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Comparison of the incidence rates of selected gastrointestinal events reported for patients prescribed celecoxib and meloxicam in general practice in England using prescription-event monitoring (PEM) data.

BACKGROUND: Celecoxib and meloxicam are classified as cyclo-oxygenase (COX)-2 selective inhibitors, and were developed to minimize the risk of gastrointestinal (GI) toxicity commonly associated with non-steroidal anti-inflammatory drugs (NSAIDs). The Drug Safety Research Unit (DSRU) monitored the safety of these drugs immediately after launch in England using the non-interventional observational cohort technique of prescription-event monitoring (PEM). Our objective was to investigate whether there is a clinically relevant difference in incidence of reported symptomatic (acid/peptic) and complicated upper GI conditions (perforations/bleeding) between celecoxib and meloxicam during use in general practice. METHODS: Patients were identified from dispensed prescriptions written by general practitioners (GPs) for meloxicam (December 1996 to March 1997) and celecoxib (May to December 2000). Simple questionnaires requesting details of events occurring during/after treatment and potential risk factors (including age, sex, history of upper GI problems, and NSAIDS prescribed within 3 months of treatment) were posted to prescribing GPs at least 6 months after the first prescription for each patient. Incidence rates of the first event were calculated; crude and adjusted rate ratios (RR) obtained using regression modelling. RESULTS: For celecoxib and meloxicam, respectively, 1054 (6.0%) and 1376 (7.2%) patients had symptomatic (acid/peptic) upper GI events whereas 42 (0.2%) and 67 (0.4%) had complicated upper GI conditions (perforations/bleeding). A higher proportion of the celecoxib cohort had an indication for osteoarthritis (28.1 vs 23.2%), were female (68.3 vs 67.1%), were aged 60 yr or more (59.5 vs 55.0%), were prescribed NSAIDs within 3 months of starting treatment (49.4 vs 47.9%), and had a past medical history of upper GI conditions (54.7 vs 29.2%) than those prescribed meloxicam. This suggests differential channelling of groups at higher risk of such events on to celecoxib compared with meloxicam. There was no difference between the two drugs in the time to occurrence of either group of event. The RR over the 270-day study period for celecoxib compared with meloxicam were 0.77 (95% CI 0.69, 0.85) and 0.56 (95% CI 0.32, 0.96) for symptomatic (acid/peptic) upper GI events and complicated upper GI conditions (perforations/bleeding), respectively, adjusted for age, age2, sex, indication, medical history of upper GI problems and whether NSAIDs were prescribed within 3 months prior to starting treatment. CONCLUSIONS: This study reports a relative reduction (23%) in the incidence of symptomatic (acid/peptic) GI events, and a relative reduction (44%) in the incidence rate of complicated upper GI conditions (perforations/bleeding) for celecoxib compared with meloxicam.

Adult↗

Comparison of the incidence rates of thromboembolic events reported for patients prescribed rofecoxib and meloxicam in general practice in England using prescription-event monitoring (PEM) data.

BACKGROUND: Rofecoxib and meloxicam are classified as cyclo-oxygenase (COX)-2 selective inhibitors. The Drug Safety Research Unit (DSRU) monitored the post-marketing safety of these drugs in England using the non-interventional observational cohort technique of prescription-event monitoring (PEM). OBJECTIVES: To compare the incidence rates of selected thromboembolic (TE)(cardiovascular, cerebrovascular and peripheral venous thrombotic) events reported for patients prescribed rofecoxib and meloxicam in general practice. METHODS: Patients were identified from dispensed prescriptions written by general practitioners (GPs) for meloxicam (December 1996 to March 1997) and rofecoxib (July to November 1999). Simple questionnaires requesting details of events recorded during/after treatment, indication and potential risk factors (including age, sex and NSAIDs prescribed within 3 months of treatment) were posted to prescribing GPs approximately 9 months after the first prescription for each patient. Incidence rates of the first event within each TE group were calculated; crude and age- and sex-adjusted rate ratios (RR) obtained using regression modelling. RESULTS: During the 9 months after starting treatment, 21 (0.14%) and 19 (0.10%) patients were reported to have cardiovascular TE events, and 74 (0.48%) and 52 (0.27%) cerebrovascular TE events, and 6 (0.05%) and 20 (0.10%) were reported to have peripheral venous thrombotic events for rofecoxib and meloxicam, respectively. Regarding time to first event, there was a persistent divergence between the two drugs from the start of treatment for both the cerebrovascular TE event group (log rank test P = 0.0063) and the peripheral venous thrombotic event group (log rank test P = 0.0264). Indication and use of a NSAID within 3 months prior to starting treatment had no statistically significant effect on the relative risk estimates of the event groups and was excluded from subsequent analyses. Adjusting for the two identified risk factors of age (age2) and sex, for rofecoxib the adjusted cerebrovascular TE event group rate was higher than for meloxicam [RR 1.68 (95% CI 1.15, 2.46)]; lower than meloxicam for the peripheral venous thrombotic event group [RR 0.29 (95% CI 0.11, 0.78)], and not different for the cardiovascular TE event group [RR 1.38 (95% CI 0.71, 2.67)]. CONCLUSIONS: This study reports a relative increase in the rate of cerebrovascular TE events and a relative reduction in peripheral venous thrombotic events in users of rofecoxib compared with meloxicam. There was no difference in the rate of cardiovascular thromboembolic events. The incidence of these three groups of events reported in each of these two drug cohorts was low (less than 0.5%), therefore the relevance of our findings needs to be taken into consideration with other clinical and pharmacoepidemiological studies.

