FDA drug classification system.

The purpose and use of the FDA's classification system for new drug products are described. Investigational new drug applications (INDs) and new drug applications (NDAs) are submitted to the FDA's Center for Drug Evaluation and Research. To establish the priority of the product in the review process, expert reviewers classify each product according to chemical type and therapeutic potential. Drug products that receive a high therapeutic rating (e.g., 1AA or 1A) are reviewed for approval more quickly than drugs that receive a lower therapeutic rating (e.g., 1B or 1C). Because this system is the only national therapeutic rating system for drug products, it has been used in legislation, in clinical evaluation of new drug products as they are approved, and in formulary decisions. However, caution is needed because the therapeutic rating assigned at the time of the product's approval may not reflect its importance relative to all agents available at a later date. The FDA classification system was designed to guide new drug products through the application process and should be used only with caution for other purposes.

Harvey A. K. Whitney Lecture. To a new beginning from converging paths.

The implementation of the pharmaceutical care concept is discussed. Current activities of professional pharmacy organizations are laying the groundwork for the new emphasis on patient outcomes, which is seen in the mission statements of the American Pharmaceutical Association (APhA) and the Joint Commission of Pharmacy Practitioners (JCPP). APhA is revalidating its standards of practice; the American Association of Colleges of Pharmacy (AACP) has formed a Commission to Implement Change in Pharmaceutical Education; the American Council on Pharmaceutical Education (ACPE) is revising its standards to be consistent with entry-level practitioners' ability to provide pharmaceutical care and seeking ways in which pharmacists currently practicing in all sites can upgrade their skills. These groups are called on to implement pharmaceutical care: To make known the "value-added services" encompassed in pharmaceutical care, JCPP should market to the public its concept of pharmacists' mission. APhA should analyze pharmaceutical services currently provided and promote postgraduate training programs in pharmaceutical care. ACPE must focus on ways pharmacists can achieve the competencies required for pharmaceutical care, and AACP must ensure that academic programs are consistent with the needed competencies. ASHP should hold a national conference on implementation of pharmaceutical care, create a commission for this purpose, direct more effort at pharmacists practicing in nonhospital settings, and accelerate its clinical skills development program. Employers should put less emphasis on "clinical" designations and Pharm.D. degrees and more on the ability to provide pharmaceutical care. Implementation of pharmaceutical care is imperative.

Accuracy and time requirements of a bar-code inventory system for controlled substances.

The effect of a bar-code system on personnel time requirements and data-entry accuracy in an existing automated controlled substances inventory system was determined. In the previous system, technicians used a keyboard and alphanumeric codes to enter into the computer data about the physical transfer of controlled substances among hospital areas. A system for barcode data entry was adapted for use with the existing procedure. After learning to use the bar-code system, four experienced technicians entered data by the keyboard method for eight days and the bar-code method for eight days during a 32-day study period. The amount of time required to enter all transactions and the accuracy of data entry were measured. Mean data-entry times for the keyboard and bar-code methods were not significantly different, most likely because of the greater number of manipulations needed for bar-code data entry. The mean percentage error associated with the bar-code method (0.79%) was significantly less than the error associated with the keyboard method (1.53%). For this particular computer system in which bar-code data entry was adapted to existing procedures, use of bar codes to enter controlled substances inventory data was not substantially faster but was more accurate than a traditional key-board data-entry method.

Comparison of videocassette and personal instruction methods for training pharmacy personnel in aseptic technique.

A videocassette self-instruction method of aseptic-technique training was compared with a one-on-one instructor-trainee method to determine the effectiveness and cost of each method. Pharmacy department personnel and pharmacy students with no previous training in aseptic technique were randomly assigned to receive either personal or videocassette instruction. The trainees completed an identical set of practice activities. Three measures were used to determine competency in aseptic technique: written testing on information presented, direct observation monitoring of trainees' technique in preparing broth admixtures, and sterility testing of end products. A total of 28 individuals participated in the study, 14 in each group. Trainees in the group receiving personal instruction had significantly higher overall test scores than did trainees receiving videocassette instruction. Trainees receiving videocassette instruction had more difficulty in aseptic manipulation of needles, syringes, vials, ampuls, bottles, and bags; in properly cleaning the laminar-airflow hood; and in inspecting the prepared admixtures. However, no broth admixture in either group showed evidence of microbial growth. The personal instruction method was more than two and one-half times as expensive as the videocassette method. A combination of videocassette instruction in aseptic technique and instructor intervention during the training process should result in a cost-effective training method.

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.

Drug usage guidelines, Part 3: assessment of acceptance of the program.

The Drug Usage Guidelines (DUG) program, as perceived by the members of the P & T Committee and by physicians who had prepared and submitted DUGs, was demonstrated to be an effective method for evaluating drugs for formulary inclusion. The majority of P & T members felt that the DUG program had strengthened the drug review process without being too tedious or preventing the addition of valuable drugs to the formulary. Sixty-eight percent of physicians who had submitted a DUG expressed the opinion that it served as a vehicle for providing educational information on rational therapeutics. A majority of respondents stated that they would recommend the DUG program to other hospitals.

