LOUISIANA MEDICAID PROGRAM ISSUE DATE: 12 01 05 PROVIDER MANUAL REVISED DATE: CHAPTER 37: PHARMACY BENEFITS MANAGEMENT SERVICES SECTION: 37.1 GENERAL PROGRAM INFORMATION.
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STUDY RESULTS: Gastrointestinal Safety: No statistically significant differences were demonstrated for the incidence of complicated ulcers at the doses studied among the three treatment groups in all patients. Secondary analysis showed that the incidence of complicated and symptomatic ulcers was lower for CELEBREX than for ibuprofen, but not for diclofenac, in all patients and in those patients not taking ASA. Approximately 22% of patients were taking low-dose ASA. Concomitant low-dose ASA use increased the rates of complicated and symptomatic ulcers to four times that of patients not taking ASA. CELEBREX at the doses studied had a significantly lower incidence of gastrointestinal intolerability compared to diclofenac, but not ibuprofen. CELEBREX demonstrated a significantly lower incidence of clinically relevant decreases in hemoglobin 2 g dl ; hematocrit $ 10 points ; than either ibuprofen or diclofenac, regardless of ASA use. Renal and Cardiovascular Safety: In the CLASS study, the rates of hypertension in all patients on CELEBREX 400 mg BID 4-fold and 2-fold the recommended doses for OA and RA ; , and common therapeutic doses of ibuprofen 800 mg TID ; and diclofenac 75 mg BID ; were 2.0%, 3.1% and 2.0%, respectively. The corresponding rates for edema were: 3.7%, 5.2% and 3.5%, respectively. The corresponding rates for cardiac failure were: 0.2%, 0.5% and 0.1%, respectively. The incidence rates of myocardial infarction fatal and non-fatal ; in all patients including those taking ASA for cardiovascular prophylaxis were: 0.5% for CELEBREX 400mg BID, 0.5% for ibuprofen 800 mg TID, and 0.2% for diclofenac 75 mg BID. The corresponding rates for patients not taking ASA were: 0.2%, 0.1%, and 0.1% respectively. General Safety: The adverse event profile from the CLASS study was similar to those reported in the arthritis-controlled trials. No significant differences were seen across treatment groups in the incidences of serious adverse events. The following standard Contraindications set by Health Canada for all NSAIDs have been added to the Product Monograph for CELEBREX: Active peptic ulcer, active GI bleeding, or active inflammatory disease of the bowel Significant hepatic impairment or active liver disease Severe renal impairment creatinine clearance 0.5 mL sec: 30 mL min ; or deteriorating renal disease individuals with less degrees of renal impairment are at risk of deterioration of their renal function when prescribed NSAIDs and must be monitored and cephalexin.
On the other hand, some studies have suggested that the anti-inflammatory effects, at least in celebrex and meloxicam movicox ; , may have beneficial effects on blood vessels that would be heart protective.
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By patients. Standard laboratory full polysomnography PSG ; CPAP titration is still considered the gold standard for determining the level of pressure required for each patient. However a proportion of patients remain untreated because of the lack of acceptance to this treatment. Several studies demonstrated that auto-titrating positive airways pressure APAP ; devices improve compliance, comfort and therefore adherence to treatment, with no differences in functional outcomes compared to CPAP. Aim of this study was to evaluate acceptance and compliance to APAP in a population of OSA patients in which standard manual titration failed and therefore have been considered "untreatable". Methods : Three hundred and seventy six consecutive severe OSA patients AHI 20 ; referred to our sleep disorders center in 1-year period underwent one full-night PSG manual CPAP titration. Based on compliance time spent with CPAP on ; , patients were classified as: compliant C; 4 hours ; and not compliant NC ; including those who were poorly compliant NC1; between 2 and 4 hours ; and those not compliant NC0; less than 2 hours ; . The night after manual titration, these NC patients received treatment with APAP REMstar Auto Respironics Inc. ; . Results : Characteristics of the whole sample n 376 ; were: 320M, 56W; mean age: 54.212.8 yrs., Mean Oxygen Desaturation Index ODI ; : 41.822.3 per hour; minimal SaO2% : 73.810.2. Forty-six patients 12.2%; 39M, 7W; mean age: 53.113.2 yrs., mean ODI: 48.519.6; minimal SaO2%: 70.711.1 ; were classified as NC NC0: n 32; NC1: n 14 ; and therefore were treated with APAP. Of them, 3 patients showed no compliance also to APAP. Nine patients still had a compliance than 4 hours mean average use: 2.11.7hours, average pressure: 5.81.1 cmH2O; 90th centile pressure: 8.21.6 cmH2O ; while 34 46 73.9% ; patients showed a good compliance to APAP mean average use: 6.71.5 hours; average pressure: 8.41.9 cmH2O; 90th centile pressure: 10.22.2 cmH2O ; . Conclusion : The vast majority of patients in which manual CPAP titration