Developing an effective P & T Committee, Part 2.

The changes in health care have had a direct impact on the functions of the P & T Committee. P & T Committee members must be prepared to face new issues, especially concerning cost-effective drug therapy. Formulary admissions and use of nonformulary agents are discussed. The role of the P & T Committee in relation to the various hospital committees, the roles of physicians and pharmacists, and the role of the pharmacy director as manager are identified. Advice regarding standardization of therapy and drug-dosing policies is provided.

Developing an effective P&T Committee, Part I.

Many challenges confront P & T Committees when trying to promote rational drug therapy that is not only safe and efficacious but cost-effective as well. Strategies are discussed for implementing successful P & T policies, including techniques for establishing a well-functioning formulary. New directions are proposed for P & T Committees to respond to our changing health care environment.

Fiscal and clinical evaluation of home parenteral nutrition.

The clinical management activities performed by nonphysician members of a home parenteral nutrition (HPN) service were evaluated, and the costs of providing a home-care service with a hospital-based supply were projected. The nutrition support service team included two pharmacists, one nurse, one dietitian, one social worker, and two physicians. The clinical activities of the nonphysician members of the service were documented for a one-year period involving 13 patients. Inventory data for items dispensed were obtained from the commercial vender supplying the patients during the study. Projected charges for the hospital pharmacy to deliver supplies were based on actual contract costs to the hospital. An arbitrarily assigned markup of 40% was used to calculate break-even data. The clinical management of the HPN patients required 203 hours of the nonphysician health-care professionals' time. For the initial fiscal year, the fixed and variable costs were projected as $253,360, which amounted to $89.82 per calendar day of home therapy. The hospital would have to provide 1416 calendar days of home parenteral nutrition before revenues equaled expenses at $168,504. The projected annual savings for a patient receiving parenteral nutrition at home rather than in the hospital was $651,651. Supply alternatives for HPN should be evaluated according to specific institutional needs.

Competency-based advancement program for pharmacists.

A competency-based advancement program for practicing pharmacists is presented. The criteria for selecting this method of providing incentives for pharmacists are outlined. Procedures for developing and implementing this competency-based program are described. Five competency levels for pharmacists were developed based on the pharmacist's educational background, training, and experience. Differentiated position titles and competency expectations for each level are summarized. Criteria for pharmacist placement and promotion from one completely level to another are outlined. The administration of the program is described, including budget considerations and methods for evaluating its effectiveness. This system recognizes and rewards accomplishments of staff pharmacists without removing them from patient care roles.

Effect of laminar air flow and clean-room dress on contamination rates of intravenous admixtures.

The effect of laminar air flow conditions and clean-room dress on the microbial contamination rates of intravenous admixtures was investigated. Intravenous admixtures were prepared by one investigator using aseptic technique under four environmental conditions: laminar air flow conditions with clean-room dress; laminar air flow without clean-room dress; clean table top with clean-room dress; and clean table top without clean-room dress. In each environmental condition, 350 admixtures were compounded. Negative-control samples (n = 150) were also tested, as were 10 positive-control samples. Samples were tested in each of two growth media and incubated at 35 degrees C for 14 days or until growth occurred. The incidence of contamination of admixtures compounded in laminar air flow conditions was significantly less than the contamination of those compounded on a clean table top (p less than 0.05) regardless of the operator's dress. The incidence of contamination of admixtures compounded while wearing clean-room dress was not significantly different from those prepared while not wearing clean-room dress regardless of the environment in which the admixture was prepared. The overall low level of contamination [0.79% (11/1400)] was inconclusive regarding the effect of dress on the incidence of contamination when admixtures were prepared under LAF conditions. It is concluded that, when one adheres to aseptic technique, the environment in which admixtures are compounded is the most important variable affecting the microbial contamination rate.

Water permeation through polyvinyl chloride bags without overwrap.

Water loss by permeation from polyvinyl chloride i.v. containers (Viaflex, Travenol Laboratories) without an overwrap is reported. Viaflex bags without the overwrap containing 0.9% sodium chloride injection or 5% dextrose injection in 50-ml, 100-ml, 500-ml, and 1000-ml sizes were used. All sizes were stored at room temperatures (25 degrees C) and in a refrigerator (4-8 degrees C); the two smaller sizes were additionally in a frost-free freezer (-20 degrees C) and in a non-frost-free freezer (-20 degrees C). Ten bags of each type were stored for 84 days; each container weighed on days 0, 7, 14, 21, 28, 42, 56, 70, and 84 days. Based on the weight change exhibited during this initial period, the time required to lose 10% of the weight was predicted. The bags were stored for that period of time and then weighed. The weight loss exhibited zero-order kinetics. At room temperature, the 50-ml containers of both solutions lost greater than 10% during the 84-day period. During this time, the 100-ml containers of both solutions lost 9% of their weight. Weight loss in the larger sizes was less than 5% during the 84-day period at room temperature. Under the colder storage conditions, weight loss averaged much less than 5% for all sizes during the 84 days. During extended storage, weight loss continued at the same rate for the 100-ml container but was slower for the larger sizes. The Viaflex container without the overwrap may be stored in a refrigerator or freezer for up to 84 days without substantial loss of water by permeation.

Strategies for deleting popular drugs from a hospital formulary.

