Download Practice Guidelines for Community-Based Parenteral Anti

787
Practice Guidelines for Community-Based Parenteral Anti-Infective Therapy
David N. Williams, Susan J. Rehm, Alan D. Tice,
John S. Bradley, Allan C. Kind, and William A. Craig
From the Hennepin County Medical Center, the University of Minnesota
Medical School, and the Park Nicollet Medical Center, Minneapolis,
Minnesota; the Cleveland Clinic Foundation, Cleveland, Ohio;
Infections Limited, Tacoma, Washington; Children’s Hospital of San
Diego, San Diego, California; and the Veterans Affairs Medical Center,
Madison, Wisconsin
This is the fourth in a series of practice guidelines commissioned by the Infectious Diseases
Society of America through its Practice Guidelines Committee. The purpose of this guideline is to
provide assistance to clinicians when making decisions on when and how to best administer parenteral antimicrobial therapy. The targeted providers are internists, pediatricians, family practitioners,
and other providers of outpatient antiinfective therapy. Criteria for selecting the appropriate patients
and settings to deliver therapy in the community are described. Panel members represented experts
in adult and pediatric infectious diseases. The guidelines are evidence-based. A standard ranking
system is used for the strength of the recommendations and the quality of the evidence cited in the
literature reviewed. The document has been subjected to external review by peer reviewers as well
as by the Practice Guidelines Committee and was approved by the IDSA Council. An executive
summary and tables highlight the major recommendations. The guideline will be listed on the IDSA
home page at http://www.idsociety.org.
—Peter A. Gross, MD for the IDSA Practice Guidelines Committee
Executive Summary
These guidelines were formulated to provide guidance for
physicians on various aspects of the administration of community-based parenteral anti-infective therapy (CoPAT). Nine
areas are addressed. Patient evaluation and selection criteria
are discussed in detail, with an emphasis on the importance of
determining the need for parenteral therapy as well as assessing
the patient’s general medical condition and the infectious process.
The section on ‘‘Key Elements for a CoPAT Program’’
underscores both the team concept (the patient, nurse, pharmacist, and physician) and the importance of assuring clear lines
of communication between members of the team. A list of
evaluation criteria is provided to address the dilemmas facing
physicians when insurance companies or managed care organizations designate a specific home care program that the prescribing physician may be unfamiliar with.
The physician’s roles and responsibilities as a member of
the CoPAT team are also addressed, emphasizing unique responsibilities such as establishing a diagnosis, authorizing treatment when the final care plan is developed, determining the
appropriate site of care, and monitoring the patient’s clinical
Received 10 June 1997; revised 27 June 1997.
This guideline is part of updated or new guidelines from the IDSA that will
appear in CID.
Reprints or correspondence: Dr. David N. Williams, Hennepin County Medical Center, 701 Park Avenue, Minneapolis, Minnesota 55415.
Clinical Infectious Diseases 1997;25:787–801
q 1997 by The University of Chicago. All rights reserved.
1058–4838/97/2504–0003$03.00
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response to therapy. Many responsibilities are shared between
members of the team.
Monitoring the care of patients receiving CoPAT includes
attention to venous access, monitoring by means of specific
laboratory tests, and emphasizing the importance of administering the first dose of an antibiotic in a supervised setting. Antiinfective selection and administration issues involving CoPAT
include observations that once-daily drug administration is convenient and, in the case of aminoglycosides, has potential therapeutic advantages; vancomycin use should be limited to defined
situations.
While there are many reassuring retrospective studies on the
efficacy and safety of CoPAT, few prospective studies have
been conducted to compare the risks and outcomes for patients
treated as inpatients rather than outpatients. The outcome studies of pneumonia in cystic fibrosis patients, for which several
parameters were used, showed no significant differences between inpatient and outpatient therapy. The Joint Commission
on Accreditation of Healthcare Organizations has devised a
number of indicators for home infusion therapy, and in this
paper, a number of other parameters are recommended for
possible inclusion for comparative and trend analyses.
For carefully selected patients, the benefits of CoPAT outweigh the risks; these benefits include the direct cost savings
that accrue to the health care system as well as the indirect
and intangible benefits that accrue to the individual. It is not
always easy to calculate precisely how much less costly CoPAT
is than inpatient administration of antibiotics because of differences in definitions of costs and charges in various publications.
However, in most publications, the message is clear: CoPAT
saves money when it is used appropriately. Provision of CoPAT
for patients who are eligible for Medicare is limited by the fact
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Williams et al.
that home expenses other than skilled nursing visits are not
covered.
While there are potential risks associated with CoPAT, the
benefits to the patient and society are considerable. CoPAT
should be embarked upon as a team approach to medical care,
with structured services and outcome analyses to assure both
safety and quality. The physician’s role in coordinating patient
care is crucial.
Introduction
The practice of administering parenteral anti-infective therapy in the home and in other community settings has grown
rapidly over the past 20 years [1 – 11]. In the United States,
community-based parenteral anti-infective therapy (CoPAT) is
a multibillion-dollar-a-year industry. It is estimated that more
than 250,000 Americans are treated with CoPAT each year,
and the growth rate for this practice is estimated to exceed
10% per year. The growth of CoPAT has been fueled by a
variety of factors including an increased emphasis on cost containment, the availability of antibiotics that can be administered
once or twice daily, technological advances in vascular access
and in infusion devices, increased acceptance of such therapy
by both patients and health care personnel, and the availability
of structured services for CoPAT.
These guidelines were drafted in an attempt to ensure appropriate and successful implementation of parenteral anti-infective
services for patients in a variety of community settings including
the home, outpatient facilities (e.g., physicians’ offices and infusion centers), skilled nursing facilities, and rehabilitation centers.
The guidelines have been formulated from the physician’s standpoint, emphasizing the physician’s responsibilities. However, it
is appreciated that CoPAT is a multidisciplinary activity demanding close cooperation between nurses, pharmacists, and
other members of the health care team [5–7, 12, 13]. Accordingly, the overlapping roles and responsibilities have to be reconciled to ensure success and reduce potential risks.
The guidelines proposed herein are general and may need
modification in certain settings. We would encourage consultation with an infectious diseases physician in such circumstances. The guidelines address basic definitions, patient evaluation and selection criteria, basic prerequisites and key
elements for CoPAT programs, responsibilities of team members (with an emphasis on the physician’s role), clinical aspects,
including monitoring, anti-infective selection and administration, outcome measures, economic considerations, and riskbenefit analysis.
Basic Definitions
The guidelines were formulated on the basis of the collective
clinical experience of the Guideline Committee. Wherever possible, the strength of the recommendation and quality of evi-
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CID 1997;25 (October)
dence available to support the recommendation were assessed
with use of previously published criteria [14].
The term community based is used to reflect the various
noninpatient hospital settings (a home, an infusion center, a
physician’s office, a skilled nursing facility, or a rehabilitation
center) where parenteral therapy is administered. The term parenteral is favored to reflect both intravenous and intramuscular
routes of administration. Anti-infective is used, as it reflects the
growing use of antiviral and antifungal therapies as well as
antibiotic therapies in community settings. Patient is used
throughout this paper rather than client, consumer, or any other
designation. Caregiver refers to any individual with the ability
and willingness to administer treatment and observe and report
significant events. The caregiver may be a family member,
friend, or health care professional (i.e., a nurse or physician).
All caregivers, particularly nonprofessionals, need to be trained
and educated to perform designated tasks.
CoPAT delivery systems refers to infusion companies, hospital-based home care services, or other organizations that ensure
delivery of drugs and devices.
Patient Evaluation and Selection Criteria
Initiation of CoPAT requires that a qualified physician determines that such therapy is needed to treat a defined infection,
that there is a reasonable expectation of control of the infection,
and that alternate routes of drug delivery are not feasible or
indicated.
Determination of need for parenteral anti-infective therapy.
There is potential for both overuse and underuse of CoPAT.
A careful analysis of patients referred for home therapy will
demonstrate that a subset of referrals are inappropriate. Some
patients require hospitalization; for others, oral antibiotic therapy is adequate, and for some, it is reasonable to discontinue
antibiotic therapy altogether. Because of their experience and
expertise in this area, infectious diseases specialists or physicians who are interested and experienced in CoPAT should be
involved in the evaluation of patients who are candidates for
therapy. The infectious diseases specialist should analyze the
need for anti-infective therapy, recommend the anti-infective
agent, provide orders for therapy, monitor the patient during the
course of treatment, and comprehensively evaluate the patient’s
clinical response.
Guidelines for patient selection. The following guidelines
should be observed in determining which patients should receive CoPAT.
(1) The patient’s medical care needs do not require hospitalization and do not exceed resources available at the proposed
site of care.
(2) The patient or caregiver is capable of safely and effectively delivering parenteral anti-infectives and is compliant
with recommended treatment and, after discussion of the benefits, risks (including informed consent when appropriate), and
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CoPAT Practice Guidelines
economic considerations (e.g., insurance issues), willing and
able to participate in the proposed therapy.
