Over a hundred million Americans suffer from chronic pain. To combat this epidemic, health-care providers have increasingly turned to opioid analgesics. As a result, opioid analgesic use has risen dramatically over the past decade. While opioid use has skyrocketed, the use of non-opioid analgesics has remained constant.
Research and development continues to create new opioid medication options for patients suffering from chronic pain. Last year, the U.S. Food and Drug Administration (FDA) approved Zohydro, a potent opioid painkiller. More recently, QRXPharma attempted to become the first company to obtain FDA approval for a drug combining multiple opioids. Moxduo, a mix of morphine and oxycodone, was denied approval by the FDA in April.
Along with the increase in the availability of opioid medication and complications from opioid use, health-care professionals have seen a significant uptick in medical board disciplinary action related to opioid prescribing practices. According to data published by the National Practitioner’s Data Bank, medical malpractice payments on behalf of physicians have decreased by more than 40 percent in the last 10 years. During the same period, adverse actions by medical boards against practitioners have increased more than 41 percent. Pain medication prescription issues have accounted for part of this significant increase in disciplinary actions.
The Ohio Medical Board has reviewed an average of 35 allegedly improper prescribing cases a year since 2010. During the previous decade, the board saw an average of only three such cases a year. The North Carolina Medical Board estimates that nearly 30 percent of all investigations in the state involve prescription problems. In California and New York, inappropriate prescriptions have been among the top four causes of disciplinary actions for the past 10 years.
Over a decade ago, the Federation of State Medical Boards (FSMB), an organization of state medical boards, foresaw the looming opioid prescription problem and created a model policy for prescribing controlled substances. The FSMB uniform model includes several recommendations for physicians prescribing pain medications. The policy has been revised twice, most recently in 2013. Several state medical boards have adapted the FSMB policy for practitioners in their states.
The FSMB model policy has extensive guidelines for the care and the treatment of a patient with pain management issues. It recommends that a physician undertake a detailed patient evaluation and document at least one recognized medical indication for opioids. It recommends that every patient undergo a systems review, relevant physical examination, and laboratory investigations as indicated. The physician should also conduct a careful clinical interview and document the potential risk factors for abuse, including a family history of alcohol or drug abuse and a medical evaluation for mental health disorders. A patient’s history of abuse could warrant the involvement of an addiction specialist before a physician prescribes opioids. Importantly, the FSMB policy would place on the prescribing physician the burden of obtaining corroboration of the patient’s self-reports: “[r]eports of previous evaluations and treatments should be confirmed by obtaining records from other providers, if possible.”
The FSMB model policy suggests that a physician check his or her state’s searchable online database of prescription medications to determine whether a patient currently receives prescription drugs from other providers. Forty-eight states have developed such a database for physicians and pharmacists to access patient prescription drug history. These systems have come online in the last decade. North Carolina’s system has already undergone a legislative revision based on physician suggestion that the database require any physician-dispensed medication in excess of a 48-hour supply to be reported to the system. A Maryland bill awaiting the governor’s signature expands the role of that state’s prescription database program to give monitoring responsibilities to the database program itself. Md. H. Bill 1296. Under the new changes, the program itself “may review prescription monitoring data for indications of possible misuse or abuse of a monitored prescription drug.” If such abuse is found, the program reports to the prescribing physician.
The National Association of Boards of Pharmacy has created a method known as InterConnect to link information among participating states. Twenty-four states are fully operational with the connection, allowing the participating states to share and receive prescription drug information across state lines.
The FSMB model policy also places a great emphasis on a written treatment plan. It recommends that physicians construct a unique treatment plan for each individual patient, accounting for the particular benefits and risks of opioid use by the patient. The treatment plan should include set objectives. The physician should revisit the treatment plan throughout his or her treatment of the patient.
The FSMB also recommends the use of a treatment contract that outlines the responsibilities of the patient and the physicians. The treatment contract, sometimes known as a pain management agreement, can discuss the goals of the treatment and restrictions on the patient’s use of the medication. The agreement can also be used to secure the patient’s consent to drug screening and agreement to obtain his or her medication from only one physician or practice. When a patient has executed an agreement, the FSMB recommends that the physician enforce the agreement or fully document any instances in which the agreement has been compromised.
According to the FSMB, only after following the above-enumerated steps should the physician prescribe opioids. Even then, the prescription should be authorized on a trial basis of no more than 90 days. The FSMB recommends the lowest dose possible for a first-time opioid patient. The FSMB also recommends that the physician attempt, with permission, to obtain secondary information from friends and family members about the patient’s progress.
