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PubMed2004

A critical review of the possible benefits associated with homeopathic medicine.

OBJECTIVE: To evaluate the recent scientific research progress on homeopathy. METHODOLOGY: Homeopathy was evaluated in terms of its clinical research; in vitro research, and physical foundations. The Medline database was the main reference source for the present research, concerning data of approximately the last 10 years. Secondary references (not available in this database) were obtained by means of direct requests to authors listed in the primary references. RESULTS: Clinical studies and in vitro research indicate the inefficacy of homeopathy. Some few studies with positive results are questionable because of problems with the quality and lack of appropriate experimental controls in these studies. The most recent meta-analyses on the topic yielded negative results. One of the few previous meta-analyses with positive results had serious publication bias problems, and its results were later substantially reconsidered by the main authors. The sparse in vitro homeopathic research with positive results has not been replicated by independent researchers, had serious methodological flaws, or when replicated, did not confirm the initial positive results. A plausible mechanism for homeopathic action is still nonexistent, and its formulation, by now, seems highly unlikely. CONCLUSIONS: As a result of the recent scientific research on homeopathy, it can be concluded that ample evidence exists to show that the homeopathic therapy is not scientifically justifiable.

Evidence-Based Medicine↗
PubMed1994

Spontaneous reporting of adverse drug reactions to non-steroidal anti-inflammatory drugs. A report from the Spanish System of Pharmacovigilance, including an early analysis of topical and enteric-coated formulations.

Non-steroidal anti-inflammatory drugs (NSAIDs) are the third most commonly prescribed group of drugs in Spain. We present here the profile of adverse drug reactions (ADRs) attributed to them and reported to the Spanish System of Pharmacovigilance (SSPV) between 1983 and 1991, together with a preliminary analysis of topical, slow-release (SR) and enteric-coated (EC) preparations. Out of 18,348 reports of ADRs included in the SSPV database, 1609 (8.8%) implicated an NSAID. NSAIDs ranked second after antibiotics (15.1% of all reports) among the most commonly implicated drugs. Half of the patients were more than 55 years old, and 60% were women. Diclofenac (364 reports), piroxicam (282), indomethacin (197), naproxen (155), and ketoprofen (137) were the most commonly implicated NSAIDs in reports of ADRs. The most commonly reported ADRs were gastrointestinal (39%), cutaneous (20%), and those affecting the central and peripheral nervous system (9%). Seven reactions had a fatal outcome, and 138 were considered life threatening. Forty-nine reports included previously undescribed ADRs. There were 98 reports describing ADRs attributed to topical NSAIDs; 5 of these described 11 general reactions, such as duodenal ulcer, gastrointestinal bleeding, diarrhoea, dyspnoea, facial oedema, aggravation of bronchospasm, and angioedema. One hundred and sixty-eight reports referred to SR and EC preparations. The ratio of gastrointestinal to non-gastrointestinal reactions to SR-EC diclofenac was higher in the case of SR-EC diclofenac than in the case of plain diclofenac (P = 0.037); similarly, the ratio of CNS to non-CNS reactions to SR-EC indomethacin was also higher than the corresponding ratio with plain indomethacin (P = 0.002).(ABSTRACT TRUNCATED AT 250 WORDS)

Administration, Cutaneous↗
PubMedDate not supplied

Group processes of decision making for hospital-based technology assessment committees.

There are a variety of group-judgment methods to resolve controversial issues in health care. Meta-analysis and group judgment methods such as consensus conferences are attempts to bring diverse elements of information together for synthesis. Leape notes that a significant body of literature exists regarding the techniques used to elicit opinions from groups. Organizational structures and functions of groups vary in terms of the natures of interactions among group members and the manners in which final conclusions are reached and expressed. The introduction of the process of technology assessment into the hospital setting introduces a problem inherent in the introduction of somewhat academic processes into the operational real world of interpersonal relations, administrative and medical staff interactions, staff costs, and institutional priorities. Hospital administrative processes are based on the committee approach. Medical staff credentialing, drug formularies, and administrative policies are all developed, approved, and implemented through committees. It would seem logical that if technology assessment is to be effective in the hospital setting, then those same group decision processes inherent in committees should be used in technology assessment. Relatedly, if technology assessment is to be successful in the hospital setting, then how can the limited resources of hospital-based staff be best utilized to carry through the assessment of elected technologies? This paper discusses group decision processes, particularly as they relate to technology assessment. The processes of particular interest are those that focus on group interactions rather than theory-based decision processes. The purpose for the paper is to provide to clinical engineering management and senior hospital management background information to use in the formulation of the operating parameters of a hospital-based technology assessment committee.

