Survey of sterile product compounding practices in Canadian hospital pharmacies.

Improper preparation of sterile products by hospital or community pharmacies may have serious consequences. Recent reports of deaths or injury to patients as a result of receiving products that were contaminated during their preparation in a pharmacy have highlighted the importance of maintaining good sterile compounding practices. Efforts are now underway to develop revised guidelines for the compounding of sterile products in order to minimize the potential for future recurrence of similar incidents. This survey study was undertaken to provide background data on current sterile products compounding practices and procedures in Canadian hospital pharmacies. It was also anticipated that these data would be helpful in identifying issues that needed to be addressed in the new guidelines. Surveys were distributed to 700 Canadian hospitals with 50 or more beds. Responses from returned surveys were entered into and analyzed using the database program RBase. A total of 306 hospital pharmacies responded, with 200 indicating that sterile products were compounded within their department. The information provided by respondents provides insight into the types of sterile products being prepared in Canadian hospitals, the training background of staff involved in sterile product preparation, the type of facilities and equipment used for compounding these preparations, and the quality control/quality assurance procedures that are in place in hospital pharmacies. The information arising from this survey underscores the need for comprehensive guidelines or standards with respect to sterile product compounding, and the need for improved training of personnel involved in sterile product compounding. The results should be of interest to hospital pharmacy administrators, pharmacy regulatory bodies, and government agencies responsible for assuring the safety of pharmaceutical products used in patient care.

Long-term psychosocial adjustment in patients with severe burn injuries: a follow-up study.

An investigation of the long-term psychosocial adjustment of patients with severe burn injuries is presented. In the selected 13-year period (1968-80) 46 patients fulfilled the entry criteria: burns covering more than 30 per cent body surface area (deep dermal or full skin thickness). Seventeen patients died early and one later. Of the remaining 28 patients, contact was made with 25 (89.3 per cent) who all participated. The observation time ranged between 7 and 21 years. The patients received a semi-standardized interview adjusted for age at the time of burn injury, a psychiatric interview and a physical examination to assess the permanent character and functional loss. The principal findings were: no correlation could be found between degree of disfiguration/function loss and the long-term psychosocial adaptation after severe burn injuries. The determinant factor was the premorbid psychiatric/psychological integration and, to some extent, support from staff and relatives.

Development of a modulator to measure water vapor selectively in a gaseous mixture.

NASA: Selective thermal modulation (STM) is a technique which produces a concentration-dependent pulse by selectively modulating a sample in a gas stream. Several types of modulation techniques, both chemical and physical, using adsorption, decomposition, and catalytic and mechanical methods have been developed for use with multiplex gas chromatography. Two of these applications involve selective modulation of the components present in the sample gas stream. The selective modulation of the concentration of specific sample molecules or classes of molecules provides additional analytical selectivity which can lead to selective detection. For some specific applications, the column may even be eliminated. Chemical modulation by absorption of a substance from the sample stream by a stationary phase will also produce a change in the signal intensity. Removal of a substance from the sample stream results in a signal containing a vacancy peak. In the work reported here, a selective thermal modulation technique has been developed as a method for determination of water vapor for possible use in Mars' atmosphere.^ieng

Continuous monitoring of a changing sample by multiplex gas chromatography.

Multiplex gas chromatography (MGC) is a technique in which multiple samples may be introduced into a chromatographic system regardless of the elution time of the individual components. Although the output obtained from a MGC experiment is not directly interpretable, computational techniques can be used to obtain the chromatogram from the detector output data. This is done by calculating the impulse response function from the multiplexed output data.

The effects of pentoxifylline on cochlear blood flow in normotensive and spontaneously hypertensive rats.

Normotensive and spontaneously hypertensive rats (SHRs) were given arterial infusions of saline and pentoxifylline in doses of 1.5, 2.0, and 3.0 mg/kg/min. Blood pressure decreased in a dose related fashion with increasing doses of pentoxifylline. Cochlear blood flow, measured via laser Doppler flowmeter, increased with infusion of pentoxifylline in members of both rat strains, but to a greater extent in SHRs than in normotensive animals. The mechanism of action appears to be decreased red blood cell rigidity which allows increased penetration of red blood cells into microvessels of the cochlea.

Effects of prolonged naloxone infusion in septic shock.

Fourteen patients suffering sixteen episodes of septic shock requiring inotrope and/or vasopressor support were randomised to receive a 30 micrograms/kg naloxone intravenous bolus followed by a 30 micrograms/kg/h infusion or an equivalent volume placebo bolus and infusion for 8-16 h in a double-blind study. pH and pulmonary wedge pressure were kept constant, and inotrope and/or vasopressor were titrated to maintain a preselected mean blood pressure. Inotrope/vasopressor requirements in the naloxone-treated group were significantly lower than those in the control group at 8 h (eight patients in each group, p less than 0.005) and at 16 h (five patients in each group, p less than 0.02). Late but significant improvements in stroke volume (p less than 0.02) and heart rate (p less than 0.05) were also noted in the eight naloxone-treated patients.

A retrospective-prospective study of medication errors: basis for an ongoing monitoring program.