(3) Lines of communication between the patient, caregiver,
physician, and other health care personnel are sufficient for
monitoring therapy.
(4) The home/outpatient environment is safe and adequate
to support care.
The primary goal of community-based therapy programs is
to allow patients to safely and effectively complete treatment
in the comfort of the home or another site, thereby avoiding
the inconveniences, complications, and expense of prolonged
hospitalization. This goal must not be overlooked in the midst
of efforts to reduce hospital use.
Medical assessment and resource needs. Determination of
the status of a patient’s underlying medical condition(s) is a
critical component of the assessment process. A patient’s overall condition must be stable, and the risk of sudden, life-threatening changes in health should be low. The risk assessment
includes determining the status of the infectious process as
well as concomitant conditions that might influence the safety
of continuing care outside the hospital. Patients with terminal
conditions are appropriate recipients of CoPAT if the proposed
therapy contributes to their quality of life and comfort. CoPAT
often enables the completion of a course of therapy started in
the hospital, but CoPAT may be initiated in an emergency
department, outpatient clinic, or office setting if the patient’s
condition does not otherwise warrant care as an inpatient.
A wide range of infections have been successfully treated
through CoPAT programs (table 1) [15 – 63]; the patient’s participation is usually more dependent on the stability of medical
and psychosocial factors than on the type of infection present.
For most of the conditions listed, the strength of each recommendation was categorized as indicating good (A) or moderate
(B) evidence in support of the use of CoPAT [14]. For the
most part, the quality of the evidence on which recommendations were based was assigned a Grade III (evidence based on
clinical experience or descriptive studies). There were very few
Grade I recommendations (evidence from at least one properly
randomized control trial) and few Grade II recommendations
(e.g., evidence from at least one well-designed clinical trial
without randomization) [14].
In general, patients with sepsis or focal infections such as
meningitis, endocarditis, septic arthritis, or severe pneumonia
should be hospitalized for initiation of parenteral antibiotic
therapy [12, 15 – 17] because of the need for intensive medical
care or the risks that such patients’ medical conditions may
suddenly change. For example, patients with endocarditis and
persistently positive blood cultures, poorly controlled congestive heart failure, large (ú10 mm) vegetations, recurrent embolic events, or conduction abnormalities are at risk for complications of endocarditis; their eligibility for completion of
therapy with CoPAT must be carefully assessed. Some patients
with left-sided native valve endocarditis due to Staphylococcus
aureus may develop sudden complications despite clinical sta-
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bility [52]. There is significant experience in treating nonenterococcal streptococcal endocarditis on an outpatient basis
with once-daily dosing of ceftriaxone [53 – 54].
In all situations, the patient must be able to tolerate the selected
antimicrobial agent before CoPAT is initiated. Patients who are
treated at home typically receive two to three skilled-nurse visits
per week, although in selected situations, daily nurse visits may
be appropriate. Physicians may visit once or twice a week or as
deemed necessary. Most patients or their caregivers must be able
to assume responsibility for the infusion and for the care of the
catheter site. Daily treatments in a physician’s office or infusion
center may be an option if the patient’s physical condition and
resources, including transportation, are adequate. If the patient
requires rehabilitation or extra assistance with daily care, supervised anti-infective therapy in a subacute care facility, nursing
home, or rehabilitation center is preferred.
Capability and compliance. The capabilities of patients who
receive parenteral anti-infectives at home need to be carefully
evaluated before such patients are accepted in the program.
Participation in CoPAT by selected patients with physical disabilities may be facilitated through the use of various devices
such as iv pumps and elastomer-regulated infusion devices.
If self-administration of anti-infectives is impossible despite
exploration of these options, a caregiver or home care nurse
may assume responsibility for this aspect of care. Home care
of children requires the participation of parents or guardians
as caregivers; the standards for evaluation of competence, compliance, and willingness to participate that apply to adults also
apply to children.
The appropriateness of CoPAT for drug- or alcohol-using
patients should be carefully evaluated before therapy is initiated. Patients who are likely to abuse an iv system are not
desirable candidates for CoPAT [12, 64], although the use of
computerized iv pump technologies reduces the likelihood of
tampering. Patients’ safety, as well as ability to comply with
the prescribed regimen, will determine whether therapy outside
the hospital setting is advisable. If a patient was actively abusing parenteral drugs immediately before the acute presentation,
administration of iv antibiotics in a supervised setting is advised. The presence of other drug-using family members in
the home may also lead to a recommendation that therapy be
completed in a hospital, subacute care facility, or nursing home.
Patients should be aware of the economic aspects as well as
the medical aspects of CoPAT before the initiation of therapy.
Patients should be counseled regarding insurance coverage and
anticipated out-of-pocket costs to allow an informed decision
about participation in a CoPAT program.
Communication. Ongoing communication between the patient, caregiver and/or nurse, vendor-supplier, and physician is
critical to the success of CoPAT. If the patient has no telephone,
alternate means of communication through neighbors or friends
must be established before CoPAT is initiated. Patients must
have access to transportation for physician appointments and
access to emergency services.
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Table 1. Infectious conditions suitable for treatment with community-based parenteral anti-infective therapy.
References
Site of infection or condition
[2, 18]
[4, 6, 8, 10, 13, 16, 19 – 33]
[5]
[4, 6, 23, 25, 27, 28, 33]
[2, 5]
[1, 3, 4, 6, 8, 10, 11, 16, 19 – 38]
[2, 5, 18]
[3, 4, 6, 11, 13, 19, 20, 22 – 32, 36]
[11, 20, 27, 33]
[2]
[4, 6, 8, 13, 16, 19, 20, 22 – 26, 29 – 32, 39]
[40]
[9, 41]
[16, 22, 25, 26, 32, 42 – 51]
[4, 6, 13, 16, 23, 25, 27, 29, 31, 32]
[4, 13, 16, 19, 25, 26, 30 – 32]
[2, 5, 52, 53, 54]
[1, 3, 4, 6, 10, 11, 13, 16, 20 – 29, 34, 55 – 58]
[4, 8, 16, 25, 26]
[10, 11]
[20, 21, 25]
[31]
[6, 8, 13, 16, 21, 23, 24, 26, 29, 31]
[18]
[2, 4, 6, 8, 13, 16, 22 – 24, 26, 29 – 32]
[4, 6, 8, 13, 16, 19, 22, 25]
[18, 60]
[8, 20, 22 – 25, 27, 30, 59]
[5]
[20 – 23, 25, 27, 29]
[25]
[8, 27, 61]
[6, 13, 21, 23, 25, 29]
[18]
[1, 2, 16, 19, 20, 23 – 26, 29, 32, 34]
[6, 11, 21 – 23, 26, 29]
[6, 11, 13, 16, 21, 23, 25, 62 – 63]
Strength of recommendation*
Quality of evidence†
Cellulitis/
Soft-tissue infection
Wound infection
B
B
B
Osteomyelitis
A
Septic arthritis/bursitis
A
Prosthetic joint infections
Pneumonia/severe lower respiratory infections
A–B
B
Cystic fibrosis (infectious exacerbations)
A
Sinusitis (complicated)
Chronic otitis/mastoiditis
Endocarditis
B
B
B
Intravenous access – associated
Vascular graft infections
Hepatic abscess
Peritonitis
Intra-abdominal abscess
Complicated urinary tract infections
(pyelonephritis, perinephric abscess)
B
B
B
B
B
B
II
III
II
III
II
III
II
III
III
II
III
I
II
III
III
III
II
III
III
III
III
III
III
II
Tubo-ovarian abscess/pelvic inflammatory
disease
Meningitis
B
III
III
B
Brain and epidural abscesses
B
Splenic abscess
Neutropenic fever
Lyme disease
Bacteremia
B
B
B
B
Fungemia/systemic mycoses
Cytomegalovirus infections
B
B
II
III
II
III
III
III
III
II
III
III
III
* Letters represent strength of evidence in support of the use of community-based parenteral anti-infective therapy. A Å good; B Å moderate [14].
†
Numbers represent quality of evidence on which recommendations were based; I Å randomized controlled trial; II Å well-designed clinical trial; III Å clinical
experience [14].
Environment. The place where anti-infectives are administered
must be clean. Space should be available for the storage of
supplies. In most cases, a refrigerator and running water in the
home are required. In addition, a defined mechanism for needle
disposal (this may vary with local or state regulations) is necessary. Other criteria for determining the most suitable setting for
CoPAT are more difficult to define; for example, family dynamics
may significantly influence the patient’s ability to safely and
successfully complete therapy outside the hospital.
