when practicing addiction psychiatry. The content in this presentation is intended solely to provide general information concerning developments in the area of risk management. It is not intended as legal or medical advice, nor does it offer or solicit for offers with respect to any insurance product. Legal or medical advice should be obtained from qualified legal counsel or other professionals to address specific facts and circumstances and to ensure compliance with applicable laws and standards. And listeners should consult their own insurance advisors for information pertinent to the purchase of any insurance product. This content may not be reproduced or redistributed in whole or in part without the prior written consent of Allied World. This activity has been approved and implemented in accordance with the accreditation requirements and policies of the Accreditation Council for Continuing Medical Education through the joint providership of the American Psychiatric Association and Allied World. The APA is accredited by the ACCME to provide continuing medical education for physicians. The APA designates this enduring activity for a maximum of one AMA ERA category one credit. Physicians should only claim credit commensurate with the extent of their participation in the activity. No one in a position to influence course content has anything to disclose. So I'm Alyssa Pinocelli and I'm co-presenting with my colleague Kara Stouts. We are both Assistant Vice Presidents for AWACS Services, a member company of Allied World. We provide risk management services to Allied World's professional liability policyholders and insured psychiatrists, psychologists, psychiatric nurse practitioners, and physician assistants. So this presentation objectives are recognizing ethical policy and legal considerations when addressing addiction psychiatry. We'll be exploring risk management and liability exposures when practicing addiction psychiatry. We'll be exploring risk management considerations when treating high-risk populations and identifying risk management strategies when practicing addiction medicine. So let's start with the definition of addiction. For the American Society of Addiction Medicine, it is a treatable chronic medical disease involving complex interactions among brain circuits, genetics, the environment, and an individual's life experiences. This includes people with addiction such as alcohol or opioid addiction and engage in behaviors that become compulsive and often continue despite harmful circumstances. Prevention efforts and treatment approaches for addiction are generally as successful for those with other chronic diseases. According to the CDC in 2021, over 80,000 Americans die from an opioid overdose. That equates to approximately 219 opioid-related deaths per day. Many of these deaths involve multiple drugs present in the patient's system. In 2017, the U.S. Department of Health and Human Services declared a public health emergency and announced a five-point strategy to combat the opioid crisis. Their five-point strategy included better addiction prevention, treatment, and recovery services, improved data collection, enhanced based practice, and improved opioid prescribing, improved availability of overdose reversing drugs, and increased research. So as you know, substance use treatment refers to treatment or counseling that is received for illicit drug or alcohol use or for medical issues associated with illicit drug or alcohol use. Each person has unique needs for addiction services and therefore addiction psychiatrists provide services in a variety of settings. The liability exposures addiction psychiatrists face may vary depending on the setting and patient populations. These settings may include the inpatient hospital setting, a drug or alcohol rehabilitation facility, and that could be in or outpatient, mental health centers, an office-based setting, correctional settings, and adolescent treatment centers. So according to the study by SAMHSA, which is the Substance and Mental Health Services Administration, in 2021, for persons age 12 and older, over 61 million people used illicit drugs in the past year, marijuana being the most commonly used drug, and over 9 million people misused an opioid. 46 million met the DSM-5 criteria for substance use disorder in the past year, and 94% of people with substance use disorder considered themselves not seeking treatment. 13.5% of young adults, so that's adults ages 18 to 25, had both a substance use disorder and a mental health diagnosis. One in three adults had either a substance use disorder or a mental illness, and the statistics are even higher for those with multiracial individuals. And then 7 in 10 adults with substance use disorder consider themselves in recovery or recovered. Unfortunately, there's a shortage of psychiatrists, both adult and child, available to treat these individuals. In 2017, there were 41,740 child and adolescent psychiatrists in the U.S. By 2030, there's an anticipated deficit of psychiatrists needed by over 32%. There's a proposed federal law, the Physician Shortage Reduction Act of 2023, that would increase residency training slots. Several programs are attempting to address the shortage of psychiatrists through psychiatric residency incentives, such as more hands-on experience, and through the American Psychiatric Association emphasizing alternatives, including telehealth and collaborative care with primary care physicians, to try and meet the demand for care. Interestingly, 60% of current psychiatrists are age 55 and older. 