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PubMed2005

Demand clean vials.

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Drug Contamination↗
PubMed2000

Is your technetium generator eluate sterile?

OBJECTIVE: This study was performed to assess the sterility of multidose 99mTc generator eluate vials at the end of a working day. METHODS: Expired 99mTc generator eluate vials were collected over a period of 10 wk and stored until the activity reached background. Four batches of 10 vials each were selected randomly and sent to an independent microbiology laboratory for sterility testing. RESULTS: No eluate showed any microbial growth after 14 d incubation in growth media. CONCLUSION: Retrospective sterility testing of 99mTc generator eluate confirmed the validity of our departmental protocol for radiopharmaceutical preparation. Sterility testing has become part of our quality control program.

2-Propanol↗
PubMed1998

Nurses' and pharmacists' exposure to antineoplastic drugs: findings from industrial hygiene scans and urine mutagenicity tests.

Data from 83 nurses and pharmacists handling antineoplastic drugs and 35 nurse/pharmacist controls who participated in a national study of antineoplastic drug-handling risks were examined to investigate antineoplastic drug exposure. Measures of external exposure included self-completion drug logs and industrial hygiene scans conducted in clinical settings. Internal exposure was measured by urine mutagenicity tests on end-of-week 24-hour urine specimens. To control for potential confounders, the staff was asked to complete food and hobby diaries and to avoid identified mutagenic substances for 1 week before collection of 24-hour urine samples. On the scans of the drug handlers, 13% showed one or more spots of drug contamination on gloved and ungloved hands, gowns, or shoes. Of the 24-hour urine samples, 15% were mutagenic for Salmonella typhimurium: Rates did not differ significantly for drug handlers and controls. Among nurses who both prepared and administered antineoplastics, those with positive mutagenicity tests handled more doses of the drugs, used less skin protection, and had more skin contact with the drugs than those with negative tests. Nurses who only administered the drugs and had positive mutagenicity tests handled fewer doses of drugs than those with negative tests, but they also reported less use of protection and more skin contact. For both groups of nurses, skin contact with antineoplastics was associated with positive mutagenicity test results (p < 0.01).

Adult↗
PubMed2003

[Causes of hospitalization and death in the MANIF 2000 cohort, composed of HIV-infected patients contaminated by intravenous drug use, 1995-1999].

OBJECTIVE: To describe the causes of hospitalization and mortality among the MANIF 2000 cohort study, composed of HIV-infected patients contaminated through intravenous drug use. METHOD: Data collection with a standardized questionnaires with clinical, biological, therapeutic and psycho-sociologic data on inclusion and every six months. Dates and causes of hospitalization and death were collected retrospectively by nurses from the hospital clinical records. Comparison were made using the chi(2) or Mann-Whitney tests with 5% significance threshold. RESULTS: The MANIF 2000 cohort study included, between October 1995 and June 1998, 467 patients with a median age of 33 years, 30% of whom were women. On inclusion, 42.2% were still injecting drugs (half of them were on substitution therapy), 10.5% had stopped injections of drugs, 32% exhibited more than 500CD4/mm(3) and 55.7% had not taken antiretroviral treatment. As of December 31(st) 1999, 21 patients had died, i.e. a mortality rate of 19% persons/years of follow-up (10-fold greater than that expected in the general population). Less than 5 deaths were due to HIV (n=4). Suicides and liver disease each represented the same number of deaths. Out of the 335 patients not having missed more than one follow-up throughout the 24 month period, 120 had been hospitalized at least once (n=223 hospitalizations), i.e., a hospitalization rate of 2.8 per 100 persons/month of follow-up. A quarter of hospitalizations were due to benign infections or stage B or C pathologies according to the 1993 classification of HIV infections and one hospitalization out of 5 was due to psychiatric problems (in majority depressive syndromes). Other predominant causes were worsening of general state of health, trauma, problems related to alcohol consumption, drugs abuse or hepatic decompensation. CONCLUSION: HIV-infected patients contaminated by intravenous drug use represent a particular population that cumulates many risk factors and which requires careful monitoring of co-morbidities such as hepatic and psychiatric diseases in order to avoid premature death.

Adult↗
PubMed2001

Ensuring vaccine safety in immunization programmes--a WHO perspective.

Ever since vaccines were firstly used against smallpox, adverse events following immunization have been reported. As immunization programmes expand to reach even the most remote communities in the poorest countries, it is likely that many more events will be temporally linked with vaccine administration. Furthermore, the profound shift in the general public and media interest in adverse events may lead to undue concerns and allegations which may ultimately jeopardize immunization programmes world-wide. While the health professional has understood this issue for some time, the public and the media have now also become all too aware of the significance of vaccine-related adverse events. The familiar vaccines, well-tested over decades, have not changed--but the perception regarding their safety has shifted. Claims outrageous or reasonable are being made against both the old and the newly-introduced vaccines. At the same time, the immunological and genetic revolution of the last decade may well bring to our notice some hypothetical risks that need to be addressed at pre-clinical level. WHO has been at the leading edge to guarantee vaccine safety for the last 30 years and will continue to do so. The Organization's plans for the next decade and beyond include the Safe Injection Global Network (SIGN), the development and introduction of safer technologies, and the prevention, early detection and management of AEFIs. The new technologies include needle-containing injection devices such as the autodisable syringe, as well as mucosal and transcutaneous immunization. Training will continue to be at the centre of WHO's efforts, limiting human error to a minimum. Mechanisms have been set in place to detect and respond to new and unforeseen events occurring. Above all, there is a willingness to respond to new climates and new technologies so that the Organization is in the best position to ensure safe immunization for all the world's children.

