As pharmacy practice moves to a more patient-centered concept of pharmaceutical care, pharmacists will rely more than ever on new and expanded roles for support personnel

SECTION 1

INTRODUCTION TO INTRAVENOUS ADMIXTURES

Intravenous solutions are commonly administered to patients who are cared for in hospitals, long-term care facilities, home care programs, infusion centers, and emergency transport vehicles such as ambulances and helicopters. They are used extensively to replace body fluids and to serve as a vehicle for injecting drugs into the body. Special education and training are required by personnel who prepare and administer sterile intravenous solutions, frequently referred to simply as I.V solutions.

One or more drugs are commonly added to the I. V. solution to prepare the final sterile product. The drug is referred to as the additive and the final product is referred to as the admixture.

RESPONSIBILITY FOR PREPARING ADMIXTURES

Because the compounding of I. V. admixtures clearly is drug preparation, it is appropriately the responsibility of a pharmacist. Support for this point of view can be found in standards published by the Joint Commission on Accreditation of Healthcare Organizations (JCAHO), by the American Society of Health-System Pharmacists (ASHP), and by the National Coordinating Committee on Large Volume Parenterals (NCCLVP). JCAHO is a national organization that establishes standards of practice for various health care organizations and is the agency responsible for accrediting hospitals in the United States. ASHP is the national professional organization for pharmacists practicing in health system organizations. NCCLVP is an interdisciplinary group of health professionals gathered to review methods of compounding intravenous admixtures.

JCAHO standards are undergoing significant modification as they focus on functions and processes (e.g., assessment of patients; treatment of patients) rather than individual departments. Although previous JCAHO standards have specifically required pharmacy preparation of I. V. admixtures in all but emergency situations, beginning in 1994 they have become less prescriptive as to who performs a task as long as it is done appropriately. JCAHO's 1995 Comprehensive Accreditation Manual for Hospitals, (JCAHO, Oakbrook Terrace, IL, 1994) states, in part:

Section 1: Care of Patients, Medication Use

TX.3 The organization has a functioning mechanism designed to ensure the safe use of medication. The design of this mechanism is based on a framework that addresses the following:

TX.3.2 The preparation and dispensing of medication(s) including

3.2.1 adherence to applicable law, regulation, licensure, and professional standards of practice;

3.2.2 appropriate control of medications;

3.2.3 a patient medication dose system;

3.2.4 the review of prescriptions or orders by a pharmacist

Intent of TX.3.2.2 through TX.3.2.4

The organization develops and maintains a mechanism designed to ensure the safe and accurate

dispensing of medications; The mechanism includes a review of each prescription or order for medication, with input from the prescriber or orderer if questions arise. The mechanism also addresses a standard method for appropriately and safely labeling medications dispensed to both inpatients and outpatients. In, addition, medications are dispensed in as ready-to-administer forms as possible to minimize the need for further manipulations that introduce opportunities for error.

Because this standard is now less detailed and prescriptive, pharmacy practice standards, such as those published by the ASHP, must be consulted for contemporary interpretation.

ASHP's document, ASHP Guidelines: Minimum Standards for Pharmacies in Institutions (Am J Hosp Pharm 1985;42:372-5), states, in part:

Standard III: Drug Distribution and Control

Pharmacy personnel shall prepare all sterile products (e.g., chemotherapy injections, continuous and intermittent I.V. preparations, irrigation solutions), except in emergencies.

Another document, ASHP Technical Assistance Bulletin on Hospital Drug Distribution and Control (Am J Hosp Pharm 1980;37:1097-1103), states, in part:

The Medication System

The preparation of sterile products (e.g., I.V. admixtures, "piggy-backs," irrigations) is an important part of the drug control system. The pharmacy is responsible for assuring that all such products used in the institution are: (1) therapeutically and pharmaceutically appropriate (i.e., are rational and free of incompatibilities or similar problems). for the patient; (2) free from microbial and pyrogenic contaminants; (3) free from unacceptable levels of particulate and other toxic contaminants; (4) correctly prepared (i.e., contain the correct amounts of the correct drugs), and (5) properly labeled, stored, and distributed. Centralizing all sterile compounding procedures within the pharmacy department is the best way to achieve these goals.

Additionally, the National Coordinating Committee on Large Volume Parenterals adopted a statement (Recommended methods for compounding intravenous admixtures in hospitals. Am J Hosp Pharm 1975;32:261-70), which states, in part:

Section II D, Compounding Responsibilities

1. The compounding of LVPs (large volume parenterals) is a professional function requiring the expertise of a licensed pharmacist in all but emergency situations when a pharmacist is unavailable.

2. LVPs can usually be best prepared in a centrally located pharmacy.

There are certain advantages to having a pharmacy admixture program. A pharmacy I.V. admixture program:

1. Centralizes the responsibility for compounding, dispensing, and controlling parenteral admixtures.

2. Reduces the need for nurses and physicians to compound admixtures, providing them additional time for their professional responsibilities.

