[Show abstract][Hide abstract] ABSTRACT: Our goal was to investigate the use of hypnosedatives (HSs) before and during hospitalization, explore the relationship between their use and various demographic and clinical variables, and compare the results with data from a similar 2000 study with particular interest in adherence to hospital formulary guidelines.
A cross-sectional observational survey of 326 hospitalized patients recruited from ten wards of the Ghent University Hospital, Gent, Belgium, with a patient interview and by evaluating medical and nursing files.
In 30.7% of patients, the use of a HS before admission was reported. According to the patient interview, 33.1% used a HS during hospitalization. However, according to medical and nursing files, use of HSs in the hospital was 10% higher (43.3%). In 19.4% of patients who took HSs before admission, their use was discontinued in the hospital. In 15.6% of patients who took no HS before admission, a HS was started in the hospital, according to the formulary guidelines (data from files). There was a positive correlation between HS use in the hospital and older age, longer hospitalization, not coming from home, higher number of HSs taken before hospitalization, sleeping problems emerging during hospitalization, and central nervous system (CNS) disorders. In comparison with 2000, we registered a slight decrease in HS use during hospitalization and a decrease in the number of newly started patients.
The prevalence of HS use in our university hospital is high, mostly as a result of continuation of HSs started before admission, as there seems to be no general policy of active cessation. Compared with the survey performed 10 years ago, fewer hospitalized patients are newly started on HSs, and when this is the case, the formulary guidelines are followed.
Full-text · Article · Jul 2011 · European Journal of Clinical Pharmacology
[Show abstract][Hide abstract] ABSTRACT: To investigate the frequency and type of drug related problems (DRPs) in geriatric patients (> 65 years), and to assess their contribution to hospital admission; to explore the appropriateness of drug therapy according to the Beers' criteria.
Cross-sectional observational survey of 110 elderly patients admitted during three non-consecutive months to the geriatric ward of a university hospital. Explorative assessment of appropriateness of drug therapy prior to hospital admission based on the Beers' criteria.
A DRP was the dominant reason for hospital admission in 14 out of the 110 patients (12.7%); for another 9 patients (8.2%), a DRP was partly contributing to hospital admission. For these 23 patients, adverse drug reactions and noncompliance were the most important types of DRPs. We found no relationship between drug related hospital admission and intake of a drug listed in the Beers criteria for inappropriate drug use in the elderly. Patients admitted for a DRP took more drugs before admission than patients admitted because of other reasons.
DRPs are an important cause for admission on the geriatric ward of our hospital. The drugs causing DRPs in this study were not those listed in the Beers list of inappropriate drugs in the elderly.
Full-text · Article · Jun 2010 · The Journal of Nutrition Health and Aging
[Show abstract][Hide abstract] ABSTRACT: : Intermittent claudication (IC) is pain caused by chronic occlusive arterial disease, that develops in a limb during exercise and is relieved with rest. Buflomedil is a vasoactive agent used to treat peripheral vascular disease. However, its clinical efficacy for IC has not yet been critically examined.
Objectives : To evaluate the available evidence on the efficacy of buflomedil for IC.
Search strategy : We searched the specialized trials register of the Cochrane Peripheral Vascular Diseases Review Group (last searched November 2007), the Cochrane Central Register of Controlled Trials (CENTRAL) in The Cochrane Library (Issue 4, 2007), MEDLINE (1966 to November 2007), International Pharmaceutical Abstracts (IPA) (from inception to November 2007), Science Citation Index (from inception to November 2007). We contacted Abbott Laboratories (buflomedil distributor) for controlled clinical trial data and approached authors for additional trial information.
Selection criteria : Double-blinded, randomized controlled trials (RCTs) in patients with IC (Fontaine stage II) receiving oral buflomedil compared to placebo. Pain-free walking distance (PFWD) and maximum walking distance (MWD) were analysed by standardized exercise test.
Data collection and analysis : Two authors independently assessed trial quality and extracted data. We contacted study authors for additional information.