Drug Contamination↗
PubMedDate not supplied

Collaborative study of a control standard endotoxin using the Limulus amebocyte (gel-clot) test.

A collaborative study was undertaken to determine the potency in endotoxin Units (EU) and International Units (IU) of a control standard endotoxin, LIF-1. Five laboratories from the Swedish Pharmaceutical Industry participated in the study. As reference preparations, two official standards, USP reference standard endotoxin, EC-5 (expressed in EU) and WHOs international standard endotoxin (expressed in IU), were used. The study was performed using the Limulus Amebocyte Lysate (LAL), gel-clot test. The test protocol included dilutions of the endotoxin in steps of 1:1.25 instead of the conventional 1:2 step dilution method. This gave more precise and standardized results. The content of one vial of LIF-1 (CSE) was calculated to be 22 EU and 16 IU which indicates that 1 EU (USP) corresponds to 0.7 IU (WHO).

Drug Contamination↗
PubMed1979

[Hepatitis and drug addiction: clinical and immunological studies].

The association drug addiction-hepatitis has so increased in recent years to represent a social epidemiological and clinical problem all over the world. Although the clinical picture of hepatitis is already well defined in drug-abusers, it remains to be completely understood the mechanism responsible for the significant incidence of progression from acute to chronic hepatitis in this population. The viral infection, the drug itself, the drug contaminants, the immunological defects (cellular and/or humoral) may be considered as possible contributing factors to this event. For this reason the Authors have performed an immunological study either in a group of drug-abusers with acute and chronic hepatitis, or in a group of 82 "asymptomatic" drug addicts without a history of liver diseases. The results of this study are the following: - In all the drug-addicts considered there is a common contact with virus B. - There are significant alternations of the cellular and humoral immunity in drug-addicts with acute and chronic hepatitis. - In the "asymptomatic" group the humoral immunity is slightly altered (hyper IgM, circulating immunocomplexes), while normal the cellular response. All these findings are critically evaluated also in respect with the new immunopathological mechanisms of hepatitis B.

Acute Disease↗
PubMed1989

[Evaluation of predictability of in vitro SDI assay in comparison with in vivo nude mouse assay].

Twenty lines of human gastro intestinal and breast cancer xenografts, in which chemosensitivity spectra by the in vivo nude mouse assay had been clarified. were subjected to the in vitro SDI (succinate dehydrogenase inhibition) assay using MTT dye to assess the accuracy of this drug sensitivity test against 4 drugs i.e., mitomycin C (MMC), adriamycin (ADM) 5 fluorouracil (5-FU), and cisplatin (CDDP). After 3 days incubation, the suspension of every tumor cells including small fragments showed a marked decrease of SD activity even when no anticancer drug was added to the assay medium. Among these 4 drugs evaluated MMC exhibited a statistically significant correlation between chemosensitivity values of the in vitro SDI assay and those of the nude mouse assay. However, the other 3 drugs demonstrated no correlation between the values of these two methods. Since the primary cultured fibroblasts revealed, in general, lower sensitivity to these drugs, contamination of fibroblast may decrease the SDI values when materials from solid tumors with rich stroma such as a type of stomach cancer were subjected. It is considered that the prediction of chemosensitivity to every drug will be impossible by a in vitro SDI assay.

Animals↗
PubMed1999

Local drug delivery via transvascular injection.

BACKGROUND: In this experimental series we tested drug distribution and systemic leakage using local drug delivery with a new transvascular injection system. METHODS: Porcine femoral and carotid arteries (n = 56) underwent local drug application with a new 5 French (Fr) over-the-wire needle-injection catheter system (NIC) using three needles. A radioactive indicator [C14-Carvedilol, 2.0 milliliter (ml); 0.03 milligram (mg)] was injected in two carotid and two femoral vessels in parallel. Serial blood withdrawal was performed thereafter. After randomization to different explantation times, the vessels, perivascular tissue, liver and spleen were removed [0.5, 1, 1.5, 3 and 4 hours after injection, respectively]. Radioactivity was determined in a scintillation counter or with autoradiography. The indicator amount was calculated in relation to total drug amount (100%). RESULTS: Use of the NIC caused vessel texture alteration in non-diseased porcine vessels, seen as vessel wall penetration and perivascular edema. After single injection the maximum of the indicator was found in perivascular tissue 0.5 hours at the application site (carotid perivascular tissue: 7.48%; femoral perivascular tissue: 2.56%). Thereafter, radioactivity in the artery increased and perivascular content declined. The maximum in femoral arteries (1 hour; 1.96%) occurred earlier and was significantly lower compared to carotid arteries (2 hours; 7.75%). Four hours post-injection, 1.4% of total drug amount was detectable in the carotid arteries and 0.6% was detected in the femoral arteries. Systemic content was measured after C14-Carvedilol application with a maximum in serum of 28% (10 minutes), liver 30% (0.5 hour) and spleen 0.6% (0.5 hour). After 3 hours, still 5% of the indicator was still measureable in the serum and liver and less than 0.1% was measurable in the spleen. LDD with the NIC system is dependent on the vascular anatomy. The data indicate redistribution from perivascular to vascular space thus allowing a prolonged vascular and perivascular drug delivery. The amount deliverable is lower than expected due to substantial systemic drug contamination with this catheter.

