Alabama Battle Over Alprazolam is Done. For Now.

Prescription Medication Medicine Pill TabletsThe 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 from Alabama Live, members of the Alabama Pharmacy Association opposed this change and as noted in our most recent update, the Alabama Board of Pharmacy was also encouraging pharmacists to reach out to their legislators to share their concerns. It looks like all of this hard work has paid off. Will this come back? Hard to tell, but we will continue to watch how Alabama and other states try to manage and prevent the abuse of prescription medications.

Alabama Continues Efforts to Make Alprazolam a Schedule II Drug

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 and reschedule zolpidem from Schedule IV to Schedule III. The proposed rule was passed by the State Committee of Public Health and is currently scheduled to be effective on June 15, 2017.

But don’t change your systems yet. Because the rule change has not yet undergone legislative review, it is possible that the committee could vote against the rule, send it back to the state committee for reconsideration, or change the effective date.

We will provide an update when the legislative committee takes action. Read more in our alert.

DEA Decisions: In the Matter of Wesley Pope, M.D.

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. Continue Reading

Washington Post Article Highlights Alleged Improper Drug Practices By NFL Teams

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.

Continue Reading

Alprazolam a Schedule II Substance?

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 recordkeeping, reporting, prescribing and security obligations. In recent years, state scheduling actions have also been a harbinger of rescheduling actions by DEA. Some states took action to schedule carisopridol and tramadol and to up-schedule hydrocodone before the DEA initiated scheduling actions on those substances.  Is this proposed rule a sign of things to come?  Stay tuned to the DEA Chronicles for updates on scheduling actions and other matters involving DEA regulatory and enforcement actions.

DEA Reverses Decision to Change Registration Policy

a rural mailbox chocked full of mail

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. Continue Reading

DEA Decisions: Evidence of “Red Flags” of Drug Diversion

On November 10, 2016, the DEA issued its final decision and order in the case against Jones Total Health Care Pharmacy, L.L.C. (“Jones Pharmacy”) and SND Health Care L.L.C. (“SND”). The
Administrator ordered that the DEA deny Jones Pharmacy’s registration renewal application and also deny SND’s pending registration application. These orders were consistent with the Administrative Law Judge’s (“ALJ’s”) recommendations, which were largely based on circumstantial evidence that Jones Pharmacy ignored “red flags” that prescriptions it dispensed were not for a “legitimate medical purpose.” The Administrator also agreed with the ALJ’s determination that the “unlawful” dispensing practices at Jones Pharmacy should impact SND’s application request because the two pharmacies were “one integrated enterprise” under common individual ownership and operation.

DEA Red Flags Test

The ALJ’s recommendations in this case were largely based on evidence that Jones Pharmacy failed in its responsibility to address “red flags” based on the DEA’s three-part test set forth in Holiday CVS, LLC d/b/a CVS Pharmacy Nos. 219 and 5195.

Under the Holiday CVS “red flags” test, the DEA must prove that:

  1. The registrant dispensed a controlled substance;
  2. A red flag was or should have been recognized at or before the time the controlled substance was dispensed; and
  3. The question created by the red flag was not resolved conclusively prior to the dispensing of the controlled substances.

The Administrator agreed with the ALJ’s determination that Jones Pharmacy knew or should have known that it was dispensing controlled substances that were not for a legitimate medical purpose in violation of 21 C.F.R. § 1306.04 based on the following red flags: (1) patients traveled long distances for filling prescriptions, often from out of state; (2) prescriptions were filled for common “cocktail medications,” (i.e., short term pain relief); (3) prescriptions were issued by doctors prescribing outside their scope of practice; (4) prescriptions were dispensed on the same day to patients with the same out-of-state address for the same controlled substance; and (5) such prescriptions dispensed were paid for in cash.

The ALJ’s initial analysis focused on whether the red flags were “resolved” prior to dispensing the controlled substances in question. Based on expert testimony that the prescriptions at issue presented multiple red flags that were “unresolvable” on their face, and Jones Pharmacy’s failure to rebut this presumption, the ALJ determined that Jones Pharmacy failed to resolve the red flags. The ALJ also decided that because Jones Pharmacy did not “unequivocally” accept responsibility for the dispensing of prescriptions with red flags present, the ALJ would not consider the “remedial efforts” that Jones Pharmacy took. The Administrator agreed.

Key Takeaways: Red Flags Analysis

In adopting the ALJ’s conclusions that Jones Pharmacy knew or should have known of red flags of drug diversion, the Administrator made the following key observations that registrants should keep in mind when conducting a red flags analysis:

  • Circumstantial evidence, just like in Holiday CVS, can be enough to prove that a registrant ignored red flags even if no witness testifies that he or she had “personal knowledge” that drugs were being diverted;
  • DEA does not “have the resources to personally brief” every registrant on “red flags” following its discovery of new patterns of drug diversion;
  • Patients frequently traveling long distances from out-of-state and presenting multiple prescriptions for controlled substances, such as oxycodone, and paying in cash creates an “obvious and compelling” level of suspicion that the prescriptions lack a legitimate medical purpose;
  • Certain circumstances should raise “red flags” for a registrant, such as those described above, even prior to the DEA expressly stating in an agency opinion that such circumstances are red flags (i.e., Jones Pharmacy could not rely on the fact that the DEA did not identify cash payments as a “red flag” until its decision in East Main Street Pharmacy on October 27, 2010, for dispensing that occurred at Jones Pharmacy prior to that date);
  • When prices a pharmacy charges for controlled substances far exceed those charged by other pharmacies, the DEA may infer that the pharmacy is charging higher prices due to the fact that it is knowingly supplying the drugs to individuals seeking to abuse or divert controlled substances.

