MONITORING CHRONIC OUTPATIENT INFECTIONS: PROVIDING COMPREHENSIVE HOME HEALTHCARE PHARMACY SERVICES Bruce H. Ackerman and Jonathan J. Wolfe
ABSTRACT: Managementof acute illness has been increasingly shifted to communitypractitioners. Expansionof communitypharmacy into home healthcarehas brought new opportunities and responsibilities to community practitioners. These practitioners are gaining expertise in total parenteral nutrition,intravenousinfusion systems, intravenous catheters,parenteral antibiotics, and clinical phannacokinetics-areas historically managed by hospitaland long-termcare facility pharmacists, This shift to community pharmacy-basedcare has brought with it the need for community pharmaciststo develop expertise in therapeutic monitoringof chronic disease states. Dose adjustmentof medications based upon careful analysis of blood concentrationsis no longer limited to institutional pharmacy practice.Community pharmacistsnow must master basic infectiousdisease principlesand possess internal medicine knowledgeto ensure appropriatemonitoringof their patients.This articlediscusses severaldisease states currently managed with community pharmacy-based home healthcare,summarizingbasic monitoring parametersfor comprehensivepatient care, and provides sample supply lists and documentationforms for home healthcareproviders.
DICP Ann Pharmacother 1991;25:840-8.
for intravenous infusion outside the hospital setting places the institutional pharmacist in a situation whereby the safety and efficacy of such therapy must be ensured. In order to carry out this responsibility, the institutional pharmacist must make certain that all parties to the proposed therapy possess the knowledge to safely carry out self-care tasks. Policies and procedures must be written and approved by institutional authorities. The community pharmacist providing these therapies mus~ p~ssess similar documentation before dispensing medications for home intravenous administration. Multiple surveys have demonstrated that the community pharmacist is a well-respected source of healthcare information, particularly in the area of self-treatment. As such, the expansion of community practice to provide outpatient antibiotic therapy, including instruction on drug administration, common adverse effects, and expected outcome with therapy, represents further extension of the role of the community pharmacist in patient care. The community pharTHE DECISION TO DISPENSE MEDICAnONS
BRUCE H. ACKERMAN, Phann.D., is an Associate Professor, Department of Pharmacy Practice, College of Pharmacy, University of Arkansas for Medical Sciences; and JONATHAN J. WOLFE, B.S.Phann., Ph.D., is an Assistant Professor, Department of Pharmacy, Outpatient Pharmacy Services, J.L. McClellan Veterans Affairs Medical Center, Little Rock, AR. Reprints: Bruce H. Ackerman, Phann.D., UAMS College of Pharmacy, Slot 522, 430 I W. Markham St., Little Rock, AR 72205.
840
•
DICP, The Annals ofPharmacotherapy
•
macist should be informed of all pharmaceutical and medical issues affecting continuity of care by pharmacists from the institution where the patient is being discharged. This communication can be very helpful for the community pharmacist with regard to disposition parameters observed, any adverse effects already noted, changes in antibiotic therapy during the course of treatment, as well as clinical and microbiologic data. This interaction will ensure continuity of care. Background
Increased management of chronic infections outside the hospital presents community pharmacists with an outstanding opportunity to gain and apply skills traditionally thought to be the domain of institutional practitioners. Government and private third-party payers have encouraged this shift to outpatient care.' In light of this shift, successful outpatient therapy will require the cooperation of hospital pharmacists in identifying an op~al antibiotic dosing regimen and training a patient, caregiver, or both in intravenous administration techniques and a cot.J1IDunity pharmacist familiar with compounding ~d momtoring skills appropriate to bridge the process of discharge and long-term care. The community-based pharmacist must have knowledge of available parenteral products as well as general knowledge of intravenous product manufacturing, including knowledge of drug stability and storage. The pharmacist should be aware of which products are available as premixed frozen or refrigerated parenteral solutions, the various doses of premixed parenteral antibiotic solutions, and available patient-convenient products.to .simplify patient compounding. Knowledge of proper dilution volumes, reconstitution techniques, various sizes of syringes and needles for use with syringe pumps, and available infusion devices and the supplies necessary for safe and effective device use is also important. Dispensing of sufficient quantities of each item should be dictated by length of therapy and product stability. Solutions for an entire cours~ of therapy should be dispensed if appropriate; however, In cases of limited stability or extended therapy, enough supplies should be provided for the patient with a minimum number of deliveries, and with appropriate extra stock to ensure that therapy will not be interrupted.
