ISSN # 1941-9481 www.prnnewsletter.com No. 45 The Newsletter for Community Pharmacists July/August, 2012

What’s Inside… …….NEW DRUGS……..NEW DRUGS……..NEW DRUGS……. Rx News………………...1 QSYMIA (Phentermine and Topiramate). RAYOS (Prednisone Delayed-Release). Category: Anorexiant. Category: Oral Corticosteroid. Medicaid Update……….2 Initial dose: 3.75 mg/23 mg taken once daily in Initial dose: 5 mg once daily taken with food.

Law Review……………. 2 the morning for 14 days, then increase to 7.5 MDD: Depends upon condition being treated. mg/46 mg. The FDA has approved Rayos, a delayed-release MDD: 15 mg/92 mg. Feature Article: formulation of prednisone tablets distributed by Alzheimer’s Disease Following a 13 year period during which the Horizon Pharma, Inc. Rayos is approved for all Review………………..... 3 FDA did not approve any drugs for weight loss, the usual indications for prednisone, including the agency has now approved 2 diet drugs in as allergic, dermatologic, gastrointestinal, respira- Ask PRN………….....…. 4 many months. The approval of Belviq in June is tory, and rheumatologic conditions, and will be

now followed by that of Qsymia. Qsymia, mar- available in 1, 2, and 5 mg strengths. Rayos is Did You Know?...... 4 keted by Vivus, Inc., is actually a combination of unique, however, in that it is a delayed-release 2 previously marketed drugs, the anorexiant Pharmacy Fun………….4 formulation which releases the active ingredient phentermine and the anti-epileptic topiramate, approximately 4 hours after intake. In clinical tri- which has been shown to reduce weight. als, patients were administered Rayos at 10 PM FDA NEWS Qsymia is indicated for chronic weight manage- to achieve therapeutic blood levels in the middle ment in adults with an initial body mass index of the night, the time when both cytokine and en- .FDA Warning on Post- 2 2 Tonsillectomy Use of (BMI) of 30 kg/m or greater or 27 kg/m or dogenous cortisol levels start to rise. Patients Codeine in Children greater in the presence of at least on weight- currently on immediate-release prednisone, pred- related comorbidity (e.g., hypertension, type 2 The FDA has issued a Drug nisolone, or methylprednisolone can be switched Safety Communication re- diabetes, dyslipidemia). Qsymia will, at least to Rayos at an equivalent dose based on relative garding recent reports of initially, be distributed only by mail order potency. deaths in children given through certified pharmacies in the Qsymia codeine for pain relief after Home Delivery Network. TUDORZA PRESSAIR (Aclidinium Bromide). tonsillectomy and/or adenoi- Category: Anticholinergic (Respiratory). dectomy. The cases in- VASCEPA (Icosapent Ethyl). Initial dose: One inhalation (400 mcg) twice volved children with an in- Category: Antihyperlipidemic. daily. herited ability to convert Initial dose: 4 grams daily taken as 2 capsules MDD: One inhalation (400 mcg) twice daily. codeine into life-threatening twice daily with food. or fatal amounts of codeine. Forest Pharmaceuticals has announced approval These so-called “ultra-rapid MDD: 4 grams daily. metabolizers” represent of Tudorza Pressair, a new twice-daily anticho- between 1 and 28 percent of Amarin Corporation has been granted approval linergic inhaler indicated for maintenance treat- populations, depending on to market Vascepa, the second prescription- ment of bronchospasm associated with chronic ethnic background (the high- only Omega-3 fatty acid (the first was Lovaza). obstructive pulmonary disease (COPD), including est rates are found in people Vascepa contains an ethyl ester of eicosapen- chronic bronchitis and emphysema. Tudorza of African descent). The taenoic acid (EPA), while Lovaza contains ethyl Pressair will be available in a 60-dose dry powder FDA offers the following esters of both EPA and docosahexaenoic acid recommendations: inhaler, which includes a dose counter and a con- (DHA). Vascepa is indicated as an adjunct to trol window to verify that the dose has been in-  Codeine should be diet to reduce triglycerides in adults with severe haled correctly. The inhaler should be discarded used on an “as hypertriglyceridemia (≥500 mg/dL). 45 days after opening if still in use. needed” basis and should not be adminis- Mayo Clinic Study Finds Off-Label Prescribing A Common Practice tered more than six (6) times a day in children. A recent analysis by the Mayo Clinic has found that off-label drug use (OLDU), the prescribing of drugs for conditions other than their FDA-approved uses, is a common practice, accounting for up  If a child receiving co- 1 deine exhibits unusual to 1 in 5 prescriptions for some commonly used medications. Since the practice of medicine is not sleepiness, confusion, regulated by the Food and Drug Administration (FDA), it is permissible for physicians to prescribe or difficult or noisy drugs for off-label use. Some common examples of OLDU seen in the community pharmacy setting breathing, seek medical include trazodone for insomnia, metformin for polycystic ovary syndrome, and tamsulosin for kidney attention immediately. stones. Since the dosing and duration