USP <797>: Making the Case for Increasing Environmental Controls in Pharmaceutical Compounding. By Eric S. Kastango, M.B.A., R.Ph.

Transcription

1 USP <797>: Making the Case for Increasing Environmental Controls in Pharmaceutical Compounding By Eric S. Kastango, M.B.A., R.Ph., FASHP SUPPORTED BY AN UNRESTRICTED EDUCATIONAL GRANT FROM HOSPIRA, INC. Modified from the original breakfast symposium held during the NHIA 14th Annual Conference on February 13, 2005 at the Hilton Riverside Hotel, New Orleans.

2 TABLE OF CONTENTS Impact of USP <797> 3 Professional Responsibility 4 What is Risk? 5 Engineering Controls vs. Work Practices 6 Strategies for Reducing Risk: Starting at the Top 8 Conclusion 8 References 9 CE Test 10 This NHIA supplement is co-sponsored by the National Community Pharmacists Association. NCPA is approved by the Accreditation Council on Pharmaceutical Education as a provider of continuing pharmaceutical education. NCPA has assigned 1.0 contact hours (0.01 CEUs) of continuing education credits to this supplement. Eligibility to receive continuing education credit for this supplement expires three years from the month published. The universal program number for this program is H01. CONTINUING EDUCATION OBJECTIVES After reading this monograph the pharmacist should be able to: Discuss the significance of USP Chapter <797> on the infusion pharmacy profession Describe the differences in risk for different sterile preparations Review the underlying rationale for reducing the number of manipulations made while compounding sterile preparations Discuss strategies for reducing sterile compounding risk level 2

3 O ver the past year, the pharmacy profession has been trying to comprehend the magnitude of changes brought about by United States Pharmacopeia (USP) Chapter <797> Pharmaceutical Compounding-Sterile Preparations, published in the Fall of 2003 and effective January 1, The chapter addresses the compounding, preparation, and labeling of sterile drug preparations and applies to all organizations that compound sterile preparations, including health care institutions, home infusion pharmacies, and other facilities. Many infusion pharmacists believed that the chapter, and the fact that it is now enforceable by state boards of pharmacy, was unnecessary. Because so few patients experienced problems with the compounded sterile preparations (CSPs) prepared in infusion pharmacies, most pharmacists in our sector felt that they were already fulfilling their responsibility to ensure the sterility, safety, and efficacy of these preparations. However, in recent years, isolated published reports of patient injury and death related to improperly compounded CSPs have brought increased attention to compounding pharmacies both from inside and outside the profession. These reports have prompted state, federal, and professional organizations to examine the adequacy of the current framework of standards pertaining to CSPs. This movement along with an increased national focus on patient and medication safety were driving forces in the USP s efforts to define a standard of practice that would benefit the health and safety of patients receiving CSPs. In fact, the preamble of Chapter <797> states that, the intent of this chapter is to prevent harm and fatality to patients that could result from microbial contamination (non-sterility), excessive bacterial endotoxins, large content errors in the strength of correct ingredients and incorrect ingredients in CSPs. 1 As expected, the most sensational side of compounding mishaps are what makes national headlines. But, these incidents are only the headlines that make it to press. How many near-misses have occurred but are never reported? Almost any practicing pharmacist knows of at least one, but the true magnitude of this problem is not known and may never be because there is no reporting requirement. Further complicating the issue are recent rare incidents of contamination that result from unlikely pathogenic microorganisms that are not commonly associated with human illness. For example, Exophiala dermatitidis, a fungus found in soil, was the causative microorganism in a contamination incident at a South Carolina pharmacy. As a result, patients contracted fungal meningitis 152 days after injection of the contaminated CSP. 2 Just because incidents like this haven t happened in your practice, doesn t mean that they can t. Over the past decade, infusion pharmacies have used a wide range of resources to guide the preparation of CSPs, including professional practice guidelines published by the American Society of Health-System Pharmacists (ASHP Guidelines on Quality Assurance for Pharmacy-Prepared Sterile Products) and the United States Pharmacopeia (USP <1206>, "Sterile Drug Products for Home Use"); national accreditation standards of the Joint Commission on Accreditation of Healthcare Organizations (JCAHO), the Accreditation Commission for Healthcare (ACHC), and the Community Health Accreditation Program (CHAP); and, where applicable, state laws governing pharmacy practice. 3,4 While adherence to these professional standards have served the majority of patients well, compliance with USP <797> is an important next step in ensuring safety and efficacy of CSPs. Perhaps Institute for Safe Medication Practices President Michael Cohen, M.S., D. Sc., F.A.S.H.P., said it best: "Unfortunately, there are too many in health care who feel that if it hasn't happened to them, the adverse experiences of others do not apply. PROFESSIONAL RESPONSIBILITY It is critical that pharmacy personnel (pharmacists and technicians) clearly understand that they are professionally and personally responsible for the sterility and accuracy (quality) of CSPs. The best way to meet that responsibility is to be knowledgeable in the state-of-the-art and current standards of practice, and to follow these standards meticulously. Many aspects of USP <797> are vague in detailing the activities required to meet standards in areas such as proper environmental monitoring, employee training, and cleaning and sanitizing. However, since 1999, there have been a number of journal articles, book chapters, multimedia training tools, and educational programs offered to help those working with CSPs gain the necessary insight and skills to successfully meet the chapter requirements. The major barrier to recognizing the inherent risk of contamination in CSPs is a combination of pride, ignorance, and resistance to change. This attitude is unfounded and must be overcome. In fact, numerous studies have demonstrated that contamination errors can occur even in the most professional compounding environment even the slightest error rate can become dangerous when multiplied by voluminous doses and patients served. For example, in a multi-hospital study that examined compounding errors, researchers found that nine out of every 100 compounded sterile preparations were prepared incorrectly and that one of these incorrectly prepared CSPs posed a substantial risk to patient health. 5 Another study of medium-risk level asep- 3

