Medmarx system led to an increase in the number of reported medication errors and improvements in the medication-use process.

Adverse Drug Reaction Reporting Systems↗
PubMed2005

ASHP national survey of pharmacy practice in hospital settings: prescribing and transcribing--2004.

PURPOSE: Results of the 2004 ASHP national survey of pharmacy practice in hospital settings that pertain to prescribing and transcribing are presented. METHODS: A stratified random sample of pharmacy directors at 1183 general and children's medical-surgical hospitals in the United States was surveyed by mail. SMG Marketing Group, Inc., supplied data on hospital characteristics; the survey sample was drawn from SMG's hospital database. RESULTS: The response rate was 41.7%. Compared with the results of the 2001 survey, the number of times pharmacy and therapeutics committees met increased, suggesting an increase in efforts to monitor and manage medication use in hospitals. There was an increase in the use of quality-of-life information to make formulary decisions, indicating a shift away from cost-based formularies. There was a decrease in the rates of formulary compliance, but an increase in the use of evidence-based clinical practice guidelines, suggesting the emergence of more comprehensive approaches to improving prescribing. The use of medication-use evaluations increased in smaller hospitals, suggesting greater use of best practices is occurring in these institutions. The use of drug information services continues to decline, as the use of more efficient and easily accessible online sources of drug information increases. Reading back oral orders to improve accuracy dramatically increased since 2001. The adoption of computerized prescriber-order-entry systems continues to be slow, with fewer than 5% of hospitals reporting their use. CONCLUSION: The 2004 ASHP survey results indicate that pharmacists are continuing to improve medication use at the prescribing and transcribing steps of the medication-use system.

Computer Systems↗
PubMed2004

Embolization itself stimulates thrombus propagation in pulmonary embolism.

The role of active thrombosis in the pathophysiology of pulmonary embolism is unclear. We tested the hypothesis that venous thrombi significantly increase their thrombotic activity once they embolize into the high-flow circulation of the pulmonary arteries. Thrombotic activity was measured using an immunoassay that measures both fibrinopeptide B (FPB) as well as its most abundant metabolite des-arginine FPB. Thrombi were formed in the femoral veins of adult dogs. In one group, the thrombi were embolized without anticoagulation. In the second group, heparin (300 U/kg bolus, then 90 U x kg(-1) x h(-1) infusion) was administered before embolization to prevent subsequent thrombotic activity. Plasma FPB concentrations were significantly suppressed in the heparinized group relative to the nonheparinized group for 1 h postembolization (P = 0.038). We conclude that pulmonary embolization itself causes preexisting venous thrombi to greatly intensify their thrombotic activity and that embolization-associated thrombus propagation can be prevented by heparin.

Ancrod↗
PubMed2004

ASHP national survey of pharmacy practice in hospital settings: monitoring and patient education--2003.

PURPOSE: Results of the 2003 ASHP national survey of pharmacy practice in hospital settings that pertain to monitoring and patient education are presented. METHODS: A stratified random sample of pharmacy directors at 1173 general and children's medical-surgical hospitals in the United States was surveyed by mail. SMG Marketing Group, Inc., supplied data on hospital characteristics; the survey sample was drawn from SMG's hospital database. RESULTS: The response rate was 47.1%. Virtually all hospitals (95.3%) had pharmacists regularly monitoring medication therapy in some capacity. Patient monitoring has improved since 2000; fewer respondents reported monitoring less than 25% of patients in the hospital, and most hospitals reported an increase in the amount of time pharmacists devoted to monitoring activities. Pharmacists were provided computer access to laboratory information in 78% of hospitals to facilitate this function. Detection and reporting of adverse drug events (ADEs) have substantially increased since 1999, with an increase of 42% in events reported internally. Strategies to improve ADE reporting were in place in 84% of hospitals, indicating that pharmacists are adopting the widely recommended philosophy of learning from errors. Errors were less widely reported externally, limiting the value of aggregated data for improving the medication-use process. Most hospitals (85.5%) had an interprofessional infrastructure in place to discuss and learn from voluntary reports of ADEs. Medication counseling continued to be relatively infrequent, with nearly three fourths of hospitals reporting fewer than 26% of inpatients received medication education. Pharmacist staffing in hospitals has risen significantly, from an average of 8.6 full-time equivalents (FTEs) in 2002 to 9.4 FTEs per hospital. Vacancy rates for pharmacists decreased from 7.3% in 2002 to 43%. It is now estimated that there are 1846 vacancies in hospital pharmacies. CONCLUSION: Notable improvements in hospital pharmacy practice have been made. The percentage of patients whose medication therapy is monitored by pharmacists has increased, and most hospitals reported that the amount of time pharmacists spent monitoring patients' medication therapy had increased. Internal and external reporting of ADEs has increased, and pharmacist vacancies have decreased from 2002. Staffing has also improved, suggesting an abatement of the critical shortage of pharmacists in the hospital setting.

