Abstract
Diversion of opioids and other controlled substances for personal use by physicians poses a risk to patient health, safety and welfare, as well as the health and well-being of the physicians themselves. This type of diversion places patients at risk for infectious disease transmission, substandard patient care, and/or denial of medication. State medical boards (SMBs) have an obligation to ensure that the highest quality of care is provided to all patients, which includes a multifaceted role in investigating, monitoring and disciplining physicians and a responsibility to make concerted efforts to prevent harm to patients. Thus, SMBs are an integral part of the process when a physician is suspected of being impaired. Implementation of both preventive and responsive measures is crucial in attempting to not only avoid physician drug diversion, but to effectively address drug diversion when it occurs. In April 2011, the House of Delegates of the Federation of State Medical Boards (FSMB) adopted its Policy on Physician Impairment. The policy provides guidance for state medical and osteopathic boards on the inclusion of physician health programs (PHPs) to facilitate evaluation, recovery and rehabilitation and monitoring of physicians, as well as to protect the public from impaired physicians. This article reviews the problem of controlled-substances diversion by physicians and its adverse effect on public and personal safety, and it demonstrates how SMBs or other parties can use the FSMB Policy on Physician Impairment as a guide to develop their own professional assistance programs to ensure public safety.
Introduction
Medical regulators are obliged to evaluate physicians suspected of diverting controlled substances for personal use and thus decrease or prevent risks to patient health, safety and welfare, as well as risks to the health of the physician. The methodologies for diversion are many. One example is the removal of a portion of a controlled substance from a vial and the replacement of it with another substance. If a vial and the replacement substance are accessed multiple times, the vial may become contaminated with bacteria or viruses that put the patient at risk for blood-borne pathogens, which can cause serious acute and chronic infections. Further, because the medication is now diluted with the replacement substance, a lower dose than prescribed is administered, resulting in substandard care of the patient. In other cases, physicians may write prescriptions for controlled substances and divide the supply with the patient. In all of these cases, impaired physicians put themselves at risk of losing their professional license and, worst of all, death due to overdose. The overall result can be substandard patient care, transmission of infection, and/or denial of pain medication or the anesthetic agent, which has been replaced or divided.
The U.S. Centers for Disease Control and Prevention (CDC) has investigated and documented many infectious disease outbreaks related to diversion of substances for personal use. Table 1 summarizes several actual outbreaks and other possible serious blood-borne pathogens that can be transmitted (including both viral and bacterial) with association to health care workers in various scopes of practice. From 1983 to 2013, a total of 225 cases of patients who have been infected by contaminated vials related to health care provider drug-diversions have been documented.1
Summary of Infectious Disease Outbreaks Related to Health Care Worker Drug Diversion of Injectable Drugs United States 1983–20131–12
The outbreaks described in Table 1, which represent the injectable drug diversion outbreaks investigated in the United States from 1983 to 2013, demonstrate gaps in monitoring systems to detect diversion.
In addition to the clear patient harm documented in Table 1, the diversion of opioids and other controlled substances by physicians also raises the problem of harm to the physicians themselves.
The dual goal of protecting patients from potential harm caused when physicians divert medications for personal use and, at the same time, preventing physicians from becoming impaired, requires a multidisciplinary approach to detect and investigate diversion. In this environment, state medical boards (SMBs) are positioned to play a significant role.
This article describes the role of medical regulation in preventing diversion, ensuring the quality of care and responding to physician impairment.
Physician Impairment
Physicians, like the general population, are at risk for substance-abuse disorders. Physicians have higher rates of opioid and benzodiazepine abuse than the general population, and the highest among health care providers. Estimates of physicians' chemical dependency to drugs or alcohol during their careers vary from 10 to 15%, which is similar to the general population.13–16 A survey in 2005 reported that anesthesiologists are overrepresented with substance use disorders in PHPs and are more likely to abuse fentanyl and sufentanil.17 They are more likely to enroll in PHPs, due to opioid abuse and higher rates of intravenous drug use. Over a five-year period, anesthesiologists were less likely to fail a drug test during administrative substance abuse monitoring and had no statistically significant differences in their rate of PHP completion, disciplinary actions, return to work, or death than other physicians.18 In addition, the overall relapse rate for physicians enrolled in a PHP is significantly less than the 40% to 60% relapse rate in the general population.19 A retrospective cohort study found that the physician relapse rate increased with use of a major opioid, co-existing psychiatric illness or a family history of substance use disorder.20
Preventing Drug Diversion
Prevention of drug diversion requires an interdisciplinary approach. It is essential to the safety of the patients in a health care facility and is the individual responsibility of every employee. Drug diversion is difficult to completely prevent; however, due to its adverse consequences, many health care facilities have incorporated systems to deter controlled substance diversion and promptly identify it and intervene when it occurs.21 Such systems are multifaceted and require close cooperation between multiple stakeholders, such as departments of pharmacy, safety and security, nursing, legal counsel and human resources.21
Beyond effective reporting and investigation, education and policy implementation are keys to the prevention of drug diversion. Some examples of preventive strategies include pre-employment criminal background checks, as well as education and training of all employees at orientation and throughout the duration of their employment — especially for those directly handling controlled substances. The implementation of policies that adhere to federal, state and local laws, together with regulations such as controlled substance tracking, handling and surveillance, all contribute to the prevention of drug diversion.
