US Pharm. 2012;37(10):56-59.
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
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
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
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.
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.
. Accessed September 12, 2012.
3. Electronic prescriptions for controlled substances.
Approved certification processes. DEA.
. 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,
6. Von Korff M, Rosenblatt RA. Opioids for chronic pain:
the status quo is not an option. Northwest Regional Primary Care
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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