Adverse Drug Reaction Reporting Systems↗
PubMed2004

Single photon emission computed tomography of pulmonary emboli and venous thrombi using anti-D-dimer.

Previous attempts to diagnose thromboemboli using radiolabeled antibodies and nuclear medicine imaging have been disappointing. We present the results of experiments with intravenous technetium-99m-labeled deimmunized antifibrin Fab' fragments to diagnose thromboemboli using single photon emission computed tomography (SPECT), a highly sensitive scintigraphic imaging technique. Pulmonary emboli (PEs) and lower extremity deep vein thrombi (DVTs) were formed in five dogs, then technetium-99m-labeled Fab' ( approximately 400 mg, approximately 260 MBq) were injected via forelimb veins. Thoracic and lower extremity SPECT scans were performed at 2-hour intervals after antibody infusion to visualize the thromboemboli. Four hours after antibody infusion, all PEs and DVTs of mass 0.4 g or greater were clearly visualized on SPECT scans as 'hot spots' within the lungs and legs, respectively. PEs (0.48 +/- 0.09 g) were intensely radiolabeled, yielding clot/blood radioactivity ratios of 22.8 +/- 5.6. DVTs (0.45 +/- 0.31 g) also had high clot/blood ratios (11.7 +/- 2.6). Infusion of these radiolabeled antibody fragments, combined with SPECT, produces clear images of PEs and DVTs within a clinically feasible time frame. The technique reliably identified even peripheral thromboemboli of relatively small size, which are difficult to diagnose with currently available imaging techniques, and may enable imaging of PEs, DVTs, or both in the same patient.

Acute Disease↗
PubMed2004

Improved imaging of deep venous thrombi during anticoagulation using radiolabelled anti-D-dimer antibodies.

OBJECTIVES: Radiolabelled anti-fibrin antibodies have not yet enabled reliable and practical diagnosis of venous thromboembolism. However, previous unsuccessful clinical trials were performed with anti-fibrin beta-chain antibodies that do not optimally bind to thrombi during anticoagulation. The current experiments were performed to determine if radiolabelled anti-D-dimer antibodies more reliably allowed nuclear medicine imaging of deep venous thrombi during anticoagulation than anti-beta-chain antibodies. METHODS: Dogs with pre-existing unilateral femoral vein thrombi were anticoagulated with heparin (300 units.kg (-1) bolus followed by 90 units.kg(-1).h(-1) continuous infusion). They were then allocated to receive one of three (111)In labelled antibodies: anti-D-dimer, anti-beta or a non-specific control antibody. Gamma scans of the legs were performed at regular intervals for 24 h. Scans were interpreted in a blinded fashion and the number of gamma counts from the femoral area on the thrombosed side was compared to the contralateral side. Clot/blood isotope density ratios were determined post-mortem. RESULTS: Leg thrombi were 100% detectable in the anti-D-dimer group, but only 60% detectable in the anti-beta group. Mean +/- SD relative counts in the thrombosed femoral area was 137 +/- 10% compared to the contralateral side in the anti-D-dimer group, but only 116 +/- 20% in the anti-beta group. The clot/blood ratio was 24.5 +/- 2.8 in the anti-D-dimer group, but only 7.8 +/- 2.0 in the anti-beta group. CONCLUSIONS: In labelled anti-D-dimer provides superior nuclear medicine images of thrombi during intensive anticoagulation compared to anti-beta. Clinical results with radiolabelled anti-D-dimer may be more promising than those previously observed with other anti-fibrin antibodies.

Animals↗
PubMed2003

National survey of quality assurance activities for pharmacy-compounded sterile preparations.

The compliance of hospitals' quality assurance practices for pharmacy-compounded sterile preparations with the American Society of Health-System Pharmacists (ASHP) Guidelines on Quality Assurance for Pharmacy-Prepared Sterile Products was studied. A survey based on the 2000 ASHP guidelines was developed to determine current practices for compounding sterile preparations in hospital pharmacies. Practices were compared with those identified in a 1995 ASHP survey. The survey was mailed in July 2002 to a stratified random sample of 600 hospital pharmacy directors. There were a total of 182 usable responses, for a net response rate of 30.3%. Quality assurance practices for some quality domains showed low compliance with the 2000 ASHP guidelines. Only 5.2% of pharmacies that compounded risk level 1 preparations were compliant with garb requirements. Only 4.7% of pharmacies compounding risk level 3 preparations were compliant with recommendations for documentation. Compliance with guidelines on the use of resources to determine expiration dates was high (95.5%). Hospitals were moderately compliant with guidelines related to personnel training (62.7%) and labeling (61.1%). Although some improvements were observed, hospital pharmacies in 2002 were still not fully compliant with the ASHP Guidelines on Quality Assurance for Pharmacy-Prepared Sterile Products.

Data Collection↗
PubMed2003

Urine and plasma levels of fibrinopeptide B in patients with deep vein thrombosis and pulmonary embolism.

