ISSN # 1941-9481 www.prnnewsletter.com No. 44 The Newsletter for Community Pharmacists May/June, 2012
What’s Inside… …….NEW DRUGS……..NEW DRUGS……..NEW DRUGS……. Rx News………………...1 BELVIQ (Lorcaserin HCl). DYMISTA (Azelastine HCl and Fluticasone Propi- Category: Anorexiant. onate Nasal Spray). Medicaid Update……….2 Initial dose: 10 mg twice daily. Category: Combination nasal steroid and nasal
MDD: 10 mg twice daily. Law Review……………. 2 antihistamine. The FDA has approved Belviq, the first new diet Initial dose: 1 spray in each nostril twice a day. Feature Article: pill approved by the agency in 13 years. Belviq MDD: 1 spray in each nostril twice a day. Review of Sun and will be marketed by Eisai, Inc. once the DEA Meda Pharmaceuticals has been granted ap- Heat-Related Illness….. 3 has scheduled the drug (the FDA has recom- proval to market Dymista, a combination nasal mended that Belviq be classified as a controlled spray containing both an antihistamine and ster- Ask PRN………….....…. 4 substance). Belviq is a serotonin 2C receptor oid. Dymista is indicated for the relief of symp- agonist indicated for weight management in toms of seasonal allergic rhinitis in patients 12 Did You Know?...... 4 adults with an initial body mass index (BMI) of years of age and older. The most common ad- 30 kg/m2 or greater (obese) or 27 kg/m2 or verse reactions seen in clinical trials were dys- Pharmacy Fun………….4 greater (overweight) in the presence of at least geusia, epistaxis, and headache. Patients should one weight-related comorbid condition (e.g., be instructed to prime the pump before initial use FDA NEWS hypertension, dyslipidemia, type 2 diabetes). and when it has not been used for 14 days. FDA Position on Long- Belviq should be discontinued if a 5% weight Term Bisphosphonate Use loss has not been achieved by week 12 of treat- MYRBETRIQ (Mirabegron). Category: Beta-3 agonist for overactive bladder. The FDA has weighed in on ment. Because of the risk of Serotonin Syn- the question of how long drome, extreme caution should be used in com- Initial dose: 25 mg once daily, with or without bisphosphonates should be bining Belviq with other serotonergic drugs, food. taken to reduce the risk of such as SSRIs, SNRIs, MAOIs, triptans, bu- MDD: 50 mg. fracture in patients with os- propion, dextromethorphan, or St. John’s Wort. teoporosis. In a review pub- The FDA has approved Myrbetriq, the first and lished in The New England STENDRA (Avanafil). only beta-3 agonist approved for the treatment Journal of Medicine, the Category: PDE-5 inhibitor for erectile dysfunc- of overactive bladder with symptoms of urge agency concludes that most urinary incontinence, urgency, and urinary fre- patients do not receive any tion. additional benefit from taking Initial dose: 100 mg approximately 30 minutes quency. Myrbetriq is an extended-release tab- the drug for more than 3 to 5 before sexual activity as needed. let which should be swallowed whole with wa- years, although the author MDD: 200 mg. ter and not chewed, divided, or crushed. Be- did not make any specific cause Myrbetriq is a beta receptor agonist, it recommendations for discon- Vivus, Inc. has announced approval of Stendra, tinuation of the drug. The the fourth phosphodiesterase-5 inhibitor for can increase blood pressure. Periodic blood concern over long-term use erectile dysfunction to be marketed in the U.S. pressure determinations are recommended, of bisphosphonates stems As with other PDE-5 inhibitors, Stendra is con- especially in hypertensive patients. Myrbetriq from reports of serious ad- is not recommended for use in patients with verse events, including traindicated in patients using any form of or- femoral fractures, jaw necro- ganic nitrate. Patients on stable alpha-blocker severe uncontrolled hypertension, severe he- sis, and esophageal cancer, therapy should be started with the 50 mg dose. patic disease, or end stage renal disease. in patients on the drugs for many years. In a companion article published in the Jour- Glaxo Fined $3 Billion in Largest Ever Pharma Fraud Case nal, several specific recom- The British pharmaceutical giant GlaxoSmithKline has pleaded guilty to criminal charges involving mendations are made by endocrinologists, including failure to report critical safety data and marketing drugs for unapproved uses, leading to a 1 billion the following: dollar fine from the U.S. Department of Justice. The company will pay another $2 billion in fines to settle civil charges of marketing violations. The total price tag of $3 billion is the largest penalty to Patients with acceptable date levied against a drug company. The