Main results : We included two RCTS with 127 participants. Both RCTs showed moderate improvements in PFWD for patients on buflomedil. This improvement was statistically significant for both trials (WMD 75.1 m, 95% confidence interval (CI) 20.6 to 129.6; WMD 80.6 m, 95% CI 3.0 to 158.2), the latter being a wholly diabetic population. For both RCTs, MWD gains were statistically significant with wide confidence intervals (WMD 80.7 m, 95% CI 9.4 to 152; WMD 171.4 m, 95% CI 51.3 to 291.5), respectively.
Authors' conclusions : There is little evidence available to evaluate the efficacy of buflomedil for IC. Most trials were excluded due to poor quality. The two included trials showed moderately positive results; these are undermined by publication bias since we know of at least another four unpublished, irretrievable, and inconclusive studies.
Buflomedil's benefit is small in relation to safety issues and its narrow therapeutic range.
Full-text · Article · Feb 2008 · Cochrane database of systematic reviews (Online)
[Show abstract][Hide abstract] ABSTRACT: International research has proved that academic detailing positively influences the prescribing behaviour of physicians. In the North-East Flanders region of Belgium, a quantitative study of the feasibility and acceptability of academic detailing in general practice has demonstrated that academic detailers are appreciated by physicians.
In addition to the quantitative study, a qualitative study was carried out to determine physicians' attitudes to academic detailing and their objections against it.
This study took place in general practice in the North-East Flanders region of Belgium, using semistructured interviews. Nineteen physicians who had previously had a visit from an academic detailer in the quantitative study, and 19 who had refused were invited for an interview.
Eighteen physicians who had been visited by an academic detailer, and nine who had refused a visit agreed to be interviewed. Although most physicians who had had a visit from an academic detailer appreciated the visit, some barriers were revealed. Physicians had doubts about the objectivity, stated that the information was not new or that they had other ways to obtain information. These barriers were also mentioned by the physicians who had refused a visit. Additional barriers were that the visits were time-consuming, meant to cut expenses, politically coloured, and patronising.
Doubts about independence and objectivity of the information were stated as important barriers both by physicians who had accepted a visit from an academic detailer and by those who had not. These issues need to be dealt with when designing future interventions with academic detailers.
No preview · Article · Jul 2005 · The European Journal of General Practice
[Show abstract][Hide abstract] ABSTRACT: To investigate the feasibility and acceptability of academic detailing in general practice in the North-East-Flanders region of Belgium.
All local quality groups in the study region were randomly allocated to either (1) two academic detailing visits to the individual members or (2) two academic detailing visits during the meetings of the local quality group. During these visits, the results of a systematic review of the literature on non-steroidal anti-inflammatory agents (NSAIDs) were presented.
Of 14 local quality groups, 12 allocated to the individual intervention agreed to participate. Of the 184 physicians invited to receive an academic detailer, 142 had two visits on NSAIDs. One hundred and five physicians gave their opinion on the visits by means of a questionnaire. The great majority of the responders (90%) wished to receive an academic detailer on other topics in the future, with a frequency of two visits per year. Of 13 local quality groups, 12 allocated to the group intervention, with a total number of 192 physicians who agreed to participate. Ten local quality groups with 166 members received the information on NSAIDs. The actual attendance rate per intervention session was approximately two out of three physicians. All 166 physicians of the participating local quality groups were offered an evaluation form, and 79 responded. Of the responders who received the full group intervention, 88% wished to have more academic detailing visits on other topics in their local quality group. A comparison between the evaluation forms of the individual and the group intervention revealed no major differences concerning the acceptability of the intervention.
The pilot study showed that academic detailing is feasible in the North-East-Flanders region of Belgium. Both the individual visits and the visits to the local quality groups were rated positively, and a majority of the general practitioners who returned the evaluation questionnaire wished to receive such visits in the future. The structure of the local quality groups implies limitations to the practical organisation of a visit, but requires less time investment than individual visits.
