RPhLink - Relief Pharmacy Services - Pharmacy Management & Pharmacy Staffing Solutions.  Clients looking for help, please call 920-841-3431. Pharmacists, for more information about RPhLink Relief Pharmacy Services team member, please e-mail us at info@RPhLink.com.

RPhLink.com  The Pharmaceutical Care Network!

From: Lilly                            January 26, 2005 Medication Errors Alert Dear Healthcare Professional: Eli Lilly and Company has received reports of medication dispensing or prescribing errors between our atypical antipsychotic ZyPREXA (olanzapine) and the antihistamine ZYRTEC (cetirizine HCL) marketed by Pfizer. These reports include instances where Zyprexa was incorrectly dispensed for Zyrtec and vice versa, leading to various adverse events or potential relapse in patients suffering from schizophrenia or bipolar disorder. The FDA-approved indications for each of these drugs differ considerably. Zyprexa is indicated for the short-term and maintenance treatment of schizophrenia and is also indicated for the short-term treatment of acute mixed or manic episodes associated with Bipolar I Disorder and as a maintenance treatment in bipolar disorder ( normal doses 5 to 20 mg/day), while Zyrtec is indicated for the treatment of allergic rhinitis or chronic urticaria ( normal doses 5 to 10 mg/day). However, many similarities do exist that could contribute to medication errors, including manes starting with the same 2 letters, the availability of same dose strengths ( 5 mg to 10 mg tablets), the same dosing interval ( once daily) and the fact that these two products are generally stored near each other on pharmacy shelves. It is these similarities that likely contribute to errors in dispensing or prescribing. The ZYPREXA 2.5 mg, 5 mg, 7.5 mg, and 10 mg tablets are white, round, and imprinted in blue ink with LILLY and tablet number. The 15 mg tablets are elliptical, blue, and embossed with LILLY and tablet number. The 20 mg tablets are elliptical, pink, and embossed with LILLY and tablet number. ZYRTEC tablets are white, film-coated, rounded-off rectangular shaped containing 5 mg or 10 mg cetirizine hydrochloride engraved with "ZYRTEC" on one side and dose strength on the other. Lilly is committed to the safety of patients and helping to increase the likelihood that the correct medications are being dispensed. Some of the measures that Lilly has taken or will be taking to help reduce the potential for future errors include: -Changes to label on the 10 mg bottles from ZYPREXA to ZyPREXA, for easier identification, -Launch awareness direct mail campaign to pharmacists, -Sponsor medication error prevention continuing education, -Journal ads focusing in this dispensing error potential, with emphasis on good prescribing and good dispensing practices The Institute for Safe Medication Practices (ISMP) recommends that products with reports of medication errors, such as Zyprexa and Zyrtec, be stored in different locations. The ISMP also recommends that prescribers print both the brand and generic names of medication on all prescriptions. Furthermore, they recommend that healthcare professionals remember to discuss medications, their indications, and their proper use when counseling patients. Additional information on medication errors and good prescribing and dispensing practices in various healthcare settings can be found at the ISMP website, www.ismp.org. Please refer to the full prescribing information for Zyprexa included with this letter. If you become aware of a prescription dispensing error involving these products, please contact the appropriate manufacturer (Eli Lilly and Company: 1-800-Lilly RX; Pfizer Inc: 1-800-438-1985). You can also report medication errors to the FDA's MEDWATCH program at www.fda.gov/medwatch. 1-800-FDA-1088 or fax to 1-800-FDA-0178 or USP- ISMP Medication Errors Reporting Program (1-800-FAIL-SAFE). Sincerely, Dr. Paul Eisenberg Vice President, Global Drug Safety Eli Lilly and Company

