James C. McAllister III, MS, FASHP; Pharmacy Times Editor, Health-Systems Pharmacy Section
In early September, the Drug Enforcement
Administration (DEA) proposed
an amendment to current regulations
to allow practitioners to provide
patients with multiple prescriptions for
CII substances, which would in effect
allow patients to receive a 90-day supply
of a substance. I appreciate that the
intent of the change is to enable patients
with chronic pain and other conditions to
avoid unnecessary trips to a prescriber.
Furthermore, I agree that a visit to the
physician just to have a prescription written
to comply with a federal regulation is
something that we should strive to avoid.
If this proposed rule is adopted, however,
what problems have we solved?
The 30-day limit for CII substances was
initially imposed in an attempt to minimize
abuse and diversion. This proposed
rule enables prescribers to write 3 prescriptions
to be filled sequentially with a
specified date, before which the second
and third prescriptions cannot be filled
by any pharmacy. I suggest that while we
may have saved patients with chronic
pain conditions a few trips to their physician,
we have created a new cottage
industry in which even more prescriptions
can now be diverted for illegitimate
purposes. Instead of a single
prescription being used for
diversion purposes, the successful
"entrepreneur" will
receive 3.
It seems to me that the original
intent of the amended rule
could be met through collaborative
practices established
between pharmacist and
physician. The patient would
thus be required to return to
the same pharmacy for filling
all 3 prescriptions. Based on
the collaborative relationship,
the patient can be referred
back to the physician if the
pharmacist believes there is a
need to modify the prescriptionwhether it would include
a dosage adjustment (up or down), or
reassessment of pain management
based on patient compliance. Requiring
the prescription to be filled at the same
pharmacy all 3 times minimizes diversion
potential since the pharmacist can verify
identical patient identification for refills
and ensure compliance with intended
refill dates each time.
Even more enlightening is a quote
from the DEA in a September 6, 2006,
news release which acknowledges that
they "...listened to over 600 physicians,
pharmacists?," which resulted in its proposed
rule making. This statement validates
what we teach our professional
students. The voices of a relative few can
often have a profound impact on legislation
and regulation. Comments to the
DEA must be received by November 6,
2006. If you have thoughts on this topic,
let them be heard where you can make a
difference.
Mr. McAllister is director of pharmacy
at University of North Carolina (UNC)
Hospitals and Clinics and associate
dean for clinical affairs at UNC
School of Pharmacy, Chapel Hill.