55% of U.S. counties have no psychiatrists available, excluding Alaska and Hawaii, and 77% of U.S. counties had an insufficient number of licensed psychiatrists to meet the demand for care. The demand for mental health professionals is outpacing the number of mental health providers available. One thing influencing the number of psychiatric medical residency slots is due to Medicare. Although the number of medical school graduates has increased significantly over the past two decades, Medicare-funded training opportunities for these graduates has remained frozen at 1996 levels. As a result, more than 3,300 applicants lacked residency slots in 2022. Furthermore, the caps have created imbalances that favor allocation of slots toward lower cost and higher reimbursement specialties, rather than more urgently needed primary care and behavioral health. While some hospitals are filling in the gaps by self-funding a portion of their own, this model is not sustainable over the long haul. So addiction medicine is recognized as a subspecialty of the American Board of Medical Subspecialties, who hold subspecialty board certification in addiction medicine. And you can get one of these certifications through the American Board of Preventative Medicine, a certificate of added qualification in addiction medicine conferred by the American Osteopathic Association, subspecialty board certification in addiction psychiatry from the American Board of Psychiatry and Neurology, or certification from the International Society of Addiction Medicine. There are multiple pathways available to achieve subspecialty certification in addiction medicine through the American Board of Preventative Medicine. You can complete an Accreditation Council for Graduate Medical Education, or ACGME, Accredited General Psychiatry or Addiction Psychiatry Training Program. Obtains board certification in psychiatry first, and then taking the addiction psychiatry certification exam from the ABPN. Pass the addiction psychiatry certification examination from the ABPN. Next, Kara is going to discuss various laws related to addiction. Thank you, Allison. There are several federal laws, in addition to applicable state laws, that impact substance use disorder treatment. We will review the following laws on the next several slides, and we'll begin with H.R. 6, known as the SUPPORT Act. The SUPPORT Act, also known as the Substance Use Disorder Prevention, that promotes opioid recovery and treatment for patients and communities Act of 2018. This bill was created and passed, was the most comprehensive response to the opioid epidemic. The bill is comprised of dozens of individual bills, which directs federal funding resources towards education, coverage, treatment, workforce, and law enforcement. Some of the key components of the Act are, it expands the addiction treatment workforce, and also enhanced first responder training, which trains first responders to administer drugs for opioid overdose, and expands the program to include safety training around fentanyl. Standardize the delivery of addiction medicine with expanded access to high-quality, evidence-based care, and cover addiction medicine in a way that facilitates the delivery of coordinated and comprehensive treatment. Next is the 21st Century Cures Act, which addresses critical issues in the areas of leadership and accountability for behavioral health disorders at the federal level, and stresses the importance of evidence-based programs and prevention of mental and substance use disorders, and the imperative to coordinate efforts across government. The Cures Act, as established, established the position of the Assistant Secretary for Mental Health and Substance Use, as well as the national role of the Chief Medical Officer. The Act organized the Center for Behavioral Health Statistics, which serves as the lead agency on behavioral health statistics for the federal government. The Comprehensive Addiction and Recovery Act, also known as CARA, authorizes over 181 million appropriated each year to respond to the opioid epidemic, and intends to continue to increase both prevention and availability of treatment programs. The highlights on this slide represent The highlights on this slide represent the areas that the Act addresses. Strengthen prescription drug monitoring programs to help states monitor and track prescription drug diversion, and to help at-risk individuals access services. Expanded prevention and education efforts with a focus on teens, parents, and other caretakers and aging populations. Increased recovery support for students. Created resources to identify and treat incarcerated individuals with addiction. Expanded availability for naloxone to law enforcement agencies and first responders, to help in the reversal of overdoses to save lives. And reaffirmed grant programs for residential opioid addiction treatment of pregnant and postpartum women and children. The Affordable Care Act, also known as the ACA, was aimed at reforming the healthcare system, making insurance more affordable. In particular, people living with mental health and substance use disorders often had difficulty obtaining insurance. The Act added special protections to avoid these limitations. The travel law and Act order, this law was aimed at creating reforms within the government so that the justice, safety, education, youth, and alcohol, substance abuse prevention, and treatment issues relevant to Indigenous people remain the subject of consistent focus and requires an interagency collaboration. The Mental Health Parity and Addiction Equity Act of 2008 requires insurance groups offering coverage for mental health or substance use disorders to make these benefits comparable to general medical coverage. The Americans with Disabilities Act of 1990 and was amended in 2008 establishes requirements for equal opportunities in employment, state and local government services, public