Learning Outcomes
After completing this chapter, you will be able to
Identify the historical reasons for establishing home care services and the growth of the home care industry.
Cite the seven goals of home care therapy.
Identify the members of the home care team and describe their primary roles in the home care process.
List at least three different methods of drug distribution in which technicians play an active role.
Identify the most common diseases or conditions treated with home care services.
Identify the top drug classes used in home infusion therapy. List one or two parameters for these drugs that affect how they are used in the home environment.
Compare the advantages and disadvantages of the types of infusion systems available for use in a patient’s home.
List the labeling requirements for sterile products that are to be used in a patient’s home.
Outline the factors that are important to consider when determining expiration dates for sterile products used in the home care setting.
Key Terms
| case manager | Helps determine the location of the therapy. The case manager may work for the insurance company, the hospital, or the home care company. The case manager works to manage the cost of medical care for the patient and may be very influential in steering a patient toward home care. |
Historical Overview and Current Practices
Purpose and Goals of Home Infusion Therapy
The Home Care Team and Specific Roles
Administration of Medications in the Home Care Patient Compounding in the Home Care Setting Guidelines for Sterile Compounding Devices Used for Sterile Compounding Labeling and Expiration Dating of Compounded Products Packaging and Transport of Compounded Products Supplies for the Home Care Patient Infection Control and Safe Disposal |
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Home health care is the provision of health care services in the patient’s home, rather than an institutional setting or provider’s office.1 Home care pharmacy is part of home health care practice. The majority of pharmaceuticals in noninstitutional settings are provided through the community pharmacy system. The role of home care pharmacy is to provide intravenous (IV) medications and hightechnology services in the home. In the home care setting, the pharmacy technician can assist the pharmacist in the preparation of parenteral products as well as being involved with inventory maintenance and control, creating and maintaining patient supply inventory, and making deliveries to patients’ homes. Much of the material covered in Chapter 16, Aseptic Technique, Sterile Compounding, and Intravenous Admixture Systems, complements this chapter. Technicians planning to practice in a home care setting should review both chapters thoroughly.
Historical Overview and Current Practices
Patients first began receiving infusion therapy in the home, rather than in an institutional setting, in the late 1970s. The driving force for sending patients home was twofold: keeping patients in the hospital to receive longterm intravenous antibiotic therapy or parenteral nutrition was becoming too expensive, and patients and their families considered it a hardship to “live” in the hospital for the duration of the patients’ treatment. These long-term patients often required minimal intensive medical care other than the care associated with their infusion therapy. The search for alternatives to hospitalization led to the development of programs to treat long-term infusion patients at home, and the home infusion industry was born. In the past 25 years, home care, and in particular home infusion, has become one of the fastest growing segments of health care.2 The alternate-site infusion therapy sector continues to expand. This is being driven by heightened emphasis on cost-effectiveness and cost containment, and the desire of patients to resume normal lifestyles and work activities while recovering from illness. This sector is currently estimated to represent approximately 9 to 11 billion dollars per year in U.S. health care expenditures serviced by 700 to 1,000 infusion pharmacies.3
Home infusion has grown rapidly for several reasons. First, a number of studies have shown that administration of long-term IV therapy in the home is safe and effective, as well as less expensive, which helped physicians and insurance companies overcome any fear or reluctance they may have had in sending their patients to home health care agencies. In addition, the explosion of technology has supported the movement of patients to the home care setting. New developments have brought infusion pumps that are portable, small, easily programmable for a wide range of therapies, and, in some cases, disposable. These new infusion pumps have made it easier to teach nonprofessionals, such as patients and their families, to administer complicated therapies at home. Although consumers have demanded home care—citing improved quality of life, ability to return to work, and greater independence—the strongest impetus for home health care came from the dramatic changes in our health care system. Escalating health care costs forced hospitals to decrease the length of time patients spent in the hospital. As a result, patients are discharged earlier in the course of treatment and often need additional care when they get home. The need for more intensive medical care and support in the home provided opportunities for the home health care industry to grow. Finally, treating patients at home has the advantage, in some cases, of helping them to avoid the development of new infections in the hospital, such as hospital-acquired pneumonia.