Full-text · Article · Aug 2003 · European Journal of Clinical Pharmacology
[Show abstract][Hide abstract] ABSTRACT: To test a method for registration of adverse drug reactions (ADRs) resulting in hospital admission and of ADRs occurring during hospital stay. Spontaneous reporting was compared with data from patient interview.
Spontaneous reporting of ADRs by nurses and physicians, as well as patient interviews by pharmacists. This pilot project was carried out in the geriatric ward of the Ghent University Hospital over a period of 8 months in order to develop suitable registration forms and to test feasibility. Causality, severity, type and level of intervention of the reported ADRs were analysed. Reports from physicians and nurses were compared with the data obtained by patient interviews.
During the 8 months, for 168 patients, 12 spontaneous reports were received from physicians and nurses. Fifty-six of these patients were interviewed and 32 ADRs were reported. Only 2 ADRs detected by patient interview were also reported spontaneously. The interviews of the 56 geriatric patients indicated that 20% of them were admitted to the hospital because of an ADR. ADRs occurred during hospital stay in another 20% of those patients.
Spontaneous reporting by physicians and nurses revealed considerably fewer ADRs than patient interview by pharmacists. Physicians and nurses reported the more serious ADRs that occurred during hospital stay, whereas the interviews revealed more ADRs that caused hospital admission. Our data confirm that ADRs are an important cause of hospital admission of geriatric patients and occur frequently during their hospital stay.
Full-text · Article · Mar 2003 · European Journal of Clinical Pharmacology
[Show abstract][Hide abstract] ABSTRACT: In 1996-1997, a drug use evaluation (DUE) of human albumin was conducted in the Ghent University Hospital (Belgium) to determine the pattern and appropriateness of the albumin use. The DUE was followed by permanent review of the albumin consumption. This paper describes how the DUE was carried out and how the albumin use in our hospital changed over time.
The study was based on criteria for indications and end of treatment, accepted by consensus of the physicians prescribing albumin. Albumin treatment episodes were classified as appropriate or inappropriate according to these criteria.
For 115 treatment episodes in 90 patients, the researchers found 21 (18.3%) deviations from the developed criteria. After analysis, half out of them were considered as minor. Most deviations involved starting treatment too early (n = 17). Follow-up results indicated that the overall consumption of albumin dropped by 50.1% from 1994 to 1999, while the consumption of colloid solutions during the same period remained stable.
A good compliance with internally developed criteria for indications and end of treatment with human albumin was observed. Discussion with the clinicians involved led to the development of stricter criteria and a continuous decrease in albumin consumption.
No preview · Article · Jul 2002 · International Journal of Clinical Pharmacy
[Show abstract][Hide abstract] ABSTRACT: Intermittent claudication is pain, caused by chronic occlusive arterial disease, that develops in a limb during exercise and is relieved with rest. Buflomedil is a vasoactive agent claimed to have beneficial effects on the microcirculation. It is used chiefly to treat peripheral vascular disease and to a lesser extent for cerebrovascular arterial disease. However, its clinical efficacy for intermittent claudication has not yet been critically examined.
To evaluate the available evidence on the efficacy of buflomedil for intermittent claudication.
We searched Medline, International Pharmaceutical Abstracts (IPA) and the Cochrane Controlled Trials Register. Abbott Laboratories, the distributor of buflomedil, was asked to provide reports of controlled clinical trials. Reference lists of retrieved articles were checked, and enquiries sent to authors of known trials, to identify additional trials. Finally, we conducted a Science Citation Index search.
Trial reports had to be double-blinded, randomized, and conformed to our PIO-criteria (Patients, Intervention, Outcome) to be considered for inclusion. Patients were required to have proven intermittent claudication (Fontaine stage II); the intervention was to be oral administration of buflomedil compared to placebo; and outcomes had to include pain-free walking distance (PFWD) and maximum walking distance (MWD) analysed by standardized exercise test.