4 tic technique manipulation testing at MD Anderson Cancer Center found a contamination rate of just over five percent (5.2%). 6 In that case, the poor technique of the compounding personnel could lead to the contamination of 52 out of every 1,000 CSPs, posing a serious health and safety risk to patients. When considering the quantities of CSPs prepared each day in such facilities, the potential for patient risk should not be ignored. Exhibit 1 RISK LEVELS ASSOCIATED WITH COMPOUNDED STERILE PREPARATIONS Ingredient: CSP relationship One to one (1:1) One to many or Many to one (1: ) or ( :1) # of components > 3 Any ingredient-csp relationship using non-sterile ingredients and/or devices radiation or a CSP that requires terminal sterilization (filtration, steam, heat, gas or ionizing radiation) Source: Clinical IQ, LLC WHAT IS RISK? The published risk schema of USP <797>, with low-, medium-, and high-risk levels, is based on the inherent risk of a CSP becoming contaminated or being incorrectly prepared (see Exhibit 1). The risks are greatly affected by a number of factors, which include but are not limited to: Ingredients - sterile vs. non-sterile Compounding methods - simple aseptic manipulations vs. multiple and complex manipulation The relationship between the ingredients used and the number of CSPs prepared Methods of sterilization The environment - International Organization of Standardization (ISO) Class 7 clean room and ISO Class 8 ante- Risk Level Examples Comments Low-Risk Compounding Medium-Risk Compounding High-Risk Compounding Reconstitution and transfer of a 1-gram vial of cefazolin into a syringe or minibag A bulk 10-gram vial of vancomycin distributed amongst several final doses The combination of several ingredients (>3) into one final dose (TPN) Alum bladder irrigation Patient-controlled analgesia (PCA) or epidural from powdered morphine Hydromorphone A majority of compounding that is performed in hospitals and home care occurs as either low- or mediumrisk level compounding. A small percent of CSPs fall into this category. Great care must be taken when working within this risk level. room) and engineering controls, such as laminar airflow workbenches (LAFWs), biological safety cabinets (BSCs), or barrier isolators, used during the preparation of compounding sterile preparations By understanding the risk schema, pharmacy personnel can be better aware of the methods and techniques needed to ensure the accuracy and sterility of the final compounded preparation. Most compounding is performed by humans rather than by automated machinery, 4