Home infusion services are provided by a number of organizations, including hospitals, community pharmacies, home health nursing companies, integrated health care systems, and independent home infusion companies. After the tremendous expansion of home health care organizations, we are now seeing a consolidation, with mergers of companies and shifting of dominance among the providers of home infusion services.
In addition, there appear to be more home infusion services that are providing therapies for niche markets, including national specialty pharmacies. These providers often focus care on patients requiring growth hormone and anti-hemophilic factor; however, in the past few years, their practice has expanded into the provision of biotechnology products and the treatments of rare, chronic diseases.4
Summary of Home Care Practice
Purpose and Goals of Home Infusion Therapy
The purpose of home care pharmacy practice is to provide high-technology therapy, which is usually available in an institutional setting, at home. The goals of home care services are summarized in table 5-1.
Overall, the major goal of home care pharmacy practice is to provide safe and effective infusion therapy in the home that is also cost-effective.
The Home Care Process
A patient may enter the home care process a number of ways. Usually a physician will recommend that a patient complete therapy at home. In some instances, the patient and the patient’s family advocate home therapy, or the patient’s insurance company may dictate where therapy will be provided. Sometimes an individual called a case manager will mediate the location of the therapy. The case manager may work for the insurance company, the hospital, or the home care company. The case manager works to manage the cost of medical care for the patient and may be very influential in steering a patient toward home care. The hospital may also initiate the process as it tries to control its costs by reducing patients’ length of stay.
Table 5–1. Goals of Home Care
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Allow patients to leave the hospital earlier
Allow patients to receive treatment without being hospitalized
Allow patients to return to work or normal activities sooner
Allow patients to recuperate in the comfort of the home environment
Decrease health care costs
Provide safe and effective treatment and care
Decrease the risk of hospital-associated complications (e.g., infections)
Achieve a smooth, non-stressful transition of treatment between the hospital and the patient’s homeOnce the decision has been made to send a patient home, a social worker or a discharge planner contacts the home care agency and initiates the process. In many hospitals, the discharge planner is a registered nurse with home care experience, who will begin preparing the patient for home therapy.
An intake coordinator at the home care company receives the patient referral. This person is responsible for retrieving the patient’s contact information (address, phone number, etc.), diagnosis, requested home care therapy, pertinent medical data, and insurance information. Home care personnel must keep patient information confidential, especially in light of the regulations inherent to the Health Insurance Portability and Accountability Act (HIPAA). The intake coordinator is often a nurse but may also be a technician specially trained for the job.
When all the necessary data have been obtained, the home care team decides whether to accept or refuse the referral. This determination is based on the ability and willingness of the patient or the caregivers to perform the tasks required to administer therapy at home. Other factors used to decide if a referral is acceptable include the appropriateness and feasibility of the therapeutic plan and the assurance that home care therapy will not place too much of a financial burden on the patient or the home infusion company.
Once the patient is accepted, the home care team begins providing services, which include determining the necessary medical supplies (e.g., tubing, dressing, needles, and syringes), selecting an appropriate infusion device (e.g., gravity system, pump) depending on the patient’s therapy, preparing the drug for the infusion device in a sterile environment, assembling the appropriate patient educational materials and home care paperwork, and negotiating charges with the insurer. When all materials and supplies are ready, a delivery is made to the patient’s home. The pharmacy technician may be involved in gathering supplies, educational material, and paperwork and in arranging deliveries. The technician is always involved in preparing the drugs.
A registered nurse trained in home infusion makes the initial patient visit. Once the patient has been informed of his or her rights and responsibilities as a home care patient, the nurse begins to teach the patient about the supplies and drugs and how to care for the catheter so the patient can eventually administer the medications. If a patient cannot administer the medications, a caregiver learns how to do it, or, on rare occasions, a nurse will administer the medications. Several nursing visits are often required to ensure that the patient can perform medication administration and other procedures properly.
The initial referral process usually takes 24 to 48 hours; occasionally, it must be performed in just a few hours. Empathy is essential in this process. Many times the idea of home infusion of medications overwhelms patients and their caregivers. What is routine for the home care professional is often very foreign to the patient. Therefore, crucial members of the team (home care nurse, pharmacist) must be available (usually by cell phone or pager) to the patient 24 hours a day, 7 days a week.