Searches of bibliographic databases yielded three eligible randomized controlled trials (RCTs) and a meta-analysis referring to nine eligible trials. Two of these nine trials had already been identified; two had been published in journals not referenced in traditional bibliographic indexes; and five were unpublished. Despite multiple requests, only one of the five unpublished trials was provided by the author of the meta-analysis, the other four could not be retrieved. Four of the six eligible trials retrieved were subsequently excluded after quality evaluation. Data on walking distances were extracted from the two remaining trials. Differences in incremental gain between active and placebo groups for PFWD and MWD with their confidence intervals were calculated.
Both RCTs showed moderate improvements in PFWD for patients on buflomedil. In one trial this improvement (75 m, 95% CI 37-114) was statistically significant, but in the other, with a wholly diabetic population, it was non-significant (81m, 95% CI -9-170) compared to placebo. For both RCTs the gains in MWD were statistically significant, but with wide confidence intervals (81 m, 95% CI 30-131; and 171 m, 95% CI 27-316 respectively). Pooling of the data was not attempted.
There is little evidence available to evaluate the efficacy of buflomedil for intermittent claudication. Most available trials are of poor quality and were excluded. The two trials included showed moderately positive results but these are undermined by publication bias since we know of another four unpublished, irretrievable, and inconclusive studies. There is a lack evidence for the efficacy of buflomedil in intermittent claudication.
No preview · Article · Feb 2001 · Cochrane database of systematic reviews (Online)
[Show abstract][Hide abstract] ABSTRACT: To evaluate the role of orally administered vasoactive medication in the management of intermittent claudication.
We limited our study to the products on the market in Belgium: cinnarizine, cyclandelate, isoxsuprine, naftidrofuryl, pentoxifylline, xanthinol nicotinate and buflomedil.
We conducted a systematic literature search involving Medline, International Pharmaceutical Abstracts, the Cochrane Library, direct contact with marketing companies and key authors, snowballing and Science Citation Index search. We looked for randomised placebo-controlled trials (RCTs) in patients with Fontaine stage II, in which pain-free and/or maximal walking distance were measured using a standardised exercise test. For isoxsuprine and xanthinol nicotinate, no trials conforming to these criteria were found. Thirty-six trials on cinnarizine, cyclandelate, buflomedil, naftidrofuryl and pentoxifylline met our inclusion criteria.
After quality assessment, 26 trials were excluded, mainly because of short trial duration (less than 12 weeks), small sample size (less than 30 patients) and/or failure to report details on variability (standard deviation or confidence limits). For cinnarizine and cyclandelate, none of the three selected RCTs was included.
For buflomedil, of six published RCTs, two were included after quality assessment, each showing a marginally positive effect of buflomedil versus placebo. For naftidrofuryl, nine RCTs were selected; six were included of which five showed a significant positive result. The likelihood of publication bias and the heterogeneity of the results within and between trials precluded a meta-analysis. For pentoxifylline, of the 18 selected RCTs, only two could be included, both with inconclusive results.
A national consensus conference, based on this review, concluded that health resources should be allocated to prevention and rehabilitation of intermittent claudication rather than to reimbursement of these products with doubtful efficacy.
No preview · Article · Jul 2000 · European Journal of Clinical Pharmacology
[Show abstract][Hide abstract] ABSTRACT: To study, in institutionalized mentally retarded patients, the prevalence of regular laxative use, and to identify its correlates.
Twenty-one of the 22 institutions for the mentally retarded in Flanders (Belgium) provided the setting for the study, which included a population of 3712 residents with an IQ of < 50. This was a descriptive cross-sectional study of a random sample of 20 patients per institution, consisting of a structured interview of the personnel responsible for daily care of the selected patients. The study population consisted of 420 mentally retarded patients. Their median age was 29 years (range 2-72 years). Twenty-six percent of patients had an IQ of 35-49, 40% an IQ of 20-34 and 34% an IQ of <20. Sixteen percent of the patients were non-ambulant.