5 so properly trained and educated pharmacy personnel are the first and best line of defense against dangerous CSPs. Conversely, the same personnel can be a significant liability if they remain unaware of the points of failure for each compounding method. Since touch is such a significant source of contamination, it is important to understand that the greater number of aseptic manipulations occurring during any compounding procedure, the greater the risk of contamination. Employee work practices also appear to have a significant influence on sterility and incidence of contamination. Unpublished studies have shown that if compounding personnel follow a systematic method of routinely sanitizing their gloved hands initially and throughout the compounding procedure and properly sanitize and wipe down the source component containers prior to placing them into the ISO Class 5 compounding area, the rate of contamination can be greatly reduced. This phenomenon was also observed with the use of aseptic procedures, such as a basic 30-second skin scrub, prior to performing venipuncture procedures. 7 ENGINEERING CONTROLS VS. WORK PRACTICES Practitioners have two primary options in achieving the desired level of contamination control: control the compounding environment or control the people who work in the environment. The best option is to control both. Controlling the environment entails the use of properly constructed and applied primary and secondary engineering controls to create a setting that has a regulated number of particles and performs at a known level of cleanliness (see Exhibit 2). This level of cleanliness has been demonstrated in many industries outside of pharmacy to have a positive influence on contamination control within a room. Until passage of USP <797>, there were few published and/or standardized requirements for pharmacists and technicians working in clean rooms and anterooms. However, good pharmacy practice has dictated the use of ISO-Class primary engineering controls, such as LAFWs, BSCs, and barrier isolators, when compounding sterile preparations. Building and maintaining a clean room (secondary engineering control) can be a significant capital investment. Unfortunately at this time, few peer-reviewed studies demonstrate the need for or can justify the cost of properly designed and constructed clean rooms. Now, under USP <797>, which dictates that CSPs be prepared in an ISO Class 5 primary engineering control located in an ISO 7* clean room, such engineering controls will become standard pharmacy practice. Exhibit 2 PRIMARY AND SECONDARY ENGINEERING CONTROLS EXAMPLES OF PRIMARY ENGINEERING CONTROLS Laminar Airflow Workbenches (LAFWs) Horizontal or Vertical airflow Biological Safety Cabinets (BSCs) Barrier Isolators Positive Pressure Unidirectional airflow Turbulent airflow Negative Pressure Unidirectional airflow Turbulent airflow EXAMPLES OF SECONDARY ENGINEERING CONTROLS ISO Class 7 clean room with ISO Class 8 anteroom, characteristics include: Pre-defined levels of air cleanliness (number of particles per cubic meter of air) Number of air exchanges Room pressurization Source: ISO

