Another DEA License fee increase! In spite of opposition by the American Dental Association, the Drug Enforcement Agency has raised the three-year fee for a Controlled Substance License exponentially from $20 in 1987 to $732 today. Question:
Is $732 reason enough for a dentist to drop his or her DEA Controlled Substance License? Answer: Renewal or non-renewal is a decision that every license holder must decide for him- or herself after careful review of its value to patients, while also giving serious consideration to the risks and responsibilities that accompany prescribed addictive narcotics. Discussion: The increased three year Controlled Substance License fee may be a catalyst for serious review before renewal.
First Consideration: Non-Renewal
The October 3, 2011 issue of the ADA News reported that the ADA was unhappy with DEA license fee increases for dentists and was “urging reconsideration of the latest fee hike”. The November 7, 2011 issue of ADA News printed a letter from Jim Slattery, D.D.S. of Elk Point, South Dakota. His letter pointed out the rising cost of DEA license fees, which were $20 in 1987 and are now $552, with an increase to $732 in the near future.
The editors responded, “The ADA has repeatedly fought against DEA fee increases that have steadily risen since the early 1990s. When the Association approached the House Small Business Committee to contact the DEA for clarification of the rationale for the increases, the DEA response to the committee chair simply repeated what was contained in the proposed and final rules and did not address the ADA’s concerns over the disproportionate fees paid by providers when compared to drug manufacturers and dispensers. Even so, the ADA is continuing to work with a coalition of other health care providers to fight against disproportionate fee increases.”
The tone and content of the ADA News editor’s response makes it clear that not much success can be expected from efforts of the ADA in its confrontation with the powerful and massive DEA bureaucracy. However, each dentist has the option of non-renewal, which eliminates license costs and associated risks. For a dentist to arrive at this decision, a thoughtful and serious individual evaluation of prescribing frequency and the value of prescription narcotics related to patient care must be made. If frequency is low, and non-narcotic pain medication is an option, non-renewal can be a good choice. This option eliminates the $732 from the long and growing list of taxes paid by dentists to support government agencies. Also, some dentists share a misconception that a DEA license is necessary for all medications prescribed. A DEA license is only necessary when prescribing controlled substances. Currently, many dental practices have made the decision to drop or not renew their narcotics license, with a net effect of no license fee paid to the DEA and no negative impact on their practices.
Second Consideration: Renewal Continuation of the DEA Controlled Substance license obligates the licensee to a thorough understanding of Hydrocodone and Oxycodone, including adverse consequences. These two medications comprise the narcotic ingredient in virtually all of the opioid prescriptions written yearly for dental pain. Every prescribing dentist must recognize that our profession is a large stakeholder in a worldwide prescription drug problem that he or she affects with each dose prescribed. Risks to patient and public safety should always be considered when prescribing these drugs. Opioid narcotics are highly addictive, which often results in negative behavior and encouraging abuse, misuse, and diversion. Serious consequences often follow, and many reports of criminal activity have been documented in various media outlets at almost a daily rate.
A legal prescription for Hydrocodone or Oxycodone which is within established guidelines of one or two doses every four to six hours for no more than three days is a common and well accepted protocol for patients with moderate to severe dental pain. Although prescribing guidelines are useful and should be followed, a dentist must remember the risks associated with each dose prescribed. Twelve to 36 doses prescribed are a seemingly small quantity, but even one dose can be deadly if misused.
To underscore the seriousness of Hydrocodone and Oxycodone risks, excerpts follow that focus only on the worst of all risks: death.
Risk: Death By Abuse
In the ADA Professional Product Review of October 2010, Dr. Ellen Byrne, D.D.S., Ph.D., states, “In street abuse, Oxycontin tablets are being crushed to make the entire dose immediately available, and then snorted or dissolved in water and injected intravenously. When taken in this way by people with no tolerance to the drug, a single 80 mg dose can be fatal.”
From the Duluth News Tribune August 3, 2010: “Bail set for Wrenshall man accused in drug death. Oxycontin was sold, injected; the purchaser died.”
From the Minneapolis Star Tribune July 23, 2011: “Derek Boogaard, former Minnesota Wild player, found dead in a Minneapolis apartment May13; brother charged in overdose. Prosecutor said, ‘Boogaard had ‘a lot’ of Percocet, Oxycontin, and Oxycodone in his system in addition to ‘a lot’ of alcohol.’ He was found dead after a night of partying.”
Among those prescribing were dentists and oral surgeons.
Risk: Death by Party Drug Misuse
From Bloomberg Newsweek: “The most dispensed drug in the U.S. was Hydrocodone with acetaminophen, known as Vicoden. Vicoden has a reputation as a party drug, and 97% of U.S. high school seniors reported non-medical use in 2008. A study by the Florida Medical Examiner’s Commission found that legal prescription opioids caused more than twice as many deaths as cocaine, heroin, and methamphetamine combined: 2,328 to 989.”
Risk: Death by Accident (Abuse)
From Dr. Gordon Christensen’s Clinicians Report January 2010: “The prescription pad can be a lethal document. Last year the accidental death from inappropriate use of prescription drugs killed more people than automobiles or suicide.”
Risk: Death by Robbery
From the Minneapolis Star Tribune July 23, 2011: “Pharmacy robberies sweeping the U.S. from Richmond WA to St. Augustine FL. Criminals are holding pharmacists at gunpoint and escaping with thousands of addictive pills that can sell for $80 apiece on the street. In one of the most shocking crimes yet, a robber walked into a neighborhood drugstore in New York’s Long Island and gunned down the pharmacist, a teenage store clerk, and two customers before leaving with a backpack full of pills containing Hydrocodone.”
