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PubMed2006

Analysis of pharmacokinetic data provided in Japanese package inserts and interview forms focusing on urinary excretion of pharmacologically active species.

In optimizing oral pharmacotherapy for patients with renal failure, information on actual urinary excretion ratio of the unchanged drug, which is obtained by dividing a urinary excretion ratio by a bioavailability after oral dose, is quite helpful. In addition, urinary excretion ratio of the active species is sometimes equally important where metabolites have a pharmacological potency. In the present study, we conducted a survey of Japanese package inserts and interview forms of drugs, which is being prescribed at the University of Tokyo Hospital, on pharmacokinetic data that enables an estimation of actual urinary excretion ratio. The total urinary excretion of a drug was documented in 70.1% of package inserts and 84.5% of interview forms, respectively. The total urinary excretion is often measured by radioactivity and thus includes its metabolites and degradation products. However, inclusion of degradation products/metabolites was described explicitly for 43.7% and 66.2%, and the absolute fraction of the unchanged drug or degradation product/metabolite was given only for 29.0% and 48.9% in package inserts and interview forms, respectively. The pharmacological activity of metabolite(s) was documented for 19.8% and 54.3%, and the oral bioavailability was described only for 5.7% and 30.6% in respective documents. For some drugs, the time period for the urine collection was too short to evaluate the urinary excretion ratio. With regard to 65 drugs (38.7%), more detailed information on urinary excretion was found in published books, but not provided in the package inserts or interview forms. It is hoped that more distinct and sufficient descriptions on the urinary excretion and bioavailability will be associated to the package inserts and the interview forms in future, for safe and efficient use of prescription drugs.

Administration, Oral↗

PubMedDate not supplied

Review of homecare packages for paediatric HPN patients.

This study explored the existing nursing homecare packages required by children who receive home parenteral nutrition and their families, in order to evaluate the effectiveness of the support required. The study forms the basis for ongoing financial discussions with PCTs to ensure high-quality nursing services are available and meet the needs of families. Families' views about homecare packages developed in response to the needs of care for parenterally fed children were explored. Findings indicated three emergent themes that families face: physical, psychological and burden of care. Homecare packages developed in response to family needs were highlighted as being essential. A 24-hour on-call service with expert paediatric nursing staff was a key factor for families to feel secure. It was felt that the individualized homecare packages supported the vulnerable patient group. Families felt that nursing their child at home was a major advantage in the homecare package, but improved delivery of social and medical care was necessary to meet individual child and family needs.

Adult↗

PubMed2000

[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.

Drug Labeling↗

PubMed1977

Evaluating municipal policy: an analysis of a refuse packaging program.

The effect of a municipal enforcement program to improve residents' packaging of refuse was analyzed in a multiple-baseline design across two areas of a city. The enforcement program involved instruction concerning refuse-packaging regulations, collection only of appropriately packaged refuse, and feedback notices to residents concerning the reasons for noncollection of their inadequately packaged refuse. Both the number of violations and the percentage of residences violating each day were markedly reduced during the enforcement program. Furthermore, sanitation workers considered that the packaging of refuse and the safety and efficiency of refuse collection had improved. This study served as a pilot evaluation of a policy change in the city sanitation department, and was functional in determining the direction of that policy.

Journal Article↗

PubMed1983

Dining out with children: effectiveness of a parent advice package on pre-meal in appropriate behavior.

The effectiveness of an advice package designed to restructure the restaurant environment and encourage parent praise was examined. Experiment 1 assessed the usefulness of the package when used with experimenter assistance. Videotapes were used to record the target child's behavior. Pre-meal inappropriate behavior decreased an average of 51% across target children. Mealtime inappropriate behavior and parent praise and disapproval were also measured. Experiment 2 was designed to determine whether families could implement the package without experimenter assistance and whether effects obtained would generalize to a different restaurant. Data were taken in vivo. Nine families were randomly assigned to one of three groups. Group assignment determined the order in which families went to two restaurants, the number of dinners each family participated in, and the point at which parents received the advice package. The order in which the families went to the two restaurants as well as the number of baseline meals was counterbalanced. Results of Experiment 2 showed that, when using the advice package, parents in all sequences were able to decrease pre-meal inappropriate behavior of their children, and that these effects generalized to a second restaurant.

