Adverse Drug Events, which includes Opioids. Stevi Sy PharmD, RPh Regional Medication Safety Lead Mountain-Pacific Quality Health May 16, 2018

Transcription

1 Adverse Drug Events, which includes Opioids Stevi Sy PharmD, RPh Regional Medication Safety Lead Mountain-Pacific Quality Health May 16, 2018

2 Objectives By the end of this event you will be able to: Describe the estimated rates and trends of anticoagulant, diabetic and opioid adverse drug events in Wyoming Outline tools, process and policies to address adverse drug events and prevent future adverse drug events Discuss the state of the opioid epidemic in Wyoming

3 Adverse Drug Events An overview

4 Adverse Drug Event Defined as an injury resulting from medical intervention related to a drug Events include: Medication errors Adverse drug reactions Allergic reactions Overdoses Kohn L T, Corrigan J M, Donaldson MS (Institute of Medicine). To err is human: building a safer health system. Washington, DC: National Academy Press, 2000.

5 Medication Errors and Events Gandhi TK, Seger DL, Bates DW Identifying drug safety issues: From research to practice. International Journal for Quality in Health Care 12(1):69 76.

6 Barriers to Adverse Drug Event Identification No national database on medication errors or adverse drug events Health System professional organizations do collect some data National Electronic Injury Surveillance System Cooperative Adverse Drug Event Surveillance project (NEISS CADES) No incentive or requirement to share information across facilities Healthcare processes, policies, and training do not support continuous screening for adverse drug events Diagnostic errors affect 1 in 20 US adults 1 1 Singh H, Meyer AND, Thomas EJ. The frequency of diagnostic errors in outpatient care: estimations from three large observational studies involving US adult populations. BMJ Qual Saf Published Online First: 17 April doi: /bmjqs

7 Scope of the Problem

8 ADEs Treated in Emergency Departments (EDs) 2.5% of estimated ED visits were due to ADEs 6.7% of estimated hospitalizations for unintentional injuries were due to ADEs Patients aged 65 years 10.8% of all estimated unintentional injury visits 37.0% of estimated unintentional injury visits requiring hospitalization 48.9% of estimated ADE visits requiring hospitalization Budnitz DS, Pollock DA, Weidenbach KN, Mendelsohn AB, Schroeder TJ, Annest JL. National Surveillance of Emergency Department Visits for Outpatient Adverse Drug Events. JAMA. 2006;296(15): doi: /jama

9 High Risk Medications and Adverse Events Anticoagulants Hemorrhage GI bleed Hemarthrosis Poisoning Diabetic Agents Hypoglycemia Syncope Altered mental state Diabetic ketoacidosis Opioids Asphyxia Respiratory arrest, respiratory failure Hypoxemia Opioid dependence Opioid abuse Withdrawal Somolence Poisoning

10 Adverse Drug Events % of all ADEs occurred with medications that require increased provider monitoring Antidiabetic agents Warfarin Anticonvulsants Digitalis glycosides Theophylline Lithium For patients 65 years old these medications were implicated in: 85.4% of estimated overdose visits 87.0% of estimated overdoses requiring hospitalization 54.4% of all estimated hospitalizations Budnitz DS, Pollock DA, Weidenbach KN, Mendelsohn AB, Schroeder TJ, Annest JL. National Surveillance of Emergency Department Visits for Outpatient Adverse Drug Events. JAMA. 2006;296(15): doi: /jama

11 Adverse Drug Events most common drug classes implicated in ADEs (27.7% of estimated ADEs) Insulins Opioid-containing analgesics Anticoagulants Amoxicillin-containing agents Antihistamines/cold remedies Insulins and/or warfarin were implicated in one in every seven estimated ADEs treated in EDs Insulin and/or warfarin were implicated >1/4 of all estimated ADE hospitalizations Budnitz DS, Pollock DA, Weidenbach KN, Mendelsohn AB, Schroeder TJ, Annest JL. National Surveillance of Emergency Department Visits for Outpatient Adverse Drug Events. JAMA. 2006;296(15): doi: /jama

