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[APROPOS OF A SEARCH FOR NEW MATERIALS FOR PACKAGING DRUGS. (ABSORPTION OF ULTRAVIOLET RAYS BY NEW MATERIALS FOR PACKAGING DRUGS)].
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[Influence of the drug package information paper on compliance of neurological and psychiatric outpatients].
The influence of demographic parameter, the number of different drugs or the frequency of the single doses on the reliability of compliance was subject in different studies. The goal of this investigation was to examine the influence of the drug package information paper on the compliance of neurological-psychiatric patients. 951 patients of one quarter of a neurological-psychiatric practice were given a questionnaire, which examined the income behavior and the estimate of the meaning of the drug package information paper. 352 patients answered the questionnaires. Only 15.6 % refused it to answer the questionnaire. The remaining were not able to answer because of different reasons (dementia, aphasia, acute psychiatric disorders, foreign language origin, immobility, etc.). 98.1 % considered the drug package information paper to be important. Older patients and patients with lower education degree judged the drug package information paper to be too extensive. Only few patients (11.5 %) let the physician explain the drug package information paper. 86.3 % of the patients assumed the medication prescribed by the physician to be correct. 58.1 % of the patients however were not satisfied with the information by the physician. Patients with neuroses were particularly dissatisfied over the clearing-up by the physician (77.3 %). 73.3 % of the patients were deterred from taking in their medicines occasionally or frequently by the side effects described in the drug package information paper. 59.9 % of the patients would take the medicine, if the physician insisted on it. Independently of the influence of the drug package information paper 57.5 % of the patients forgot to take their medicines occasionally or frequently. Patients with epilepsies and M. Parkinson were most compliant. In summary the investigation showed that the clearing-up only by the drug package information paper in contrast to the clearing-up by the physician leads to more non-compliance.
[Assessment of the comprehension of new rephrasing drug package inserts].
BACKGROUND: The information included in drug package inserts is often difficult for users to understand. The impact of rephrasing inserts on comprehension was assessed. SUBJECTS AND METHOD: A community double-blind clinical trial was undertaken with random allocation of subjects to unmodified or modified inserts, in which presentation and structure had been improved and technical content expressed in plain language. A questionnaire on comprehension of the use of four common drugs was administered to all participants. The following aspects were analyzed: indications, interval of administration, administration in relation to meals, contraindications, storage and what to do in cases of missing a dose or improvement in symptoms. RESULTS: 1,560 participants were included, among whom 770 randomly received the unmodified inserts. The mean proportion of correct answers was 45.7% in the unmodified insert group and 75.5% among those who received the modified version. In all groups of age, study level and employment status, participants with modified texts achieved a higher correct response rate than the unmodified group. An improvement > 73% in the correct response rate was observed in interval of administration, administration in relation to meals and what to do in cases of missing a dose. With the modified leaflet the odds ratio of successfully answering more than 70% of questions was 13.5 (95% confidence interval, 10.5-17.5) compared with the unmodified leaflet. CONCLUSIONS: The comprehension of drug package inserts may be considerably improved by making simple changes in their content. These changes may contribute to accident prevention or inappropriate use of commonly prescribed drugs.
Availability of pharmacogenomics-based prescribing information in drug package inserts for currently approved drugs.
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[Esophageal rupture with aortic-esophageal fistula due to ingestion of foil packaged drugs].
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[Microbiological experience with the distribution of factory-packaged drugs in hospital departments].
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[The dissolution rate of certain administration forms of packaged drugs].
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New methods of packaging drugs help reduce medication errors.
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Safeguarding packaged drugs from bacteria and mold attack.
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Unit-dose packaged drugs for treating malaria.