RPhLink.com  The Pharmaceutical Care Network! From: Ortho-McNeil                                                                                                02-28-05 When a patient receives a prescription for ORTHO EVRA, she is receiving the #1-prescribed birth control brand that has been accepted by over 4 million women. In this regard, she should be given every opportunity to receive all that ORTHO EVRA has to offer-including an extraPatch. When a women first starts ORTHO EVRA, her healthcare professional writes two prescriptions-one for her regular monthly cycle, and one for an extraPatch. Having access to both these "put-ups" is important. Therefore, it is important that you stock both the ORTHO EVRA monthly cycle patches-NDC # 0062-1920-15 and the ORHTO EVRA extraPatch-NDC # 0062-1920-01. Importantly, a valuable patient rebate certificate, good for up to $12, is enclosed in every extraPatch package. There is no action required on your part to complete this rebate. Please see the enclosed flashcard for details. Thank you for your commitment to meeting patient needs by stocking a complete supply of ORTHO EVRA contraceptive patches. For additional information about ORHTO EVRA, please visit out Web site at www.orthoevra.com, or call 1-800-682-6532. Important safety information Serious as well as minor side effects have been reported with the use of hormonal contraceptives. Serious risks include blood clots, stroke, and heart attacks. Cigarette smoking increases the risk of serious cardiovascular side effects, especially in women over 35. Women who use the contraceptive patch are strongly advised not to smoke. The contraceptive patch does not protect against HIV or other sexually transmitted diseases. Please see enclosed full Prescribing Information.

RPhLink.com  The Pharmaceutical Care Network!

From Novartis Oncology January 2005 FEMARA (letrolzole tablets) is now the first and only treatment indicated for the extended adjuvant therapy. On October 29, 2004, the FDA approved FEMARA for the extended adjuvant treatment of early breast cancer in postmenopausal women who have received 5 years of adjuvant tamoxifen therapy. The effectiveness of FEMARA in extended adjuvant treatment of early breast cancer is based on an analysis of disease-free survival in patients treated for a median of 24 months. Further data will be required to determine long-term outcome. As you know, the risk of recurrence continues for an indefinite period after surgery, radiation, chemotherapy and adjuvant hormonal therapy. Even after 5 years of tamoxifen, the risk remains significant. This is true for both node-positive and node-negative disease. FEMARA is the first and only treatment option to help reduce the risk of recurrence after adjuvant tamoxifen therapy. The new indication is based on the pivotal MA-17 trial conducted by the National Cancer Institute of Canada, as well as SWOG, ECOG, CALGB, NCCTG, and several sites in Europe. An interim analysis of the MA-17 data was published in November 2003 in the New England Journal of Medicine, and June 2004, the final efficacy analyses and updated safety data were presented during the Best of Oncology session at the ASCO convention in New Orleans. The MA-17 trial was a phase 111, double-blind, randomized, multicenter study comparing administration of FEMARA (2.5 mg qd) versus placebo following 4.5 years to 6 years of adjuvant tamoxifen in more than 5100 postmenopausal women with primary breast cancer. The primary end point was disease-free survival (DFS), defined in the FEMARA Prescribing Information as the time from randomization to the earliest event of locoregional or distant recurrence of the primary disease or development of contralateral breast cancer or death. Because the trial reached its stopping criteria, an independent Data and Safety Monitoring Committee recommended its unblinding approximately 1 year earlier than planned. At the time of unblinding, patients had been followed for a median of 28 months, 30% of patients had completed 3 or more years of follow-up, and less than 1% of patients had completed 5 years of follow-up. Data were premature for an analysis of survival. In the final analyses of 2582 patients assigned FEMARA and 2586 Assigned placebo: -FEMARA reduced overall recurrence 38% versus placebo (P=0.00003) (HR=0.62, 95% CI:0.49-0.78) -39% in node-positive patients (HR=0.61,95% CI:0.46-0.81) -39% in node-negative patients (HR=0.61, 95% CI:0.41-0.91) -36% in patients receiving prior chemotherapy (HR=0.64, 95% CI: 0.46-0.90) -40% in patients receiving no prior chemotherapy (HR=0.60, 95% CI:0.44-0.81) -Femara reduced distant recurrence 39% versus placebo (P=0.003) (HR=0.61,95% CI:0.44-0.84) Commonly reported side effects are generally mild to moderate. Those seen more often with FEMARA were hot flashes (50% vs 43%), arthralgia (22% vs 18%), and myalgia (7% vs 5%). Other side effects, while not statistically different from placebo, include fatigue (34% vs 32%), seating (24% vs 22%), headache (20% vs 20%), edema (18% vs 16%), hypercholesteremia (16% vs 16%), dizziness (14% vs 13%), constipation (11% vs 12%), nausea (9% vs 8%), and arthritis (7% vs 5%). A patient-reported measure that captures treatment impact in important symptoms associated with estrogen deficiency demonstrated a difference in favor of placebo for vasomotor and sexual symptom domains. Since fatigue and dizziness have been observed with the use of FEMARA and somnolence was uncommonly reported, caution is advised when driving or using machinery. Osteoporosis was reported more frequently with FEMARA than with placebo (6.9% vs 5.5%). Bisphosphonates were administered to 21.1 % of the patients who received FEMARA and 18.7% of the patients who received placebo. Preliminary results ( median duration of follow-up was 20 months) from the bone substudy ( calcium 500 mg and vitamin D400 IU per day mandatory; bisphosphonates not allowed) demonstrated that at 2 years the mean decrease compared with baseline in hip bone density (BMD) in FEMARA patients was 3% versus 10.4% for placebo (P=0.048). The mean decrease from baseline BMD results for the lumbar spine at 2 years was FEMARA 4.6% abd placebo 2.2% (p=0.069). FEMARA may cause fetal harm when administered to pregnant women and caution should be exercised when FEMARA is administered to nursing women. FEMARA is contraindicated in patients with known hypersensitivity to FEMARA or any of its excipients. There is no clinical experience to date on the use of FEMARA in combination with other anticancer agents. With he information provided above, you can recommend FEMARA in the extended adjuvant setting to help address your postmenopausal patients' continuing risk of recurrence. If you have questions about these data, please feel free to contact Novartis at 1-888-NOW-NOVA. Sincerely, John A. Hohneker, MD                                               Judith A. Prestifilippo, MD Vice President                                                         Senior Medical Director Novartis Oncology Medical Affairs & Services                 Novartis Oncology Medical Affairs One Health Plaza East Hanover, NJ 07936