3. Standardizes the labeling of admixture solutions.

4. Provides effective control over the use of unstable, deteriorated; or outdated drugs in admixtures.

5. Provides for proper screening of incompatibilities in drug admixtures.

6. Provides the proper controlled environmental conditions during the compounding process, through the use of a laminar airflow hood.

7. Provides accuracy in the calculation of the quantity of components and the compounding process.

8. Makes possible individualized tailoring of solutions and additives to meet the specific needs of the patient.

TECHNICIAN RESPONSIBILITIES

A technician is a person skilled in a specific technical process or type of work. Many health care professions-most notably medicine, dentistry, and nursing-use supportive personnel to perform duties formerly done only by professionally trained and licensed personnel. A pharmacy technician who compounds I. V. admixtures under the direct supervision of a pharmacist is an example of how support personnel in health care organizations are assuming increasingly important roles. Several factors are contributing to an expanded role for pharmacy technicians:

1. The profession of pharmacy is moving toward the philosophy of pharmaceutical care, which is the direct, responsible provision of medication-related care for the purpose of achieving definite outcomes that improve a patient's quality of life. As the pharmacist becomes more involved in providing direct patient care, support personnel will assume many of the drug distribution responsibilities done by pharmacists.

2. A national movement supported by many pharmacy organizations favors the voluntary certification of technicians, a move that should result in more competent support personnel capable of assuming these expanded roles.

3. Many state boards of pharmacy have a more flexible attitude toward a legitimate, well-defined role for pharmacy technicians. This can be seen in the fact that several states have recognized pharmacy technicians in state board regulations and a few even permit credentialed technicians to check other technicians in limited situations.

However, in many states, the state board of pharmacy still imposes severe limitations on the activities of pharmacy technicians. Thus, technicians in some states may not be allowed to perform the procedures described in this training manual. Directors of pharmacy must investigate what limitations apply to the use of technicians in their specific situation before instituting any program using support personnel.

An I.V. admixture technician commonly performs the following duties, depending on the policies of the particular pharmacy department and the limitations imposed by the state board of pharmacy:

Prepares complete, uniform labels
Gathers and assembles drugs and solutions to be used in compounding each admixture. Reconstitutes drug additives, using appropriate aseptic technique. Compounds the admixture, using appropriate aseptic technique
Checks the admixture for clarity and presence of particulate matter
Labels the admixture, including the assignment of an expiration date
Maintains a patient profile so that admixtures can be prepared and delivered to the nursing unit when needed
Enters data, such as the admixture order, into a pharmacy computer and requests data, such as labels or profiles, from the computer system
Delivers completed admixtures to the patient care area and returns unused admixtures to the pharmacy
Restocks the admixture area
Maintains work load records
Initiates patient charges for admixtures administered and credits for admixtures returned unused
Maintains the admixture area in a neat and orderly manner

PHARMACIST RESPONSIBILITIES

A pharmacist working with a pharmacy technician is responsible for coordinating the preparation of admixtures and for supervising all activities of the technician. Responsibilities of this individual include the following duties:

Interprets physicians' orders, consulting with nursing and medical staff members when necessary. Every new admixture prescription received in the pharmacy must be checked by a registered pharmacist, inasmuch as the pharmacist has legal responsibility for the accuracy of medications dispensed from the pharmacy. Thus, a pharmacist must interpret the prescription for accuracy, dosage, rate of administration, compatibility, stability, and mathematical calculations needed.
Oversees the proper storage and handling of drugs in the I. V. admixture area .Assures that proper labeling practices are followed
Assures that technicians follow proper aseptic technique in preparing I. V. admixtures
Checks the patient profile or computer entry against the original prescription order for accuracy Checks the completed I. V. admixture for accuracy and clarity. Having assumed ultimate responsibility for accurate preparation, only a pharmacist should perform the final check of the end product. Documentation must include identification (e.g., initials) of the responsible pharmacist.
Coordinates the overall needs of the nursing and medical staffs for essential pharmaceutical services (e.g., delivery schedules, emergency admixtures, specially prepared admixtures, etc.)

PERSONAL ATTITUDE

In compounding and dispensing medications, the pharmacist's primary concerns must be safety, accuracy, and appropriateness. Both pharmacists and technicians must adhere to high standards of performance and conduct in order to provide accurate, high-quality admixture products and service.

A responsible, conscientious attitude is extremely important when preparing I. V. admixtures. Mistakes that could be harmful to the patient could easily go unnoticed unless both the pharmacist and the technician have the right attitude to guide their conduct. For example, If a pharmacist or technician suspects that he or she may have accidentally contaminated an l V. admixture, either would be obligated to discard that admixture and start over. Likewise, pharmacy managers must willingly support, rather than reprimand, a pharmacist or technician for admitting to a possible break in technique, even though it results in wasted product. In the interest of good patient care, it is imperative that all personnel involved in the preparation of I. V. admixtures d1splay a responsible, conscientious attitude toward the important work they perform.