accommodations, commercial facilities, transportation, and telecommunications for citizens with disabilities. And it's important to note this includes people with mental illnesses and addictions. Sober Truth on Prevention, also known as STOP, Underage Drinking Act of 2006, created a national adult-oriented public service media campaign. In addition, a grant program providing additional current funds to current or former grantees under the Drug-Free Communities Act of 1997 to prevent and reduce alcohol use amongst youth ages 12 to 20. The act also established a committee to prevent underage drinking involving several leadership from SAMHSA, which also requires annual reporting to Congress. The Children's Health Act of 2000 reauthorized SAMHSA programs that work to improve mental health and substance abuse services for children and adolescents. In addition, it provides a waiver from the Narcotic Addict Treatment Act, which allows physicians to dispense and prescribe Schedule III, IV, and V narcotics approved by the FDA to treat heroin addiction, as well as provides a comprehensive strategy to combat methamphetamine use. So we've just covered so many of the laws and protections surrounding substance use and addiction. Now we are going to shift gears a little bit and talk about confidentiality protections within the treatment of substance abuse and addiction. So in addition to the confidentiality protections afforded under HIPAA, there are several protections for substance abuse treatment under the federal regulation, commonly referred to as Part 2. Part 2 was enacted in the 1970s after Congress recognized that there was a stigma associated with substance abuse and fear of prosecution deterred people from entering treatment. Part 2 protects patients' privacy and encourages their entry into treatment. Federal and state laws and regulations mandate strict confidentiality for information about patients being treated for substance use disorders. These requirements go well beyond what HIPAA protects, and there are some discussions that the collaboration is to try to merge Part 2 regulations with HIPAA to make them more compatible so that there is some consistency. But for now, Part 2 applies to, and we'll spell this out a little bit, any individual or entity that is federally assisted and holds itself out as providing and provides alcohol or drug abuse diagnosis, treatment, or referral for treatment. So for example, an identified unit in a general medical facility that holds itself out as providing substance use disorder diagnosis, treatment, or referral. Medical personnel in a general medical facility whose primary function is providing substance use disorder diagnosis, treatment, or referral, and who are identified as such providers. Most drug and alcohol treatment programs are federally assisted. For-profit programs and private practitioners that do not receive federal assistance of any kind would not be subject to the requirements of Title 42 of the Code of Federal Regulations, so Part 2, unless state licensing or a certification agency requires you to comply. So remember, any clinician who uses a controlled substance for detoxification or maintenance treatment of a substance use disorder requires a federal DEA registration and becomes subject to the Part 2 regulations through their DEA license. So even if you are an individual provider providing substance use disorder treatment through a medical assistance treatment program, you would need to comply with the Part 2 regs. Not every primary care provider who prescribes controlled substances meets the definition of a program or a part of a program under Part 2. So for providers to be considered programs covered by the Part 2 regulations, they must be both federally assisted and meet the definition of a program under the federal code. Again, physicians who prescribe controlled substances to treat substance use disorder under the DEA license do meet the test for federal assistance and are subject to the Part 2 confidentiality requirements. It is important to be aware of federal and state regulations to ensure you are in compliance. The SAMHSA website has tremendous resources and information on all of these regulations we have discussed. I do encourage you to reference their website for additional information. So under Part 2, consent is needed for communication with any third party, including pharmacies and other providers. The HIPAA treatment payment exceptions do not apply to substance use disorder treatment, so you do need consent to communicate with other providers. It is recommended that each new patient sign consents to communicate with the pharmacy, especially when they're receiving medication-assisted treatment. Pharmacies may also not redisclose patient information, so keep that in mind. They cannot keep sharing information with others if you've received consent from the pharmacy. The only time that you would not need consent to communicate would be when a patient hand delivers a buprenorphine prescription without telephone confirmation or other direct communication from a physician to the pharmacist, and the pharmacist has questions. The pharmacist can call the prescriber to ask questions, and the prescriber can talk to the pharmacist without consent. Whenever you have the patient sign consent to be able to communicate, there needs to be a statement regarding the prohibition against redisclosure. So Part 2 mandates that nothing can be redisclosed. So if you receive substance abuse treatment records and are subsequently asked to provide these records, you may not send those substance abuse treatment records that you received as part of the records request without patient consent. Again, there is an easy-to-follow, epic view on consent