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Outpatient antibiotic therapy formerly focused on short courses of oral agents with relatively high margins of safety. Unfortunately, not all infections suitable for home ~~rarY can be managed with two to four weeks of oral antibiotic, Table I lists some common pathogens causing chronic infections for which parenteral antibiotic therapy is often required. A family of permanent indwelling intravenous catheters for outpatient use has evolved in the past ~en years. These devices vary in features; however, all penrut safe access to central venous blood flow, allowing rapid dilution of agents in large, central venous volumes otherwise not capable with unsupervised peripheral vein administration.' The decision to implant these devices and to prescribe potent antibacterial agents for home administration requires a pharmacist to be able to supervise therapies with lower therapeutic indexes than those required in the past. Community pharmacy-based home healthcare services cannot be limited. to the mere provision of drugs and supplies (Table 2) for maintenance of the patency of indwelling catheters. The pharmacist must be able to teach the patient how to use particular brands of these supplies and to reinforce aseptic technique. Table 1. Common Pathogens Treated with Outpatient Antibiotics PATHOGEN
CHRONIC INFECTION
Staphylococcus aureus
osteomyelitis, surgical wound infection, endocarditis prosthesis infection, catheter tunnel infection, endocarditis osteomyelitis, pneumonia, malignant otitis extema osteomyelitis, abscesses osteomyelitis, pneumonia pneumonia abscesses, endocarditis chronic urinary tract infection Lyme disease pneumonia
Staphylococcus epidermidis Pseudomonas aeruginosa Nocardia Serratia marcescens Acinetobacter baumanii Viridans streptococci Enterococci Borrelia burgdorffi Pneumocystis carinii
Patient Preparation
The initial step in patient preparation is to ascertain whether the patient or caregiver understands the treatment to be done in the home, the purpose of the therapy, and the expected outcome. The patient and the home-support ~et work must accept the responsibility to perform exactmg techniques for a considerable ~riod of.time. The p~ti~nt ?r caregiver must also have received satisfactory trammg m the techniques to be used. The instruction provided before initiating therapy can only be considered successful if the responsible party can demonstrate what is to be done in actual practice. The patient must have a clearly defined "safety net" in case of untoward events. At a ~nimum, the patient must have telephone access at all times to a medical professional able to interv~ne in cas.e of emerge~cy. The patient may also require a kit of supplies to deal Witha possible adverse drug reaction. The patient or caregiver must know the contents of the kit and understand when and how to use each component. Finally, the physician prescribing at-home infusion therapy must certify that the patient is sufficiently stable to allow home therapy to be completed safely. The physician must continue to provide for the patient, or arrange for care to be given under a clear assignment of responsibility. To ensure compliance with these requirements, a pharmacist should employ documentation as suggested in Figures 1-3. Forms such as these serve to document that all parties to the therapy are in agreement as to the exact treat-
FORM I STATEMENT OF POLICY AND PROCEDURES FOR DISPENSING OF MEDICATION FORHOMEINFUSION (Name of Pharmacy providing service) Policy
Medications and supplies for homeinfusion shall be dispensed by (Name) Pharmacy in a manner consistent with patient safelyand appropriate clinical outcome.
Procedure I
The physician ordering medications and/orsolutions for homeinfusion shallcertify in writing that the patientis suitable for safeand effective treatment in this manner. Thiscertification shall accompany the original prescription orderfor homeintravenous therapy.
Procedure II
The patient to receive infusion therapy in the homeshall be properly educated in the techniques needed for safe and effective administration of the medications and/or solutions. Documentation of this training shall accompany the original prescription orderfor homeintravenous therapy.
Procedure III
The patient shallreceive and understand a planfor action in the eventof untoward eventsassociated withthe home infusion therapy. Documentation of this planandthe patient's acknOWledgment of the planshall accompany the original prescription orderfor homeintravenous therapy.
Polley IV
All orders for intravenous therapy shall be issued in writing. Facsimile machine copies or orders may be substituted, exceptwheresuchuseis prohibited by lawor regulation. No ordershall be accepted verbally by the pharmacy, exceptin the caseof bonafideemergency. Any suchordershallas soonas possible be reduced to writing and delivered to the pharmacy.
Policy V
(Name) Pharmacy shallcoordinate preparation and delivery of homeintravenous medications, solutions, and/orsupplies to promote patient safelyand effective treatment.
Table 2. Supplies Required for Patient Self-Administration of Intravenous Medications Hand wash povidone-iodine surgical scrub chlorhexidine gluconate (patients allergic to povidone-iodine) latex gloves (caregivers for immunocompromised and/or infectious patients) Venous access ancillary items injection cap (Luer-Lock) alcohol prep pad, sterile syringe, 3 mL (peripheral line) syringe, 5 mL (central line) NaCI 0.9% 30-mL vial (no vial used for more than 48 h) heparin sodium 100 units/mL or NaCl 0.9% and heparin sodium 100 units/mL are preferred, if available occlusive dressing for central venous line puncture site Miscellaneous needles (not over 20-gauge bore or I inch in length) iv administration set disposal safety container for needles pm
I bottle/30 d I bottle/30 d I pair/dose
l/wk/port IIdose 2/dose 2/dose 113 doses I dose
IIdressing change
3/dose lid
Figure 1. Form documenting policy and procedures for dispensing home-infusion medication.
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ment prescribed and expectations about the treatment. The patient certifies through these forms that information, education, and procedures for routine and emergency needs have been provided. Pharmacists protect their patients and themselves by seeing that these matters are defined and clearly understood before the home-infusion therapy begins. Under this decentralized home healthcare treatment system, the patient is discharged early. The doses of medication are prepared and delivered, and home healthcare nurses assist in patient management. These services are not limited to providing patients with parenteral antibiotics. Additional services include continuous infusion opiates for pain management, chemotherapy, and hyperalimentation. The management and evaluation of these chronic therapies require the innovative community-based pharmacist to learn basic patient monitoring skills commonly employed by hospital pharmacists.' Because patient laboratory data are accessible, interpreting these data and determining appropriate laboratory tests for the extended duration of therapy are essential. Evaluation of the proposed therapy, awareness of common adverse effects and expected outcomes, and the ability to troubleshoot explanations for unexpected responses are skills that need development.'" In addition to providing therapeutic assessments, th~ community. pharmacist will need to be able to suggest VIable alternatives to apparently ineffective therapy," The following sections focus on several chronic disease states for which prolonged antibiotic therapy is required and discuss their outpatient management," Tables 3-8 provide a less-than-comprehensive list of monitoring parameters for the disease states discussed. FORM II
PATIENTSELECTION CHECKLIST 1. Physiclsn Certlflestlon I certify that (Patient Name) is medically stable. This patient may safely receive intravenous therapy at home. _ _ _ _ _ _ _ _ _ _ _ M.D.
_
(Physician Signature)
Date
2. Pstlent certlflestlon I wish to receive intravenous infusion treatment at my home. My physician has explained the therapy to me. I understand the benefits and the risks involved. I also understand the outcome planned. These are as follows: Type of venous access: Solution and/or medication: Length of therapy: Risks of therapy: Benefits of therapy: Outcome planned for therapy: (Patient Signature)
Date
3. Pstlent Eduestlon I certify that I have been instructed in proper techniques for safe and effective administration of the above listed intravenous therapy in my home. Details of the training are listed on my Patient Education Checklist. I understand the plan of action for my use in case of an emergency related to my home intravenous therapy.