After the initial visit, the home care team develops a care plan for the patient. The care plan includes how the home care team will monitor the patient’s therapy and watch for complications of therapy, as well as signs that the therapy is effective. Home care team members visit or contact the patients on a regular basis to assess their status, inventory their supplies, and make interventions when necessary. Generally, supplies and drugs are prepared and delivered weekly. Nevertheless, this schedule may vary, depending on the stability of the medications or solutions and the laboratory work that is being conducted on the patient. The home care team maintains records of the patient’s home care course. These records become the patient’s home care chart and include documentation of all communications concerning the patient, physician orders and prescriptions, records of drugs and supplies sent to the patient, and laboratory results. The goal of the home care process is for the patient to experience a successful course of therapy without any adverse events. Once home care therapy is completed, the patient is discharged from the home care service.
The Home Care Team and Specific Roles
The primary members of the home care team are actively involved in the care of the majority of home infusion patients. Secondary members are involved only when a particular patient requires their service. Examples of secondary members include registered dietitians, respiratory therapists, social workers, physical and occupational therapists, and certified nursing assistants (CNAs).
Physician
The physician is the leader of the team, and he or she is ultimately responsible for the care of the patient. The physician provides the direction of care. Any major changes in therapy require the physician’s approval. To ensure that the physician remains in charge of the patient’s care, the physician reviews and signs a Certificate of Medical Necessity and Plan of Treatment. Physician drug orders (prescriptions) are usually given to the pharmacist over the phone, as in the community pharmacy setting. Written and signed physician orders received via facsimile machine, however, are becoming more common. Rules and regulations regarding prescriptions may be specific to each state, especially for narcotics. The technician should be aware of the regulations of the state in which the home care pharmacy is located. In the home care environment, the physician does not see the patient daily or even weekly. The physician often relies on the nurse or pharmacist to evaluate and report the patient’s clinical condition.
Nurse and Pharmacist
The infusion nurse and pharmacist are key members of the team. They work together to coordinate patient supplies, develop a plan of care, monitor and document the patient’s status, communicate with the physician, coordinate physician orders, and make appropriate interventions. The nurse and pharmacist should not only be responsible for selecting the infusion devices, but also be proficient in programming and troubleshooting the devices. Both disciplines are intensely involved with assessing and educating home care patients and work jointly to perform the organization’s clinical quality assurance activities, such as measuring and documenting catheter infections, re-hospitalizations, adverse events, and outcomes of the plan of care. Together, the nurse and pharmacist are responsible for communicating and coordinating all patient care activities.
Nurse
The nurse is the primary educator of the patient, responsible for teaching all aspects of home care therapy. When visiting the patient, the nurse assesses the patient’s physical status, the patient’s adherence to the treatment plan, the condition of the catheter, and any psychosocial issues the patient may be facing. Maintenance of intravenous catheters is the sole responsibility of the nurse. Home care infusion nurses are skilled in the placement of peripheral catheters, and many are skilled in the insertion of peripheral long-term catheters or the peripherally inserted central venous catheter (PICC), discussed later in this chapter. Nurses also schedule and perform all blood work that is ordered.
Pharmacist
The pharmacist is solely responsible for the proper acquisition, compounding, dispensing, and storage of drugs. The pharmacist is also an educator, responsible for instructing the patient and the nurse on the drugs being administered.
The pharmacist regularly assesses the home care patient with a focus on monitoring the laboratory data, the patient’s symptoms, and the patient’s compliance with drug therapy.
Important additional clinical pharmacy roles are pharmacokinetic dosing of vancomycin and aminoglycosides, providing nutritional support services, and having input in the selection of the most appropriate drug for the patient. The pharmacist is the drug information source for all other team members.
Pharmacy Technician
Pharmacy technicians support the pharmacist by performing the majority of the technical pharmacy functions. These functions consist of generating medication labels; compounding, preparing, and labeling medications; and maintaining the compounding room and drug storage areas. The technician is the coordinator of the IV room, working with the pharmacist to arrange the mixing schedule, ordering and maintaining drug and mixing supplies, and performing quality assurance on compounding activities. Pharmacy technicians are often responsible for managing the warehouse and inventory of non-drug supplies, keeping track of accounts receivable, picking and packaging supplies for shipment to patients, and arranging for delivery of supplies to patients. In smaller companies, the pharmacy technician may wear many of these hats. In larger companies, separate individuals (who may be pharmacy technicians) perform each of these functions. For example, some technicians may be experienced drivers who only make patient deliveries.