BACKGROUND: Unit-dose packaging of antimalarial drugs may improve malaria cure by making it easier for patients to take their treatment correctly. OBJECTIVES: To summarize the effects of unit-dose packaged treatment on cure and treatment adherence in people with uncomplicated malaria. SEARCH STRATEGY: We searched the Cochrane Infectious Diseases Group Specialized Register (November 2004), CENTRAL (The Cochrane Library Issue 4, 2004), MEDLINE (1966 to November 2004), EMBASE (1980 to November 2004), LILACS (November 2004), conference proceedings, and reference lists of articles. We also contacted pharmaceutical companies, organizations, and researchers in the field. SELECTION CRITERIA: Randomized controlled trials (RCTs), cluster-RCTs, quasi-RCTs, and controlled before-and-after studies of unit-dose packaged drugs for treating uncomplicated malaria. DATA COLLECTION AND ANALYSIS: We independently assessed study eligibility and methodological quality, and extracted data for an intention to treat analysis, where possible. We combined binary data using relative risk (RR) and the fixed-effect model, and presented them with 95% confidence intervals (CI). We attempted to contact study authors for additional information. MAIN RESULTS: Three quasi-RCTs (895 participants) and one cluster-RCT (6 health facilities) met the inclusion criteria. Trials were of poor methodological quality, and none adequately assessed treatment failure. Unit-dose packaged drugs (in conjunction with prescriber training and patient information) appeared to be associated with higher participant-reported treatment adherence in all trials.A meta-analysis of two trials (596 participants) showed that participant-reported treatment adherence was higher with blister-packed tablets compared with tablets in paper envelopes (RR 1.18, 1.12 to 1.25). Two trials using tablets in sectioned polythene bags as the intervention also noted an increase in participant-reported treatment adherence: the cluster-RCT (6 clusters) compared it with tablets in paper envelopes, and the other trial compared it with syrup in bottles (RR 2.15, 1.76 to 2.61; 299 participants). AUTHORS' CONCLUSIONS: There is insufficient evidence to determine the effect of unit-dose packaged antimalarial drugs on treatment failure. Unit-dose packaging supported by prescriber training and patient information appears to improve participant-reported treatment adherence, but these data come from trials with methodological limitations.
[An examination in comparison Web site with other root on the revised information of drug package insert].
To obtain revised information on drug package inserts, we evaluated the quality and comprehensibility of such information provided by the Web site of the Pharmaceuticals and Medical Devices Agency (PMDA site), medical representatives (MRS), Drug Safety Updates (DSUS), and informational publications of the wholesale distributor Company F (wholesaler F). In the comparison of the total amount of revised information obtained from April 2003 to March 2004, the PMDA site was 90% or greater of comprehensible. In comparison with the distribution information on the notice of the Ministry of Health, Labor and Welfare, an informational delay or lack occasionally occurred and variations among pharmaceutical companies were observed. Moreover, on the PMDA site, the number of revisions was 1972. Among them, clinically important information, such as warnings, contraindications, adverse effects, and drug interactions, totaled 37%. From these results, it is suggested that there are variations in the information from each pharmaceutical company on the PMDA site although the site is excellent in terms of comprehensibility.
Analysis of 683 drug packages seized from "body stuffers".
The wrappings and contents of 683 drug containers (bubbles) seized from 154 street dealers have been analysed since 2001, when the law enforcement policy in Hamburg, Germany, allowed the application of emetics to be used by so-called body stuffers for the recovery of swallowed drug packages. Of the bubbles recovered 96% contained cocaine. Cases of intoxication have not yet been observed but a 20-year-old man with a previously unknown toxic cardiomyopathy died 3 days after a sudden cardiac arrest which followed the forced application of ipecacuanha via correctly placed nasogastral tube.
Incident reporting in anesthesia: misidentification of propofol concentrations due to similarities in drug packaging.
We report three cases of misidentification of propofol concentrations due to similarities in drug packaging, which were identified by the incident reporting system. Incident reporting is an approach used to assess the incidence of adverse and potentially adverse events, established to manage the contributing factors and to develop appropriate strategies to prevent errors in anesthesia. Inadvertently, 2% propofol was administered instead of 1%, causing overdosage and prolonged anesthesia in two consecutive patients in the same operating room. The third case was a near-miss that occurred in another operating room of the hospital: a syringe containing 2% propofol instead of 1% was prepared by the nurse, but the anesthesiologist checked the concentration before the induction of anesthesia. The errors occurred due to the presence of similar propofol packaging in the operating rooms. They were the result of both human error because the anesthesia personnel forgot to check the propofol concentration, and system failure, due to the color code of the packaging. In our experience, incident reporting detected the recurrence of drug related errors. Therefore, a preventive strategy was put in place by eliminating 2% propofol packaging from the operating rooms. This paper highlights the need for a cultural shift in the way we collect information on incidents, and it is an example of effective improvement to prevent drug error by reducing the complexity of the system.
[Drug package inserts and the adequacy of patient's drug information].
OBJECTIVE: To investigate the adequacy of the content and format of the patient information section in package inserts of commonly prescribed drugs at the internal medicine service of a school hospital. METHODS: Forty eight package inserts were collected from six pharmacies of the city of Porto Alegre in June 1998. The presence of mandatory notification and other information required by Brazilian laws that regulate inserts content was examined. RESULTS: No one package inserts contained all the notification required by law. Warnings about medication storage and expiration date were the most frequently information found in package inserts analyzed. CONCLUSION: Important information for the drug user was not presented in package inserts analyzed, limiting the purpose of inserts as an instrument for patient education.
[Standardization of drug packaging].
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Expiry date display on drug packages.
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