Behavior Therapy↗

PubMed2006

Detection of Escherichia coli in packaged alfalfa sprouts with an electronic nose and an artificial neural network.

A rapid method for the detection of Escherichia coli (ATCC 25922) in packaged alfalfa sprouts was developed. Volatile compounds from the headspace of packaged alfalfa sprouts, inoculated with E. coli and incubated at 10 degrees C for 1, 2, and 3 days, were collected and analyzed. Uninoculated sprouts were used as control samples. An electronic nose with 12 metal oxide electronic sensors was used to monitor changes in the composition of the gas phase of the package headspace with respect to volatile metabolites produced by E. coli. The electronic nose was able to differentiate between samples with and without E. coli. To predict the number of E. coli in packaged alfalfa sprouts, an artificial neural network was used, which included an input layer, a hidden layer, and an output layer, with a hyperbolic tangent sigmoidal transfer function in the hidden layer and a linear transfer function in the output layer. The network was shown to be capable of correlating voltametric responses with the number of E. coli. A good prediction was possible, as measured by a regression coefficient (R2 = 0.903) between the actual and predicted data. In conjunction with the artificial neural network, the electronic nose proved to have the ability to detect E. coli in packaged alfalfa sprouts.

Biosensing Techniques↗

PubMed1981

Prescription drug products that require patient package inserts; ampicillin and phenytoin--Food and Drug Administration. Final rule.

The Food and Drug Administration (FDA) amends its patient package insert regulations to list ampicillin and phenytoin as drugs that must be dispensed with patient package inserts. The ampicillin patient package insert applies to drug products containing amoxicillin, ampicillin, or hetacillin. Elsewhere in this issue of the Federal Register, FDA announces the availability of final guideline patient package inserts for ampicillin and phenytoin and applies the agency's patient package insert regulations to them.

Ampicillin↗

PubMed2000

From science to application: the development of an intervention package.

Many community-based organizations and health departments want to implement HIV prevention interventions with scientifically demonstrated effectiveness. The Replicating Effective Programs (REP) project supported researchers in developing intervention packages designed to help prevention partners replicate effective programs in their settings. Intervention packages convey the intervention's foundation, components, and methods and are one part of a larger system needed to transfer research-based HIV prevention technology to service providers. Implementation packages were developed using a multistage process. The original researchers drafted the materials, advisory groups reviewed the packages, and adopting agencies used the materials in trial runs. The advisory groups and adopting agencies recommended extensive use of examples, thorough explanations about the rationale for each intervention component, explicit representation of people of color in the materials, clear statements about the intended audience(s), and an easy-to-use and visually appealing format. Packages were revised based on these recommendations and the outcomes of the trial runs.

Community Health Services↗

PubMed2001

Developing a nutrition education package for Malaysian hemodialysis patients.

OBJECTIVE: To develop an education package with uniform nutrition messages appropriate for Malaysian patients undergoing hemodialysis. METHODS: Nutritional problems and socioeconomic, ethnic, cultural, and religious factors influencing food habits of HD patients were considered in planning the package. The package comprised a Flipchart and 55 food Fotocards. The Flipchart used a modular format to target nutrition education in stages. The food Fotocards were designed to help the patient plan a daily menu and enjoy greater food variety. Photographs related to common food servings carried symbols for significant nutrient sources of energy, protein, fat, sodium, potassium, and phosphate. A traffic-light color system quantified potassium and phosphate content. The package was evaluated by 25 respondents, composed of nephrologists, nurses, dietitians, and patients. RESULTS: Eighty percent of evaluators rated the Flipchart as good and 20% rated it as excellent, whereas 28% rated the Food Fotocards as good and 72% rated them as as excellent. CONCLUSION: This package is a useful nutrition education tool for both health educators and dietitians to present first-line nutrition advice to patients undergoing hemodialysis.