Reimbursement Specialist
Although not active in direct patient care, the reimbursement specialist is key to the economic viability of the company. The reimbursement department is the interface among the insurer, the home infusion company, and the patient. The primary responsibility of this department is to coordinate all the billing and collection for services provided. To fulfill this responsibility, reimbursement specialists brief staff regarding the services and drugs that are paid for by the insurers, negotiate the price of services with insurers, and brief the insurers regarding the status of the patient and the therapeutic plan. The timeliness of this function is crucial to the financial survival of the organization. The reimbursement specialist is also well-versed in public aid and government reimbursement programs, such as Medicaid and Medicare.
Patient Service Representative
Many companies employ a patient service representative. The representative is responsible for controlling the patient’s inventory of supplies and screening for problems. This person’s job is to contact the patient or caregiver weekly or on a routine basis, depending on the anticipated delivery schedule. Often, this individual helps coordinate the pickup of supplies and equipment when the patient’s therapy is completed. Occasionally a pharmacy technician may be responsible for this job.
Patient and Caregiver
Not to be forgotten as team members are the patient and the caregivers. In home care, much of the burden falls on their shoulders. They must be involved in the decision making and the development of the care plan. The patient’s right to be involved is clearly stated in the rights and responsibilities document that is presented on the initial visit. This document outlines how the patient and caregivers are included in the management of the patient at home.
Types of Home Care Therapies
Anti-Infectives
Anti-infectives account for the majority of pharmaceuticals used in home infusion therapy. The most common IV antibiotics and anti-infectives used in the home are listed in table 5-2 and are discussed below.5,6 Relatively few infectious diseases require long-term infusion therapy. The most common infectious diseases seen in home care patients are listed in table 5-3.
Table 5–2. Common Antimicrobials Used in Home Care
| Drug Class | Examples |
| Cephalosporins | Cefazolin (Ancef), cefepime (Maxipime), ceftriaxone (Rocephin) |
| Penicillins | Ampicillin/sulbactam (Unasyn), nafcillin, oxacillin, penicillin G, piperacillin/tazobactam (Zosyn) |
| Fluoroquinolones | Ciprofloxacin (Cipro), levofloxacin (Levaquin), moxifloxacin (Avelox) |
| Carbapenems | Ertapenem (Invanz), imipenem/cilastatin (Primaxin), meropenem (Merrem) |
| Other | Vancomycin, daptomycin (Cubicin), linezolid (Zyvox), quinupristin/dalfopristin (Synercid) |
| Antifungals | Amphotericin B, fluconazole (Diflucan), voriconazole (Vfend),anidulafungin (Eraxis), caspofungin (Cancidas), micafungin (Mycamine) |
| Antivirals | Foscarnet, acyclovir, ganciclovir |
Table 5–3. Common Infectious Diseases Treated in Home Care Patients
| Infectious Disease | Definition | Common Anti-infectives Used for Treatment | Typical Duration of IV Therapy |
| Osteomyelitis | Infection that occurs when bacteria (e.g., Staphylococcus aureus) invades bone | Nafcillin, oxacillin, vancomycin, daptomycin | 4–6 weeks |
| Cellulitis | Acute inflammatory infection of the skin that often extends deep into the subcutaneous tissue (tissue under the skin) | Nafcillin, oxacillin,cephalosporins, vancomyci | 10–14 days |
| Septic arthritis | Infection of the tissue that lines the joints (synovium) | Vancomycin, cephalosporins, penicillins, carbapenems | Initially 2–3 weeks, may be as long as 6 weeks |
| Endocarditis | Infection of the heart valves or heart tissue | Vancomycin, penicillin plus gentamicin, daptomycin | 4–6 weeks |
| AIDS-related infections | Fungal Infections Viral Infections | Amphotericin, other antifungals | 1–2 months |
| Cytomegalovirus (CMV) | Ganciclovir, foscarnet | 2–3 weeks initially for induction treatment, followed by daily maintenance therapy for an indefinite period of time |
Antibiotics
The administration of antibiotic therapy is the leading home infusion service, comprising 40 to 70 percent of the current home infusion business.5,7 Most available IV antibiotics can be used in the home environment. In general, antibiotics are chosen based on the organism(s) identified in the blood, bone, joint, and/or wound cultures and their susceptibilities to the various antibiotics, as well as individual patient characteristics.