Cystic Fibrosis Cystic fibrosis is a devastating, hereditary, childhood disease complicated by persistence of bacteria in the bronchi with periodic bouts of fulminant infection. Disturbances in electrolyte transport render secretions thick, viscous, and of smaller volume than normal. Advances in the management of these patients has produced greater survival of children into adulthood with an increasing number of patients requiring chronic management. In early childhood, the cystic fibrosis patient becomes colonized first with Staphylococci and then with Pseudomonas spp. that persist as chronic pathogens. Of particular concern is P. aeruginosa, which is capable of encapsulating in the mucous secretions, eroding the bronchi, and resisting eradication because of greatly decreased antibiotic permeability. For these patients, Pseudomonas will occasionally cause a relapsing or persisting pneumonia controlled only after several antibiotic treatment courses. With frequent antibiotic exposures, an additional concern is the emergence of resistance. Pharmacists managing these patients must bear this in mind throughout all antibiotic treatment courses. Table 3 outlines monitor-
FORM III
PATIENTEDUCATION CHECKLIST PATIENT NAME: PATIENT ADDRESS: PATIENT TELEPHONE: 1. Patient can state the name of each medication, solution, and diluent to be used in the prescribed therapy. 2. Patient can read the labels and differentiate the products to be used. 3. Patient can state the name and purpose of each item prescribed for the home infusion therapy. 4. Patient can state the frequency of doses and the time period over which each is to be infused. 5. Patient can state the location of venous access. 6. Patient can state the solution and the volume of solution required to flush and maintain the venous access. 7. Patient can state the proper technique for assuring patency of venous access. 8. Patient has demonstrated the preparation and administration of a dose as planned for home therapy. 9. Patient states the proper technique for disposal of medical wastes from the proposed home infusion therapy. 10. Patient demonstrates the proper use of a disposal device for syringes and needles. 11. The patient can state the procedures to be followed in case of an adverse event associated with home infusion therapy: a. Physician responsible for therapy: b. Telephone number for assistance: c. Place to come for emergency care: 12. If patient has an emergency drug kit, a. Patient can state the name of each drug and item in the kit (listed on separate prescription order to be delivered with initial supply of medications and/or solutions). b. Patient can read the name and differentiate each item in the emergency kit. 13. If a caregiver other than the patient will perform the prescribed home infusion therapy, list that person's name, address, and telephone number here: NAME: ADDRESS: TELEPHONE NUMBER: The above person meets the education criteria set out above.
(Patient Signature)
Date
THISFORMMUSTACCOMPANYTHEORIGINALPRESCRIPTION ORDER. Figure 2. Fonn documenting patient certification.
842 •
Witness
Date (Witness shall be the person who performed the training)
Figure 3. Form documenting patient education.
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Home Healthcare
ing parameters for patients with nosocomial pneumonia. The realistic therapeutic outcome for these patients is to contain Pseudomonas and reduce, but not eliminate, its presence in the bronchi and sputum. In general, cystic fibrosis patients have increased drug clearance. As a result, higher doses of antibiotics or more frequent antibiotic administrations are required. The most notable research concerning altered disposition of drugs has been with the arninoglycosides, where Kearns et al. have demonstrated larger apparent volumes of distribution and increased clearance of aminoglycosides.'? Clinical management of aminoglycoside-treated cystic fibrosis patients must include pharmacokinetic monitoring. Patients are likely to require larger doses of arninoglycosides with more frequent administration than would be predicted by the various empiric methods. II Thorough development of clinical pharmacokinetic monitoring skills is necessary before attempting pharmacokinetic dosing of arninoglycosides in these patients. Pharmacokinetic knowledge is also important when adjusting antibiotic doses for which serum concentration monitoring is not routinely available. Beta-Iactam antibiotics require the maintenance of serum concentrations between doses at several times the minimum inhibitory concentration (MIC) of Pseudomonas. Thus, shortening the dosing interval may reduce febrile episodes in these patients as well as increase the efficacy of the chosen antibiotic regimen." The advent of oral quinolone antibiotics has revolutionized the management of infections, as these agents may permit early discontinuation of parenteral antibiotics. The quinolones achieve lung tissue concentrations approximately twice those of the serum and thus appear to be ideal for the adult cystic fibrosis patient." The decision to change to a fluoroquinolone is often based on the rapid resolution of pneumonia symptoms. The limited Streptococcus spp. coverage by the fluoroquinolones is one problem for these patients, and continued follow up may be needed following discontinuation of parenteral antibiotics.P VentiloJor-Dependent Patients
Other patients who are subject to repeated pneumonias are those who for various reasons have become ventilatordependent. Most often these patients have diaphragmatic dysfunction or neurologic disease. Intubation and mechan-