Biomedical Engineering↗
PubMed2005

Evaluation of an antibiotic intravenous to oral sequential therapy program.

AIM: This study was designed to analyse the drug consumption difference and economic impact of an antibiotic sequential therapy focused on quinolones. METHOD: We studied the consumption of quinolones (ofloxacin/levofloxacin and ciprofloxacin) 6 months before and after the implementation of a sequential therapy program in hospitalised patients. It was calculated for each antibiotic, in its oral and intravenous forms, in defined daily dose (DDD/100 stays per day) and economical terms (drug acquisition cost). At the beginning of the program ofloxacin was replaced by levofloxacin and, since their clinical uses are similar, the consumption of both drugs was compared during the period. RESULTS: In economic terms, the consumption of intravenous quinolones decreased 60% whereas the consumption of oral quinolones increased 66%. In DDD/100 stays per day, intravenous forms consumption decreased 53% and oral forms consumption increased 36%. CONCLUSIONS: Focusing on quinolones, the implementation of a sequential therapy program based on promoting an early switch from intravenous to oral regimen has proved its capacity to alter the utilisation profile of these antibiotics. The program has permitted the hospital a global saving of 41420 dollars for these drugs during the period of time considered.

Administration, Oral↗
PubMed1996

The efficacy of Prrrikweg gel in the treatment of insect bites: a double-blind, placebo-controlled clinical trial.

OBJECTIVE: This study was conducted to examine the efficacy of Prrikweg gel, a homeopathic after-bite gel, in relieving the effects of mosquito bites, in particular itching and erythema. DESIGN: A double-blind, randomized, placebo-controlled clinical trial. SETTING: London School of Hygiene and Tropical Medicine. SUBJECTS: 100 healthy volunteers. METHODS: All subjects were bitten under laboratory conditions by Aedes aegypti mosquitoes at one spot on the ventral aspect of the left forearm and another on a corresponding position on the right forearm. One spot was treated with the homeopathic after-bite gel and the other with a placebo gel. MAIN OUTCOME MEASURES: Itching was assessed on a 5-point discrete rating scale at 0, 0.5, 1, 26.5, and 48 h post-bite to compare the itch-relieving efficacy of the two treatments. Erythema development was assessed by photographing the bite sites, measuring length and width of the erythema with a calliper, and comparing the ratio of the erythema surface at baseline T(0) to the mean erythema surface at 0.5, 1, 26.5, and 48 h post-bite (T mean) for the two treatments. RESULTS: Testing erythema development by comparing the ratio T(0)/T (mean, after-bite gel) and the ratio T(0)/T (mean, placebo gel) gave a two-tailed p = 0.098(95% Cl, -0.031-0.361) in favour of the after-bite gel. There was not a statistically significant difference between the itch relief provided by the two treatments (two-tailed p = 0.424; 95 percent Cl, -0.541-0.191). The correlation between itching and erythema was significant (r = 0.46; p < 0.001). CONCLUSIONS. There are strong indications that the homeopathic after-bite gel reduces erythema development following mosquito bites. The homeopathic mother tinctures of Echinacea angustifolia DC., Ledum palustre L., Urtica urens L. as well as the Hamamelis extract in this gel, whether alone or in combination, are the biologically active ingredients. The homeopathic after-bite gel was not demonstrated to relieve itching; however, based on the correlation between erythema and itching, an effect on itching is not inconceivable.

Adult↗
PubMed1988

Quality control of hospital formularies.

