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| Important Update - Generic OxyContin Availability
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Important Product Information: Generic OxyContin Availability
Effective January 31, 2008, it is anticipated that all manufacturers of generic OxyContin (oxycodone controlled-release) will have exhausted their supply, meaning no additional product will be available for purchase by wholesalers.
Generic product will continue to be available from wholesalers and pharmacies that currently have stock, however, it is impossible to determine exactly which wholesalers and pharmacies will have generic OxyContin and for how long the product will be available.
Going forward, the accessibility to generic OxyContin will become increasingly unpredictable. The sourcing issue can be dealt with in one of two ways:
1. To allow payment for all oxycodone controlled release products, both brand OxyContin and all generic product still available.
2. To require patients prescribed OxyContin to go from pharmacy to pharmacy in hopes of finding generic product.
Our recommendation in managing this situation is to allow payment for all oxycodone controlled-release products, both brand and generic. By taking this position, it will allow for those patients prescribed OxyContin to receive seamless access to the pharmaceutical care they need.
If no generic is available, a DAW 8 Product Not Available will be noted on the invoice.
January 2008 MWG ScripNet Clinical Pharmacist
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| Icy Hot Product Recall
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Important Drug Recall Information from Chettem, Inc:
Icy Hot Product Recall
Chattem, Inc. has issued a voluntary nationwide recall of its Icy Hot Heat Therapy products because of more then 200 consumer reports of first, second, and third degree burns in addition to skin irritation. All lots and sizes of the following Icy Hot Heat Therapy products have been recalled:
- Icy Hot Heat Therapy Air Activated Heat-Back
- Icy Hot Heat Therapy Air Activated Heat- Arm, Neck, and Leg
- Icy Hot Heat Therapy Air Activated Heal- Arm, Neck, and Leg
Some of the recalled products were samples of the Icy Hot that were issued with a promotional package of the 3 oz. size of Aspercreme Pain Relieving Creme.
Due to the potential for very serious burns, consumers should immediately stop using these products and return them to the manufacturer.
Anyone who has had any adverse reactions because of an Icy Hot product are encouraged to file a report with the FDA Adverse Event Reporting Program, either online at www.fda.gov/medwatch/report.htm, or by fax at 800-FDA-0178.
Icy Hot Heat Therapy products may be returned for a full refund (average retail price) by contacting Chattem's Consumer Affairs Department at 1-877-742-6275 (M-F from 8AM to 4PM EST) or via their web site, www.icyhot.com.
February 2008 MWG ScripNet Clinical Pharmacist
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| Important Drug Update - Duragesic Recall
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Important Drug Recall Information from PriCara:
Duragesic 25mcg/hr Patch Recall
PriCara, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc. has announced that all lots of 25 microgram/hour (mcg/hr) DURAGESIC? (fentanyl transdermal system) CII patches sold by PriCara in the United States and all 25 mcg/hr fentanyl patches sold by Sandoz Inc. in the United States are being voluntarily recalled as a precaution from wholesalers and pharmacies. All other strengths, the 12.5, 50, 75, and 100mcg/hr patches are NOT affected.
The recalled patches all have expiration dates on or before December 2009, and all are manufactured by ALZA Corporation, an affiliate of PriCara. The recall is being conducted in cooperation with the U.S. Food and Drug Administration. All 25 mcg/hr fentanyl patches manufactured by ALZA and sold in Canada also are being recalled.
The DURAGESIC 25 mcg/hr (fentanyl transdermal system) and Sandoz Inc. 25 mcg/hr fentanyl transdermal system patches being recalled may have a cut along one side of the drug reservoir within the patch. The result is possible release of fentanyl gel from the gel reservoir into the pouch in which the patch is packaged, exposing patients or caregivers directly to fentanyl gel.
Fentanyl patches that are cut or damaged in any way should not be used. Exposure to fentanyl gel may lead to serious adverse events, including respiratory depression and possible overdose, which may be fatal. Anyone who comes in contact with fentanyl gel should thoroughly rinse exposed skin with large amounts of water only; do not use soap. Immediately dispose of affected patches with cut edges by flushing them down the toilet, using caution not to handle them directly. Patches with a cut edge that have leaked gel will not provide effective pain relief.
Anyone with 25 mcg/hr DURAGESIC patches being recalled should call 800-547-6446.