Diet↗

PubMed2001

Introduction of water conservation education packages: the opportunites and constraints affecting their success.

The Remote Area Developments Group in the Institute for Environmental Science at Murdoch University developed a video and booklet education package on water conservation. The package was developed after research, review of current efforts in water conservation, and consultation with communities showed that there was a need in this area. The package was distributed to all communities within Western Australia. Several different workshops were conducted with Indigenous Environmental Health Workers from around Western Australia in remote areas and in the Perth Metropolitan communities using the package. This paper will briefly describe the opportunities and constraints that exist for water conservation in remote Aboriginal communities in Western Australia as well as give an evaluation of the education package based on workshops, trials and survey instrument. This paper will explain the conclusions that have been drawn from the study: that a broad delivery style is the most advantageous style for remote communities, allowing the facilitator to assess the best style of delivery.

Australia↗

PubMed1990

A standard data collection-package for medical follow-up studies.

A standard method of collecting identifying data for medical follow-up studies has been developed by Statistics Canada. By helping improve health record-keeping, this method has the potential to make it easier to track populations exposed to potentially hazardous agents through lifestyle, work, environmental factors, ecological disasters, or medical treatments. The data collection package, which has been reviewed by expert groups and pilot tested, can reduce costs, save time and result in more comparable data. The package guides the user in developing an easily maintained and accessed database using either the Data Collection Package handbook or the personal computer package option. Part I of this article gives an overview of the new data collection package and how it can be used. Part II gives the background and methodological notes on its development.

Canada↗

PubMed1995

An improved system for packaging recombinant adeno-associated virus vectors capable of in vivo transduction.

Adeno-associated virus (AAV) vectors are potentially useful for gene therapy of a number of human diseases. However, the use of these vectors has been limited by the lack of stable vector-packaging cell lines. The difficulties in developing packaging cell lines relate to low levels of rep gene expression from the AAV-p5 promoter, and to the propensity of Rep proteins to suppress continued growth of immortalized cell lines. We describe here two new techniques which allow these problems to be circumvented. First, we have demonstrated that expression of rep from the human immunodeficiency virus (HIV) long terminal repeat (LTR) promoter results in a 10-fold improvement of packaging efficiency. Second, we have overcome the inefficiency of vector plasmid transfection by generating cell populations containing rescuable AAV recombinant genomes. These improvements yielded a net increase of 50-fold in the packaging efficiency of the AAVp5neo and AAVp5lacZ recombinant vectors. The AAVp5lacZ vector packaged with this method was administered systemically to recently weaned C57BL mice, and mediated efficient expression of the beta-galactosidase reporter gene in cells of the airway epithelium and spleen. This indicates the in vivo activity of these vector stocks, and their potential utility for gene therapy.

Animals↗

PubMed1994

Consultation competence in general practice: establishing the face validity of prioritized criteria in the Leicester assessment package.

