PL CE LIVE April 2012 Forum

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1 April 2012 PL CE LIVE Rachel Maynard, Pharm.D. Assistant Editor Pharmacist s Letter/Pharmacy Technician s Letter Sherri Boehringer, Pharm.D., BCPS Associate Editor Pharmacist s Letter/Pharmacy Technician s Letter CE Information Pharmacist's Letter / Therapeutic Research Center is accredited by the Accreditation Council for Pharmacy Education (ACPE) as a provider of continuing pharmacy education. PL CE LIVE editors disclose: No financial interests related to the content No commercial support and no advertising Supported entirely by subscriptions PL CE LIVE Drug Information Analysts disclose: Dr. O Mara reports that her spouse is employed by Celgene Pharmacist Objectives Identify emerging trends in drug therapy and their place in patient care practices. Summarize recommended strategies for treating insomnia. List three methods for preventing recurrent urinary tract infections. Describe the significance of the new safety warnings for statins. Pharmacy Technician Objectives Identify emerging trends in drug therapy and their place in pharmacy practice and operations. List three drugs that will be available as generic products by the end of Recognize antibiotic dosing regimens that are used to prevent recurrent urinary tract infections. Identify two new safety concerns for statin drugs. Generic Drugs in

2 Are Generics the Same as the Brand? Therapeutic equivalent drugs that are pharmaceutical equivalents and bioequivalents AND have the same safety and efficacy profile as the brand Pharmaceutical equivalent Same drug, dosage form, route of administration, and strength Bioequivalent Same rate of absorption and amount of drug absorbed May differ in appearance, release mechanism, inactive ingredients, expirations, storage What To Tell Patients The standards used to test generic drugs against branded drugs are the same as testing different batches of branded drugs Reassure patients that generic equivalents produce the same therapeutic results Bringing a Generic to Market Brand name patents are valid for 20 years from the date of filing the application New branded drugs lose almost half of their patent protection before they ever reach the market Bringing a Generic to Market First generic company to challenge the patent has the exclusive right to marketing for 180 days Lack of competition may result in lack of significant cost savings initially But, brand companies may launch an authorized or branded generic Brand name product relabeled and marketed as generic Prices fall when multiple generics are available 2

3 The Tale of Plavix (clopidogrel) Apotex challenged the patent early and launched a generic Bristol Myers/Sanofi got an injunction to stop sales of the generic until a final ruling was made Final court ruling that brand patent was still valid Product already in distribution was fine to sell until supplies were exhausted Generics Expected in 2012 Brand Name Generic Name Estimated Date of Generic Avapro Irbesartan March 2012 Boniva Ibandronate March 2012 Lexapro Escitalopram March 2012 Seroquel Quetiapine March 2012 Plavix Clopidogrel May 2012 Actos Pioglitazone August 2012 Singulair Montelukast August 2012 And more: Diovan (valsartan), Lunesta (eszopiclone), Clarinex (desloratadine), Maxalt (rizatriptan)... When Switching, Remember... Alert patients to any differences expected with a therapeutic interchange Suggest comparable doses Monitor patients appropriately when a switch is made Managing Insomnia Concerns with Sleeping Pills Warnings of strange sleep related behavior and severe allergic reactions MedGuide required with dispensing Concerns with benzodiazepines Abuse, dependence, withdrawal, falls, depression, etc What s the Latest Buzz? Prospective observational study over 2.5 years ~10,000 patients with sleeping pill Rxs ~25,000 controls without sleeping pill Rxs Primary endpoint of death Result: Those with sleeping pill Rxs had a 4.6 fold increase in death compared to those without Rxs 3

4 Potential Mechanisms for Mortality Reduced respiratory drive and worsened sleep apnea Impaired motor and cognitive skills, leading to falls, accidents, depression Increased gastroesophageal regurgitation, which could lead to cancer Keep This in Perspective... Link between sleeping pills and mortality is controversial Lack of data on diagnoses Results based on Rxs, not on pills taken Patients with sleeping pill Rxs tend to be sicker than those without At this point, it s too soon to blame sleeping pills for excess deaths The Big Picture Identify and treat underlying causes of insomnia Sleep apnea, pain, depression, restless legs, etc Identify and reduce potential drug side effects Caffeine, stimulants, SSRIs, diuretics, etc The Big Picture Discourage overuse of sleeping pills Pills are only modestly effective Taper when possible Recommend behavioral therapy and sleep hygiene Only go to bed when sleepy, stick to regular sleep schedule, remove the clock from sight, avoid large meals/exercise late in the evening, etc Prophylaxis Options Antibiotic prophylaxis Management of Recurrent UTIs in Women Non antibiotic prophylaxis Other tips 4