RPhLink.com  The Pharmaceutical Care Network!

From: Ortho McNeil Re: Topamax                                    12-2003 Important Drug Warning The Prescribing information for Topamax (topiramate/topiramate capsules) Tablets/Sprinkle Capsules has been revised to include a warning that TOPAMAX causes hypercloremic, non-anion gap metabolic acidosis (decreased serum bicarbonate). TOPAMAX is approved and marketed for the adjunctive treatment of partial-onset seizures, generalized tonic-clonic seizures associated with the Lennox-Gastaut syndrome in adults and children two years of age and older. Data on hyperchloremic, non-anion gap metabolic acidosis are derived from placebo-controlled trials and post-marketing experience in over 2.5 million patients. In clinical trials, the rate of occurrence of a persistently decreased serum bicarbonate ranges from 23-67% for patients treated with topiramate and 1-10% for placebo. The incidence of markedly low serum bicarbonate in clinical trials ranges from 3-11% for topiramate and 1 to <1% for placebo. Generally, decreases in serum bicarbonate occur soon after initiation of topiramate, although they can occur at any time during treatment. Bicarbonate decrements are usually mild-moderate, with an average decrease of 4mEQ/L at daily doses of 400 mg in adults and approximately 6 mg/kg/day in pediatric patients. Rarely, patients can experience decrements to values below 10 mEq/L. Conditions or therapies that predispose to acidosis (such as renal disease, severe respiratory disorders, status epilepticus, diarrhea, surgery, ketogenic diet, or drugs) may be additive to the bicarbonate lowering effects of topiramate. Some manifestations of acute or chronic metabolic acidosis may include hyperventilation, nonspecific symptoms such s fatigue and anorexia, or more sever sequelae including cardiac arrhythmias or stupor. Chronic, untreated metabolic acidosis may increase the risk for nephrolithiasis or nephrocalcinosis, and may also result in osteomalacia (referred to as rickets in pediatric patients) and/or osteoporosis with an increased risk for fractures. Chronic metabolic acidosis in pediatric patients may also reduce growth rates. A reduction in growth rate may eventually decrease the maximal height achieved. The effect of topiramate on growth and bone-related sequelae has not been systematically investigated. Measurement of baseline and periodic serum bicarbonate during topiramate treatment is recommended. If metabolic acidosis develops and persists, consideration should be given to reducing the dose or discontinuing topiramate (using dose tapering). If the decision is made to continue patients on topiramate in the face of persistent acidosis, alkali treatment should be considered. The following has been added to TOPAMAX prescribing information. Under WARNINGS Metabolic Acidosis Hyperchloremic, non-anion gap, metabolic acidosis (i.e., decreased serum bicarbonate below the normal reference range in the absence of chronic respiratory alkalosis) is associated with topiramate treatment. This metabolic acidosis is caused by renal bicarbonate loss due to the inhibitory effect of topiramate on carbonic anhydrase. Such electrolyte imbalance has been observed with the use of topiramate in placebo-controlled clinical trials and in the post-marketing period. Generally, topiramate-induced metabolic acidosis occurs early in the treatment although cases can occur at any time during treatment. Bicarbonate decrements are usually mild-moderate (average decrease of 4mEq/L at daily doses of 400 mg in adults and at approximately 6 mg/kg/day in pediatric patients); rarely, patients can experience severe decrements to values below 10mEq/L. Conditions or therapies that predispose to acidosis (such as renal disease, severe respiratory disorders, status epilepticus, diarrhea, surgery, ketogenic diet, or drugs) may be additive to the bicarbonate lowering effects of topiramate. In adults, the incidence of persistent treatment-emergent decreases in serum bicarbonate (levels of <20 mEq/L at two consecutive visits or at the final visit) in controlled clinical trials for adjunctive treatment of epilepsy was 32% for 400 mg/day, and !