Approved Procedures for Prescribing and Monitoring Controlled Substances in South Carolina

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1 Approved Procedures for Prescribing and Monitoring Controlled Substances in South Carolina Robert B. Hanlin, M.D., FAAFP Vice Chair, Medical Staff Affairs Greenville Health System Greenville, SC

2 Disclosures I have no conflicts of interest to disclose.

3 Learning Objectives 1. Participants will be able to discuss the magnitude of controlled substances abuse, misuse, and diversion. 2. Participants will develop a strategy for safely prescribing and monitoring controlled substances in their practices.

4 Outline Definitions Is there a problem? Patient Stories. Consequences Patient Society Physician

5 Outline (Continued) Responses State Prescription Drug Monitoring Program Joint Revised Pain Management Guidelines Enhanced Enforcement Physicians and other providers Action Plan References Resources

6 Meeting the New South Carolina CME Requirement You MUST have attended the morning session on Prescription Monitoring in South Carolina. If you did not attend this session, please raise your hand now. You MUST attest to at least: 45 minutes in the morning session 75 minutes in this workshop

7 Meeting the New South Carolina CME Requirement IF you meet the above requirements, we will send you a separate CME certificate for Approved Procedures for Prescribing and Monitoring Controlled Substances in South Carolina. We anticipate that your CME certificates will be sent to you by May 15. If you have not received the certificate by May 20 th, contact the CME Office.

8 Meeting the New South Carolina CME Requirement When you renew your license, you will be asked to certify that you have completed the required 2 hours of CME. You will NOT have to send the certificate. You MUST keep a copy of the certificate. You MAY be required to produce a copy of the certificate if your CME is audited by the Board of Medical Examiners.

9 Definitions Controlled Substances Opioids Non-Opioids Benzodiazepines Muscle Relaxants Stimulants Most of our talk will deal with Opioids, but the principles apply to all controlled drugs.

10 Definitions Diversion Misuse Abuse Addiction Pseudo-Addiction Tolerance Dependence

11 Definitions Diversion Misuse Abuse Addiction Pseudo-Addiction Tolerance Dependence

12 Definitions Diversion Misuse Abuse Addiction Pseudo-Addiction Tolerance Dependence

13 Definitions Diversion Misuse Abuse Addiction Pseudo-Addiction Tolerance Dependence

14 Definitions Diversion Misuse Abuse Addiction Pseudo-Addiction Tolerance Dependence

15 Definitions Diversion Misuse Abuse Addiction Pseudo-Addiction Tolerance Dependence

16 Definitions Diversion Misuse Abuse Addiction Pseudo-Addiction Tolerance Dependence

17 Definitions Diversion Misuse Abuse Addiction Pseudo-Addiction Tolerance Dependence

18 Is there a problem? The next few slides are from the CDC

19 Prescription Drug Abuse and Overdose: Public Health Perspective [Residency educators may use the following slides for their own teaching purposes.] CDC s Primary Care and Public Health Initiative October 24, 2012

20 Number of Prescriptions (in millions) Opioid Prescriptions Dispensed by Retail Pharmacies United States, Year IMS Vector One. From Prescription Drug Abuse: It s Not what the doctor ordered. Nora Volkow National Prescription Drug Abuse Summit, April Available at

21 Number of ED Visits Emergency Department Visits Related to Drug Misuse or Abuse United States, ,600,000 Illicit Drugs Pharmaceuticals Opioid Pain Relievers Benzodiazepines 1,400,000 1,200,000 1,000, , , , , Year SAMHSA. Highlights of the 2010 Drug Abuse Warning Network (DAWN) Findings on Drug-Related ED Visits, 2011.

22 Admissions per 10,000 Population Primary Substance of Abuse at Treatment Admission United States, Alcohol only Heroin Cocaine Stimulants Alcohol w/secondary drug Other opiates Marijuana/hashish Other drugs Year SAMHSA Treatment Episode Data Set,

23 Deaths per 100,000 population Motor Vehicle Traffic, Poisoning, and Drug Poisoning (Overdose) Death Rates United States, Motor Vehicle Traffic Poisoning Drug Poisoning (Overdose) Year NCHS Data Brief, December, Updated with 2009 and 2010 mortality data.

24 Number of Drug Overdose Deaths Involving Opioid Pain Relievers and Other Drugs United States, Any opioid analgesic Specified drug(s) other than opioid analgesic Only non-specified drug(s) CDC, National Center for Health Statistics, National Vital Statistics System. 24

25 Number of Deaths Drug Overdose Deaths by Major Drug Type, United States, ,000 Opioids Heroin Cocaine Benzodiazepines 16,000 14,000 12,000 10,000 8,000 6,000 4,000 2, Year CDC, National Center for Health Statistics, National Vital Statistics System, CDC Wonder. Updated with 2010 mortality data.