ical ventilation are not benign procedures but are fraught with multiple complications.P Intubated patients no longer have a cough reflex and are therefore unable to remove secretions well. Suctioning of secretions may introduce bacteria into the trachea as well as damage the mucosa. Abscesses and infections may occur around an endotracheal tube or the patient may have an inflammatory response to its presence. Patients with a permanent tracheostomy receive ventilations without the benefit of the natural defenses of the nose and throat. In addition, the normal hydration of air that is accomplished by the nasal passages must be duplicated mechanically by the bubbling of air through a water chamber. This hydrated air may cause condensation of water in the respirator tubes and could thus be a source for colonization by such water-loving bacteria as Serratia, Acinetobacter, and Pseudomonas. IS Like cystic fibrosis patients, the ventilator-dependent patient may become colonized in the bronchi with pathogenic bacteria resulting in periodic bouts of pneumonia. These patients may also fail to eradicate the pathogen and the therapeutic outcome may be to reduce the potential for subsequent pneumonias." Patients may require innovative therapeutic management, such as arninoglycoside nebulizations, to reduce the bacterial burden in the bronchi. Poor penetration of most antibiotics in the lung complicates the management of chronic respirator patients.'? Single-antibiotic treatment of a nosocomial pneumonia is seldom wise. Even potent antibiotics such as imipenem/cilastatin should not be used alone in these patients. The manufacturer of imipenem/cilastatin currently recommends administration of an arninoglycoside for synergy because of the poor penetration of beta-Iactam antibiotics into the lungs. There are many antibiotic choices for appropriate management of the ventilator-dependent patient. For the pharmacist providing parenteral antibiotics, therapeutic evaluation of the antibiotic regimen chosen is important as well. Skills described for the management of pneumonias in therapeutics texts should be helpful in making this assessment (Table 3). Briefly, patients should demonstrate substantial improvement within five days of initiating antibiotic therapy. White blood cell counts should return to normal and the patient should defervesce. Hemodynamic and metabolic derangements likewise should be normalizing. Monitoring blood pressures may be difficult in spinal cord injury patients because of the use of phenoxybenzarnine hydrochlo-
Table 3. Monitoring Parameters for Patients with Nosocomial Pneumonia
PARAMETER
Serum creatinine Fevers White blood cells Patient-specific parameters sputum production hypotension and/or tachycardia electrolytes normal? tachypnea? Gentamicin concentrations, see Table 4 Tobramycin concentrations, see Table 4 Amikacin concentrations, see Table 4 Vancomycin concentrations, see Table 4 Ciprofloxacin concentrations, see Table 4
STAPHYLOCOCCI AND METHICILLIN-RESISTANT STAPHYLOCOCCI
ENTEROBACTERIACEAE
PSEUDOMONAS AERUGINOSA
weekly break at day 5 fall to normal in 5 d
weekly break at 5-7 d normal with fever lysis
weekly break at 5-7 d normal with fever lysis
rapidly decrease yes -e call MD no -e call Mlr yes -e call Ml)
markedly decrease yes -e call Mlr
markedly decrease yes -e call Mu no s-e call Ml) yes -e call Mlj
no~callMD yes~callMD
MD = patient's physician.
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843
ride and other alpha-blockers used to prevent periodic spikes of hypertension. These drugs prevent periodic hypertensive crises resulting from normal or near-normal systemic release of epinephrine or norepinephrine. Therefore, treated patients will normally be hypotensive. Interpreting blood pressures from bedridden patients with chronic illness also may be difficult. The need for increased respirator settings, apparent metabolic acidosis, or respiratory alkalosis may instead indicate increased metabolic stress secondary to infection. Among the most severe infections besetting the chronically ill patient are infections with Staphylococcus Spp.18 These organisms are capable of elaborating toxins, hiding from the immune system, and persisting and relapsing in spite of apparently adequate antibiotic treatment. The emergence of methicillin resistance, particularly among S. epidermidis, is a serious problem. Many chronically ill patients require maintenance of intravenous catheters, endotracheal tubes, and Foley catheters that may be infected and colonized by S. epidermidis. As a result, the risk of bacteremia with Staphylococcus spp. among these patients is potentially very high. Violations of aseptic technique may occur when family members or patients administer antibiotics, potentially resulting in bacteremia, endocarditis, or osteomyelitis because of the introduction of organisms onto the catheter with dissemination into the bloodstream. Osteomyelitis
Home healthcare has been extensively used in the management of acute and chronic osteomyelitis." Previously, osteomyelitis patients were unknown to community practitioners; osteomyelitis therapy is now often completed with parenteral antibiotics by community pharmacists. In the past, patients were hospitalized for four to six weeks to receive parenteral antibiotic therapy. Increasingly, patients
are admitted for five to nine days for initial management to ensure the efficacy of a chosen antibiotic regimen and then discharged to home healthcare providers for continuation of the four- to six-week course of parenteral antibiotics. Pediatric osteomyelitis often can be treated with oral antibiotics after three to five days of parenteral therapy." Clinical experience with adult oral therapy following parenteral antibiotics is limited at this time and continuation of parenteral antibiotics is currently suggested. Osteomyelitis of the long bones, elbow, and knee is common in children. Most pediatric osteomyelitis results from local trauma with contiguous spread from soft tissue to bone. Osteomyelitis of the vertebrae, skull, hip, and around orthopedic prostheses is more common in adults. Adult osteomyelitis results from bacteremias, complications of arteriosclerosis or diabetes mellitus, or from contiguous spread from improperly treated skin infections or decubiti. Adult osteomyelitis may be characterized as a subtle infection with few definitive signs. Usually it is a very localized infection of a single bone involving Staphylococcus, anaerobic Streptococci, Enterobacteriaceae including Salmonella, or Pseudomonas spp. These bacteria are all capable of sequestering in the bone and persisting if initiation of treatment is delayed. Children often have local pain and fever whereas adults have much more diffuse pain and may or may not have fever. If untreated, the patient will progress to night sweats, profound weight loss, anemia, and swelling of soft tissue above the bone. Erythrocyte sedimentation rates (ESRs) are frequently the most prominent laboratory abnormality in children, but in adults, elevation of ESRs can be the result of many noninfectious diseases. The complete blood count may be unremarkable with minimalleukocytosis and anemia. Elevation of monocytes indicates that the osteomyelitis has been untreated for at least seven days and the patient is at greater risk for chronic osteomyelitis. Monitoring parameters are outlined in Table 4.
