Recent DEA Developments

Over the past several months, this column and countless other sources have devoted much attention to developments in enforcement and regulatory matters under the jurisdiction of the Drug Enforcement Administration (DEA). Opiate addiction, overprescribing, extraordinary purchases, and excessive dispensing of pain medications have consumed many of these considerations. The DEA and the courts ruling on such matters deal with many other varied and diverse subjects that arguably are worth just as much discussion. Here are just a few of those issues.

Electronic Prescribing of Controlled Substances

The DEA recently amended its regulations to specify the conditions under which controlled substance prescriptions may be issued electronically. Most important for pharmacists, before any electronic prescription or pharmacy application may be used to transmit prescriptions, a third party must audit the application for compliance with the regulations, or an authorized organization whose certification process has been approved by the DEA must verify and certify the application.¹

On August 1, 2012, the DEA announced the entities that are now in compliance with the certification process for authorized electronic prescribing of controlled substances (EPCS).² The DEA Web site containing the relevant information indicates that systems developed
by InfoGard Laboratories, Inc., Drummond Group Inc., and iBeta LLC have each been approved and that other company programs are under consideration for approval. Take note, however, that “the list of certifying organizations for EPCS does not constitute an endorsement by the DEA of these companies or their products or services.”³

Approval of the certification process is the final regulatory step at the federal level to allow e-prescribing of controlled substances. However, several states have yet to change their laws to allow this practice, most notably for Schedule II (C-II) drugs.

Physician Group Asks the FDA and DEA to Revise Prescribing Information for Opiates

Claiming that the Food, Drug, and Cosmetic Act of 1936 (FDCA), as amended, established a requirement that a drug intended to treat a human disease must be proven safe and effective for labeled uses, Physicians for Responsible Opioid Prescribing (PROP) argued that the current labeling on opioid analgesics fails to meet this mandate. In a statement on its Web site, PROP claims: “Our mission is to reduce morbidity and mortality resulting from prescribing of opioids and to promote cautious, safe, and responsible opioid prescribing practices.”⁴ Its petition urged the agencies to eliminate the word “moderate” from the labeling for use in noncancer pain, leaving its indication only for “severe” pain. It also asked that the labels include a statement that would add a maximum daily dose equivalent to 100 mg of morphine for noncancer pain and a limitation of 90 days of continuous duration when an opioid is not being used for cancer pain.⁵

In a statement entitled, “Opioids for Chronic Pain: The Status Quo Is Not an Option,” the organization alleges that the “United States is experiencing an unprecedented epidemic caused by prescription drug abuse and misuse” and that “compassionate care of chronic pain patients has been inappropriately equated with access to opioids.”⁶ It cites studies claiming that opioids are no better for treating chronic pain than other nonopioid analgesics. As might be imagined, this controversial position is not universally accepted in the health care community.⁷ As of the date of this publication, neither federal agency has formally responded to PROP.

DEA Regulations in the Court: Prescription Misuse

In a recent decision from the Kentucky Court of Appeals, it was ruled that the assertion that “consumption of leftover oxycodone prescribed earlier for pain of ovarian cyst constitutes illegal use if taken for pain in the defendant’s tooth” cannot form the basis for a criminal charge of manslaughter.⁸ The defendant was charged with the criminal offense when her car crossed a lane line and collided with a motorcycle, killing its driver. Before the accident, she took some hydrocodone and benzodiazepam that had been legally prescribed for her by a physician who operated on her ovarian cyst at least 2 months earlier. After the accident, a blood screen showed that she had hydrocodone in her system before and at the time of this incident.

Trial: Testifying as an expert witness for the prosecution, a doctor of pharmacy claimed that a patient should consult with a physician before taking medication for a use other than the one it was prescribed for. Any other use would be an abnormal deviation from the intent of the prescription, according to this pharmacist. Although not exactly clear from the opinion, it appeared that the defendant had obtained hydrocodone prescriptions from other physicians for various medical conditions. The prosecutor argued to the jury that this was evidence that the defendant engaged in drug-seeking behavior by “doctor shopping.”

