Potential drug interactions in cancer therapy: a prevalence study using an advanced screening method.

BACKGROUND: In cancer patients, drug interactions may intensify adverse events or reduce antitumour effects. We assessed the prevalence of potential drug interactions (PDIs) among ambulatory cancer patients on i.v. treatment using an advanced screening method. PATIENTS AND METHODS: Data on drugs used for comorbidities, anticancer agents, over-the-counter (OTC) drugs, and comorbidities were collected by means of a structured interview among the patients and review of medical charts. PDIs were identified using electronic (Drug Interaction Facts software, version 4.0) and manual screening methods (peer-reviewed reports). RESULTS: In this study, 278 patients were enrolled. We identified 348 PDIs. Of all patients, 161 (58%) had at least one PDI. Of all PDIs, 34% was classified as major and 60% as moderate. Coumarins, quinolones, antiepileptics, and hydrochlorothiazide were frequently part of a PDI. Interactions that potentially cause QT interval prolongation, gastrointestinal toxicity, and central nervous system depression were also common. In multivariate analysis, an increasing number of drugs [odds ratio (OR) = 1.4, confidence interval (CI) 1.23-1.52; P < 0.001] and the use of an OTC drug (OR = 0.56, CI 0.32-0.97; P = 0.045) were risk factors. CONCLUSIONS: PDIs are common in patients treated for an (haemato-) oncological disease. Screening for potential interactions should take place routinely before administering chemotherapy.

Laparoscopic gastric banding for morbid obesity: outpatient procedure versus overnight stay.

BACKGROUND: In western countries, laparoscopic gastric banding is increasingly used in the surgical treatment of morbid obesity. This study aimed to investigate the feasibility, safety, morbidity, and costs of an outpatient procedure (OP) compared with an overnight stay (OS). METHODS: In a 2-year period, 50 consecutive patients were randomized to an OP group or an OS group. RESULTS: In the OP group, 76% of the patients were successfully discharged the same day, without readmissions. Four procedures were converted, and one complication occurred. The patients in the OP group seemed to experience more pain (p = 0.009). Satisfaction scores were 8.1 (OP) and 8.8 (OS) (p = 0.06). Half of the OP patients and most of the OS patients preferred a clinical admission. The OP treatment cost 600 euros less than OS. CONCLUSION: With proper patient selection, laparoscopic gastric banding can be performed safely and at lower cost as an outpatient procedure.

Particulate matter determination in LVPs produced in Dutch hospital pharmacies, Part 1: Particle-counting accuracy.

Reproducible particle counting using the light-obscuration technique is often troublesome because no absolute standard is available. Therefore, at the Laboratory of Dutch Pharmacists the "calibration-in-time" method was developed. This method enables checking of the amount of particles counted from a diluted latex suspension as a function of time. A particularity of the method is the one-step dilution procedure. The calibration-in-time method is compared with the particle-counting accuracy test according to the USP < 788 >. Advantages and disadvantages of both methods are discussed.

Particulate matter determination in LVPs produced in Dutch hospital pharmacies. Part 2: Overview of the results.

The Laboratory of Dutch Pharmacists determines LVP particulate matter contamination of LVPs produced in Dutch hospital pharmacies. The investigated LVPs must conform to the NVZA/LNA criteria, which prescribes eight samples and sets limits for particles > or = 2 microns, > or = 5 microns, > or = 10 microns, and > or = 25 microns for both mean and mean + 2x standard deviation. LVPs produced in 500 mL glass containers or plastic containers mostly met the NVZA/LNA criteria, but LVPs produced in 100 mL glass containers showed higher levels of particulate matter contamination. The composition of the LVP significantly affected the extent of particulate matter contamination, but the effect was relatively small when compared to the influence of the type of container. LVPs produced in Dutch hospital pharmacies and LVPs obtained from pharmaceutical industries showed comparable amounts of particulate matter contamination.

Microbiological aspects of heat sterilization of medicines. II. A method for the determination of the effectiveness of a sterilization process using the bioburden and the bioburdens heat resistance.