Cephalosporins, such as ceftriaxone (Rocephin), cefazolin (Ancef), and cefepime (Maxipime), comprise most of the IV antibiotic courses administered in the home. Cephalosporins are very easy to use in home care because they have a low incidence of adverse reactions and require minimal monitoring.6 Ceftriaxone is often prescribed because it can be given once daily, which decreases the costs of supplies and requires less work for the patient or caregiver. Most cephalosporins are stable for 10 days after admixture, so they are ideal for weekly deliveries. Moreover, many of the cephalosporins can be administered as IV push, a method of administration in which the drug is directly injected into the patient’s catheter slowly over 2 to 5 minutes. This is a convenience for the patient because of the short administration time.
Penicillins are also a common IV antibiotic used in the home.6,7 Typical drugs used in this class are ampicillin/sulbactam (Unasyn), piperacillin/tazobactam (Zosyn), ticarcillin/clavulanate (Timentin), nafcillin or oxacillin, and penicillin G. Penicillins are more difficult to use in the home because they need to be given frequently (every 4 to 6 hours). These types of dosing regimens are difficult for some patients to adhere to because of the time they have to take out of their day for administration. Portable pumps, called ambulatory pumps, that can automatically give continuous or intermittent doses throughout the day are often used for penicillin therapy. Stability is another problem with this class. Ampicillin has short stability and must be mixed in the home prior to infusion. The availability of the ADD-Vantage® and Add-Ease® systems (see Chapter 16, Aseptic Technique, Sterile Compounding, and IV Admixture Programs) makes mixing in the home much easier and safer. Most of the other penicillins have just 7 days of stability. Pushing penicillins to their stability limit is a concern because they may break down as they expire, and the breakdown products are associated with an increased risk of allergic reactions. The most common adverse effect in this class is an allergic reaction, such as a rash. Penicillins are also very irritating to veins, frequently causing phlebitis (redness and inflammation of the vein). It is highly recommended that patients receiving penicillins at home have a central venous catheter, a catheter that is placed in a large central vein such as the subclavian vein.
Vancomycin is also a frequently prescribed drug in home care.6,7 Vancomycin should be infused at a rate of no greater than 1 gram over 60 minutes to prevent Red Man Syndrome, which is an infusion-related reaction that causes a redness or flushing of the head and torso. This can be accomplished by using a pump or infusion control device, or by placing vancomycin in larger amounts of fluid (e.g., 150 to 250 mL). The pharmacist uses pharmacokinetics and the results of vancomycin blood levels to individualize patient dosing of vancomycin. Vancomycin is irritating to the veins and, in the home setting, is best given through a central catheter. If a peripheral catheter is used, vancomycin should be placed in larger amounts of IV solution (e.g., 250 to 500 mL of solution) to avoid vein irritation.
Additional antibiotics that are becoming more frequently used in the home care setting include azithromycin (Zithromax), doxycycline, and the fluoroquinolones, such as ciprofloxacin, levofloxacin (Levaquin), and moxifloxacin (Avelox). Azithromycin, doxycycline, and many of the newer fluoroquinolones can be given via IV once daily, thus making them convenient for patients receiving therapy at home.8 The carbapenems, namely, imipenem/cilistatin (Primaxin), meropenem (Merrem), and ertapenem (Invanz), are being used more and more in the home care setting. However, because of their short stability, administration often requires the use of a bag and vial attachment system such as the Add-Ease® or Minibag® Plus systems.9 Because of widespread cases of resistance to vancomycin, newer antibiotics such as daptomycin (Cubicin), linezolid (Zyvox), and quinupristin/dalfopristin (Synercid) are being more frequently prescribed in home infusion patients. Their use should be reserved for limited situations since resistance to these agents is somewhat limited at this point in time.9 Limited stability information is available for these agents, which may pose some challenges in the home care setting and require that patients “home-mix” the medications themselves.
