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PubMed2004

[A 30-year history of the change in package insert for Japanese pharmaceutical medicines].

Package inserts are very important in the medical field. They are full of useful and fundamental information. We have edited two books, named 'Drugs in Japan - Ethical Drugs' and 'Drugs in Japan - Over-the-Counter Drugs' based on the review of package inserts provided for pharmaceutical medicine for more 30 years. We tried to analyze the change in package insert contents; in particular, information quality and quantity.The quality of the information provided in package inserts has improved year by year, with drastic improvements being seen three times. The information quantity has also increased in proportion to the improvement in quality. We created a graph based on package inserts, Warfarin; Eisai, chronologically. It shows that improvement in information quality is supported by the amount of text in the package insert.

Drug Labeling↗
PubMed1977

Effect of unit dose packaging of respiratory therapy medications on incidence of pulmonary infections.

The effect on pulmonary infection rate of using respiratory therapy medications packaged in unit dose syringes versus multiple-dose vials was studied. Study data were collected on 141 patients during a three-month period; 78 patients were treated with respiratory medications packaged exclusively in unit dose syringes, and the balance received medications from multiple-dose vials. Based on information collected from patient charts, the presence of definite or probable pulmonary infections was determined. Of the 83 patients who did not have pulmonary infections prior to therapy, 23% developed one; there was no significant difference in the incidence of infection according to type of medication packaging. Nor did packaging have a significant effect on the incidence of infection among the 39 patients who were predisposed to infection. Finally, method of packaging had no significant effect among the 58 patients who had an infection before therapy started. It is suggested that the decision to employ unit dose packaging for respiratory therapy medications must be based on factors other than the incidence of infection.

Bacterial Infections↗
PubMed1982

Evaluation of glutaraldehyde and hydrogen peroxide for sanitizing packaging materials of medical devices in sterility testing.

External surfaces of packaging materials used for sterile medical devices may introduce contaminants into working areas used for sterility testing. Light wiping with tissues moistened with alkaline 2% glutaraldehyde (Cidex) or 3% hydrogen peroxide effectively reduced counts on 5 X 8 cm strips of packaging material (Tyvek) inoculated with 10(7) spores of Bacillus subtilis. The ability of antimicrobial agents to penetrate packaging material and kill contaminants on the medical device was tested by inoculating filter membranes with ca 100 cells of Pseudomonas aeruginosa or Staphylococcus aureus or ca 100 spores of Bacillus subtilis. A sterile square of test packaging material placed over the inoculated membrane (direct method) or 0.5 cm above the membrane (indirect method) was wiped with the antimicrobial agent. Except for polyethylene film (3 mil), all materials tested, including glassine and several types of coated and uncoated Tyvek, were penetrated by the agents, killing cells on the inoculated membranes. Death rates varied, depending on the organism, packaging material, and testing method. It is suggested that penetration tests be performed before using antimicrobial agents for sanitizing packaging materials during sterility tests.

Aldehydes↗
PubMed1994

Consultation competence in general practice: testing the reliability of the Leicester assessment package.

BACKGROUND: An acceptable assessment must be both valid and reliable; the face validity of the Leicester assessment package has already been established. AIM: This study set out to test the reliability of the Leicester assessment package, and the factors influencing it, when used by multiple assessors to assess performance in general practice consultations. METHOD: Six randomly selected course organizer assessors simultaneously used the package to conduct independent assessments of the performance of five doctors of widely varying abilities in consultation with six simulated patients. The scores allocated were subjected to generalizability analysis. RESULTS: The mean scores allocated for consultation performance of individual doctors ranged from 51% to 70%, with the lower scores being allocated to the less experienced doctors. Scores of each assessor across the cases were examined for internal consistency and five of the six assessors consistently scored the doctors with an alpha coefficient of the minimum accepted level of 0.80 or greater. The other assessor had a consistency of only 0.22. Measurements of consistency within cases between markers indicated that the first case produced unreliable results (alpha coefficient 0.25) but all other cases were scored consistently. Two independent assessors scoring eight consultations are the requisite numbers to achieve acceptable levels of reliability in a formal assessment process; seven consultations produce the minimum acceptable generalizability coefficient of 0.80 plus the first 'non-counting' consultation. CONCLUSION: Required levels of reliability can be achieved when the package is used by multiple markers assessing the same consultations over a wide range of consultation performance. To achieve reliability only two hours of assessment time are required using the Leicester package compared with the previously regarded minimum of 32 hours. Although assessors can produce reliable scores with minimal training, intra-assessor reliability cannot be taken for granted and all assessors should be trained and calibrated before being sanctioned to conduct assessments, particularly for regulatory purposes. The Leicester assessment package has now been shown to be valid, reliable, feasible and easy to use in practice. It can, therefore, be recommended for use in both formative and summative assessment of consultation competence in general practice.