failed, precluding eventual treatment, surprisingly showed good compliance to APAP. Our data suggest that APAP could be a valid therapeutic alternative in those patients judged "untreatable" with conventional respiratory devices before considering other treatment options weight loss, ENT surgery etc. ; . Support optional ; : tions. P values 0.05 were statistically significant. Results : There were 226 subjects 151 F, 75 M ; with female: male ratio of 2: 1. The following variables were significantly different: age 52.2w vs. 46.3m ; , BMI 38.0w vs. 31.3m ; , neck circumference 38.6w vs. 41.9m[cm] ; , number cardiovascular risk factors 1.5w vs 0.9m ; and REM index 40.6w vs. 35.7m ; . Variables which were not significantly different when stratified by gender included: ESS, REM latency, TST, AHI, NREM AHI, percentage REM sleep and depression. Conclusion : To our knowledge, this is the first study to delineate characteristics of patients with REM OSA. We hypothesize that distinct mechanisms of REM OSA exist for men and women. Female hormones may limit sleep-disordered breathing to REM sleep in obese females. The pathophysiology of REM OSA in men is less clear. Further investigation is necessary. Support optional and
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20. Use of venous thromboembolism prophylaxis on medical at-risk patients. Hongjun Yin, M.S.1, Leo Lichtig, Ph.D.2, Paul J. O'Connor, RPh, . M.B.A2, F Randy Vogenberg, RPh, Ph.D.2; 1 ; University of Illinois at Chicago, Chicago, IL; 2 ; Aon Consulting Life Sciences Practice, Wellesley, MA. PURPOSE: Patients having prolonged immobility are at high risk of developing venous thromboembolism VTE ; . Use of thromboprophylaxis TP ; for preventing VTE was recommended by the 2001 American College of Chest Physicians guidelines. Consequently, patients with inpatient stays longer than 5 days should be given TP. TP utilization, however, varies widely across hospitals. This study focused on heart failure and shock patients to show utilization rate of TP and factors associated with its use. METHODS: An administrative database from 15 hospitals across the United States was used to identify and analyze the cohort. Descriptive statistical analysis was done to identify TP utilization rates. Logistic regression was performed to identify factors associated with TP as well as the relationship between length of stay LOS ; and VTE risk. VTEs identified within 90 days after the index admission were assumed to be associated with that admission. The analysis included 31co-morbidities, using Charlson's and Elixhauser's comorbidity measures. RESULTS: For patients with LOS 5 days, only 61.1% received TP. TP utilization ranged from 32.2% to 87.5% across the hospitals. Patients with longer LOS, history of thrombosis, myocardial infarction, cardiac arrhythmias, valvular disease, obesity or greater number of co-morbidities were more likely to receive TP. Patients with mild liver disease, anemia, or older patients are less likely to receive TP. CONCLUSIONS: Rate of TP use should be increased to achieve desired improved clinical and economic outcomes. Further study is needed on the factors influencing use of TP and specific role s ; for pharmacists. 21. Assessment of physician satisfaction with services provided by a clinical pharmacist managed cardiac risk reduction service. James D. Nash, Pharm.D., Kari L. Olson, Pharm.D., Angela Hardy, Pharm.D., Kara Uram, Pharm.D.; Kaiser Permanente Colorado Region, Aurora, CO. PURPOSE: The Clinical Pharmacy Cardiac Risk Service CPCRS ; of Kaiser Permanente of Colorado KPCO ; collaborates with primary care physicians and cardiologists in co-managing cardiac risk factors in approximately 10, 000 patients with cardiovascular disease. Since its inception in 1998, no evaluation of physician satisfaction has been conducted. The purpose of this study was to determine physician satisfaction with services provided by CPCRS. METHODS: Eligible physicians from internal medicine, family practice, preventive medicine and cardiology, who had one or more patients enrolled in CPCRS for at least one year were mailed a 21-question survey. The survey was reviewed for content and face validity by experts prior to mailing. Surveys were mailed, collected, and tabulated by an external independent research firm to maintain confidentiality. The questions pertained to overall satisfaction and to individual components of the service using a Likert-type and
