Microbial viability in preparations packaged for single use.
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We evaluated microbial viability in preparations packaged for single use only which mandate that residual solution be discarded such as albumin and globulin preparations as blood products, preparations containing albumin (such as urokinase and interferon), fat emulsions, and a preparation containing fat emulsions (propofol). In most preparations, Serratia marcescens and Burkholderia cepacia proliferated rapidly at 30 degrees C. However, in globulin preparations containing 1-2.25% glycine to prevent protein degradation (Gamma-Venin P, Venilon-I, Globulin Injection, and Ahlbulin), no growth of S. marcescens and B. cepacia was detected over 24 h at 30 degrees C. For globulin preparations containing 1-2.25% glycine, the injunction to "Discard residual solution after the package has been used" in the package inserts can be revised to "It is possible to use residual solution within 24 h after the package has been used with storage in a cool place." (+info)
Attitude of women in western Uganda towards pre-packed, unit-dosed malaria treatment for children.
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In the context of a larger study on malaria related knowledge, attitudes, practices and beliefs in western Uganda 813 women aged 15-49 years were shown a sample of a pre-packed, unit-dosed malaria treatment for children, its use was explained and attitudes of the women were investigated. Of all women, 90.5% (86% urban, 92% rural) said they would prefer the pre-packed over the conventional type of treatment and 93.9% of these were willing to pay between 0.17 (rural) and 0.29 (urban) US dollars more for this treatment. Two-thirds (67.8%) thought that they would not have to ask their spouses before making a decision on the kind of treatment and 59.5% said they would rather stock the treatment at home than buy it when a child gets sick. The most mentioned reason for preferring pre-packs was their safety and cleanliness, while ease of application, dosing and compliance were secondary. We conclude that pre-packed, unit-dosed malaria treatment is accepted by the caretakers of children in the area studied and that they readily understand and accept its concept. This indicates a high potential for this approach to improve the home management of malaria fevers and reduce malaria-related morbidity and mortality if adequate coverage can be achieved and if the intervention is embedded into an appropriate programme of behavioural change communication and provider training. (+info)
Nebulized bronchodilator formulations: unit-dose or multi-dose?
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BACKGROUND: Nosocomial infections linked to the use of multi-dose bronchodilator nebulizer formulations have been reported in the literature. OBJECTIVE: Survey American hospital respiratory therapy services to determine practice patterns, opinions, and awareness regarding unit-dose and multi-dose bronchodilator formulations. METHODS: A quota sample targeted 4 hospital size categories (0-100 beds, 101-200 beds, 201-400 beds, and > 400 beds) using a listing of general medical/surgical hospitals from the American Hospital Association. Hospitals were contacted via telephone to identify the director of respiratory therapy services, who was invited to complete a 29-item Web-based survey of their hospital practices and their opinions about and knowledge of issues with multi-dose and unit-dose bronchodilator formulations. RESULTS: One thousand forty-seven hospitals were recruited and 409 valid surveys were completed (completion rate 39%). The reported mean +/- SD percentage of unit-dose nebulizer treatments was 80.2 +/- 26.2%. Seventy-two percent (296) of respondents indicated having a policy and procedure manual that deals specifically with nebulized bronchodilator solutions, but only 107 reported having internal monitoring guidelines for compliance with those policies and procedures. Multi-dose bottles of bronchodilator concentrate were used with multiple patients in 77% of cases, and on average 9.7 +/- 8.5 patients were treated with the same multi-dose bottle. Eighty-one percent of respondents reported that treatments from multi-dose bottles are prepared at the bedside. The length of time a multi-dose bottle was kept (after being opened) ranged from 24 hours (8%) to 1 month (11%), and only 3% of respondents reported following manufacturers' recommendations. In the respondents' opinion the chief advantage of multi-dose was cost per dose (84%), and the chief advantage of unit-dose was less risk of contamination (92%). With other factors (therapist time, cost of saline diluent for multi-dose concentrate, dose-error, and contamination) considered, 73% thought that unit-dose vials were more cost-effective. Three hundred thirty-six respondents (82%) thought that a sterile, low-volume (0.5 mL) unit-dose vial of bronchodilator concentrate would be useful, and 249 (74%) of those 336 respondents indicated that such a formulation would replace multi-dose bottles. Only 56% of respondents knew about the evidence regarding the risk of contamination with multi-dose bottles. CONCLUSIONS: Multi-dose bottles of bronchodilator solution are used in approximately 20% of nebulizer treatments, and without strict adherence to infection control procedures they are a potential source of nosocomial infection. A sterile, low-volume unit-dose vial of bronchodilator concentrate would be a useful alternative to multi-dose concentrate for modifying doses or mixing drugs in nebulizer therapy. (+info)
Iron-containing supplements and drugs; label warning statements and unit-dose packaging requirements; removal of regulations for unit-dose packaging requirements for dietary supplements and drugs. Final rule; removal of regulatory provisions in response to court order.