Antifungals
Antifungal agents may be used in the home care setting when a provider services a large transplant or immunocompromised patient population, such as those patients with acquired immunodeficiency syndrome (AIDS). Intravenous amphotericin B products are commonly prescribed for severe fungal infections. Many patients experience fever, chills, and shakes from amphotericin infusions. This reaction often requires premedication with oral acetaminophen and diphenydramine. Some patients have such severe reactions that IV meperidine and hydrocortisone are given. The home care infusion pharmacy usually supplies these premedications. Infusions of amphotericin should always be given with an infusion pump. Normal saline, commonly used to flush the catheter before and after the infusion of medication, is incompatible with amphotericin B—mixing the two results in a precipitate. Therefore, the pharmacy compounds dextrose 5 percent syringes for flushing the catheter when amphotericin is used in the home. Lipid-based amphotericin B (Amphotec) and liposomal amphotericin B (Ambisome) are being used more often, especially for patients who cannot tolerate plain amphotericin B or who have compromised renal function.9
To prevent errors, the technician should work closely with the pharmacist when preparing amphotericin B formulations. Dispensing the correct product is essential and dosing guidelines vary widely between the traditional and the lipid-based products.9
Intravenous azole antifungal agents such as fluconazole (Diflucan) and voriconazole (Vfend) are used in home infusion patients as an alternative to the amphotericin B products for some severe systemic fungal infections. A relatively new class of antifungal agents, the echinocandins, are being used more frequently in the home care setting. Anidulafungin (Eraxis), caspofungin (Cancidas), and micafungin (Mycamine) comprise this class of agents. Caspofungin is approved for use in pediatric patients;10 thus its use in this patient population is growing in the home care setting. Caspofungin is not compatible with dextrose-containing solutions.
Antivirals
Ganciclovir is a commonly prescribed parenteral antiviral agent used in transplant patients or patients with human immunodeficiency virus (HIV) who have cytomegalovirus (CMV) infection. Special precautions must be taken when preparing and administering ganciclovir due to its cytotoxic nature. Ganciclovir almost always causes bone marrow toxicity in AIDS patients. Filgrastim (Neupogen) therapy is often added to offset bone marrow toxicity. An alternative to ganciclovir is foscarnet. Patients must receive hydration fluids while receiving foscarnet because it may have effects on the kidneys. To help prevent kidney damage, foscarnet is compounded in 500 to 1,000 mL of fluid and infused with a pump, or 500 to 1,000 mL of normal saline is given prior to each infusion. Intravenous acyclovir is sometimes administered to immunocompromised patients in the home and is usually given every eight hours. Because it can cause phlebitis, patients receiving this agent must have adequate intravenous access.9
Other
Pentamidine is occasionally given in immunocompromised patients as prophylaxis for a particular type of pneumonia. The route of administration for this agent for prophylactic use is inhalation, via a special nebulizer, Respigard®, every 4 weeks.9,11 Patients may receive the nebulized treatments at home or in an ambulatory infusion suite.
Parenteral Nutrition
Total parenteral nutrition (TPN) is intravenous nutrition that provides a patient with all of the fluid and essential nutrients he or she needs when oral nutrition is difficult or impossible. Patients with Crohn disease (inflammatory disease of the small and large intestines) and bowel loss or dysfunction are the major recipients of parenteral nutrition. Malnutrition associated with cancer and AIDS is another indication for parenteral nutrition. Patients who absorb some nutrients from the food they eat, but not enough to completely sustain them, may require supplementation with parenteral nutrition. These patients require smaller volumes of parenteral nutrition and may not need daily infusions.
Parenteral nutrition may be infused continuously over 24 hours, or, typically in the home infusion patient, it is given cyclically. The cycles can range from 12 hours to 20 hours, whereby the patient will not infuse the nutrition solution during some hours of the day. Allowing the patient to be off of the parenteral nutrition solution for some time during the day gives him or her the opportunity to have a more active lifestyle and may cause less long-term adverse effects versus a continuous infusion. Patients receiving parenteral nutrition often require other IV medications. Many of these medications are not compatible with parenteral nutrition, which creates a difficult situation to manage in the home, especially if the patient is receiving the parenteral nutrition continuously. The patient must learn to stop and start the parenteral nutrition and adequately flush the catheter to administer other medications. One alternative is for these patients to have a central catheter with at least two separate lumens, which are tunnels within the catheter. The parenteral nutrition is infused in one lumen, while other medications are administered in the other lumen. Another alternative (as noted earlier) is for the parenteral nutrition to be cycled to infuse over 12 to 14 hours at night, instead of continuously over 24 hours. Medications could be administered while the parenteral nutrition solution is not infusing.