criminal charges involved Paxil, Wellbutrin, and Avan- bone mineral density after 3 dia. In the case of Paxil, the company illegally promoted the drug’s use in children and teenagers, to 5 years of treatment are unlikely to benefit from despite the fact that the company had data from its own trials showing an increase in suicides in continued therapy. teenagers taking the drug. Glaxo promoted Wellbutrin for everything from weight loss to sexual dys- function without FDA approval, and, in perhaps the most serious case, the company withheld data Patients with low bone mineral density after 3 to 5 demonstrating that Avandia increased the risk of heart attack, stroke, and death. While the actions years of treatment, or who of Glaxo leadership undoubtedly led to a number of avoidable patient deaths, no executives were have an existing vertebral charged or prosecuted in this case. And the 3 billion dollar fine, while the largest to date, pales in fracture, may benefit from 1 continued therapy. comparison to the combined $27.9 billion in sales the company realized from the three drugs. LAW REVIEW MEDICAID UPDATE Regulatory Issues Affecting Pharmacy in New York State Information Regarding the New York State Medicaid Program Changes and Additions to Controlled Substance Prescriptions Preferred Drug Program Update A common problem facing community pharmacists is the presentation of a pre- scription for a controlled substance which is missing legally required information. The following changes to the New Additionally, there are often clinical, insurance coverage, or patient preference is- York State Medicaid Preferred Drug sues which require changes to be made to such prescriptions. Not surprisingly, program are scheduled to take ef- one of the most frequent queries we receive at PRN involves the question of which fect on July 12, 2012: changes or additions can legally be made to such prescriptions. The chart below, Preferred Agents: which applies to both C-II and C-III-IV-V prescriptions, is based on sections 80.69(l), 80.69(m), 80.73(m) and 80.73(n) of the Rules and Regulations on Con- Dulera trolled Substances in New York State, also known as “Part 80.” The regulations ProAir HFA also specify that a pharmacist must document the addition or change by indicating Non-Preferred Agents: the date the oral authorization was received on the prescription and affixing his or her signature. In the case of changes to a prescription, the pharmacist must also Celebrex indicate the change on the prescription and initial the change. Crestor Daliresp Dextroamphetamine SR N.Y. STATE REGULATIONS ON ADDITIONS AND CHANGES TO Diflunisal CONTROLLED SUBSTANCE PRESCRIPTIONS Effexor XR Etodolac SA ADDITIONS TO CONTROLLED CHANGES TO CONTROLLED Fenoprofen SUBSTANCE RX SUBSTANCE RX Focalin Pharmacist may Pharmacist may Pharmacist may Pharmacist may Ketoprofen SA add without add with change without change with Meclofenamate prescriber’s prescriber’s prescriber’s au- prescriber’s Mefanamic Acid authorization authorization thorization authorization Nexium Omeprazole OTC Patient’s Prescriber’s Patient’s Prescriber’s Savella Tolmetin address DEA # address DEA # Valturna Patient’s Institution’s Patient’s Institution’s Ventolin HFA sex DEA # sex DEA #
Dispense Brand When Less Ex- Patient’s Drug Patient’s Drug pensive Program Update age strength age strength Effective May 25, 2012, Zyprexa will Directions Quantity be removed from the New York for use State Medicaid Dispense Brand Dosage When Less Expensive Program, Maximum form which allows pharmacists to dis- daily dose Directions pense certain brand name drugs even if the prescriber has not indi- Condition for use code cated “Dispense As Written.” The Maximum current list of drugs included in the daily dose program follows: Condition Adderall XR Epivir code Arixtra Kadian Astelin Lexapro NEVER ADD NEVER CHANGE Carbatrol Lovenox Patient’s name Patient’s name Combivir Nasacort AQ Prescriber’s signature Prescriber’s signature Concerta Uroxatral Date written Date written Diastat Valtrex Drug name Drug name Quantity Geodon 2 Number 44 PRN ~ The Newsletter for Community Pharmacists May/June, 2012 Feature Article… REVIEW OF SUN AND HEAT-RELATED ILLNESS
Summer Is Upon Us, and with it comes a whole host of maladies peculiar to the time between the summer solstice and the autumnal equinox. Chief among these warm-weather complaints are sunburn and heat exhaustion, but there are a number of other conditions related to the sun that pharmacists may come across in their practice. Below is a review of the most common of these, along with the latest treatment recommendations.