Adult↗

Comparison of the incidence rates of thromboembolic events reported for patients prescribed celecoxib and meloxicam in general practice in England using Prescription-Event Monitoring (PEM) data.

BACKGROUND: Celecoxib and meloxicam are classified as cyclooxygenase (COX)-2 selective inhibitors. The Drug Safety Research Unit monitored the post marketing safety of these drugs in England using the non-interventional observational cohort technique of Prescription-Event Monitoring (PEM). OBJECTIVES: To compare the incidence rates of selected thromboembolic (TE) (cardiovascular, cerebrovascular and peripheral venous thrombotic) events reported for patients prescribed celecoxib and meloxicam in general practice. METHODS: Patients were identified from dispensed prescriptions written by general practitioners (GPs) for meloxicam (December 1996-March 1997) and celecoxib (May and December 2000). Simple questionnaires requesting details of events occurring during/after treatment, indication and potential risk factors (including age, sex and whether NSAIDs had been prescribed within 3 months of treatment) were posted to prescribing GPs at least 6 months after the first prescription for each patient. Incidence rates of the first event were calculated; crude and adjusted rate ratios (RRs) were obtained using Poisson regression modelling. RESULTS: During the 9 months after starting treatment, 28 (0.16%) and 19 (0.10%) of patients were reported to have experienced cardiovascular TE events, 68 (0.39%) and 52 (0.27%) cerebrovascular TE events, and 17 (0.10%) and 20 (0.10%) experienced peripheral venous thrombotic events for celecoxib and meloxicam, respectively. Regarding time to first event, there was a persistent divergence between the two drugs from 30 days after the start of treatment for both the cardiovascular TE event group (log rank test P = 0.0153) and cerebrovascular TE event group (log rank test P = 0.0055). Indication and use of an NSAID within 3 months prior to starting treatment had no effect on the relative risk estimates of the event groups and was excluded in subsequent analyses. Adjusting for the two identified risk factors of age (age2) and sex, the cerebrovascular TE event group rate was higher for celecoxib than for meloxicam, RR 1.66 (95% CI 1.10-2.51), over the study period and no different for the cardiovascular TE event group, RR 1.72 (95% CI 0.87-3.40) or peripheral venous thrombotic group, RR 1.06 (95% CI 0.51-2.19). CONCLUSIONS: This study reports a relative increase in the rate of cerebrovascular TE events in users of celecoxib compared to meloxicam. There was no difference in the rate of cardiovascular TE events or peripheral venous thrombotic events between users of these two drugs. The incidence of these three groups of events reported in each of these two drug cohorts was low (<0.5%), therefore the relevance of our findings need to be taken into consideration with other clinical and pharmacoepidemiological studies.

Adult↗

A dog's breakfast: prescription drug coverage varies widely across Canada.