Table 4. Monitoring Parameters for Infected Osteomyelitis Patients STAPHYLOCOCCI AND METHICILLIN-RESISTANT STAPHYLOCOCCI
PARAMETER
weekly weekly therapeutic failure q2wk not helpful 15-22 mgIL 2-4 mgIL 8mgIL
ABSTRACT: Managementof acute illness has been increasingly shifted to communitypractitioners. Expansionof communitypharmacy into home healthcarehas brought new opportunities and responsibilities to community practitioners. These practitioners are gaining expertise in total parenteral nutrition,intravenousinfusion systems, intravenous catheters,parenteral antibiotics, and clinical phannacokinetics-areas historically managed by hospitaland long-termcare facility pharmacists, This shift to community pharmacy-basedcare has brought with it the need for community pharmaciststo develop expertise in therapeutic monitoringof chronic disease states. Dose adjustmentof medications based upon careful analysis of blood concentrationsis no longer limited to institutional pharmacy practice.Community pharmacistsnow must master basic infectiousdisease principlesand possess internal medicine knowledgeto ensure appropriatemonitoringof their patients.This articlediscusses severaldisease states currently managed with community pharmacy-based home healthcare,summarizingbasic monitoring parametersfor comprehensivepatient care, and provides sample supply lists and documentationforms for home healthcareproviders.
DICP Ann Pharmacother 1991;25:840-8.
for intravenous infusion outside the hospital setting places the institutional pharmacist in a situation whereby the safety and efficacy of such therapy must be ensured. In order to carry out this responsibility, the institutional pharmacist must make certain that all parties to the proposed therapy possess the knowledge to safely carry out self-care tasks. Policies and procedures must be written and approved by institutional authorities. The community pharmacist providing these therapies mus~ p~ssess similar documentation before dispensing medications for home intravenous administration. Multiple surveys have demonstrated that the community pharmacist is a well-respected source of healthcare information, particularly in the area of self-treatment. As such, the expansion of community practice to provide outpatient antibiotic therapy, including instruction on drug administration, common adverse effects, and expected outcome with therapy, represents further extension of the role of the community pharmacist in patient care. The community pharTHE DECISION TO DISPENSE MEDICAnONS
BRUCE H. ACKERMAN, Phann.D., is an Associate Professor, Department of Pharmacy Practice, College of Pharmacy, University of Arkansas for Medical Sciences; and JONATHAN J. WOLFE, B.S.Phann., Ph.D., is an Assistant Professor, Department of Pharmacy, Outpatient Pharmacy Services, J.L. McClellan Veterans Affairs Medical Center, Little Rock, AR. Reprints: Bruce H. Ackerman, Phann.D., UAMS College of Pharmacy, Slot 522, 430 I W. Markham St., Little Rock, AR 72205.
840
•
DICP, The Annals ofPharmacotherapy
•
macist should be informed of all pharmaceutical and medical issues affecting continuity of care by pharmacists from the institution where the patient is being discharged. This communication can be very helpful for the community pharmacist with regard to disposition parameters observed, any adverse effects already noted, changes in antibiotic therapy during the course of treatment, as well as clinical and microbiologic data. This interaction will ensure continuity of care. Background
Increased management of chronic infections outside the hospital presents community pharmacists with an outstanding opportunity to gain and apply skills traditionally thought to be the domain of institutional practitioners. Government and private third-party payers have encouraged this shift to outpatient care.' In light of this shift, successful outpatient therapy will require the cooperation of hospital pharmacists in identifying an op~al antibiotic dosing regimen and training a patient, caregiver, or both in intravenous administration techniques and a cot.J1IDunity pharmacist familiar with compounding ~d momtoring skills appropriate to bridge the process of discharge and long-term care. The community-based pharmacist must have knowledge of available parenteral products as well as general knowledge of intravenous product manufacturing, including knowledge of drug stability and storage. The pharmacist should be aware of which products are available as premixed frozen or refrigerated parenteral solutions, the various doses of premixed parenteral antibiotic solutions, and available patient-convenient products.to .simplify patient compounding. Knowledge of proper dilution volumes, reconstitution techniques, various sizes of syringes and needles for use with syringe pumps, and available infusion devices and the supplies necessary for safe and effective device use is also important. Dispensing of sufficient quantities of each item should be dictated by length of therapy and product stability. Solutions for an entire cours~ of therapy should be dispensed if appropriate; however, In cases of limited stability or extended therapy, enough supplies should be provided for the patient with a minimum number of deliveries, and with appropriate extra stock to ensure that therapy will not be interrupted.