Anyone with 25 mcg/hr Sandoz Inc. patches being recalled should call 800-901-7236.
Patients using fentanyl patches who have medical questions should contact their health-care providers.
February 2008 MWG ScripNet Clinical Pharmacist
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| New Opana ER Strengths
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Important Drug Information: New Opana ER Strengths
Endo Pharmaceuticals has announced the introduction of three (3) new strengths of the opioid pain reliever Opana ER. The new intermediate formulations will be 7.5mg, 15mg, and 30mg tablets. These strengths will be added to the current strengths available, which are 5mg, 10mg, 20mg, and 40mg tablets. These new strengths are available as of April 1, 2008.
BRAND NAME: Opana ER? 5mg, 7.5mg, 10mg, 15mg, 20mg, 30mg, 40mg by Endo Pharmaceuticals
GENERIC NAME: Oxymorphone HCL Extended-Release Tablets
INDICATIONS:
Opana ER is for the management of moderate to severe pain when a continuous, around-the-clock analgesic is needed for a prolonged period of time. Opana ER is NOT intended for use as a prn (as needed) analgesic.
WARNINGS:
1. Tablets MUST be swallowed whole. Crushed or chewed tablets leads to a rapid release and absorption of a potentially fatal dose of oxymorphone.
2. Drug abuse and addiction. As with other opioids, Opana ER has a high risk for abuse and addiction.
RECOMMENDATIONS:
It is our recommendation that no long-acting (controlled released) narcotic pain reliever be prescribed as a first line agent, and be subject to Prior Authorization/Medical Review. It is recommended that it would be best to treat with short acting narcotic pain relievers (i.e. Percocet, Tylenol with Codeine, etc) or Anti-Inflammatory Agents (such as Ibuprofen, Naproxen, etc) to allow for a proper assessment of the Injured Workers' condition. Once an initial assessment has been performed and patient response to the short acting medications has been determined (side effects and positive outcomes), then and only then, will the administration of Opana ER and other long-acting narcotic pain reliever be considered an appropriate choice of therapy.
References available upon request
MWG April 2008 ScripNet Clinical Pharmacist
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| OxyContin Announcement
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Generic Manufacturers Cease Distribution and Sale of Extended-Release Oxycodone Tablets
Purdue Pharma L.P. has announced that as of February 1, 2008, Teva Pharmaceuticals USA, Inc., IMPAX Laboratories, Inc. and IMPAX's distributor DAVA Pharmaceuticals, Inc. have ceased distribution and sales of their generic versions of Purdue's OxyContin (oxycodone HCl controlled-release) Tablets pursuant to the terms of their licensing agreements with Purdue. On December 31, 2006, Endo Pharmaceuticals ceased distribution of its generic version of OxyContin pursuant to its license with Purdue. Purdue will continue to sell and distribute OxyContin Tablets and expects to be able to meet all demand for long-acting oxycodone prescriptions.
The licenses granted to Teva, IMPAX and Endo Pharmaceuticals preceded the January 7, 2008 decision of the United States District Court for the Southern District of New York in which the court ruled that Purdue Pharma had not committed inequitable conduct in obtaining its OxyContin patents and that its patents are not unenforceable for that reason. The last of Purdue's patents on OxyContin Tablets expires April 2013.
Purdue has proactively taken steps to help healthcare practitioners transition their patients from generic extended-release products to the branded product where necessary. The company is providing practitioners with a "Dear Patient" educational tool that they can provide to their patients. This tool provides information about the difference patients may see in tablet color as well as addressing concerns about costs and access to the medication.
In order to minimize any financial impact on patients, Purdue has been negotiating with managed care organizations and other insurers to encourage healthcare coverage of, and lower co-payments for, OxyContin Tablets. Additionally, except where prohibited by state or federal law or healthcare insurers, Purdue is offering patient savings cards through physicians to help reduce patients' out-of-pocket costs. Purdue's patient assistance program will continue to provide assistance to eligible low-income individuals who do not have healthcare insurance.
Healthcare professionals and patients who have concerns or questions about prescribing, dispensing or taking OxyContin Tablets should contact Purdue's Medical Services department at (888) 726-7535 (prompt #1).
February 2008 MWG ScripNet Clinical Pharmacist
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