26 Public Health Impact of Opioid Use For every 1 overdose death in 2010, there were Past Year Nonmedical Users 733 People with abuse/dependence 108 ED visits for misuse or abuse 26 Abuse treatment admissions 10 Treatment admissions are for primary use of opioids from Treatment Exposure Data set. Emergency department visits are from DAWN (Drug Abuse Warning Network), Abuse/dependence and nonmedical use in the past month are from the National Survey on Drug Use and Health.

27 Economic Costs $72.5 billion in health care costs 1 Opioid abusers generate, on average, annual direct health care costs 8.7 times higher than nonabusers 2 1. Coalition Against Insurance Fraud. Prescription for peril: how insurance fraud finances theft and abuse of addictive prescription drugs. Washington, DC: Coalition Against Insurance Fraud; White AG, Birnbaum, HG, Mareva MN, et al. Direct costs of opioid abuse in an insured population in the United States. J Manag Care Pharm 2005;11(6):

28 Opioid Sales and Deaths

29 Opioid Sales and Deaths Note the statistic on the previous slide: Approximately 7 kg / 10,000 population per year = 7,000 gm / 10,000 population per year = 0.7 gm / person per year = 700 mg / person per year = 2 mg EVERY DAY FOR EVERY PERSON IN THE UNITED STATES!

30 Non-Medical Users

31 Opioid Risks Every day in the United States, 44 people die as a result of prescription opioid overdose. 1 Among those who died from prescription opioid overdose between 1999 and 2013: Most were ages 25 to 54. This age group had the highest overdose rates compared to other age groups. However, the overdose rate for adults aged increased more than seven-fold during this same time period. The large majority were non-hispanic whites. The age-adjusted rate of prescription painkiller overdose deaths among non-hispanic white persons increased 4.3 times, from 1.6 per 100,000 in 1999 to 6.8 per 100,000 in Centers for Disease Control and Prevention. National Vital Statistics System mortality data. (2015) Available from URL:

32 Opioid Risks Men were more likely to die from prescription opioid overdose, but the mortality gap between men and women is closing. Deaths from prescription painkiller overdoses among women increased more than 400% during , compared to 237% among men Centers for Disease Control and Prevention. Vital Signs: Overdoses of Prescription Opioid Pain Relievers and Other Drugs Among Women United States, MMWR 2013; 62(26);

33 Opioid Risks Drug overdose was the leading cause of injury death in Among people 25 to 64 years old, drug overdose caused more deaths than motor vehicle traffic crashes Centers for Disease Control and Prevention. Web-based Injury Statistics Query and Reporting System (WISQARS) [online]. (2014) Available from URL:

34 Opioid Risks There were 43,982 drug overdose deaths in the United States in Of these, 22,767 (51.8%) were related to prescription drugs. 1 Of the 22,767 deaths relating to prescription drug overdose in 2013, 16,235 (71.3%) involved opioid painkillers, and 6,973 (30.6%) involved benzodiazepines. 1 People who died of drug overdoses often had a combination of benzodiazepines and opioid painkillers in their bodies Centers for Disease Control and Prevention. National Vital Statistics System mortality data. (2015) Available from URL:

35 Patient Stories HM&feature=player_embedded CYU&feature=player_embedded s&feature=player_embedded ps&feature=player_embedded

36 Opioid Prescriptions by State

37 Opioid Prescriptions by State

38 Opioid Prescriptions Increasing prescriptions for opioids, but NO increase in reported pain by patients. Highly variable amounts of opioids prescribed by state. Conclusion: There is a wide variability in the amount of Opioid prescribing by individual physicians. This variability probably reflects opportunities to improve medical practice.

39 Is there a problem? Houston, we have a problem.

40 Responses: State Prescription Drug Monitoring Programs (PDMP) Many states have implemented these programs. Some states have mandated their use. Data shows that THESE PROGRAMS WORK (see following slides).

41 Prescription Drug Monitoring Programs

42 Prescription Drug Monitoring Programs

43 Prescription Drug Monitoring Programs Response by the Board of Medical Examiners of South Carolina - Prescription Drug Monitoring Program SCRIPTS (South Carolina Reporting & Identification Prescription Tracking System) Use is not required by law in South Carolina Use is strongly encouraged in South Carolina Use is now considered the standard of care in South Carolina.

