February 7, 2013—The Office of Pharmacy Affairs (OPA) sent letters to 340B hospitals in late January requesting details about their use of the Allergan drugs Botox and Botox Cosmetic. Although Botox is perhaps best known for its cosmetic use, it is widely used medically to treat specific neuromuscular conditions affecting the upper limbs, eyes, and neck.[ms-protect-content id=”2799″] It is also used to prevent chronic migraine headaches and, just days ago, was approved to treat overactive bladder symptoms. In addition, Botox is often prescribed to treat juvenile cerebral palsy and cramping and muscle spasms in adults.
This is believed to be the first instance of OPA questioning 340B covered entities about their use of a particular drug based upon a manufacturer’s concerns. Speaking via videoconference on Jan. 24 during the recent 340B Coalition meeting in San Francisco, OPA Director Cmdr. Krista Pedley said that, based upon a drug manufacturer’s allegations of inappropriate use of a specific drug, OPA was writing to the drug’s top 340B-enrolled purchasers asking how they used the medication. Cmdr. Pedley did not name the manufacturer on whose behalf OPA was acting, but the circumstances indicate it might be Allergan.
Last summer, Allergan sent letters to 340B hospitals giving its interpretation of OPA guidelines against the diversion of 340B-discounted drugs to ineligible patients and expressing concern that the hospitals might be in noncompliance with respect to Botox.
OPA asked the hospitals to provide the following information regarding Botox and Botox Cosmetic use in the 340B program (plus related policies and procedures) by March 8:
- Assurance of compliance with OPA’s 340B outpatient facility guidelines.
- Assurance of compliance with OPA’s 340B patient definition guidelines.
- How and where Botox and Botox Cosmetic are prescribed and dispensed.
- Similarities and differences in how Botox and Botox Cosmetic are prescribed and dispensed.
- The amounts of Botox and Botox Cosmetic prescribed and dispensed.
- The amounts of Botox and Botox Cosmetic purchased outside of 340B, if any.
Other drug companies have sent letters to 340B covered entities inquiring about their use of the manufacturer’s products. OPA has said that a 340B hospital’s failure to respond to such information requests could provide a manufacturer with grounds to initiate an audit.[/ms-protect-content]