BACKGROUND: Each province in Canada independently assesses drugs for their reimbursement eligibility. Publicly funded access to specific drugs is therefore dependent on province of residence. OBJECTIVE: Evaluate the variability of access and its determinants for publicly available prescription drugs across Canada, and discuss the feasibility of implementing a national plan. METHODS: For a sample of 58 drugs receiving Health Protection Branch approval in Canada between 01/01/1996 and 12/31/1997, all provinces were surveyed about their formulary inclusion/exclusion decision. Kappa values were estimated to measure concordance between provincial coverage decisions. Logistic analysis using Generalized Estimating Equations was used to assess the impact of key features of provincial plans on the decision. RESULTS: Among the 58 drugs, 5 (9%) were included in all 10 and 14 (24%) by at least 8 provincial formularies. None were excluded by all the provinces. Concordance rates among provinces were low (overall kappa-like statistic = 0.20 and range of pairwise kappa = -0.11 to 0.64). Logistic regression showed that therapeutic category, price ratio to comparator, the integration of public with private coverage, and the existence of ability-to-pay criteria were significant determinants of the inclusion decision. CONCLUSIONS: Findings show that public access to the same prescription medications differs widely across provinces. If Canada were to adopt a "National" plan without disrupting current individual prescriptions, all currently funded drugs in each province would have to be "grandfathered" and included in the new National formulary. Such an all-inclusive list would also make such a plan unaffordable.

Canada↗

Effect of vaccination by community pharmacists among adult prescription recipients.

BACKGROUND: Millions of doses of influenza vaccine are administered each year in the United States at nontraditional sites and by nontraditional vaccine providers. Pharmacists are increasingly becoming vaccine providers. OBJECTIVES: To measure association between availability of pharmacist-immunizers and immunization delivery to adult prescription recipients, and the relative contributions of various types of vaccine providers. RESEARCH DESIGN: Mailed survey in spring 1999, contrasting adults in urban Washington State, where pharmacists administer vaccines, to adults in urban Oregon, where pharmacists did not. SUBJECTS: Cluster sample based on October 1998 prescription records suggesting need for influenza vaccine, derived from 24 community pharmacies belonging to one pharmacy chain. MEASURES: Vaccination status and choice of vaccine provider. RESULTS: Influenza vaccination rates among respondents 65 years or older increased 4.7% more in Washington than in Oregon between 1997 and 1998 (P = 0.20). The net increase in influenza vaccination rate among younger respondents taking indicator medications for chronic diseases for which influenza vaccination is recommended was 10.6% (P = 0.05). Among respondents unvaccinated against influenza in 1997, the 1998 influenza vaccination rate was 34.7% in Washington, compared with 23.9% in Oregon (P = 0.01). CONCLUSIONS: Vaccine delivery by pharmacists is associated with higher rates of vaccination among those younger than 65 taking indicator medications medications for chronic diseases, as well as prescription recipients unvaccinated against influenza in the previous year.

Adult↗

Economic messages in prescription drug advertisements in medical journals.

BACKGROUND: The extent to which pharmaceutical companies promote the economic advantages of their products in advertisements in medical journals, and whether such claims are supported by evidence, has not been quantified. Our objectives were to examine how often prescription drug advertisements in leading medical journals contain economic messages, and to determine the types of promotional claims made and whether supporting evidence is provided. METHODS: All prescription drug advertisements appearing in six leading general medical and specialty journals in 3 selected months annually from 1990 to 1999 were reviewed. Using a standard data collection form, two reviewers examined each ad for economic content-including mention of the drug's price, value, cost saving, or cost-effectiveness. RESULTS: Economic messages appeared in 237 (11.1%) of the 2144 advertisements examined. Proportion of ads with economic content has increased over time (P = 0.003). Most frequently, economic ads contained statements that drugs were "less expensive" or "cost less" than alternative treatments (50.6% of economic ads). Supporting evidence for economic claims was clearly reported in 63.7% of cases, and typically referred to published drug prices rather than more detailed economic analysis. Ads for calcium channel blocking agents and ACE inhibitors frequently contained economic messages. CONCLUSIONS: Economic messages about prescription drugs are used in advertisements in leading medical journals and their frequency may be rising. Physicians should be aware of this phenomenon, and its potential impact on their prescribing decisions. More scrutiny of the supporting evidence underlying economic claims by the medical community and regulators may be needed.

Advertising↗

Appropriateness of antibiotic prescriptions in community-acquired acute pediatric respiratory infections in Spanish emergency rooms.

