New Do Not Use Abbreviation added to Medical Center List

Transcription

1 TABLE OF CONTENTS Patient Safety Initiative: New Do Not Use Abbreviation List 1 Health Advisories: Antidepressants and Atypical Antipsychotics 2-3 Management of Otitis Media 3 Post Menopausal Use of Estrogen and Progestin 3-4 New on the Horizon: Rimonibant 4-5 P&T Committee Formulary Action - Feb/Mar/Apr New Do Not Use Abbreviation added to Medical Center List The Medical Center Do Not Use abbreviations list was recently updated to include T.I.W. T.I.W. is used to mean three times a week but can be misread as three times a day (T.I.D). This list is in effect now and will be the list used during our JCAHO visit in early The use of these abbreviations has resulted in medical errors that cause patient harm. These abbreviations should not be used in any clinical documentation (e.g. prescriptions, clinical notes, and orders). Medical Center Do Not Use Abbreviations List Item Abbreviation Potential Problem Preferred Term 1 U (for unit) Mistaken as zero, four or cc. Write unit 2 IU Mistaken as IV (intravenous) or (for international unit) 10 (ten). Write international unit Q.D. (for daily) Q.O.D. (for every other day) Zero after decimal point ( 2.0 mg) No zero before decimal point (.5 mg) MS (for morphine) Mistaken for QID. The period after the Q can be mistaken for an I. Mistaken for QD and QID. If the O is poorly written it looks like a period or I. Decimal point is missed. 2.0 mg becomes 20 mg. Decimal point is missed..5 mg becomes 5 mg Mistaken for magnesium sulfate. Write daily or every day Write every other day Never write a zero by itself after a decimal point (2 mg) Always use a zero before a decimal point (0.5 mg) Write morphine or morphine sulfate 8 MSO 4 (for morphine) Mistaken for magnesium sulate Write morphine or morphine sulfate MgSO 4 (for magnesium sulfate) µg (for microgram) Nitro (for nitroprusside or nitroglycerin) Mistaken for morphine sulfate Mistaken for mg Mistaken for each other Write magnesium sulfate Write mcg Write full name nitroglycerin or nitroprusside 12 T.I.W. (for three times per week) Mistaken as 3 times per day Write out as 3 times weekly or three times weekly or specify the three days (e.g., every Mon-Wed-Fri ) 1

2 Health advisories on antidepressants and atypical antipsychotics Recently, the FDA has issued two Public Health statements concerning the risk of suicide associated with the use of antidepressants in certain populations and the increased risk of hyperglycemia and diabetes in patients treated with atypical antipsychotics. SSRIs and risk of suicide Recommendations of the FDA s Psychopharmacologic Drugs and Pediatric Subcomittee of the Anti-Infective Drugs Advisory Committee In June 2003, the Food and Drug Administration (FDA) issued a statement regarding the safety of selective serotonin reuptake inhibitors (SSRIs), in particular paroxetine, in pediatric patients with major depression. Concern was raised about the safety of paroxetine in this population after preliminary review of data from clinical trials indicated a possible increased risk of suicidal thinking or suicide attempts among children and adolescents treated with paroxetine for major depressive disorder. Pooled analysis of data from 3 unpublished trials involving 663 children and adolescents found the frequency of suicide attempts, suicide thoughts, and episodes of self harm with paroxetine to be 5.3% versus 2.8% with placebo. In a review of another trial for social anxiety disorder, suicide-related adverse events were reported in 2.4% of 165 children given paroxetine compared to none of 157 children treated with placebo. A study sponsored by the manufacturer of paroxetine (Paxil, GlaxoSmithKline) reported that 10 of 93 children being treated for depression with paroxetine withdrew from the study due to psychiatric events (including worsening depression, emotional liability (e.g. suicide ideation), behavioral disturbances (e.g., aggression or hostility), and euphoric effects. The FDA has begun a full investigation of these and other reports. Although there is not yet a clear association between antidepressant use and suicidal ideation, the FDA has asked manufacturers of 10 antidepressants (buproprion, citalopram, fluoxetine, fluvoxamine, mirtazapine, nefazodone, paroxetine, sertraline, escitalopram, and venlafaxine) to revised the product labeling to include a stronger warning about the need to monitor for worsening depression and suicidal ideation among both adults and children. These recommendations come from the FDA s Psychopharmacologic Drugs and Pediatric Subcomittee of the Anti-Infective Drugs Advisory Committee. Results of expert and FDA analyses of data on pediatric suicides will be released later in Atypical antipsychotics and diabetes The FDA has also recently asked manufacturers of atypical antipyschotics to make revisions in product labeling to reflect the increase risk of diabetes and hyperglycemia found in association with the use of these agents. The warning states