6 Exhibit 3 GOWNING AREA PARTICLE GENERATORS Activity Person emits during garmenting process Cleanest skin (hands) Employee street clothes Floor and bench surfaces No. of particles (>= 0.3µm) 3,000,000/min. 10,000,000/ft2 10,000,000 to 30,000,000/ft2 >10,000,000/ft 2 Garments supplied by clean room laundry 1,000,000/ ft 2 Source: Encyclopedia of Clean Rooms, Bio-Clean Rooms and Aseptic Areas, Dr. Philip Austin, P.E., 2000 Barrier isolators are also mentioned in <797> as a viable alternative to clean rooms. It is important to note that the effectiveness of these devices can depend on construction and design, making them far from the panacea that many believe them to be. Barrier isolators have been used for more than 20 years in Europe but not without incident. When considering barrier isolators, research is strongly recommended. The Controlled Environment Testing Association (CETA; has published an excellent resource guide, CETA Applications Guide for the use of Barrier Isolators in Compounding Sterile Preparations in Healthcare Facilities, that provides valuable information about the different types of barrier isolators, airflow characteristics (unidirectional vs. turbulent airflow) and construction characteristics, such as high-efficiency particulate air (HEPA)-filtered, pressurized passthroughs versus static, non-pressurized and HEPA-filtered pass-throughs. Compounding personnel working within a clean room or controlled environment contribute the greatest amount of contamination through the natural shedding of skin, fiber, and other particles. Exhibits 3 and 4 demonstrate the number of particles inherent in the human organism and the number of particles emitted during movement within the clean room. At the same time, pharmacy personnel can also exercise the greatest amount of control over the compounding environment, by consistently using proper technique. Understanding proper technique and incorporating each step into daily work practices, requires thorough and ongoing training and evaluation. Effective training employs three strategies: 8 Didactic education with knowledge validation (graded test) Psychomotor skill assessment (observed behavior) Aseptic media fill verification via suitable growth medium (trypticase soy broth, TSB) Training should not only focus on aseptic technique but principles of contamination control, personal hygiene (hand washing), gowning and gloving, pharmaceutical calculations, documentation practices, and work practices. Proper garbing technique (hair covers, face masks, gowns, gloves, and shoe covers) is required to prevent viable and non-viable particles generated by the person from negatively affecting the quality of the CSP. In addition to proper garbing techniques, proper employee work practices are critical to ensure sterility. Examples of proper employee work practices include but are not limited to: When using a barrier isolator, allow the pass-through chamber to recover (purge the dirty air introduced dur- 6

7 Exhibit 4 AUSTIN CONTAMINATION INDEX Particles >= 0.3µm emitted per minute in garment indicated Personnel Activity Snap Smock Standard Coverall Two-Piece Coverall Tyvek Coverall Membrane Coverall No Movement 100,000 10,000 4,000 1, Light Movement 500,000 50,000 20,000 5, Heavy Movement 1,000, ,000 40,000 10, Change Position 2,500, , ,000 25, Slow Walk 5,000, , ,000 50, Fast Walk 10,000,000 1,000, , ,000 1,000 Source: Encyclopedia of Clean Rooms, Bio-Clean rooms and Aseptic Areas, Dr. Philip Austin, PE, 2000 Note: Light/heavy movement refer to partial body movements (motioning with arm, tapping toes, etc.). Change of position refers to whole body motion (standing up, sitting down, etc.). ing the stocking phase) by waiting 45 seconds, or a time recommended by the manufacturer, prior to moving the supplies into the main compounding chamber Wiping down the surfaces of vials, bottles, bags, totes (non-paper-based packaging items) with isopropyl alcohol, 1% bleach, 3% hydrogen peroxide, or another suitable disinfecting agent prior to placing them in the immediate and critical compounding area Sanitizing gloved hands with isopropyl alcohol or another suitable cleaning agent immediately after gloving and frequently throughout the compounding process (especially after removing hands from the ISO Class 5 area Discarding a CSP if touch contamination is suspected during compounding when in doubt, throw it out. STRATEGIES FOR REDUCING RISK: STARTING AT THE TOP While employee controls can be effective in reducing the risk of contamination, the emphasis on good work practices must originate with management. The U.S. Food and Drug Administration (FDA) stresses the importance of management on quality in the following statement: The quality system should be an integrated effort a total systems approach, to satisfy the particular safety and performance needs of a specific manufacturer, product, and user-market. The quality assurance (QA) activities do not simply consist of inspection and testing spot solutions or "fire-fighting, no matter what the product is or how small the manufacturer. In all cases, quality should be considered at the earliest stages in every significant area that has an effect on the quality, safety, and effectiveness of the device. These areas include product development, design verification and validation, component and/or supplier selection, documentation, development of labeling, design transfer, process development and validation, pilot production, routine manufacturing, test/inspection, device history record evaluation, distribution, service or repair, and complaints. 7