/991 July/August, Volume 25
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Outpatient antibiotic therapy formerly focused on short courses of oral agents with relatively high margins of safety. Unfortunately, not all infections suitable for home ~~rarY can be managed with two to four weeks of oral antibiotic, Table I lists some common pathogens causing chronic infections for which parenteral antibiotic therapy is often required. A family of permanent indwelling intravenous catheters for outpatient use has evolved in the past ~en years. These devices vary in features; however, all penrut safe access to central venous blood flow, allowing rapid dilution of agents in large, central venous volumes otherwise not capable with unsupervised peripheral vein administration.' The decision to implant these devices and to prescribe potent antibacterial agents for home administration requires a pharmacist to be able to supervise therapies with lower therapeutic indexes than those required in the past. Community pharmacy-based home healthcare services cannot be limited. to the mere provision of drugs and supplies (Table 2) for maintenance of the patency of indwelling catheters. The pharmacist must be able to teach the patient how to use particular brands of these supplies and to reinforce aseptic technique. Table 1. Common Pathogens Treated with Outpatient Antibiotics PATHOGEN
CHRONIC INFECTION
Staphylococcus aureus
osteomyelitis, surgical wound infection, endocarditis prosthesis infection, catheter tunnel infection, endocarditis osteomyelitis, pneumonia, malignant otitis extema osteomyelitis, abscesses osteomyelitis, pneumonia pneumonia abscesses, endocarditis chronic urinary tract infection Lyme disease pneumonia
Staphylococcus epidermidis Pseudomonas aeruginosa Nocardia Serratia marcescens Acinetobacter baumanii Viridans streptococci Enterococci Borrelia burgdorffi Pneumocystis carinii
Patient Preparation
The initial step in patient preparation is to ascertain whether the patient or caregiver understands the treatment to be done in the home, the purpose of the therapy, and the expected outcome. The patient and the home-support ~et work must accept the responsibility to perform exactmg techniques for a considerable ~riod of.time. The p~ti~nt ?r caregiver must also have received satisfactory trammg m the techniques to be used. The instruction provided before initiating therapy can only be considered successful if the responsible party can demonstrate what is to be done in actual practice. The patient must have a clearly defined "safety net" in case of untoward events. At a ~nimum, the patient must have telephone access at all times to a medical professional able to interv~ne in cas.e of emerge~cy. The patient may also require a kit of supplies to deal Witha possible adverse drug reaction. The patient or caregiver must know the contents of the kit and understand when and how to use each component. Finally, the physician prescribing at-home infusion therapy must certify that the patient is sufficiently stable to allow home therapy to be completed safely. The physician must continue to provide for the patient, or arrange for care to be given under a clear assignment of responsibility. To ensure compliance with these requirements, a pharmacist should employ documentation as suggested in Figures 1-3. Forms such as these serve to document that all parties to the therapy are in agreement as to the exact treat-
FORM I STATEMENT OF POLICY AND PROCEDURES FOR DISPENSING OF MEDICATION FORHOMEINFUSION (Name of Pharmacy providing service) Policy
Medications and supplies for homeinfusion shall be dispensed by (Name) Pharmacy in a manner consistent with patient safelyand appropriate clinical outcome.
Procedure I
The physician ordering medications and/orsolutions for homeinfusion shallcertify in writing that the patientis suitable for safeand effective treatment in this manner. Thiscertification shall accompany the original prescription orderfor homeintravenous therapy.
Procedure II
The patient to receive infusion therapy in the homeshall be properly educated in the techniques needed for safe and effective administration of the medications and/or solutions. Documentation of this training shall accompany the original prescription orderfor homeintravenous therapy.
Procedure III
The patient shallreceive and understand a planfor action in the eventof untoward eventsassociated withthe home infusion therapy. Documentation of this planandthe patient's acknOWledgment of the planshall accompany the original prescription orderfor homeintravenous therapy.
Polley IV
All orders for intravenous therapy shall be issued in writing. Facsimile machine copies or orders may be substituted, exceptwheresuchuseis prohibited by lawor regulation. No ordershall be accepted verbally by the pharmacy, exceptin the caseof bonafideemergency. Any suchordershallas soonas possible be reduced to writing and delivered to the pharmacy.
Policy V
(Name) Pharmacy shallcoordinate preparation and delivery of homeintravenous medications, solutions, and/orsupplies to promote patient safelyand effective treatment.
Table 2. Supplies Required for Patient Self-Administration of Intravenous Medications Hand wash povidone-iodine surgical scrub chlorhexidine gluconate (patients allergic to povidone-iodine) latex gloves (caregivers for immunocompromised and/or infectious patients) Venous access ancillary items injection cap (Luer-Lock) alcohol prep pad, sterile syringe, 3 mL (peripheral line) syringe, 5 mL (central line) NaCI 0.9% 30-mL vial (no vial used for more than 48 h) heparin sodium 100 units/mL or NaCl 0.9% and heparin sodium 100 units/mL are preferred, if available occlusive dressing for central venous line puncture site Miscellaneous needles (not over 20-gauge bore or I inch in length) iv administration set disposal safety container for needles pm
I bottle/30 d I bottle/30 d I pair/dose
l/wk/port IIdose 2/dose 2/dose 113 doses I dose
IIdressing change
3/dose lid
Figure 1. Form documenting policy and procedures for dispensing home-infusion medication.
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ment prescribed and expectations about the treatment. The patient certifies through these forms that information, education, and procedures for routine and emergency needs have been provided. Pharmacists protect their patients and themselves by seeing that these matters are defined and clearly understood before the home-infusion therapy begins. Under this decentralized home healthcare treatment system, the patient is discharged early. The doses of medication are prepared and delivered, and home healthcare nurses assist in patient management. These services are not limited to providing patients with parenteral antibiotics. Additional services include continuous infusion opiates for pain management, chemotherapy, and hyperalimentation. The management and evaluation of these chronic therapies require the innovative community-based pharmacist to learn basic patient monitoring skills commonly employed by hospital pharmacists.' Because patient laboratory data are accessible, interpreting these data and determining appropriate laboratory tests for the extended duration of therapy are essential. Evaluation of the proposed therapy, awareness of common adverse effects and expected outcomes, and the ability to troubleshoot explanations for unexpected responses are skills that need development.'" In addition to providing therapeutic assessments, th~ community. pharmacist will need to be able to suggest VIable alternatives to apparently ineffective therapy," The following sections focus on several chronic disease states for which prolonged antibiotic therapy is required and discuss their outpatient management," Tables 3-8 provide a less-than-comprehensive list of monitoring parameters for the disease states discussed. FORM II
PATIENTSELECTION CHECKLIST 1. Physiclsn Certlflestlon I certify that (Patient Name) is medically stable. This patient may safely receive intravenous therapy at home. _ _ _ _ _ _ _ _ _ _ _ M.D.
_
(Physician Signature)
Date
2. Pstlent certlflestlon I wish to receive intravenous infusion treatment at my home. My physician has explained the therapy to me. I understand the benefits and the risks involved. I also understand the outcome planned. These are as follows: Type of venous access: Solution and/or medication: Length of therapy: Risks of therapy: Benefits of therapy: Outcome planned for therapy: (Patient Signature)
Date
3. Pstlent Eduestlon I certify that I have been instructed in proper techniques for safe and effective administration of the above listed intravenous therapy in my home. Details of the training are listed on my Patient Education Checklist. I understand the plan of action for my use in case of an emergency related to my home intravenous therapy.
