PUBLIC POLICY & REGULATION
another by the pharmacist, and the final form would eventually find unclear how these pain consultants would be compensated for their
its way to the appropriate state agency.20,21 Many of these earlier time. Third, some physicians may simply opt out of treating chronic
models only tracked Schedule II drugs, which in turn led some pre- pain, which in turn decreases the number of healthcare providers, inscribers to write for lower scheduled drugs or even over-the-counter creases costs, and decreases access.33
drugs (OTCs), thereby avoid the reporting requirements (and the
scrutiny).21-23 Over time, states abandoned the multiple-copy format
and moved towards an electronic data transfer system, a model that
4.
helped reduce the time lag associated with data entry and the use
of handwritten copies. States also expanded reporting requirements
beyond Schedule II drugs,20 and while most of the states now have Another governmental intervention in prescribing concerns federal
operational electronic PMPs, there are many variations and challeng- and state efforts to eliminate pill mills. Pill mill is a pejorative term
es associated with them.21,24 For instance, not all PMPs are located defined in a proposed law as “a doctor’s office, clinic, or healthcare
in identical state agencies25; many clinicians are unaware of the pro- facility that…routinely prescribes or dispenses controlled substances
grams or have difficulty accessing them; patient privacy and delivery
of care issues have been raised; and monitoring has a negative impact on legitimate prescribing behavior.20,25 Despite their challenges,
PMPs have enormous potential to reduce pharmaceutical diversion,
provided that they are “constructed and implemented properly” to
help maintain balance so that efforts to reduce harm do not come at
the expense of patients (medicolegal iatrogenesis).20,25
pill mill legislation
3. dosage
triggers with mandatory pain consults
In 2007, Washington State introduced opioid dosing guidelines for
prescription pain medication in an effort to reduce the occurrence
of injuries and deaths associated with opioids. This advisory guideline was “developed as an educational tool for primary care providers,” and called for clinicians to seek a pain consultation whenever a
patient reached a dosage level of 120-mg morphine equivalent dose
(MED) per day.26 To facilitate use of the guideline, the state provided
an online opioid dosing calculator that enabled clinicians to determine whether the opioid they were prescribing reached the 120-mg
threshold that would in turn trigger a pain consultation.27
In 2010, the Washington state legislature passed ESBH 2876, a law
which would significantly alter the way pain was treated and opioids
were prescribed in the state.28 Instead of asking prescribers to seek a
consultation, the new law and its concomitant regulations required it.
Regulations have already been adopted by various agencies, and the
guidelines further clarify that “acute pain, cancer pain, surgery-related pain, or end-of-life or hospice care” are exempted from the
rules.29,a Remarkably, the original lead sponsor of ESBH 2876 had
only proposed a continuing medical education (CME) requirement
for prescribers (personal communication, Representative Jim Moeller, September 6, 2011), not a mandatory consultation requirement
based on a dosage trigger.30 It is also worth mentioning that while
the CME-only approach was rejected by some members of the Washington medical community, voluntary prescriber education remains
a key component of another federal inter vention in prescribing: the
FDA’s Risk Evaluation and Mitigation Strategy (REMS) for extended-release opioids.31
Several groups and individuals remain concerned about the negative
impact of this intervention, particularly as it relates to the consultation requirement. First, a mandatory pain consultation is required
once a patient reaches 120 mg MED per day, and there are well over
15,000 patients at or above this triggering threshold.32 Second, it is
42 | PWJ | www.painweek.org
PiLL MiLL iS A
PeJORATiVe TeRM
DeFiNeD iN A
PROPOSeD LA AS
W
A DOCTOR’S OFFiCe, CLiNiC, OR
HeALTHCARe FACiLiTY THAT…
ROUTiNeL PReSCRiBeS
Y
OR DiSPeNSeS
CONTROLLeD SUBSTANCeS
OUTSiDe THE SCOPe
OF THe PReV
AiLiNG STANDARDS
OF MeDiCAL PRACTiCe
iN THe COMMUNiTY
iN ReLATiON TO THe PReSCRiBiNG
OR DiSPeNSiNG OF
CONTROLLeD PReSCRiPTiON
DRUGS.
outside the scope of the prevailing standards of medical practice in
the community in relation to the prescribing or dispensing of controlled prescription drugs.”34 This definition appeared in the federal
Pill Mill Crackdown Act of 2011, a proposed federal law that would
amend the CSA by: (1) increasing the term of imprisonment and fines
for violations involving Schedule I and II substances; (2) enhancing
the penalty if the recipient of the controlled substance was under the
age of 21; (3) providing for the alternative distribution of forfeited
funds; and (4) criminalizing those considered to be “operators,” defined as “any practicing physician affiliated with a pill mill; or any
owner, director, officer, or partner of a pill mill.”34 Both congressional versions of the Pill Mill Crackdown Act were referred to committee, and it is unlikely that they will become law anytime soon.
Q3 | 2013