8 Exhibit 5 RISK PYRAMID FOR COMPOUNDED STERILE PREPARATIONS High-Risk CSPs from nonsterile components or devices Source: Clinical IQ, LLC Medium-Risk Automated Compounding Devices Low-Risk Proprietary bag systems (e.g. ADD-Vantage ) NO-RISK Pre-mixed or RTU sterile dosage units (premixes, syringes, bags) Most important of all is management commitment. Management and employees should have the correct attitude if their quality system program is to be effective. Quality consciousness should be developed in every employee. Each person should be made aware of the importance of his or her individual contributions in the overall effort to achieve an acceptable level of quality. 9 It is only management that has the authority to bring about change in the quality system and the management of the quality system. 10 JCAHO and ACHC assert this concept through their survey requirements that all pharmacies (including infusion pharmacies) comply with USP <797>. In each instance, leaders from accredited organizations must review and approve their pharmacy s gap analysis, action plan, and supporting budget for achieving compliance. Without commitment, true changes cannot be achieved and a return to status quo and aseptic mediocrity is likely to occur. Such malaise will only continue to place patients at risk. Since risk is associated with the complexity and number of aseptic manipulations, reducing both factors (when possible or feasible) will positively affect the quality of the CSP. Exhibit 5 shows ways to minimize risk. *Current USP <797> requirements call for ISO Class 8 but revisions have been propposed to increase the cleanliness requirement of the clean rooms to ISO Class 7. CONCLUSION Pharmacists and technicians have a tremendous array of intellectual resources to assist them in improving patient care and reducing risks associated with compounding sterile preparations. But first, there needs to be an understanding and acceptance of the clear link between the activities of compounding personnel and the incidence of CSP contamination. As such, the people who can have the greatest impact on the quality of CSPs, the pharmacy personnel, must have access to the resources that can guide and improve the safety of the compounding process. The pharmacy profession must also accept that not all of the requirements stipulated in USP <797> can be supported by evidence-based science at this time. However, such requirements can be supported and are self-evident in all other industries where asepsis and the principles of contamination control are required the reasoning behind USP s setting its standards at this level. Waiting for irrefutable proof that clean rooms are needed or to fully determine the value of environmental monitoring is not an option. Media reports of patient injury and death related to contaminated CSPs as well as the number of undocumented near-misses should be enough to support instituting controls that reduce risk of contamination on behalf of the patient. When contemplating the need to act, ask yourself if you would be willing to administer a CSP prepared by you or a colleague on yourself or a loved one? 8