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That androgen ablation can mitigate tolerance to prostate specific antigens, allowing prostate-specific T cells to expand and develop effector function after vaccination [258]. These results suggest that DNA vaccination against PC may be more efficient when administered after androgen blockade. Another important aspect to consider is tumor escape. One potential approach to avoid loss of the target antigen from the tumor is to include several genes, all encoding different target antigens, into one combined DNA vaccine. Such strategies have been applied successfully for DNA vaccines against infectious disease and for cell-based immunotherapeutic protocols for cancer. Inhibition of angiogenesis is another method that can enhance anti-tumor immunity induced by DNA vaccines. This might be a feasible approach in the clinic, since no apparent toxicity or impairment of normal blood vessels was observed when this approach was investigated in mice [259]. Finally, new improvements in techniques for monitoring of immune responses will enhance our understanding of the induction of immune responses to DNA vaccination against cancer. Already the use of tetramer assays, intracellular cytokine staining and direct ELISPOT assays without the requirement for repetitive in vitro stimulations have improved our possibilities to measure immune responses after clinical vaccination. Immune monitoring is an early evaluation of patient's responses to the vaccine, and is essential for us to maintain a dynamic learning approach in the conquest of eradicating tumors with help from the patients own immune system. The continuation of the work in this thesis will be to evaluate our in vivo EP delivery technique in combination with i.d. injection of a xenogenic PSA DNA vaccine in patients with PC. The DNA vaccine, pVAX-rhPSA v53l, that will be used in the next clinical trial encodes PSA from a rhesus macaque. To facilitate the monitoring of vaccine efficacy after DNA delivery to PC patients we have modified a T cell epitope sequence, psa52-60 v53l, in rhesus PSA. The aim is that the rhesus PSA DNA vaccine will induce PSA-specific CTLs capable of killing PC cells expressing human PSA. The introduction of the modified epitope, which was shown to efficiently activate human T cells in vitro, will improve the monitoring of vaccinated PC patients and allow us to more accurately determine the efficacy of vaccination. Taken together, the results from the papers in this thesis suggest that therapeutic DNA vaccination against cancer is feasible and that with improvements such as those discussed in this thesis, might have the potential to prolong disease free survival of cancer patients. Therefore, for cancer patients in otherwise good health, DNA vaccination may become a promising therapeutic option that avoids toxicities associated with conventional treatments used today and
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A 69 year old man arrived at the emergency room with minor injuries following a horse riding accident. The doctor ordered 10 milligrams of morphine to be given for pain prior to discharging him. A few hours later, he was rushed back to the ED unconscious and not breathing and died shortly afterward. What went wrong? He was given 10 mg of hydromorphone instead of morphine. Hydromorphone is much more potent than morphine and is typically given in much lower doses. A review board at the hospital found several reasons why the error was made. The two drugs have similar names and labels, they were stored next to each other, and the nurse selecting the drug was distracted by another patient. According to a 1999 Institute of Medicine report, approximately 7000 deaths occur each year due to medication errors. Thousands more result in mild to severe symptoms. Many of these errors are the result of name confusion: drug names that sound-alike and look-alike. Often, the indications and doses are the same or similar. In some cases, patients do not pronounce the names of their medications correctly, leading to confusion. The following are some of the drug name mix-ups and their indications ; that nurses should be aware of: Reminyl dementia ; and Amaryl diabetes ; Methadone analgesic, opiate dependence ; and Metadate ADHD ; Keppra seizure disorder ; and Kaletra HIV ; Celebr4x pain, inflammation ; , Celexa antide pressant ; and Cerebyx seizures ; Serzone antidepressant ; and Seroquel antipsychotic ; Serophene ovulatory stimulant ; and Sarafem anti depressant ; Zyrtec allergies ; , Zyprexa antipsychotic ; , and Zantac H2 blocker ; Symbyax bipolar disorder antidepressant ; and Cymbalta antidepressant ; Narcan opiate antagonist ; and Norcuron neuromuscular blocker ; Accutane acne ; and Accupril hypertension ; Chlorpromazine antipsychotic ; and chlorpropamide diabetes ; Hydrocodone analgesic ; and hydrocortisone corticosteroid ; Azithromycin antibiotic ; and erythromycin antibiotic ; Zebeta beta blocker ; and Diabeta diabetes ; Flomax benign prostatic hyperplasia ; and Volmax bronchospasm ; Lamictal antconvulsant ; , Lamisil antifungal ; , lamivudine HIV ; , Ludiomil depressant ; and Lomotil antidiarrheal ; Xanax anxiety ; and Zantac H2 blocker ; Taxotere chemotherapy ; and Taxol chemotherapy ; Primaxin antibiotic ; and Primacor CHF ; Olanzapine antipsychotic ; and clozapine antipsychotic ; MgSO4 magnesium sulfate ; and MSO4 morphine sulfate ; Any drug and its extended release form i.e., Depakote and Depakote ER ; How are drug names chosen and reviewed? Nonproprietary names are reviewed and approved by