This paper identifies various uses of the formulary concept, outlines factors that underlie the need for such an administrative device, and reviews four barriers to effective formulary control. It then examines selected components of the formulary system and specifies the need for supporting techniques, both internal and external. Twelve guidelines for developing a model drug formulary are presented. While administrative elements associated with implementation of a formulary are stressed, concerns about more intangible behavioural forces are introduced.

Drug Prescriptions↗
PubMed1991

Cost of hospital antimicrobial chemotherapy. A method for global cost calculation.

We will describe the method of cost-identification analysis, which was performed in a Dutch hospital during a review of antimicrobial drugs usage. In the present Dutch hospital budget system, in-patients' drug costs generate no revenues. Efforts to diminish drug costs result in financial benefit for the institution. To maximize cost containment, efforts are to be directed to all cost components. We chose wholesale purchase prices of antimicrobial drugs and national prices for salaries and hospital costs. Global cost comparison shows the most cost effective system of intravenous administration. Push injection is the most economic way to administer intravenous drugs which do not require dilution or prolonged infusion time. For stable solutions, such as metronidazole, ready-to-infuse bags are the most economic system. A global cost calculation is listed for commonly used antimicrobial drugs for in-patients. A cost comparison is given for vancomycin CP and teicoplanin, two antistaphyloccocal drugs, which are probably equieffective. The result of global cost comparison contributes to the decision to include new drugs into the hospital formulary or to replace older ones.

Anti-Bacterial Agents↗
PubMedDate not supplied

Survey of pharmacists' and physicians' perceptions of therapeutic interchange.

Therapeutic interchange has long been an integral part of drug formulary management, but physicians' and pharmacists' attitudes toward such programs are relatively unknown. This survey was undertaken to determine pharmacists' attitudes, physicians' potential response to a hypothetical interchange, and how well pharmacists predicted physicians' responses. A survey that described a drug interchange program and several potential responses to the proposed switch was provided to 300 staff physicians at a 512-bed community facility in southwest Florida; the survey was also mailed to pharmacy directors or clinical pharmacy coordinators at 42 southwest Florida hospitals. Responses were obtained from 98 physicians and 95 pharmacists. Most physicians would not cooperate with an interchange if they were not familiar with the proposed drug; 16% would continue to prescribe the original drug, knowing that the new agent would be provided; and 58% would switch to another agent with which they had clinical experience. Only 26% of physicians would follow the interchange program. In contrast, 48% of pharmacists believed that physicians would continue to order the original therapy, 32% believed that physicians would order the new agent, and only 20% believed that physicians would switch to an alternative drug (P<.005 vs physician responses). Clearly, pharmacists' expectations of physicians' response to a therapeutic interchange differ significantly from the physicians' expected behavior. This difference has potentially important implications for actual versus projected cost savings of therapeutic interchange.

Attitude of Health Personnel↗
PubMed2000

[Effects of restrictions on use of vancomycin in a German university hospital].

BACKGROUND: Recently, increasing antibiotic resistance has been observed among gram-positive bacteria. However, only few isolates were found to be resistant against glycopeptides. Therefore, internationally accepted guidelines recommend a restricted use of vancomycin and other glycopeptide antibiotics in order to prevent the development of resistance against these clinically important antibiotics. In many countries, the hospital pharmacies play a key role in control and reinforcement of antibiotic formulary restrictions. In Germany, however, the hospital pharmacies usually do not take over such control functions, and most wards keep a stock of regularly used drugs including antibiotics, which makes reinforcement of restrictions difficult. METHODS: In an attempt to achieve a restriction of vancomycin use, the pharmacy of our university hospital was advised to deliver vancomycin to the wards only on request with a special order form signed by an attending, individually for every patient who should receive vancomycin. The efficacy of this restriction measure was evaluated in 3-month periods before and after the restriction became effective. RESULTS: Hospitalwide, this led to a 20.1% reduction of i.v. vancomycin and an 85.7% reduction of oral vancomycin use per 1000 patient days. If the hematology/oncology units were not considered, the reduction of i.v. vancomycin use was 41.8%, and the total use after the restriction 24.2 g per 1000 patient days. Microbiology results which justified the use of vancomycin decreased by 8.3% (10.9% hematology/oncology units not considered) between the 2 observation periods. Assuming a 7-day mean course of i.v. vancomycin therapy, the empirical use of i.v. vancomycin decreased from 39.9% to 8% after the restriction had been instituted. CONCLUSION: Allowing only experienced physicians (attendings) to decide on the use of vancomycin therapy, proved in our experience to be an effective measure to reduce unnecessary vancomycin use.