of the occurrence of hyperglycemia sometimes resulting in ketoacidosis, hyperosmolar coma, or death among patients treated with atypical antipsychotics. Patients with diabetes mellitus should be carefully monitored for worsening of glucose control. Periodic fasting blood glucose testing should be done for patients with risk factors for diabetes (i.e., obesity, family history). All patients should be monitored for signs and symptoms of hyperglycemia, including polydipsia, polyuria, polyphagia, and weakness. Although the incidence of hyperglycemia and diabetes mellitus with atypical antipsychotic use is not known, a total of 89 case reports have appeared in the literature. Olanzapine and clozapine have the highest number of reports of associated hyperglycemia and diabetes, with 52 and 30 case reports each, respectively. A consensus development conference was convened by the American Diabetes Association, the American Psychiatric Association, the American Association of Clinical Endocrinologists, and the North American Association for the Study of Obesity to examine the metabolic risks of atypical antipsychotics, including diabetes, weight gain, and dyslipedemia. One factor that confounds establishing the true risk of atypical antipsychotics is the higher prevalence of obesity and diabetes among individuals with schizophrenia and affective disorders an estimated 1.5 to 2 times higher compared to the general population. Weight gain associated with atypical antipsychotics compared to placebo varies from 0.5 to 5.0 kg at 10 weeks of therapy, primarily gained as fat. The mechanism of weight gain from the atypicals is unknown, but may be related to the effect of these agents on neurotransmitters with subsequent alterations on hunger and satiety. Weight gain appears to be greatest with clozapine and olanzapine, followed by risperidone and quetiapine, then aripirazole and ziprasidone. The mechanism of new onset or exacerbation of existing diabetes mellitus reported with the atypical antipsychotics is unknown. Impairment of insulin action, or insulin resistence, has been proposed as a possible mechanism, as a result of weight gain, a change in the distribution of fat in the body, or a direct effect on insulin-sensitive tissues; studies to date have found β-cell function to be unaffected by antipsychotics. The panel also addressed the effects of atypical antipyschotics on serum lipids. Increases in total cholesterol, LDL cholesterol, and triglycerides, with decreases in HDL cholesterol have been seen with the atypicals. As with weight gain, clozapine and olanzapine appear to have the greatest effect, followed by risperidone and quetiapine, then aripirazole and ziprasidone. Based on the available information regarding the metabolic risks of atypical antipsychotics, the panel recommends baseline assessment and periodic monitoring for significant changes in weight, lipid profile, and glycemic control. Baseline screening should include: Assessment of personal and family history of obesity, diabetes, dyslipidemia hypertension, and cardiovascular disease Weight and height (for body mass index [BMI] calculation) Waist circumference measurement Blood pressure Fasting plasma glucose Fasting lipid profile Follow-up monitoring should be done periodically, with weight reassessed at 4, 8, and 12 weeks, and then quarterly, thereafter. Other parameters should be reassessed at 12 weeks, and then annually (except for lipid profile). Patients who are overweight or obese at start of therapy should receive nutrition and exercise counseling for weight management. Patients, families, and caregivers should also be educated on the signs and symptoms of diabetic ketoacidosis. Patients who develop 2

3 hyperglycemia, diabetes, or hyperlipidemia while receiving an atypical antipsychotic should be switched to an agent less likely to affect glycemic or lipid control; referral should also be made to specialized services for appropriate medical care. Management of Acute Otitis Media Clinical Practice Guideline of the American Academy of Pediatrics The American Academy of Pediatrics and the American Academy of Family Physicians recently convened a committee of primary care physicians and experts to review data on the diagnosis and management of acute otitis media (AOM). This effort was prompted in part by the large number of antibiotic prescriptions written annually for otitis media. In addition, there is concern about the rising incidence of antibacterial resistance and the increasing cost of prescription medications. In many European countries, initial management of AOM involved symptomatic relief and observation. Antibiotic therapy is instituted only after symptoms fail to resolve with short-term observation. Initial Management The committee identified a total of 3461 publications related to AOM; of these, 74 were fully reviewed. The committee determined that observation without use of antibiotics may be appropriate in some children with uncomplicated AOM. This observation option is deferring