under Part 2 on the SAMHSA website for further clarification. So often we're asked, what is Part 2's relationship to state laws? You are obligated to follow Part 2 regulations, however, state law can provide additional and more stringent regulations, and state law may not require any disclosure that is prohibited by Part 2. So permitted disclosures. So there are certain permitted disclosures under Part 2, and they are permitted under the following circumstances. The patient has given written consent or disclosure to medical personnel is in response to a medical or psychiatric emergency. Remember, information disclosed to the medical personnel who are treating a medical or psychiatric emergency may be redisclosed by such personnel for treatment purposes as needed. If there's a court order authorizing disclosure. Disclosure to protect or warn third parties of potential harm by the patient. You can disclose as part of your duty to warn obligation if there is an immediate threat to health or safety of an individual. And you can disclose if there has been an immediate threat to the health or safety of person involved in the Part 2 program. Notifications for law enforcement. You can disclose to law enforcement if an immediate threat to the health or safety of an individual exists. You can disclose to report a crime or an attempted crime committed at the treatment program or against program staff under the federal code. And Part 2 permits a program to disclose information regarding the circumstances of such incident, including the suspect's name, address, last known whereabouts, and the status as a patient in the program. If there's any suspected child abuse or neglect or elder abuse or neglect, you can report this. You can breach to report the abuse of elderly individuals only if your state permits this reporting. And keep in mind when reporting suspected child or elder abuse or neglect, you cannot release the medical record without a court order. The original alcohol and drug abuse records maintained by the program are confidential and cannot be part of the reporting to state or local authorities, including the use for civil or criminal proceedings that may arise out of the reporting. On-call coverage. So information can be disclosed to psychiatrists who may be on call for the primary care provider as long as they are listed on the consent form. So if you have substance use providers who provide on-call coverage for you, then they must be included on the initial consent form. When information is being disclosed, you must keep an accounting of the disclosures in the medical record, including who received the information, who disclosed the information, the date and time of the disclosure, and the nature of the emergency and why the information was disclosed. Again, this is very technical and detailed information, so we do recommend under some of these circumstances where law enforcement may be involved or the courts that if you do have questions to contact your malpractice insurer, risk management professional, or attorney for advice prior to disclosing. Permitted redisclosure. Again, under the Federal Register Part 2, there are limited circumstances where information can be redisclosed. So once Part 2 information has been initially disclosed with or without patient consent, no redisclosure is permitted without the patient's express consent to redisclose unless it's otherwise permitted under Part 2. Disclosures made with patient consent must be accompanied by a statement notifying the recipient that Part 2 redisclosure is prohibited unless a written consent is obtained and the patient expressly authorizes the release. Redisclosures are allowed without patient consent in limited circumstances, such as medical emergencies, child abuse reporting, crimes on program premises, or against program personnel, and court-ordered disclosures when procedures and criteria are met. Limited redisclosures are permitted without patient consent for research, audits, and evaluations under the Qualified Service Organization Agreements and authorizing court orders. When information is disclosed pursuant to a court order, Part 2 does require that steps are taken to protect patient confidentiality. So in a civil case, Part 2 requirements of the court order authorizing a disclosure include limits to disclosure for patient's protection. This may include stealing the record from the public. In a criminal case, the court order must limit disclosure to law enforcement and prosecutorial professionals who are responsible for or conducting the investigation or prosecution and must limit their use of the record to cases involving extremely serious crimes or suspected crimes. Again, all of this can seem very complicated, and I do encourage you to go to the American Society of Addiction Medicine webpage for more information specific about disclosure consent and redisclosure requirements under Part 2. And now Allison will discuss treatment principles. Thanks, Kara. So let's talk about some general treatment principles regarding substance use treatment at a high level. So generally the care of individuals with substance use disorders include conducting a complete assessment, treating intoxication and withdrawal symptoms as necessary, addressing co-occurring psychiatric and general medical conditions, referring for specialty treatment when appropriate, and developing and implementing an overall treatment plan and updating the treatment plan as the patient moves through their treatment program. With respect to patient assessment, this is a list of information as you can see on the slide that should be acquired and documented during the assessment. States may require additional information to be included when assessing and