Ashp guidelines on quality assurance for pharmacy-prepared sterile products

American Journal of Health-System Pharmacy

Volumn 57, Issue 12, 2000, Pages 1150-1169

  Buchanan, E Clyde ^a  

^a NONE

Author keywords

Administration; American society of health system pharmacists; Compounding; Control quality; Guidelines; Organization; Pharmacy institutional hospital; Quality assurance; Sterile products

Indexed keywords

DRUG;

ARTICLE; DRUG FORMULATION; DRUG INDUSTRY; DRUG QUALITY; DRUG STERILITY; DRUG STORAGE; PHARMACEUTICAL CARE; PRACTICE GUIDELINE; PRIORITY JOURNAL; PROFESSIONAL PRACTICE; QUALITY CONTROL;

EID: 0034659470     PISSN: 10792082     EISSN: None     Source Type: Journal    
DOI: 10.1093/ajhp/57.12.1150     Document Type: Article

References (127)

1. Hughes CF, Grant AF, Lick BD et al. Cardioplegic solution: a contamination crisis. J Thorac Cardiovasc Surg. 1986; 91:296-302.
2. Pittsburgh woman loses eye to tainted drugs; 12 hurt. Baltimore Sun. 1990; Nov 9: 3A.
3. ASHP gears up multistep action plan regarding sterile drug products. Am J Hosp Pharm. 1991; 48:386-90.
4. Dugleaux G, Coutour XL, Hecquard C et al. Septicemia caused by contaminated parenteral nutrition pouches: the refrigerator as an unusual cause. JPEN J Parenter Enteral Nutr. 1991; 15:474-5.
5. Solomon SL, Khabbaz RF, Parker RH et al. An outbreak of Candida parapsilosis bloodstream infections in patients receiving parenteral nutrition. J Infect Dis. 1984; 149: 98-102.
6. Food and Drug Administration. Hazards of precipitation with parenteral nutrition. Am J Hosp Pharm. 1994; 51:427-8.
7. Pierce LR, Gaines A, Varricchio R et al. Hemolysis and renal failure associated with use of sterile water for injection to dilute 25% human albumin solution. Am J Health-Syst Pharm. 1998; 55:1057,1062, 1070.
8. Flynn EA, Pearson RE, Barker KN. Observational study of accuracy in compounding i.v. admixtures at five hospitals. Am J Health-Syst Pharm. 1997; 54:904-12.
9. Santell JP, Kamalich RF. National survey of quality assurance activities for pharmacy-prepared sterile products in hospitals and home infusion facilities - 1995. Am J Health-Syst Pharm. 1996; 53:2591-605.
10. Kastango ES, Douglass K. Improving the management, operations and cost effectiveness of sterile-product compounding. Int J Pharm Compd. 1999; 3:253-8.
11. Guynn JB Jr, Poretz DM, Duma RJ. Growth of various bacteria in a variety of intravenous fluids. Am J Hosp Pharm. 1973; 30: 321-5.
12. Hasegawa GR. Caring about stability and compatibility. Am J Hosp Pharm. 1994; 51: 1533-4. Editorial.
13. Stability considerations in dispensing practice (general information chapter 1191). In: The United States pharmacopeia, 24th rev., and The national formulary, 19th ed. Rockville, MD: The United States Pharmacopeial Convention; 1999:2128-30.
14. Pharmacy compounding practices (general information chapter 1161). In: The United States pharmacopeia, 24th rev., and The national formulary, 19th ed. Rockville, MD: The United States Pharmacopeial Convention; 1999:2118-22.
15. Sterile drug products for home use (general information chapter 1206). In: The United States pharmacopeia, 24th rev., and The national formulary, 19th ed. Rockville, MD: The United States Pharmacopeial Convention; 1999:2130-43.
16. Good compounding practices applicable to state licensed pharmacies. Natl Pharm Compliance News. 1993; May:2-3, Oct:2-3.
17. Model rules for sterile pharmaceuticals. Chicago: National Association of Boards of Pharmacy; 1993:12.1-3.
18. National Advisory Group on Standards and Practice Guidelines for Parenteral Nutrition. Safe practices for parenteral nutrition formulations. JPEN J Parenter Enteral Nutr. 1998; 22:49-66.
19. Standard 3.3. Policies and procedures support safe medication prescription or ordering. In: 1999 Hospital accreditation standards. Chicago: Joint Commission on Accreditation of Healthcare Organizations; 1999:88.
