- Email: [email protected]
Sterility of intravenous therapy in home care settings
When Patients Ask Omudhome
Ogbru, PharmD
Sterility of Intravenous Therapy in Home Care Settings Providing sterile parenteral therapy for patients in home care settings has been an option for clinicians for two decades.“’ Initially, home intravenous therapy was prepared only by pharmacists in carefully controlled environments or by nurses in the patient’s home using strict aseptic techniques. Today, patients or their caregivers may be responsible for preparing parenteral products for home administration.
he provision of home parenteral therapy by home health care pharmacists includes several alternatives, such as reconstituting sterile drug products, preparing large volume parenteral products, or providing the components of parenteral therapy to be prepared by the patient or caregiver at home. Each of these alternatives has a different risk level for the introduction of microbial contamination, so different procedural guidelines are needed. The use of guidelines help ensure the sterility of parenterals at home as an important aspect of quality assurance (QA) and infection control.
T
The following information is provided to highlight several published guidelines from the pharmacy literature related to providing parenteral therapy to patients in their homes. USP GUIDELINES In I 994, the United States Pharmacopeia (USP) published new guidelines and standards for parenteral products administered in the patient’s home.3 These procedures were further modified and published in USP 23.” Typical procedures reported by USP 23 that are necessary to prepare and dispense sterile drug products intended for home use include: l
l
Validation
of sterilization
and aseptic process
Quality and control of environmental operations
l
Personnel training
l
Aseptic techniques
l
Finished product testing
l
Storage and expiration
l
Control
l
Patient or caregiver training
l
Patient monitoring
l
QA program
conditions
dating
of product quality beyond the pharmacy
and complaints
FEBRUARY 1999, VOL. 4 NO. 1
for aseptic
According to USP 23,’ the pharmacist who dispenses any home-use sterile product is responsible for ensuring that the product has been prepared, labeled, controlled, stored, dispensed, and distributed properly. This duty includes ensuring that the product is kept under appropriate controlled conditions at the location of use and is administered properly through adequate labeling and verbal or written instructions. The dispensing pharmacist also is responsible for ensuring that the product retains its quality attributes within acceptable limits through a written QA program. This program should ensure that, for the entire labeled life of the product or until manipulated by the patient or caregiver, the potency, pH, sterility, freedom from pyrogens, particulate limits, container integrity, appearance, and other qualities or characteristics that the home-use sterile drug is expected to have do exist. The QA program should encompass every home-use sterile drug under the pharmacy’s control and include all phases of its preparation, distribution, storage, administration, and use. The dispensing pharmacy should use proper analytical testing where appropriate to ensure the microbiologic, chemical, and physical quality of all home-use sterile drugs. These responsibilities apply equally to commercially available injectable drug products that are dispensed to patients without compounding or other manipulation and to home-use sterile drugs that have been repackaged, reconstituted, diluted, admixed, blended, or otherwise manipulated (collectively referred to as “compounded”) in any way before dispensingP ASHP GUIDELINES The American Society of Health-System Pharmacists (ASHP) routinely has established guidelines for pharmacists to use when providing home health care products and services. For example, in 199 1, ASHP published its first Tecb~ical AssistanceBulletin OHQuality Assurancefor Pbamacy Prepured Sterile Products.5In I 993, ASHP published specific guideline9 related to home care that provided rec-
HOME
CARE PROVIDER
19
ommendations on patient assessment; patient education, training, and counseling; product selection; pharmaceutical care plans; patient monitoring; effective communication; drug preparation, delivery, storage, and administration; patient safety; documentation; adverse drug reaction reporting; participation in QA activities; and policies and procedures. The ASHP guidelines5,6 related to sterile products specify that compounding should comply with applicable practice standards, accreditation standards, and pertinent state and federal regulations. Storage in the patient’s home should be designed such that stability and sterility are ensured. Preparation and administration in the home should adhere to reasonable standards for parenteral therapy. JCAHO EXPECTATIONS Surveillance, prevention, and control of infection are important components of the Joint Commission on Accreditation of Healthcare Organization’s (JCAHO) expectations of home care providers. The intent of the key processes is to reduce the risk of infections in patients and staff alike. Coverage of JCAHO’s specific guidelines and standards is beyond the scope of this article, so the reader should refer to the appropriate JCAHO publication.‘,* ENSURING AND ASSESSING STERILITY Ensuring and assessing sterility of parenteral drug therapy for administration in the home is a critical aspect of infection control. A combination of education, monitoring, and testing provides an appropriate degree of confidence in parenteral sterility. Educating the patient or caregivers who will be responsible for the preparation and/or administration of the sterile product is a vital first step. Instruction should be an active process that directly involves the patient caregiver. Observing the aseptic technique of the patient or caregiver as warranted by the procedure is a primary method to ensure competence. In addition, microbial tests should be used to evaluate aseptic technique and product sterility. These tests should be performed periodically to ensure that patients and caregivers continue to practice acceptable aseptic techniques,