9 ABOUT THE AUTHOR Eric Kastango, M.B.A., R.Ph., FASHP, earned a B.S. in Pharmacy from the Massachusetts College of Pharmacy and Allied Health Sciences and an M.B.A. from the University of Phoenix. Since 1980, he has practiced pharmacy in a number of practice settings (hospitals, community, and home care) and in a number of different of roles, including the Corporate Vice President of Pharmacy Services for Coram Healthcare Corporation, which has 72 pharmacies in 44 states. He also managed an FDA-registered cgmp manufacturing operation for Baxter Healthcare Corporation. In 1999, Kastango founded Clinical IQ, LLC, based in Florham Park, New Jersey. Clinical IQ consults with a variety of clients requiring expertise in the area of aseptic processing (pharmacy and pharmaceutical-based), medical device manufacturing, and the implementation of extemporaneous compounding quality systems. Kastango is a Fellow of the American Society of Health-System Pharmacists (ASHP), has served on ASHP s Council of Education Affairs, has served as a pharmacy surveyor for the Accreditation Commission for Health Care (ACHC), and is a member of the NHIA Standards and Accreditation Committee. He lectures nationally on a variety of pharmacy practice topics such as sterile product preparation, pharmacy compounding errors, quality systems, collaborative pharmacy/nursing practice models, tocolytic therapy and on the pharmacist s role in the evaluation of therapeutic effectiveness of drug therapy. Kastango is also the author of the ASHP Discussion Guide on Sterile Preparation: Summary and Implementation of USP Chapter <797>, and the ASHP Sterile Product Preparation CD-ROM: A Multimedia Learning Tool, and the ASHP web-based <797> Compliance Advisor Gap Analysis Tool. He is also a contributing author of three chapters for the Second Edition of Compounding Sterile Preparations, the Sterile-Product Preparation Section Editor for the International Journal of Pharmaceutical Compounding, and publishes in the field of sterile product preparation. REFERENCES 1. The United States Pharmacopeia, 27th rev., and the National Formulary 22nd ed. USP Chapter General Chapter <797>: Pharmaceutical Considerations: Sterile Preparations. The United States Pharmacopeial Convention, 2004: Exophiala Infection from Contaminated Injectable Steroids Prepared by a Compounding Pharmacy United States, July November Centers for Disease Control, MMWR Weekly, December 13, 2002 / 51(49); American Society of Health-System Pharmacists (ASHP). ASHO Guidelines on quality assurance for pharmacy-prepared sterile products. Am J Hosp Pharm. 200;57: Sterile drug products for home use (USP Chapter <1206>). In: Unites States Pharmacopeia, 26th rev./national formulary, 21st ed. Rockville, MD: United States Pharmacopeial Convention; 2004: Flynn, EA, Pearson, RE, Barker, KN. Observational study of accuracy in compounding IV admixtures at five hospitals. Am J Health-Syst Pharm Apr 15; 54: Trissel, LA, Gentempo, JA, Anderson, RA, Lajeunesse, JD. Using a medium-fill simulation to evaluate the microbial contamination rate for USP medium-risk-level compounding. Am J Health-Syst Pharm. 2005; 62: Hughes JM. SENIC Project. Chemotherapy 1988;34: Eudy, J. Ask Jan: Increasing the Level of Contamination Control. A2C2 Magazine, February 2005 (8)34. Available online: Accessed April 27, Code of Federal Regulations, Title 21, Part 820, Part 2, Quality Systems. 10. Deming, W. E Out of the Crisis. Cambridge, MA. Massachusetts Institute of Technology Center for Advanced Engineering Study. Pg