Cystic Fibrosis Cystic fibrosis is a devastating, hereditary, childhood disease complicated by persistence of bacteria in the bronchi with periodic bouts of fulminant infection. Disturbances in electrolyte transport render secretions thick, viscous, and of smaller volume than normal. Advances in the management of these patients has produced greater survival of children into adulthood with an increasing number of patients requiring chronic management. In early childhood, the cystic fibrosis patient becomes colonized first with Staphylococci and then with Pseudomonas spp. that persist as chronic pathogens. Of particular concern is P. aeruginosa, which is capable of encapsulating in the mucous secretions, eroding the bronchi, and resisting eradication because of greatly decreased antibiotic permeability. For these patients, Pseudomonas will occasionally cause a relapsing or persisting pneumonia controlled only after several antibiotic treatment courses. With frequent antibiotic exposures, an additional concern is the emergence of resistance. Pharmacists managing these patients must bear this in mind throughout all antibiotic treatment courses. Table 3 outlines monitor-
FORM III
PATIENTEDUCATION CHECKLIST PATIENT NAME: PATIENT ADDRESS: PATIENT TELEPHONE: 1. Patient can state the name of each medication, solution, and diluent to be used in the prescribed therapy. 2. Patient can read the labels and differentiate the products to be used. 3. Patient can state the name and purpose of each item prescribed for the home infusion therapy. 4. Patient can state the frequency of doses and the time period over which each is to be infused. 5. Patient can state the location of venous access. 6. Patient can state the solution and the volume of solution required to flush and maintain the venous access. 7. Patient can state the proper technique for assuring patency of venous access. 8. Patient has demonstrated the preparation and administration of a dose as planned for home therapy. 9. Patient states the proper technique for disposal of medical wastes from the proposed home infusion therapy. 10. Patient demonstrates the proper use of a disposal device for syringes and needles. 11. The patient can state the procedures to be followed in case of an adverse event associated with home infusion therapy: a. Physician responsible for therapy: b. Telephone number for assistance: c. Place to come for emergency care: 12. If patient has an emergency drug kit, a. Patient can state the name of each drug and item in the kit (listed on separate prescription order to be delivered with initial supply of medications and/or solutions). b. Patient can read the name and differentiate each item in the emergency kit. 13. If a caregiver other than the patient will perform the prescribed home infusion therapy, list that person's name, address, and telephone number here: NAME: ADDRESS: TELEPHONE NUMBER: The above person meets the education criteria set out above.
(Patient Signature)
Date
THISFORMMUSTACCOMPANYTHEORIGINALPRESCRIPTION ORDER. Figure 2. Fonn documenting patient certification.
842 •
Witness
Date (Witness shall be the person who performed the training)
Figure 3. Form documenting patient education.
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Home Healthcare
ing parameters for patients with nosocomial pneumonia. The realistic therapeutic outcome for these patients is to contain Pseudomonas and reduce, but not eliminate, its presence in the bronchi and sputum. In general, cystic fibrosis patients have increased drug clearance. As a result, higher doses of antibiotics or more frequent antibiotic administrations are required. The most notable research concerning altered disposition of drugs has been with the arninoglycosides, where Kearns et al. have demonstrated larger apparent volumes of distribution and increased clearance of aminoglycosides.'? Clinical management of aminoglycoside-treated cystic fibrosis patients must include pharmacokinetic monitoring. Patients are likely to require larger doses of arninoglycosides with more frequent administration than would be predicted by the various empiric methods. II Thorough development of clinical pharmacokinetic monitoring skills is necessary before attempting pharmacokinetic dosing of arninoglycosides in these patients. Pharmacokinetic knowledge is also important when adjusting antibiotic doses for which serum concentration monitoring is not routinely available. Beta-Iactam antibiotics require the maintenance of serum concentrations between doses at several times the minimum inhibitory concentration (MIC) of Pseudomonas. Thus, shortening the dosing interval may reduce febrile episodes in these patients as well as increase the efficacy of the chosen antibiotic regimen." The advent of oral quinolone antibiotics has revolutionized the management of infections, as these agents may permit early discontinuation of parenteral antibiotics. The quinolones achieve lung tissue concentrations approximately twice those of the serum and thus appear to be ideal for the adult cystic fibrosis patient." The decision to change to a fluoroquinolone is often based on the rapid resolution of pneumonia symptoms. The limited Streptococcus spp. coverage by the fluoroquinolones is one problem for these patients, and continued follow up may be needed following discontinuation of parenteral antibiotics.P VentiloJor-Dependent Patients
Other patients who are subject to repeated pneumonias are those who for various reasons have become ventilatordependent. Most often these patients have diaphragmatic dysfunction or neurologic disease. Intubation and mechan-
ical ventilation are not benign procedures but are fraught with multiple complications.P Intubated patients no longer have a cough reflex and are therefore unable to remove secretions well. Suctioning of secretions may introduce bacteria into the trachea as well as damage the mucosa. Abscesses and infections may occur around an endotracheal tube or the patient may have an inflammatory response to its presence. Patients with a permanent tracheostomy receive ventilations without the benefit of the natural defenses of the nose and throat. In addition, the normal hydration of air that is accomplished by the nasal passages must be duplicated mechanically by the bubbling of air through a water chamber. This hydrated air may cause condensation of water in the respirator tubes and could thus be a source for colonization by such water-loving bacteria as Serratia, Acinetobacter, and Pseudomonas. IS Like cystic fibrosis patients, the ventilator-dependent patient may become colonized in the bronchi with pathogenic bacteria resulting in periodic bouts of pneumonia. These patients may also fail to eradicate the pathogen and the therapeutic outcome may be to reduce the potential for subsequent pneumonias." Patients may require innovative therapeutic management, such as arninoglycoside nebulizations, to reduce the bacterial burden in the bronchi. Poor penetration of most antibiotics in the lung complicates the management of chronic respirator patients.'