Key Elements of a CoPAT Program
The key elements of a CoPAT program are as outlined (table
2). While any physician can legally order CoPAT, not all physi-
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cians are experienced in doing so. There has been enormous
nationwide growth in all home care services; however, paradoxically, direct physician involvement has not kept pace,
partly because of limited reimbursement for management of
care in this setting [65, 66]. The responsible physician should
be knowledgeable in infectious diseases and CoPAT so that
problems such as therapeutic failure, drug toxicity, and iv access issues are avoided or appropriately and promptly addressed. In some clinical settings, an infectious diseases consultation is required before a patient is sent home to receive
CoPAT [5, 67]. Recent discussions have focused on accreditation requirements to establish minimum standards for physician
supervision and management of home care agencies [68]. Intravenous therapy nurses and pharmacists in the CoPAT program
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CoPAT Practice Guidelines
Table 2. Key elements of a community-based parenteral anti-infective program.
Health care team
Communications
Written policies and
procedures
• Physician knowledgeable about infectious
diseases and CoPAT
• Primary care physician motivated to
participate actively in CoPAT
• Nurse knowledgeable about intravenous
therapies and CoPAT
• Pharmacist knowledgeable about CoPAT
• Access to other health care professionals
including physical therapist, dietician,
occupational therapist, and social worker
• Availability of physician, nurse, and
pharmacist on a 24-hour basis
• System for rapid communication with
patient and among team members
• Outline of responsibilities of team
members
• Patient admission information
• Patient selection criteria
• Patient education
NOTE. CoPAT Å community-based parenteral anti-infective therapy.
should be knowledgeable and experienced, as should other
members of the health care team (e.g., social workers, physical
therapists, dietitians, and occupational therapists). The American Society for Hospital Pharmacists has developed specific
guidelines on the pharmacist’s role in home care [69, 70].
CoPAT programs must have systems for rapid communication between nurses, pharmacists, physicians, and patients.
Such systems are required both for initial treatment planning
and for the monitoring of ongoing care. Communication via
pagers, cellular phones, facsimile machines, and electronic mail
has become increasingly important. Programs should have written policies and procedures that outline the responsibilities of
the team members and address issues such as patient selection
criteria, antibiotic preparation, vascular access, laboratory monitoring guidelines, and waste and needle disposal. Patient education materials should provide specific information about the
program, a list of emergency-access telephone numbers, and a
statement regarding precautions and risks as well as specific
information about the disease process and the anti-infectives
used.
Plans for quality assurance and outcomes monitoring (see
below) should be incorporated into CoPAT programs. Policies
and procedures may be developed for an individual program
or accessed via one of several commercial sources.
An experienced physician director or advisor for the CoPAT
delivery organization is important for the success of the program. This position is analogous to that of the medical directors
for hospice programs. Such persons provide clinical input into
policies and procedures and oversee quality-of-care activities.
Physicians who prescribe CoPAT may face dilemmas when
insurance companies or managed care organizations designate
referrals to specific home care programs. In some cases, the
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791
prescribing physician may be unfamiliar with a program; in
other cases, he or she may be aware of quality issues as a result
of previous encounters with the program. The characteristics
of CoPAT programs listed in table 2 should be useful in assessing the capabilities of the delivery system (see ‘‘CoPAT
delivery systems’’ on page 788). In addition, specific administrative elements, as listed in table 3, should be in place. Since
prescribing physicians remain responsible for clinical care decisions, it is important for them to assess the quality of care
provided by the CoPAT delivery organization. In general, physicians are considered legally responsible for deciding when it
is appropriate to discharge patients from hospitals [71]. It is
incumbent upon consultants to clarify their postdischarge role
with other doctors involved in a patient’s care [72].
Role of the Team Members in CoPAT
As in the hospital setting, an effective CoPAT program requires a team of professionals, each with his or her area of
Table 3. Criteria for evaluating a community-based parenteral antiinfective therapy program.
• Medical director or advisor knowledgeable about infectious
diseases and CoPAT
• Defined roles for prescribing physician in relation to case
management, medical director, nurse, and pharmacist
• Standards for nurse, pharmacist, physician, and other patient care
personnel in regard to training, experience, and licensure
• Accreditation or certification (e.g., JCAHO or other)
• Experience in providing CoPAT
• Policies regarding:
a. frequency of physician’s and nurse’s clinical assessments of
the patient
b. staffing and on-call policies
c. frequency of clinical status reports to physicians
d. reporting of laboratory results to physicians within 24 hours
e. rapid reporting of patient problems and critical laboratory
values
• Willingness to share quality and outcomes information (see
table 9)
• Willingness to share charge information regarding individual
patients as well as data on:
• Anti-infective preparation and dispensing
• Vascular access systems and care
• Infusion device care
• Monitoring guidelines for physician
visits, nurse evaluations, and laboratory
studies
• Waste disposal
Patient education and
• Instructions for emergency situations
resource materials
• Information about anti-infective use and
possible adverse effects
• Understanding of potential risks and
problems and patient responsibilities in
regard to CoPAT
System for ongoing
• JCAHO home infusion therapy
quality assurance and
indicators (see table 9)
outcome monitoring
• See section on outcome measures
NOTE. CoPAT Å community-based parenteral anti-infective therapy;
JCAHO Å Joint Commission on Accreditation of Healthcare Organizations.
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Table 4. Roles of physicians, nurses, pharmacists, and patients in a community-based parenteral antiinfective therapy program.
Function
Establish diagnosis
Authorize treatment
Evaluate for suitability for CoPAT
Develop treatment plan
Provide education and training
Coordinate care
Establish vascular access
Monitor vascular access
Prepare anti-infective agent
Provide supplies
Monitor for drug toxicity
Follow infection status
Availability on a 24-hour basis
Outcome assessment
Physician
Nurse
Pharmacist
Patient and/or parent
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
No
No
Yes
Yes
Yes
Yes
No
No
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
No
No
Yes
Yes
Yes
Yes
No
No
Yes
Yes
Yes
No
Yes
Yes
No
No
Yes
No
No
No
No
Yes
Yes
No
Yes
Yes
Yes
Yes
NOTE. Data are from [6]. CoPAT Å community-based parenteral anti-infective therapy.
expertise, as well as a willingness and interest in working
together for optimal patient care [5, 7]. The outpatient team
differs from the in-hospital team particularly with regard to
challenges in communication. Reports of laboratory values,
patient assessments, and problem-solving are often handled by
phone or facsimile instead of through face-to-face contact. The
basic CoPAT team consists of a physician, an iv therapy nurse,
and a pharmacist. The patient should also be considered a
member of the team, since outside the hospital setting he or
she usually plays a much more active role and may be responsible for reporting clinical problems and monitoring vital signs
(table 4) [6]. There are many areas of overlapping responsibilities, and all team members should be constantly available for
handling problems that may arise.
The physician’s role in CoPAT has several unique aspects,
including the establishment of a diagnosis, the authorization
of treatment when the final plan of care is developed, and the
determination of the appropriate site for care. Both the physician and nurse should participate in determining appropriate
vascular access. The physician is responsible for monitoring the
patient’s clinical response to therapy, evaluating for evidence of
drug toxicity, continually assessing for other medical problems
that may arise, and coordinating the efforts of other members
of the team. Physicians who serve as the medical directors
of outpatient therapy programs have additional responsibilities
including some of the administrative aspects of the program,
communication with other physicians, utilization review, quality assurance, and resolution of problems regarding the medical
issues of service and treatment.
The choice of a model for administering CoPAT varies on
the basis of individual patients’ needs, the program resources
available, and the payer. It is possible to change the type of
delivery model depending on the anti-infective used, the patient’s ability for self-care, and the need for other medical
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services. The delivery models can be roughly classified on the
basis of whether therapy is self-administered, administered by
a visiting nurse, administered at an infusion center, or administered at a skilled nursing facility. The advantages and disadvantages of these delivery models are shown in table 5 [19].
The self-administration model can be provided by the patient, a family member, or another responsible person. This
model may be combined with other models and has the advantage of autonomy for the patient, as well as reduced expense.
Methods by which therapy can be self-administered include
gravity bags and a variety of infusion devices that can be
adapted to the needs of the patient, the vascular access device,
and the drug used. Physicians may allow patients some flexibility in iv dosing requirements so as to reduce family and work
conflicts and to ensure that patients get adequate rest.
If a visiting nurse service has staff who are experienced in
home infusion and iv line maintenance, medications can be
provided in the home under the direct supervision of a nurse.
This model is relatively safe and convenient for the patient,
but medication scheduling conflicts may arise. While most
medications are given as 30-minute infusions, there has been
a tendency towards rapid infusion (or iv push) therapy [73].
Because of its expense (due in particular to frequently dosed
medications), nurses’ travel schedules, and the occasional concerns about patient privacy and caregiver safety, this model
may not be appropriate in some situations.
The infusion center model may be established in a variety of
locations including a clinic or physician’s office, a freestanding
infusion center, a hospital outpatient clinic, or, less frequently,
an emergency department or extended care facility. These centers offer the advantage of ready access to medical equipment
and personnel but require travel to the facility for treatment.
Skilled nursing facilities may be used to provide parenteral
antibiotic therapy and have replaced prolonged hospitalization
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Table 5. Models for administering a community-based parenteral anti-infective therapy program.
