The Controlled Substances Pendulum

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 numbers.¹²

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 prescriptions.

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

Analysis

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 decisions.

REFERENCES

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 11, 2012.
8. Maginn M. Living with pain: physician abandonment and suicide in Florida. American News Report. June 7, 2012. http://americannewsreport.com/living-with-pain-physician-abandonment-and-suicide-in-florida-8814494.html?goback=%2Egde_43112_member_123174236. 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. http://thehill.com/blogs/healthwatch/medical-devices-and-prescription-drug-policy-/219137-lawmakers-prescription-drug-abuse-fight-needs-federal-hand?goback=.gde_43112_member_105107880. Accessed May 3, 2012.

To comment on this article, contact rdavidson@uspharmacist.com.