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Legislative Responses to the OxyContin "Crisis" In Florida Legislative Responses to the OxyContin "Crisis" In Florida OxyContin is a sustained release product that contains oxycodone, a morphine-like opioid analgesic. Other products containing oxycodone have been marketed for years, but they have lacked the convenience of the sustained release quality that permits OxyContin to be dosed less frequently throughout the day. The other products have been of lower strength than OxyContin, and have contained either aspirin or acetaminophen with the oxycodone. Some patients do not tolerate, or prefer not to use, large does of aspirin or acetaminophen. OxyContin was first marketed in 1996, when the health care community was beginning to embrace the idea that pain should be aggressively managed. The timing was perfect, and the drug became very popular because it works so well. Because the advantages of OxyContin became so well known, its use skyrocketed, and the abuse of it soon followed. Media attention to reported OxyContin abuse has led law enforcement authorities in many states to the conclusion that an expanding crisis exists with opioid addiction, and that state health care regulators should more seriously involve themselves in the search for a solution to this problem. Politically correct lip service is being paid to the idea that "drugs do not cause drug abuse," and that "no specific product should be singled out." Great care is taken (sometimes) to provide assurance that the needs of legitimate pain patients will not be interfered with. But the message from law enforcement authorities is clear: Health care regulators should find a workable internal solution to the problem, or a solution will be found by others, and the external solution could be an unattractive one for the health care professions. Florida is a "Hot-Spot" of concern about OxyContin abuse. A student at the University of Florida died in 2000 from an overdose of OxyContin supplied to him by another student who had stolen the drug from a local pharmacy. The dead student's mother has filed a lawsuit against OxyContin's manufacturer, and against the pharmacy, alleging negligence that led to her son's death. A South Florida physician, whose patients died while using OxyContin, has been charged with criminal negligence in the prescribing of controlled substances. Medical Examiners have reported a dramatic increase in deaths due to OxyContin throughout the state. On August 29, at a meeting of the Florida Board of Medicine Quality Assurance Committee, coordinated efforts were initiated by law enforcement and health care regulators to solve the problem of OxyContin abuse. Florida Attorney General Bob Butterworth addressed the committee, and suggested that OxyContin should be withdrawn from the market by the FDA until it can be reformulated to prevent abuse. A representative of the state "Drug Czar" cited a "tremendous number of overdose deaths" from OxyContin, and he indicated that his office's concern is "creating a system that will prevent drug abuse in the future." Senator Lock Burt, who chairs the Florida Senate's Criminal Justice Committee, grilled the Executive Director of the Florida Board of Pharmacy regarding the steps being taken by the pharmacy board to address the problem of inappropriate opioid prescribing. Health care professionals in the audience shook their heads, breathed a deep sigh, and began to perspire a bit. The law enforcement folks had made their point. There is a problem with substance abuse, and we are a small part of the problem. We are also a big part of the solution. Clearly the time has come for the health care professions to collaborate with law enforcement authorities in the development of a more effective but balanced approach to opioid regulation. We hold the key to the medicine chest, and we need to lock the chest when inappropriate requests are made of us. But we need to open the chest when legitimate patients in need of pain relief seek our products and services. How can we all work together to make sure that the medicine chest is closed when it should be and open when it must be? The Florida meeting provided these suggested solutions:
Dr. Gary Winchester, Chairman of the Florida Board of Medicine's Quality Assurance Committee, opened the meeting by referring to the Florida Board of Medicine guidelines on the use of controlled substances for pain. These guidelines have been adapted from a template produced by the Federation of State Medical Boards. With regard to the guidelines, Dr. Winchester said "If physicians knew about these and followed them, then our problems would disappear." Clearly, part of the opioid problem is that health care providers do not have a sufficient understanding of appropriate pain management. Educational programs could effectively address this deficiency.