of therapy in OLDU may differ from those for approved uses,  Consider using alter- it is important that pharmacists become familiar with the latest trends in OLDU, and have a good nate analgesics for working knowledge of the different dosing regimens involved. To that end, we have recently begun children having tonsils answering some OLDU questions in our Ask PRN section, including this month’s edition, where we or adenoids removed. discuss the use of erythromycin for gastroparesis. LAW REVIEW MEDICAID UPDATE Regulatory Issues Affecting Pharmacy in New York State Information Regarding the New York State Medicaid Program I-STOP Bill Passes New York Legislature Unanimously EPIC Benefits to be Restored On June 11, 2012, both houses of the New York State legislature unanimously passed the Internet System for Tracking Over-Prescribing Act, also known as I- The Department of Health has an- STOP. The legislation, a program bill initiated jointly by Attorney General Eric nounced that, effective January 1, Schneiderman and Governor Andrew Cuomo, seeks to address the growing prob- 2013, EPIC will once again provide lem of prescription drug abuse. The main provision of I-STOP is the establishment secondary coverage for Medicare of an online database of controlled substance prescriptions prescribed and dis- Part D covered drugs. The Elderly pensed in New York State, with mandatory real-time reporting by both prescribers Pharmaceutical Insurance Program and pharmacists. Additional provisions include the rescheduling of several pre- (EPIC) is available to New York scription drugs, and the development of a program allowing for safe disposal of State residents 65 years and older expired or unneeded controlled drugs by consumers. The governor is expected to with low incomes. In 2012, the pro- sign the bill into law soon. gram stopped offering secondary coverage for Part D, and many sen- Key Components of I-STOP iors were faced with large increases  I-STOP will make New York the first state in the nation to mandate that in their pharmacy co-payments. For physicians consult a database of a patient’s prescription history before 2013, EPIC rules include: prescribing a schedule II, III, or IV controlled substance. Accurate patient  EPIC members must be en- histories and better training will help physicians detect doctor shoppers rolled in a Medicare Part D and better serve patients at risk of addiction. Doctors can also use this plan. information to avoid potentially dangerous drug interactions.  EPIC will reinstate its Fee and  I-STOP will make New York the largest, and only second state in the na- Deductible plans. tion, to require real-time reporting by pharmacists when schedule II, III, IV, or V prescriptions are filled.  EPIC will provide secondary coverage for EPIC and Medi-  I-STOP will make New York one of the first states to schedule the univer- care Part D covered drugs sal mandate of e-prescribing for controlled substances in December of after any Part D and/or EPIC 2014. The regulations will be promulgated by December, 2012. This will deductible is met. nearly eliminate the problem of forged or stolen prescriptions—used by both addicts, and criminal organizations obtaining pills to resell on the  EPIC co-payments for cov- street. ered drugs will continue to be $3 to $20, depending on the  I-STOP will reschedule HYDROCODONE to schedule II, thereby prohibit- cost of the drug. ing refills for this highly abused drug.  EPIC will continue to cover  I-STOP will schedule TRAMADOL, a “drug of concern,” to schedule IV (it many Medicare Part D ex- is currently unscheduled). cluded drugs, such as pre-  I-STOP will establish a safe disposal program providing a place for New scription vitamins and pre- Yorkers to get rid of expired and unneeded drugs to ensure that they are scription cough and cold not left in medicine cabinets for children or addicts to access. preparations. Some prescribers have expressed concern over the feasibility of the proposed re-  EPIC will continue to pay porting system, based on their experience with the current prescription monitoring Medicare Part D premiums, program (PMP), which is know to be hard to access, time consuming, and which is up to the amount of a basic not accessible by pharmacists. The following table outline the differences between plan, for members in the Fee the old system and I-STOP. and Deductible plans with income up to $23,000 (single) SYSTEM Practitioner Practitioner Pharmacist Pharmacist or $29,000 (married). Reviewing Reporting Reviewing Reporting  Epic will also lower the EPIC Optional; Mandatory report- deductible, by the annual Access to ing of controlled cost of a basic Medicare Part Current PMP information None None substances at least once every D drug plan, for members restricted 45 days with higher incomes that are responsible for paying their Mandated re- Report issuing Access to Mandatory report- ing of controlled own Medicare Part D pre- view of patient prescription at system and I-STOP history before time of issuance reviewing is substances as they are dispensed mium. prescribing mandated

