US Pharm. 2012;37(7):60-62.
Like a grandfather clock’s pendulum swaying back and
forth, government regulations and their enforcement sometimes resemble
the ebb and flow of the tides. While the goal of a regulatory
enforcement scheme might be to find the perfect middle ground, the
reality looks more like the pendulum—sometimes controlled substances
(CS) laws are enforced to the maximum, and at other times they seem
rather laxly pursued. Regular readers of this column will recall that
the April and May 2012 editions focused on the oxycodone menace that
seems to have wracked south-central Florida.1,2 My blogs on the PharmQD Web site have also reflected on these developments.3,4
Acting As Gatekeepers
Let’s focus on that “perfect middle ground” for just a
moment. In this Utopia, all patients who have a legitimate medical need
for opioid pain medications have access to them with prescriptions
issued by prescribers in the usual course of medical treatment, and
pharmacists fill and dispense the prescriptions as good health
practitioners would do without question.5 But there is no
Utopia in the real world. As such, both prescribers and pharmacists are
assigned a “gatekeeper” function as a condition of having a Drug
Enforcement Administration (DEA)-issued CS registration authorizing the
prescribing and dispensing of CS.6 The gatekeeper is supposed
to assure that no “bad” people get access to CS that will be used for
some reason other than a legitimate medical need. There is an abundance
of literature available to tell pharmacists what signs to look for in
people engaged in “drug-seeking behavior.”7
Here is the problem with being both a good health care
practitioner and a law-abiding gatekeeper in a land where no Utopia
exists: Because there is no single, absolutely positive test for the
legitimacy of any prescription, as opposed to a number of factors we are
supposed to take into account before making a judgment, errors will be
made. Some folks will err on the side
of being a good health care practitioner, making sure all
legitimate patients get their necessary opioid medications, even if that
means a few “bad apples” slip through the gate and get hold of drugs
they are not entitled to. Using the same common sense and professional
discretion, others will err on the side of caution, making sure no “bad”
prescriptions are dispensed, even if that means occasionally turning
away somebody with a legitimate need.
As an exercise in finding out a little bit about yourself,
answer this question: Which side of the gatekeeper fence are you on?
Are you on the side that helps all needy patients even though a couple
of unlawful scripts might get dispensed, or are you the kind of
pharmacist who looks at every CS prescription with disdain and declines
to fill any that seem questionable, even though a few really needy
patients are refused service? Are you the helpful pharmacist you went to
college to learn how to be, or are you the pharmacist living in fear of
a legal quagmire that an encounter with the DEA might produce?
Whichever side of this fence you land on, no judgment is intended. There
are good reasons for both mind-sets.
Perhaps these questions are a little too absolute. The
pendulum-like effect on the importance of the factors we are supposed to
take into account when deciding whether to fill a CS prescription could
have a major impact on how you answer these questions. It would not be
uncommon at all for individual pharmacists to switch sides of that
imaginary fence depending on the totality of the circumstances present
at the time a prescription is received. In other words, it may be only
on a case-by-case basis that you are able to answer those questions
honestly and with a good rationale for your decision making.
Even so, there are consequences as to which side of the
gatekeeper barrier you come down on. Imagine a cancer patient with
intractable pain in south-central Florida. Assume that medically and
legally, the only thing that helps the patient cope is oxycodone. With
all of the legal actions against prescribers, distributors like Cardinal
Health, big chains like CVS and Walgreens, and a few independent
pharmacies that gave up and closed their doors, it might be difficult to
get an oxycodone prescription filled anywhere in that state.8
And if the patient has no insurance and has to pay cash for the
medication, it is going to get even tougher to obtain the drug. Then
what if a caregiver for this patient pulls up to a pharmacy
drive-through window and offers to pay cash for an oxycodone
prescription? This absolutely must be an illegal prescription, right?