Sunburn Heat Cramps Sun Allergy The most common sun-related illness Heat cramps are painful muscle The term “sun allergy” represents a is sunburn, which can begin after as spasms resulting from loss of fluids range of conditions in which patients little as 15 minutes of sun exposure, and electrolytes during exertion in hot exhibit photosensitivity reactions. The depending on skin type and time of weather. Treatment consists of rest, major types of sun allergy are: day. Symptoms generally appear in 1 replenishment of fluids and electro- 1. Polymorphic Light Eruption to 24 hours, and peak at about 72 lytes, and passive stretching and mas- (PMLE): Symptoms appear within hours. Possible complications of in- sage of the affected muscle group. 30 minutes to several hours after tense or frequent sunburn include sun exposure and include itchy, red photoaging (dry, wrinkled skin, etc.), Heat Exhaustion skin with small bumps or plaques. actinic keratoses, and skin cancer. Heat exhaustion is a syndrome result- PMLE is the most common sun Symptoms: ing from a decreased capacity to regu- allergy and is most often seen in girls and women under age 30. Redness of exposed skin late body temperature due to dehydra- tion and exposure to heat. Symptoms Treatment includes oral antihista- Skin warm to the touch included profuse sweating, rapid mines, topical corticosteroids, and heart rate, cool, moist skin, head- moderation of sun exposure. More Skin painful or tender ache, fatigue, dizziness, and nau- severe cases may require a short course of oral steroids. Some pa- Swelling sea. Temperature may be mildly ele- vated, not exceeding 103° F. Treat- tients respond to hydroxychloro- Development of fluid-filled blis- ment consists of fluid replacement, quine 200 mg bid to tid. ter resting in a cool place (preferably air 2. Solar Urticaria: Symptoms include Constitutional symptoms conditioned), and applying cool water hives, itching, and blistering and (headache, fever, chills, weak- to the skin. If not recognized and prop- can develop within minutes of sun ness) may develop if a large erly treated, heat exhaustion can pro- exposure, even in areas of skin area is affected gress to a much more serious condi- covered by clothing. If large areas tion known as heatstroke. are affected, patients may experi- Treatment: ence syncope, dizziness, and Avoid further sun exposure Heatstroke wheezing. Treatment includes oral antihistamines and desensitization Drink plenty of fluids Heatstroke is a serious medical condi- with psoralen plus UVA (PUVA). tion requiring emergency medical treat- Apply cool water compresses ment. Heatstroke occurs when the 3. Actinic Prurigo: A chronic condi- to skin or take a cool bath body loses the ability to regulate inter- tion characterized by nodular le- sions which may persist throughout Take an NSAID (e.g., ibuprofen) nal temperature, and may result from the year, worsening in the summer to reduce pain and swelling untreated heat exhaustion. Symptoms include temperature of 104°F or months. There is a hereditary com- Apply a moisturizer, preferably greater, dry, hot skin, a lack of ponent, with American Indian popu- one containing aloe vera. Topi- sweating, rapid heart rate and rapid lations most commonly affected. cal hydrocortisone may also be breathing, nausea, vomiting, and Symptoms first appear within hours helpful for itching and inflam- altered mental status. Treatment con- or days of sun exposure. Approxi- mation sists of IV hydration and various cool- mately 75% of patients present with ing techniques to lower body tempera- cheilitis (inflammation and cracking Avoid topical products with ture. Ice water immersion can be used, of the lips), and 45% experience anesthetics, such as benzo- but evaporative cooling methods are conjunctivitis. Treatment includes caine, which may cause contact preferred, such as spraying a continual topical steroids and sun avoidance. dermatitis cool mist on the patient while fanning Resistant cases have been treated If blisters form, do not attempt and massaging the skin. Benzodiazepi- with some success using various to break them. When blisters nes such as diazepam or lorazepam systemic drug therapies, including rupture, apply antibiotic cream may be used to reduce shivering and thalidomide, hydroxychloroquine, or ointment prevent seizures. and pentoxyphylline. Number 44 PRN ~ The Newsletter for Community Pharmacists May/June, 2012 3
What are the rules for partially filling pre- following: scriptions for controlled substances in P.R.N. (ISSN # 1941-9481) 1. Each partial filling is recorded in the New York State? is published bi-monthly by: same manner as a refill. In the case of Schedule II drugs, a prescrip- PRN Publishing LLC 2. The total quantity dispensed does not tion may be partially filled, at the patient’s 68-37 Yellowstone Boulevard exceed the total quantity prescribed for request, after the pharmacist has received Suite C-22 oral authorization to change the quantity from a 30 day period. Forest Hills, New York 11375 the prescriber. The remaining quantity is Note that “recorded in the same manner as a Phone & Fax (718) 263-4632 voided and may not be dispensed. On the refill” refers to documenting the partial fill on other hand, if a partial quantity is dispensed the original Rx, but does not add refills to the Founder and Editor: by a pharmacist due to an out of stock situa- prescription. Any quantity remaining from a James Murphy, RPh tion, the remaining quantity may be dis- partial fill or partial refill must be dispensed pensed within 72 hours. After 72 hours the within the 30 day life of that fill or refill; after Medical Liaison: remaining quantity is voided. For Schedule 30 days any remaining quantity is voided. Deborah Blenner, MD III-IV-V drugs, partial filling at the patient’s request is allowed under section 80.74 of the Got Questions? WE HAVE ANSWERS!
Rules and Regulations on Controlled Sub- Send your questions to us at: Marketing: stances in New York State, which states the [email protected] Michelle Ye PRN welcomes your questions on any topics relating to the practice of pharmacy. All answers are researched by our staff and, 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. ©2012 by PRN Publishing LLC All rights reserved. No part of this DID YOU KNOW? publication may be reproduced without DID YOU KNOW that the laboratory in New Jersey where Librium and Valium were in- the express written permission of the vented is being shut down? The site, in Nutley, N.J., served as the American headquar- publisher. ters for the Swiss pharmaceutical giant Roche for 80 years, but will be closed by the end of 2013. In 1960, the Polish pharmacist and chemist Leo Sternbach developed the first benzodiazepine, chlordiazepoxide (Librium), at the Nutley facility. Three years later The information contained in P.R.N. Sternbach followed up this discovery with an even more important breakthrough: he is for educational purposes only. produced diazepam (Valium), which became the best selling pharmaceutical in the Always use professional judgment in United States between 1969 and 1982. clinical practice.
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