20. Standard TX 5.1. Medications are prepared safely. In: 1999-2000 Comprehensive accreditation manual for home care. Chicago: Joint Commission on Accreditation of Healthcare Organizations; 1999:182.
21. Standard TX 2.3. The pharmacy organization maintains proper conditions of sanitation, temperature, light, moisture, ventilation, segregation, safety, and security for preparing medications. 1996-1998 Standards for long term care pharmacies. Chicago: Joint Commission on Accreditation of Healthcare Organizations; 1996:70-1.
22. Standard TX 3.3. Prescribing and ordering of medications follow established procedures. 1998-99 Comprehensive accreditation manual for ambulatory care. Chicago: Joint Commission on Accreditation of Healthcare Organizations; 1998:211.
23. Food and Drug Modernization Act of 1997, Pub. L. No. 105-115, 111 Stat. 2296.
24. Centers for Disease Control. Guideline for prevention of intravascular infections. Am J Infect Control. 1983; 11(5):183-93.
25. Centers for Disease Control. Guideline for handwashing and hospital environmental control. Am J Infect Control. 1986; 4(8): 110-29.
26. American Society of Hospital Pharmacists. ASHP technical assistance bulletin on handling cytotoxic and hazardous drugs. Am J Hosp Pharm. 1990; 47:1033-49.
27. American Society of Hospital Pharmacists. ASHP technical assistance bulletin on pharmacy-prepared ophthalmic products. Am J Hosp Pharm. 1993; 50:1462-3.
28. Cleanrooms and associated controlled environments - part 1: classification of air cleanliness. International standard ISO 14644-1. 1st ed. New York: American National Standards Institute; 1999.
29. Federal standard no. 209E. Airborne particulate cleanliness classes in cleanrooms and clean zones. Washington, DC: General Services Administration; 1992.
30. Microbiological evaluation of clean rooms and other controlled environments (general information chapter 1116). In: The United States Pharmacopeia, 24th rev., and The national formulary, 19th ed. Rockville, MD: The United States Pharmacopeial Convention; 1999:2009-106.
31. Validation of aseptic filling for solution drug products. Technical monograph no. 22. Philadelphia: Parenteral Drug Association; 1996.
32. Formulations: Int J Pharm Compd. 1999; 2: 297-307.
33. Buchanan EC. Policies and procedures for sterile product preparation. In: Principles of sterile product preparation. Bethesda, MD: American Society of Health-System Pharmacists; 1995:133-8.
34. Standard operating procedure of a horizontal laminar air flow hood. Int J Pharm Compd. 1997(Sep/Oct); 1:344-5.
35. Standard operating procedure for general aseptic procedures carried out at a laminar air flow workbench. Int J Pharm Compd. 1998(May/Jun); 2:242.
36. Standard operating procedure for particulate testing for sterile products. Int J Pharm Compd. 1997(Jan/Feb); 2:78.
37. Quality assurance of pharmacy-prepared sterile products. Bethesda, MD: American Society of Hospital Pharmacists; 1994. Videotape and workbook.
38. Safe handling of cytotoxic and hazardous drugs. Bethesda, MD: American Society of Health-System Pharmacists; 1990. Videotape and study guide.
39. Schneider PJ, Buchanan EC. Personnel education, training and evaluation. In: Principles of sterile product preparation. Bethesda, MD: American Society of Health-System Pharmacists; 1995:9-15.
40. Hunt ML. Training manual for intravenous admixture personnel. 5th ed. Chicago: Precept; 1995.
41. Gallagher M. Home care pharmacist competency assessment program. Am J Health-Syst Pharm. 1999; 56:1549-53.
42. Dirks I, Smith FM, Furtado D et al. Method for testing aseptic technique of intravenous admixture personnel. Am J Hosp Pharm. 1982; 39:457-9.
43. Brier KL. Evaluating aseptic technique of pharmacy personnel. Am J Hosp Pharm. 1983; 40:400-3.
44. McKinnon BT. Handling of sterile products within the pharmacy. In: Principles of sterile product preparation. Bethesda, MD: American Society of Health-System Pharmacists; 1995:111-6.