Model*
Self-administration
Advantages
Disadvantages
Reduced health care costs
Patient autonomy
Visiting nurse
Opportunity for home inspection
Supervised drug administration
Skilled clinical assessments
Infusion center
Skilled nursing facility
Availability of registered nurse on a 24-hour
basis
Expert resources available if problems arise
Ability to directly supervise therapy
Can be combined with visits to the physician
Medical facility with staff
Ability to directly supervise therapy
Can deal with medical problems, including
dementia and drug abuse
Lack of immediate support if
problems arise
Compliance issues
Requirement for patient
education and training
Cost of nurse’s time and
travel
Concerns over privacy
Lack of immediate support if
problems arise
Safety concerns for health
care providers
Cost of clinic facility
Patient has to travel to clinic
Cost of staff and facility
Requirement for staff training
* Patients may participate in more than one model and move from one model to another [19].
in situations where patients are incapable of self-care, do not
have satisfactory caregivers, have multiple medical problems,
are undergoing rehabilitation, or have problems with compliance.
Clinical Aspects, Including Monitoring
As emphasized earlier, CoPAT is used for a wide variety of
infections. In some geographic areas, patients with infectious
complications of HIV infection and AIDS become the major
users of CoPAT programs; these patients require careful clinical monitoring because of the complexity of their care. Likewise, patients with endocarditis and meningitis require carefully directed and structured monitoring because of the
potential for life-threatening sequelae. The duration of iv antiinfective therapy is not specifically addressed in the present
guidelines except to underscore the concern that some patients
receive inappropriately prolonged therapy for Lyme disease
[74 – 76].
Clinical monitoring. A plan of care needs to be established
prospectively and will vary with the acuity of a patient’s illness,
the clinical stability of a patient’s condition, and the drug(s)
used. For example, a patient with an acute infection who is
admitted directly to a CoPAT program without antecedent hospitalization may need to be seen by a physician daily during
the first several days of care. Clinical monitoring needs to be
coordinated between physicians and nurse specialists, and the
treatment plan should clearly identify the physician responsible
for the care of a given patient. The degree, complexity, and
frequency of nurses’ visits will vary with the clinical situation.
A nurse’s visit should include assessments of compliance with
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the treatment program, the status and patency of the venous
access device, and the patient’s overall status; a directed physical examination tailored to the diagnosis; and a review of side
effects (e.g., rash or gastrointestinal symptoms) associated with
the prescribed anti-infective.
A variety of factors should prompt consideration of a change
in the type and route of administration of parenteral anti-infective therapy; these factors include clinical evidence that a patient’s condition has not improved, unwanted side effects, and
complications of drug administration. The reason(s) for any
change of therapy should be recorded as part of programmatic
outcome measures.
Venous access. Venous access routes include a variety of
short peripheral iv catheters, mid-line peripheral iv catheters,
peripherally inserted central venous catheters (PICCs), centrally inserted central venous catheters (CVCs), and subcutaneously implanted infusion port devices. In the United States, im
antibiotic therapy is infrequently used; however, in some parts
of the world, im drugs are used extensively, in part because of
their low cost. Data on the efficacy of the im route exist for a
few selected drugs including cefonicid [28], ceftriaxone [30,
34, 36], the aminoglycosides [77], and teicoplanin [78, 79].
Peripheral vascular access is simple and is associated with
few complications. The iv therapy nurse’s role is critical for
peripheral line access and maintenance. Peripheral lines are
used primarily for anti-infectives that are well tolerated and
are given at infrequent intervals and in situations where there
is a low likelihood that phlebitis will develop. Typically, the
course of therapy is relatively short (usually õ2 weeks, or õ1
week for children), and venous access is easy. In infants and
young children, short peripheral iv catheters usually do not
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remain patent for more than a few days, and reinsertion is often
required when therapy extends beyond 3 – 5 days.
Mid-line catheters are longer (length, 3 – 8 inches) than peripheral iv catheters and may be used for longer courses of
therapy. They are inserted via the antecubital fossa into the
proximal basilic or cephalic veins. Overall, mid-line catheters
appear to be associated with low rates of phlebitis and infection
and are less expensive than CVCs. Anaphylactoid reactions
and other severe reactions have recently been reported in association with one type of mid-line catheter made of an elastomeric hydrogel [80]. PICCs of various types are now increasingly used because they appear to be associated with fewer
mechanical complications and cost less than CVCs. PICCs are
inserted into the antecubital fossa and threaded into the distal
superior vena cava. PICC lines may be used in a number of
specific situations — e.g., when venous access is difficult, when
a longer course of therapy (usually ú2 weeks) is anticipated,
when potentially irritant or vesicant drugs are administered,
and when the use of infusion devices is contemplated.
While CVC-associated infection rates vary as a result of a
number of factors, including use of single vs. multiple-lumen
catheters or a subclavian vs. internal jugular access site, duration of insertion, or the presence of neutropenia, most infectious
diseases consultants favor tunneled catheters for administering
CoPAT. In general, the rates of infection associated with the
use of tunneled CVCs have been significantly lower than those
reported with the use of nontunneled CVCs [81]. However, a
recent prospective randomized study involving 212 CVCs in
169 immunocompromised patients at one center showed no
difference in infection rates between subcutaneous tunneled
CVCs and nontunneled subclavian CVCs [82]. Implanted infusion ports are rarely used solely for anti-infective therapy.
Dressing changes and examination of the venous access site
are usually performed by the iv nurse. Protocols for the frequency of dressing changes will vary with the type of venous
access.
The venous access site and device generally need to be
carefully examined every 3 – 4 days by a nurse or physician for
evidence of local tenderness, phlebitis, infiltration, erythema, or
other signs of local infection. Investigators for the Centers for
Disease Control and Prevention have recently drafted general
guidelines for prevention of intravascular device-related infections [81].
Traditionally, patients or their caregivers have infused antiinfective drugs by the gravity-infusion method. A variety of
alternative methods including elastomeric infusion devices, syringe pumps, programmable infusion devices, or direct iv bolus
injection techniques have been used increasingly to circumvent
several potential barriers to the use of CoPAT [83]. Circumstances when infusion pumps may be used are as shown (table
6) [20]. A descriptive listing of infusion devices has recently
been published [84].
Laboratory monitoring. Laboratory monitoring should be
tailored to the likely or known side-effect profile of the anti-
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CID 1997;25 (October)
Table 6. Indications for infusion pump therapy.
• Patient requires frequent (every 4 – 6 h) or continuous iv drug
administration
• Patient is unwilling or unable to learn the necessary techniques for
injection of anti-infectives or has a caregiver who is unable or
unwilling to learn these techniques
• Patient lacks a support person at home
• Patient has impaired manual dexterity or cognitive function
• Patient has an aversion to needles*
• Patient is immunologically compromised (reduces the number of
times the iv cannula has to be manipulated)
NOTE. Data are from [20].
* New ‘‘needleless’’ systems may help.
infective agent used. The recommendations contained herein
are tailored to safety and toxicity concerns rather than the
response to therapy. There are no firm data or guidelines indicating the frequency of laboratory testing [85]; this lack of
guidance was demonstrated in a recent report on monitoring
iv pentamidine therapy in the home [39]. Therefore, many
infusion companies have developed their own criteria. A schedule of laboratory testing for patients with normal or stable renal
function is shown (table 7). Most of the laboratory tests have
been assigned a BII designation (indicating that the strength
of the recommendations has moderate supportive evidence, and
the quality of the evidence was based on at least one welldesigned nonrandomized clinical trial [14]).
For children receiving b-lactam antibiotics, the required
complete blood count and serum creatinine level determination
may be done less frequently (e.g., every 2 weeks) than for
adults. Blood levels of aminoglycosides may be determined at
the outset to ensure adequacy of therapy; however, there are no
recommendations for routine rechecking of these blood levels
unless there is a change in renal function (e.g., an increase in
the serum creatinine level of §0.5 mg/mL over baseline).
If aminoglycosides are going to be administered for moreprolonged periods (ú2 weeks), baseline audiograms should be
obtained as close to the initiation of therapy as possible, and
repeated audiograms should be obtained every 2 weeks. This
recommendation was assigned a CIII designation, indicating
both poor evidence in support of a recommendation for or
against use and that the quality of the evidence was based on
opinions of respected authorities [14]. Patients who should be
routinely evaluated with audiograms include those who have
preexisting renal failure, those who are aged §65 years, those
who have a family history of hearing problems related to
aminoglycosides, or those who are being treated with prolonged
courses of aminoglycosides.
There are no reliable, universally agreed-upon standards for
the definition of drug-induced ototoxicity. In most studies, ototoxicity is considered to have occurred if there is an increase
in the auditory threshold of §15 decibels over baseline at any
two frequencies or 20 decibels over baseline at one or more
frequencies [86]. Such changes should prompt discontinuation
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Table 7. Laboratory parameters that should be monitored on a weekly basis during community-based parenteral anti-infective therapy.