antibiotic treatment for 48 to 72 hours with management of pain. Acetaminophen and ibuprofen are the most effective agents for relief of mild to moderate pain; narcotic analgesics are effective for children with moderate to severe pain; however, there is an increase in the incidence of adverse events. Topical agents may provide some limited benefits. The option of deferring antibiotic treatment is recommended to be limited to otherwise healthy children 6 months to 2 years of age with non-severe illness and an uncertain diagnosis of AOM; and to children 2 years and older without severe symptoms or with an uncertain diagnosis. Antibiotics are recommended for children less than 6 months (due to the risk of serious infection in this age group); children 6 months to 2 years with severe illness (moderate to severe otalgia or fever = 39 C); and for children older than 2 years with severe illness and a certain diagnosis of AOM. A summary of outcomes of clinical trials of initial observation versus initial antibiotic therapy for AOM is given in table 1. Table 1. Outcomes of clinical trials comparing observation versus antibiotic therapy for acute otitis media. Initial Initial antibiotic Outcome observation therapy* Symptomatic relief: at 24 hours at 3 days at 4-7 days 59% 87% 71% 60% 91% 71% Clinical resolution: at 7-14 days Mean duration of pain 72% 3.3 days 82% 2.8 days 0.5 days Mean duration of crying 1.4 days (p<.001) Mean analgesic use (doses) (p<.004) 2.0 days Median duration of fever 3.0 days (p<.004) Incidence of mastoiditis or 0.17% 0.59% suppurative complications Persistent middle ear effusion: at 4-6 weeks at 3 months 48% 26% 45% 21% From: American Academy of Pediatrics, American Academy of Family Physicians. Subcommittee on Management of Acute Otitis Media. Clinical Practice Guidelines. ( Accessed April 1, 2004; *Rate of antibiotic-associated vomiting or diarrhea was 16%; rate of antibiotic-associated skin rash was 2%. Antibiotic choice Recommendations were also made by the committee regarding choice of antibiotics for treatment of AOM. These are summarized in table 2. Table 2. Antibiotics for treatment of AOM. Severity As initial treatment* For treatment failure after h of initial antibiotic Non-severe (temp < 39 C and mild otalgia Severe (temp = 39 C or severe otalgia) Amoxicillin mg/kg/day Ceftriaxone for 1or 3 days For treatment failure after h of initial observation Amoxicillin mg/kg/day *Alternatives for penicillin allergy include: non-type I allergy cefdinir, cefuroxime, cefpodoxime, or ceftriaxone; type I allergy azithromycin or clarithromycin. Summary This clinical practice guideline was developed using evidence from published literature on the diagnosis and management of AOM. An accurate diagnosis and a consistent definition of AOM is essential in the treatment of this childhood illness. Pain management has been identified as an essential component of care. The option use observation with symptomatic care as initial therapy in AOM may result in a decreased use of antibiotic Postmenopausal use of estrogen and progestin results from the Women s Health Initiative trials The Women s Health Inititative (WHI) trial was designed to assess the risks and benefits of therapies that could potentially reduce the incidence of cardiovascular disease, breast and colorectal cancer, and osteoporosis-related fractures in postmenopausal women. Between 1993 and 1998, a total of 161,809 postmenopausal women were enrolled into a series of WHI clinical and observation trials. Two of the trials were designed to determine the risks and benefits of hormone replacement therapy (HRT) with either estrogen alone or estrogen plus progestin. However, both clinical trials were stopped early after interim analyses revealed a higher incidence of cardiovascular diseases and breast cancer. Detailed results of the estrogen-progestin trial have been published. Preliminary results of the estrogen alone trial have been released, with full publication expected anticipated later in Estrogen plus progestin In the estrogen-progestin trial, 16,608 healthy postmenopausal women with an intact uterus were randomly assigned to treatment with either conjugated equine estogen mg and medroxyprogesterone 2.5 mg daily (Prempro ) or placebo daily. Follow-up annual clinic visits, self-administered questionnaires, and 6-month standardized interviews were used to identify clinical events. Cardiovascular events included coronary heart 3