Communication↗
PubMed1997

Use of circular permutation to assess six bulges and four loops of DNA-packaging pRNA of bacteriophage phi29.

A 120-base phage phi29 encoded RNA (pRNA) has a novel role in DNA packaging. This pRNA possesses five single-base bulges, one three-base bulge, one bifurcation bulge, one bulge loop, and two stem loops. Circularly permuted pRNAs (cpRNA) were constructed to examine the function of these bulges and loops as well as their adjacent sequences. Each of the five single-base bulges was nonessential. The bifurcation bulge could be deleted and replaced with a new opening to provide flexibility for maintaining an overall correct folding in three-way junction. All of these nonessential bulges or their adjacent bases could be used as new termini for cpRNAs. The three-base (C18C19A20) bulge was dispensable for procapsid binding, but was indispensable for DNA packaging. The secondary structure around this CCA bulge and the phylogenetically conserved bases within or around it were investigated. Bases A14C15U16 were confirmed, by compensatory modification, to pair with U103G102A101. A99 was needed only to allow the proper folding of CCA bulge in the appropriate sequence order and distance constraints. Beyond these, the seemingly phylogenetic conservation of other bases has little role in pRNA activity. Each of the three stem loops was essential for procapsid binding, DNA packaging, and phage assembly. Disruption of the middle of any one of the loops resulted in dramatic reductions in procapsid binding, subsequent DNA packaging, and phage assembly activities. However, disruption of the loops at sequences that were close to double-stranded regions of the RNA did not interfere with pRNA activity significantly. Our results suggest that double-stranded helical regions near these loops were most likely not involved in interactions with components of the DNA-packaging machinery. Instead, these regions appear to be merely present to serve as a scaffolding to display the single-stranded loops that are important for pRNA tertiary structure or for interaction with the procapsid or other packaging components.

Bacillus Phages↗
PubMed2026

Self-healing materials for food packaging: Design principles, activation mechanisms and implications for food safety.

Self-healing materials (SHMs), originally developed to restore mechanical integrity, have recently attracted growing interest in food packaging. By autonomously repairing physical damage, SHMs help preserve packaging integrity, barrier performance, food safety, and shelf-life during storage and transportation. This review summarizes recent advances in the design principles, activation mechanisms, material systems and food packaging applications of SHMs. Key healing strategies, including microencapsulation, dynamic covalent bond exchange, reversible non-covalent interactions and responsiveness to external stimuli such as temperature, pH, and humidity, are discussed. Representative material systems, including biopolymer-based films, hydrogels, nanocomposites, and stimuli-responsive polymers are evaluated with respect to their relevance to packaging animal-derived foods, fruits, and vegetables. Performance evaluation methods, sustainability implications, and food-contact safety concerns are addressed. Despite promising healing efficiency and mechanical resilience, challenges remain regarding production cost, food-grade safety, migration risks, trigger compatibility and stability under fluctuating environmental conditions. Future research should focus on scalable manufacturing, standardized evaluation protocols, repeated damage-healing safety assessment, regulatory compliance, and integration with intelligent packaging technologies.

Food Packaging↗
PubMed2005

Dynamic modelling of packaging material flow systems.

A dynamic model has been developed for reused and recycled packaging material flows. It allows a rigorous description of the flows and stocks during the transition to new targets imposed by legislation, product demand variations or even by variations in consumer discard behaviour. Given the annual reuse and recycle frequency and packaging lifetime, the model determines all packaging flows (e.g., consumption and reuse) and variables through which environmental policy is formulated, such as recycling, waste and reuse rates and it identifies the minimum number of variables to be surveyed for complete packaging flow monitoring. Simulation of the transition to the new flow conditions is given for flows of packaging materials in Greece, based on 1995--1998 field inventory and statistical data.

Beer↗
PubMed2002

The effectiveness of child-resistant packaging for aspirin.

