You’ve got questions, and we have answers.
Below is a listing of our most frequently asked questions about home infusion and IVIG. We know how overwhelming, confusing and scary it can be for someone newly diagnosed with a chronic illness that may require infusion therapy. We hope this is a helpful resource for patients and family members looking for information about potential treatments.
Infusion therapy involves the administration of medication through a needle or catheter. It is prescribed when a condition is so severe it cannot be treated effectively by oral medications, or there are no oral therapies that meet the needs of the patient. Typically, infusion therapy means that a drug is administered intravenously, but the term also may refer to subcutaneous infusions. Prescription drug therapies commonly administered via infusion include intravenous immunoglobulin (IVIG), antibiotics, antifungals, antivirals, chemotherapy, hydration, pain management and parenteral nutrition. Infusion therapy is also provided to patients for treating a wide assortment of often chronic and sometimes rare diseases for which specialty infusion medications are effective when given on a weekly or monthly basis.
Diseases commonly requiring infusion therapy include neuromuscular, dermatological and immune diseases and infections that are unresponsive to oral steroids or oral antibiotics including cancer and cancer-related pain, dehydration, gastrointestinal diseases or disorders which prevent normal functioning of the gastrointestinal system, and more. Other conditions treated with specialty infusion therapies may include congestive heart failure, Crohns disease, hemophilia, rheumatoid arthritis and more.
Specialty infusion therapy is a term in use when specialty infusion medications are administered. In this situation the term specialty indicates that the drug therapy itself requires significant pharmacy expertise to safely administer the therapy in the home as well as to obtain third party payment for the therapy and, finally, coordinating the interactions between the home infusion pharmacy and the home health nursing service. Complex ordering, shipping, mixing, storing, delivering and monitoring activities are all involved in the specialty infusion therapy process.
Until the 1980s, patients receiving infusion therapy had to remain in the inpatient hospital setting for the duration of their therapy. Heightened emphasis on cost-containment in health care, as well as developments in the clinical administration of the therapy, led to strategies to administer infusion therapy in alternate settings. For individuals requiring long-term therapy, inpatient care is not only tremendously expensive but also prevents the individual from resuming normal lifestyle and work activities and may increase the chances of contracting a hospital acquired infection.
The technological advances that enabled safe and effective administration of infusion therapies in the home, the desire of patients to resume normal lifestyles and work activities while recovering from illness, and the cost-effectiveness of home care are important. Consequently, home infusion therapy has evolved into a comprehensive medical therapy service that is a much less costly alternative to inpatient hospital treatment.
Home infusion has been proven to be a safe and effective alternative to inpatient care for many disease states and therapies. For many patients, receiving treatment at home or in an outpatient infusion suite setting is preferable to inpatient care.
A thorough patient assessment and home assessment are performed before initiating infusion therapy at home to ensure that the patient is an appropriate candidate for home care.
An infusion therapy provider is most normally a “closed-door,” state-licensed pharmacy that specializes in provision of infusion therapies to patients in their homes or other alternate-sites. The infusion therapy always originates with a prescription order from a qualified physician who is overseeing the care of the patient. Extensive professional pharmacy services, care coordination, infusion nursing services, supplies and equipment are provided to optimize efficacy and compliance.
Qualified infusion pharmacies must satisfy licensing and other regulatory requirements imposed by state pharmacy boards as well as accreditation standards required by most third-party payers. Home infusion pharmacies may also provide additional professional therapies and services.
Pertaining directly to the medications used, the infusion pharmacy ensures that infusion drugs are:
- Compounded in a sterile environment.
- Maintained at an appropriate temperature and in air quality controlled conditions to ensure sterility and stability of the drug.
- Administered at exactly the right dose and on the right schedule by a highly trained home IV Nurse.
- Administered using an appropriate drug delivery device, typically an electronic pump.
- Flushed with the proper flushing solution between doses to assure the IV catheter remains functional.