2 Number 45 PRN ~ The Newsletter for Community Pharmacists July/August, 2012 Feature Article… ALZHEIMER’S DISEASE REVIEW

The Statistics Are Alarming. Currently, one in eight people age 65 or older has Alzheimer’s disease, and almost half of people age 85 and older suffer from the condition. As the United States population continues to age, the problem is expected to worsen, with projections of a doubling or tripling of the number of Alzheimer’s patients by 2050. Already the sixth leading cause of death in the U.S., Alzheimer’s disease will continue to be a major focus of research and devel- opment in the pharmaceutical industry for the foreseeable future, and pharmacists can expect to find themselves on the front lines of the battle against this disease. Alzheimer’s: Definition Alzheimer’s: Symptoms Alzheimer’s: Diagnosis Alzheimer’s Disease, named for the Ger- The Alzheimer’s Association has identified the While there is yet no definitive test for man physician who first described it in following 10 early warning signs of Alzheimer’s Alzheimer’s disease, new guidelines point 1906, is the leading cause of dementia in disease: to a more accurate method to detect the the U.S., accounting for between 60 and  Memory loss that disrupts daily life disease at a very early stage. Currently, 80 percent of cases. A progressive, de-  Challenges in planning or solving problems the diagnosis is based primarily on a phy- generative disease, Alzheimer’s attacks sician’s clinical judgment, utilizing patient brain cells, leading to loss of memory, loss  Difficulty in completing familiar tasks history, cognitive and neurological testing, of cognitive and language abilities, and  Confusion with time or place and brain imaging to rule out other possi- behavioral changes. Most cases occur in  Trouble understanding visual images and ble causes of dementia. Under new guide- people aged 65 and older, and 2/3 of pa- spatial relationships lines recommended by the National Insti- tients are women, probably due to longer  New problems with words in speaking or writ- tute on Aging, physicians may one day be life expectancy. The two characteristics ing able to identify preclinical Alzheimer’s brain lesions of Alzheimer’s are beta- disease in asymptomatic patients through  Misplacing things and inability to retrace steps amyloid plaques and neurofibrillary tan- blood and cerebrospinal fluid tests. Such gles of tau protein. While age is the great-  Decreased or poor judgment test would look for biomarkers of the dis- est risk factor for developing Alzheimer’s,  Withdrawal from work or social activities ease, such as beta-amyloid or tau protein several genetic factors have also been  Changes in mood and personality accumulation and/or evidence that brain identified. cells are actually injured or degenerating. FDA-Approved Pharmacotherapy For Alzheimer’s Disease Brand Name Dosage Forms and Generic Initial Dose and Maxi- Mechanism of FDA Approval by (active ingredient) Strengths Available? mum Dose Action Alzheimer’s Stage

Aricept Tablet (5, 10, 23 mg) Yes (except Initial dose 5mg QD. Reversibly inhibits Approved for Mild, (donepezil) ODT (5, 10 mg) 23 mg) May increase to 10 mg centrally-active Moderate, and Se- QD after 4 to 6 weeks acetylcholinesterase. vere Alzheimer’s and to 23 mg QD after Disease ≥ 3 months.

Exelon Capsule (1.5, 3, 4.5, 6 mg) Yes Initial dose 1.5 mg Reversibly inhibits Approved for Mild to (rivastigmine) Solution (2 mg/mL) (capsules BID. May increase centrally-active Moderate Alz- Patch (4.6 mg/24 hours, only) every 2 weeks to maxi- acetylcholinesterase heimer’s Disease 9.5 mg/24 hours) mum of 6 mg BID. Patch initial dose 4.6 mg QD. May increase to 9.5 mg QD after ≥ 4 weeks.

Namenda Tablet (5, 10 mg) No Initial dose 5 mg QD. N-methyl-D-aspartate Approved for Moder- (memantine) Solution (2 mg/mL) Titrate by 5 mg daily at receptor antagonist ate to Severe Alz- ≥ 1 week intervals to heimer’s Disease target dose of 10 mg BID (all doses above 5 mg should be given in 2 divided doses).