USAN United States Adopted Name Council ; . Proprietary names for medications are sometimes chosen by manufacturers to reflect the indication Prevacid prevents acid ; or pharmacology of the drug Lexapro is the prodrug of Celexa ; , or have no correlation to the drug itself. The Food and Drug Administrations Office of Postmarketing Drug Risk Assessment OPDRA ; performs a review of proprietary names to evaluate the potential for errors. This process consists of expert panel review, computer assisted analysis to check the sound-alike and look-alike potential for drug names, and labeling, handwriting and verbal analysis. Once on the market, manufacturers often respond to reports of drug name mix-ups by sending alerts to health professionals, changing brand names or changing the labeling to highlight part of the name to avoid confusion. How can nurses minimize the risk of drug name mix-ups? Print drug names clearly on prescriptions and in patient charts. Add the generic name and indication for use to written prescriptions and orders. Speak clearly and spell out the name when giving verbal orders or reports. When taking verbal orders, repeat the drug name back to the prescriber and ask for the indication. Do not hesitate to call back and clarify an order. Doing so may save a patient from a serious and even life-threatening medication error. Do not use abbreviations for drug names, dosage units or directions. QD has been mistaken for OD and the drug placed in the right eye; MSO4 morphine sulfate ; has been given instead of MgSO4 magnesium sulfate ; . Ask patients to bring their medicine bottles or a list of their medications with them to all visits. Ask patients why they are taking the drug. Check the strength of the drug. Doses that seem relatively large or small compared to commercially available strengths should be double-checked. Incorrect or unusual routes of administration should be investigated. If the patient doesnt have the original bottle and is not sure of the drug name, call the poison center with a description of the tablet or capsule for help in identifying it. Do not store containers of products with similar names near each other. Educate patients to ask their pharmacist about what was dispensed when the tablet or capsule looks different than what they have received in the past. In most cases, the drug is a generic product from a different manufacturer; however, it could also be a different drug that was inadvertently dispensed. Call the Maryland Poison Center at 1-800-222-1222 for help in identifying drugs and treating adverse effects associated with drug name mix-ups. All actual or potential medication errors due to name confusion should be reported to the FDAs MedWatch program via telephone 800-FDA-0188 ; , website : fda. gov medwatch ; or fax 800-FDA-1078 and
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Effects of MgSO4 on NO and cGMP Levels in an Animal Model of Preeclampsia B.J. Coates, BS, P.R. Standley, PhD, L.M. Batia, BS, C.A. Standley, PhD; Department of Physiology, Midwestern University, Arizona College of Osteopathic Medicine, Glendale, AZ 85308 Objective: Nitric oxide NO ; is an important regulator of vascular tone in normal pregnancy. However, vascular NO adaptations to pregnancy are likely to be compromised in preeclampsia, leading to hypertension. Since magnesium sulfate MgSO4 ; is the therapeutic agent for preeclampsia, we determined if MgSO4 alters plasma and urinary NO signaling metabolite levels in an animal model of preeclampsia. Interventions: On gestational day 17, rats were anesthetized and osmotic minipumps were implanted to continuously deliver saline, L-NAME 50 mg kg, an NO synthase inhibitor, to induce hypertension and proteinuria ; L-NAME + MgSO4 60 mg kg ; or MgSO4 alone 10-12 rats per group ; . Blood pressure was recorded along with urine and tail blood collection on days 17, 18, and 21 of pregnancy. Plasma and urinary NO, urinary cGMP and urinary protein were determined. Results: Pregnant rats treated with L-NAME displayed significant hypertension on days 18 and 21 P 0.05, compared to saline group ; . MgSO4 significantly reduced MAP by gestational day 21 compared to L-NAME group 128.4 + 6 vs. 147 + 4 respectively, P 0.05 ; . Plasma magnesium levels were significantly increased in the MgSO4 treated rats P 0.05 ; . Plasma and urinary NO levels were decreased in both the L-NAME and LNAME + MgSO4 groups P 0.05, compared to saline ; . MgSO4 treatment alone had no significant effect on plasma or urine NO levels. Urinary cGMP decreased in the L-NAME group and this decrease was most pronounced in the L-NAME + MgSO4 group by gestational day 21. L-NAME rats exhibited significant proteinuria, which was not as pronounced in the group receiving MgSO4. Conclusion: Elevated MgSO4 effectively reduces blood pressure in an animal model of preeclampsia. However, the blood pressure lowering effects of this dose of magnesium do not appear to be through an induction of NO.
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