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The Food and Drug Administration (FDA) is removing, in part, a final rule that required unit-dose packaging for iron-containing dietary supplement and drug products that contain 30 milligrams (mg) or more of iron per dosage unit. FDA is taking this action in response to the Court's ruling in Nutritional Health Alliance v. FDA, in which the Court concluded that the Federal Food, Drug, and Cosmetic Act (the act) does not provide FDA with authority to require manufacturers of iron-containing dietary supplement and drug products to use unit-dose packaging for poison prevention purposes. Today's action takes the ministerial step of removing the unit-dose packaging provisions from title 21 of the Code of Federal Regulations. (+info)
Cytotoxic drug contamination on the outside of vials delivered to a hospital pharmacy.
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We recently carried out a study of two UK hospital pharmacy units preparing cytotoxic drugs using isolators that showed low level contamination on floor surfaces and disposable gloves worn by staff. It has been suggested that this level of contamination may be related to some level of contamination on the drug vials as delivered from manufacturers rather than leakage from the isolators. We have investigated the level of cytotoxic drug contamination on the external surfaces of the drug vials as delivered to a hospital pharmacy stores. We monitored 30, randomly chosen vials for the drugs cisplatin, carboplatin, cyclophosphamide, ifosfamide and methotrexate using well-established methods. A 0.5 m2 floor area directly in front of the shelves used for storing the cytotoxic drugs was also wipe sampled and the disposable gloves worn while wiping the vials for each drug were also analysed. A significant number of vials had a quantifiable level of external contamination. Levels of contamination up to 344 ng/vial were found. Levels of glove and floor contamination for some drugs were found to be comparable with values found in our study of the clean rooms where the isolators were situated and the pharmacy staff prepared the cytotoxic drugs. (+info)
Multispectral imaging of tablets in blister packaging.
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This experiment tested the hypothesis that using near-infrared (IR) imaging spectrometry on tablets through blister packs permits the identification and composition of multiple individual tablets to be determined simultaneously. Aspirin was selected for this study because its breakdown mechanism is well understood. Near-IR cameras were used to collect thousands of spectra simultaneously from a field of packaged aspirin tablets. Tablets were selected by a principal component analysis selection algorithm. Graphs of the columns of the transformation matrix showed that salicylic acid and acetylsalicylic acid in the samples were modeled by the principal components. The bootstrap error-adjusted single-sample technique chemometric-imaging algorithm was used to draw probability-density contour plots that revealed tablet composition. Choice of color was used to represent constituent identity, whereas intensity represented concentration. The percentage of usable pixels in the indium antimonide (InSb) array was 99.9%. The SEP was 0.06% of the tablet mass for both water uptake and salicylic acid production. The number of tablets that a typical near-IR camera can currently analyze simultaneously was also estimated to be approximately 1300. (+info)
Glass recycling in the labour suite is environmentally sound and economical.
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BACKGROUND: Glass bottles are used for the storage of local anaesthetics in the US and are recyclable. Recycling would result in hospital solid waste reduction. METHODS: The members of the Department of Anaesthesia were surveyed to determine where these local anaesthetic bottles were disposed of. From November 2002 to April 2003, glass bottles used on the labour and delivery suite were saved for recycling. The number of bottles and the weight recycled were recorded. The number of procedures involving anaesthesia were also recorded during this time period. RESULTS: Residents dispose of the local anaesthetic bottle in the sharps container while consultants dispose of them in the trash (P<0.05). Both means of disposal are not recycled in the US. The average amount of glass recycled per month was 19.37 (3.15) kg. Our hospital pays $0.46/kg (0.26 UK pound/kg) for sharps disposal. By not disposing of the glass in the sharps container, the average savings per month was $8.95 (1.45) (5.15 UK pounds (0.84)). CONCLUSION: The recycling of glass is good for the environment through waste reduction and results in small savings to the hospital. (+info)
UK legislation on analgesic packs: before and after study of long term effect on poisonings.
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OBJECTIVE: To evaluate the long term effect of legislation limiting the size of packs of analgesics sold over the counter. DESIGN: Before and after study. SETTING: Suicides in England and Wales, data from six liver units in England and Scotland and five general hospitals in England, and UK data on sales of analgesics, between September 1993 and September 2002. DATA SOURCES: Office for National Statistics; six liver units in England and Scotland; monitoring systems in general hospitals in Oxford, Manchester, and Derby; and Intercontinental Medical Statistics Health UK. MAIN OUTCOME MEASURES: Deaths by suicidal overdose with paracetamol, salicylates, or ibuprofen; numbers of patients admitted to liver units, listed for liver transplant, and undergoing transplantations for paracetamol induced hepatotoxicity; non-fatal self poisonings with analgesics and numbers of tablets taken; and sales figures for analgesics. RESULTS: Suicidal deaths from paracetamol and salicylates were reduced by 22% (95% confidence interval 11% to 32%) in the year after the change in legislation on 16 September 1998, and this reduction persisted in the next two years. Liver unit admissions and liver transplants for paracetamol induced hepatotoxicity were reduced by around 30% in the four years after the legislation. Numbers of paracetamol and salicylate tablets in non-fatal overdoses were reduced in the three years after the legislation. Large overdoses were reduced by 20% (9% to 29%) for paracetamol and by 39% (14% to 57%) for salicylates in the second and third years after the legislation. Ibuprofen overdoses increased after the legislation, but with little or no effect on deaths. CONCLUSION: Legislation restricting pack sizes of analgesics in the United Kingdom has been beneficial. A further reduction in pack sizes could prevent more deaths. (+info)