OBJECTIVE: To evaluate the effectiveness of child-resistant packaging in reducing the mortality rate from the unintentional ingestion of aspirin for children younger than 5 years. DESIGN: Estimates of the annual aspirin-related mortality rate for children younger than 5 years in the United States were developed for the 1958-1990 study period. A multivariate negative binomial regression model was then used to estimate the independent effect of the packaging requirements on the child mortality rate during the postintervention period. The analysis controlled for changes in the per capita use of aspirin, long-term safety trends, and other extraneous and potentially confounding factors that may have affected the aspirin-related child mortality rate. MAIN OUTCOME MEASURE: Estimated percentage reduction in the child mortality rate associated with the use of child-resistant packaging. RESULTS: After controlling for covariates, the use of child-resistant packaging was associated with a 34% reduction in the aspirin-related child mortality rate. This mortality rate reduction equates to the prevention of about 90 child deaths during the 1973-1990 postregulatory study period. CONCLUSIONS: Child-resistant packaging has been effective in reducing aspirin-related child poisonings. However, because its effectiveness is only partial, further poison prevention strategies should be developed and instituted.

Aspirin↗
PubMed2005

Unit-dose packaging of iron supplements and reduction of iron poisoning in young children.

BACKGROUND: Iron poisoning is a major cause of unintentional poisoning death in young children. The US Food and Drug Administration proclaimed a regulation for unit-dose packaging of iron supplements in 1997. OBJECTIVE: To determine whether the requirement for unit-dose packaging of iron supplements decreases the incidence of iron ingestion and the incidence of deaths due to iron poisoning in children younger than 6 years. METHODS: This is a preintervention-postintervention study of the US federally mandated requirement for unit-dose packaging of iron supplements. The 10 years prior to the intervention were compared with the 5 years after its promulgation. The incidences of iron ingestion and of iron poisoning deaths for children younger than 6 years were obtained from the annual reports of the American Association of Poison Control Centers (Washington, DC). RESULTS: The average number of iron ingestion calls per 1000 of all calls to poison control centers regarding children younger than 6 years decreased from 2.99 per 1000 to 1.91 per 1000 (odds ratio, 1.29 [95% confidence interval, 1.27-1.32]; P<.001). The number of deaths decreased from 29 to 1 (odds ratio, 13.56 [95% confidence interval, 1.85-99.52]; P = .03). CONCLUSIONS: These are the first data that show a decrease in the incidence of nonintentional ingestion of a specific drug by young children and a decrease in mortality from poisoning by this drug after the introduction of unit-dose packaging. There was a decrease in the incidence of iron ingestion and a dramatic decrease in the number of deaths due to iron poisoning. This validates unit-dose packaging as an effective strategy for the prevention of iron poisoning and iron poisoning deaths in young children. This highly effective intervention should be considered for other medications with a high hazard for morbidity and mortality when taken as an overdose.

Cause of Death↗
PubMed2005

The effect of inert atmospheric packaging on oxidative degradation in formulated granules.

PURPOSE: Oxidative degradation of drug substances in pharmaceutical products is well documented and is thought to occur in many cases via autoxidative processes involving headspace molecular oxygen in the primary package. Reducing the headspace oxygen concentration inside a package could thus be an option for reducing oxidative degradation in pharmaceutical products. The purpose of this study is to examine the effect of headspace oxygen concentration and relative humidity (RH) on the oxidative degradation of a model pharmaceutical formulation. METHODS: Model formulations, including a drug substance known to exhibit oxidative degradation, at two different drug/excipient ratios were packaged in stoppered glass vials maintained at different oxygen concentrations, (from 0% to 20.9%) and headspace relative humidities and were stored at 40 degrees C. The oxidative degradation was quantified as a function of time. RESULTS: The results clearly show dependence of oxidative degradation on headspace oxygen concentration, relative humidity, drug loading and time. CONCLUSIONS: The results provided insight into the effectiveness of inert atmospheric packaging (IAP) for protecting oxidation-labile products. In light of these observations, a few strategies for practically implementing inert atmosphere packaging are also presented.

Chemistry, Pharmaceutical↗
PubMed1996

Attitude of physicians toward patient package inserts for medication information in Belgium.

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.

Adult↗
PubMed2006

Characterisation of the dominant bacterial population in modified atmosphere packaged farmed halibut (Hippoglossus hippoglossus) based on 16S rDNA-DGGE.