Regular laxative use was found in 26.4% (111/420) of the residents. In addition, occasional laxative use was found in 2% (10/420) of the residents. Oral laxatives were used daily by 13% (56/420) and oral laxatives daily in combination with enemas were used by 9% (39/420). Enemas but no oral laxatives were used by 3% (11/420); manual evacuation in combination with oral laxatives and enemas was used by 1% (5/420). Seventy-eight percent (78/100) of the oral laxative users used them for more than 1 year. Seventy-one percent (71/100) used one laxative, 23% two and 6% three. Thirty different brands of oral laxatives were used. Sixty-seven percent (67/100) used osmotic laxatives alone or in combination, 30% used stimulant laxatives, 19% used bulk forming laxatives and 19% mineral oil. Oral laxatives were always prescribed by attending physicians, while enemas were also initiated by nurses in 35% (18/52). Laxative use was positively and independently correlated with female gender, with being non-ambulant, with oral motor dysfunction and with the use of medication other than laxatives. It did not correlate with age. Within the institutions, laxative use varied from one to 15 users out of the 20 randomly selected patients (median 4/20).
Laxative use is frequent in institutions for the mentally retarded, with a large inter-institution variation, indicating that constipation is an important problem and underlining the need for research into cost-effective treatment.
No preview · Article · Feb 1999 · European Journal of Clinical Pharmacology
[Show abstract][Hide abstract] ABSTRACT: In Belgium, the distribution of medications to outpatients in community pharmacies is almost exclusively by branded unit-of-use packages, with a package insert inside every package. At the time of the study (spring 1990), the implementation of legislation that mandated a shift from highly technical documents to patient package inserts (PPIs), understandable by the lay person, had begun. This study explores the attitude of practising physicians toward written medication information for patients. A mail questionnaire was sent to 1500 (8% random sample) Belgian general practitioners and to 500 (22% random sample) internal medicine specialists. A total of 543 usable questionnaires were returned (27.5% return rate). Ninety-two percent of the physicians stated that their patients seldom or never requested additional information on drug efficacy or side effects, during routine consultation; 30% estimated that more than half of their patients read the PPI; 75% expect that a patient would experience side effects after reading about them in the PPI; 59% agreed that the PPI could help the patient react more adequately in unforeseen situations. It was possible to cluster the respondents in a stable segmentation of three clusters: moderately positive physicians (20%), ambiguous to neutral physicians (44%), physicians overtly negative to written drug information (36%). The low response rate to this extensive postal questionnaire limits the conclusions to a qualitative description of relevant clusters of respondents. In contrast with the opinion of physicians about patient readership, results from other studies indicate that the vast majority of patients read the package inserts.
[Show abstract][Hide abstract] ABSTRACT: The beta-blocking agent oxprenolol is used therapeutically as the racemate. In humans and animals it is metabolized i.a. to ether glucuronide diastereomers. A stereoselective HPLC assay was developed to determine directly, without hydrolysis to their parent enantiomers, the oxprenolol glucuronides in biological samples. The glucuronide standards for this direct assay are prepared by incubation of rabbit liver microsomes with RS-oxprenolol. The glucuronides obtained are purified and concentrated with solid-phase extraction, and their concentration is measured by an indirect method, i.e. HPLC assay of the oxprenolol enantiomers after enzymatic hydrolysis with beta-glucuronidase. The direct assay involves separation by HPLC using a C18-reversed-phase column, with UV detection at 274 nm; nalorphine is used as internal standard. On injection onto the column, without previous hydrolysis, the limit of detection is 20 ng for both glucuronides. The assay is sensitive, accurate and reproducible. The method is suitable for the assay of glucuronides in liver microsomal incubates and plasma.