Besides the conditions and appearances of a CS
prescription, pharmacists have to take into consideration what is going
on in the world in general and in their neighborhood in particular. Once
upon a time, all that pharmacists had to worry about was the DEA and
state licensing agencies. With one recent development, more than one Big
Brother will now be monitoring pharmacies.
Controlled Substances Violations
Cardinal Health entered into a settlement with the DEA on
May 14, 2012, to stop distributing CS from its Lakeland, Florida,
facility for 2 years.9 But that is only the tip of the
iceberg. Cardinal must also establish a compliance program to detect and
prevent CS diversion, including a program to review orders from clients
and to report suspicious orders to the DEA. In addition, it will have
to establish procedures in all states for either a Cardinal employee or a
third-party inspector to conduct site visits or anonymous inspections
of pharmacies to review “suspicious orders.” Under the terms of the
settlement, Cardinal will have to establish a “Large-Volume Tactical and
Analytical Committee” that will be able to review and make decisions
regarding higher-volume retail and chain pharmacy customers.10
While CS violations in Florida have been taking up much of
the media attention, the DEA is also active in other states. An
independent pharmacy in Las Vegas, Nevada, recently paid a $1 million
civil fine and surrendered its DEA registration for violation of several
CS regulations that allegedly took place over a 6-year period. Consider
what the lead U.S. attorney said in announcing this settlement: “This
is the largest civil settlement of its kind against a nonchain or
noninstitutional pharmacy in the United States. Civil settlements such
as this are an extremely important component in our strategy to combat
unlawful prescription drug trafficking in Nevada. We will continue to
work with our federal and local law enforcement partners to pursue
criminally and civilly physicians, pharmacists, and pharmacies that are
involved in the unlawful distribution of prescription drugs.”11
In Houston, Texas, another independent pharmacy owner paid
a $600,000 civil fine to settle DEA charges of “excessive purchases” of
hydrocodone, alprazolam, and oxycodone. The pharmacy allegedly
dispensed over 20,000 prescriptions with invalid DEA registration
In another development, the DEA and Omnicare entered into a
settlement agreement on May 11, 2012, whereby Omnicare will pay $50
million in civil fines for alleged abuses in dispensing controlled
substances to patients in long-term care (LTC) facilities.13
Alleged violations included routinely dispensing CS drugs to residents
of LTC facilities without a prescription signed by a practitioner; in a
limited emergency situation, dispensing CS without an oral prescription
called in by a practitioner; dispensing CS from prescriptions missing
essential elements; and not properly documenting partially filled
Future developments might bring additional oversight to
pharmacy CS dispensing practices. Right now, 48 out of 50 states have CS
monitoring systems, often referred to as prescription drug monitoring programs
(PDMPs), that track every CS prescription dispensed by a pharmacy,
making patient names, prescriber identity, and pharmacy data available
to one degree or another to health care providers and law enforcement
personnel. Interestingly, the number of states with this kind of service
has tripled since 2002. Missouri and New Hampshire are the only states
without these types of programs; each of those states may introduce
enacting legislation later this year.14 One of the main
complaints about state-based PDMPs is that the databases are only
available to concerned persons in the state under consideration.
That limitation might be addressed by pending federal
legislation. HR 4292, the so-called “Interstate Drug Monitoring
Efficiency and Data Sharing Act,” introduced by a bipartisan group of
Senators in March 2012, would, if passed, “link states’ individual
PDMPs, allowing doctors to see if a new patient has a history of abuse
in another state before issuing a prescription. It would also ease the
work of law enforcement in tracking and prosecuting drug dealers.”
