Spotlight on doctors' role in prescription drug abuse
Physicians can be held criminally liable
A Virginia physician was sentenced to four years for drug trafficking when patients resold their prescriptions.
In the 11th Circuit United States Court of Appeals case, U.S. v. Webb, a physician received three concurrent life sentences for deaths of patients who overdosed from his prescriptions.
In a Massachusetts case, a physician was found liable for a patient's drug overdose because he refilled the patient's opiate prescription earlier than he was supposed to.
In the Ohio Sixth District Court of Appeals Case Conrad - Hutsell v. Colturi, a court found it was a question to go to the jury to determine whether medical malpractice occurred when a patient was prescribed opiates by a gastrointestinal physician and became addicted.
"The court would not allow a directed verdict to stand on the case," says Samantha L. Prokop, JD, an associate at Brennan, Manna & Diamond in Akron, OH.
There are increasing numbers of cases, civil and criminal, involving physicians who prescribe narcotics to patients who sell the drugs or abuse them, warns Prokop. She adds that one of her firm's clients, a pain management practice, recently stopped prescribing opiates to patients because of the liability risks involved.
Here are risk-reducing strategies Prokop shares with hospitals during risk consultations in this area:
• Be sure all physicians in the practice or group are consistent in prescribing practices.
After several high school students died of overdoses, Prokop consulted with a local hospital to look at the prescribing practices of its physicians. One of the first things they learned was that physicians at the health system's EDs and multiple urgent care centers varied widely in their prescribing practices.
"It really didn't take much to get all the physicians together, once we told them, 'Look, in the long run this will keep drug-seeking patients from coming back here to obtain illegal drugs. It will make things safer for patients and will protect you legally," says Prokop.
• Access online prescription monitoring databases.
"There is a huge move toward this right now. The physician can go look and see how many times the prescription got refilled and who they are getting them from," she says.
While the databases have been available for some time in most states, there are now mandatory in some states, notes Prokop. "If the patient is getting controlled substances on a regular basis, there is a duty to continue to review that database on a regular basis," she says. "Our physicians don't have a choice anymore; in certain situations, it's mandated."
• Document carefully.
If you suspect a patient has a drug dependency, Prokop advises charting what you learned from the monitoring database, how many times the prescription was refilled, what the patient stated to you, and his or her symptoms, but keep the wording objective and not judgmental.
She gives this example of judgmental charting: "The patient came in today and advised that she was allergic to two out of the three pain medications I attempted to prescribe. She is adamant that she be prescribed __________, a narcotic. The patient cannot pinpoint the location of her back pain. Her symptoms appear to be a figment of her imagination. The patient has been to the ED five times in the past month. It is clear this patient is a drug-seeker. I am not prescribing narcotics today in hopes that this patient will not come back to our ED seeking drugs for illicit use.
Prokop gives this example of objective documentation: "The patient came in today and reported that she was allergic to two out of three pain medications I suggested. I asked the patient what types of symptoms she exhibited with these medications, and she indicated she broke out in hives with each one. The patient complained of low back pain that was not present upon palpation. The patient's family expressed concern that the patient has not been taking her medications as prescribed. I reviewed the Ohio Automated Prescription Reporting System database. The patient has received early refills three out of the last four times for her pain medication. Due to the risks of the patient not taking medications as prescribed, I am ordering a urine test prior to prescribing narcotics for this patient. I discussed with the patient the concerns of taking medications as prescribed and the risk for drug dependency and potential abuse associated with these drugs. She admits to not taking medications as prescribed. The patient is willing to undergo counseling for drug dependency issues. I have referred her to ___________ for follow-up."
"You don't want to get yourself in a position where you've got a defamation or libel case because the patient says you defamed them in a medical record or inappropriately labeled them as a drug-seeker," says Prokop. (See related stories on what prosecutors are looking for, and what constitutes "corrupt intent," below.)
