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.

Development of an operating room pharmacy substation on a restricted budget.

Pharmaceutical services implemented in an operating room (OR) pharmacy substation without addition of staff in a 764-bed teaching hospital with 22 operating rooms are described. In 1984 an interdepartmental task force recommended that pharmacy take control of responsibility for controlled drugs used in anesthesia. The anesthesia department contributed space for a pharmacy substation and some of the necessary equipment. Two technicians staff the substation (1.5 full-time equivalent positions); pharmacy contributed 0.5 FTE and the additional FTE was obtained through staffing adjustments in other departments. Anesthesiologists and nurse anesthetists obtain controlled drugs directly from the technicians, and records of drug disposition are compared with inventory twice daily. The substation also handles exchange carts for noncontrolled drugs for anesthesia and for other drugs used in the operating rooms. Total cost (additional cost to pharmacy and other departments) for operating the substation for its first year was +2161, and there were no unresolved discrepancies in controlled drug accounting. Undocumented use of noncontrolled drugs has been reduced by 67%, and cooperation and communication between the pharmacy and anesthesia departments has improved. Substation personnel do not prepare intravenous admixtures or provide clinical services. An operating room substation staffed by technicians 10.5 hours daily Monday through Friday provided cost-effective pharmacy control of drugs used in the OR.

Planning and coordinating pharmaceutical purchasing.

The planning and coordination of the pharmaceutical purchasing process are discussed. Planning for pharmaceutical purchasing should begin with decisions regarding why a purchasing policy is needed, what the institution's purchasing policy will be, and what departments will be involved in purchasing. General goals of purchasing and procedures for revising purchasing functions are presented, and the role of the pharmacy department, materials management, and other hospital departments in purchasing is discussed. Coordinating input on purchasing decisions from medical staff, administration, and clinical and technical pharmacy personnel to achieve purchasing goals and objectives is discussed. A well-designed pharmaceutical purchasing system provides for planned and scheduled purchases, competitive bidding, product standardization, group purchasing, information sharing, internal accountability, and quality assurance.

Aminoglycoside pharmacokinetics on a microcomputer.

The authors describe the use of a microcomputer to evaluate an existing dosage regimen and to determine a new regimen and steady-state peak and trough levels for four aminoglycoside antibiotics--amikacin, gentamicin, kanamycin, and tobramycin. The microcomputer program is based on a one-compartment open pharmacokinetic model for the aminoglycosides. It accounts for patients' sex, age, height, obesity, and ascitic compartment. The program is divided into seven subprograms for each of the four aminoglycosides: (1) steady-state peak and trough levels are predicted, based on serum creatinine for a given dosage regimen; (2) a dosage regimen that conforms to 6, 8, 12, 16, or 24 hours is ascertained, based on serum creatinine; (3) a dosage regimen is determined, on the basis of serum creatinine, for desired steady-state peak and trough levels; (4) a dosage regimen that conforms to 6, 8, 12, 16, or 24 hours is ascertained for given aminoglycoside serum levels; (5) a dosage regimen for desired peak and trough levels is ascertained for given aminoglycoside serum levels; (6) a dosage regimen that conforms to 6, 8, 12, 16, or 24 hours is ascertained from data collected using Sawchuk's and Zaske's method; and (7) a dosage regimen, estimated for desired peak and trough levels, is estimated from data collected using Sawchuk's and Zaske's method.

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.

Hemorrhagic shock.

The treatment of hemorrhagic shock is discussed, based on principles illustrated in a hypothetical case. The pathophysiology and clinical monitoring of hypovolemic shock are reviewed. A practical approach to volume replacement therapy in hemorrhagic shock is suggested.

Blood and blood substitutes for treating hemorragic shock.

Blood substitute products for the treatment of hemorrhagic shock are discussed with regard to their composition, physical and therapeutic characteristics, adverse effects, cost, and market availability. Commercially available plasma expanders discussed include blood derivatives (whole blood, packed red blood cells, plasma, normal human serum albumin, and plasma protein fraction), synthetic colloids (dextrans 40 and 70) and a balanced salt solution (lactated Ringer's injection). Plasma substitutes alone are administered until the hematocrit falls below 30% of coagulation difficulties develop. Normal serum albumin 5% and plasma protein fraction 5% are excellent colloidal plasma expanders without the potential hazard of hepatitis. Lactated Ringer's injection is the fluid of choice to replace lost blood up to 10% of the vascular volume.