- Monitored for adverse reactions and therapeutic efficacy.
Infusion pharmacies also provide an extensive array of professional services:
- Patient assessment and admission.
- Education and training.
- Care planning and coordination with physicians.
- Nurses and the patients payor.
- Care management by clinical infusion pharmacists.
- Trouble-shooting and treatment plan oversight.
and much more, all essential to achieving high-quality outcomes for patients receiving infusion therapy. Also essential are the specialized equipment (infusion pumps, etc) and many administration supplies (such as IV sets, syringes, and more) required for infusion therapy. The infusion pharmacy also supplies these to the patient and services the equipment when necessary.
To ensure safe and proper administration of infusion drugs, infusion pharmacists provide the following services:
- Comprehensive assessment that considers patient history, current physical and mental status, lab reports, cognitive and psychosocial status, family/care partner support, prescribed treatment, concurrent oral prescriptions and over-the-counter medications.
- Maintenance of appropriate procedures for the compounding and distribution of sterile infusion products as outlined in the national standards and state and federal regulations.
- Drug interaction monitoring and identification of potential drug, dose or drug catheter incompatibilities.
- Comprehensive admission procedures that include patient education of medical and disposable equipment use, medication storage and handling, emergency procedures, vascular access device management, recognition and reporting of adverse drug reactions.
- Comprehensive care planning that considers actual or potential drug or equipment-related problems, therapy monitoring with specific patient goals and coordination of activities with other providers such as home health agencies and physicians.
- Ongoing patient monitoring and reassessment activities to continually assess for response to treatment, drug complications, adverse reactions and patient compliance.
- Laboratory report reviews, as applicable and subsequent consults with care professionals to adjust medication orders if necessary.
- Maintenance of appropriate physical facilities for storage, preparation, dispensing and quality control of all infusion medications and equipment.
- Ongoing employee education and competence validation activities.
- Maintaining an active accreditation status with an approved accrediting body. This is a significant commitment that allows the infusion pharmacy to assure outside parties that the services provided to its patients are of the highest quality. It is typically also needed to be allowed to provide therapy for insurance companies and to comply with State and Federal regulations.
- Performance improvement programs that include collection of clinical outcomes data, patient perception data, trending and analysis of these and other performance measurement data and root cause evaluations of all sentinel events.
- These essential specialized services listed above are paid for by the majority of health insurance plans.
Depending on local practices, regulation and availability of skilled infusion nurses, infusion nursing services are provided directly by the infusion pharmacy or by an affiliated or separate nursing agency. Along with the infusion pharmacy staff, infusion nurses are key members of the infusion care team and work closely in the coordination of care plans and other activities with the infusion pharmacy and the ordering physician. When infusion therapy is provided in a the home of a patient, the infusion nurse will ensure proper patient education and training and monitor the care of the patient in the home. Infusion nurses will have special education, training and expertise in home or other alternate-site administration of drugs and biologics via infusion. Services they typically provide include evaluation and assessment, education and training for the patient or caregiver, inspection and consultation of home environment, catheter insertion and patient assessment.
Medicare part B covers some IV and enteral nutritional and cancer treatment drugs in the home but their admission criteria to assure payment is complex and often not obtainable for many patients under actual clinical conditions. Most infusion drugs, including those not covered under part B may be covered by the Medicare Part D, the prescription drug benefit. However, the Centers for Medicare Medicaid Services (CMS) has determined that Part D does not have the authority to cover the infusion-related services, equipment and supplies under Part D. Thus, it is recommended that you speak directly to a reimbursement specialist to determine eligibility for your individually ordered medication and services since the Medicare approval process involving Parts B and D can be complex.
Reference:1. Information modified from the National Home Infusion Association (NHIA): Infusion FAQs. Available at: http://www.nhia.org/faqs.cfm. Accessed January 10, 2011.
