Tolerance, safety and efficacy of Hedera helix extract in inflammatory bronchial diseases under clinical practice conditions: a prospective, open, multicentre postmarketing study in 9657 patients.

In this postmarketing study 9657 patients (5181 children) with bronchitis (acute or chronic bronchial inflammatory disease) were treated with a syrup containing dried ivy leaf extract. After 7 days of therapy, 95% of the patients showed improvement or healing of their symptoms. The safety of the therapy was very good with an overall incidence of adverse events of 2.1% (mainly gastrointestinal disorders with 1.5%). In those patients who got concomitant medication as well, it could be shown that the additional application of antibiotics had no benefit respective to efficacy but did increase the relative risk for the occurrence of side effects by 26%. In conclusion, it is to say that the dried ivy leaf extract is effective and well tolerated in patients with bronchitis. In view of the large population considered, future analyses should approach specific issues concerning therapy by age group, concomitant therapy and baseline conditions.

Selecting alternate drug therapies.

This study investigates the pharmacist's use of four cues--cost of alternative drug therapies to the patient, convenience afforded patients by alternative drug therapies, the patient's social support system, and the severity of the patient's illness--in a judgement of his or her likelihood of selecting an alternative drug therapy. A survey instrument using the four cues at low and high intensities resulted in a 2 x 2 x 2 x 2 crossover design with repeated measures. A linear prediction model for pharmacists' judgment concerning the likelihood of selecting an alternative drug therapy resulted. Sixty-four percent of the variation in these subjects judgment policies concerning the likelihood of selecting an alternative to the one prescribed was explained. Cost of therapy was weighed greatest among the variables studied, followed by severity, support, and convenience. However, cost of drug therapy was used least frequently by the subjects. Most often, pharmacists were concerned with the severity of a patient's illness, followed by support, convenience, and then cost. Pharmacists' use of patient convenience information is questioned.

Test method for evaluation of loss of prime in metered-dose aerosols.

A new test method is described for assessing the loss of prime in metered-dose aerosols. Two representative metered-dose valve designs and two storage positions were used to assess the utility of this test method at three different sites. Loss of prime, defined as a valve delivery 15% below the mean, was detected in three of the four test configurations. The first significant loss of prime in this study was observed at the two-week time point for valves without drain tanks stored in the upright position. Onset of loss of prime was shown to be dependent on valve design as well as storage position, thus alternate valves or storage conditions should yield different results. This test method appeared to be reproducible over the three test sites, with a slight variation in results attributed to differences in storage conditions and agitation during sample handling. This test method intentionally excluded agitation which is in sharp contrast to the normal "shake well before use" instruction to the patient. Following one priming actuation, all of the valves returned to their mean valve delivery.

Elderly ambulatory care patients' knowledge about drugs.

The extent of knowledge that elderly ambulatory clinic patients possessed about their maintenance prescription and nonprescription medications was determined using 17 selected questions. Information was obtained by using structured interviews from 100 subjects, 65 years of age or older, selected from a general medicine clinic using the simple two-stage cluster sampling method. The medical charts and various medication teaching manuals were used as criteria to determine whether or not the questions were answered correctly. The questions bout adverse reactions, nonprescription medications to avoid, and activities to avoid or perform with caution were answered correctly less than 30% of the time. Thus, practitioners should not assume that elderly ambulatory patients on maintenance drug therapy possess sufficient knowledge to use their medications safely and effectively.

Comparative content evaluation of the de Haen and Drugdex drug information systems.

The Missouri evaluation protocol was used for comparing the contents of the Drugdex and de Haen drug information systems. Criteria for evaluating (1) general information content and (2) content of drug-drug interactions are given in the Missouri protocol. To check the two drug information systems for content, 113 sample drugs were randomly selected to represent all pharmacologic-therapeutic categories of the American Hospital Formulary Service. A list of 215 sample drug-drug interactions was randomly selected from Hansten's Drug Interactions. Each system was then search, applying each general content criterion and drug interaction criterion to each sample drug and sample interaction, respectively. Raw data were transformed into the Missouri protocol's seven weighted variables, and aggregate scores were obtained by summing the weighted scores for the variables. All scoring measurements were done by one investigator. Both raw (unweighted) and weighted scores were analyzed. Aggregate scores showed no significant differences between Drugdex and de Haen for either general information content or content of drug-drug interactions. However, analysis of raw data contradicted these results by showing differences between systems for several variables. The de Haen system included general information on a greater percentage of the sample drugs, but Drugdex covered more information criteria per drug. Drugdex contained a greater percentage of the sample drug-drug interactions, but de Haen covered more criteria for a listed interaction. The results of this study suggest that neither Drugdex nor the de Haen system can be recommended for use in lieu of the other. The Missouri protocol has flaws that preclude its routine use for comparative evaluation of drug information systems.

Test for reproducibility of metered-dose aerosol valves for pharmaceutical solutions.

Seven independent testing sites received metered-dose aerosols containing a standard test solution to assess a newly designed protocol for studying the reproducibility of metered-dose aerosol valves. In accordance with the rather small sampling protocol design, the amount of product dispensed per actuation was measured over the life of the aerosol at designated regions of actuation. A statistical analysis of the data collected at each testing site clearly indicated that the testing protocol is sufficiently reliable and workable for assessing the reproducibility of valve delivery for a given lot of metered-dose valves.