treating patients with addiction issues. Include a detailed history of the patient's past and present substance use. Access the prescription drug monitoring program to detect unreported use of other medications or medications that may interact adversely with the addiction treatment medications. A comprehensive medical or psychiatric history and evaluation is essential to the guide treatment of the patient with a substance use disorder. Include the level of risk for morbidity and mortality associated with substance use. The first clinical priority should be given to identifying and making appropriate referrals for an urgent, emergent medical or psychiatric problems including overdose or withdrawal management. It may be necessary to provide treatment intervention to provide safety to the patient in a medically monitored environment. Also keep in mind that psychiatrists are often the only medical contacts for patients with co-occurring psychiatric and substance use disorders. And remember to include a history of psychiatric treatments and outcomes including family and social history. So testing. So we want to conduct appropriate laboratory tests to help confirm the presence or absence of conditions that frequently co-occur with substance use disorders. That includes screening of blood, breath, or urine for substances used. And with written authorization from the patient, consider contacting the patient's spouse or significant other or family members for additional information. So let's talk a little bit more about treatment plan. So the goals of treatment and the specific therapies chosen to achieve these goals may vary among patients and even for the same patient at different phases of their illness. That's why it's important to update the treatment plan and progress as the intensity and specific components of treatment may vary over time. So let's look at the requirements for the required elements of a treatment plan in your state. Generally, the treatment plan will include psychiatric management, the strategy for achieving abstinence or reducing the effects of or use of substances of abuse, efforts to enhance ongoing adherence with the treatment program, prevent relapse, and improve functioning, and additional treatments necessary for patients with a co-occurring psychiatric illness or general medical condition. And certainly, I wouldn't be a good risk manager if I didn't say all this needs to be documented appropriately in the patient's medical record. Continually assess safety and changes in the patient's status throughout treatment as circumstances and risk factors may change. Just as important as conducting the assessment is thoroughly documenting the assessment each time it's conducted. Immediate intervention may be necessary to provide safety to the patient in terms of withdrawal, altered mental status, suicidal ideation, or homicidal or ideation of violence towards others. Document risky and dangerous behaviors such as driving under the influence, domestic violence, child abuse and neglect issues, and risk of accidental overdose. Document any concerns related to the treatment including the patient's adherence to or non-compliance with the program. If the patient requires a higher level of care or alternative type of treatment, document the recommendations and referrals to the patient. And make sure you document your assessment and interventions at each patient encounter. So according to several studies, the frequency of suicide attempts and death by suicide is substantially higher among patients with a substance use disorder than in the general population. With respect to the risk of suicide, assess and document information such as the onsite of the substance disorder, the severity of substance dependence, are multiple substances being used, is the individual separated or divorced, does the patient have a co-occurring psychiatric disorder? Significant high rates of substance use disorders are seen among individuals who have attempted suicide. So if you have someone coming to you following a suicide attempt, include a substance use assessment as part of your documentation. As in the care of any patient with a psychiatric disorder, suicide risk should be assessed and regularly in a systematic manner. Assessment of suicide risk includes determining the presence or absence of current suicidal thoughts, intent, and plan, a history of suicide attempts, a family history of suicide, a history of aggression, for example, use of weapons, a history of impulsive behavior, the current treatment regimen and response, the intensity of current depressive and other mood symptoms, real life stressors, like if they were recently separated or lost a job, substance use patterns, presence of psychotic symptoms, and current living situation and do they have social supports. In current substance-using individuals, suicidal ideation and suicide attempts may occur in the context of a major depressive episode or result from substance-induced sadness or dysphoria combined with increased impulsivity and poor judgment. So remember, it's important to document and assess for the potential for aggressive behaviors in individuals with a substance use disorder and to assess for substance use disorders in all individuals who present with a history of agitation or aggression. Substance use disorders are associated with an increased risk for, again, aggressive behaviors towards others, including physical assault, sexual aggression, domestic violence, child abuse, and homicide. Substance intoxication and withdrawal may be associated with anxiety, irritability, agitation, impaired impulse control, disinhibition, decreased pain sensitivity, and impaired reality testing. Intoxication or withdrawal can lead to aggressive