Ultimately, when a physician diverts controlled substances, mandatory reporting to various agencies — such as a professional licensing board — becomes an important part of ongoing drug-diversion prevention.
The Role of Medical Regulation in the Quality of Care
SMBs have an obligation to ensure that the highest quality of care is offered to patients. Over the years there have been many ways of achieving this goal — from physician self-reporting of errors to mandatory testing and even public notices and action taken against a physician's license.22 The need for intervention is never more evident than when a physician is impaired due to drug diversion. SMBs have a multifaceted role in the investigation of impaired physicians, ensuring that any potential patient harm is limited, while addressing the physician's rehabilitation.
The first aspect in determining physician impairment involves the investigation of the quality of care provided by the physician. This may include obtaining the medical records of patients, an on-site inspection, staff interviews and/or a hearing. The matter may also require a “look-back” investigation to determine the number of exposed patients that should be contacted for recommended follow-up testing to determine if disease transmission occurred and whether there is a need for subsequent treatment. The “look-back” is usually conducted as a collaborative effort between local and state public health departments and the CDC. CDC support includes technical guidance, consultation by epidemiologists, on-site assistance with field investigations, and laboratory assistance. The CDC has developed a four-section tool kit that can be used during these investigations. The toolkit includes information on risk communication and sample patient notification and patient test result letters, media planning and communication strategies (including sample press releases and fact sheets), communication resources to support patient notification (including frequently asked questions for call center utilization) and strategies to coordinate with the media when releasing patient notification letters.23,24 In one of the examples of drug diversion noted in Table 1, an anesthesiologist with chronic hepatitis C used the same needle to anesthetize his patients that he had used to administer fentanyl to himself. He also gave patients anesthetics from an ampule contaminated with his own blood. More than 1,200 patients were tested for hepatitis C, 33 of whom were confirmed by molecular analysis to have been infected with hepatitis C by the anesthesiologist and needed treatment with antiviral medications. The anesthesiologist was arrested and convicted of spreading hepatitis C.4
AS THE PHYSICIAN SHORTAGE GREW AND REHABILITATION BECAME MORE SUCCESSFUL, REGULATORS DEVELOPED PROCESSES TO FACILITATE PHYSICIAN REHABILITATION AND REENTRY TO PRACTICE.
The Role of Medical Regulation in Physician Impairment
In addition to potential disciplinary actions to protect the public, SMBs also must consider potential actions to address physician impairment if the diversion is for self-administration. They play an integral role in the process of addressing physician impairment.
Incidences of health care providers becoming dependent on controlled substances have existed since their discovery. One prominent case involved 19th century American surgeon William Halstead, who early in his medical career developed a substance use disorder when he experimented with cocaine and morphine — both of which were being used in surgical treatments at the time. Halstead, who went on to a historically significant surgical career at Johns Hopkins, continued to use the drugs throughout his professional life.26
THE NEED FOR SMB INTERVENTION IS NEVER MORE EVIDENT THAN WHEN A PHYSICIAN IS IMPAIRED DUE TO DRUG DIVERSION.
Historically, SMBs have viewed physician impairment as a disciplinary matter. To a degree, they still are. Impairment and narcotic actions made up the majority of SMB disciplinary actions from 1963 to 1972. The focus started to change to recovery and rehabilitation with passage of the Florida “Sick Doctor Law” in 1969. Since then, the policy on physician impairment has evolved.27 As the physician shortage grew and rehabilitation became more successful, regulators developed processes to facilitate physician rehabilitation and reentry to practice.