It is not well understood why Atlantic halibut (Hippoglossus hippoglossus) has longer shelf-life than most other white fish species. Our approach was to examine the microbiological diversity of the spoilage microbiota during modified atmosphere (MA) packaging of farmed Atlantic halibut. Portions were packaged with gas mixtures of CO(2):N(2) and CO(2):O(2) (50%:50%) and with air as a reference. The packages were stored at 4 degrees C and samples were taken 6 times during the 23 days of storage. Analyses with molecular techniques (PCR-DGGE) determined profiles of the bacterial populations in the various samples and sequencing detected the bacterial species present. In addition, samples were analysed for microbial, chemical and sensory parameters. The shelf-life was 10-13 days when stored in air and between 13 and 20 days for MA packages, with oxygen-enriched packages suggested as the better gas mixture, based on microbial growth and sensory scores. From sequence analyses of the bacterial population Photobacterium phosphoreum and Pseudomonas spp. were found to dominate in the halibut. Brochothrix thermosphacta was found in most samples at the end of the storage period. Shewanella putrefaciens was found sporadically and in low concentrations based on microbial methods, but not detected by PCR-DGGE.

Animals↗
PubMed2004

The phiX174 protein J mediates DNA packaging and viral attachment to host cells.

Packaging of viral genomes into their respective capsids requires partial neutralization of the highly negatively charged RNA or DNA. Many viruses, including the Microviridae bacteriophages phiX174, G4, and alpha3, have solved this problem by coding for a highly positively charged nucleic acid-binding protein that is packaged along with the genome. The phiX174 DNA-binding protein, J, is 13 amino acid residues longer than the alpha3 and G4 J proteins by virtue of an additional nucleic acid-binding domain at the amino terminus. Chimeric phiX174 particles containing the smaller DNA-binding protein cannot be generated due to procapsid instability during DNA packaging. However, chimeric alpha3 and G4 phages, containing the phiX174 DNA-binding protein in place of the endogenous J protein, assemble and are infectious, but are less dense than the respective wild-type species. In addition, host cell attachment and native gel migration assays indicate surface variations of these viruses that are controlled by the nature of the J protein. The structure of alpha3 packaged with phiX174 J protein was determined to 3.5A resolution and compared with the previously determined structures of phiX174 and alpha3. The structures of the capsid and spike proteins in the chimeric particle remain unchanged within experimental error when compared to the wild-type alpha3 virion proteins. The amino-terminal region of the phiX174 J protein, which is missing from wild-type alpha3 virions, is mostly disordered in the alpha3 chimera. The differences observed between solution properties of wild-type phiX174, wild-type alpha3, and alpha3 chimera, including their ability to attach to host cells, correlates with the degree of order in the amino-terminal domain of the J protein. When ordered, this domain binds to the interior of the viral capsid and, thus, might control the flexibility of the capsid. In addition, the properties of the phiX174 J protein in the chimera and the results of mutational analyses suggest that an evolutionary correlation may exist between the size of the J protein and the stoichiometry of the DNA pilot protein H, required in the initial stages of infection. Hence, the function of the J protein is to facilitate DNA packaging, as well as to mediate surface properties such as cell attachment and infection.

Bacteriophages↗
PubMed1989

Compliance packaging: a patient education tool.

As a direct response to the profound negative impact that the high rate of noncompliance is having on therapeutic efficacy and total health-care costs, some pharmaceutical manufacturers have taken steps to develop compliance packaging for some products prescribed for ambulatory patients. The purpose of compliance packaging is to serve as a patient-education tool for health professionals and to make it easier for patients to remember to take their medications correctly at home. The ideal compliance package will be developed according to patient-education guidelines. Compliance packaging holds promise as a significant patient-education tool when health professionals combine it with personalized patient counseling and well-written medication instructions. Well-controlled cost-effectiveness studies are needed to determine the impact of compliance packaging on reducing total health-care costs.

Drug Labeling↗
PubMed2001

The effects of packaging on the stability of a moisture sensitive compound.