12 Adverse Drug Events ED visits for adverse drug events occurred per 1000 individuals annually 27.3% of ED visits for adverse drug events resulted in hospitalization 34.5% of ED visits for adverse drug events occurred among adults aged 65 years or older in % in Since , proportions of ED visits for adverse drug events from anticoagulants and diabetes agents have increased Proportion from antibiotics has decreased 59.9% of ED visits for adverse drug events involved anticoagulants, diabetes agents, and opioid analgesics 46.9 % of ED visits for adverse drug events involved anticoagulants, antibiotics, and diabetes agents Hemorrhage (anticoagulants) moderate to severe allergic reactions (antibiotics) hypoglycemia with moderate to severe neurological effects (diabetes agents) Shehab N, Lovegrove MC, Geller AI, Rose KO, Weidle NJ, Budnitz DS. US Emergency Department Visits for Outpatient Adverse Drug Events, JAMA. 2016;316(20): doi: /jama

13 Adverse Drug Events Adults aged 65 years or older 9.7 visits to the ED for ADEs per 1000 individuals in per 1000 in More ED visits for adverse drug events involved females (57.1%; 95% CI, 55.6%-58.7%) Supratherapeutic effects most common type of ADE(37.2%) Medication errors were documented in 1 of 10 ED visits for adverse drug events (10.5%) 27.3% of ED visits for ADEs resulted in hospitalization Highest for age 65 years 43.6% were hospitalized When adjusted for population, this hospitalization rate was seven times higher than for those younger than 65 years of age Shehab N, Lovegrove MC, Geller AI, Rose KO, Weidle NJ, Budnitz DS. US Emergency Department Visits for Outpatient Adverse Drug Events, JAMA. 2016;316(20): doi: /jama

14 Adverse Drug Events Most commonly implicated drug classes were: Anticoagulants (17.6%) Antibiotics (16.1%) Diabetes agents (13.3%) Opioid analgesics (6.8%) Antiplatelets (6.6%) Renin-angiotensin system inhibitors (3.5%) Antineoplastic agents (3.0%) Sedative or hypnotic agents (3.0%) Shehab N, Lovegrove MC, Geller AI, Rose KO, Weidle NJ, Budnitz DS. US Emergency Department Visits for Outpatient Adverse Drug Events, JAMA. 2016;316(20): doi: /jama

15 Adverse Drug Events Hospitalization rates following ED visits for ADE Digitalis glycosides (82.1%) Antineoplastic agents (59.7%) Immune modulators (55.7%) Oral diabetes agents (53.0%) Five of the 15 most common drug products implicated in ED visits for ADE for patients 65 were insulin, metformin, glipizide, glyburide and glimepiride Anticoagulants (48.8%) Four of the 15 most common drug products implicated in ED visits for ADE for patients 65 were warfarin, rivaroxaban, dabigatran and enoxaparin Anticoagulants alone were implicated in 27.5% of ED visits for ADE among adults aged 65 to 79 years and in 38.8% of visits among those aged 80 years or older Shehab N, Lovegrove MC, Geller AI, Rose KO, Weidle NJ, Budnitz DS. US Emergency Department Visits for Outpatient Adverse Drug Events, JAMA. 2016;316(20): doi: /jama

16 Adverse Drug Events Anticoagulants Warfarin involved in 85.7% of ED visits for anticoagulant ADEs among adults 65 years Apixaban, dabigatran and rivaroxaban involved in 12.0% Documented hemorrhage in 79.4% of ED visits for ADE involving anticoagulants Shehab N, Lovegrove MC, Geller AI, Rose KO, Weidle NJ, Budnitz DS. US Emergency Department Visits for Outpatient Adverse Drug Events, JAMA. 2016;316(20): doi: /jama

17 Wyoming Adverse Drug Event Rates

18 Probable Adverse Drug Event Rate in Medicare Population July June 2017 Wyoming OBS Stays 173 Rate 9.09/1000 ED Visits 626 Rate 32.88/1000 Inpatient Hospitalizations 294 Rate 15.44/1000 Overall 1,093 Rate 57.41/1000 National OBS Stays 63,359 Rate 7.59/1000 ED Visits 188,092 Rate 22.91/1000 Inpatient Hospitalizations 131,767 Rate 16.05/1000 Overall 382,218 Rate 46.55/1000

19 Opioid Adverse Events July June 2017 OBS Stays 83 Rate 8.71/1000 ED Visits 231 Rate 24.24/1000 Inpatient Hospitalizations 134 Rate 14.06/1000 Overall 448 Rate 47.01/1000

20 Anticoagulant Adverse Events July June 2017 OBS Stays 53 Rate 8.92/1000 ED Visits 312 Rate 52.50/1000 Inpatient Hospitalizations 150 Rate 25.24/1000 Overall 515 Rate 86.67/1000

21 Diabetic Agent Adverse Events July June 2017 OBS Stays 59 Rate 5.61/1000 ED Visits 134 Rate 12.73/1000 Inpatient Hospitalizations 22 Rate 2.09/1000 Overall 215 Rate 20.43/1000

22 Addressing Adverse Drug Events Across Health Care Settings

23 Preventable and Nonpreventable Gandhi TK, Seger DL, Bates DW Identifying drug safety issues: From research to practice. International Journal for Quality in Health Care 12(1):69 76.