OBJECTIVE: To describe the variability and appropriateness of antibiotic prescriptions in community-acquired acute respiratory infections (ARI) during childhood in Spain. METHODS: A descriptive, multicenter study of variability in clinical practice was conducted by evaluating a prospective series of pediatric patients attending the emergency rooms of 11 Spanish hospitals and diagnosed with community-acquired ARI. The appropriateness of the antibiotic prescriptions was assessed by comparing our clinical practice with consensus guidelines developed for this study. RESULTS: We collected data from 6,249 ARI emergencies studied on 30 separate days. Antibiotics were prescribed in 58.7% of the ARI (bronchiolitis, 11.5%; bronchitis, 40.2%; pharyngotonsillitis, 80.9%; nonspecified ARI, 34.8%; pneumonia, 92.4%; otitis, 93.4%; sinusitis, 92.6%). The most commonly used antibiotics were amoxicillin/clavulanate (33.2%), amoxicillin (30.2%), cefuroxime axetil (8.5%) and azithromycin (6%). According to the consensus guidelines developed for this study, therapy was considered to be appropriate in 63.1% of the ARI (first choice, 52.1%; alternative choice, 11.0%) and inappropriate in 36.9%. The percentages of inappropriate prescription according to ARI groups were: bronchiolitis, 11.5%; bronchitis, 31.5%; pharyngotonsillitis, 54.8%; nonspecified ARI, 34.7%; pneumonia, 13.9%; otitis, 25.6%; and sinusitis, 22.2%. CONCLUSIONS: There is excessive use of antibiotics in acute respiratory infections that are presumably viral in origin. An important number of ARI of potentially bacterial origin are treated with antibiotics that are not sufficiently efficacious or that have a broader spectrum than necessary.

Acute Disease↗

An interdisciplinary effort to help patients with limited prescription drug benefits afford their medication.

BACKGROUND: Patients without prescription benefits present a significant challenge to health care providers. The inability of patients to afford medication may serve as a barrier to adherence and may ultimately result in poor patient outcomes. In this report, we describe the system used at a university-based adult internal medicine center to assist patients in affording medication. METHODS: Patients in need of prescription assistance are identified by any member of the interdisciplinary team, which consists of physicians, clinical pharmacists, nurses, a social worker, a financial counselor, and a dietitian. Medication profiles are reviewed to identify less expensive alternatives. State, federal, institutional, and pharmaceutical company assistance program eligibility is determined, and the appropriate program is accessed. RESULTS: The described approach is effective in assisting patients without prescription benefits with the procurement of medication. CONCLUSION: Use of this interdisciplinary approach is an innovative solution to a common problem encountered in the outpatient setting.

Adult↗

Current worldwide practice of dialysis dose prescription in acute renal failure.

PURPOSE OF REVIEW: The practice of renal replacement therapy for acute renal failure varies greatly around the world. This is especially true for the dose of renal replacement therapy. This review describes the epidemiology of dialysis prescription and delivery around the world based on recent observational studies and international surveys. Furthermore, a brief speculation on the concept of adequacy of therapy is provided. RECENT FINDINGS: Following the publication of the first large prospective randomized trial on the effects of treatment dose on outcome of patients with acute renal failure a certain consensus has been achieved on the adequacy of 35 ml/kg/h of clearance in continuous therapies. Surveys conducted in 1998 had demonstrated that such adequate therapy was only prescribed in a minority of patients. Recent observations based on questionnaires and surveys confirm that the number of centers prescribing adequate dialysis dose is increasing, but there is still a large number of institutions where prescription is made with no specific adequacy targets and effective delivery is not measured. Several barriers have been identified to reach adequacy targets including logistics, costs, personnel and others. SUMMARY: The analysis of the epidemiology of dialysis dose around the world shows a complex picture. Wide variations in practice are present although a significant effort has been made to standardize the prescription and delivery of therapy.

Acute Kidney Injury↗

Validity of a prescription claims database to estimate medication adherence in older persons.

BACKGROUND: Prescription claims data have been used to estimate refill medication adherence through calculations of cumulative medication acquisition (CMA) and cumulative medication gap (CMG) values. Few studies have assessed the validity of these calculated rates. OBJECTIVES: We sought to assess the validity of CMA and CMG calculated from the Manitoba prescription claims database (DPIN) against pill count medication adherence, targeting overall medications and angiotensin converting enzyme inhibitors (ACEIs). METHODS: Using a survey of a convenience sample of subjects recruited through community pharmacies, subjects who were eligible for study (ie, 65 years or older, noninstitutionalized, taking 2 or more "discrete" prescribed medications, including an ACEI, and willing to provide informed consent) were studied. Pill counts were conducted on all prescribed medicines during 3 home interviews over the course of 4 months. Ten months of DPIN data also were collected on each subject. RESULTS: The concordance between CMA and pill count for overall medications was 411/522 (79%) and for ACEIs was 89/101 (88%) with no systematic differences (McNemar's P = 0.68 and P = 0.097, respectively). CMG and pill count showed even better concordance of 438/514 (85%) for overall medications and 96/101 (95%) for ACEIs, although systematic differences were noted for overall medications (McNemar's P = 0.0012) but not for ACEIs (McNemar's P = 0.500). Spearman's rank correlations were weak for all comparisons. CONCLUSIONS: The high concordance between prescription claims database and pill counts suggested that the rate with which patients refill their medications usually is consistent with the rate they consume them. DPIN is not accurate for nondiscrete dosage forms or medications prescribed for "as-required" use.