CONCLUSION An important part of infection control is to ensure that the people involved in handling, preparing, or administering parenterals use proper aseptic technique. Assessing and ensuring that the quality of aseptic technique complies with guidelines on home parenteral therapy can minimize the risk of infection as a result of contaminated products. REFERENCES 1. Catania PN, Rosner MM. Home health care practice. 2nd ed. Palo Alto (CA): Health Markets Research; 1994. 2. Hughes BA, Fleming CR, Berkner S, et al. Patient compliance with home parenteral nutrition program. J Parent Enteral Nutr 1980;4:12-24. 3. USP-NF. 5th suppl. Rockville (MD): US Pharmacopeial Convention, Inc.; 1994. 4. USP 23 NF 18. Rockville (MD): US Pharmacopeial Convention, Inc.; 1995. 5. Practice standards of the American Society of Health-System Pharmacists. ASHP Technical Assistance Bull 1993;50:771. 6. ASHP guidelines on the pharmacist’s role in home care. Am J HealthSyst Pharm 1993;50:1940. 7. Joint Commission on Accreditation of Healthcare Organizations. Comprehensive accreditation manual for home care. Oakbrook Terrace (IL): The Commission; 1997. 8. Joint Commission on Accreditation of Healthcare Organizations. Complete guide to the 1997-98 survey process: home care. Oakbrook Terrace (IL): The Commission; 1997. 9. Lima HA. Using media fills to evaluate aseptic technique. Infusion 1994;1:29-33. 10. Turco S, Miele WH, Barnoski D. Evaluation of an aseptic technique testing and challenge kit (Attack). Hosp Pharm 1993;28:1 l-6. 11, Addi-Chek II quality assurance test kit. Bedford (MA): Millipore Corp.; 1994.
Two basic approaches that may be used as quality control methods for product sterility are process validation and microbial analysis.9,‘o Process validation also is known as media fill testing or process simulation testing.g Media fill is a microbiologic test that assessesboth the compounder’s aseptic technique and the reliability of the compounding procedures used to prepare sterile parenteral products. According to Lima,g media fills provide a means of ensuring that the compounding process used within a home care organization does in fact result in a sterile product. Media fills also show that appropriate aseptic technique was used. However, this quality control method does not assessthe actual sterility of the parenteral product but rather the presence of bacteria in a simulated product. Another quality control method for assessing product sterility is using commercially available test kits that analyze parenteral products for microbial contamination.” These kits are designed to capture and culture microorganisms that may have been introduced during preparation by contaminated solutions, poor aseptic technique, or environmental contaminants. Results typically are available within 7 to I 4 days.
20
HOME
CARE PROVIDER
FEBRUARY 1999, VOL. 4 NO. I
Ogbru, PharmD
Sterility of Intravenous Therapy in Home Care Settings Providing sterile parenteral therapy for patients in home care settings has been an option for clinicians for two decades.“’ Initially, home intravenous therapy was prepared only by pharmacists in carefully controlled environments or by nurses in the patient’s home using strict aseptic techniques. Today, patients or their caregivers may be responsible for preparing parenteral products for home administration.
he provision of home parenteral therapy by home health care pharmacists includes several alternatives, such as reconstituting sterile drug products, preparing large volume parenteral products, or providing the components of parenteral therapy to be prepared by the patient or caregiver at home. Each of these alternatives has a different risk level for the introduction of microbial contamination, so different procedural guidelines are needed. The use of guidelines help ensure the sterility of parenterals at home as an important aspect of quality assurance (QA) and infection control.
T
The following information is provided to highlight several published guidelines from the pharmacy literature related to providing parenteral therapy to patients in their homes. USP GUIDELINES In I 994, the United States Pharmacopeia (USP) published new guidelines and standards for parenteral products administered in the patient’s home.3 These procedures were further modified and published in USP 23.” Typical procedures reported by USP 23 that are necessary to prepare and dispense sterile drug products intended for home use include: l
l
Validation
of sterilization
and aseptic process
Quality and control of environmental operations
l
Personnel training
l
Aseptic techniques
l
Finished product testing
l
Storage and expiration
l
Control
l
Patient or caregiver training
l
Patient monitoring
l
QA program
conditions
dating
of product quality beyond the pharmacy
and complaints
FEBRUARY 1999, VOL. 4 NO. 1
for aseptic
According to USP 23,’ the pharmacist who dispenses any home-use sterile product is responsible for ensuring that the product has been prepared, labeled, controlled, stored, dispensed, and distributed properly. This duty includes ensuring that the product is kept under appropriate controlled conditions at the location of use and is administered properly through adequate labeling and verbal or written instructions. The dispensing pharmacist also is responsible for ensuring that the product retains its quality attributes within acceptable limits through a written QA program. This program should ensure that, for the entire labeled life of the product or until manipulated by the patient or caregiver, the potency, pH, sterility, freedom from pyrogens, particulate limits, container integrity, appearance, and other qualities or characteristics that the home-use sterile drug is expected to have do exist. The QA program should encompass every home-use sterile drug under the