Razadyne Tablet (4, 8, 12 mg) Yes (except Initial dose 4 mg BID Reversibly inhibits Approved for Mild to (galantamine) Capsule ER (8, 16, 24 mg) solution) or 8 mg ER QD. May centrally-active Moderate Alz- Solution (4 mg/mL) increase at ≥ 4 week acetylcholinesterase heimer’s Disease intervals to a maximum and stimulates nico- daily dose of 24 mg. tinic receptors

Number 45 PRN ~ The Newsletter for Community Pharmacists July/August, 2012 3

We have recently received several pre- improved emptying of the stomach. Eryth- scriptions for low dose erythromycin for romycin is most effective for gastroparesis P.R.N. (ISSN # 1941-9481) adults, usually in liquid form. Upon when given intravenously, but this route is is published bi-monthly by: checking with the physician, we were usually reserved for severe cases. The oral PRN Publishing LLC informed the patient was being treated dose most commonly used is 125 to 250 68-37 Yellowstone Boulevard for gastroparesis. What is the rationale mg given 3 to 4 times a day, 30 minutes Suite C-22 for this off-label use? before meals. Several studies have indi- Forest Hills, New York 11375 cated that the liquid form is more effective Gastroparesis is a disorder of the stomach Phone & Fax (718) 263-4632 than tablets, due to faster absorption and in which the normal motility which serves to earlier maximum serum concentration propel food into the small intestine is either Founder and Editor: (tmax). Since erythromycin is known to in- greatly reduced or absent altogether. This James Murphy, RPh teract with many drugs, some clinicians results in bloating, nausea, epigastric pain, have tried azithromycin as an alternative, reflux, and early fullness when eating. One although there is not nearly as much pub- Medical Liaison: of the most common causes of gastropare- lished evidence for its effectiveness. There Deborah Blenner, MD sis is diabetes, affecting between 25 and is currently a Phase 2 clinical trial under- 30 percent of patients. Erythromycin, a way at the University of Florida to compare Marketing: macrolide antibiotic approved for use in a the two drugs head-to-head for their effi- Michelle Ye wide range of infections, has been used cacy in treating gastroparesis. with some success in the treatment of gas- ©2012 by PRN Publishing LLC troparesis. It is believed to work by binding Got Questions? WE HAVE ANSWERS! All rights reserved. No part of this to motilin receptors in the stomach and Send your questions to us at: publication may be reproduced without small intestine, resulting in peristalsis and [email protected] the express written permission of the PRN welcomes your questions on any topics relating to the practice of pharmacy. All answers are researched by our staff and, publisher. when necessary, discussed with the appropriate regulatory agencies. The information provided is not intended as legal ad- vice, nor is it a substitute for professional judgment in clinical practice.

The information contained in P.R.N. is for educational purposes only. DID YOU KNOW? Always use professional judgment in that a number of well-know brand-name prescription drugs actually clinical practice. DID YOU KNOW started out with different names than the ones they are known by today? To avoid con-

fusion with sound-alike drugs, the FDA occasionally steps in and requests a name

change for the newer agent. Some example include Prilosec, which started life as We welcome your input. Please Losec, but was altered to avoid confusion with Lasix, Lovaza, which used to be known forward any comments, suggestions, or as Omacor (too close to Amicar), Razadyne, formerly answering to Reminyl, which questions to us at: sounded a bit too much like Amaryl, and Altoprev, which was originally called Altocor [email protected] until it was changed to avoid being confused with Advicor.

Visit us on the web at: PHARMACY FUN www.prnnewsletter.com The months of July and August and named after consecutive leaders of the Roman Empire, Julius Caesar and Augustus, and though by most accounts Augustus was

the better ruler (Pax Romana, etc.), it is Caesar who is best remembered today. The same is often true for pharmaceuticals; we remember the first new drug in any category better than the second, even though the second may work better or have SUBSCRIPTION INFORMATION fewer side effects. For each innovator drug listed below, can you name the second Subscriptions are available: drug to hit the market in the same class? The first reader to submit the correct One year (6 issues)…….….$45.00 answers to [email protected] will receive a custom-printed PRN binder. (Student Discount Available Online) 1. Cozaar 4. Prilosec 7. Retrovir To pay by credit card via secure server go to the SERVICES page of our web- 2. Inderal 5. Proscar 8. Tagamet site: www.prnnewsletter.com or 3. Mevacor 6. Prozac 9. Viagra Send a check or money order payable to PRN Publishing to: Answers to last month’s PHARMACY FUN: PRN Publishing 1. Xifaxan 2. Canasa 3. Dipentum 68-37 Yellowstone Boulevard Suite C-22 References: Forest Hills, New York 11375 1. Wittich CM, Burkle CM, Lanier WL. Ten common questions (and their answers) about off-label drug use. Mayo Clinic Proceedings Volume 87, Number 8 (published online August 8, 2012 at www.mayoclinicproceedings.com). 4 Number 45 PRN ~ The Newsletter for Community Pharmacists July/August, 2012