AIM: This study set out to test the face validity of prioritized criteria of consultation competence in general practice as contained in the Leicester assessment package. METHOD: A questionnaire was sent to a geographically stratified random sample of 100 members of the United Kingdom Association of Course Organisers to seek their views on the categories, components and weightings contained in the Leicester assessment package and to determine the proportion of respondents who rejected or suggested a new category, component or weighting or reallocated components to other categories or amended weightings. Their views were sought on a six-point scale (strongly approve, approve, tend to approve, tend to disapprove, disapprove and strongly disapprove). RESULTS: There was a 73% response rate. Of the respondents 99% either strongly approved or approved of the overall set of categories of consultation competence. Only two respondents (3%) expressed any disapproval of individual categories. Thirty five of the 39 suggested components of consultation competence were supported by more than 80% of respondents. There was minimal support for excluding any categories or components of consultation competence, for moving any components to different categories or for the inclusion of new categories or components. Eighty eight per cent of respondents were in favour of the need to identify priorities between any agreed categories of consultation competence and 79% expressed approval of the suggested weightings. Although 42% of respondents indicated a wish for some alteration in weightings, the mean values for all consultation categories suggested by all respondents were almost identical to the original weightings in the Leicester package. CONCLUSION: The face validity of the categories and components of consultation competence contained in the Leicester assessment package has been established, and the suggested weightings of consultation categories have been validated. Consequently, the criteria contained in the Leicester package can be adopted with confidence as measures against which performance can be judged in formative or summative assessment of consultation performance in general practice.

Clinical Competence↗

PubMed1995

Confirmation of the helical structure of the 5'/3' termini of the essential DNA packaging pRNA of phage phi 29.

Bacteriophage phi 29 is typical of double-stranded DNA viruses in that its genome is packaged into a preformed procapsid during viral assembly. An intriguing feature of phi 29 is the presence of a 120-base virus-encoded RNA (pRNA) that is indispensable for DNA packaging. Phylogenetic comparison of similar RNAs in numerous phages has revealed that the secondary structure of the pRNA is well conserved. Computer analysis predicts the presence of an extensive segment of helix with three single-base bulges generated by the pairing of the 5' and 3' ends. The desire to understand the role played by the pRNA in DNA packaging has led to a mutational analysis of the 5'-/3'-terminal region, which is believed to be important in DNA translocation. Deletion of 3 bases from the 3' end of the RNA, shortening the pRNA from 120 to 117 bases, was tolerated without loss of activity, but additional deletion of the base 117 resulted in 100-fold less activity, and a 115-base pRNA was virtually nonfunctional. Additionally, the three unpaired one-base bulges within the helical stretches of the paired proximate ends were nonessential for pRNA activity, as demonstrated by deletion of the bulge individually. An extensive series of helix disruptions by single- and multiple-base substitution almost invariably led to the loss of DNA packaging activity. Additional mutations that restored predicted base pairings rescued pRNA activity. This second site suppression confirmed that the 5'- and 3'-end region was paired and was indeed a helical stretch. The secondary structure was of greater importance than the primary sequence, with the exception of the requirement of an adenine at either the third or fourth position. The specific requirement of an adenine in phi 29 pRNA at this position, as well as conservation of this position in other phage pRNAs, implicates that this base may play a special role in either the DNA-packaging reaction or the maintenance of the pRNA tertiary structure.

Bacillus Phages↗

PubMed1997

Boundary of pRNA functional domains and minimum pRNA sequence requirement for specific connector binding and DNA packaging of phage phi29.

Bacteriophage phi29 utilizes a viral-encoded 120-base RNA (pRNA) to accomplish dsDNA packaging into a preformed procapsid. Six pRNAs bind to the procapsid and work sequentially. The pRNA contains two functional domains, one for binding to the DNA translocating connector, and the other for interacting with another component of the DNA packaging machinery during DNA translocation. By UV crosslinking, the pRNA was found to bind to the connector specifically and not to the capsid or scaffolding proteins. When purified connectors were incubated with pRNA, rosette-like connector oligomers were observed. These oligomers were found to contain pRNA. A series of deletion mutants of the pRNA were constructed and their ability to perform various tasks involved in phi29 assembly were assayed. The minimum sizes of the pRNA needed for the following activities have been determined: (1) specific binding to procapsid or to connectors; (2) connector or procapsid binding with full efficiency compared with wild-type pRNA; and (3) genomic DNA packaging. In summary, bases 37-91 (55 nt) comprised the minimum sequence required for specific connector binding, although with lower efficiency; bases 6-113 (105 nt with the additional deletion of two nonessential bases, C109 and A106) comprised the minimum sequence required for full connector binding activity; and bases 1-117 comprised the minimum sequence needed for full DNA packaging activity. These data indicate clearly that the helical region composed of bases 1-6 and 113-117 plays a crucial role in DNA translocation, but is dispensable for connector binding. A model for the role of the pRNA in DNA packaging was also presented.