Packages that provided stability (less than a 10% loss in potency) of a moisture sensitive compound (PGE-7762928) in tablet form at accelerated conditions for 6 months were identified. The equilibrium moisture content of the tablets at 25 degrees C/60%RH, 30 degrees C/60%RH and 40 degrees C/75%RH were 2.3,2.4, and 2.9%, respectively. The tablet equilibrium moisture content, degradation rate of unpackaged product, and the moisture barrier properties of the packages were used to predict the stability of the packaged product. The physical and chemical stability (HPLC assay) of the products were measured after 2,4,6,8,12, and 24 weeks at ICH conditions. The Containers-Permeation(1) of polyvinyl chloride blisters, cyclic olefin blisters, aclar blisters, cold-form aluminum blisters was 0.259, 0.040, 0.008 and 0.001 mg per blister per day, respectively. At 6 months at 40 degrees C/75%RH, the percent active was 84% in polyvinyl chloride blisters, 91% in cyclic olefin blisters, 97% in aclar blisters, 100% in cold-form aluminum blisters and 99% in an high density polyethylene bottle with a foil induction seal. The stability results for the packaged product were fairly consistent with the predictions based on the moisture sensitivity of the product and the moisture barrier properties of the respective package. To gain a better prediction, the flux value determined by the Containers-Permeation procedure was adjusted for the internal moisture concentration of the blister.

Chemistry, Pharmaceutical↗
PubMed2005

Parametric analysis of environmental performance of reused/recycled packaging.

Annual environmental performance of packaging products which are reused at least once per year is analyzed with respect to three specific criteria: (1) waste quantities, (2) virgin material demand and resource depletion, and (3) environmental impacts from manufacturing. Packaging flow performance is assessed via a combined reuse/ recycle rate index expressed solely in terms of two dimensionless parameters: the conventional recycling rate and the mean number of reuse trips. Quantitative expressions describe the effect of the following physical quantities: annual reuse frequency, lifetime, maximum number of reuse trips, amount of packaging present in the market, annual production plus net trade imports, recycle rate of consumer discard, reuse rate and consumer discard. The results may serve for packaging monitoring and assessment of alternative packaging systems and for setting more efficient environmental policy targets in terms of the reuse/recycle rate.

Conservation of Natural Resources↗
PubMed2003

Irradiation and modified atmosphere packaging effects on residual nitrite, ascorbic acid, nitrosomyoglobin, and color in sausage.

The present study was undertaken to evaluate the irradiation and modified atmosphere packaging effects on emulsion-type cooked pork sausage during storage for 4 weeks. CO(2) (100%), N(2) (100%), or 25% CO(2)/75% N(2) packaged sausage were irradiated at 0, 5, and 10 kGy, and residual nitrite, residual ascorbic acid, nitrosomyoglobin (NO-Mb), color values, and their correlation were observed. Irradiation significantly reduced the residual nitrite content and caused partial reduction of NO-Mb during storage. No difference was observed in ascorbic acid content by irradiation. Irradiation decreased the Hunter color a value of sausage. CO(2) or CO(2)/N(2) packaging were more effective for reducing residual nitrite and inhibiting the loss of the red color of sausage compared to N(2) packaging. Results indicated that the proper combination of irradiation and modified atmosphere packaging could reduce the residual nitrite in sausage with minimization of color change.

Animals↗
PubMed2005

Improvement of table grapes quality and safety by the combination of modified atmosphere packaging (MAP) and eugenol, menthol, or thymol.

Table grape is a nonclimacteric fruit that shows a rapid loss of quality during storage and is very susceptible to colonization by fungi, especially Botrytis cinerea, which is considered the most important disease of this commodity. To solve this problem, synthetic fungicides have been used, although legal restrictions and consumer's concern demand the search of other safe means. In the present paper, and as an alternative of synthetic fungicides, an active packaging to improve MAP effectiveness on preserving table grape (cv. Crimson Seedless) quality and safety was developed by the addition of 0.5 mL of eugenol, thymol, or menthol inside the packages. Packages were stored at 1 degree C for 35 days. The final gas composition inside the packages was 1.4-2.0 and 10.0-14.5 kPa of CO(2) and O(2), respectively, with no significant slight differences among treatments. Results showed that the addition of eugenol, thymol, or menthol improved the beneficial effect of MAP in terms of delaying weight loss and color changes, retarding degrees Brix/acidity ratio evolution, and maintaining of firmness. Thereafter, these treatments showed additional benefit in terms of delayed rates of rachis deterioration and berry decay. Finally, the total viable counts for both mesophilic aerobics and especially yeast and molds were significantly reduced in the grapes packaged with the natural antimicrobial compounds. All of the above effects led to maintenance of table grape quality and safety for longer storage periods (3 additional weeks as compared to controls under MAP only).

Carbon Dioxide↗