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.