behavior. Intoxication with substances such as alcohol, cocaine, methamphetamine, PCP, anabolic steroids, and hallucinogens may be associated with high aggression due to high levels of anxiety, paranoia, and faulty perceptions of reality. Withdrawal from substances such as alcohol, opioids, sedative, hypnotics, and cannabis may also lead to aggressive behaviors. So patients may also act aggressively in an effort to obtain illicit or expensive substances or when a provider refuses to write a prescription for them. So some patients with high-risk medical or psychosocial conditions require additional risk management considerations and documentations. So here's a slide that identifies some of those. Listed here, you see some of the high-risk populations that may require additional specialty care or consultation for treatment of their addiction. Psychiatrists should consider whether a specialized treatment program or referral to an addiction specialist is indicated before treating these patients in an office setting. This can get tricky because patients being treated for addiction may only be seeing a psychiatrist with no other physician. So let's look at a little scenario here. So we have Jane. She's a 30-year-old female who is being seen for opioid use disorder and major depression. You have been seeing her for six months and prescribed buprenorphine and an antidepressant. And she has limited social supports. And then you find out at one of her visits that she has expressed her excitement in becoming pregnant. So when using methadone and buprenorphine to treat pregnant women, it's important to utilize evidence-based treatment and monitoring protocols. For example, pregnant patients prescribed methadone may require an increased or split dose in the third trimester due to changes in how methadone is metabolized or eliminated from the patient's system. On the other hand, patients who become pregnant during treatment are usually maintained at their pre-pregnancy dosage and are maintained with the same dosing principles as non-pregnant patients. Pregnant women are encouraged to consider ongoing maintenance treatment after delivery. It's important to make sure there is an adequate handoff and transition of the patient when she is discharged after delivery. There should be documentation of the transition plan and the specific health care provider that is accepting care of the patient, including the name, address, and phone number of that provider. Buprenorphine has not been well studied in adolescence, so patients under 18 with a short addiction history are at high risk for complications such as overdose, HIV, suicide, and infectious diseases. Treatment of patients younger than 18 years of age can be complicated due to psychosocial considerations, the involvement of family members, parents, and guardians, and state minor consent and reporting laws. There may be associated ethical considerations regarding the appropriate level of parent-guardian involvement even when the patient consents. State laws vary whether an adolescent may continue to consent to substance use disorder treatment without parental consent. More than half of the states permit individuals younger than 18 to consent without parental consent. However, if the state requires parental notification, then the adolescent has to be willing to have the program communicate with the parent or guardian in order to obtain that consent. The psychiatrist must be aware of state mandatory child abuse reporting requirements as a history of neglect or abuse may be revealed during the care of adolescent patients. Mandatory child abuse reporting takes precedence over the federal addiction treatment confidentiality regulations that Cara mentioned earlier under Part 2. Ethical conflicts may arise when an adolescent requests treatment but refuses to permit notification of a parent or guardian. Federal confidentiality regulations prohibit physicians or their designees from communicating substance abuse treatment information to any third parties including parents without patient consent. There is one exception that allows the program director or also known as the treated physician to communicate to the parent or guardian when there is a substantial threat to the life or physical well-being of the patient or someone else. When there is a concern involving the minor's health or well-being, call mobile crisis or have the patient go immediately to the emergency department by ambulance. For questions regarding what to be disclosed to a parent or guardian, consult your risk management professional or healthcare practice attorney. So, I'm going to turn it back over to Cara and she's going to start off by talking about naloxone. So, you all know what naloxone is, an FDA approved medication which is used to rapidly reverse the opioid overdose. So, it is an opioid antagonist that binds to opioid receptors and can reverse and block the effects of heroin, morphine, and oxycodone. It is a temporary treatment. All 50 states and the District of Columbia have some form of a naloxone access law. However, the laws do vary by state. The Legislative Analysis and Public Policy Association website does have a great resource which does list the state laws at legislativeanalysis.org. In addition, there are good Samaritan laws in place. However, they also vary. There are 48 jurisdictions, 47 states, and the District of Columbia have enacted good Samaritan laws when you are looking at the naloxone access laws. So, the medication can be given in several ways, intranasal spray, intramuscular, subcutaneous, or intravenous injection. And so, lastly, SAMHSA continues to be the best site and resource to find up-to-date information on the appropriate use and, again, the laws regarding