The West Virginia Board of Pharmacy (“Board”) rolled out a new mandatory suspicious order reporting form for wholesalers at its board meeting last month. The one-page form is designed to be filled out for each individual suspicious order being reported. This will require wholesalers that currently create and submit automated suspicious order reports to adapt their reporting for West Virginia.
Federal and state policy makers struggle to come up with solutions to the ongoing opioid crisis. As with many areas of public policy, political leaders are turning to the tax laws as a possible way to curtail opioid abuse. In the past two years, there have been many proposals to impose special or excise taxes on the sale of opioids. To date none have passed. But we believe that without the implementation of other policies to address the issue, a number of states will impose taxes in the coming year.
On June 30, 2017, the Court of Appeals for the D.C. Circuit issued an order in Masters Pharmaceutical, Inc. v. Drug Enforcement Administration (No. 15-1335). In sum, the Court denied Masters Pharmaceutical, Inc.’s (“Masters”) Petition for Review seeking to overturn the Drug Enforcement Administration’s (“DEA”) revocation of Masters’ DEA registration. This decision has wide-ranging implications for DEA-registered wholesalers, who are required to detect and report suspicious orders of controlled substances.
Recently, the Oregon Board of Pharmacy adopted a new rule for wholesale distributors, requiring that they report suspicious orders to the Board for review. The rule goes into effect on July 1, 2017.
The adoption of the new rule followed several recent settlements by wholesale distributors around the country, who are facing severe penalties for failing to report suspicious orders of controlled substances to the Drug Enforcement Administration (DEA).
The battle is over! For now.
Yesterday, Alabama lawmakers blocked the proposal to move Alprazolam into Schedule II, as well as blocking the other proposed changes described in this series of client updates. See here and here. The pharmacy community in Alabama took an active role in opposing these changes. According to this article
As an update to our January 9, 2017 blog post, the Alabama Department of Public Health (ADPH) has continued with its efforts to make Alprazolam a Schedule II drug, along with rescheduling all other benzodiazepines from Schedule IV to Schedule III. The rule change would also reschedule pregabalin from Schedule V to Schedule IV
An Oklahoma doctor wrote 19 Schedule II controlled substance prescriptions for a patient with low back pain over eight months without thoroughly documenting the patient’s history, confronting the patient over aberrant drug tests, or talking to other doctors who were prescribing the patient controlled substances. The Chief Administrative Law Judge felt the doctor should be granted a new registration, but placed on probation for one year. Acting Administrator Chuck Rosenberg disagreed. He reviewed the case and concluded that DEA proved that the doctor knew the patient was abusing or diverting the drugs and prescribed anyway. Dr. Wesley Pope’s application for a new DEA registration was denied as inconsistent with the public interest.
The Washington Post reported last week that it obtained sealed court documents describing how National Football League teams have violated federal prescription drug laws regarding the storage, tracking, transportation, and distribution of controlled substances. The documents—prepared by lawyers representing more than 1,800 former professional football players—include testimony and records that implicate all 32 NFL teams and a number of league personnel.
Plaintiffs filed Evans v. Arizona Cardinals Football Club, LLC in the U.S. District Court of Northern California in May 2015, after a federal judge dismissed a similar claim filed in state court (Dent v. Natl. Football League) on preemption grounds. Although the basis of the claims have long been public knowledge, the sealed documents cited in the article have renewed public interest by painting a detailed picture of alleged improper dispensing and overprescribing.
Alabama is considering making alprazolam a Schedule II substance under state law. Our colleague, Susan Trujillo, reports on this proposed rule which also proposes up-scheduling other benzodiazepines, pregabalin and zolpidem. DEA registrants are required to follow the stricter of federal law or applicable state law. Up-scheduling of controlled substances at the state level often changes
We recently reported that the Drug Enforcement Administration (DEA) was changing its longstanding policy of allowing for a grace period for registrants who file an untimely application for renewal. This notice was posted on the homepage of DEA’s Office of Diversion Control’s website.
A Revised Announcement Regarding Renewal Applications is now posted on DEA’s website indicating that, except for one minor change, DEA is retaining its current policy and procedures regarding registration renewals. The announcement now reads:
Starting January 2017, DEA will no longer send its second renewal notification by mail. Instead, an electronic reminder to renew will be sent to the email address associated with the DEA registration.