5 Is Antibiotic Prophylaxis for Everyone? Benefits Can reduce recurrent UTIs by 95% Risks Yeast infections, GI upset, C. difficile diarrhea, antibiotic resistance Consider for women with frequent/bothersome symptoms Antibiotic Prophylaxis Dosing regimen Drugs of choice Antibiotic Prophylaxis: Dosing Regimen Continuous prophylaxis Duration: 6 to 12 months, or longer Daily at bedtime Every other night Three times a week Postcoital prophylaxis Single dose within 2 hours of intercourse Self starting 3 day regimen started after symptoms begin Contact prescriber if symptoms aren t gone in 48 hours Antibiotics for Prophylaxis Low doses for prophylaxis Drug Cefaclor Cephalexin Ciprofloxacin Nitrofurantoin Trimethoprim TMP/SMX Dose 250 mg mg 125 mg mg 100 mg 40/200 mg Treatmentdoses for self start regimen A Note About Nitrofurantoin Discourage use of nitrofurantoin: For longer than 6 months If creatinine clearance < 60 ml/min Counsel patients to report possible symptoms of lung or liver toxicity Cough Shortness of breath Flu like symptoms Non-Antibiotic Prophylaxis Vaginal estrogens for postmenopausal women Cranberry Conflicting evidence due to the wide variety of products and doses studied Not enough evidence to support Probiotics D mannose Methenamine 5

6 Other Tips to Prevent UTIs Discourage use of spermicides and diaphragms, if appropriate Hydration and postcoital voiding have not been proven to help or harm Statin Safety Concerns Mechanism Statin effects on muscle and the liver may cause insulin resistance Blocking cholesterol synthesis may inhibit glucose uptake and insulin release from the pancreas Evidence for an Effect JUPITER trial About 6 more cases of diabetes per 1,000 patients taking rosuvastatin (Crestor) 20mg/day for 2 years Women s Health Initiative Increased risk of diabetes in post menopausal women Meta analyses 9% increased risk for diabetes (Sattar et al) Higher risk of diabetes with high doses compared to moderate doses (Preiss et al) Diabetes Risk vs. Cardiovascular Benefit? Roughly one more case of diabetes compared to 9 fewer cardiovascular events...for every 1000 patients on a statin/year. 6

7 Recommendations Usually the statin doesn t need to be stopped if diabetes occurs or worsens Suggest pravastatin if only moderate LDL lowering is needed Only statin without updated diabetes labeling Recommend usual diabetes screening At least every 3 years in high risk patients and those age 45 and over What do you tll tell patients? Keep the Risk in Perspective Statins cardiovascular benefits outweigh the risk of diabetes Increase in glucose or A1C is likely to be small Benefits of statins are even GREATER in people with diabetes than those without Mechanism Cholesterol is a component of the nervous system Excess inhibition of cholesterol synthesis MIGHT slow thought and memory Evidence for an Effect Controversial On the one hand Several case reports of memory loss, trouble recalling words, and confusion On the other hand Some studies suggest that statins provide a protective benefit and protect against the development of Alzheimer s dementia 7

8 Recommendations If cognitive symptoms occur: Suggest ruling out other causes Aging Underlying cerebrovascular disease Other meds (anticholinergics, etc) Suggest switching statins or decreasing the dose before stopping it entirely Keep in mind no statin is more or less likely to cause cognitive impairment What do you tll tell patients? Again Keep This Risk in Perspective Any cognitive effects due to statins: Aren t common and are usually mild Can occur anytime after starting the statin Memory problems can be due to other reasons Drug Interactions Lovastatin Limits Don t exceed 40 mg Don t exceed 20 mg Try to avoid Interacting Drugs amiodarone danazol, diltiazem, verapamil cyclosporine, gemfibrozil Don t use at all strong CYP3A4 inhibitors such as erythromcyin, clarithromycin, itraconazole, HIV protease inhibitors Statins and gemfibrozil Try and avoid ALL statins with gemfibrozil Suggest fenofibrate when a fibrate is needed New Drug Sprix 8

9 Sprix (ketorolac) nasal spray Similar to IM or PO ketorolac: Onset of effect Side effects (cardiovascular, renal, bleeding risks) Warning to not use for more than 5 days due to GI bleeding risk Usual dose: One spray in each nostril every 6 8 hours, up to 8 sprays per day Each preservative free inhaler lasts for ONE day Store in fridge until dispensed Polls/Questions 9

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