The financial impact of investigational drug services

The pharmacy-based investigational drug service plays an important role in the clinical research process. Investigators and sponsors often rely on the research pharmacist to assure drug accountability and to assist in educating staff about drug studies, reporting adverse reactions, and providing drug information. While many pharmacy departments across the country have established investigational drug services, there is an increasing need to justify these services from a financial perspective. Our pharmacy department currently provides investigational drug services for over 100 protocols. We have established a fee-for-service billing mechanism, but only 61% of our protocols are drug-company or investigator-sponsored, which reimburse for pharmacy services. As a result, we are unable to collect all operating costs through our billing mechanism. Many protocols, however, are sponsored by the National Cancer Institute (NCI), which provides free drugs for cancer protocols. Some NCI drugs are also on the market, so the hospital experiences savings in drug costs when patients are placed on certain NCI protocols. When we combine direct costs recovered through billing with the indirect cost savings from dispensing "free drugs, we find that the total benefit of operating an investigational drug service more than outweighs the cost of operating the service.     

Copper in drinking water, Nebraska, 1994

In 1993, the levels of copper (Cu) in much of Nebraska's drinking water exceeded the U.S. Environmental Protection Agency's (EPA) action level of 1.3 mg/L. To determine the association of copper with gastrointestinal (GI) illness in August 1994 the authors interviewed persons living in households with 1993 Cu levels > 3 mg/L (51 households), 2-3 mg/L (54 households), and < 1.3 mg/L (43 households). Cases were defined as persons who had experienced the rapid onset of vomiting or nausea with abdominal pain during the preceding two weeks. To validate their exposure index, the authors immediately resampled drinking water in the households of 25 cases and 27 controls matched for age. Reassessment in December 1994 of the exposure and case status of the original cohort showed no association between copper in drinking water in 1993 and case status in 1994. The risk of GI illness seemed no greater with Cu > 3 mg/L (RR = 1.03; 95% CI = 0.43, 2.49) or 2-3 mg/L (RR = 0.50; 95% CI = 0.18, 1.41) than with Cu < 1.3 mg/L. The 1993 Cu concentrations could not be reproduced in August 1994; resampling in December 1994 again showed no association between GI illness and Cu exposure (RR > 1.3-2.9 mg/L, < or = 1.3 mg/L = 0.25, 95% CI = 0.10, 0.64, and RR > or = 3.0 mg/L, < or = 1.3 mg/L = 0.36, 95% CI = 0.09, 1.49).     

Regulatory peptides in the heart and major vessels of man and mammals

Studies on the distribution of peptides in human tissues have been made either by measuring responses to localized stimuli or by subjecting extracts of different regions to radioimmunoassay (RIA). Attempts at isolating regulatory peptides from the mammalian tissues have resulted in the isolation of many bioactive fragments. Later, modification of initial isolation methods led to the identification of the native molecules in various tissues and body fluids. The present study examined atrial natriuretic peptide (ANP) and several other peptides in cardiac tissues of several species of laboratory mammal and human beings; using a sensitive and highly specific radioimmunoassays.In all the species studied, ANP-like immunoreactivity appeared to be highest in the heart tissue of rat. The peptide was highest in the right atrium (RA) of rat and lowest in the RA of guinea pig (P< 0.002). Neuropeptide Y (NPY) another abundant cardiac peptide was present in the cardiac tissues of all species but was more in the left atrium (LA) than the RA of all species (P<0.05). Calcitonin gene-related peptide (CGRP) was present throughout the cardiovascular system of the rat and guinea pig. Small but detectable amount of Neurotensin (NT) immunoreactivity was found in the rat but was consistently negative in the guinea pig cardiac tissues (P< 0.05). Substance P (SP) immunoreactivity was detected in the rat and higher quantities being in the Aorta but no trace of the peptide was detected in the left ventricle, aorta nor the pulmonary vein of post mortem human.Though the structure of most of the species studied has been elucidated, the primary structure of guinea pig ANP has not been fully generated. Thus the data obtained may suggest that in keeping with these mammalian peptides, the primary structures may be variant. With most of the peptides studied (e.g. ANP, Neuropepdide Y), immunoreactivity occurs predominantly in the atrial tissues, but is also present in vessels outside the heart, a finding which may be of functional significance.     

Re-engineering operating theatres: the perspective assessed

Refers to the widely experienced and appreciated difficulties in scheduling hospital operating theatres to make effective use of resources, and to avoid delays and overruns that can adversely affect patient care and staff morale. Reports the findings and recommendations of a project based in the Surgical Directorate of Leicester General Hospital NHS Trust which sought to address these problems from a business process re-engineering perspective. Covering the whole patient trail, from referral to discharge describes the project's progress through four phases concerning process mapping, the collection of staff opinions and ideas through a combination of interviews and surveys, collection of data on patient flows and procedure times, and a final "handover" phase in which broad recommendations were passed back to the Surgical Directorate for implementation with staff involvement. Details the recommendations which include a shift to cross-functional teamworking in a number of areas, along with the development of a revised theatres policy and a strengthened theatres co-ordination function. In view of recent substantial and harsh criticisms of the re-engineering perspective, seeks to offer a balanced assessment of the perspective applied to a health care setting, exploring both the problems and benefits.     

Feasibility of using Travenol sets in an IVAC 230 controller

The feasibility of using Travenol regular and minidrip sets to deliver intravenous solution with IVAC 230 controllers was investigated. Intravariability within Travenol regular sets proved to be negligible. Likewise, intervariability among IVAC controllers is negligible. The least squares fit obtained from drops per minute (dpm) versus flow rate (ml/hr) for Travenol regular sets using dextrose 5% in water was y = 4.50x + 0.8 (r greater than 0.99). Similarly, the least squares fit for sodium chloride 0.9% was y = 4.50x - 0.6 (r greater than 0.99). Therefore, the calculated dpm for the required flow rate for both solutions is similar using Travenol regular sets. Also, no significant difference is found between the drip rate of dextrose 5% in water and sodium chloride 0.9% with Travenol minidrip at 5, 30, and 60 dpms. This study shows that interchangeability of IVAC administration sets with Travenol regular and minidrip sets is possible for dextrose 5% in water and sodium chloride 0.9% solutions.