45. Morris BG, Avis KE. Quality-control plan for intravenous admixture programs. 1: Visual inspection of solutions and environmental testing. Am J Hosp Pharm. 1980; 37: 189-95.
46. Buchanan EC. Sterile compounding facilities. In: Principles of sterile product preparation. Bethesda, MD: American Society of Health-System Pharmacists; 1995:25-35.
47. Schneider PJ. Equipment for sterile product preparation. In: Principles of sterile product preparation. Bethesda, MD: American Society of Health-System Pharmacists; 1995:37-43.
48. Lau D, Share R, Yen J. Quality assurance for sterile products: simple changes can help. Am J Hosp Pharm. 1994;51:1353. Letter.
49. Rahe H, Containment Technologies Group, Inc. Personal communication. 1999 Oct.
50. Hunt ML. Training manual for intravenous admixture personnel. 5th ed. Chicago: Precept; 1995:67-70.
51. Buchanan TL, Barker KN, Gibson JT et al. Illumination and errors in dispensing. Am J Hosp Pharm. 1991; 48:2137-45.
52. Denny VF, Kopis EM, Marsik FJ. Elements for a successful disinfection program in the pharmaceutical environment. PDA J Pharm Sci Technol. 1999; 53:115-24.
53. Frieben WR. Control of the aseptic processing environment. Am J Hosp Pharm. 1983; 40:1928-35.
54. Scheckelhoff DJ. Handling, preparation and disposal of cytotoxic and hazardous agents. In: Principles of sterile product preparation. Bethesda, MD: American Society of Health-System Pharmacists; 1995: 63-9.
55. Favier M, Hansel S, Bressole F. Preparing cytotoxic agents in an isolator. Am J Hosp Pharm. 1993; 50:2335-9.
56. Mosko P, Rahe H. Barrier isolation technology: a labor-efficient alternative to cleanrooms. Hosp Pharm. 1999; 34:834-8.
57. Pilong A, Moore M. Conversion to isolators in a sterile preparation area. Am J Health-Syst Pharm. 1999; 56:1978-80.
58. Tillett L. Barrier isolators as an alternative to a cleanroom. Am J Health-Syst Pharm. 1999; 56:1433-6.
59. Bryan U, Marback RC. Laminar air flow equipment certification: what the pharmacist needs to know. Am J Hosp Pharm. 1984; 41:1343-9.
60. McKinnon BT. Personnel behavior and garb use. In: Principles of sterile product preparation. Bethesda, MD: American Society of Health-System Pharmacists; 1995: 57-62.
61. Coriell LL, McGarrity GJ, Horneff J. Medical applications of dust-free rooms: I. Elimination of airborne bacteria in a research laboratory. Am J Public Health. 1967; 57: 1824-36.
62. NIOSH recommends steps for reducing work-related exposure to latex. Am J Health-Syst Pharm. 1997; 54:1688,1691.
63. Dasher G, Dasher T. The growing problem of latex allergies. Infusion. 1996; 2(Jan):23-7.
64. Hunt ML. Techniques used in preparing intravenous admixtures. In: Training manual for intravenous admixture personnel. Chicago: Precept; 1995:87-103.
65. Scheckelhoff DJ. Use of aseptic technique. In: Principles of sterile product preparation. Bethesda, MD: American Society of Health-System Pharmacists; 1995:49-56.
66. Buchanan EC. Sterile product formulation and compounding. In: Principles of sterile product preparation. Bethesda, MD: American Society of Health-System Pharmacists; 1995:17-24.
67. Kessler DA. MedWatch: The new FDA medical products reporting program. Am J Hosp Pharm. 1993; 50:1921-36.
68. Rice SP, Gutfeld MB. Preparation of latex-safe products. Am J Health-Syst Pharm. 1998;55:1462-7.
69. Holzman RS. Latex allergy: an emerging operating room problem. Anesth Analg. 1993; 76:635-41.
70. McDermott JS, Gura KM. Procedures for preparing injectable medications tor latex-sensitive patients. Am J Health-Syst Pharm. 1997; 54:2516-7.
71. Schneider PJ. Process validation. In: Principles of sterile product preparation. Bethesda, MD: American Society of Health-System Pharmacists; 1995:121-4.
72. McKinnon BT. Factors influencing expiration dates. In: Principles of sterile product preparation. Bethesda, MD: American Society of Health-System Pharmacists; 1995: 95-103.
73. McEvoy GK, ed. AHFS drug information 99. Bethesda, MD: American Society of Health-System Pharmacists; 1999.