Anti-infective agent
b-Lactams
Aztreonam
Cephalosporins*
Carbapenems (imipenem/meropenem)
Anti-pseudomonal penicillins*
Ticarcillin
Mezlocillin
Piperacillin
Aminoglycosides
Miscellaneous
Clindamycin
Glycopeptides (vancomycin/
teicoplanin)
Trimethoprim-sulfamethoxazole
Pentamidine
Antifungals
Amphotericin B
Fluconazole
Antivirals
Ganciclovir
Acyclovir
Forscarnet
Cidofovir
Complete blood
count
Creatinine
level
1
1
1
1
1
2
1
1
1
1
2
2
1
2
1
1
2
1
2
1
1
1
1
2
1
1
Potassium
level
Magnesium
level
Other
2
Blood levels as clinically indicated;
consider audiogram†
Blood levels as clinically indicated†
1
2
2
2
2
1
1
1
Daily blood sugar (finger stick);
chemistry profile‡ (2 1 w)
Chemistry profile‡ (1 1 w); include
calcium level
Urinalysis; chemistry profile‡
(1 1 w)
NOTE. Data are number of times per week that test should be done and represent minimal criteria for patients with normal or stable renal function (different
criteria may apply for children; see text).
* For patients receiving naficillin, oxacillin, or ceftriaxone, monitoring of liver function tests may be indicated.
†
See text for details.
‡
Chemistry profile Å liver function tests and electrolyte level determinations.
of therapy. There is evidence that once daily dosing of aminoglycosides is associated with a lower degree of hearing loss
than is traditional dosing [87]. There are no good laboratory
indicators of vestibular toxicity. For this reason, patients should
be aware of this potentially disabling side effect and should be
told to report suggestive symptoms such as dizziness, unexplained nausea (e.g., while watching television or traveling in
a car), or a sense of imbalance to their physicians. Patients’
understanding of the risks associated with aminoglycoside therapy should be clearly documented in their medical records.
As part of the care plan, physicians should establish parameters for the notification of abnormal laboratory values, for follow-up visits, and for anticipated therapy stop dates. Physicians
should be notified immediately in the event of significant laboratory abnormalities.
First-dose policies. As a rule, the first dose of an anti-infective should be administered in a supervised setting where a
physician is readily available (e.g., a physician’s office or an
outpatient clinic) and where medication, equipment for resuscitation, and trained personnel are readily available. The complexities of this issue have been addressed elsewhere [88].
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Anti-infective Selection and Administration
Several factors, including the likely infecting organism, pharmacodynamic and pharmacokinetic factors, and drug stability,
must be taken into account in selecting anti-infectives. While
almost any anti-infective can be used for CoPAT, drugs with
long half-lives continue to be extensively prescribed. Use of
agents that can be administered once or twice daily results in
minimal disruption of daily activities and limits the number of
iv line manipulations and, thus, the potential for iv catheter –
associated complications. In most published series on outpatient antibiotic therapy, ceftriaxone and other cephalosporins
have been the most commonly prescribed drugs. The choice
of anti-infectives for CoPAT needs to be monitored because
of increasing concerns regarding the development of resistance,
even in community settings.
Recent research on pharmacodynamic factors has influenced
the dosing of drugs (table 8) [21]. Thus, aminoglycosides,
which show concentration-dependent killing, should be dosed
once a day. Such a regimen may offer therapeutic advantages
and may also reduce the incidence of nephrotoxicity and oto-
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Table 8. Correlation of pharmacodynamic factors and efficacy of various agents used for community-based parenteral anti-infective therapy.
Anti-infective agent
Pharmacodynamic characteristics
Goal of dosage regimen
Aminoglycosides, fluoroquinolones,
metronidazole
Penicillins, cephalosporins,
aztreonam
Carbapenems, vancomycin,
clindamycin, macrolides
Concentration-dependent killing,
prolonged persistent effects
Time-dependent killing, short or
no persistent effects
Time-dependent killing,
prolonged persistent effects
Maximization of concentrations
Maximization of exposure time
Maximization of exposure time
(serum levels can fall below
MIC)
Parameter correlating
with in vivo efficacy
Peak level, MIC*
24-Hour AUC, MIC†
Time serum levels
exceed MIC/MBC
Time serum levels
exceed MIC/MBC
NOTE. Data are from [21]. AUC Å area under the curve.
* Applies only to aminoglycosides.
†
Applies only to fluoroquinolones and metronidazole.
toxicity [89, 90]. However, the use of once-daily aminoglycoside therapy in pregnant women, children, the elderly, and
critically ill patients has not been fully evaluated. This applies
to patients with renal dysfunction, neutropenia, burns, liver
disease, or endocarditis as well [91].
Certain cephalosporins and penicillins with half-lives of
£60 minutes might be best used by continuous infusion
because these drugs exhibit time-dependent killing and limited postantibiotic effects [92]. On the other hand, drugs
such as ceftriaxone and vancomycin have sufficiently long
half-lives to provide serum concentrations above the MICs
for susceptible organisms for 12 – 24 hours and thus can be
given once daily. Vancomycin has been used extensively in
outpatient settings because of its attractive dosing characteristics and the appearance of methicillin-resistant S. aureus.
The increasing concern regarding vancomycin-resistant enterococci has necessitated limiting the use of vancomycin to
defined situations [93].
The stabilities of imipenem/cilastatin and ampicillin in solution are of concern. These drugs are stable at room temperature
for only 4 and 8 hours, respectively, so they cannot be administered via continuous infusion therapy unless the solutions are
prepared freshly and changed frequently. Side effects are a
concern with all anti-infective therapy and should be specifically monitored on the basis of clinical and laboratory criteria
(table 7).
Outcome Measures
While there are many reassuring retrospective studies on
the efficacy and safety of CoPAT, few prospective studies
comparing the risks and outcomes for patients treated as inpatients rather than outpatients have been performed [40, 94].
Donati et al. [40] prospectively studied the outcome of pneumonia in cystic fibrosis patients treated at home or in the hospital.
These investigators used several parameters and did not note
any significant differences in outcome, with the exception of
improved vital capacity in the hospitalized patients. Wilimas
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et al. [94] undertook a prospective randomized study of outpatient iv ceftriaxone therapy for selected febrile children with
sickle-cell disease. These investigators concluded that with the
use of conservative eligibility criteria, at least half of febrile
episodes in children with sickle-cell disease could be safely
treated with ceftriaxone as outpatients.
Members of the Joint Commission on Accreditation of
Healthcare Organizations have devised a number of indicators
for home infusion therapy (table 9) that emphasize processes
and outcomes of home-infusion plans [95]. Process refers to
the rendering of care and includes patient-selection criteria,
patient education, implementation and coordination of therapy,
and the monitoring of care with particular emphasis on identification of complications and other untoward events [85]. Outcome measures the effects of care on the overall health status
of a patient and includes clinical endpoints, complications,
quality of life, and patient satisfaction. The parameters outlined
in table 9 enable a CoPAT provider to calculate the overall
incidence of a particular indicator. These and other parameters
should be monitored over time within a CoPAT program, and
the findings should be compared with those for other programs.
Examples include (1) resource utilization (i.e., equipment and
nurse visits); (2) frequency of equipment malfunction (e.g.,
infusion pumps); (3) care-coordination events (e.g., prompt
reporting, by the nurse or other care provider, of a change in
a patient’s clinical condition, and reporting of critical clinical
laboratory results); (4) interruption of care (e.g., noncompliance, nondelivery of anti-infectives, or drug errors); (5) quality
of life and patient satisfaction (e.g., the number of complaints);
(6) overall measures of outcome (e.g., death, successful
completion of the program, or number of changes in the
anti-infective therapy); (7) the reason for a change in the antiinfective therapy; (8) a change in the route of drug administration; and (9) a change in the type of venous access (e.g., peripheral to central).
Limited data suggest that the risk of iv catheter – associated
phlebitis and infection in adults is reduced when they are
treated in home iv therapy programs [23].
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Table 9. Joint Commission on Accreditation of Healthcare Organizations home infusion therapy
indicators.
Indicator
Explanation
Unscheduled inpatient admission
Early discontinuation of infusion therapy
Interruption in infusion therapy
Prevention and surveillance of infection
Adverse drug reaction
Patients who have an unscheduled inpatient admission,
subcategorized by reason for admission
Courses of infusion therapy discontinued before
prescribed completion, subcategorized by reason for
discontinuance
Total number of interruptions in infusion therapy,
subcategorized by reason for interruption
Patients with central venous lines whose catheters are
removed or who are receiving anti-infective therapy
for suspected or confirmed catheter-related
infections, subcategorized by type of central-line
catheter and number of lumens
Total number of suspected or confirmed adverse drug
reactions, subcategorized by type and severity of
reaction and by drug class
NOTE. Data are from [95].
