| Food and Drug Administration (FDA) FDA Quick Links February 2, 2010 Experiencing shortages of morphine sulfate oral solution 20 mg/ml? Take our survey! Last week we reported that the U.S. Food and Drug Administration (FDA) approved Roxane Laboratories' New Drug Application for morphine sulfate oral solution 20 mg/ml. Other manufacturers must either seek approval or cease distributing their unapproved product within 180 days of January 26, 2010, the date of the Roxane approval. Roxane has indicated that they have sufficient product to meet the current market demand. ASCP has developed a very brief 7-question survey to monitor the situation and to help report shortages or other issues that may arise due to this change in the market. Please note: this survey is intended for dispensing pharmacists and owner/operators. The survey should not take more than 5-10 minutes.
FDA Approves Morphine Sulfate Oral Solution for Relief of Acute and Chronic Pain ASCP learned today that the U.S. Food and Drug Administration (FDA) has approved Morphine Sulfate Oral Solution for the relief of moderate to severe, acute and chronic pain in opioid-tolerant patients. This medicine will be available in 100 milligrams per 5 mL or 20 milligrams per 1 mL. This is the only FDA-approved morphine sulfate oral solution available at this concentration. The manufacturer is Roxane Laboratories. Although the use of this medicine to manage pain has been common practice for many years, this form and concentration of morphine was not FDA approved until now. Today's action is part of the FDA's unapproved drugs initiative. As part of this program, the FDA has worked with the manufacturer of the now-approved product to ensure that there is enough supply of the drug available for patients. The FDA will also be working with organizations such as ASCP and prescribers so that they are aware that an approved product is available, and can notify the FDA if there are any problems with availability. During a telephone call today with FDA's Douglas Throckmorton, M.D., Deputy Director, Center for Drug Evaluation and Research (CDER), ASCP learned that:
For more FDA information on this issue: 1. March 31, 2009 Warning Letters, companies, and affected products 2. List of FDA-approved drug products July 1, 2009 FDA Advisers Make New Recommendations on Limiting Acetaminophen Dosage An FDA advisory committee has recommended that prescription products with acetaminophen, such as Percocet and Vicodin, be withdrawn from the market. They also recommended lowering the maximum daily dose of acetaminophen and lowering the maximum amount of acetaminophen per dose to 650 mg in nonprescription products.
ASCP Comments to FDA on Opiate REMS ASCP submitted comments on FDA's plans to develop Risk Evaluation and Mitigation Strategies (REMS) for certain opiate medications. May 27, 2009 FDA Releases Draft Guidance on Advertising for Pharmaceutical Industry This week the Food and Drug Administration issued a new guidance document for the pharmaceutical industry on how it assess promotional pieces to determine if the industry equitably presents associated risks pertaining to pharmaceuticals and medical devices. The promotional materials addressed in this draft guidance include those distributed to both patients and health care professionals. Within the document, published in the May 27th Edition of the Federal Register, the FDA cites that, "omission or minimization of risk information is the most frequent violation of the regulations cited in advertising and promotion enforcement letters sent" to the pharmaceutical and medical device industry. May 22, 2009 ASCP Leads Efforts with FDA on Verbal Orders for C-II Controlled Substances in Long-Term Care and Hospice ASCP's Policy and Advocacy Director Claudia Schlosberg led a contingent of stakeholders representing physicians, nurse practitioners, nurses, and pharmacists who work in long term care and hospice to the FDA for a meeting. FDA participants included Doug Throckmorton, MD, Deputy Director of CDER as well as key staff within FDA who work on drugs regulated under the Controlled Substances Act (CSA). The purpose of the meeting was to educate FDA on the clinical and practice realities of treating long term care residents and hospice patients who need pain relief and why practitioners cannot rely on prescription orders transmitted via facsimile but must use verbal orders for CIIs to ensure adequate and timely pain management. Under the CSA, although DEA enforces the law, the FDA has the legal authority to interpret the definition of emergency situation. To read a copy of ASCP's memorandum entitled, "Clinical Realities Related to Pain Management For Nursing Home Residents and Hospice Patients – What is an Emergency Situation?" submitted to FDA on May 29, 2009, click below. April 9, 2009 FDA Reverses Decision On Morphine 20mg/ml Manufacture In a telephone conference call with stakeholders today, Douglas Throckmorton, MD, Deputy Director, Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA), announced that FDA has notified manufacturers of morphine sulfate 20mg/ml oral concentrate that they will be permitted to continue to manufacture the product. The decision effectively reverses warning letters sent on March 31, 2009 advising the manufacturers that they must stop production and distribution within 90 days. In reversing FDA's earlier decision, Dr. Throckmorton was remarkably candid, stating that FDA had not fully understood the needs of the palliative care community when it made the initial decision to send warning letters to manufacturers. Once the needs of the palliative care community became clear, FDA determined it was necessary to make achange. Dr. Throckmorton made clear that while morphine 20 mg/ml remains an unapproved drug, it is medically necessary, and he stated,"We have no alternatives." FDA's decision comes one day after ASCP sent a letter to FDA Acting Commissioner Joshua Sharfstein alerting the FDAto severe shortages of appropriate narcotics for hospice and long-term care patients. Click here to read the FDA's announcement of the interim approval plan. To access a replay of FDA's Stakeholder Conference Call, in the United States and Canada dial 1-866-419-2678 (international