% for placebo. Metabolic acidosis has been observed at doses as low as 50 mg/day. The incidence of a markedly abnormally low serum bicarbonate (i.e., absolute value <17mEq/L and >5 mEq/L decrease from pretreatment) in these trials was 3% for 400 mg/day, and 0% for placebo. Serum bicarbonate levels have not been systematically evaluated at daily doses greater than 400 mg/day. In pediatric patients (<16 years of age), the incidence of persistent treatment-emergent decreases in serum bicarbonate in placebo-controlled trials for adjunctive treatment of Lennox-Gastaut Syndrome or refractory partial onset seizures was 67% for TOPAMAX (at approximately 6 mg/kg/day), and 10% for placebo. The incidence of a markedly abnormally low serum bicarbonate (i.e., absolute value <17mEq/L and >5mEq/L decrease from pretreatment) in these trials was 11% for TOPAMAX and 0% for placebo. Cases of moderately severe metabolic acidosis have been reported in patients as young as 5 months old, especially at daily doses above 5 mg/kg/day. Although not approved for the prophylaxis of migraine, the incidence of persistent treatment-emergent decreases in serum bicarbonate in placebo-controlled trials for adults for prophylaxis of migraine was 44% for 200 mg/day, 39% for 100 mg/day, 23% for 50 mg/day, and 7% for placebo. The incidence of a markedly abnormally low serum bicarbonate (i.e., absolute value<17 mEq/L and >5mEq/L decrease from pretreatment) in these trials was 11% for 200 mg/day, 9% for 100 mg/day, 2% for 50 mg/day, and 1% for placebo. Some manifestations of acute or chronic metabolic acidosis may include hyperventilation, nonspecific symptoms such as fatigue and anorexia, or more severe sequelae including cardiac arrhythmias or stupor. Chronic, untreated metabolic acidosis may increase the risk for nephrolithiasis or nephrocalcinosis, and may also result in osteomalacia (referred to as Rickets in pediatric patients) and / or osteoporosis with an increased risk for fractures. Chronic metabolic acidosis in pediatric patients may also reduce growth rates. A reduction in growth rates may eventually decrease the maximal height achieved. The effect of topiramate on growth and bone related sequelae has not been systematically investigated. Measurement of baseline and periodic serum bicarbonate during topiramate treatment is recommended. If metabolic acidosis develops and persists, consideration should be given to reducing the dose or discontinuing topiramate (using dose tapering). If the decision is made to continue patients on topiramate in the face or persistent acidosis, alkali treatment should be considered. Under Precautions: Laboratory Tests Measurement of baseline and periodic serum bicarbonate during topiramate treatment is recommended ( see WARNINGS). Pediatric Use: Safety and effectiveness in patients below the age of 2 years have not been established. Topiramate is associated with metabolic acidosis. Chronic untreated metabolic acidosis in pediatric patients may cause osteomalacia (rickets) and may reduce growth rates. A reduction  in growth rate may eventually decrease the maximal height achieved. The effect of topiramate on growth and bone-related sequelae has not been systematically investigated (see Warnings). Under OVERDOSE: Topiramate overdose has resulted in severe metabolic acidosis (see WARNINGS). You can further our understanding of adverse events by reporting all cases to Ortho-McNeil at the contact numbers listed below or to the FDA MedWatch Program by phone (1-800 FDA 1088), by fax (1-800-FDA-0178, by mail (using postage paid form to MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787) or via www.accessdata.fda.gov/scripts//medwatch/. A copy of the full Prescribing Information is enclosed for your reference. If you have any questions regarding TOPOMAX tablets and TOPOMAX Sprinkle Caplets, please feel free to call Ortho-McNeil Medical Affairs Division at 1-800-682-6532 Sincerely, Joseph Hulihan, MD Group Director, CNS Research Ortho-McNeil Pharmaceutical, Inc. 1000 Route 202, PO Box 300 Raritan, NJ  08869-0602       908-218-6000 Telephone

