In August, I reported, with optimism, that the DEA and a group of pain management experts had collaboratively developed and released a FAQ entitled, "Prescription Pain Medications: Frequently Asked Questions and Answers for Health Care Professionals and Law Enforcement Personnel." Unfortunately, in early October, the DEA removed the FAQ from their site, and asked those who had collaborated with them on it to do the same. The only information offered was a vague statement about misstatements, which was published on the DEA web site.
Immediately after the FAQ was withdrawn, many people contacted the DEA, asking why it had been withdrawn and when we could expect it to be reissued. Sadly, nobody at the DEA would talk with any of us, and we were left to wonder.
In the Federal Register for November 16, 2004, the DEA has finally issued an interim policy statement, excerpted below. Unfortunately, it really contains few answers for pain patients.
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Dispensing of Controlled Substances for the Treatment of Pai
ACTION: Interim policy statement.
SUMMARY: In August 2004, DEA published on its Office of Diversion Control Web site a document entitled: "Prescription Pain Medications: Frequently Asked Questions and Answers for Health Care Professionals and Law Enforcement Personnel" (August 2004 FAQ). The August 2004 FAQ was not published in the Federal Register and was not an official statement of the agency. DEA subsequently withdrew the document because it contained misstatements. This interim policy statement explains how some of the statements in the August 2004 FAQ were erroneous...
SUPPLEMENTARY INFORMATION: ...Nonetheless, the subject matter-dispensing controlled substances for the treatment of pain-is extremely important to the public health and welfare. As the agency primarily responsible for enforcement and administration of the federal laws and regulations governing controlled substances, DEA believes that further discussion of the subject is warranted for two fundamental reasons. First, the abuse of pharmaceutical narcotics and other prescription controlled substances is increasing in the United States...
Second, chronic pain is a serious problem for many Americans. It is crucial that physicians who are engaged in legitimate pain treatment not be discouraged from providing proper medication to patients as medically justified...
Misstatements in the August 2004 FAQ
Although not an exhaustive discussion, the following is an explanation of some of the misstatements that were contained in the August 2004 FAQ.
Commencement of investigations-
The August 2004 FAQ erroneously stated: "The number of patients in a
practice who receive opioids, the number of tablets prescribed for each patient,
and the duration of therapy with these drugs do not, by themselves, indicate a
problem, and they should not be used as the sole basis for an investigation by
regulators or law enforcement." In fact, each of the foregoing factors-though
not necessarily determinative-may indeed be indicative of diversion....
Moreover, it is a longstanding legal principle that the Government "can investigate merely on suspicion that the law is being violated, or even just because it wants assurances that it is not." United States v. Morton Salt Co.... It would be incorrect to suggest that DEA must meet some arbitrary standard or threshold evidentiary requirement to commence an investigation of a possible violation of the Controlled Substances Act (CSA).
Refills of schedule II prescriptions-
The August 2004 FAQ stated: "Schedule II prescriptions may not be refilled;
however, a physician may prepare multiple prescriptions on the same day with
instructions to fill on different dates." (Italics added.) The first part of
this sentence is correct, as the CSA expressly states: "No prescription for a
controlled substance in schedule II may be refilled."... However, the second
part of the sentence (italicized above) is incorrect. For a physician to prepare
multiple prescriptions on the same day with instructions to fill on different
dates is tantamount to writing a prescription authorizing refills of a schedule
II controlled substance...
Reselling of controlled substances-
The August 2004 FAQ listed a number of behaviors, or "red flags," that are
"probable indicators of abuse, addiction, or diversion." These behaviors include
"selling medications." ... The document went on to state that these behaviors...
"should not be taken to mean that a patient does not have pain, or that opioid
therapy is contraindicated."...
The behaviors listed in the August 2004 FAQ as "red flags" are indeed indicators of possible diversion. However, the August 2004 FAQ understated the degree of caution that a physician must exercise to minimize the likelihood of diversion when dispensing controlled substances to known or suspected addicts...
>>For a more in-depth article with the complete DEA statement, click HERE.<<