Aged↗

Prevalence of comorbid conditions and prescription medication use among patients with gout and hyperuricemia in a managed care setting.

BACKGROUND: : Comorbid disorders and multiple prescription drug use are common among patients with gout and/or hyperuricemia and may influence the clinical course and outcome of gout. OBJECTIVE: : We wanted to document the conditions and associated medications in a large group of patients with gout in a managed care setting. METHODS: : This study was a 2-year, retrospective, administrative claims analysis examining comorbid conditions and medication use among managed care enrollees with gout/hyperuricemia across the United States. RESULTS: : Of the 9482 study subjects (82.1% men, mean age 52 years), 57.9% had hypertension, 45.3% had a lipid disorder, 32.5% had both conditions, and 19.9% had diabetes mellitus. During the 24-month follow-up period, subjects had 5 +/- 3.14 (mean +/- standard deviation) different comorbid conditions and filled prescriptions for of 11.0 +/- 7.90 different medications. The most commonly filled prescriptions included antihypertensive drugs, 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase inhibitors (statins), and nonsteroidal antiinflammatory drugs (NSAIDs). CONCLUSIONS: : The study indicates a high prevalence of both comorbid conditions and multiple medication use among managed care enrollees with gout and/or hyperuricemia. Heightened awareness of these associated disorders is important because they may warrant treatment of their own accord and often some modification of gout management. Drugs, particularly diuretics and prophylactic aspirin, could potentially contribute to the development of hyperuricemia and gout.

Journal Article↗

Sirolimus and ketoconazole co-prescription in renal transplant recipients.

Ketoconazole inhibits cytochrome P 3A4, leading to a 10-fold increase in sirolimus blood levels. Although it has not been reported in the clinical setting so far, sirolimus and ketoconazole co-prescription can lead to cost saving by reducing the dose of sirolimus administered. After informed consent was obtained, sirolimus and ketoconazole co-prescription was studied in six patients who could not afford the current recommended doses. Patients received one-eighth to one-fourth of the recommended dose of sirolimus (0.25-0.5 mg) with 100 to 200 mg of ketoconazole. Sirolimus levels were monitored, and the dose of ketoconazole was increased to achieve target levels of sirolimus. The loading dose was 3 mg of sirolimus with 100 mg of ketoconazole. After sirolimus rescue therapy was started, serum creatinine decreased in five patients. The mean serum creatinine for the group decreased from 2.6 +/- 0.3 mg/dL at the initiation of rescue therapy to 2.2 +/- 0.5 mg/dL on the last follow-up. Sirolimus ketoconazole co-prescription with monitoring of sirolimus levels is possible and safe and needs to be explored further.

Adult↗

Integrated data mining and network pharmacology to explore the prescription patterns from a senior TCM oncologist's clinical practice in treating chemotherapy-induced hand-foot syndrome.