74. Bing C, ed. Extended stability for parenteral drugs. Bethesda, MD: American Society of Health-System Pharmacists; in press.
75. Trissel LA. Handbook on injectable drugs. 10th ed. Bethesda, MD: American Society of Health-System Pharmacists; 1998.
76. Catania PN, ed. King guide to parenteral admixtures. St. Louis, MO: King Guide; 1999.
77. American Society of Health-System Pharmacists. ASHP guidelines: minimum standard for home care pharmacies. Am J Health-Syst Pharm. 1999; 56:629-38.
78. Scheckelhoff DJ. Labeling of sterile products. In: Principles of sterile product preparation. Bethesda, MD: American Society of Health-System Pharmacists; 1995:105-9.
79. Davis NM. Optimal checking of pharmacy-prepared sterile products. Hosp Pharm. 1996; 31:102. Editorial.
80. Schneider PJ. End-product evaluation. In: Principles of sterile product preparation. Bethesda, MD: American Society of Health-System Pharmacists; 1995:125-8.
81. Meyer GE, Novielli KA, Smith JE. Use of refractive index measurement for quality assurance of pediatric parenteral nutrition solutions. Am J Hosp Pharm. 1987; 44: 1617-20.
82. Scheckelhoff DJ. Handling of sterile products outside the pharmacy. In: Principles of sterile product preparation. Bethesda, MD: American Society of Health-System Pharmacists; 1995:117-20.
83. Chamallas SN, Fishwick JJ, Riesenberg M. Special delivery, keeping the product stable during shipping. Infusion. 1997; 4(3):30-2.
84. McKinnon BT. Documentation of sterile product preparations. In: Principles of sterile product preparation. Bethesda, MD: American Society of Health-System Pharmacists; 1995:129-31.
85. Schumock GT, Kafka PS, Tormo VJ. Design, construction, implementation, and cost of a hospital pharmacy cleanroom. Am J Health-Syst Pharm. 1998; 55:458-63.
86. Gianino RR. Misconceptions about cleanrooms. Am J Hosp Pharm. 1994;51:239-40. Letter.
87. Fundamentals of a microbiological environmental monitoring program. Technical report no. 13. Philadelphia: Parenteral Drug Association; 1990.
88. Whyte W. In support of settle plates. PDA J Pharm Sci Technol. 1996; 50:201-4.
89. Hyde HA. Origin of bacteria in the clean room and their growth requirements. PDA J Pharm Sci Technol 1998; 52:154-8.
90. ASHP guidelines on the safe use of automated compounding devices for the preparation of parenteral nutrition admixtures. Am J Health-Syst Pharm. In press.
91. Davis NM. Unprecedented procedural safeguards needed with the use of automated iv compounded. Hosp Pharm. 1992; 27:488. Editorial.
92. Murphy C. Ensuring accuracy in the use of automatic compounders. Am J Hosp Pharm. 1993; 50:60. Letter.
93. Dickson LB, Somani SM, Herrmann G et al. Automated compounder for adding ingredients to parenteral nutrient base solutions. Am J Hosp Pharm. 1993; 50:678-82.
94. Fishwick JJ, Murphy CC, Riesenberg MC et al. Weight-based accuracy of parenteral nutrient solutions prepared with an automated compounder. Am J Health-Syst Pharm. 1997; 54:678-9.
95. Johnson R, Coles BJ, Tribble DA. Accuracy of three automated compounding systems determined by end-product laboratory testing and comparison with manual preparation. Am J Health-Syst Pharm. 1998; 55: 1503-7.
96. Combeau D, Rey JB, Rieutord A et al. Accuracy of two filling systems for parenteral nutrient solutions. Am J Health-Syst Pharm. 1998; 55:1606-10.
97. Boylan JC. Essential elements of quality control. Am J Hosp Pharm. 1983; 40:1936-9.
98. McKinnon BT. Preparation and sterilization of batch compounds. In: Principles of sterile product preparation. Bethesda, MD: American Society of Health-System Pharmacists; 1995:71-7.
99. McKinnon BT. Batch preparation documentation. In: Principles of sterile product preparation. Bethesda, MD: American Society of Health-System Pharmacists; 1995: 79-94.
100. Lima HA. Required documentation for home infusion pharmacies - compounding records. Int J Pharm Compd. 1998; 2:354-9.
101. Avis KE. Assuring the quality of pharmacy-prepared sterile products. Pharmacopeial Forum. 1997; 23:3567-76.