Richard Kerlikowske, director of the Office of National Drug Control
Policy (the “drug czar”), said the current administration would likely
support this bipartisan bill. He stated that prescription drug abuse “is
wreaking havoc on communities small and large and cutting across
socioeconomic and gender lines...It is high time we get these systems
linked up to eliminate the interstate doctor shopping, which has been
fueling the pill pipeline around our country.”15
Taking these cases and legislative initiatives into
account, it appears that the pendulum of DEA activity to control drug
abuse is swinging far past the middle ground into the territory of
stricter enforcement actions. This is not meant as a critique; it’s just
a fact. These developments should not be of any concern to the vast
majority of pharmacists who are both faithful health care providers and
vigilant gatekeepers. The pharmacists who are not so cautious, however,
may have good reason to think twice about the consequences of their
1. Vivian JC. Corporate social responsibility: justice without due process. US Pharm. 2012;37(4):61-62. www.uspharmacist.com/content/d/pharmacy_law/c/33684/. Accessed June 11, 2012.
2. Vivian JC. DEA continues corporate responsibility drive. US Pharm. 2012;37(5):56-58. www.uspharmacist.com/content/d/pharmacy_law/c/34108/. Accessed June 11, 2012.
3. Vivian JC. DEA and corporate responsibility: an opinion. PharmQD. March 24, 2012. www.pharmqd.com/blog/dea-and-corporate-responsibility-opinion. Accessed June 11, 2012.
4. Vivian JC. Cardinal Health settles controlled substances distribution dispute. PharmQD. May 23, 2012. www.pharmqd.com/blog/cardinal-health-settles-controlled-substances-distribution-dispute. Accessed June 11, 2012.
5. See e.g., 21 CFR § 1306.04(a): “A prescription for a
controlled substance to be effective must be issued for a legitimate
medical purpose by an individual practitioner acting in the usual course
of his professional practice. The responsibility for the proper
prescribing and dispensing of controlled substances is upon the
prescribing practitioner, but a corresponding responsibility rests with
the pharmacist who fills the prescription. An order purporting to be a
prescription issued not in the usual course of professional treatment or
in legitimate and authorized research is not a prescription within the
meaning and intent of section 309 of the Act (21 USC 829) and the person
knowingly filling such a purported prescription, as well as the person
issuing it, shall be subject to the penalties provided for violations of
the provisions of law relating to controlled substances.”
6. Brushwood DB. From confrontation to collaboration:
collegial accountability and the expanding role of pharmacists in the
management of chronic pain. J Law Med Ethics. 2001;29:69-93.
7. Pharmacist’s manual: an informational outline of the
Controlled Substances Act. Revised 2010. Office of Diversion Control.
www.deadiversion.usdoj.gov/pubs/manuals/pharm2/index.html. Accessed June
8. Maginn M. Living with pain: physician abandonment and suicide in Florida. American News Report.
June 7, 2012.
Accessed June 12, 2012.
9. Cardinal settles with DEA over Lakeland, Florida
distribution, facility—may not distribute controlled substances from
facility for 2 years. American Society for Pharmacy Law. Pharma Law E-News. May 2012. www.aspl.org/pharma-law-e-news. Accessed June 12, 2012.
10. DEA and Cardinal Health, Inc. Administrative
memorandum of agreement. May 14, 2012. http://1.usa.gov/J8TWu3. Accessed
June 12, 2012.
11. Las Vegas pharmacy to pay $1 million fine, surrender DEA registration. DEA News Release. February 7, 2012. www.justice.gov/dea/pubs/states/newsrel/2012/la020712a.html. Accessed June 18, 2012.
12. Pharmacist pays record fine for alleged violations. DEA News Release. April 4, 2008. www.justice.gov/dea/pubs/states/newsrel/houston040408.html. Accessed June 18, 2012.
13. Omnicare in $50 million settlement—largest controlled substance settlement in history. DEA News Release. May 11, 2012. www.justice.gov/dea/pubs/states/newsrel/2012/det051112.html. Accessed June 12, 2012.
14. Priddy B. Prescription monitoring bill wins, loses. Missourinet. May 4, 2012. www.missourinet.com/2012/05/04/prescription-monitoring-bill-wins-loses-audio/. Accessed June 12, 2012.
15. Viebeck E. Lawmakers: prescription drug abuse fight needs federal hand. Healthwatch. The Hill.
March 29, 2012.
Accessed May 3, 2012.
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