Sources
For more information on liability risks of prescribing narcotics, contact:
- Michael E. Clark, JD, LLM, Special Counsel, Duane Morris, Houston, TX. Phone: (713) 402-3905. Fax: (713) 583-9182. Email: [email protected].
- Samantha L. Prokop, JD, Brennan, Manna & Diamond, Akron, OH. Phone: (330) 253-3766. Fax: (330) 253-3768. Email: [email protected].
Prosecutors looking at prescribing practices As a federal prosecutor, Michael E. Clark, JD, LLM, prosecuted several physicians for illegally prescribing highly addictive controlled substances — mostly Schedule II narcotics — that while having legitimate medical purposes, were also not the first choice of treatment for patients. "The law is clear that a physician cannot use his or her medical license as a means to engage in medical practice outside the accepted norms of legitimate medical standards," says Clark, now special counsel at Duane Morris in Houston, TX. Such conduct not only would expose a physician to criminal prosecution, but it also could result could in civil actions filed by administrative agencies and/or malpractice lawsuits, adds Clark. Typically, a physician who is a subject or target of an investigation involving allegations of illicit prescription drug prescribing won't be made aware of the investigation until the government is ready to file charges, according to Clark. "In drug diversion investigations, it's not uncommon in developing evidence to support a prosecution for undercover agents to pose as patients as a means to test the integrity of the physicians," he says. Off-label use is issue Clark says there "has long been a tension" between allowing pharmaceutical companies from engaging in off-label marketing activities that encourage physicians to prescribe products not properly submitted and approved by the Food and Drug Administration and the residual rights of physicians to prescribe products which they, in their professional judgment, decide are appropriate for treating their patients. "Indeed, many off-label uses of prescription products are well within the mainstream, particularly in areas where drug manufacturers haven't sought approval, such as in pediatrics and oncology," he says. However, physicians who do so always run the risk that the government could claim they have violated drug laws by prescribing controlled substances outside the course of legitimate medical practice or that plaintiffs' attorneys could sue them for alleged malpractice, says Clark. For example, in some states, a plaintiff's attorney could sue a physician for a catastrophic result from alleged misconduct in prescribing narcotics, such as a fatal car crash by an impaired patient. "There is always a causation and foreseeability issue involved which may or may not be something that can be proven, depending on the facts," says Clark. In many states, the state medical boards and legislatures have responded to the claimed problems of prescription drug abuse by tightening up the standards for pain management practitioners and targeting those who are perceived to be engaging in drug diversion activities by prosecution and administrative sanctions, he says. "The problem, of course, is that at some point such measures can result in limiting the access of needy individuals to legitimate medical treatments," says Clark. |
Did physician have 'corrupt intent?' What makes a physician the subject of an investigation involving allegations of illicit prescription drug prescribing? "Prosecutors are looking for high-profile cases," says Michael E. Clark, JD, LLM, special counsel at Duane Morris in Houston, TX, and a former federal prosecutor. "They will want to be able to demonstrate that a physician's practice was far off the norm of expected medical practice or that he or she made huge amounts of money engaging in outlier activities." Such evidence will help to demonstrate the physician's "corrupt intent," he says. "On the other hand, having documentation and witnesses available to demonstrate otherwise will be critical in limiting a professional's exposure," adds Clark. He gives these risk-reducing strategies: • Be particularly careful that your documentation supports the medical care provided. • Pay close attention to applicable coding and billing rules and regulations. • Have independent periodic reviews conducted by qualified third parties. "Basically, prepare as though you could be placed in the position of having to justify your actions later on with a program integrity auditor, licensing board, plaintiffs' malpractice lawyer, or even a prosecutor," says Clark. • Have an attorney review compliance measures. "This will help to preserve any applicable privileges that may need to be observed and also demonstrate that the professional lacked the type of corrupt intent needed to prosecute," says Clark. |
A Virginia physician was sentenced to four years for drug trafficking when patients resold their prescriptions.
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