Hand-foot syndrome (HFS) is a common and refractory adverse effect of chemotherapy lacking specific therapeutic strategies currently. Traditional Chinese medicine (TCM) has shown empirical efficacy in clinical HFS management. This study integrated data mining and network pharmacology to systematically elucidate the medication principles and molecular mechanisms underlying Professor Gang Xie's prescriptions for HFS. All medical records from Professor Xie's specialist clinic (January 2020 to March 2025) were retrospectively collected and standardized in Excel. Prescriptions were analyzed through frequency statistics, association and clustering. Active ingredients of core herb pairs and their disease-related targets were identified using TCMSP, HERB, GeneCards, PharmGKB and GEO databases. Protein-protein interaction (PPI) networks, gene ontology (GO), and Kyoto encyclopedia of genes and genomes (KEGG) pathway analyses were performed. Molecular docking validated interactions between key bioactive compounds and targets. This study involved 217 prescriptions containing 150 herbs. Core herb combinations comprised Radix Astragali (Huangqi), Poria (Fuling), and Radix Pseudostellariae (Taizishen), predominantly classified as spleen-tonifying agents with warm properties, targeting lung, spleen, and stomach meridians. Network analysis identified 67 bioactive compounds and 899 disease targets. Quercetin, kaempferol, acacetin and luteolin were identified the key ingredients. The core targets (TP53, STAT3, PIK3CA, HSP90AA1, AKT1, CTNNB1, PI3KR1, MAPK1) were enriched in MAPK and PI3K-Akt signaling pathways. Molecular docking confirmed strong binding affinity between key compounds and targets. Professor Xie's therapeutic strategy for HFS emphasizes "spleen fortification, phlegm elimination, and stasis resolution." The core herb combination likely exerts anti-HFS effects via modulation of MAPK and PI3K-Akt pathways, providing a pharmacological basis for TCM-driven HFS management.

Network Pharmacology↗

Patient knowledge and prescription of ulcer healing drugs in medical inpatients.

If patients on ulcer healing drugs are ill-informed about their medication or diagnosis their lack of knowledge may prejudice them from receiving potentially beneficial treatment, such as thrombolytic therapy, because of concern about upper gastrointestinal side effects. Furthermore because ulcer healing drugs are safe and effective there is a tendency to prescribe these drugs inappropriately. We therefore assessed patients' knowledge about their ulcer healing drugs and whether the prescriptions were appropriate or not. Consecutive patients on ulcer healing drugs admitted as emergencies to the general medical take-in underwent a structured interview designed to assess knowledge of drugs prescribed prior to admission. Patient responses (fully correct, partially correct or incorrect) and appropriateness (appropriate, possibly appropriate or inappropriate) of the prescriptions were graded by reference to information obtained from hospital notes and/or general practitioner. Seventy-nine out of a total of 537 patients (15%) were on ulcer healing drugs. Mean age was 64 years (range 26-91). Fifty-five (70%) of these patients could be analysed for correctness and 62 (78%) for the appropriateness. Patients gave an incorrect indication for 18% of ulcer healing drugs but only for 10% of non-ulcer healing drugs (P < 0.05). Factors associated with a poorer knowledge of drugs overall, were increasing age and impaired mental test score but not the number of drugs the patient was taking. The trends were similar for ulcer healing drugs alone. Sixteen out of 62 (26%, 95% CI 16-39%) prescriptions for ulcer healing drugs were deemed inappropriate. Our findings demonstrate a need for greater attention to patient education about drugs, especially ulcer healing drugs.(ABSTRACT TRUNCATED AT 250 WORDS)

Adult↗

General practitioners' ranking of evidence-based prescribing quality indicators: a comparative study with a prescription database.

BACKGROUND: To ensure that indicators for assessing prescribing quality are appropriate and relevant, physicians should be involved in their development. How general practitioners (GPs) rank these indicators is not fully understood. AIMS: (i) To determine how GPs in Ireland rank a set of evidence-based prescribing quality indicators in order of importance and relevance to their practice, and (ii) to compare the GPs' ranking of the defined set of indicators with actual prescribing practice using a prescription database. METHODS: A postal questionnaire was sent to 105 GPs, who were asked to rank a set of 11 prescribing quality indicators, identified from the literature from most to least important. The results were aggregated and a weighted score for each indicator determined. These same prescribing indicators were then applied to a prescription database to compare the ranking provided with actual prescribing practice. RESULTS: Eighty-six GPs (82%) returned the completed questionnaire. The higher ranks were for quality issues-use of inhaled corticosteroids, statins and benzodiazepines. Actual prescribing data showed prolonged use of benzodiazepines in over half of the prescriptions dispensed (n = 18 171), 52.48% (95% confidence interval 51.95, 53.01) and low usage of generic drugs, 17.78% (17.70, 17.90) despite their high ranking by the GPs. CONCLUSION: While GPs have diverse views about the value of different prescribing quality indicators, the results suggest that they do rank evidence-based guidelines on patient management highly, but those based on costs and less evidence the lowest. There was considerable divergence between theory and practice in the application of quality indices.

Databases, Factual↗

To describe or prescribe: assumptions underlying a prescriptive nursing process approach to spiritual care.