callers , dial 1-203-369-0759) . April 8, 2009 Nationwide Shortages of Narcotics for Long-Term Care and Hospice Patients -- Helpful Resources and Survey Pharmacies serving long-term care and hospice patients throughout the United States are experiencing severe shortages of narcotic pain medications. ASCP has notified the FDA (click here to read ASCP's letter to FDA Acting Commissioner Joshua M. Sharfstein) and is monitoring the situation. This notice is designed to provide you with basic information about the shortages, which products are approved and which are unapproved, what ASCP is doing to address the issue, and some recommendations for how to cope with some of the challenges that pharmacists face as a result. For patients who will need to be switched, we have developed some template letters that you can customize and send to prescribers. Links to each of these documents can be found below. Finally, please take a short five-minute survey on the availability of narcotics for long-term care and hospice patients by clicking on this link. The information from the survey will be used to provide FDA with updated information on the impact of these shortages on long-term care and hospice patients. Please e-mail ASCP's Policy & Advocacy department with any questions. Links
FDA Releases Final Rule Regarding Labeling Requirement for Toll-Free Number to Report Adverse Drug Events In their Final Rule, the FDA reiterates the requirements set forth in the Interim Final Rule (see below below), but they extend the implementation deadline from January 1, 2009 to JULY 1, 2009! Please take note of this change. Also, please visit this link to view the text of the Final Rule. As to the applicability of the rule to long-term care settings, there were no clarifications provided in the Final Rule other than to reiterate that the rule applies to both "new prescriptions and refills dispensed to consumers by pharmacies and authorized dispensers in an outpatient setting." See information below for exemptions mentioned in the Interim Final Rule. September 24, 2008 FDA takes action against topical drug products containing papain FDA intends to take enforcement action against unapproved topical drug products containing papain, as well as those who manufacture or cause the manufacture of such products or their shipment in interstate commerce. In an announcement slated for publication in the Sept. 23 Federal Register, FDA notes that potentially serious adverse events were reported with topical drug products containing papain. Topical drug products containing papain are new drugs that require approved applications because they are not generally recognized as safe and effective. Currently no firm has an approved application to market a topical drug product containing papain. Manufacturers who wish to market topical drug products containing papain must obtain FDA approval of a new drug application (NDA) or an abbreviated new drug application (ANDA). Download the FDA's notice by clicking on this link (422 KB PDF). January 3, 2008 Labeling Requirement for Toll-Free Number to Report Adverse Drug Events The FDA released its Interim Final Rule (downloadable here) requiring the addition of a statement on the labeling of medications that includes a toll-free number and advises that the number is to be used only for reporting side effects and is not intended for medical advice. As mandated by the Food and Drug Administration Amendments Act of 2007 (FDAAA), this interim final rule does not apply to over-the-counter drug products approved as new drugs under the act if the product packaging includes a manufacturer’s or distributor's toll-free number for reporting complaints. The regulation requires two steps: (1) A statement to be placed on all prescription products. The FDA is continuing to conduct research on the wording for the side effects statement. The proposed statement reads: "Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088." (2) Side effect statements are required to be issued with the prescription, in one or more ways: (a) on a sticker attached to the package unit (b) on a preprinted pharmacy prescription vial cap; (c) on a separate sheet of paper, in consumer medication information; d) or an appropriate FDA approved Medication Guide that already contains the side effects statement. Regarding the applicability to long-term care settings, the following text is included in the rule: "This part is not intended to apply to authorized dispensers dispensing or administering prescription drug products to inpatients in a hospital or health care facility under an order of a licensed practitioner, or as part of supervised home health care." Behind the Counter (BTC) Medications FDA Request for Feedback on Proposed “Behind-the-Counter” Medications (October 2007)
FDA Compliance Guidelines DRAFT FDA Guidance: “Good Reprint Practices” for Articles/Publications Discussing Off-Label Use of Medications (February 2008) Consultant pharmacists often need to back up their recommendations or help a facility justify the use of medications off-label when queried by surveyors in long-term care facilities. A draft guidance document released on February 15, 2008 by the Food and Drug Administration (FDA) on “Good Reprint Practices” for industry may make such evidence more readily available to health care professionals. The draft guidance document discusses the distribution of medical or scientific journal articles and reference publications that involve unapproved uses of FDA-approved medications. FDA is recommending that manufacturers follow specific guidelines when distributing scientific or medical journal reprints, articles, or reference publications e.g.:
DRAFT FDA Guidance: Expiration Dating of Unit-Dose Repackaged Drugs (May 2005) ASCP Comments on FDA Guidance on Expiration Dating of Unit-Dose Repackaged Drugs (August 2005) FDA Guidance: Alternative to Certain Prescription Device Labeling Requirements
Links FDA Website Home Page FDA MedWatch Program Home Page Medicare Part D Coverage of Marketed Unapproved Drugs (DESI) Other Documents FDA NPRM for Bar Coding Requirements - 3/14/03 ASCP Comments on FDA NPRM - Reforming Generic Rx Approvals - 1/14/02 FDA Moves to Simplify Prescription Drug Labels - 12/22/00 |