Bacillus Phages↗

PubMed1998

The effect of an educational intervention package about aggressive behaviour directed at the nursing staff on a continuing care psychogeriatric ward.

INTRODUCTION: Levels of aggressive behaviour on continuing care wards are high. Various staffing factors, potentially amenable to improvement by training, are important in reducing and preventing aggressive behaviour. METHOD: The efficacy of an educational package, directed at the nursing staff, in reducing aggressive behaviour on a psychogeriatric continuing care ward was prospectively evaluated over an 18-week period. The package was administered during the middle 6-week period. Aggressive behaviour was measured using the RAGE and SOAS scales. RESULTS: Aggressive behaviour on both these scales was reduced after the educational package, and the educational intervention package may explain this reduction. CONCLUSIONS: The educational package may have genuinely reduced aggressive behaviour or improved the nursing staffs tolerance and reporting threshold for aggressive behaviour. Studies with improved methodology in several different settings are suggested.

Adult↗

PubMed1998

Functional MRI statistical software packages: a comparative analysis.

Currently, there are many choices of software packages for the analysis of fMRI data, each offering many options. Since no one package can meet the needs of all fMRI laboratories, it is helpful to know what each package offers. Several software programs were evaluated for comparison of their documentation, ease of learning and use, referencing, data input steps required, types of statistical methods offered, and output choices. The functionality of each package was detailed and discussed. AFNI 2.01, SPM96, Stimulate 5.0, MEDIMAX 2.01, and FIT were tested. FIASCO, Yale, and MEDx 2.0 were described but not tested. A description of each package is provided.

Algorithms↗

PubMed1996

Effectiveness of breast self-examination prompts on oral contraceptive packaging.

BACKGROUND: The purpose of this study was to determine if a breast self-examination (BSE) "prompt" on oral contraceptive pill (OCP) packages would improve the frequency and timing of BSE among women who use OCPs. METHODS: Women between 13 and 40 years of age who were initiating, restarting, or continuing use of OCPs completed a baseline survey that assessed health behavior and practices. All received BSE education, and then were randomized to take either OCPs with a BSE prompt or regularly packaged OCPs (without BSE prompt) for three cycles. Three months later, subjects completed a follow-up survey that assessed BSE frequency and timing. A telephone survey of randomly selected subjects conducted 6 months after the baseline survey assessed BSE compliance after discontinuation of the prompt. RESULTS: Of the 907 subjects at baseline, 49.3% performed BSE monthly but only 24.5% performed BSE during the correct time of the menstrual cycle. Among subjects who never performed BSE prior to the study, 40.3% of prompt subjects and 36.4% of the education-only subjects began BSE by the 3-month survey. Among subjects who performed BSE less than once per month at baseline, 50.9% of prompt subjects and 45.5% of education-only subjects increased the frequency of BSEs to a monthly basis by the 3-month survey. More women performed BSE during the correct time of the menstrual cycle at the 3 month follow-up survey (68.1% prompt, 62.2% education only) and 6-month survey (57.4% prompt, 48.9% education only) when compared with the baseline survey (24.7% prompt, 24.1% education only). Ninety-one percent of women in this study expressed a preference for a BSE prompt on OCP packaging. CONCLUSIONS: An increased frequency of BSE was observed when women were exposed to an OCP package prompt, particularly for women who at baseline were already partially compliant with performing monthly BSE. A small but significant improvement was observed for correct BSE timing and this effect continued after the prompt was removed, although at a reduced level. The innovative BSE prompt was overwhelmingly well received by women in this study.

Adolescent↗