BACKGROUND: Many patients with pulmonary thromboembolism remain undiagnosed, possibly because of the difficulty clinicians have in determining which patients merit work-up with accurate (but expensive) imaging techniques. OBJECTIVES: We present the first prospective clinical study of pulmonary embolism (PE) and deep venous thrombosis (DVT) detection using the FPBtot assay, which measures fibrinopeptide B and its first derivative, des-arginine fibrinopeptide B. METHODS: Twenty three patients with signs or symptoms of PE or DVT were enrolled in the study prior to the performance of definitive testing. Using a novel immunoassay, FPBtot levels were measured in urine and plasma samples from patients as well as from healthy controls. Urine and plasma FPBtot levels were compared to the diagnostic results, as blindly adjudicated by one of the investigators. Patients were excluded if they withdrew (n =1), had inconclusive diagnostic testing (n = 7), or did not give samples (n = 2 for urine, n = 3 for plasma). RESULTS: The mean FPBtot concentration in the urine of the 'DVT/PE positive' group was 78.4 +/- 35.2 ng/ml and 2.7 +/- 1.9 ng/ml in the 'DVT/PE negative' group (p = 0.03). The urine FPB(tot) concentrations in the 'DVT/PE negative' group were not significantly different from those in the healthy control group (2.2 +/- 0.4 ng/ml, p = 0.40). The area under the ROC curve for urine FPB(tot) concentrations was 97.3 +/- 3.8%, suggesting a high degree of diagnostic accuracy. Plasma FPB(tot) concentrations were not significantly different between groups. CONCLUSIONS: Urine FPBtot levels may help detect patients with PE and DVT.

Adolescent↗
PubMed2003

ASHP national survey of pharmacy practice in hospital settings: dispensing and administration--2002.

Results of the 2002 ASHP national survey of pharmacy practice in hospital settings that pertain to dispensing and administration are presented. A stratified random sample of pharmacy directors at 1101 general and children's medical-surgical hospitals in the United States were surveyed by mail. SMG Marketing Group, Inc., supplied data on hospital characteristics; the survey sample was drawn from SMG's hospital database. The response rate was 46.7%. During 2002, both inpatient and outpatient hours of service increased compared with 2001. Paradoxically, there was an 8.5% decrease in pharmacy staffing and a 7% vacancy rate, suggesting that pharmacists are busier. Most hospitals (80%) had a centralized inpatient dispensing system, but 44% were planning to become more decentralized. Automated dispensing cabinets were used by 58% of hospitals with decentralized drug distribution systems. Most hospitals (81.4%) dispensed more than three quarters of oral doses as unit doses and 63.3% of injectable doses to non-critical care patients, increases from 1999. A large percentage of hospitals (89%) repackaged both oral and injectable medications. More hospitals were repackaging medications than three years ago, primarily because of lack of commercial availability. Approximately 20% of pharmacies either partially or completely outsourced drug preparation activities. Nurses administered medications in virtually all hospitals (99.7%). Despite widespread recommendations to use bar-code technology to check and document doses administered, only 1.5% of hospitals used this technology, an increase from 1.1% in 1999. Nearly two thirds of hospitals used computer-generated medication administration records. While pharmaceutical services are expanding, workforce issues continue to challenge pharmacists trying to maintain and enhance safe medication systems. Safe systems continue to be in place in most hospitals, but the adoption of new technology to improve safety is slow.

Documentation↗
PubMed2002

Compliance with safe practices for preparing parenteral nutrition formulations.

Compliance with the guidelines of the National Advisory Group on Standards and Practice Guidelines for Parenteral Nutrition (NAG) was studied. A questionnaire based on the NAG guidelines was developed to identify common practices used in the preparation of parenteral nutrition formulations in a variety of health care settings. The questionnaire was mailed in January 2000 to a national sample of 1445 pharmacists. There were a total of 633 usable responses, for a net response rate of 45.2% (based on 1400 deliverable surveys). Almost 80% of the respondents were employed in an urban setting, and 64.3% worked in hospitals. Relatively high compliance was reported for guidelines related to filtration (86.9% and 85.9%), verification of product stability and compatibility by a pharmacist or computer program (86.4%), evaluation of the aseptic technique of persons preparing sterile products (81.4%), and having a pharmacist assess formulations to determine whether the contents are within acceptable standard ranges (78.8%). Low compliance was reported for guidelines related to the inclusion of dosing weight on the label (15.4%), the use of amount per day as the unit of measure for labeling ingredients (26.1%), direct pharmacist-to-pharmacist communication about prescriptions when patients are transferred among health settings (33.4%), and daily in-process or end-product quality assurance testing of formulations. The NAG guidelines on parenteral nutrition formulations with which pharmacists' practice was most discrepant were the use of amount per day as the unit of measure for labeling ingredients, inclusion of the patient's dosing weight on the label, direct pharmacist-to-pharmacist communication when patients are transferred, and daily quality assurance testing.

Adult↗