IVIG stands for intravenous immunoglobulin. It is a purified plasma treatment that contains antibodies collected from the plasma of healthy donors and purified through a special process so that the therapy is safe and effective. Most of the antibodies are of the IgG class of antibodies, also called immunoglobulin G or gamma globulin which neutralizes toxins that cause bacterial and viral infections. This set of immunogenic response, pooled from thousands of patients, can be used to treat diseases where the patient has less than a normal functioning immune system or, conversely, for patients that have an overly active immune system that is attacking parts of the patients own body.
For patients with immune deficiency disorders, IVIG is given as a “replacement” therapy and provides them with the antibodies that they are either missing or which are malfunctioning. In patients with autoimmune neurological or dermatological disorders, IVIG provides healthy antibodies to block the immune and inflammatory processes and bind rogue autoantibodies and remove them from circulation.
IVIG may be given intravenously or subcutaneously, which means through a needle directly into a vein or into your subcutaneous skin tissue. Your doctor will work with a trained KabaFusion pharmacy specialist to determine the correct dosage and route of administration, based on a number of individual factors, including your weight, your condition, and how well the IVIG treats or prevents symptoms. In many cases the final route of administration for auto immune disorders is the IV route while many patients with immune deficiencies can utilize the subcutaneous route. This is primarily based on the size of the dose, quality of the skin of the patient and the amount of fluid required per administration.
Immune deficient patients may be able to get their infusion on a weekly or monthly basis. However, for patients with autoimmune disorders, which typically require much higher doses, the initial dosage regimen is usually divided over several days and given in 4-6 hour infusion periods. Ongoing doses for autoimmune patients may be given on weekly or biweekly basis. In terms of frequency of infusion, your specific response to therapy will be monitored and an individualized therapeutic regimen will be developed and coordinated with your doctor. IVIG requires expert clinical administration, assessment and monitoring for optimal benefit.
IVIG is used to treat a number of autoimmune disorders, idiopathic diseases (disease of unknown cause) and infections.
FDA Approved Uses
The US Food and Drug Administration has approved the use of IVIG for the following seven conditions:
- Chronic inflammatory demyelinating polyneuropathy (CIDP)
- Immune thrombocytopenic purpura (ITP)
- Primary immunodeficiency
- Secondary immunodeficiency in chronic lymphocytic leukemia
- Multifocal motor neuropathy
- Pediatric human immunodeficiency virus (HIV) infection
- Kawasaki disease
- Prevention of graft vs. host disease in adult bone marrow transplant recipient
The first four conditions account for 70% of IVIG use.
Given the broad action of IVIG, it can also be used to treat a variety of other conditions.
1.Darabi, K., O. Abdel-Wahab, and W.H. Dzik, Current usage of intravenous immune globulin and the rationale behind it: the Massachusetts General Hospital data and a review of the literature. Transfusion, 2006. 46(5): p. 741-53. Medline.
The majority of side effects are mild, transient and self-limited and do not require discontinuation of therapy.Fortunately, most patients who experience side effects can be helped by slowing down the rate of infusion. Premedication with acetaminophen, antihistamines or occasionally steroids can also help decrease side effects. A customized infusion protocol will be developed for each patient based on their unique clinical conditions to minimize the incidence of side effects.
1.Bertorini TE, Nance AH, Horner LT, Greene , Gelfand M, Jaster JH. Complications of intravenous gammaglobulin in neuromuscular and other diseases. Muscle Nerve 1996;19: 388-391. 2.Ippoliti C, Williams LA, Huber S. Toxicity of rapidly infused concentrated intravenous immune globulin. Clinical Pharmacology 1992;11:1022-1026.
Most commercial and government health insurances including Medicare and Medicaid provide coverage for IVIG. However, each payor has different rules regarding which diseases are covered and where IVIG is administered (i.e. hospital, physicians office, nursing home or patients home). Many insurance companies require pre-authorization before the start of IVIG treatment. In cases of using IVIG therapy off-label (i.e. experimental or investigational) many insurance plans require case-by-case approval for the treatment.