102. Fontan JE, Arnaud P, Brion F. Laminar-airflow ceiling in a hospital pharmacy cleanroom. Am J Health-Syst Pharm. 1998; 55:182-3. Letter.
103. Chandler SW, Trissel LA, Wamsley LM et al. Evaluation of air quality in a sterile-drug preparation area with an electronic particle counter. Am J Hosp Pharm. 1993; 50:2330-4.
104. Schneider PJ. Environmental monitoring. In: Principles of sterile product preparation. Bethesda, MD: American Society of Health-System Pharmacists; 1995:45-8.
105. Bacterial endotoxins test (general tests and assays chapter 85). In: The United States pharmacopeia, 24th rev., and The national formulary, 19th ed. Rockville, MD: The United States Pharmacopeial Convention; 1999:1829-31.
106. Roberts JH, Wilson JD. Technical report no. 26: sterilizing filtration of liquids. PDA J Pharm Sci Technol. 1998; 52(suppl S1):1-31.
107. Akers MJ. Sterilization and depyrogenation: principles and methods. Int J Pharm Compd. 1999; 3:263-9.
108. Pyrogen test (general tests and assays chapter 151). In: The United States pharmacopeia, 24th rev., and The national formulary, 19th ed. Rockville, MD: The United States Pharmacopeial Convention; 1999: 1850-1.
109. Aspects of container/closure integrity. Technical information bulletin no. 4. Philadelphia: Parenteral Drug Association; 1983.
110. Neidich RL. Selection of containers and closure systems for injectable products. Am J Hosp Pharm. 1983; 40:1924-7.
111. Validation of steam sterilization cycles. Technical information bulletin no. 1. Philadelphia: Parenteral Drug Association; 1978.
112. Turco S, ed. Sterile dosage forms: their preparation and clinical application. Philadelphia: Lea & Febiger; 1994:57-78.
113. McKinnon BT, Avis KE. Membrane filtration of pharmaceutical solutions. Am J Hosp Pharm. 1993; 50:1921-36.
114. Eudailey WA. Membrane filters and membrane filtration processes for health care. Am J Hosp Pharm. 1983; 40:1921-3.
115. Wilson JD. Aseptic process monitoring - a better strategy. PDA J Pharm Sci Technol. 1999; 53:111-4.
116. Sterility tests (general tests and assays chapter 71). In: The United States pharmacopeia, 24th rev., and The national formulary, 19th ed. Rockville, MD: The United States Pharmacopeial Convention; 1999:1818-23.
117. Choy FN, Lamy PP, Burkhart VD et al. Sterility-testing program for antibiotics and other intravenous admixtures. Am J Hosp Pharm. 1982; 39:452-6.
118. Doss HL, James JD, Killough DM et al. Microbiologic quality assurance for intravenous admixtures in a small hospital. Am J Hosp Pharm. 1982; 39:832-5.
119. Posey LM, Nutt RE, Thompson PD. Comparison of two methods for detecting microbial contamination in intravenous fluids. Am J Hosp Pharm. 1981; 38:659-62.
120. Akers MJ. Progress toward a preferred method of monitoring the sterility of intravenous admixtures. Am J Hosp Pharm. 1982; 39:1297. Editorial.
121. Hoffman KH, Smith FM, Godwin HN et al. Evaluation of three methods for detecting bacterial contamination in intravenous solutions. Am J Hosp Pharm. 1982; 39:1299-302.
122. Miller CM, Furtado D, Smith FM et al. Evaluation of three methods for detecting low-level bacterial contamination in intravenous solutions. Am J Hosp Pharm. 1982; 39:1302-5.
123. DeChant RL, Furtado D, Smith FH et al. Determining a time frame for sterility testing of intravenous admixtures. Am J Hosp Pharm. 1982; 39:1305-8.
124. Bronson MH, Stennett DJ, Egging PK. Sterility testing of home and inpatient parenteral nutrition solutions. JPEN J Parenter Enteral Nutr. 1988; 12:25-8.
125. Levchuk JW, Nolly RJ, Lander N. Method for testing the sterility of total nutrient admixtures. Am J Hosp Pharm. 1988; 45:1311-21.
126. Akers MJ, Wright GE, Carlson KA. Sterility testing of antimicrobial-containing injectable solutions prepared in the pharmacy. Am J Hosp Pharm. 1991; 48:2414-8.
127. Murray PR, Sandrock MJ. Sterility testing of a total nutrient admixture with a biphasic blood-culture system. Am J Hosp Pharm. 1991; 48:2419-21.