the use and treatment. So, informed consent regarding medication-assisted treatment. An informed consent policy is highly recommended. It is a must in terms of risk management strategy and really best practice in patient care. So, consider the following elements in your policy. Consider having permission to contact references, permission to contact prior physicians and pharmacies, and screening information as part of your informed consent process. Advise and educate your patients on the prescription drug monitoring program and how you will be utilizing that program to access it to see what their use has been, past use for, you know, obtaining medication. You know, in terms of consents for pregnancy, Allison did talk in great detail on the prior slide. So, for buprenorphine, you know, and having those discussions with pregnant patients who may be entering into a medication-assisted treatment program, it's important to offer information and refer them to prescribing providers who may be treating a pregnant person with opioid use disorder. And, lastly, be mindful on how you document. We do recommend avoiding using agreement or contract in your documentation. Rather, explain the treatment process through the informed consent process. We like to always say that informed consent is a discussion, not a form. It's a discussion of the risks and benefits of the treatment, and the form is really the patient's acknowledgement that they have an understanding of what we've discussed. So, the American Society of Addiction Medicine website has a great, you know, sample of consent forms if you're looking for one. Allison mentioned documentation is one of our risk management principles, and so we've covered a lot of topics today in great detail, and key risk management strategies, you know, involve documentation. So, again, it's important to document the following in patient's records. Consents for treatment. Document any telephone calls that involve treatment. So, if treatment is discussed during a phone call, make sure that there's a note captured in the medical record. Obviously, prescriptions, make sure you're including, you know, what the dosing amounts are, you know, and any instructions given. Communications by email. So, if there's anything involving, again, treatment discussions, include that in the medical record, and that is why we recommend to limit communications through texting and email to really the scheduling of, canceling of appointments, and avoid having a lot of patient care details in there. One, from a privacy standpoint, but then two, because you have to make sure that it ends up in the medical record. Allison went over in great detail what an assessment should look like. That should be in the record. Your psychiatric evaluation on comorbidity. That detailed treatment plan. Any referrals or consultations. Again, include that information in the record. Conversations with the patient, family, or third parties. Any instructions or, you know, details, and then your, you know, prescription monitoring, the PDMP reports, and obviously, your progress session notes from a documentation standpoint. So, your office policies and procedures are very important, especially when you're treating substance use disorder. So, it's important to incorporate the following into a policy and procedure. Patient confidentiality. It goes without saying, privacy and confidentiality is paramount. So, be sure to have a well-established procedure, and discuss these up front with the patient and your staff as well. If you have any planned absences, you know, from your office, and even from an unplanned standpoint, what is your coverage plan? Be sure to provide this detail so that patients understand and are prepared for any absence you may have. Have a well-established community referral resource library available to patients, as well as a referral network for specialists and opioid treatment programs. And be sure to be compliant with the PDMP and monitor for any potential flags identified within that system. Establishing your appropriate, you know, protocols for medication, and what are those parameters, whether it's routine follow-up, monitoring, testing, make sure that you have that written into policy. And then workplace safety plan in place, as well as policy and staff education. So, what is that workplace safety plan? Really, again, addressing any violent behaviors. Workplace violence can happen, especially in this environment of treating addiction and substance use. So, make sure you have an appropriate safety plan for your staff as well in your office. So, you know, what are some behaviors, red flag behaviors you should be looking at? And again, establishing, you know, how to handle that. So, it's important as part of, you know, improved outcomes of medication-assisted treatment in, you know, office-based settings, that you must be clear as providers what your treatment philosophy is, your expectation, and really your office rules. And that's why that informed consent, those office policies and procedures are really important to address upfront at the start of treatment with all patients. So, it's important that, you know, managing medication, you know, accurately during all stages of treatment is important. And you should be informing your patients of your clinic policies, procedures, and protocols, what are your hours of operation, important phone numbers, both during office hours and after hours, procedures for making appointments, what are fees, proper medication administration and storage, side effects and precautions, rights and responsibilities, and any other practice-specific protocols or guidelines. So, again, listed in the slide are really some of these behaviors that really should be