It should be noted that police and media reports are not accurate in many cases when reporting the type of narcotic being abused, misused, or diverted. The prosecutor on Derek Boogaard’s overdose case said, “He had a lot of Percocet, Oxycontin, and Oxycodone in his system.” Percocet and Oxycontin are Oxycodone in combination with other, different medications.
This type of misunderstanding extends to prescribing dentists and poses another risk. Because Hydrocodone and Oxycodone are packaged with many names, a dentist prescribing one of these may not recognize other pain medications which are on a patient’s list of medications and contain one of these two narcotics. Careful attention is needed with all narcotic medications being taken by a patient to avoid inadvertent redundancy. The following are drug formulations with Hydrocodone and Oxycodone.
Hydrocodone: Lortab, Vicoden, Lorcet, Anexsia, Bancap HC, CetaPlus, CoBesic, Hycet, Margesic, Maxidone, Norco, Stagesic, Zydone, and Vicoprophen.
Oxycodone: Oxycontin, Percocet, Percodan, Oxydose, Oxyfast, Roxicodone, Intensol, Supendol, Endocet, Oxycocet, Endodan, and Oxydododan.
It is a good bet that most dentists recognize fewer than half of the Hydrocodone and Oxycodone narcotics on these lists.
An Addiction Epidemic
Both Hydrocodone and Oxycodone are in great demand throughout the U.S., and can only be supplied by prescription from a DEA Licensed Provider. A mind-boggling number of prescriptions are being written by both physicians and dentists. At a two-day conference of the Tufts Healthcare Institute’s program on opioid risk management, and reported June 7, 2010 by the ADA News, Nathanial Katz, director of the risk management program, pointed out a powerful statistic from a study done that said dentists in 2002 prescribed 12% of opioids in the U.S., amounting to one billion doses.
And the numbers continue to rapidly increase. In the Duluth News Tribune April 6, 2012, Chris Hawley of the Associated Press reported: “Painkiller sales soar around the U.S., fuel addiction.” He points to an A.P. analysis stating that “the push to relieve patients’ suffering is spawning an addiction epidemic.” The painkillers identified in this article are none other than Hydrocodone and Oxycodone. DEA figures cited show that there is a dramatic rise in sales of as much as sixteenfold between 2000 and 2010. It is reported that pharmacies received and ultimately dispensed the equivalent of 69 tons of pure Oxycodone and 42 tons of pure Hydrocodone in 2010, the last year for which statistics are available; enough to give 40 5 mg Percocets and 24 5 mg Vicodins to every person in the U.S. As well, the Centers for Disease Control and Prevention reported 14,800 overdose deaths in 2008 alone.
Gil Kevlikowski, the U.S. drug Czar, told Congress in March 2012, “we all now recognize that these drugs can be just as dangerous as illicit substances when misused or abused.” Opioids like Hydrocodone and Oxycodone can release intense feelings of well being. If diverted from a legitimate source such as grandma’s leftover prescription found in her medicine cabinet, they can be deadly. Whether smoked, snorted, injected, or swallowed in combination with alcohol, these drugs will kill.
Ethics and Professional Conduct
Now it’s time for a sobering “Ethical Moment”. Before writing that $732 check to the DEA, careful and serious consideration must be given to the fundamental cornerstone of all successful dental practice: the dentist/patient relationship. Two fundamental principles of ethics must always govern this relationship. They are beneficence and nonmaleficence.
The ADA Principles of Ethics and Code of Professional Conduct (ADA code), section 3, Principle of Beneficence — i.e., “Do good” — reminds us that the dentist has a duty to promote the patient’s welfare. This principle expresses the concept of professional duty to act for the benefit of others above self. Under this principle, the dentist’s primary obligation is service to the patient and the public at large.
The second governing principle, that of nonmaleficence, which dates back to Hippocrates, requires that clinicians “Do No Harm” to patients. As dentists and members of the ADA, we have agreed to adhere to the principles of ethics and professional conduct. The Code clearly emphasizes welfare of patients, honor of the profession, and trust placed in dentists by society. This being said, it is clear that each dentist assumes complete responsibility for every dose of addictive narcotic prescribed.
That Is the Question
Now back to the question “Is renewal of the DEA license to prescribe controlled substances worth the cost and the risk?” Each prescriber must make a decision only after thoughtfully considering the safety of patients and the public, including the legal and ethical responsibilities that go with each dose prescribed. Legal considerations need to include all elements of informed consent and due diligence. Ethical principles of nonmaleficence, requiring clinicians to do no harm to their patients, and beneficence, which assigns priority to act in the patient’s best interest and not for convenience or enhancement of the clinician or his or her image must be followed.
The guest editorial in the Journal of the American Dental Association (JADA) November 2011 deals with ethical and legal matters related to non-narcotic drug prescribing. An editorial by Mark Donaldson, B.Sc. (Pharm), R.Ph., Pharm.D., FASHP, FACHE is titled “The Spider Man Principle”, referencing “With great power there must also come great responsibility!” the credo with which Stanley M. Lieber (aka Stan Lee) introduced Spider Man. While Dr. Donaldson was not writing about prescription narcotic abuse or DEA license renewal, the introduction to his editorial is profound when applied to dentist responsibilities in prescribing narcotics: “The privilege to write prescriptions is one of the most important responsibilities that dentists can acquire on their licensure. Patient safety is paramount to all that health care providers do; proper prescribing and medication safety should never be taken lightly.”
If renewal of the three-year DEA Controlled Substance License is deemed worth the cost and risks, the caveat that applies to all hazardous commodities should be observed: HANDLE WITH EXTREME CARE!
*Dr. Wainio is a general dentist in Duluth, Minnesota. He is Chair of the Northeastern District Dental Society Ad Hoc Committee on Controlled Substances. Contact information is phone: (218) 722-1846; email is email@example.com.