The approach used by a hospital pharmacy in planning, implementing, and evaluating a major formulary revision and the strategies used in deleting popular analgesics from the formulary are described. All phenacetin-containing products were deleted from the formulary of The Ohio State University Hospitals. The following steps of the process are described; identification of the problem, literature evaluation, soliciting medical staff support, presentation to the pharmacy and therapeutics committee, designing an implementation timetable, education, monitoring analgesic use, coordination of departmental activities, implementation and follow-up. The strategy used in this case resulted in the policy being implemented successfully.

Stability of antibiotics frozen and stored in disposable hypodermic syringes.

The effect of freezing on the stability of several reconstituted antibiotics packaged in disposable hypodermic syringes was studied. The following drugs were reconstituted and, after taking samples for initial assay, were frozen at -20 degrees C in Hy-Pod hypodermic syringes: cephalothin, 1 g/5 ml; cefazolin (with water), 1 g/3 ml; cefazolin (with lidocaine injection), 1 g/3 ml; cefamandole, 1 g/3.5 ml; and nafcillin, 1 g/4 ml. At three, six, and nine months, samples of the frozen solutions were allowed to thaw at room temperature and then were assayed microbiologically. All antibiotics maintained at least 90% potency at the end of nine months. Cefazolin with lidocaine, however, turned cloudy after thawing. The data suggest that cephalothin, cefazolin with water, cefamandole, and nafcillin, when frozen and stored at -20 degrees C in Hy-Pod hypodermic syringes, may be used within nine months of initial freezing.

Effect of microwave radiation on redissolving precipitated matter in fluorouracil injection.

The effect on the stability of fluorouracil injection of using microwave radiation to redissolve precipitated matter was studied. Fifteen ampuls each of Fluorouracil Injection, USP, containing precipitate were heated to 60 degrees C in a microwave oven and water bath, respectively. The contents of each heated ampul and of 15 control ampuls (unheated, no precipitate) were assayed by high-performance liquid chromatography, and the pH value of each sample was measured. Each test group fell within USP concentration requirements and showed no significant decrease in potency. Among the microwave-heated ampuls, a mean drop of 0.03 pH units was significant (p less than 0.05) but did not affect drug stability or solubility, since all samples remained within the USP pH range of 8.6-9.0. Precipitated matter in fluorouracil injection can be redissolved by heating with microwave radiation without significantly affecting the drug's stability.

Stability of five liquid drug products after unit dose repackaging.

The room temperature stabilities of repackaged pentazocine hydrochloride injection, promethazine hydrochloride injection, haloperidol oral concentrate, phenytoin oral suspension, and isoetharine inhalation solution were determined. After being repackaged as unit doses in a Hy-Pod Hypodermic Syringe, Ped-Pod Oral Dispenser, or NebuJect Nebulizer Injector (all made by MPL, Inc., SoloPak Division), several containers of each drug were stored at room temperature. Isoetharine samples were assayed after 15 and 30 days, while samples of the other drugs were assayed after 90, 180, and 360 days. Also, separate samples of pentazocine and promethazine were stored at 40, 50, and 60 degrees C and were assayed after 15, 30, and 90 days. The long-range stabilities of the drugs stored at elevated temperatures were predicted using the Arrhenius technique. The results indicate that, under the conditions tested, isoetharine can be stored for at least 30 days at room temperature and promethazine, pentazocine, haloperidol, and phenytoin can be stored for at least a year, all with less than 10% loss in potency. Arrhenius data indicate that pentazocine injection probably would be stable at room temperature for much longer than the 360 days for which it was tested.

Stability of cefazolin sodium admixtures in plastic bags after thawing by microwave radiation.

The effect on antibiotic stability of thawing, with microwave radiation, cefazolin sodium admixtures frozen in polyvinyl chloride minibags was studied. Two brands of cefazolin sodium (Ancef and Kefzol) were reconstituted and placed in 50-, 100- and 250-ml polyvinyl chloride minibags of 5% dextrose in water or 0.9% sodium chloride. The resulting solutions were assayed for antibiotic stability, using an agar disk diffusion technique, and for pH. The solutions were then stored at -20 degrees C for 48 hours, thawed to room temperature in a microwave oven, and kept at room temperature for four hours, after which they were reassayed for potency and pH. The results indicated that after the freeze-thaw process, the cefazolin sodium minibag admixtures retained at least 90% of their initial antimicrobial activity. The minimal pH changes could not be related to changes in antimicrobial activity, and no color changes could be detected visually. Using a microwave oven can greatly reduce thawing time of antibiotic admixtures. To maintain solution stability and prevent accidents, it is important to calibrate the oven, avoid solution overheating, and observe full precautions in oven operation.

Compounding times and contamination rates associated with the preparation of intravenous admixtures in three types of plastic containers.

The compounding times and contamination rates associated with the preparation of admixtures in three different plastic i.v. containers of dextrose 5% in water were compared. The time required for a technician to prepare, in a laminar air flow hood by the needle and syringe technique, 120 admixtures in each of three different plastic i.v. containers was measured and recorded by two investigators. The 360 admixtures were tested within one hour of preparation for sterility using an enriched brain heart infusion broth. The total time required to compound the i.v. admixtures varied significantly with container design (p less than 0.01), preparation being fastest with the Accumed container, followed by the LifeCare then the Viaflex containers. The major contributing factors to increased compounding time were (1) removal of outer wrap, (2) swabbing of LifeCare and Viaflex medication ports with isopropyl alcohol pads and (3) freeing of the hangar flap from the Viaflex container. Sterility tests revealed no detectable contamination of any of the admixtures. Container design of plastic i.v. containers did influence the preparation time for admixtures but did not influence admixture sterility.