Animals↗
PubMed1992

[Microbial contamination of twenty drugs of plant origin].

Twenty drugs of plant origin were analysed in order to determine the microbial contamination level. A light homogenizing method was used to avoid an increase in the antimicrobial capacity of certain drugs, which would falsify the analytical results. The total viable aerobic count (TVC) varied from 10(1) to 10(7) CFU/g and in 11 samples out of 21 was equal to or higher than 10(5) CFU/g. The number of fungi varied from one drug to another, but was generally lower than the aerobic TVC to the power of 10. No cases containing Aspergillus flavus were found. The total viable anaerobic count consisted mainly of facultative anaerobic germs. Aerobic spores and facultative anaerobic bacteria were abundant. They often represented more than 50% of the aerobic TVC and among them, Bacillus cereus was found. Concerning specified micro-organisms, Escherichia coli was found 3 times, Staphylococcus aureus 2 times and Pseudomonas (not aeruginosa) a few times. Salmonella was never found. The Enterobacteriaceae, on the other hand, were often found and in some cases their number can be greater than 10(4) CFU/g. The typed bacteria corresponded to Enterobacter spp. Some drug samples in bags were analysed. The level of contamination was identical to that found in the bulk drugs. The analysis in parallel of a black tea sample showed an aerobic TVC of 4.10(3) CFU/g. Specified micro-organisms were not found in the infusions. In comparison with non-boiled drugs, the survivors can represent up to 30% of the aerobic TVC.

Bacteriological Techniques↗
PubMed2002

[The network of community and national reference laboratories for residues].

The European Union established in the early 1990's a network of Community reference laboratories (CRL) for residues in living animals and their products. This field is regulated at present by the Council Directive 96/23/CE of 26 April 1996, adopted at the national level through the Decree DL.vo no. 336 of 4 August 1999. The four CRL are based in France, Germany, Italy and The Netherlands, respectively, each of them being responsible for different categories of residues. The CRL provides technical support to the European Commission in this matter as well as to the National reference laboratories (NRL) for residues in the member states. The four CRL bear responsibility also as regards the adoption of quality systems by NRL. In this respect, the revised principles of good laboratory practice recently issued by OECD demand that procedures be developed to inform and assist the NRL to implement them.

Animals↗
PubMedDate not supplied

In situ monitoring of soil dissolution dynamics: a rapid and simple method for determining worst-case soils for cleaning validation.

A common approach utilized in validating the cleaning of multi-product equipment is to challenge the cleaning cycle with the hardest-to-clean, or "worst-case", soil. The worst-case soil is often determined through bench-scale experiments. These experiments can be tricky and time-consuming, especially when the dissolution dynamics of the soils are characterized by crossovers beyond the limit of visual detection. This paper describes a simple in situ method for monitoring soil dissolution dynamics and rapidly determining worst-case soils for cleaning validation. The method utilizes the real-time response of electrical conductivity to identify crossovers and to determine the optimal time for endpoint analysis. The results address the sensitivity and reproducibility of the method and the identification of critical experimental parameters. The dissolution dynamics of several parenteral products are compared.

Drug Contamination↗
PubMed2002

Sulphadimethoxine and Azolla filiculoides Lam.: a model for drug remediation.

Plants can be an interesting tool for in situ remediation of drug contaminated waters. In a laboratory model Azolla filiculoides Lam., an aquatic fern known to absorb pollutants, has been exposed to an environmental persistent antibiotic commonly used in intensive farming, sulphadimethoxine (S), to test its bioremediation capability. In a 5 week experiment, plants were cultivated outdoor at four drug concentrations (50, 150, 300 and 450 mg l(-1)) in N-free mineral medium. Drug affects growth rate (as biomass yield per week), N2-fixation, heterocyst frequency, but plants are able to survive. Notwithstanding, at all concentrations tested drug was actively removed from the medium and the accumulation in the biomass is in order of magnitude up to mg g(-1) plant dry weight (1000 ppm). Drug uptake and degradation rates increase with S concentrations in the culture medium. The efficacy of the model was very high. These results demonstrated that Azolla can be taken into consideration as a tool for sulphonamides environmental monitoring and decontamination.

Adsorption↗