Follow-up visits are critical under the FSMB policy. Each follow-up visit should include a review of a patient’s mood and whether the patient has a reduction in pain or improvement in function. A physician should also review and document all adverse effects from the drugs, including aberrant behaviors. The FMSB also recommends periodic drug testing—through urine or blood tests—and even “pill-counting” to ensure that a patient is not overusing or diverting the medications.
While many in many states the state medical boards have largely been the ones to prepare policies consistent with the FSMB recommendations, a few states also have actually codified the recommendations. For instance, a 2013 law in Indiana requires pain management physicians to perform a detailed history and physical, create a treatment plan, sign a treatment agreement, perform a drug screen on a patient, check the patient on the state’s prescription drug database, and meet with the patient quarterly during the time of prescribing. Ind. P.L.185-2013 (SEA 246). Beginning in April 2013, Tennessee medical professionals must by law check the state’s online database before prescribing pain medication. 2011 Tenn. Comp. R. & Regs. 1140-11-.06. Florida has introduced a bill that would require physicians to search the online database before prescribing a controlled substance. 2014 Fla. House Bill 1381.
In addition to codifying the provisions of the FSMB model policy, states have taken increasingly creative approaches to the opioid epidemic. For instance, a Michigan medical task force distributed a seven-chapter book on responsible pain management practices to every licensed physician, resident, and pharmacist. Practitioners were expected to review the book and will be held accountable for following its recommendations.
Virtually every state legislature has attempted to address the opioid problem through increasingly creative laws. Effective October 2013, Tennessee health-care professionals—including pharmacies—cannot prescribe or dispense more than a 30-day supply of opioids. Tenn. Code. Ann. 53-11-308(e). The Tennessee legislature is considering a 2014 bill requiring patients to show identification before picking up painkiller prescriptions from a pharmacy. Tenn. S. Bill 1832 (pending). New Jersey is considering a similar bill. N.J. Bill A711.
Some states also have attempted to limit liability arising from drug overdoses. Several states have advanced legislation providing immunity for individuals suffering from a drug overdose or friends who report the individual with the overdose. E.g., Ohio S. Bill 313 (pending); La. S. Bill 422 (pending); Iowa H. File 2207 (pending). Likewise, states have sought to limit liability or to provide full immunity to health-care professionals who assist an individual during an overdose or provide an opioid antagonist. E.g., S.C. House Bill 4811 (pending); Tenn. S. Bill 1631 (enacted); Wis. Act 200 (enacted); La. S. Bill 422 (pending); Conn. H. Bill 5487 (pending).
Taking a different approach, Governor Deval Patrick of Massachusetts has directly attacked the opioid manufacturers. Despite the FDA approval of Zohydro last year, the Massachusetts Department of Public Health issued an emergency order banning Zohydro, citing the states’ recent overdose deaths as a public health emergency related to opioid addiction. When the drug went on sale nationwide in March, not a single prescription was filled in Massachusetts. The makers of Zohydro filed a lawsuit in federal court seeking an end to the prohibition. Judge Rya Zobel of the U.S. District of the District of Massachusetts granted the temporary restraining order request and prevented further enforcement of the Zohydro ban. Judge Zobel found that the drug manufacturer would likely be successful in demonstrating that the state’s action was preempted by the FDA’s approval of Zohydro.
After the decision reversing the ban, Governor Patrick doubled down these efforts by imposing additional requirements on doctors who prescribe the drug in Massachusetts through state regulations. Consistent with the recommendations of the FSMB, doctors must now complete a risk management assessment and execute a pain management agreement with a patient before prescribing these drugs. Separately, the Massachusetts health commissioner issued an emergency order requiring doctors to use the online database before prescribing Zohydro.
Pharmacists traditionally have been less exposed to civil liability for opioid issues than the physicians prescribing the medication. Several states do not recognize any duty owed by pharmacists to customers to discover a customer’s addiction status. Kintigh v. Abbott Pharmacy, 503 N.W.2d 657 (Mich. Ct. App. 1993). Florida has gone as far as to hold that even actual or constructive knowledge of an addiction does not trigger a duty. Pysz v. Henry’s Drug Store, 457 So. 2d 561 (Fla. Dist. Ct. App. 1984).
Some jurisdictions have recognized a pharmacist’s duty to warn customers about the addictive nature of the medications. See Riff v. Morgan Pharmacy, 508 A.2d 1247 (Penn. Sup. Ct. 1986); Pittman v. Upjohn Co., 890 S.W.2d 425, 434 (Tenn. 1994); Lasley v. Shrake’s Country Club Pharmacy, Inc., 880 P.2d 1129, 1131, 1133–34 (Ariz. Ct. App. 1994).