44 Physician Response Complain about government? Stop prescribing controlled substances? Not my job?

45 Not My Job Awards

46 Not My Job Awards

47 Physician Response Let s figure it out, for the benefit of our patients. For most of us, we will have to significantly alter the way we prescribe controlled substances. The old ways have too much risk Patients. Society Physicians

48 Physician Response I will review basic steps of the safe use of Controlled Substances. Safe use of Controlled Substances in your practice will require you to develop specific policies, procedures, and forms. References are included at the end.

49 Physician Response If you practice in South Carolina, the specifics of acceptable practice in the management of chronic pain are delineated in: JOINT REVISED PAIN MANAGEMENT GUIDELINES APPROVED BY THE SOUTH CAROLINA BOARDS OF MEDICAL EXAMINERS, DENTISTRY AND NURSING November 2014 This document is included as a separate reference. We will discuss it in more detail at the end of the session.

50 Safe Use of Controlled Substances The most important concept in the safe use of Controlled Substances is the evaluation of the risks and benefits of the planned therapy. With Controlled Substances, the risks to the patient are great enough that you should evaluate the patient as if you planned to do surgery.

51 Safety requires proper training

52 Lack of training can be hazardous to the physician, too.

53 Safe Use of Controlled Substances One of the most important tools to mitigate the risks of controlled substances is the use of a Prescription Drug Monitoring Program (PDMP). In South Carolina, the PDMP is called SCRIPTS. In the South Carolina Joint Revised Pain Management Guidelines, SCRIPTS is referenced 22 times. In South Carolina, you can no longer meet the standard of care without using SCRIPTS before and during the process of prescribing Controlled Substances.

54 Physicians are not immune.

55 Safe Use of Controlled Substances Evaluation should include: Establishing a doctor-patient relationship. The Federal Controlled Substances Act defines a lawful prescription as one that is issued for a legitimate medical purpose by a practitioner acting in the usual course of professional practice.

56 Safe Use of Controlled Substances Evaluation should include: Performing a thorough relevant history and physical. Documenting your findings. Formally evaluating the risk of using Controlled Substances (references are included at the end). Discussing risks and benefits with the patient, and document the discussion. Having the patient sign an informed consent document.

57 Pain Pain is an important medical complaint. Pain may be due to a serious medical diagnosis. Pain warrants a thorough evaluation. Always consider additional evaluation for pain. Imaging Specialist referral

58 Sometimes the cause of pain is more obvious

59 Pain Unacceptable physician responses to pain: I don t see pain patients Throw opioids at all pain. The inappropriate treatment of pain includes nontreatment, under treatment, overtreatment and the continued use of ineffective treatments. (6)

60 Safe Use of Controlled Substances Always consider alternatives or adjuvants to Controlled Drugs, such as: NSAIDS Topical therapies (lidocaine, NSAIDS) Physical Therapy Cognitive-Behavioral Therapy Massage Acupuncture Manipulation (Osteopathic, Physical Therapy, Chiropractic)

61 Safe Use of Controlled Substances If the patient will not consider alternatives, this may be a red flag to the physician that the patient is only after controlled drugs and not comprehensive medical care. If the physician has not documented consideration of alternatives, this may be a red flag to regulatory agencies that the physician is acting as a drug dealer instead of providing comprehensive medical care.

62 Safe Use of Controlled Substances In most cases, this comprehensive evaluation and discussion will take more than one visit. Usually, you do not want to prescribe Controlled Substances at the first visit. Exceptions might include: Acute significant injury. Patient danger from abrupt withdrawal. Emergency Department visits.

63 Some hazards are obvious

64 Safe Use of Controlled Substances Risks: Overdose Motor Vehicle Accidents Accidental trauma Masking a more serious medical diagnosis Falls Addiction Assault Arrest and Incarceration

65 Safe Use of Controlled Substances Risks: Constipation Loss of Concentration Loss of job Loss of relationships Financial problems Worsening of Sleep Apnea

66 Safe Use of Controlled Substances Potential Benefits: It is important to set treatment goals in terms of FUNCTIONAL benefits. Return to work Improved family relationships Ability to do chores Ability to do hobbies Sleep

67 Safe Use of Controlled Substances Potential Benefits: Eradication of all pain is NEVER an appropriate goal, except in end-of-life care. Death normally occurs first. A small reduction in pain is frequently an appropriate goal. It is very important for the patient to understand this.

68 Safe Use of Controlled Substances If the benefits of Controlled Substances seem to outweigh the risks: Develop a Treatment Plan, including: Goals of therapy Follow up frequency Monitoring plan

69 Safety requires the right tools

70 Treatment Agreements You should use a Treatment Agreement. Specifies appropriate and inappropriate behavior by the patient. Specifies physician duties. These are not contracts. The physician is not obligated to prescribe Controlled Substances because the patient checked all of their boxes. The physician must still use sound clinical judgment to decide if Controlled Substances are still indicated.

