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Controlled substances: Difficult times for DEA, Rx

Two recent legal cases offer insight on how pharmacy practice standards can be influenced by DEA activities.

DEA is responsible for preventing the abuse of prescription drugs, and pharmacists can play an important role in helping meet this responsibility while also meeting public expectations that they provide appropriate medicines for people who need them. Two recent legal cases offer insight on how pharmacy practice standards can be influenced by DEA activities.

Arizona wholesaler case

An Arizona pharmacy sued a wholesaler, contending that it had limited the pharmacy’s purchases of controlled substances and alleging that it had breached its contract with the pharmacy. In pursuing its case, the pharmacy served a subpoena on DEA in an effort “to fully discover the sorts of circumstances under which DEA would endorse or not endorse the termination of distribution.” DEA moved to quash the subpoena. The court sided with DEA.

Noting that the pharmacy was requesting clarification of a letter written to the wholesaler by a DEA official, the court explained that since this person conducts his DEA business in Washington, DC, and since court rules cannot require travel of a nonparty witness more than 100 miles, the court could not command that the DEA official honor an Arizona subpoena. Furthermore, the court noted that the pharmacy sought testimony about whether DEA had a policy outlining “the circumstances under which a distributor is required to terminate distribution of controlled substances to a pharmacy as well as the circumstances under which a distributor may resume distribution of controlled substances to a pharmacy.” DEA had responded that the agency “has no such policy” and cannot “produce a witness to testify whether [the wholesaler] was acting in compliance with a non-existent policy.”

While it may be frustrating to discover that a federal agency cannot or will not explain the standard it applies in limiting the availability of medications to pharmacies and their patients, this case establishes that controversies over medication supply must be resolved between pharmacies and wholesalers, with no expectation that DEA will provide any formal or informal guidance.

Ohio DEA registration case

A Southern Ohio business was newly established to conduct a community pharmacy. A pharmacist with a 40-year “unblemished record as a licensed pharmacist in Ohio” was hired to serve as the pharmacist-in-charge (PIC). The pharmacy first obtained a state license. The pharmacy then applied for a DEA registration but was initially denied. DEA contended that there was a “rampant pharmaceutical drug abuse problem” in southern Ohio and that the PIC demonstrated “a lack of understanding about the diversion and illicit use of pharmaceutical controlled substances.”

An administrative law judge conducted a hearing and evaluated the evidence. He noted that for controlled substance prescriptions, the PIC planned to institute the following procedures:

  • Require a diagnosis code.
  • Have the prescriber fax a copy of each prescription directly to the pharmacy.
  • Use the Ohio prescription drug monitoring program.
  • Require a state-issued license or identification for everyone picking up a prescription.
  • Maintain a perpetual inventory of all controlled substances.
  • Forbid insurance patients to pay cash if insurance denies payment.

When asked whether these procedures were a good idea, a DEA diversion investigator testified at the hearing that he would refuse to comment on them “because it’s above what the DEA requires.”

The judge recommended approval of the pharmacy’s application. The DEA administrator agreed with the recommendation, noting that nothing in the law allows DEA to deny an application for registration based on its assessment of “the nature and amount of diversion of controlled substances in a geographical area.” The administrator also concluded that the evidence did not support the conclusion that the PIC “will fill prescriptions even when he has reason to know that they have not been issued for a legitimate medical purpose.” The pharmacy’s application was granted.

Conclusion

The prescription drug epidemic has challenged the pharmacy profession to develop standards for relationships between pharmacies and wholesalers, as well as for the dispensing of controlled substances to patients. New standards may require that unprecedented and drastic steps be taken, such as limiting the distribution of drugs from wholesalers to pharmacists under specified circumstances and imposing specific requirements for prescribers who issue controlled substance prescriptions as well as patients who receive them.

Based on: Krueger Investments v Cardinal Health, 2012 U.S. Dist. LEXIS 112154 (August 9, 2012); Physicians Pharmacy LLC, Federal Register Doc No: 2012-19221 (August 7, 2012).

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