pharmacy’s control and include all phases of its preparation, distribution, storage, administration, and use. The dispensing pharmacy should use proper analytical testing where appropriate to ensure the microbiologic, chemical, and physical quality of all home-use sterile drugs. These responsibilities apply equally to commercially available injectable drug products that are dispensed to patients without compounding or other manipulation and to home-use sterile drugs that have been repackaged, reconstituted, diluted, admixed, blended, or otherwise manipulated (collectively referred to as “compounded”) in any way before dispensingP ASHP GUIDELINES The American Society of Health-System Pharmacists (ASHP) routinely has established guidelines for pharmacists to use when providing home health care products and services. For example, in 199 1, ASHP published its first Tecb~ical AssistanceBulletin OHQuality Assurancefor Pbamacy Prepured Sterile Products.5In I 993, ASHP published specific guideline9 related to home care that provided rec-
HOME
CARE PROVIDER
19
ommendations on patient assessment; patient education, training, and counseling; product selection; pharmaceutical care plans; patient monitoring; effective communication; drug preparation, delivery, storage, and administration; patient safety; documentation; adverse drug reaction reporting; participation in QA activities; and policies and procedures. The ASHP guidelines5,6 related to sterile products specify that compounding should comply with applicable practice standards, accreditation standards, and pertinent state and federal regulations. Storage in the patient’s home should be designed such that stability and sterility are ensured. Preparation and administration in the home should adhere to reasonable standards for parenteral therapy. JCAHO EXPECTATIONS Surveillance, prevention, and control of infection are important components of the Joint Commission on Accreditation of Healthcare Organization’s (JCAHO) expectations of home care providers. The intent of the key processes is to reduce the risk of infections in patients and staff alike. Coverage of JCAHO’s specific guidelines and standards is beyond the scope of this article, so the reader should refer to the appropriate JCAHO publication.‘,* ENSURING AND ASSESSING STERILITY Ensuring and assessing sterility of parenteral drug therapy for administration in the home is a critical aspect of infection control. A combination of education, monitoring, and testing provides an appropriate degree of confidence in parenteral sterility. Educating the patient or caregivers who will be responsible for the preparation and/or administration of the sterile product is a vital first step. Instruction should be an active process that directly involves the patient caregiver. Observing the aseptic technique of the patient or caregiver as warranted by the procedure is a primary method to ensure competence. In addition, microbial tests should be used to evaluate aseptic technique and product sterility. These tests should be performed periodically to ensure that patients and caregivers continue to practice acceptable aseptic techniques,
CONCLUSION An important part of infection control is to ensure that the people involved in handling, preparing, or administering parenterals use proper aseptic technique. Assessing and ensuring that the quality of aseptic technique complies with guidelines on home parenteral therapy can minimize the risk of infection as a result of contaminated products. REFERENCES 1. Catania PN, Rosner MM. Home health care practice. 2nd ed. Palo Alto (CA): Health Markets Research; 1994. 2. Hughes BA, Fleming CR, Berkner S, et al. Patient compliance with home parenteral nutrition program. J Parent Enteral Nutr 1980;4:12-24. 3. USP-NF. 5th suppl. Rockville (MD): US Pharmacopeial Convention, Inc.; 1994. 4. USP 23 NF 18. Rockville (MD): US Pharmacopeial Convention, Inc.; 1995. 5. Practice standards of the American Society of Health-System Pharmacists. ASHP Technical Assistance Bull 1993;50:771. 6. ASHP guidelines on the pharmacist’s role in home care. Am J HealthSyst Pharm 1993;50:1940. 7. Joint Commission on Accreditation of Healthcare Organizations. Comprehensive accreditation manual for home care. Oakbrook Terrace (IL): The Commission; 1997. 8. Joint Commission on Accreditation of Healthcare Organizations. Complete guide to the 1997-98 survey process: home care. Oakbrook Terrace (IL): The Commission; 1997. 9. Lima HA. Using media fills to evaluate aseptic technique. Infusion 1994;1:29-33. 10. Turco S, Miele WH, Barnoski D. Evaluation of an aseptic technique testing and challenge kit (Attack). Hosp Pharm 1993;28:1 l-6. 11, Addi-Chek II quality assurance test kit. Bedford (MA): Millipore Corp.; 1994.
Two basic approaches that may be used as quality control methods for product sterility are process validation and microbial analysis.9,‘o Process validation also is known as media fill testing or process simulation testing.g Media fill is a microbiologic test that assessesboth the compounder’s aseptic technique and the reliability of the compounding procedures used to prepare sterile parenteral products. According to Lima,g media fills provide a means of ensuring that the compounding process used within a home care organization does in fact result in a sterile product. Media fills also show that appropriate aseptic technique was used. However, this quality control method does not assessthe actual sterility of the parenteral product but rather the presence of bacteria in a simulated product. Another quality control method for assessing product sterility is using commercially available test kits that analyze parenteral products for microbial contamination.” These kits are designed to capture and culture microorganisms that may have been introduced during preparation by contaminated solutions, poor aseptic technique, or environmental contaminants. Results typically are available within 7 to I 4 days.
20
HOME
CARE PROVIDER
FEBRUARY 1999, VOL. 4 NO. I