addressed as soon as they appear. Don't wait for them to become a pattern. Again, make sure you're addressing. So, missed appointments, testing refusals, so whether it's your urine testing or fertilizers, running out of medications too soon, taking medications off schedule, are they having inappropriate outbursts of anger, reporting of lost or stolen medications, you know, are they having physical injuries or, you know, getting into car accidents more often, do they appear to be intoxicated or disheveled or sounding intoxicated over the phone. Again, these are some and not limited, you know, these are red flags that you do need to address and, again, document appropriately. So, we talked about that prescription drug monitoring program. This is an electronic database that's tracking controlled substances prescriptions and it really can help you identify who may be at risk for an overdose. So, the PDMP data can be helpful, you know, when patient medication history is unavailable and when there's care transition. So, somebody may be moving, changing providers by, you know, logging into that system, you may be able to see what their history is. Each state does have a PDMP, it's important to check it so that you can improve opioid prescribing practices, you know, and ultimately it helps you, the provider, to be informed and improve patient care and safety. Ideally, the PDMP should be checked when initiating opioid therapy for acute, subacute, or chronic pain and then every three months or more frequently if necessitated when continuing opioid therapy. So, ideally, it should be reviewed before every opioid prescription. DEA inspections. So, DEA inspections of data waived physicians. So, the Drug Enforcement Administration is responsible for ensuring that physicians who are registered with the DEA pursuant to the Drug Addiction Treatment Act comply with recordkeeping, security, and other requirements for administering, dispensing, or prescribing controlled substances under the Controlled Substance Act. So, as a result, they do have a right to conduct on-site unannounced inspections under the authority of the CSA. So, all physicians who do administer, dispense, or prescribe Schedule 3 substances are subject to these routine random inspections. So, essentially, you know, the DEA will inspect a data-waivered physician every 15 years from when they are approved to prescribe buprenorphine with the first inspection usually taking place within the first three years after they are initially waivered. If a physician applies for a higher patient limit, then that 15-year inspection period renews from the date that higher limit is approved and then will likely be inspected within the first three years after that patient increase. So, key considerations for this refer to the American Society for Addiction Medicine and DEA office inspection tips on how to prepare for a DEA office inspections. But essentially, the highlights are storing and dispensing. For those physicians who are dispensing medication directly from your office, you know, the federal code does stipulate that it must, your medications must be stored in a securely locked and substantially constructed cabinet. So, make sure they are in a solid cabinet, you know, and probably in a locked and secure room. You need to maintain records for every patient and treatment with documentation consistent with the recommendations of the DEA and the Federation of the State Medical Boards. DEA inspectors are going to, you know, come and they are going to identify themselves with a badge. They will likely come with two individuals. So, again, they should show you their rights before proceeding with an audit and take your time to review what your rights are. They are going to be looking for prescription, patient prescription logs, dispensing logs. If you are dispensing, they are going to be looking for where you are securing your medications. They are going to look for a list of the patients receiving those medications, and then the physicians access to behavioral health professionals. So, again, it is important for you to know what your requirements are, what are you required to do under that DEA license. Make sure staff is aware in the event these inspections occur, and be professional, be cooperative, and know your rights. So, we are coming to the conclusion of this extensive presentation today, and as, you know, we conclude, our general risk management strategies for the magnitude of information we have discussed are really observe your federal and state regulations regarding controlled substances, confidentiality, and the DEA X waiver, obtain informed consent, understand and implement prescription drug monitoring program requirements, always document all aspects of prescribing, and consult with an attorney, risk management professional when necessary. Here are the resources we have discussed today. Again, the highlights are the American Society for Addiction Medicine, SAMHSA, the American Psychiatric Association, and for any questions, please, or insurance needs, please contact the EPA Endorsed Professional Liability Program, American Professional Agency, Inc. at 1-800-421-6694, email psychiatry at Americanprofessional.com, or visit their website at www.americanprofessional.com, and Allison and I thank you for your participation today. Also, if you are insured with the EPA Endorsed Program participating in this presentation, you will receive one risk management credit towards the three credits needed for a risk management discount on your renewal premium. Thank you.

addiction psychiatry

opioid crisis

residency training programs

confidentiality protections

informed consent

documentation

naloxone

DEA inspections

prescription drug monitoring programs