4 disease (acute or silent myocardial infarction or death from coronary heart disease), stroke, and thromboembolic events (pulmonary embolism or deep vein thrombosis). Breast, colorectal, endometrial, and other cancers were documented using pathological reports. Fractures (hip, vertebral, and other osteoporosis-related fractures) were confirmed by radiology reports. An average of 8.5 years of follow-up was expected, with a final analysis conducted in However, a series of interim analyses revealed a trend towards an increase in the risk of cardiovascular disease and breast cancer. Since the suggested risk of harm was greater than the potential benefits (for fractures and colon cancer), the study was stopped after an average followup of 5.2 years. The clinical outcomes found at the end of the trial are given in the table. Table 3. Clinical outcomes of WHI estrogen-progestin trial. Outcome No patients (annualized %) CHD total CHD-death Nonfatal MI Placebo Estrogen + Progestin 122 (0.30) 164 (0.37) 26 (0.06) 33 (0.07) 96 (0.23) 133 (0.30) CABG/PTCA 171 (0.41) 183 (42) Stroke total 85 (0.21) 127 (0.29) Fatal 13 (0.03) 16 (0.04) Nonfatal Thromboembolic events total 59 (0.14) 67 (0.16) 94 (0.21) 151 (0.34) DVT 52 (0.13) 115 (0.26) PE 31 (0.08) 70 (0.16) Total cardiovascular disease 546 (1.32) 694 (1.57) Cancer total Invasive breast Endometrial Colorectal Fractures total Hip Vertebral Other osteoporetic Death Other causes Total 458 (1.11) 124 (0.30) 25 (0.06) 67 (0.16) 788 (1.91) 62 (0.15) 60 (0.15) 701 (1.70) 502 (1.14) 166 (0.38) 22 (0.05) 45 (0.10) 650 (1.47) 44 (0.10) 41 (0.09) 579 (1.31) 166 (0.40) 165 (0.37) 218 (0.53) 231 (0.52) From: Writing Group for the Women s Health Initiative Investigators. JAMA 2002;288:321-33; CHD=coronary artery disease; MI=myocardial infarction: CABG=coronary artery bypass graft; PTCA=percutaneous transluminal coronary angioplasty; DVT=deep vein thrombosis; PE=pulmonary embolism. *Unadjusted (nominal) 95% CI excludes 1; Adjusted 95% CI excludes 1. Adjusted 95% CIs were corrected for multiple analyses over time. Based on these results and those of an additional analyses of data, the investigators concluded that HRT (estrogen + progestin) was not beneficial as primary or secondary prevention of cardiovascular disease in postmenopausal women. Although continued therapy may have found increased protective effects of HRT for colon cancer and osteoporosis-associated fractures, the trend for increase cardiovascular disease and breast cancer outweighs any benefits. A smaller group of women from the WHI cohort also participated in the Women s Health Initiative Memory study (WHIMS). The purpose of this ancillary study was to determine the effects of HRT (estrogen alone or estrogen + progestin) on the risk of dementia or mild cognitive impairment in 4532 healthy women over the age of 65. After a mean follow-up period of 4 years (the time from enrollment in WHI to last assessment using the Modified Mini-Mental State Examination), 40 women in the estrogen-progestin group and 21 women in the placebo group were diagnosed with probable dementia (45 vs 22 cases per 10,000 person-years, respectively; HR 2.05 [95% CI, ]). The rate of mild cognitive impairment was also higher with HRT, but the differences did not reach statistical significance. Estrogen alone The estrogen alone trial included 10,739 healthy postmenopausal women without a uterus who were randomly assigned to treatment with either conjugated estrogen mg alone or placebo daily. As in the estrogen-progestin study, the estrogen alone study had planned to have an 8-year follow-up period to assess the effects of estrogen on cardiovascular disease, cancers, and osteoporosis-related fractures. An ancillary study on the effects of estrogen alone and dementia was also conducted. The estrogen alone WHI study was stopped in March 2004 after examination of 7-year data found no reduction in coronary heart disease with estrogen. An increase in the risk of stroke was seen with estrogen alone, along with an increase in the risk of hip fractures. Preliminary data from the WHIMS trial suggests that estrogen alone, like estrogen + progestin, is associated with an increased risk of dementia and/or cognitive impairment. According to NIH, an additional year was unlikely to change any of these results and continuation of the study may expose otherwise healthy women to an increased risk of stroke or dementia. FDA requested changes in the use of HRT Based on the result of WHI studies, the FDA has requested manufacturers of all postmenopausal HRT to revise package labeling to reflect these new findings. A black box warning includes that estrogens and progestins should not be used for prevention of cardiovascular diseases and that, although only a fixed dose of conjugated equine estrogens and medroxyprogesterone was studied, the risks for other estrogens and progestins should be considered comparable at this time. Estrogens, alone or with progestines, should be used at the lowest dose and shortest period of time possible. Finally, data from the WHIMS trial will be included in the warning and in the clinical efficacy section of labeling. The indications for estrogen are for treatment of moderate to severe vasomotor symptoms associated with menopause; treatment of moderate to severe symptoms of vaginal and vulvar atrophy associated with menopause (after consideration of topical products); and prevention of postmenopausal osteoporosis in women at high risk, with consideration given to nonestrogen therapies. New on the Horizon: Rimonabant In 2001, the leading cause of death among