NCPA to DEA: ‘Institutional facilitators’ can help LTC facilities
ALEXANDRIA, Va. The National Community Pharmacists Association sent a letter to the Drug Enforcement Administration that featured a solution to provide prescription medications to patients in long-term care facilities in a timely manner, NCPA said.
NCPA stated in its letter that recent changes in interpretation and enforcement of the Controlled Substances Act have delayed access of prescription drugs to long-term care patients; many of the medications are designed to alleviate severe pain. The CSA has upended the process in which nurses relay information between the physicians and pharmacists — when a direct physician-pharmacist communication was impractical — to ensure the timely administration of critical medications used to treat residents’ pain. DEA’s current enforcement approach allows such “nurse as agent” exchanges in a hospital setting, but not in long-term care facilities, NCPA said.
To mitigate this, NCPA has suggested that the DEA develop a subcategory of its registrant called an “institutional facilitator,” which would allow nurses to resume communicating valid prescriptions to the pharmacist so that the appropriate medicine is administered to the patient on a timely basis.
“The current system related to the lawful and prompt dispensing of controlled substances in long-term care facilities is broken,” NCPA said. “This solution provides for the common goal of ensuring timely medication access to patients in pain while recognizing the DEA’s mission to enforce the controlled substances laws and regulations of the United States.”
Approximately 31% of all independent community pharmacies service a long-term care facility, with the majority located in areas with a population of less than 20,000, NCPA noted.
MedImmune confirms second CRL from FDA for motavizumab
GAITHERSBURG, Md. AstraZeneca’s biologics unit has received a second complete response letter from the Food and Drug Administration regarding an investigational drug designed to treat respiratory syncytial virus disease.
In the second CRL, the FDA requested that MedImmune complete an additional clinical trial that supports a satisfactory risk/benefit profile to advance the registration of motavizumab, its investigational monoclonal antibody.
MedImmune filed the original biologics license application in January 2008 and received its first complete response letter in November 2008. Motavizumab was reviewed by the FDA’s Antiviral Drugs Advisory committee on June 2 of this year.
Somaxon, P&G to co-promote Silenor
SAN DIEGO A drug maker and a consumer packaged goods company will co-promote a newly approved insomnia treatment.
Somaxon Pharmaceuticals and Procter & Gamble announced their co-promotion agreement for Silenor, in which Somaxon’s promotion of the drug will target physicans, while P&G will promote Silenor to targeted pharmacies.
Somaxon will record all sales of Silenor and will pay P&G a combination of fixed fees and a royalty based on U.S. net sales. Each party will be responsible for the costs of maintaining and operating its own sales force, and Somaxon is responsible for all other costs pertaining to the commercialization of Silenor.
The term of the agreement runs through Dec. 31, 2012, renewable thereafter, and Somaxon will pay P&G a reduced royalty based on U.S. net sales of Silenor for one year after the expiration of the agreement or its earlier termination under certain circumstances. Governance of the collaboration will occur through a joint commercialization committee.
“We are extremely excited to add Procter & Gamble’s highly regarded and tenured professional sales force to our commercialization effort for Silenor,” said Richard Pascoe, Somaxon’s president and CEO. “With the combined effort of both sales forces, we will target 35,000 of the highest prescribers of insomnia products, as well as 25,000 pharmacies, which we believe will allow us to be highly competitive in the insomnia market. In addition, we are excited about the potential to partner with Procter & Gamble for the OTC rights to Silenor as a future life cycle management opportunity.”