Drug usage guidelines, Part 2: Analysis of program outcome.

The effect of integrating a Drug Usage Guidelines (DUG) program with a hospital formulary system was analyzed. Significant changes were observed in both the number of requests submitted to the P & T Committee and the number of drugs added to the formulary after implementation of the DUG program. Failure to follow the DUG submission protocol, particularly with respect to the requirement for supportive clinical data from the primary literature, led to delayed consideration and eventual withdrawal of several highly promoted drug products. The initial involvement of physicians in the planning and implementation of the DUG program has been an important factor in the continued success of the program.

Evaluation of amitriptyline use for depression when prescribed by internists and psychiatrists.

The efforts involved in structuring and implementing a drug utilization review (DUR) program that was designed to assess the use of amitriptyline for depression when prescribed by internists and psychiatrists is described. In-depth audit criteria were used to identify deviations from the criteria for each group. An immediate goal of this amitriptyline DUR program is to apply the results of the study toward the implementation of a targeted, multifaceted educational program. The design of the DUR program should emphasize the individual needs of each of the two study groups.

Strengthening the formulary system by implementing a drug usage guidelines program.

The development and implementation of a Drug Usage Guidelines (DUG) program in a 1,200-bed, federal teaching hospital are described. The program was designed to promote effective formulary control through established procedures for the review and evaluation of drugs submitted to the Pharmacy and Therapeutics (P & T) Committee for addition to the formulary. The procedures required the submission of the DUG and an oral presentation to the Committee prior to any final vote on the request. Anticipated potential benefits of the DUG program are to: (1) stimulate rational drug therapy, (2) provide reliable drug information to the professional staff in a usable format, (3) promote a thorough evaluation of therapeutic agents before approving for formulary inclusion, and (4) provide physician-generated guidelines for use as criteria in drug utilization review audits.

Evaluation of three methods for detecting bacterial contamination in intravenous solutions.

Membrane filtration, small-aliquot inoculation, and double-strength broth methods of sterility testing were evaluated for detection of small numbers of bacteria in 5% dextrose injection (D5W). Each of 240 bags of D5W 50 ml were inoculated with approximately 10 2 Staphylococcus epidermidis and subjected to one of the three test methods at 1, 3, 6, 9, 12, 18, 24, or 48 hours after inoculation. After incubating at 25 degrees C for seven days, the test units were examined for turbidity, indicating growth of bacterial contaminants. Double-strength broth was shown to be more reliable than the other two test methods, detecting the bacterial contaminants in 30 of 30 samples through six hours. Successful recovery of low-level Staph. epidermidis in D5W decreased significantly after a nine-hour delay in processing. Membrane filtration and aliquot-sampling methods were comparable, each detecting contamination in 3-4 of 10 bags at one hour after inoculation. The number of false negatives increased with time, with no contaminants detected in any of the bags tested with these two methods nine hours after inoculation. It is concluded that the testing method selected to monitor for sterility and the amount of time elapsed before processing the sample are critical to the accuracy of results.

Determining a time frame for sterility testing of intravenous admixtures.

Defining an optimal time of analysis for detecting bacterial contaminants in intravenous admixtures was studied. Three different intravenous solutions were inoculated with low-level numbers (10(1)) of Staphylococcus epidermidis and tested for sterility using the Ivex-2 Filterset method at six time intervals after inoculation: less than 1, 20, 40, 60, 120, and 240 minutes. Solutions used were 5% dextrose injection 1000 ml, 0.9% sodium chloride injection 1000 ml, and 5% dextrose injection 50 ml. At each interval, 10 solutions of each type were tested. An additional 20 controls were employed to monitor technique, facilities, and environmental conditions. Successful recovery of Staph. epidermis decreased significantly when sample processing was delayed for longer than 40-60 minutes after inoculation. Furthermore, the number of false negatives was greater for dextrose solutions than for sodium chloride solutions after this time period. Volume of admixtures had no effect on contamination detection. This study suggests that sterility testing should be completed within 40-60 minutes after preparation of intravenous admixtures.

Evaluation of three methods for detecting low-level bacterial contamination in intravenous solutions.

The accuracy of three sterility-testing methods in detecting low-level contamination in deliberately contaminated intravenous solutions was studied. One-liter bags of 5% dextrose (D5W) and 0.9% sodium chloride (saline injections were contaminated with Staphylococcus epidermidis and Pseudomonas aeruginosa; approximately 10(1) viable bacteria were injected into each bag. Two membrane-filtration methods (Ivex-2 and Addi-Chek) and one aliquot method [twice concentrated trypic soy broth (2X-TSB)] were used to test each of 10 diliberately contaminated solutions for both D5W and saline; 500 ml of each liter bag was filtered or added to 2X-TSB. Incubation containers were stored at 37 degrees C and inspected at 24, 48, and 72 hours for turbidity. There was no significant difference among the three methods in the detection of contaminated saline solutions. The Addi-Chek system was significantly less effective in detecting contamination in D5W than either of the other methods. It is concluded that the Ivex-2 system is accurate and the easiest-to-use system of the three tested.