In order to verify whether the sterilization process of 60 min at 100 degrees C for invert sugar 20% is sufficiently effective to attain the generally accepted probability of survival of maximum 1 X 10(-6), we determined the bioburden and the bioburdens heat resistance for this product. We examined 98 bottles by the membrane filtration method and found 84 bottles with 0 colony forming units (CFU's) and 14 bottles with 1-9 CFU's. Because none of the isolated CFU's was heat resistant (Bacillus species), we isolated heat resistant CFU's from the environment and determined the heat resistance in invert sugar, water and NaCl solution 0.9% of four different Bacillus species. The results in invert sugar for the most heat resistant Bacillus species were a D-value of 0.92 min at 100 degrees C. For the determination of the D-value the end-point method is the most practical one, and the D-value calculation with the most probable number method is sufficiently accurate. Because of unavoidable inaccuracies in the experimentally determined D-value, safety margins of 100% have to be taken into account in the sterilization process calculations in which these D-values are used. Hence, in our case, we have to use a D-value of 2 X 0.92 min in the sterilization process calculation for invert sugar 20%. The maximum bioburden in the examined 98 test bottles was 9 CFU's. The maximum heat resistant bioburden which must be used in sterilization process calculations may be safely fixed at 10% of the total bioburden, therefore we have to use 0.9 micro-organisms in our calculation.(ABSTRACT TRUNCATED AT 250 WORDS)

Microbiological aspects of heat sterilization of drugs. III. Heat resistance of spore-forming bacteria, isolated from large-volume parenterals.

In order to calculate the minimum sterilization process conditions to obtain the generally accepted sterility level (less than 1.10(-6) probability of microbial survival), we determined the bioburden and its heat resistance of 500 ml large-volume parenteral bottles over a period of 5 years. For the bioburden determination 1,832 bottles were examined by the membrane filtration method. Mean bioburden was 9.36 colony-forming units/bottle. Of the colony-forming units isolated 118 were heat resistant (0.69%). These were spore-forming Bacillus species. Of the isolated Bacillus species heat resistance was determined in 5% glucose, 0.9% sodium chloride and 8% amino acids solution. D values greater than 1 min at 105 degrees C were found for 2, 5 and 4 different Bacillus species in glucose 5%, sodium chloride 0.9% and amino acids 8%, respectively. 2 Bacillus species showed a D value over 2 min at 105 degrees C in all three media. D values at 110 degrees C in sodium chloride 0.9% for these 2 Bacillus species were 1.8 and 2.6 min and in amino acids 8% 0.9 and 1.7 min, respectively. The minimum sterilization process time at 110 degrees C, calculated with the experimentally determined bioburden and D values is less than 25 min. When introducing reduced exposure times/temperatures, each individual manufacturer should assess the bioburden. The time-consuming determination of the heat resistance of bioburden isolates is not always necessary. By dividing the isolated colony-forming units in a 'heat-resistant' group and a 'not-heat-resistant' group, changing from standard overkill sterilization procedures to processes with lower F0 values is possible.

The clearance of heat-damaged erythrocytes by the reticulo-endothelial system in systemic lupus erythematosus and rheumatoid arthritis.

Reticulo-endothelial function was assessed in 20 patients with active rheumatoid arthritis and 11 patients with systemic lupus erythematosus with regard to the clearance of heat-damaged erythrocytes (HDE). In contrast to previous reports, no correlations were found between disease activity, levels of circulating immune complexes and splenic function. There was no evidence of an obvious hypofunction in the reticulo-endothelial system of the spleen in patients with rheumatoid arthritis or systemic lupus erythematosus. Moreover, a splenic hyperfunction is suggested to be present in some patients. A method for measuring the specific uptake by the liver, spleen and the clearance rate (T 1/2) of the HDE is also described.

Determination of the half-life of C3 in patients and its relation to the presence of C3-breakdown products and/or circulating immune complexes.

Measurement of complement components in serum may not accurately assess the degree of activation of the complement system. An alternative approach is the measurement of conversion products of the complement components. The relation between the presence of an increased concentration of C3-conversion products and the metabolism of C3 was investigated. In a group of patients, circulating immune complexes were also measured (Clq-binding test) to see whether the combination of those markers yielded information on the C3 metabolism. In this study it is shown that static measurements of serum C3 levels is of no value for the degree of complement activation. Measurement of C3-conversion products may indicate C3 hypercatabolism (in 8 of the 11 patients with C3-conversion products), but it does not imply depressed C3 synthesis. Detection of circulating immune complexes by the C1q-binding assay did not always indicate a C3 hypercatabolism. Of 12 SLE patients studied, in 9 of them, a C3 hypercatabolism was detected, and 5 of these patients were clinically characterized by the presence of minor disease symptoms. Overall, the results indicated that detection of circulating immune complexes and/or C3-conversion products could not be used as an absolute measure for insight into the C3 metabolism.