Other jurisdictions seem to fall in the middle, recognizing that “[i]t is not for the pharmacist to second guess a licensed physician,” at the same time recognizing a duty in circumstances where the dosage “would be obviously fatal.” Heredia v. Johnson, 827 F. Supp. 1522, 1525 (D. Nev. 1993). See also Morgan v. Wal-Mart Stores, Inc., 30 S.W.3d 455, 466-69 (Tex. Ct. App. 2000) (no duty unless “neglect in the face of information on which a reasonably prudent pharmacist would have acted.”).
Even when civil liability is questionable, pharmacy boards across the country have been doling out discipline for prescription drug abuse issues. In January, the California State Board of Pharmacy revoked the licenses of three pharmacists for filling pain medication prescriptions written by two physicians. Six patients died of drug overdoses from medications apparently received from the California pharmacy where these pharmacists worked. The board did not appear to have alleged that the prescriptions were not legitimate. Instead, according to the board, the pharmacists “chose not to exercise clinical judgment, to communicate and listen, to assess the patients’ drug therapies or the effect the drug was having on the patient, to interact with the prescribers.”
The Texas Board of Pharmacy includes a publication on its website called “You Might Be a Pill Mill If . . . .” The publication identifies more than 20 potential red flags, any one of which should indicate to a pharmacist that his or her pharmacy may be violating the state’s guidelines. The guideposts include such otherwise innocuous items as “[m]ultiple people arrive at the pharmacy in the same vehicle,” or “[t]he number of controlled substances your pharmacy dispenses has significantly increased.” At the same time, some of the red flags place an affirmative burden on a pharmacist to evaluate prescriptions and patients critically. For instance, the guidelines suggest that a pharmacist is to determine whether a medication is “inconsistent with the prescriber’s area of practice” with the example “fentanyl from a dentist.”
Perhaps in response to these issues, pharmacies have been changing their practices regarding controlled substances. In late 2013, new reports circulated that a national pharmacy chain had begun refusing to fill pain medication prescriptions based on an internal checklist. According to reports, the pharmacy chain distributed to its members a “Good Faith Dispensing Checklist.” The policy reportedly required a pharmacist to follow several steps before filling a patient’s prescription. First, a pharmacist should check the state online database for the patient’s medication history. Next, the pharmacist should obtain a photocopy of the patient’s state-issued identification. Finally, the pharmacist was required to document answers to seven questions designed to draw out red flags that would trigger a more advanced review of the prescription and the patient. The seven red flags included whether the prescription was new, and in cases of a refill, whether the patient sought the refill earlier than scheduled; whether the prescription was from a new doctor for the patient; whether the patient lived close to the doctor; whether the patient was paying with cash; whether the quantity of pills was considered “excessive”; and whether the patient had taken the medication already for more than six months. If a pharmacist determined that the answers to these questions create a red flag, the pharmacist was required to take additional steps. These additional steps included calling the prescribing physician to determine the following: whether the prescription fell within the physician’s scope of practice, the physician’s diagnosis, the expected length of the physician’s treatment, the date of last physical, and whether the physician had considered or had tried alternative or less potent pain medications.
Recently, a national pharmacy chain took these types of policies a step further by advising that the pharmacy would no longer fill prescriptions for pain medications issued by physicians of internal medicine or family medicine unless the prescribing physician provided the pharmacy with a treatment plan for the individual. Without a written treatment plan, the pharmacy would refuse to fill a patient’s prescription.
This pharmacy’s decision implicates several issues for physicians, pharmacists, and patients.
A physician may be uncomfortable having a pharmacist second-guess the physician’s treatment decisions or the likely delay in filling the prescription pending the pharmacist’s approval. In such a case, the physician may be inclined to recommend to his or her patients that they seek an alternative pharmacy that does not require the submission of a treatment plan. In the event that a physician recommends that a patient use a different pharmacy and the patient suffers an adverse outcome, a plaintiff’s lawyer would be quick to point to the pharmacy change as precipitating the adverse outcome. Alternatively, a physician may agree to send a treatment plan to the pharmacist. If the pharmacist rejects the plan, the physician either has to ignore the recommendation or make changes to her treatment plan for the patient. Again, any adverse outcome would lead a plaintiff’s lawyer to second-guess the physician’s choice.
Requiring a treatment plan also affects a pharmacist’s potential liability. A pharmacist would appear to assume a role, and with the role, a duty, that she did not previously fill. Even in a jurisdiction that limits pharmacist liability, it would seem that a court would be less likely to allow a pharmacist to claim deference to a physician’s orders when the pharmacist has affirmatively based his or her decisions on a review of the treatment plan. The pharmacist’s review would seem likely to add the pharmacist to a plaintiff’s list of potential defendants. For many patients, these medications are necessary to their daily functioning. If a pharmacist refuses to fill a prescription and a patient is unable to transfer the prescription to a willing pharmacy and suffers an adverse outcome, the pharmacist would seem to have opened him or herself up to potential liability.