Additionally, this case provides another example that the DEA may view prescriptions with multiple red flags as per se “unresolvable,” consistent with the Administrator’s opinion in Holiday CVS. 77 Fed. Reg. 62,316, 62,317. In such cases, the registrant will be required to present evidence to rebut the presumption that it has failed the third prong of the Holiday CVS red flags test. Finally, this case serves as a reminder that when the DEA disciplines a registrant, it may also choose to take adverse action against another entity that is owned and operated by the same individual owner.

By: Sam Magnuson, Associate, Milwaukee Office

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DEA Changes Longstanding Registration Policy

reminder round orange grungy vintage isolated stamp

DEA recently announced a significant change to its registration renewal process.

For several years, DEA’s registration unit has allowed for a grace period for registrants who file an untimely application for renewal.  While DEA’s regulations do not contemplate such a grace period, registrants, especially individual practitioners, were allowed to keep their existing registration number — which was considered valid and active during the grace period — despite the failure to file a timely renewal application and despite multiple notifications from DEA. Continue Reading

Surgeon General Seeks Support from Doctors to End Opioid Epidemic

Pills

Last week, the U.S. Surgeon General, Dr. Vivek H. Murthy, sent a letter to 2.3 million American health professionals asking them to lead a national movement to “turn the tide” on the nation’s prescription opioid epidemic.  After visiting communities hardest hit by the opioid epidemic, Dr. Murthy’s appeal to clinicians was personal:

 

“Everywhere I travel, I see communities devastated by opioid overdoses. I meet families too ashamed to seek treatment for addiction. And I will never forget my own patient whose opioid use disorder began with a course of morphine after a routine procedure.”

Dr. Murthy wrote that health care providers “have the unique power to end the opioid crisis.”  He asked providers to commitment to this cause by pledging to:

  1. Educate ourselves to treat pain safely and effectively.
  2. Screen our patients for opioid use disorder and provide or connect them with evidence-based treatment.
  3. Talk about and treat addition as a chronic illness, not a moral failing.

Continue Reading

DEA Will Not Reschedule Marijuana

 

Marijuana is less dangerous than some substances in other schedules, but it will stay in Schedule I for now, DEA said Thursday. The agency also said that it supports marijuana research, is developing an online application system to apply for Schedule I research registrations, and will allow more manufacturers to grow marijuana for research.

DEA says FDA analysis shows marijuana’s medical effectiveness has not been proven

In a letter to the governors of Rhode Island and Washington and a resident of New Mexico, who had asked that marijuana be removed from Schedule I, DEA Acting Administrator Chuck Rosenberg said it is wrong to think of the federal drug schedules “as an escalating ‘danger’ scale,” like the Richter scale for earthquakes.  Instead, he said, the schedules are determined by statutory criteria based on medical and scientific evidence.

DEA cannot reschedule marijuana, Rosenberg said, because an analysis by FDA and the National Institute on Drug Abuse (“NIDA”) showed marijuana’s effectiveness in treating medical conditions has not been proven; it has a high potential for abuse; and it lacks accepted safety for use under medical supervision.  DEA’s full responses to the rescheduling petitions are available here and here.

DEA’s decision to keep marijuana in the class of drugs with “no currently accepted medical use” puts the federal government at odds with 25 states and the District of Columbia, all of which have passed laws allowing the use of marijuana for medical purposes.

Rosenberg said that marijuana must be studied further in scientifically-valid, well-controlled clinical trials under investigational new drug applications.  He also said that the drug approval process is the proper way to assess whether a product derived from marijuana or its constituent parts is safe and effective for medical use.

DEA will increase the number of authorized marijuana manufacturers that supply researchers

Also on Thursday, DEA announced a policy change that will expand the number of DEA-registered marijuana manufacturers.  The move could provide researchers with a more varied and robust supply of marijuana.  Currently, only the University of Mississippi is authorized to grow marijuana for the 350 individuals and institutions registered to research marijuana, marijuana extracts, derivatives, and tetrahydrocannabinols (“THC”).  Research is being conducted on marijuana’s effectiveness in treating conditions such as epilepsy and chronic pain, among others.

“[W]e will – as we have for many years – support and promote legitimate research regarding marijuana and its constituent parts,” Rosenberg wrote in the letter.  He pledged that DEA will work with NIDA to ensure that there is a “sufficient supply of marijuana and its derivatives (in terms of quantity and the variety of chemical constituents) to support legitimate research needs.”

 

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