No preview · Article · Feb 1996 · Journal of chromatography. B, Biomedical applications
[Show abstract][Hide abstract] ABSTRACT: In this review, after a short discussion of our knowledge about cytochrome P450 isoenzymes, two important sources of variability in the metabolism of drugs by cytochrome P450 are described, i.e. genetic factors and drug-drug interactions. Many hepatic cytochrome P450 enzymes play an important role in the oxidative biotransformation of numerous drugs and other foreign compounds, and of many endogenous substrates. In humans more than 20 different isoenzymes of cytochrome P450 responsible for the hepatic metabolism of drugs, have been identified. They are classified into families and subfamilies on the basis of the degree of amino acid similarity. Cytochrome P450 isoenzymes are regulated by both genetic and environmental factors. Of particular interest is genetic polymorphism in drug oxidation. Two genetic polymorphisms in drug oxidation are well known, the sparteine/debrisoquine (CYP2D6) polymorphism and the mephenytoin oxidation (CYP2C19) polymorphism. As a result of these polymorphisms, two phenotypes exist in the population, poor and extensive metabolizers. Poor metabolizers may be prone to adverse reactions towards drugs with a narrow therapeutic range. In extensive metabolizers clinically significant drug interactions between drugs metabolized by the same isoenzyme can occur.
No preview · Article · Feb 1996 · Acta clinica Belgica
[Show abstract][Hide abstract] ABSTRACT: To study the effect of probenecid on the stereoselective pharmacokinetics of oxprenolol and its glucuronides in the rabbit.
An oral dose of 50 mg/kg racemic oxprenolol was given to nine rabbits twice, in random sequence with and without the concurrent administration of probenecid. Oxprenolol enantiomers were determined in plasma and urine by an enantioselective HPLC method. Oxprenolol glucuronides were measured in plasma and urine after enzymatic hydrolysis.
The disposition of the oxprenolol enantiomers in rabbits is stereoselective, mainly due to a difference in metabolism. Renal excretion is only a minor elimination route for unchanged oxprenolol, and the renal clearances of the enantiomers are similar. Pretreatment with probenecid did not affect the plasma concentrations of the oxprenolol enantiomers, but there was a slight decrease in their urinary excretion. The plasma concentrations of the oxprenolol glucuronides are much higher than those of the parent enantiomers, and those of (S)-glucuronide are about twice those of its antipode. About 10% of the oxprenolol dose is excreted in the urine as glucuronides. The renal clearances of both glucuronides are similar, and markedly higher than the creatinine clearance. After probenecid, the mean glucuronide plasma levels were markedly higher, with for both glucuronides a more than twofold increase in mean AUC. Probenecid decreased the renal clearance of both glucuronides to about 30%. Moreover, it decreased slightly the formation clearance of (S)-glucuronide, while the formation clearance of (R)-glucuronide was not significantly influenced.
Our results show that in the rabbit, both oxprenolol glucuronide diastereomers are actively secreted by the kidney, and that this process is inhibited by probenecid.
No preview · Article · Jan 1996 · Pharmaceutical Research
[Show abstract][Hide abstract] ABSTRACT: To collect and evaluate all trials on clinical efficacy of topical treatments for head lice.
Systematic review of randomised trials identified from following data sources: Medline, International Pharmaceutical Abstracts, Science Citation Index, letters to key authors and companies, and hand search of journals.
Trials in schools or communities.
Patients infested with lice.
Cure rate (absence of live lice and viable nits) on day 14 after treatment.
Total of 28 trials were identified and evaluated according to eight general and 18 lice specific criteria. Of the 14 trials rated as having low to moderate risk of bias, seven were selected as they used the main outcome measure. These seven trials described 21 evaluations of eight different compounds and placebo (all but two evaluations were of single applications). Only permethrin 1% creme rinse showed efficacy in more than two studies with the lower 95% confidence limit of cure rate above 90%.
Only for permethrin has sufficient evidence been published to show efficacy. Less expensive treatments such as malathion and carbaryl need more evidence of efficacy. Lindane and the natural pyrethrines are not sufficiently effective to justify their use.
Full-text · Article · Oct 1995 · BMJ Clinical Research