These treatment plans may also affect pharmacies that do not review them. Plaintiffs’ lawyers are certain to claim that the duty standard requires an active review of a treatment plan and criticize a pharmacy that follows the traditional approach of filling legitimate prescriptions.
Finally, the policy changes described in this section could affect patients the most. A patient with a legitimate medical need for his or her prescription may suddenly find his or her preferred pharmacy unwilling to fill the prescription. The patient is likely to experience inconvenience as well as additional cost due to the additional time required of physicians and pharmacists to conform to these policies.
The questions that these policies raise—and many more—are likely to be answered in courts across the country if this practice requiring a treatment plan becomes prevalent.
Criminal Charges Against Practitioners
Disciplinary sanctions and civil liability are not the only hazards that face pain management professionals. Federal and state law enforcement agencies across the country have been prosecuting physicians for their prescribing practices. In New York, a physician was arrested for allegedly writing oxycodone prescriptions to fake patients. Two Atlanta physicians were arrested for prescribing, according to law enforcement officials, without patients having a medical need for the drugs. In Florida, a surgeon was arrested for drug trafficking based on his prescriptions for narcotics, and the press release announcing his arrest appeared to fault the physician for meeting with the undercover patient in an office rather than an exam room and failing to obtain vital signs. In Los Angeles, a pain management physician was arrested a year after the Los Angeles Times featured a story on one of the physician’s patients who died of an overdose. In April, a Des Moines physician began his trial for nine counts of manslaughter in overdose deaths of former patients.
Undoubtedly, some physicians so chase money rather than fill a legitimate medical need. Law enforcement involvement in those cases clearly seeks the laudable goal of preventing physicians from lining their pockets and flooding the market with pain medication. At the other end of the spectrum are the physicians treating patients who need pain medication to survive each day. In between these two ends of the spectrum is a grey area where physicians may be unknowingly providing pain medication to patients who abuse or resell the medication. Similar to Governor Patrick’s reaction to Zohydro based on legitimate concerns, the involvement of law enforcement in the grey area could compound rather than alleviate the problems.
The case of Dr. William E. Hurwitz demonstrates the difficulty in separating legitimate medicine from abusive practices. Dr. Hurwitz, a Stanford-educated pain management doctor in Virginia, was criminally prosecuted twice for drug trafficking. Following his 2007 re-trial, Dr. Hurwitz was sentenced to 57 months in jail. While harsh, the sentence was a significant reduction from the 25-year sentence vacated by the Fourth Circuit. While recognizing that much of Dr. Hurwitz’s practice was legitimate and saved patients’ lives, Judge Brinkema faulted Dr. Hurwitz for turning a blind eye to patients who were drug dealers. In an interview with the Associated Press after the trial, Judge Brinkema described the trial as eye-opening. While initially she viewed “[t]he amount of drugs Dr. Hurwitz prescribed” as “absolutely crazy,” she “totally turned around on that issue. The mere prescription of huge quantities of opioids doesn’t mean anything.”
Criminal prosecutions against doctors for drug trafficking have also run into procedural issues. In Ohio, a physician was tried for drug trafficking based on Oxycontin prescriptions. Remarkably, the state was successful in convincing the trial court that the legitimate practice of medicine was an affirmative defense to drug trafficking, rather than an element of the crime that the state must prove. In other words, the trial court forced the defendant physician to show that each prescription was based on a legitimate medical need rather than requiring the state to demonstrate beyond a reasonable doubt that the prescriptions were not medically necessary. Fortunately, the Ohio Supreme Court reversed the conviction after recognizing that the trial court’s burden-shifting standard was inappropriate: “To accept the state’s argument that [the legitimate practice of medicine is] an affirmative defense would place an unreasonable burden upon all doctors who prescribe drugs to prove compliance with statutes or regulations to avoid criminal liability for merely practicing medicine.” State v. Nucklos, Slip Opinion No. 2009-Ohio-792, ¶ 19 (Ohio Mar. 4, 2009).
While there does not appear to be a silver bullet that would inoculate against criminal liability, physicians are well served to follow their state medical board’s recommended pain medication practices. When Michigan distributed the seven-chapter booklet on pain management practices, members of the industry distributed public warnings that law enforcement officials intended to seek out practitioners who were not following the recommendations.
As the hazards of opioid prescribing practices continue to grow, someone might wonder why health-care professionals venture into the pain management market. At the same time, health-care providers chose their field due to a desire to help their patients. The ballooning population of Americans struggling with pain provides a hundred million reasons to enter pain management and attempt to provide some relief to these suffering individuals. Civil, criminal, and disciplinary concerns, however, likely hide in the back of the minds of the practitioners in this field.
*This article orginally appeared in the September 2014 Issue of For the Defense.