From the Charles A. Sammons Cancer Center, Baylor University Medical Center, Dallas, Texas.

Corresponding author: Anita L. Comley, PhD, RN, Charles A. Sammons Cancer Center, Baylor University Medical Center, 3500 Gaston Avenue, 4 Collins, Dallas, Texas75246 (e-mail: anitaco@baylordallas.edu).

The Texas Controlled Substance Act (Chapter 481 of the Texas Health and Safety Code), effective September 1989, regulates the manufacture, distribution, and dispensation of controlled substances in the state. Section 481.067 of the act mandates the record keeping and reporting of all prescriptions for controlled substances listed in the category Schedule II (for example, morphine, fentanyl, hydromorphone, oxycodone, and meperidine). Since the enactment of this law, copies of these prescriptions have been retained by the physician and filed by the pharmacy with the Texas Department of Public Safety. Historically, when multiple copy (triplicate) prescription programs are introduced into any state, the number of physicians prescribing opioids diminishes. Often the total number of prescriptions for these agents decreases by 50% to 60% (3).

To clarify misconceptions about the legitimate medical use of opioids for the treatment of pain, several states, including Texas, have adopted intractable pain treatment acts. However, such acts have not eliminated the fear of inappropriate investigation of prescribing physicians. As a result, state medical boards have begun to issue guidelines and policies for the use of controlled substances in the treatment of pain. It is hoped that these documents will allay prescribing physicians' fear of being investigated or disciplined by the board (4). The Federation of State Medical Boards of the United States issued a model for these guidelines in 1998 (5). The Texas State Board of Medical Examiners has published a position statement that addresses the appropriate use of opioids and other scheduled drugs in the treatment of pain (6).

Sergeant Andy Dunklin is a drug agent with the Texas Department of Public Safety Narcotics Service. The department employs approximately 400 drug agents statewide, but only 5 of them actively investigate medical professional practice. Sergeant Dunklin spends about 50% of his time investigating professionals for alleged violation of the Texas Controlled Substance Act. Investigations may involve physicians, nurses, pharmacists, veterinarians, or other individuals who prescribe, administer, dispense, or otherwise handle controlled substances. He also investigates individuals who are not licensed and are suspected of obtaining controlled substances through fraudulent means. The remaining 50% of Sergeant Dunklin's time is spent investigating cases of interstate smuggling of controlled substances.

Sergeant Dunklin agreed to be interviewed for the Proceedings because he is genuinely concerned that members of the medical community may have misconceptions about his role and how the Texas Controlled Substance Act impacts the prescribing of Schedule II analgesics in Texas (Figure). He wants to ensure that patients are not undertreated for pain due to unfounded fears of the regulatory system.

ALC: Sergeant Dunklin, what is the most important thing you would like to tell physicians in Texas about prescribing Schedule II analgesics?

AD: I want them to know that the laws regulating these medications were never intended to prevent physicians from prescribing them for valid medical reasons. There never was any intent to “second guess” or oversee physician practice. The intent was to protect the public and the physician from diversion of these medications by individuals for nonmedical use. I may be a patient some day, and I don't want my pain undertreated due to fears of regulation by the state government. The decrease in the prescribing of Schedule II analgesics in the state when the Texas Controlled Substance Act began requiring the use of triplicate prescription forms was unanticipated. This was and still is worrisome; I seriously doubt that Texans experience less pain today than before this law was enacted.

ALC: What situations surrounding the prescription of opioid analgesics warrant your investigation?

AD: Due to the large area I cover, I typically am able to only respond to calls from citizens regarding the actions of a physician. The first thing I do is contact the physician and get more information. Ninety percent of the time, I am able to discuss the complaint with the physician and find that no inappropriate action has taken place. Often, the patient or family member making the complaint is misinformed. Accusations of this type are screened extremely carefully, and persons intentionally making false accusations are prosecuted. In the other 10% of cases, there is evidence of inappropriate action on the part of the physician. However, often the action has been unethical but not illegal. Less than 1% of the calls I investigate result in criminal charges.

ALC: What percentage of physicians prescribing Schedule II analgesics get into trouble that impacts their licensure?

AD: Almost none. It is extremely rare. Generally, if a problem does occur, it begins when a physician prescribes these agents for office staff, friends, or family members. The physician does not medically manage that person like another patient; he or she is not seeing this person on a regular basis in the office and documenting the care given. Then, when the person becomes addicted, complications arise. For example, the person develops concurrent medical problems the prescribing physician should not treat, but the physician is hesitant to refer this friend or family member to a colleague due to the drug use issue. What starts out as a kindness or favor eventually leads to unethical behavior and, very rarely, criminal behavior on the part of the prescribing physician.

ALC: How can a physician avoid legal problems related to prescribing Schedule II analgesics?

AD: Physicians need to be very, very cautious about treating themselves or people close to them with these medications because discretion tends to be lost in these cases. If a physician cares enough about someone to prescribe controlled substances, then he or she should care enough to refer that person to a competent colleague.