? Single-antibiotic treatment of a nosocomial pneumonia is seldom wise. Even potent antibiotics such as imipenem/cilastatin should not be used alone in these patients. The manufacturer of imipenem/cilastatin currently recommends administration of an arninoglycoside for synergy because of the poor penetration of beta-Iactam antibiotics into the lungs. There are many antibiotic choices for appropriate management of the ventilator-dependent patient. For the pharmacist providing parenteral antibiotics, therapeutic evaluation of the antibiotic regimen chosen is important as well. Skills described for the management of pneumonias in therapeutics texts should be helpful in making this assessment (Table 3). Briefly, patients should demonstrate substantial improvement within five days of initiating antibiotic therapy. White blood cell counts should return to normal and the patient should defervesce. Hemodynamic and metabolic derangements likewise should be normalizing. Monitoring blood pressures may be difficult in spinal cord injury patients because of the use of phenoxybenzarnine hydrochlo-
Table 3. Monitoring Parameters for Patients with Nosocomial Pneumonia
PARAMETER
Serum creatinine Fevers White blood cells Patient-specific parameters sputum production hypotension and/or tachycardia electrolytes normal? tachypnea? Gentamicin concentrations, see Table 4 Tobramycin concentrations, see Table 4 Amikacin concentrations, see Table 4 Vancomycin concentrations, see Table 4 Ciprofloxacin concentrations, see Table 4
STAPHYLOCOCCI AND METHICILLIN-RESISTANT STAPHYLOCOCCI
ENTEROBACTERIACEAE
PSEUDOMONAS AERUGINOSA
weekly break at day 5 fall to normal in 5 d
weekly break at 5-7 d normal with fever lysis
weekly break at 5-7 d normal with fever lysis
rapidly decrease yes -e call MD no -e call Mlr yes -e call Ml)
markedly decrease yes -e call Mlr
markedly decrease yes -e call Mu no s-e call Ml) yes -e call Mlj
no~callMD yes~callMD
MD = patient's physician.
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ride and other alpha-blockers used to prevent periodic spikes of hypertension. These drugs prevent periodic hypertensive crises resulting from normal or near-normal systemic release of epinephrine or norepinephrine. Therefore, treated patients will normally be hypotensive. Interpreting blood pressures from bedridden patients with chronic illness also may be difficult. The need for increased respirator settings, apparent metabolic acidosis, or respiratory alkalosis may instead indicate increased metabolic stress secondary to infection. Among the most severe infections besetting the chronically ill patient are infections with Staphylococcus Spp.18 These organisms are capable of elaborating toxins, hiding from the immune system, and persisting and relapsing in spite of apparently adequate antibiotic treatment. The emergence of methicillin resistance, particularly among S. epidermidis, is a serious problem. Many chronically ill patients require maintenance of intravenous catheters, endotracheal tubes, and Foley catheters that may be infected and colonized by S. epidermidis. As a result, the risk of bacteremia with Staphylococcus spp. among these patients is potentially very high. Violations of aseptic technique may occur when family members or patients administer antibiotics, potentially resulting in bacteremia, endocarditis, or osteomyelitis because of the introduction of organisms onto the catheter with dissemination into the bloodstream. Osteomyelitis
Home healthcare has been extensively used in the management of acute and chronic osteomyelitis." Previously, osteomyelitis patients were unknown to community practitioners; osteomyelitis therapy is now often completed with parenteral antibiotics by community pharmacists. In the past, patients were hospitalized for four to six weeks to receive parenteral antibiotic therapy. Increasingly, patients
are admitted for five to nine days for initial management to ensure the efficacy of a chosen antibiotic regimen and then discharged to home healthcare providers for continuation of the four- to six-week course of parenteral antibiotics. Pediatric osteomyelitis often can be treated with oral antibiotics after three to five days of parenteral therapy." Clinical experience with adult oral therapy following parenteral antibiotics is limited at this time and continuation of parenteral antibiotics is currently suggested. Osteomyelitis of the long bones, elbow, and knee is common in children. Most pediatric osteomyelitis results from local trauma with contiguous spread from soft tissue to bone. Osteomyelitis of the vertebrae, skull, hip, and around orthopedic prostheses is more common in adults. Adult osteomyelitis results from bacteremias, complications of arteriosclerosis or diabetes mellitus, or from contiguous spread from improperly treated skin infections or decubiti. Adult osteomyelitis may be characterized as a subtle infection with few definitive signs. Usually it is a very localized infection of a single bone involving Staphylococcus, anaerobic Streptococci, Enterobacteriaceae including Salmonella, or Pseudomonas spp. These bacteria are all capable of sequestering in the bone and persisting if initiation of treatment is delayed. Children often have local pain and fever whereas adults have much more diffuse pain and may or may not have fever. If untreated, the patient will progress to night sweats, profound weight loss, anemia, and swelling of soft tissue above the bone. Erythrocyte sedimentation rates (ESRs) are frequently the most prominent laboratory abnormality in children, but in adults, elevation of ESRs can be the result of many noninfectious diseases. The complete blood count may be unremarkable with minimalleukocytosis and anemia. Elevation of monocytes indicates that the osteomyelitis has been untreated for at least seven days and the patient is at greater risk for chronic osteomyelitis. Monitoring parameters are outlined in Table 4.
Table 4. Monitoring Parameters for Infected Osteomyelitis Patients STAPHYLOCOCCI AND METHICILLIN-RESISTANT STAPHYLOCOCCI
PARAMETER
weekly weekly therapeutic failure q2wk not helpful 15-22 mgIL 2-4 mgIL 8mgIL
