However, several individual states have passed their own pill mill acts.
For instance, a unanimous Florida legislature passed House Bill 7095,
which became effective July 1, 2011. The 98-page law targeting pill
mills modified several existing practices related to prescribers, clinics,
controlled substances, pharmacies, drug distributors, and even the
state’s PMP. The Florida law significantly restricted onsite dispensing by practitioners and required the return of existing controlled
substances and their buy-back by wholesalers. The statute also went
so far as to list legitimate medical practice requirements, practices
that are often absent in pill mills (for example, conducting a physical
examination, taking a medical history, developing a treatment plan,
creating a controlled substance agreement).35
5. risk
model has the potential for overlap and may not be mutually exclusive (for example, criminal law enforcement could lead to noncriminal sanctions, and PMPs could detect criminal behavior leading to
criminal prosecution).c Moreover, each model has the potential to not
only reduce harm but also result in medicolegal iatrogenesis. Maintaining the principle of balance in any governmental intervention is
essential when creating good public policy,d and it is a policy that can
and should be influenced by prescribers.
evaluation and mitigation strategies
A fifth and final governmental intervention concerns the FDA REMS
initiative. The overarching purpose of REMS is to ensure the safe
use of approved drugs and biologics so that the benefits outweigh the
risks.36 One of the primary tools to achieve this end is education.37
While the FDA Amendments Act of 2007 provided the basis for the
FDA to require REMS,38 these types of strategies have actually existed in various forms over the past decades (for example, the requiring
of patient package inserts by the FDA in 1970 for oral contraceptives).
The 2007 law enabled the FDA to require REMS as a condition of
a drug’s approval and subsequent approval if postmarketing surveillance indicated the need for a REMS. Current REMS could include
medication guides (the most common), a communication plan (for
example, letters to healthcare providers or professional societies), an
implementation plan for manufacturers, timetables for assessment
of the REMS, and/or Elements to Assure Safe Use (EASU), the last
of which could involve special training or certification, dispensing
restrictions, and patient registries).36,39 Faced with increasing evidence of harm associated with the use of prescription opioids, and
concerned about the need to ensure appropriate access, the FDA created 2 sets of shared opioid REMS. One set of REMS would cover
transmucosal immediate-release fentanyl (TIRF) medicines, and the
other set, extended-release/long-acting (ER/LA) opioids. While the
REMS for TIRF medicines include, among other things, medication
guides and patient registries, opioids falling within the ER/LA shared
class require only medication guides and voluntary, not mandatory,
education of prescribers. The FDA decided to not make education a
condition of renewed DEA licensure out of concern that mandatory
education would increase costs and perhaps result in the substitution
of less effective, non-ER/LA medications.36 Manufacturers of ER/LA
opioids will bear the cost of educating prescribers consistent with the
FDA Educational Blueprint, as well as the maintenance of websites
and call centers that currently exist to assist prescribers with information and patient registration (if necessary).40 A list of opioids falling
within the ER/LA shared class and their REMS is available at the
FDA website.36
At times, the government may indeed be the problem instead of the solution,41 but in the end it is our government. Fortunately, there are many things that prescribers and policymakers can
do to help bring about balanced policy and avoid medicolegal iatrogenesis. First, prescribers can get involved in the regulatory and policy-making process. Prescribers, or any healthcare professionals, have
the ability to influence both legislation and subsequent regulation.
Contacting their representatives, state medical associations, and regulatory boards about t