Increasing attention is being paid to spirituality in nursing practice. Much of the literature on spiritual care uses the nursing process to describe this aspect of care. However, the use of the nursing process in the area of spirituality may be problematic, depending upon the understandings of the nature and intent of this process. Is it primarily a descriptive process meant to make visible the nursing actions to provide spiritual support, or is it a prescriptive process meant to guide nursing actions for intervening in the spirituality of patients? A prescriptive nursing process approach implies influencing, and in some cases reframing, the spirituality of patients and thereby extends beyond general notions of spiritual support. In this paper we discuss four problematic assumptions that form the basis for a prescriptive approach to spiritual care. We conclude that this approach extends the nursing role beyond appropriate professional boundaries, making it ethically problematic.

Attitude of Health Personnel↗

Causes of impaired delivery of hemodialysis prescription.

Urea kinetic modeling (Kt/V) is used to assess adequacy of hemodialysis (HD). However, serial Kt/V measurements may vary with time in the same patient, making the interpretation of the results difficult. The aim of the present study was to find the frequency and the causes that account for these fluctuations of Kt/V. Fifty-nine patients undergoing chronic HD were included in this prospective study. The results of monthly single pool Kt/V values were analyzed during a 6-month period. Duration of maintenance HD prior to the study was 4.49 +/- 3.6 (+/-SD) years. Any change of >0.2 from the previous 2-month average values was defined as abnormal. A total of 354 urea kinetic modeling sessions were recorded during 6 months in 59 patients. Of these, 38 (10.7%) met the criteria for abnormal value. Twenty-four measurements (6.7%) revealed lower while 14 (3.9%) demonstrated higher Kt/V values. Supervised sampling and conforming to the prescribed dialysis dose were applied for all abnormal measurements a week later. Among the group with lower Kt/V value, nine were due to noncompliance (shorter dialysis), four lower blood flow (Qb), four reversed needles, and one fistula thrombosis. Finally, in six cases no problem could be identified and a repeat measurement failed to document lower values. In the high-value group, nine cases were expected as there was an effort to increase dialysis dose prescription while five cases were due to false postdialysis sampling ("venous samples"). Overall, 29/354 (8.1%) measurements were in real disagreement with dialysis prescription. Lower-than-expected values are quite often due to reduced blood processing (shorter dialysis, lower Qb, and recirculation) and higher values due to inaccurate postdialysis sampling. Any possible pitfall in Kt/V measurements should be investigated before changing dialysis prescription in a stable HD patient.

Aged↗

A randomized controlled trial of metformin versus vitamin E or prescriptive diet in nonalcoholic fatty liver disease.

OBJECTIVES: Metformin proved useful in the treatment of nonalcoholic fatty liver disease (NAFLD), but its superiority over nutritional treatment and antioxidants has never been demonstrated. We aimed to compare the usefulness of metformin versus prescriptive diet or vitamin E. METHODS: In an open label, randomized trial, nondiabetic NAFLD patients were given metformin (2 g/day; n = 55) for 12 months. The control cases were given either vitamin E (800 IU/day; n = 28) or were treated by a prescriptive, weight-reducing diet (n = 27). Outcome measures were liver enzymes, insulin resistance (homeostasis model assessment), parameters of the metabolic syndrome, and histology. RESULTS: Aminotransferase levels improved in all groups, in association with weight loss. The effects in the metformin arm were larger (p < 0.0001), and alanine aminotransferase normalized in 56% of cases (odds ratio (OR) versus. controls, 3.11; 95% confidence interval (CI), 1.56-6.20; p= 0.0013). In multivariate analysis, metformin treatment was associated with higher rates of aminotransferase normalization, after correction for age, gender, basal aminotransferases, and change in body mass index (OR, 5.98; 95% CI, 2.05-17.45). Differences were maintained when the two control groups were separately analyzed. The distribution of positive criteria for the metabolic syndrome was reduced only in the metformin arm (p= 0.001, signed rank test). A control biopsy in 17 metformin-treated cases (14 nonresponders) showed a significant decrease in liver fat (p= 0.0004), necroinflammation, and fibrosis (p= 0.012 for both). No side effects were observed during metformin treatment. CONCLUSIONS: Metformin treatment is better than a prescriptive diet or vitamin E in the therapy of NAFLD patients receiving nutritional counseling. Limited histological data support an association between improved aminotransferases and biopsy findings, which require confirmation in a double-blind trial with appropriate statistical power based on liver histology.

Adult↗