Typical ingredients in a parenteral nutrition solution include dextrose, amino acids, electrolytes (e.g., potassium, sodium, calcium, etc.), trace minerals, and multivitamins. Lipids are another important component and can be infused separately from the parenteral nutrition solution in their own bag or bottle, or directly admixed with the other ingredients. Commonly, parenteral nutrition 3-in-1 solutions (containing lipids), also referred to as total nutrient admixtures (TNAs), are used in home infusion patients for convenience. They are stable for a shorter time period than bags without lipids, but extended stability may be achieved by using a dual-chamber bag in which the lipids are housed separately above the dextrose and amino acids. The patient “activates” the bag just before infusing it. Pre-mixed parenteral nutrition formulations (e.g., Clinimix®) are also available and may have some use in the home care setting. These formulations contain a standard amount of dextrose and amino acids, and, in some cases, electrolytes. The patient’s nutrient requirements and volume of TPN formula will need to be considered prior to using a pre-mixed parenteral formulation. The home infusion pharmacy staff may need to include additional ingredients (e.g., lipids or other electrolytes) prior to sending these formulations to a patient.
A number of ingredients in parenteral nutrition are stable for only 24 hours. These drugs are called patient additives and must be injected into the bag prior to infusion by the patient or caregiver.
Examples of drugs that the patient must add are insulin, heparin, vitamins, and H2-receptor antagonists (e.g., famotidine, ranitidine). Drugs a patient needs to add should be supplied in vials rather than in ampules whenever possible, for patient convenience. It is also advisable to limit the medications a patient must add to a parenteral nutrition bag to those that are absolutely necessary. This limitation is not only for sterility reasons but also for the sake of compliance and patient stress. The more medications that are added, the greater the complexity of the solution and the greater the chance for incompatibility or contamination.
Patients receiving parenteral nutrition require intensive monitoring, which usually includes weekly laboratory tests (chemistry and complete blood count [CBC]), blood glucose, fluid status, and patient weights. Monitoring progress toward the therapeutic goals of increasing the patient’s weight and improving his or her nutritional status, as well as screening for complications such as liver toxicity and bone breakdown, is a continual process. Before a week’s supply of solution is mixed, the pharmacist must review these parameters, as well as others. If these values are abnormal, the pharmacist must make recommendations to the physician, followed by appropriate changes in the parenteral nutrition formula (e.g., electrolyte content; volume; or amount of glucose, lipid, or protein in the solution). The pharmacist may do this in consultation with a dietician. To avoid making parenteral nutrition bags that cannot be used, the technician should coordinate mixing of a patient’s parenteral nutrition to follow scheduled laboratory blood draws and pharmacist and nursing assessments and visits. Changes to parenteral nutrition formulas are common, especially in the first few months of therapy. Patients on long-term parenteral nutrition tend to stabilize after several months and require less monitoring.
RX for Success
The pharmacy technician can play an instrumental role in collecting the laboratory and patient data, then recording it on patient flow sheets so that the pharmacist has this information readily available for monitoring the patient.
Enteral Nutrition Therapy
Some home infusion pharmacies may also provide enteral nutrition therapy. Enteral nutrition is the administration of specialized formulas that are high in required nutrients through the stomach or part of the small intestine (jejunum) to meet a patient’s nutritional needs. Patients who can eat will drink the enteral formula. Patients who cannot eat (e.g., those who are comatose) but have a working stomach or small intestine receive the formula through tubes placed either through their nose down into their stomach (nasogastric tube [NG tube]) or surgically to their stomach (gastrostomy tube [G tube]) or jejunum (jejunostomy [J tube]). Home infusion companies become involved when enteral nutrition is being administered continuously via a feeding tube, with or without a pump. When this technology is used, the expertise of the home health care team is often required. Patients who can drink their enteral formulas can usually get their therapy much cheaper through a community pharmacy and do not require home care services. Monitoring patients receiving enteral nutrition includes following their nutritional status and detecting drug-nutrient interactions.