Economic Considerations
The risks, benefits, and outcome of CoPAT must be carefully
evaluated, and this form of treatment should not be overused
or underused. For carefully selected patients, the benefits outweigh the risks: this includes the direct economic benefits that
accrue to the health care system as well as the indirect and
intangible benefits that accrue to the patient. The occupation
of a hospital bed is one of the most expensive aspects of
medical care. Because of soaring costs, alternatives to in-hospital treatment must be considered when patients no longer require careful observation and daily nursing care. Intravenous
anti-infective therapy that is given on an outpatient basis costs
significantly less per patient per day than the same treatment
administered in the hospital [16, 22, 96], primarily because
savings result when a patient no longer occupies a hospital
bed. Most publications ascribe the same costs for drugs and
laboratory monitoring whether the patient receives care in an
inpatient or an outpatient program. There are costs intrinsic to
most CoPAT programs that would not normally be incurred
during an inpatient hospital stay. These costs include those
associated with patient education, drug delivery, home nurse
visits, and, in selected situations, iv drug delivery devices.
It is not always easy to calculate precisely how much less
CoPAT costs than inpatient antibiotic administration because
investigators often do not clearly differentiate between cost
and charge, and they do not provide exactly comparable data.
However, data from a recent review [97] on this subject reveal
surprisingly uniform results (table 10) [98 – 100]. In most studies, the message is clear: CoPAT saves money when it is used
appropriately.
Provision of CoPAT for Medicare-eligible patients is limited
by the fact that home expenses other than skilled-nurse visits are
not covered. Patients covered by Medicare can be treated with iv
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anti-infectives under physician supervision in an outpatient center.
Furthermore, hospital administrators can use CoPAT as a means
of minimizing their costs for Medicare patients receiving prolonged treatment with iv anti-infectives through diagnosis-relatedgroup payment mechanisms. This requires the hospital to partner
with a CoPAT provider [24]. There is less information on the
economics of CoPAT with respect to the Medicare population
compared with other populations, and direct comparisons are difficult to make because methods of calculation differ. It has been
estimated that by using CoPAT, savings of $288 per day occur
during periods when hospital-bed occupancy is high and $125
per day during periods when hospital-bed occupancy is low [24].
Many patients who would have been hospitalized in the past
never enter the hospital and receive their entire courses of antiinfective therapy as outpatients. Some insurers are concerned
that CoPAT is so convenient that it may be overused in situations where cheaper oral anti-infective therapy would be as
effective, while physicians express the concern that patients
may be discharged into nonhospital settings prematurely because of cost issues. Interactions between physicians and insurance payers that involve CoPAT are not always harmonious.
Even though the use of CoPAT is associated with greater cost
savings than is inpatient therapy, insurers occasionally ask physicians to further reduce costs by decreasing the number of
approved visits to the home, downgrading the level of training
required of the personnel making the visits, or reducing patient
monitoring requirements in other ways. Other examples include
the refusal of an insurer to pay for the number of home visits
by a skilled nurse that are deemed adequate for a patient with
endocarditis who is in relatively unstable condition or for a
patient with meningitis in whom complications of infection
could lead to considerable morbidity or to death.
It is essential that knowledgeable physicians be able to ensure the provision of all necessary care for patients receiving
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Table 10. Comparison of inpatient and outpatient costs per day for selected groups of patients.
Reference
[2]
[98]
[99]
[100]
Infection, condition
Inpatient
cost per d ($)
Outpatient
cost per d ($)
Percentage cost of outpatient
care vs. inpatient care
193
58
30
347
618
417
108
214
155
31
35
37
Osteomyelitis, subacute bacterial endocarditis
pneumonia, staphylococcal bacteremia
Osteomyelitis, septic arthritis, brain abscess
Infectious complications of cancer in children
Cellulitis, osteomyelitis, pneumonia
NOTE. Data are from [97].
CoPAT in the same way they ensure such care for hospitalized
patients. Utilization review of CoPAT resources is often undertaken by nonmedical or nursing personnel. It is important that
the ordering physician have easy access to the insurance plan’s
medical director to facilitate appropriate medical care decisions
for patients receiving CoPAT.
Methods of administration. The method of administering an
anti-infective influences the cost of CoPAT. CVCs, including
those inserted peripherally, are convenient for patients and
nurses, are expensive to insert (there are professional fees,
material costs, and operating room expenses), and are associated with increased risk of infection when compared with short
peripheral iv catheters. Although CVCs are needed in patients
who will be receiving long-term iv therapy or in whom venous
access is inadequate, these catheters are usually not warranted
for patients whose anticipated durations of treatment are õ2
weeks. Newer methods of administration based on more rapid
iv injection of certain antibiotics (e.g., syringe infusion) result
in avoidance of the greater cost of iv ‘‘mini bags’’ and tubing
as well as time savings for patients and caregivers.
Average duration of therapy. The average duration of
CoPAT for adults is 12 – 14 days, and that for children is 5 – 7
days. While some patients with infections require close followup by physicians, most patients need to see their physicians
only once or twice weekly. The ongoing monitoring is conducted by a nurse skilled in CoPAT. Although patients with
HIV infection and its associated infectious complications are
often seen less frequently because of their prolonged treatment
course, physicians should see such patients once or twice a
month. Having patients return to an infusion center or other
dedicated outpatient location for follow-up, rather than being
visited by a nurse, is even less costly.
Laboratory monitoring. It is necessary to periodically monitor defined laboratory parameters for all patients receiving
CoPAT. Excessive laboratory testing can increase the costs
of CoPAT significantly. Specific suggestions for laboratory
monitoring have already been outlined herein (table 7). If these
recommendations are followed, treatment costs and complications should be minimized.
Physician reimbursement. In general, physicians’ professional fees are reduced by the use of CoPAT because patients
are usually seen only once or twice weekly rather than daily
in the hospital.
Advantages and benefits. Direct costs are easier to calculate
than is the substantial indirect benefit to patients that results
from the ability to stay home, return to work, or attend school.
Although difficult to measure, these advantages are real and
important. Other indirect savings of CoPAT include lower
transportation and child care costs. The psychological benefits
to infants and children are also difficult to measure but are
substantial. CoPAT is safe, effective, usually preferred by patients, and cost-effective.
Table 11. Potential benefits and risks associated with community-based parenteral anti-infective therapy.
Variable
Benefits
Risks
Individual or personal factors
At home with family; return to school
or work; reduction in infectious
risk; fewer iv cannula – associated
infections and phlebitis
Economic and societal
factors
Less costly; hospital beds and
hospital resources used for other
patients
Disruption of family routine;
increased stress;
noncompliance with
therapy; misuse of iv
access; interruption of iv
therapy; increased out-ofpocket expenses
Nonavailability for insurance
coverage (e.g., for the
elderly)
NOTE. Data are from [101].
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Risks and Benefits
There are several potential benefits and risks related to
CoPAT (table 11) [101]. Both the benefits and risks can be
defined from individual or personal perspectives as well as
from more-global economic and societal perspectives. Individual benefits include the receipt of care at home with the family,
the ability to return to school or work, and a potential reduction
in infectious risks. Risks include treatment failure due to noncompliance or caregiver withdrawal, disruption of the family
routine, and the potential for patients’ misuse of iv access
devices. With appropriate safeguards in patient selection and
monitoring, iv-related problems and interruption of therapy can
be circumvented or reduced. However, CoPAT may involve
increased out-of-pocket expenses for some patients.
As noted earlier, a number of cost-benefit analyses have
shown benefit when both direct and indirect benefits are analyzed. However, a true assessment of the cost differential between CoPAT and in-hospital treatment is a complex task requiring acknowledgement of the model of care and a more
global vision of the health care delivery system. The greatest
savings are due to the facts that a patient no longer occupies
a hospital bed, and fewer hospital resources are used. Theoretically, the use of CoPAT enables the use of hospital beds and
other resources for other admissions. Finally, most CoPAT
programs have been associated with low overall morbidity and
low levels of risk for mortality and serious iv cannula – related
problems [23].
References
1. Antoniskis A, Anderson BC, Van Volkinburg EJ, Jackson JM, Gilbert
DN. Feasibility of outpatient self-administration of parenteral antibiotics. West J Med 1978; 128:203 – 6.
2. Stiver HG, Telford GO, Mossey JM, et al. Intravenous antibiotic therapy
at home. Ann Intern Med 1978; 89:690 – 3.
3. Kind AC, Williams DN, Persons G, Gibson JA. Intravenous antibiotic
therapy at home. Arch Intern Med 1979; 139:413 – 5.
4. Poretz DM, Eron LJ, Goldenberg RI, et al. Intravenous antibiotic therapy
in an outpatient setting. JAMA 1982; 248:336 – 9.
5. Rehm SJ, Weinstein AJ. Home intravenous antibiotic therapy: a team
approach. Ann Intern Med 1983; 99:388 – 92.
6. Tice AD. An office model of outpatient parenteral antibiotic therapy.
Rev Infect Dis 1991; 13(suppl 2):S184 – 8.
7. Tice AD. The team concept. Hosp Pract 1993; 28(suppl 1):6 – 10.
8. Baumgartner J-D, Glauser MP. Single daily dose treatment of severe
refractory infections with ceftriaxone: cost savings and possible parenteral outpatient treatment. Arch Intern Med 1983; 143:1868 – 73.