In general, when treating patients with Schedule II analgesics, it is good practice to see the patient at regular intervals and document the pain assessment, the problem being treated, and the response to treatment. In the course of an investigation, a clinician cannot testify with much credibility to information contributing to the management of a case if it was not documented in the chart at the time the patient was seen. In court, our motto is “If it was important at the time the patient was treated, it is in the medical record.” Notes in the medical record that merely state “saw patient--prescription called to Eckerd” become problematic in court. As an aside, a good way to avoid civil action related to opioid prescribing is to document discussions with the patient regarding any safety issues related to side effects of the medication, such as sedation and driving or the use of machinery.

Diversion by office staff is often a problem. Limit the number of staff members who are allowed to call in prescriptions. Keep the triplicate prescription pad secured to prevent forgery. Really, all prescription pads should be secured because a highly diverted and abused drug, like hydrocodone, can be forged on a regular prescription. Keep samples of controlled substances in a secured lockbox that is attached to a cupboard so that it cannot be carried out of the office. When samples are dispensed, keep a record of the date and how many the patient received. Keeping a separate page for each drug is the easiest way to account for samples that have been distributed. Samples of all prescription drugs, not just opioids, should be monitored in the office.

ALC: Keeping the triplicate pad available to write prescriptions for patients being discharged from the inpatient setting but secured at the same time seems to be a problem for physicians. Do you have any solutions to suggest for this?

AD: I have heard that physicians are concerned about carrying the triplicate pad around. Some physicians use the narcotics lockbox in the surgical or discharge areas to store the pads. Others write the postoperative analgesic prescription in their office during the preoperative consultation. This has the added advantage of allowing patients to have the prescription filled and ready to use when they arrive home. Sometimes the surgery coordinator, physician's assistant, or nurse may carry the pad for the physician.

ALC: How many prescriptions can a physician write for Schedule II analgesics before it attracts your attention?

AD: The number of prescriptions never attracts my attention. I do receive a report listing the top 10 prescribers in my region every 6 months. Some of the names on the list are the same every time. It doesn't matter. I rarely look at the list; it just gets filed. As long as a physician is prescribing the medications for valid medical reasons, it doesn't matter how many “triplicate” scripts are written. Prescribing large volumes of Schedule II analgesics is not a cause for an investigation.

Actually, I testify in court more often in civil action against physicians who have not treated pain appropriately than in criminal action. I refute physician claims that fear of prescribing too many Schedule II analgesics is a justified reason for undertreating pain.

ALC: Does the number of pills a physician prescribes or “calls in” to a pharmacy at a time matter?

AD: No. The number may be limited by insurance companies, but it is not limited by the law.

ALC: Can you explain the changes in the handling of triplicate prescriptions that went into effect September of 1999 and how they impact physicians?

AD: Really, the changes don't impact physicians except that they no longer have to retain a copy of the prescription in their files. The change that occurred last September requires the pharmacy to report Schedule II prescription information electronically to the Department of Public Safety rather than in the paper form. By June or July of 2000, the triplicate prescription will be replaced by a single “official prescription.” Again, the information will be filed electronically by the pharmacy, and the physician will not be required to retain a copy. Physicians may use up their current triplicate prescriptions, and when they reorder, they will be sent the new official prescription.

ALC: Does the physician have to complete the prescription for a Schedule II analgesic?

AD: No, an assistant can fill it out, but the physician should never sign a blank one.

ALC: Can the prescription be mailed or postdated so that the patient doesn't have to come to the office to pick it up?

AD: The prescription can't be postdated, but it can be mailed as long as the patient will receive it in time to have it filled within 7 days of when it was written. Also, a prescription for a Schedule II medication written in Texas must be filled in Texas. It cannot be carried across state lines.

ALC: Sergeant Dunklin, do you foresee any significant changes in the Texas laws regulating controlled substances in the near future?

AD: No, I really don't. The current system, which was modeled after systems in California and New York, is really the biggest deterrent to diversion that we have. Hydrocodone, which is not regulated in this way, is by far the number 1 prescription drug abused in this part of the Western Hemisphere. In general, short-acting opioids tend to be diverted much more frequently than long-acting ones. The only people who seem to want the long-acting drugs are patients who know they work for their pain. Of the Schedule II controlled substances, it is not the opioids that are most commonly diverted and abused, it's Ritalin.

ALC: Do you have a final “take-home message” for physicians about the prescribing of Schedule II analgesics?

AD: Yes. Write for them! Write as many as you want! We at the Department of Public Safety don't care how many people you treat for pain or how many opioids it takes to do that. We do care that the citizens of Texas are not undertreated for pain because of unrealistic fears about regulation of these substances.

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4. McCaffery M, Pasero C. Pain Clinical Manual. St. Louis, Mo: Mosby, 1999.
5. Federation of the State Medical Boards of the United States, Inc. Model Guidelines for the Use of Controlled Substances for the Treatment of Pain. Euless, Tex: Federation of the State Medical Boards of the United States, 1998.
6. Texas State Board of Medical Examiners. Treatment of pain. Available at http://www.tsbme.state.tx.us/policy/policy.htm. Accessed May 18, 2000.