No matter how well a health care practitioner understands the basic concepts of pain management, if the practitioner does not have complete information about a patient's medication use, there is the possibility that opioid analgesics will be inappropriately prescribed, dispensed and administered. At the meeting there was a great deal of interest in developing an electronic database of information regarding opioid prescribing, so that physicians could quickly know, prior to prescribing an opioid, whether another physician had prescribed a similar opioid for the same patient in the not-too-distant past. There were several interesting suggestions for technological fixes of this social problem. The use of tamper-resistant prescriptions is one idea that generated interest, as well as the product reformulation to which the Florida Attorney General referred. Apparently Purdue Pharma has a "blueprint" for an OxyContin product in which they would embed beads of naltrexone that would release only if the product were crushed or chopped up. This formulation would prevent both oral and intravenous abuse of that product. It was obvious at the meeting that law enforcement authorities were learning a lot from health care regulators, and that health care regulators were learning a lot from law enforcement authorities. Criminal prosecutions and administrative actions against licenses seemed not to always be coordinated. There was frustration expressed on both sides about lack of cooperation from the other. Periodic meetings between law enforcement and health care regulators seem to be a productive solution to the problem of lack of coordination. Because new developments in substance abuse and patient care are constantly evolving, these meetings would have to be frequent. Health care practitioners who want to "do the right thing" for their patients may wonder what the right thing is. They may feel at risk for regulatory oversight if they prescribe or dispense large quantities of opioids, uncertain as to what regulators expect of them. As part of the educational programs for health care providers, clear standards should be provided, and practitioners should be given a means for comparing their practices with the standards. Everyone attending the meeting seemed to be in agreement that there are two very different circumstances under which opioid analgesic medications are diverted by prescription. First, there are a very few licensed physicians who have simply ended their legitimate practices and are creating bogus pain management clinics, at which prescriptions are sold with no pretense of quality care. Second, there are compassionate and caring physicians who are periodically duped into prescribing opioids for addicts or dealers, believing these people to be legitimate patients. Law enforcement authorities indicated that the effective prosecution of the first group is difficult, because the offenders claim to be within the second group. All agreed that one result of improved coordination could be more effective enforcement directed toward the first group. Criticism of the pharmaceutical industry centered on the promotion of opioids for appropriate pain management, without accompanying cautions regarding diversion prevention. Stories were told of sales representatives who were well versed in the pharmacologic aspects of their medications, but not well informed of the regulatory challenges for their products. While an institutional focus at many manufacturers does include the regulatory issues for opioid products, there was concern that the sales force did not always appreciate this focus. The recommendation was that sales personnel be trained to be as aggressive with their diversion prevention message as with their pain relief message, and that the company monitor to assure that both messages were being conveyed to health care providers. Perhaps the least controversial suggestion would be to forbid physician office dispensing of opioid analgesics. Apparently one significant source of diversion is from medical practices where physicians do not write prescriptions, but instead dispense directly to patients, some of whom are not patients. By requiring that a prescription be written instead, the pharmacist would serve as a buffer against outright fraud in a medical practice. The meeting was encouraging, but subsequent events have brought less optimism
that there will be productive legislative solutions to the problem of controlled
substance diversion. Senator Burt is reportedly considering the introduction
of legislation that will mandate triplicate prescriptions in Florida. Triplicate
prescriptions have been tried in several states, and are generally recognized
as a non-solution that leads to unintended adverse consequences. Senator Burt
is also considering the creation of an electronic surveillance system for opioid
prescribing and dispensing. What is not clear is whether his proposed surveillance
system is intended to improve the quality of drug therapy by providing pharmacists
and physicians with complete information about patients and their opioid use,
or instead is intended to ferret out bad patients, bad physicians, and bad pharmacists
for punishment. Health care providers will be trying to learn more about the
legislative proposals during the coming weeks. It will be important for health
care professionals to find common ground with law enforcement representatives,
so that drug diversion can be curtailed, with patient care remaining unaffected.
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