Drug Utilization↗
PubMed2002

Multicenter hospital study on prescribing patterns for prophylaxis and treatment of complications of cirrhosis.

OBJECTIVE: To describe the prescribing patterns for liver disease management. METHODS: A multicenter cross-sectional prospective observational study was carried out in 25 Spanish hospitals. Inpatients, admitted to gastrointestinal and liver units with a diagnosis of liver cirrhosis, were included in five centrally assigned index days between February and June 1999. Information was collected about demographic variables and pharmacological treatments used on admission and recommended at discharge. RESULTS: Five hundred and sixty-eight patients (70% men, mean age 61 years) were studied. Alcoholic cirrhosis of the liver accounted for 44% of the sample, ascites being the most prevalent complication. The most frequent diuretic schedule on admission was the combination of spironolactone and furosemide at a ratio of 1 (100 mg/40 mg). Hospitalization resulted in an increase in the percentage of patients that received the combination at a ratio higher than 1. Diuretics were a major cause of adverse drug events on admission (7.5%). Ulcer-healing drugs showed a notable increase at discharge (35%; range 10-59%) compared with 24% (6-37%) on admission. Utilization rates at discharge were 65% (59-74%) for diuretics, 51% (38-76%) for laxatives, 31% (0-75%) for vitamin K, 24% (4-53%) for beta-adrenergic blocking agents, and 13% (0-47%) for nitrates, which were significantly higher than on admission. CONCLUSION: These results provide the first quantitative data of drug utilization in liver disease and highlight the wide variability in prescribing practices across centers and the higher than expected use of non-evidence-based treatments, especially vitamin K and antiulcer drugs.

Adult↗
PubMed1997

Structure and activities of hospital drug committees in Germany.

OBJECTIVES: Hospital drug committees have been established to ensure rational drug use. However, with regard to their structure and duties remarkable differences between European countries may exist, reflecting the differences in drug legislation and market. Our aim was to obtain information about the structure, present activities and decision-making processes of hospital drug committees in Germany and especially the role of clinical pharmacologists in these committees. METHODS: In 1995, a questionnaire with 36 items was designed and sent to all 450 hospitals in Germany with more than 400 beds. One hundred forty three returned questionnaires were evaluated. RESULTS: According to hospital size, the median value for the annual drug budget (including the cost of blood and blood-derived products) in 1993 ranged between DM 2.4 million for hospitals with less than 500 beds and DM 30.0 million for university hospitals with more than 1,000 beds. In 53.2% of drug committees, a pharmacist holds the position of chairman, followed by medical specialists (32%); (clinical) pharmacologists hold this position in only 7.7% of the general hospitals, but in almost 50% of the university hospitals. In most cases, all clinical specialities are represented in the drug committee the number of members ranging between 5 and 40 (median 12). The number of drugs included in the internal drug list, ranging between 400 in hospitals with < 500 beds and about 700 in university hospitals, strongly correlated with the number of beds and, interestingly, with the number of drug committee members. Treatment guidelines were implemented mainly for antiinfectives (87%), infusion solutions (30%), anti-emetic drugs (5-HT3-receptor antagonists, 27%) and blood and blood-derived products such as intravenous immunoglobulins (23%). However, effective control of these guidelines was only performed in about 50% of the hospitals. A drug information service was provided in most hospitals, where 95% of queries were answered by pharmacists. CONCLUSION: The results of our survey showed that German hospital drug committees vary considerably with regard to their function and control mechanisms of drug use. Most of the responders would appreciate a more intensive exchange of current problems and treatment guidelines. Although the process of pharmacotherapeutic decision making should be supported by clinical pharmacologists, experts in this field are often not involved in German hospital drug committees.

Formularies, Hospital as Topic↗