NABP Headlines                                                                                         

State Disaster Emergency Declared in New York to Enable Efficient Implementation of H1N1 Vaccination Campaign
New York Governor Paterson issued an Executive Order declaring a State Disaster Emergency that will allow additional personnel and flexibility to local governments implementing the statewide 2009 H1N1 influenza vaccination campaign. The Executive Order will permit additional health care professionals, including pharmacists, to administer the 2009 H1N1 vaccine. Under the state’s existing law, physicians, certified nurse practitioners, and nurses may administer vaccinations. Pharmacists and other health care professionals who choose to assist in the vaccine administration will be required to complete training and will work under the direction of state and county health departments. Approximately 10 million New Yorkers fall into CDC’s 2009 H1N1 vaccination priority groups and the additional authorized vaccinators will help to meet the state’s vaccination goals as more vaccine is released.

FDA Releases New Guidance for Compounding Multiple Prescriptions of Tamiflu Oral Suspension
To assist pharmacists in meeting demand during shortages of commercially manufactured Tamiflu Oral Suspension, Food and Drug Administration (FDA) released “Guidance to Pharmacies on Advance Compounding of Tamiflu Oral Suspension to Provide for Multiple Prescriptions” on October 31, 2009. This publication provides instructions for compounding the suspension in advance of receiving prescriptions when demand is high, a practice FDA considers acceptable if the amount compounded is commensurate with the number of valid prescriptions reasonably anticipated by the pharmacy within 24 hours. The update includes instructions for compounding Tamiflu Oral Suspension in advance, as well as for storing, dispensing, and counseling patients regarding the medication. Also, as explained in the “FDA Public Health Alert: Potential Medication Errors with Tamiflu for Oral Suspension,” pharmacists should ensure that the units of measure on the prescription instructions match the dosing device provided with the drug to avoid dosing errors.

FDA Authorizes Emergency Use of the Investigational Intravenous Antiviral Peramivir for 2009 H1N1 Influenza
On October 23, 2009, FDA announced that it has issued an emergency use authorization (EUA) for the investigational antiviral drug peramivir intravenous (IV) in certain adult and pediatric patients with confirmed or suspected 2009 H1N1 influenza infection who are admitted to a hospital. Peramivir may only be used for hospitalized adult and pediatric patients, based on one or more of the following reasons:

• The patient is not responding to either oral or inhaled antiviral therapy.
• When drug delivery by a route other than an IV route -- eg, enteral (absorbed by the intestines) or inhaled -- is not expected to be dependable or feasible.
• For adults only, when the clinician judges IV therapy is appropriate due to other circumstances.

The EUA was issued in response to a request from the Centers for Disease Control and Prevention (CDC), and will expire when the declaration of emergency is terminated or the authorization is revoked by the agency. FDA emphasizes that peramivir is the only intravenously administered influenza treatment currently authorized for use under the EUA for 2009 H1N1 infections.

FDA and FTC Join to Warn Owners of Web Site Marketing Fraudulent H1N1 Supplements
FDA and Federal Trade Commission (FTC) issued a warning letter, the first to be issued jointly by the agencies, to a Web site marketing fraudulent products claiming to prevent and treat 2009 H1N1 influenza. The letter gave the Web site owners 48 hours to provide the agencies with a plan to discontinue fraudulent marketing. Andrew Weil, the site owner, defended the postings on his Web site, but also states that he had the content in question removed. He claims, “I fully support the FDA/FTC task force in its efforts.” More information can be found on the FDA Web site. FDA also posted a news release warning the public about fraudulent H1N1 products. Further, FDA maintains a “Fraudulent 2009 H1N1 Influenza Products List." Body wash, teas, masks, hand sanitizers, and test products are among the fraudulent items listed.

Washington Pharmacists Authorized to Prescribe Antiviral Drugs if Influenza Outbreak Declared
Following the protocol detailed in a new Collaborative Drug Therapy Agreement (CDTA), pharmacists in Washington state will be authorized to prescribe antiviral medications if the local health officer determines this action necessary to respond to an influenza outbreak. The CDTA was developed by a team from the Northwest Center for Public Health Practice, the Washington State Pharmacy Association, and Public Health -- Seattle & King County (PHSKC), in consultation with physicians and emergency managers, and with support from CDC pandemic preparedness funds. The CDTA was developed under a contract with the Washington State Department of Health. If the protocol is put into effect, pharmacists will be authorized to evaluate patients using local public health guidelines to determine whether antivirals should be dispensed.

FDA Reopens Comment Period for REMS for Certain Opioid Drugs
As of October 19, 2009, FDA reopened the comment period to solicit input on developing Risk Evaluation and Mitigation Strategies (REMS) for certain opioid drugs. Opioid drugs formulated with the active ingredients fentanyl, hydromorphone, methadone, morphine, oxycodone, and oxymorphone will be affected by the developing REMS. FDA emphasizes that “[a] REMS that will adequately manage the risks of these products without unduly burdening the health care system or reducing patient access to these medications must be carefully designed.” Thus, the comment period will remain open until October 19, 2010 and interested parties can submit written or electronic comments to FDA through the Regulations.gov Web site using docket number FDA-2009-N-0143.