The trial court ruled that a prescription drug monitoring program (PDMP) report obtained from the state where the defendant had previously resided (Kansas) was not admissible to show that she had had other hydrocodone prescriptions issued to her in the past. The jury issued a verdict against the defendant as guilty of second-degree manslaughter.⁸

Appeal: On appeal, the defendant argued that admission of her hydrocodone use constituted “improper admission of irrelevant and prejudicial evidence of other crimes or bad acts.” She also claimed that the hydrocodone found in her blood immediately after the accident was from medication that was “taken as directed” by a legitimate prescriber. The prosecution countered that she had taken the drug for a purpose other than the one prescribed and therefore it was proper to allow the jury to consider her previous hydrocodone use. This claim amounted to evidence of “prior acts” or a “pattern of conduct” that the jury properly considered in rendering the criminal verdict.⁸

Decision: The Court of Appeals took note that the prosecutor argued at trial that the prior hydrocodone prescriptions were evidence of doctor shopping. It then ruled that these prior acts did not constitute a pattern of conduct similar to the circumstances of the driving accident to support the manslaughter charge and should have been excluded at the trial level. The court held that
“any probative value is clearly outweighed by the danger of undue prejudice created by admission of the hydrocodone evidence.” Finding that the admission was a prejudicial error, the verdict was reversed and sent back to the judge for a new trial.⁸

Analysis of Decision: Note that this decision was based on a ruling of whether or not certain evidence of hydrocodone use should have been submitted to the jury. Ruling that the evidence should have been inadmissible, the court actually avoided the real thrust of the prosecution’s primary claim; i.e., a patient’s consumption of leftover pain medications for a condition different from the one for which they were prescribed constitutes criminal abuse of the drug. It does not appear that this particular issue has ever been addressed directly by any other courts either. Thus, there is a lack of certainty over whether patients should be allowed to use a drug legally prescribed for one purpose for another reason. Pharmacists are surely aware that this conduct happens frequently and may even encourage the practice, believing no real harm should occur absent reason to believe otherwise. There was no indication that a pharmacist made this kind of suggestion in this case.

The more disturbing part of this decision was the testimony of the pharmacist who testified that it is an “abnormal deviation” to engage in this kind of behavior or that the onus is on the patient to consult with a physician prior to doing so. If there are no common law decisions or DEA or FDA regulations suggesting there is a legal foundation for this pharmacist’s opinion, that evidence also should have been excluded.

There is a well-developed body of jurisprudence that says it is improper to admit opinion evidence unless there is a sound and recognized basis for that opinion. Unfortunately, neither the trial court nor the Court of Appeals addressed this issue. That is not very comforting for pharmacists who might be asked if it is okay to take any medications, controlled substances, or other prescription-only drugs for “off-prescribed” purposes. Knowing that this practice is common, pharmacists should not shy away from providing adequate and necessary information to help patients make informed and healthy decisions.

REFERENCES

1. 21 CFR part 1311.
2. Department of Justice, Drug Enforcement Administration. Docket No. DEA-364. Electronic prescriptions for controlled substances: notice of approved certification processes. Fed Regist. 2012;77(148):45688-45689. http://1.usa.gov/NSLMro . Accessed September 12, 2012.
3. Electronic prescriptions for controlled substances. Approved certification processes. DEA. www.deadiversion.usdoj.gov/ecom/e_rx/thirdparty.htm#approved . Accessed September 12, 2012.
4. Physicians for Responsible Opioid Prescribing (PROP). www.supportprop.org. Accessed September 12, 2012. 
5. PROP. Letter to Dockets Management Branch, FDA. July 25, 2012. www.citizen.org/documents/2048.pdf. Accessed September 12, 2012.
6. Von Korff M, Rosenblatt RA. Opioids for chronic pain: the status quo is not an option. Northwest Regional Primary Care Association. www.nwrpca.org/health-center-news/246-opioids-for-chronic-pain-the-status-quo-is-not-an-option.html. Accessed September 12, 2012.
7. Responsible opioid prescribing. Federation of State Medical Boards. www.fsmb.org/pain-overview.html. Accessed September 12, 2012.
8. Douglas v. Commonwealth of Kentucky, Slip Op. No. 2011-CA-000066-MR, Ky App 2012, Ky App LEXIS 123, July 27, 2012.

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