9. Winter RJD, George RJD, Deacock SJ, Shee CD, Geddes DM. Selfadministered home intravenous antibiotic therapy in bronchiectasis and
adult cystic fibrosis. Lancet 1984; 1:1338 – 9.
10. Grayson ML, Silvers J, Turnidge J. Home intravenous antibiotic therapy:
a safe and effective alternative to inpatient care. Med J Aust 1995; 162:
249 – 53.
11. Kayley J, Berendt AR, Snelling MJM, et al. Antimicrobial practice. Safe
intravenous antibiotic therapy at home: experience of a UK based programme. J Antimicrob Chemother 1996; 37:1023 – 9.
12. Brown RB. Selection and training of patients for outpatient intravenous
antibiotic therapy. Rev Infect Dis 1991; 13(suppl 2):S147 – 51.
/ 9c3d$$oc46
09-26-97 15:13:35
799
13. Williams DN. Home intravenous antibiotic therapy. Int J Antimicrob
Agents 1992; 1:253 – 8.
14. Gross PA, Barrett TL, Dellinger EP, et al. Purpose of quality standards
for infectious diseases. Clin Infect Dis 1994; 18:421.
15. American Thoracic Society. Guidelines for the initial management of
adults with community-acquired pneumonia: diagnosis, assessment of
severity, and initial antimicrobial therapy. Am Rev Respir Dis 1993;
148:1418 – 26.
16. Poretz DM. The infusion center: a model for outpatient parenteral antibiotic therapy. Rev Infect Dis 1991; 13(suppl 2):S142 – 6.
17. Dagan R, Einhorn M. A program of outpatient parenteral antibiotic therapy for serious pediatric bacterial infections. Rev Infect Dis 1991;
13(suppl 2):S152 – 5.
18. Bradley JS, Ching DK, Phillips SE. Outpatient therapy of serious pediatric
infections with ceftriaxone. Pediatr Infect Dis J 1988; 7:160 – 4.
19. Tice AD. Experience with a physician-directed, clinic-based program for
outpatient parenteral antibiotic therapy in the USA. Eur J Clin Microbiol
Infect Dis 1995; 14:655 – 61.
20. Williams DN, Gibson JA, Bosch D. Home intravenous antibiotic therapy
using a programmable infusion pump. Arch Intern Med 1989; 149:
1157 – 60.
21. Craig WA. Antibiotic selection factors and description of a hospitalbased outpatient antibiotic therapy program in the USA. Eur J Clin
Microbiol Infect Dis 1995; 14:636 – 42.
22. Grizzard MB, Harris G, Karns H. Use of outpatient parenteral antibiotic
therapy in a health maintenance organization. Rev Infect Dis 1991;
13(suppl 2):S174 – 9.
23. Graham DR, Keldermans MM, Klemm LW, Semenza NJ, Shafer ML.
Infectious complications among patients receiving home intravenous
therapy with peripheral, central, or peripherally placed central venous
catheters. Am J Med 1991; 91(suppl 3B):95S – 100S.
24. Hindes R, Winkler C, Kane P, Kunkel M. Outpatient intravenous antibiotic therapy in medicare patients: a cost-savings analysis. Infect Diseases in Clinical Practice 1995; 4:211 – 7.
25. Williams DN. Home intravenous antibiotic therapy (HIVAT): indications,
patients and antimicrobial agents. Int J Antimicrob Agents 1995;5:3–8.
26. Smego RA Jr, Gainer RB II. Home intravenous antimicrobial therapy
provided by a community hospital and a university hospital. Am J Hosp
Pharm 1985; 42:2185 – 9.
27. Harris LF, Buckle TF, Coffey FL Jr. Intravenous antibiotics at home.
South Med J 1986; 79:193 – 6.
28. Nadworny HA, Markowitz A. Parenteral antibiotic therapy at home:
experience with intramuscular cefonicid. Clin Ther 1987; 10:82 – 91.
29. Green SL. Practical guidelines for developing an office-based program
for outpatient intravenous therapy. Rev Infect Dis 1991; 13(suppl 2):
S189 – 92.
30. Dagan R, Philip M, Watemberg NM, et al. Outpatient treatment of serious
outpatient community-acquired pediatric infections using once-daily intramuscular ceftriaxone. Pediatr Infect Dis 1984; 3:514 – 7.
31. Goldenberg RI, Poretz DM, Eron LJ, Rising JB, Sparks SB. Intravenous
antibiotic therapy in ambulatory pediatric patients. Pediatr Infect Dis
1984; 3:514 – 7.
32. Sudela KD. Nursing aspects of pediatric home infusion therapy for the
treatment of serious infections. Semin Pediatr Infect Dis 1990;1:306–17.
33. Eron LJ, Park CH, Hixon DL, Goldenberg RI, Poretz DM. Ceftriaxone
therapy of bone and soft tissue infections in hospital and outpatient
settings. Antimicrob Agents Chemother 1983; 23:731 – 7.
34. Russo TA, Cook S, Gorbach SL. Intramuscular ceftriaxone in home parenteral therapy. Antimicrob Agents Chemother 1988;32:1439–40.
35. Kunkel MJ, Iannini PB. Cefonicid in a once-daily regimen for treatment
of osteomyelitis in an ambulatory setting. Rev Infect Dis 1984; 6(suppl
4):S865 – 9.
36. Wagner DK, Collier BD, Rytel MW. Long-term intravenous antibiotic
therapy in chronic osteomyelitis. Arch Intern Med 1985; 145:1073 – 8.
cida
UC: CID
800
Williams et al.
37. Tice AD. Osteomyelitis. Hosp Pract 1993; 28(suppl 2):36 – 9.
38. Menon J, Bowen TM, Neri C. Long-term outpatient intravenous antibiotic
therapy for orthopedic patients. Orthopedics 1984; 7:1280 – 3.
39. Gross R, Graziani AL, Laufer D, Turner JL, Onderein JP, MacGregor
RR. Adverse effects of the use of intravenous pentamidine in the home.
Infectious Diseases in Clinical Practice 1996; 5:456 – 8.
40. Donati MA, Guenette G, Auerbach H. Prospective controlled study of
home and hospital therapy of cystic fibrosis pulmonary disease. J Pediatr
1987; 111:28 – 33.
41. Rucker RW, Harrison GM. Outpatient intravenous medications in the
management of cystic fibrosis. Pediatrics 1974; 54:358 – 60.
42. Kuzemko JA. Home treatment of pulmonary infections in cystic fibrosis.
Chest 1988; 94(suppl 2):162S – 6S.
43. Trowbridge JF. Pneumonia and chronic lung disease. Hosp Pract (Office
Edition) 1993; 28(suppl 2):20 – 4.
44. Gilbert J, Robinson T, Littlewood JM. Home intravenous antibiotic treatment in cystic fibrosis. Arch Dis Child 1988; 63:512 – 7.
45. Strandvik B, Hjelte L, Malmborg A-S, Widén B. Home intravenous
antibiotic treatment of patients with cystic fibrosis. Acta Paediatr 1992;
81:340 – 4.
46. Strandvik B, Hjelte L, Widén B. Home intravenous antibiotic treatment
in cystic fibrosis. Scand J Gastroenterol 1988; 23(suppl 143):119 – 20.
47. van Aalderen WMC, Mannes GPM, Bosma ES, Roorda RJ, Heymans HSA.
Home care in cystic fibrosis patients. Eur Respir J 1995;8:172–5.
48. Hammond LJ, Caldwell S, Campbell PW. Cystic fibrosis, intravenous
antibiotics, and home therapy. J Pediatr Health Care 1991; 5:24 – 30.
49. Hjelte L, Widén B, Malmborg AS, Freyschuss U, Strandvik B. Intravenös
antibiotikabehandling i hemmet vid cystik fibros ger ökad livskvalitet.
Lakartidningen 1988; 85:1614 – 7.
50. Pond MN, Newport M, Joanes D, Conway SP. Home versus hospital
intravenous antibiotic therapy in the treatment of young adults with
cystic fibrosis. Eur Respir J 1994; 7:1640 – 4.
51. Kane RE, Jennison K, Wood C, Black PG, Herbst JJ. Cost savings and
economic considerations using home intravenous antibiotic therapy for
cystic fibrosis patients. Pediatr Pulmonol 1988; 4:84 – 9.
52. Rehm SJ, Tomford JW, Longworth DL, et al. Home intravenous antibiotic
therapy (HIVAT) for endocarditis [abstract no 18]. In: Proceedings of
the 30th Annual Meeting of the Infectious Diseases Society of America
(Anaheim, CA). Alexandria, Virginia: IDSA, 1992.
53. Francioli P, Etienne J, Hoigne R, Thys J-P, Gerber A. Treatment of
streptococcal endocarditis with a single daily dose of ceftriaxone sodium
for 4 weeks: efficacy and outpatient treatment feasibility. JAMA 1992;
267:264 – 7.