RPhLink.com The Pharmaceutical care Network! 

RPhLink.com  The Pharmaceutical Care Network!

Leitner Pharmaceuticals Dear Healthccare Professional: Synalgos DC This medication is used to treat herpes infections of the skin, mouth, mucous membranes, genital herpes, herpes zostar (shingles), and chickenpox in some individuals. This medication does not cure herpes, but relieves the pain and may make the infection clear faster. HOW TO USE: Begin taking this medication as soon as symptoms appear.       Take this medication as directed. Ask your doctor or pharmacist if you have any questions. Try to take the medication at evenly spaced intervals throughout the day and night. This will ensure a constant blood level of the medication and is most effective. SIDE EFFECTS: This medication may cause stomach upset, loss of appetite, nausea, vomiting, diarrhea, headache, dizziness, or weakness. These effects should disappear in a few days as your body adjusts to the medication. If they persist or become worse, inform your doctor.       Notify your doctor if you experience: numbness or tingling, of the hands and feet, leg pain, sore throat, skin rash, change in the amount of urine.       An allergic reaction to this drug is unlikely, but seek medical attention if it occurs. Symptoms of an allergic reaction include: rash, itching, swelling, dizziness, trouble breathing.       If you notice other effects not listed above, contact your doctor or pharmacist. PRECAUTIONS: This medication should be used cautiously during pregnancy only if clearly needed. It is not known if this medication appears in breast milk. Consult with your doctor before breast-feeding. DRUG INTERACTIONS: Inform your doctor about all the medicines you use (both prescription and nonprescription). Do not start or stop any medicine without doctor or pharmacist approval. OVERDOSE: Id overdose is suspected, contact your local poison control center or emergency room immediately. Symptoms of overdose may include sluggishness, change in amount of urine, loss of consciousness, or seizures. NOTES: Avoid sexual activity while signs and symptoms of genital herpes are present to prevent infecting your partner. Inform your doctor if this medication does not appear to decrease the frequency or severity of recurrent infections. MISSED DOSE: If you miss a dose, take as soon as remembered; do not take it if it is almost time for the next dose, instead, skip the missed dose and resume your usual dosing schedule. Do not "double-up" the dose to catch up. STORAGE: Store at room temperature away from sunlight and moisture,