Rx Update: April 2005
Joan Murhammer, R.Ph., Mary Ross, R.Ph., M.B.A., Kevin Bebout,
R.Ph.
Peer Review Status: Internally Reviewed
Adverse Drug Reaction (ADR) Reporting Program Update
It has been approximately one year since the UIHC ADR Reporting Program converted from a paper to an electronic format accessible via IPR. While the number of reports received directly from care providers per month has remained stable since the conversion in 2004, it continues to be a program goal to further increase the number of reports received each month.
Whenever you become aware of an adverse drug reaction (whether in the inpatient or ambulatory care environments), please complete and submit an adverse drug reaction incident report using IPR. Look for “Adverse Drug Reaction (NOT Med Error)” under IPR’s Incident Reporting tab. Provide as much information in the report as you can, especially about the type of reaction experienced, dates of therapy, and doses of the suspected drug that were administered. It is also important that reporters complete the causality and preventability assessments as much as possible. Summary reports delineating ADR incidents from throughout the UIHC are generated monthly for review by the Pharmacy and Therapeutics Subcommittee; based upon designated criteria, selected adverse drug reactions are then submitted to the FDA.
Please encourage other UIHC care providers to complete an Adverse Drug Reaction report whenever they encounter adverse drug reactions in the course of their care duties. Accreditation organizations such as JCAHO and government agencies such as the Centers for Medicare & Medicaid Services (CMS) expect healthcare organizations to actively identify and report adverse drug events.
If you have questions about whether an adverse event should be reported as an adverse drug reaction, or how to complete an ADR report using IPR, please contact Kevin Bebout, Administrative Pharmacy Practice Specialist. Thank you for your time and past contributions in supporting this important patient safety program.
Lanthanum carbonate (Fosrenol®) is a rare earth element that is FDA approved to treat hyperphosphatemia in patients with end stage renal disease (ESRD). The acidic environment of the upper GI tract causes dissociation of lanthanum carbonate into lanthanum ions which bind dietary phosphate to form an insoluble lanthanum phosphate complex. This results in decreased serum phosphate levels.
Lanthanum carbonate should be used with caution in patients with gastrointestinal disorders (e.g., acute peptic ulcer, ulcerative colitis, Crohn’s disease, or bowel obstruction).
The most common adverse effects with lanthanum carbonate therapy are nausea (11 to 36%) and vomiting (9 to 26%). These side effects usually decrease with time. Additional adverse reactions are dialysis graft complications and occlusions, abdominal pain, diarrhea, headache, hypotension, constipation, bronchitis, rhinitis, and rarely, hypercalcemia.
The initial recommended dosage of lanthanum carbonate is 750 to 1500 mg per day in divided doses with meals. The dose may be increased by 750 mg per day every 2 to 3 weeks until serum phosphate levels are adequately controlled. Patients generally require a total daily dose between 1500 and 3000 mg per day. Doses up to 3750 mg per day have been studied. Lanthanum carbonate tablets should be taken with or within 30 minutes following a meal. Tablets should be chewed completely before swallowing or crushed and poured into the mouth. Tablets should not be swallowed intact. Drugs that interact with antacids should be taken 2 hours before or after lanthanum carbonate. Serum phosphate levels should be monitored during dose titration and at regular intervals while on maintenance therapy.
Lanthanum carbonate is available as 250 mg and 500 mg chewable tablets.