54. Stamboulian D, Bonvehi P, Arevalo C, et al. Antibiotic management of
outpatients with endocarditis due to penicillin-susceptible streptococci.
Rev Infect Dis 1991; 13(suppl 2):S160 – 3.
55. Rehm SJ, Weinstein AJ. In: Magilligan DJ Jr, Quinn EL, eds. Home
management. Endocarditis: medical and surgical management. New
York: Marcel Dekker, 1986:117 – 27.
56. Francioli PB. Ceftriaxone and outpatient treatment of infective endocarditis. Infect Dis Clin N Am 1993; 7:97 – 115.
57. Williams DN, Kind AC, Becicka K, Williams HT. Home intravenous
antibiotic therapy (HIVAT) for infective endocarditis [abstract no 87].
In: Proceedings of the 30th Annual Meeting of the Infectious Diseases
Society of America (Anaheim, CA). Alexandria, Virginia: IDSA, 1992.
58. Durack D. Endocarditis. Hosp Pract 1993; 28(suppl 2):6 – 9.
59. Bradley JS, Farhat C, Stamboulian D, Branchini OG, Debbag R, Compogiannis
LS. Ceftriaxone therapy of bacterial meningitis: cerebrospinal fluid concentrations and bactericidal activity after intramuscular injection in children
treated with dexamethasone. Pediatr Infect Dis J 1994;13:724–8.
60. Committee on Infectious Diseases of the American Academy of Pediatrics. Treatment of bacterial meningitis. Pediatrics 1988; 81:904 – 7.
61. Talcott JA, Whalen A, Clark J, Reiker PR, Finberg R. Home antibiotic therapy
for low-risk cancer patients with fever and neutropenia: a pilot study of 30
patients based on a validated prediction rule. J Clin Oncol 1994;12:107–14.
/ 9c3d$$oc46
09-26-97 15:13:35
CID 1997;25 (October)
62. Wood G, Whitby M, Hogan P, Frazer I. Foscarnet infusion at home
[letter]. Lancet 1989; 1:156.
63. Heley A. Foscarnet infusion at home [letter]. Lancet 1988; 2:1311.
64. Poretz DM. Home management of antibiotic therapy. Curr Clin Top
Infect Dis 1989; 10:27 – 42.
65. Goldberg AI, Gardner HG, Gibson LE. Home care: the next frontier of
pediatric practice. J Pediatr 1994; 125:686 – 90.
66. Tice AD. Growing pains in outpatient intravenous antibiotic therapy.
Infectious Diseases in Clinical Practice 1995; 1:74 – 6.
67. Miller Z. Health maintenance organization. Hosp Pract Symposium 1993;
28(suppl 2):48 – 51.
68. Hanwitz PE, Keenan JM. The expanding and increasingly important role
of the home health care agency medical director. American Academy
of Home Care Physicians Newsletter 1994; 6(1):8 – 10.
69. ASHP. ASHP guidelines on the pharmacist’s role in home care. Am J
Hosp Pharm 1993; 50:1940 – 4.
70. ASHP. ASHP statement on the pharmacist’s role with respect to drug
delivery systems and administration devices. Am J Hosp Pharm 1993;
50:1724 – 5.
71. Wickline vs. State of California. California Reporter 1986:810 – 20.
72. Physicians, surgeons and other healers. American Jurisprudence 2d. 1981;
(226).
73. Bakken JS, Conlon CP, Smerud KT, Vinen J, Wijlhuizen TG. Antibiotic administration options. Infectious Diseases in Clinical Practice 1996;5:66–7.
74. Luft BJ, Gardner P, Lightfoot RW Jr. Empiric antibiotic treatment of
patients who are seropositive for Lyme disease but lack classic features.
American College of Rheumatology and the Infectious Diseases Society
of America. Clin Infect Dis 1994; 18:112.
75. Lightfoot RW Jr, Luft BJ, Rahn DW, et al. Empiric parenteral antibiotic
treatment of patients with fibromyalgia and fatigue and a positive serologic result for Lyme disease: a cost-effectiveness analysis. Ann Intern
Med 1993; 119:503 – 9.
76. Steere AC. Lyme disease. N Engl J Med 1989; 321:586 – 96.
77. Siber GR, Echeverria P, Smith AL, Paisley JW, Smith DH. Pharmacokinetics
of gentamicin in children and adults. J Infect Dis 1975;132:637–51.
78. Edelstein HE, Oster SE, Chirurgi VA, Karp RA, Cassano KB, McCabe
RE. Intravenous or intramuscular teicoplanin once daily for skin and
soft-tissue infections. DICP Ann Pharmacother 1991; 25:914 – 8.
79. Verbist L, Tjandramaga B, Hendrickx B, et al. In vitro activity and human
pharmacokinetics of teicoplanin. Antimicrob Agents Chemother 1984;
26:881 – 6.
80. Mermel LA, Parenteau S, Tow SM. The risk of midline catheterization
in hospitalized patients: a prospective study. Ann Intern Med 1995; 123:
841 – 4.
81. Pearson ML. Guideline for prevention of intravascular-device-related infections. Hospital Infection Control Practices Advisory Committee. Infect Control Hosp Epidemiol 1996; 17:438 – 73.
82. Andrivet P, Bacquer A, Ngoc CV, et al. Lack of clinical benefit from
subcutaneous tunnel insertion of central venous catheters in immunocompromised patients. Clin Infect Dis 1994; 18:199 – 206.
83. Schleis TG, Tice AD. Selecting infusion devices for use in ambulatory
care. Am J Health Syst Pharm 1996; 53:868 – 77.
84. Tice AD. Outpatient intravenous therapy: source book: a guide to products and devices available for intravenous therapy. In: Tice A, ed.
Tacoma, Washington: OPIT Source Book, 1996.
85. Kunkel MJ. Quality assurance. Hosp Pract 1993; 28(suppl 1):33 – 8.
86. Brummett RE, Fox KE. Aminoglycoside-induced hearing loss in humans.
Antimicrob Agents Chemother 1989; 33:797 – 800.
87. Tulkens PM. Pharmacokinetic and toxicological evaluation of a oncedaily regimen versus conventional schedules of netilmicin and amikacin.
J Antimicrob Chemother 1991; 27:(suppl c):49 – 61.
88. McNulty TJ Jr. Initiation of antimicrobial therapy in the home. Am J
Hosp Pharm 1993; 50:773 – 4.
89. Mattie H, Craig WA, Pechère JC. Determinants of efficacy and toxicity
of aminoglycosides. J Antimicrob Chemother 1989; 24:281 – 93.
cida
UC: CID
CID 1997;25 (October)
CoPAT Practice Guidelines
90. Barza M, Ioannidis JPA, Cappelleri JC, Lau J. Single or multiple daily
doses of aminoglycosides: a meta-analysis. BMJ 1996; 312:338 – 45.
91. Dew RB III, Sulsa GM. Once-daily aminoglycoside treatment. Infectious
Diseases in Clinical Practice 1996; 5:12 – 24.
92. Craig WA, Ebert SC. Continuous infusion of b-lactam antibiotics. Antimicrob Agents Chemother 1992; 36:2577 – 783.
93. Centers for Disease Control and Prevention. Recommendations for preventing the spread of vancomycin resistance: recommendations of the
Hospital Infection Control Practices Advisory Committee (HICPAC).
MMWR Morb Mortal Wkly Rep 1994; 44:1 – 13.
94. Wilimas JA, Flynn PM, Harris S, et al. A randomized study of outpatient
treatment with ceftriaxone for selected febrile children with sickle cell
disease. N Engl J Med 1993; 329:472 – 6.
95. Joint Commission on Accreditation of Healthcare Organizations. Accreditation manual for home care. JCAHO: Oak Brook Terrace, Illinois:
1995.
/ 9c3d$$oc46
09-26-97 15:13:35
801
96. Eisenberg JM, Kitz DS. Savings from outpatient antibiotic therapy for
osteomyelitis: economic analysis of a therapeutic strategy. JAMA 1986;
255:1584 – 8.
97. Grainger-Rousseau TJ, Segal R. Economic, clinical and psychosocial outcomes of home infusion therapy: a review of published studies. Pharmacy Practice Management Quarterly 1995;15:57–77.
98. Chamberlain TM, Lehman ME, Groh MJ, Munroe WP, Reinders TP.
Cost analysis of a home intravenous antibiotic program. Am J Hosp
Pharm 1988; 45:2341 – 5.
99. Wiernikowski JT, Rothney M, Dawson S, Andrew M. Evaluation of a
home intravenous antibiotic program in pediatric oncology. Am J Pediatr Hematol Oncol 1991; 13:144 – 7.
100. Williams DN, Bosch D, Boots J, Schneider J. Safety, efficacy and cost savings
in an outpatient intravenous antibiotic program. Clin Ther 1993;15:169–79.
101. Williams DN. Home intravenous anti-infective therapy (HIVAT): do the
benefits outweigh the risks? Drug Saf 1996; 14:1 – 7.
cida
UC: CID