10 USP CHAPTER <797>: MAKING THE CASE FOR INCREASING ENVIRONMENTAL CONTROLS IN PHARMACEUTICAL COMPOUNDING Continuing Education Assessment Questions 1. The reason why the pharmacy profession does NOT consistently follow proper aseptic processing procedures is because? A. It is commonly believed that the incidence of contaminated pharmacy-prepared sterile products is negligible B. The presence of bacteria is not a problem when using an ISO Class 5 (Class 100) laminar airflow hood C. Professional pharmacy-related organizations have not published guidelines on how to prepare sterile products properly D. The boards of pharmacy in all states highly regulate the practice of sterile compounding 2. All of the following categories of information are addressed in USP Chapter <797> except: A. The costs associated with sterile product quality assurance B. Appropriate quality assurance measures based on risk level of the preparation C. Media-fill verification of personnel technique and process adequacy D. Responsibilities of compounding personnel E. Appropriate facility requirements based on risk level 3. Gloves only need to be worn when compounding highrisk CSPs. A. True B. False 4. How does limiting the movement of people in the controlled environment contribute to ensuring an environment is appropriate for compounding of sterile preparations? A. Increases the aseptic responsibility of a smaller number of people B. Decreases the introduction of viable and nonviable particles that can adversely affect CSP quality C. Increases the generation of particles because of excessive aseptic manipulations required by fewer people D. Decreases the amount of heat generated by personnel movements, which has a beneficial effect on the aseptic environment AUGUST 2005 Expires AUGUST Which of the following is the engineering control configuration recommended in USP <797> when compounding high-risk level CSPs? A. An ISO Class 5 engineering control (LAFW) in an ISO Class 7 buffer zone physically separated from the ISO Class 8 anteroom. B. An ISO Class 5 engineering control (LAFW) in an ISO 8 room that has a line of demarcation separating the ante area from the buffer zone C. An ISO Class 5 engineering control (LAFW) in an ISO 7 room that has a line of demarcation separating the ante area from the buffer zone D. An ISO Class 5 engineering control (LAFW) in an unclassified area (no ISO class rating) 7. What organization published the September 2004 NIOSH Alert: Preventing Occupational Exposures to Antineoplastic and Other Hazardous Drugs in Healthcare Settings? A. FDA B. USP C. CDC D. JCAHO 8. The following is considered a Primary engineering control: A. Horizontal and vertical laminar airflow workbenches B. Barrier isolator C. Clean room D. All of the above E. A) and B) only 9. USP <797> risk levels allow for the categorization of sterile product preparation by: A. Matching components and compounding procedures to the type of product being prepared B. Establishing product stability without conducting sterility tests C. The potential dangers or risks associated with microbial contamination of the CSP D. All of the above E. None of the above 5. Choose the incorrect statement regarding movement of compounding supplies and medications into the clean room: A. Supplies should be removed from cardboard packing prior to entry into the clean room B. Medication vials entering the clean room must be sanitized prior to entry with suitable disinfection agent C. Supply carts may be rolled directly from the pharmacy warehouse, through the anteroom and into the clean room D. All items stored in the clean room must be wiped down at least once weekly with an appropriate disinfecting agent 10. Which of the following quality measurements for compounding sterile preparations is considered by experts as the most important process for adherence to USP Chapter <797> requirements? A. Training and evaluation of compounding personnel B. Sterility testing of CSPs, regardless of risk level C. Barrier isolator technology D. NIOSH Alert on compounding of hazardous drugs Copyright 2005 NHIA 10

11 USP CHAPTER <797>: MAKING THE CASE FOR INCREASING ENVIRONMENTAL CONTROLS IN PHARMACEUTICAL COMPOUNDING Continuing Education Credit AUGUST 2005 Expires AUGUST 2008 To earn pharmacy continuing education credit: ACPE Program H01 1. A score of 70% is required to successfully complete the C.E. quiz. Failure to achieve a passing score will result in one free re-examination. Please allow at least four weeks for notification of scores and issuance of C.E. certificates. 2. Record your quiz answers and the following information on this form NHIA Member # License # State Nonmember License # State 3. Mail this form to: NHIA, 100 Daingerfield Road, Alexandria, VA or fax to: Name Company Name Address City State Zip Phone Fax Soc. Sec. No. Date Quiz Taken Quiz: Shade In Your Choice This monograph is co-sponsored by the National Community Pharmacist Association. NCPA is approved by the Accreditation Council on Pharmaceutical Education as a provider of continuing pharmaceutical education. NCPA has assigned 1.0 contact hours (0.1 CEUs) of continuing education credits to this module. Eligibility to receive continuing education credit for this module expires three years from the month published. A B C D E Circle your choice 11.Is this program used to meet your mandatory C.E. requirements? A. Yes B. No 12. Job description A. Owner B. Manager C. Employee 13.Age Group A B C D E. Over How long have you been practicing as a home infusion pharmacist? A. 2 years or less B. 5 years or less C. 10 years or less D. More than 10 years 15. Did this module achieve its stated objectives? A. Yes B. No 16. How much of this program can you apply in practice? A. All B. Some C. Very little D. None 17. How long did it take you to complete both the reading and the quiz? minutes Copyright 2005 NHIA 11

12 This publication is a supplement to (ISSN ), the monthly journal of the National Home Infusion Association, 100 Daingerfield Road, Alexandria, VA ( ). Originally published in July/August 2005 (Vol. 11, Number 4) copyright 2005 by NHIA.