71 Safe Use of Controlled Substances Periodic reevaluation is essential: Review progress toward goals. Set new goals. Reevaluate risk. Decide if the risk-benefit analysis still favors controlled substances. Urine Drug Screens. Pill Counts. Query the SCRIPTS database. Discuss concerns with the patient.

72 Safe Use of Controlled Substances Periodic reevaluation is essential: The frequency and intensity of follow up visits should be proportional to the RISK in that patient. If the risk has become excessive, you should consider: Referral to a Pain Specialist. Referral to an Addiction Specialist. Withdrawing Opioids

73 High Risk Situations Some situations present especially high risk to the patient: Methadone Difficult to manage Complicated pharmacokinetics Very high risk of death compared to other opioids 80 mg Morphine Equivalent Dose (MED) for greater than three months.

74 High Risk Situations When a patient is prescribed 80 Morphine Equivalent Dose (MED) for longer than three continuous months, it is recommended that the prescriber: re-establish informed consent; review the patient s functional status, including daily activities, analgesia, aberrant behavior, and adverse effects, as it relates to progress toward treatment objectives established at the onset of opioid therapy; consult SCRIPTS to verify compliance; re-establish office visit intervals; review frequency of drug screens; and review and execute a new treatment agreement. (4)

75 Exit Strategy If you are going to prescribe long-term Controlled Substances, you should have an Exit Strategy. Determine what circumstances would cause you to stop prescribing Controlled Substances: Lack of benefit Unacceptable side effects Evidence of misuse or addiction Evidence of diversion

76 Exit Strategy DO NOT ABANDON THE PATIENT! Usually, you need to taper the medication. An exception would be evidence of drug diversion, when you think the patient was not taking the medication in the first place. In most cases, you can continue the doctorpatient relationship even if you have decided not to continue prescribing Controlled Substances.

77 Exit Strategy DO NOT ABANDON THE PATIENT! If the doctor-patient relationship is not repairable, you may need to withdraw from the patient s care. Follow acceptable practice: Written notification, including the reason for withdrawing from the patient s care. Offer to help the patient find another provider. Allow time for the patient to find another provider (30 days). Provide records. (You cannot withhold records because of an outstanding debt.) Send a copy of the dismissal letter to the Board of Medical Examiners.

78 Action Plan READ the Joint Revised Pain Management Guidelines Approved by the South Carolina Boards of Medical Examiners, Dentistry, and Nursing, November (PDF, 17 pages, see references) Sign up for SCRIPTS. Use SCRIPTS. Find a Controlled Substances Initial Evaluation Template. Find a Controlled Substances Risk Assessment Tool. Find a Controlled Substances Informed Consent Document. Find a Controlled Substances Treatment Agreement. Find a Controlled Substances Follow Up Evaluation Template.

79 Be safe out there!

80 Questions? Thank you for your attention!

81 References 1. Centers for Disease Control and Prevention. National Vital Statistics System mortality data. (2015) Available from URL: 2. Centers for Disease Control and Prevention. Vital Signs: Overdoses of Prescription Opioid Pain Relievers and Other Drugs Among Women United States, MMWR 2013; 62(26); Centers for Disease Control and Prevention. Web-based Injury Statistics Query and Reporting System (WISQARS) [online]. (2014) Available from URL:

82 References 4. Responsible Opioid Prescribing, A Clinician s Guide, second edition, Scott M. Fishman, M.D. (available from the Federation of State Medical Boards ) 5. Physicians for Responsible Opioid Prescribing ( ) 6. Joint Revised Pain Management Guidelines Approved by the South Carolina Boards of Medical Examiners, Dentistry, and Nursing, November ( sed_pain_management_guidelines.pdf )

83 Resources Tools for assessing opioid risk: ORT (Opioid Risk Tool) DIRE Score (The DIRE score: predicting outcomes of opioid prescribing for chronic pain.j Pain Sep ;7(9): Available as a smart phone app.) Current Opioid Misuse Measure (COMM, )

84 Resources Controlled Substances Agreements: A Proactive Approach to Controlled Substance Refills. Deanna R. Willis, MD, MBA, Gerald Eaton, BS, and Palmer MacKie, MD. Fam Pract Manag Nov-Dec;17(6): ( )

85 Resources Controlled Substances Informed Consent Document: es/newihstheme/display_objects/documents/sampl econsentcontrolsub.pdf

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