Americans of all ages, gender, and races was cardiovascular disease. As Americans and clinicians, we continue to battle this problem. There are two major preventable risk factors, which may lead to cardiovascular disease: smoking and obesity. Practitioners often struggle with the treatment of these risk factors. Cigarette smoking is not only the leading cause of preventable death but also is a risk factor for the development of cardiac, vascular, and chronic lung disease and the development of lung cancer. As the morbidity and mortality with smoking is obviously high it can be said that smoking cessation can clearly reduce disease and death burden. Approximately 30% of smokers will attempt to quit this year and the majority will not experience a successful attempt. Currently, there are a myriad of smoking cessation options for patients. Nicotine replacement therapy is available and includes gum, patches, lozenges, nasal spray, 4

5 and inhalers. Non-nicotine replacement therapies include antidepressants such as buproprion and fluoxetine. However, even with these current means of therapy many patients still struggle to break this addiction. Obesity, especially central obesity associated with metabolic syndrome, is a major concern in the treatment of patients in the westernized world. Metabolic syndrome, which consists of central or abdominal obesity, dyslipidemia, hypertension, insulin resistance, and glucose intolerance, is a major cardiovascular concern. It is approximated that 24% of patients greater than age 20 have the components of metabolic syndrome. In elderly patients the incidence increases to about 40%. Currently, therapy for metabolic syndrome includes treating its various components with lifestyle modifications, anti-hypertensives, oral hypoglycemics and lipid lowering agents. Rimonabant, the first of a new class of agents called the cannabinoid-1-receptor antagonist, may offer a solution to these obstacles. Rimonabant was the subject of two recent phase III trials; studies with rimonabant and tobacco use (STRATUS-US) and rimonabant in obesity (RIO-Lipids). 4,5 In both trials it showed to be a promising alternative in the fight against the two major preventable risk factors of cardiovascular disease and death. STRATUS-US is a double-blind, placebo-controlled, multicenter study. Seven hundred eighty-seven smokers who were considered to be of moderate to heavy nicotine addiction but motivated to quit were enrolled in the 10-week trial. Patients received either 5 or 20 mg of rimonabant or matching placebo daily. Abstinence from smoking was determined during the final four weeks of treatment and was based upon carbon monoxide concentrations in expired air. Patients treated with rimonabant 20 mg daily were significantly more likely to quit smoking than those patients who received placebo (p=.002). Changes in weight were also assessed and patients in the rimonabant group were more likely to lose a minimal amount of weight compared with the placebo group, who was more likely to gain. The average weight gain for the placebo group was 1.1 kg (p =.001). It is of note though that average weight smokers, in the rimonabant group, were more likely to maintain weight than lose weight, when compared with their heavier counterparts. There were no statically significant differences in the rate of adverse effects, the most significant of which seems to be nausea. P&T Committee Formulary Action Feb/Mar/Apr 2004 Additions Oxycodone Insulin aspart (Novolog ) Galantamine Rivastigmine Low potassium dextran organ preservation solution (Pefadex ) Line extensions Warfarin 3mg tablet Hydrochlorothiazide 12.5mg capsule Diltiazem (24hr) 360mg capsule (Cardizem CD ) Deletions Insulin lispro Morphine 10mg, 20mg suppositories Rapacuronium Heparin (beef) Authors: Joan Stachnik, PharmD, BCPS Michael Gabay, PharmD, BCPS Reviewers: Nancy Shapiro, PharmD, BCPS Larisa Cavallari, PharmD, BCPS Rob DiDomenico, PharmD Editor: Joan Stachnik, PharmD, BCPS RIO-Lipids consisted of 1,036 subjects with dyslipidemia and a body mass index of 27 to 40 kg/m 2 and more than half of these patients were considered to have metabolic syndrome. Patients were not required to adhere to a specific diet but were encouraged to decrease caloric intake by 600 kcal/d and to reduce the amount of high-fat foods consumed. Seventy percent of patients on rimonabant 20 mg experienced a 5% weight loss and 44% experienced at least a 10% weight loss. Highdensity lipoprotein was increased by 23% and triglycerides were decreased by 15%. At the end of the study the number of patients considered to have metabolic syndrome had been halved. Again the most commonly reported adverse event was nausea. Neither of these studies is to publication yet. Further conclusions will require complete evaluation of this literature. Rimonabant is not yet approved by the FDA however based on the above reports, it seems as though it will be a useful weapon in the fight against preventable disease and death caused by smoking and obesity. 5