Medication error surveillance is an important component of the quality assurance program of any hospital. The present study was undertaken in an attempt to determine the reliability of data collected retrospectively on medication error forms, as compared to data obtained from a prospective observational study within the same hospital. The results indicate that for many parameters reasonably reliable information can be obtained from voluntarily submitted error reports. Other observations made during the study were also useful to both the nursing and pharmacy departments in their efforts to minimize the occurrence of errors. Based on the information provided by this study, a more formalized medication error surveillance program has been established and a number of changes in the drug distribution and administration systems have been proposed.

Metabolic abnormalities associated with intentional theophylline overdose.

To verify the frequency and severity of metabolic abnormalities occurring as a result of intentional theophylline overdose, we retrospectively analyzed admission laboratory data from 22 cases of theophylline poisoning. Hypokalemia, hyperglycemia, and leukocytosis were frequent findings, and the magnitude of these abnormalities was related to the corresponding serum theophylline level. Although measurements were available for a smaller number of patients, respiratory alkalosis, hypophosphatemia, and hypomagnesemia were also common findings. Given the potential contribution of these abnormalities to the cardiovascular and neurologic toxicities of theophylline, it is important that their presence in patients with overdose be anticipated.

Use of sodium bicarbonate to treat tricyclic antidepressant-induced arrhythmias in a patient with alkalosis.

Sodium bicarbonate has been recommended for the treatment of arrhythmias induced by tricyclic antidepressants. It is unclear, however, whether this therapy is effective only in the presence of acidosis. A case is presented in which there was an immediate response to sodium bicarbonate in three episodes of ventricular tachycardia despite the presence of alkalosis on two of the three occasions. Given the poor response to conventional therapy of arrhythmias induced by tricyclic antidepressants the use of sodium bicarbonate may be reasonable even in the presence of alkalosis. However, in the presence of pre-existing respiratory or metabolic alkalosis, such therapy is not without risk, and it is suggested that it be reserved for life-threatening situations when the arrhythmia has failed to respond to hyperventilation or antiarrhythmics or both.

Pharmacokinetics of erythromycin in normal and alcoholic liver disease subjects.

The objective of this study was to compare the pharmacokinetic behavior of erythromycin in normal volunteers with that in subjects with alcoholic liver disease. Six normal volunteers received 500 mg erythromycin as an intravenous infusion or as two 250-mg enteric-coated tablets in a crossover fashion. The pharmacokinetics of erythromycin after intravenous administration was best described as a two-compartment model. The elimination half-life was 1.6 +/- 0.7 hours (mean +/- S.D.) after the intravenous dose and 2.0 +/- 0.7 hours after the oral dose. In patients with alcoholic liver disease the elimination half-life after oral administration of two 250-mg enteric-coated tablets was 3.2 +/- 0.5 hours, significantly different from that in normal subjects, probably due to impaired metabolism. The difference in half-life does not require dosage adjustment in this patient population. The systemic availability of erythromycin was 33.5 per cent (range 10.5 to 79.3 per cent).

Pharmacokinetic study of valproic acid in a neonate.

Valproic acid was administered to a neonate (gestational age of 39 weeks) at 24 days post partum in an initial single dose of 7.5 mg/kg. Multiple serum samples were collected for 24 hours post dose. Valproic acid was continued and the study was repeated in the same child at 6 months of age at which time the dose had been increased to 13.5 mg/kg (27 mg/kg/day). Serum samples were collected for 12 hours post dose in this second study. A one-compartment model was assumed for calculation of the relevant pharmacokinetic parameters. The half-life (t 1/2) at 24 days of age was 17.2 hours, clearance (Cl) 0.18 ml/min/kg, and volume of distribution (Vd) 0.28 liter/kg. This t 1/2 was less than reported values in neonates younger than 10 days but longer than the average t 1/2 in adults. At 6 months of age, clearance had increased to 0.53 ml/min/kg, t 1/2 had decreased to 7.5 hours, while Vd was relatively unchanged (0.34 liter/kg). Factors possibly causing these changes include hepatic enzyme maturation and concomitant administration of anticonvulsant drugs.

Use of cimetidine in hospital patients.

The use of cimetidine in 137 patients in a large Canadian teaching hospital was assessed prospectively. About 80% of the patients received the drug for treatment and 20% received it for prophylaxis. All of the prophylactic indications as well as some of the treatment indications have not been approved by the health protection branch of the Department of National Health and Welfare, nor do most have adequate literature documentation. The duration of therapy varied from less than 3 days to more than 2 months. The average cost of cimetidine therapy was $40.71. The dosage was not adjusted in over 50% of the patients in whom impairment of renal function was serious enough to warrant consideration of a dosage reduction. Approximately half of the patients received concurrent antacid therapy. Although cimetidine is relatively safe, its use in this institution was less than optimal.

Feeding and toileting devices for a child with arthrogryposis.

Patients with arthrogryposis multiplex congenita have many problems with activities of daily living because of limited upper and lower extremity joint motion and muscle strength. Feeding and toileting are two activities frequently performed at home and at school that may require one or two people to assist the child. A feeding device and a toileting ramp made from readily available materials have improved a child's independence at home and at school, have been of cosmetic and psychological value, and have minimized the need for assistance by one or more people. The feeding device may also be used for writing and art activities. No future dental problems are anticipated with the use of the feeding device over a period of time. Fabricating and training time with the feeding device is about one hour for each process. The fabricating and training time with the toileting ramp is lengthier with several hours required for each process. Patients with extensive involvement from burns or muscular dystrophy can also benefit from use of the feeding device.