Chemotherapy
Most chemotherapy is given in a clinic setting, but a number of chemotherapy agents may be given in the home environment. Chemotherapy regimens given in the home are those requiring prolonged infusion, usually greater than 24 hours. The agents that tend to be used in this manner are 5-fluorouracil, cyclophosphamide, doxorubicin (Adriamycin), oxaliplatin (Eloxatin), vincristine, vinblastine, and paclitaxel (Taxol).
One of the most common agents administered in the home care environment is 5-fluorouracil. Continuous infusions of 5-fluorouracil are used in treatment protocols for stomach, intestine, colon, and liver cancers. A central line is highly recommended for patients receiving chemotherapy at home to avoid the risk of extravasation, which is when the solution leaks into the areas outside of the vein, resulting in potentially severe tissue damage. Side effects of chemotherapy such as bone marrow toxicity (low platelets [thrombocytopenia], low white blood cells [neutropenia], and low red blood cells [anemia]) and stomatitis (sores in the mouth), are frequent with this class of drugs. Many patients require the addition of colony-stimulating factor therapy such as filgrastim (Neupogen) or sargramostim (Leukine) to counteract the chemotherapy-induced drop in white blood cells. Other supportive therapies, such as IV fluids and anti-nausea medications (e.g., prochlorperazine [Compazine], metoclopramide [Reglan], or ondansetron [Zofran]), are often administered to patients receiving chemotherapy.
Some oncology clinics and offices have home infusion pharmacies mix chemotherapy for their patients. The chemotherapy is usually compounded for IV push or short IV infusion in the clinic or office. When the home infusion company assumes this role, the home care team does not routinely monitor these patients.
Biological Response Modifiers
The biological response modifiers include filgrastim (Neupogen), a long-acting colony-stimulating factor called pegfilgrastim (Neulasta), erythropoietin (Epogen, Procrit), a long-acting erythropoietin called darbepoetin alfa (Aranesp), interferons, and growth hormone. These agents are considered high-technology or biotech drugs because they are produced through genetic engineering. They are fairly easy to administer by subcutaneous and IV routes in the home. These drugs are often administered to patients because of adverse effects associated with chemotherapy or depletion of red blood cells in patients with chronic kidney disease who receive dialysis.
Filgrastim is used for treatment of chemotherapyand AIDS-induced neutropenia (low white cell count). Erythropoietin is used to treat anemia. Interferons have roles in the treatment of multiple sclerosis, chronic hepatitis, cancer, and certain rare diseases. Growth hormone is used in children under 14 years old who are short in stature because of a deficiency in the hormone. All of these agents are proteins that should not be shaken and that require refrigeration to ensure stability.
Pain Management
Patients with chronic pain and pain associated with terminal illnesses often receive pain management therapy at home. Many home infusion pharmacies will care for hospice and/or palliative care patients with severe pain who are at the end stages of their lives. Intravenous medications are used when oral, rectal, or transdermal alternatives are not effective. Ninety percent of home care narcotic orders are for morphine.6 When morphine is not acceptable, other drugs used for pain control include hydromorphone (Dilaudid), fentanyl, or fentanyl with bupivacaine, an anesthetic. Usually one bag or cassette with enough narcotic to last the patient a week is dispensed at a time, with a back-up bag being available in case the connected bag runs out in the middle of the night. The morphine solution is usually provided in concentrations of 5 to 50 mg per mL.
In the home environment, narcotics can be given intravenously, subcutaneously, intrathecally, or epidurally. When the patient has an IV catheter, pain management is given via this route. The subcutaneous route is often used in patients without IV access. Intrathecal (injection into the fluid surrounding the brain and spinal cord) and epidural (upon or external to the membranes surrounding the brain and spinal cord) routes are saved for those patients who cannot achieve adequate pain control with IV therapy. Infusion of narcotics is accomplished using patient-controlled analgesia (PCA) pumps (see Chapter 16 for a complete description). Patients receiving PCA therapy may receive a continuous basal infusion with or without patient-activated bolus doses.
Attainment of adequate pain control, such that the patient has a decent quality of life, is the goal of the home care team. Team members assess the patient’s pain on a continual basis.