In April 2011, the FSMB's House of Delegates adopted its Policy on Physician Impairment. The policy gives guidance to state medical and osteopathic boards for inclusion of PHPs to help protect the public from impaired physicians. SMBs, such as the New Jersey Board of Medical Examiners (NJBME), may be empowered through regulations to mandate physician participation in PHPs, to communicate with and coordinate with PHPs regarding participation and fitness to practice, and to have a legal agreement with PHPs regarding licensee participation. Individual SMBs can integrate the FSMB's policy into their routine practice, as illustrated in Table 2, which uses the Professional Assistance Program of New Jersey (PAPNJ) as an example.28
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Currently PHPs are available in all states except California, Georgia, Nebraska and Wisconsin.17 The role of PHPs is to guide physician rehabilitation while protecting public safety via early identification, evaluation, treatment, monitoring and advocacy.28
The relationship between SMBs and PHPs varies from state to state. PHPs can be independent, non-profit entities, affiliated with a state medical society, or operated by the SMB. The relationship between an SMB and a PHP is usually defined in a legal agreement.28
Physicians can be referred to a PHP by an employer or colleague, independent of action by an SMB. However, SMBs can compel a physician to enroll in a PHP and comply with its recommendations.29
PHPs, including the PAPNJ, have knowledge and expertise in evaluating, diagnosing, monitoring, and treating impaired physicians, as well as physicians with a potentially impairing illness. PHPs approach substance use disorder as a treatable chronic disease. They treat both the disorder and any mental health co-morbidity with early treatment referral, long-term treatment and intensive management.
U.S. PHPs have been very successful, with only 22% of physicians testing positive within five years of PHP admission.19 An estimated 72% to 85% of physicians enrolled in a PHP for substance use disorder maintain their license and continue to practice within this timeframe.25,30
The PAPNJ is used as an example of implementation of the FSMB policy by an SMB. The mission of PAPNJ is to provide services to protect the public safety and welfare of the citizens of New Jersey through education, identification, evaluation, treatment planning, and advocacy for licensed health care and other professionals in recovery from impairing medical conditions and illnesses, including substance use/abuse, psychiatric disorders, psychosexual disorders, disruptive disorders, metabolic disorders, cognitive disorders, and physical disorders.31 Table 2 shows the areas in which the NJBME, through its PAPNJ, is consistent with the details of the FSMB policy, as well as areas in which they differ.28
Conclusion
Medical regulation of physicians not only plays an important role in protecting the health, safety and welfare of patients, but also acts to protect physicians through various measures to prevent drug diversion. Medical licensing and disciplinary boards in the United States can conduct investigations; limit, suspend or revoke licenses; and require entry into a recovery and rehabilitation program, remedial education or training, to protect the public. Boards can also address physician impairment through their relationship with PHPs. It is through these mechanisms that boards can address the diversion of opioid and other controlled substances by physicians to prevent health care worker injury or ongoing adverse patient outcomes, such as substandard care, infections, and denial of medication. The FSMB's Policy on Physician Impairment provides guidance to state medical boards and PHPs to effectively assist impaired licensees, or those with impairing illness, in coordinating intervention and treatment of the physician's health.28 States without PHPs should develop them according to the FSMB's policy. States with a PHP should review their relationship with the PHP for consistency with the FSMB policy.
U.S. PHPs HAVE BEEN VERY SUCCESSFUL, WITH ONLY 22% OF PHYSICIANS TESTING POSITIVE WITHIN FIVE YEARS OF PHP ADMISSION.
Physician rehabilitation is increasingly more important as the physician shortage grows. In this environment, PHPs have a primary commitment to uphold their state medical boards' overall mission of protecting the public. In conjunction with the PHPs and with their goal of ensuring the overall safety of the public and the practitioner, the SMBs can determine if and when — and if necessary, under what limitations — the physician can regain his or her license and resume practice, based on fitness to practice.
In drug diversion, physicians provide a substandard level of care and also put themselves at significant risk of losing their medical licenses — possibly for a lifetime. Through education, monitoring and advocacy, programs such as the PAPNJ — which are developed following the FSMB's Policy on Physician Impairment — provide a means to identify, evaluate and treat physicians who may have diseases of impairment in order to ultimately protect the public safety.
About the Authors
↵Sindy M. Paul, MD, MPH, FACPM, is the Medical Director of the New Jersey Board of Medical Examiners.
↵David Abel, DO, is an Infectious Diseases Attending Physician at Lancaster General Hospital.
↵Majella Steinberg, DO, is an Infectious Diseases Fellow at Rowan School of Osteopathic Medicine Osteopathic Postdoctoral Training Institution/Kennedy University Hospital/Our Lady of Lourdes Medical Center.
- Copyright 2017 Federation of State Medical Boards. All Rights Reserved.
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