24 U.S. Department of Health and Human Services, Office of Disease Prevention and Health Promotion. (2014). National Action Plan for Adverse Drug Event Prevention. Washington, DC.

25 Patient Safety A Value, Not a Priority Priority Value Implies that an important activity can be shifted or rearranged according to circumstance or competing concerns Idea tied to all work/priorities in an organization Change in culture Decisive and consistent

26 Adverse Drug Event Screening and Prevention Case Study on Opioids

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28 Pain Reliever Use 87.5% of patients use pain relievers appropriately Why do adults misuse prescription drugs? Center for Behavioral Health Statistics and Quality, Substance Abuse and Mental Health Services Administration. 27 July 2017: Accessed 5/1/

29 2016 U.S. Opioid Prescribing Rates U.S. County Prescribing Rates, Centers for Disease Control and Prevention. 31 July 2017: Accessed 4/30/2018

30 Understanding the Epidemic. Centers for Disease Control and Prevention. 31 Aug 2017: Accessed 4/30/

31 Increased Opioid Overdose Risk Take high daily MME Obtain overlapping opioid prescriptions from multiple providers and/or pharmacies Have mental illness or a history of alcohol or other substance abuse Receive rotation opioid medication regimens Recent discharge from emergency medical care following opioid intoxication or poisoning Prescription Opioids. Centers for Disease Control and Prevention. 29 Aug 2017: Accessed 5/1/2018 Substance Abuse and Mental Health Services Administration. SAMHSA Opioid Overdose Prevention Toolkit. HHS Publication No. (SMA) Rockville, MD: Substance Abuse and Mental Health Services Administration, Receive overlapping opioid and benzodiazepine prescriptions Receive long-acting or extended release prescriptions for acute pain Live in rural areas or having low income Completion of mandatory opioid detoxification or abstinence programs Recent release from incarceration with a history of opioid use disorder Concurrent use of opioids with alcohol or sedating medications

32 Adverse Event Screening Active surveillance is preferred Targeted queries Health record audits Awareness Educate providers and staff on ADE rates and the effects on patient outcomes Health literacy Risk Assessment tool implementation RIOSARD SOAPP-R Many others U.S. Department of Health and Human Services, Office of Disease Prevention and Health Promotion. (2014). National Action Plan for Adverse Drug Event Prevention. Washington, DC.

33 Adverse Event Prevention Conduct Root Cause Analysis (RCA) on all discovered ADEs Emphasis should be on system-related factors Apply the knowledge gained Address organizational factors Patient Safety Culture Maximize Care Coordination programs Work with a pharmacist to manage polypharmacy and formulary restrictions U.S. Department of Health and Human Services, Office of Disease Prevention and Health Promotion. (2014). National Action Plan for Adverse Drug Event Prevention. Washington, DC.

34 Root Cause Analysis Assess Determine what is happening - Physical causes, human causes, organizational causes Diagnose Determine WHY it is happening Remedy Create a solution to reduce the chances it will happen again

35 Plan of Action Should be specific and measurable What system failure led to the event? What roles where involved in the event? What needs have been identified? New or change in policy needed? Retraining on process or education on current policy needed? IT safeguards? Alert messages, double checks, peer reviews

36 Plan of Action When will needs be address? When will follow-up occur? A plan of action should be very similar to a good goal setting session: Specific Measurable Achievable Relevant Time-bound

37 Federation of State Medical Boards Model Policy for the Use of Opioid Analgesics in the Treatment of Chronic Pain

38 Model Policy Disclaimer Physicians will not be sanctioned solely for prescribing opioid analgesics or the dose (mg/mcg). However, prescribers must be held to a safe and best clinical practice. The federal Controlled Substance Act defines a lawful prescription as one that is issued for legitimate medical purpose by a practitioner acting in the usual course of professional practice.

39 Appropriate Pain Management Patient evaluation and risk stratification Supports and obstacles Social supports Housing Meaningful work Home environment Personal and family history of addiction and abuse Patients with a history of substance use disorder (SUD) are at elevated risk for opioid analgesic treatment failure Patient evaluation and risk stratification Previous evaluations and treatments should be confirmed via records from other providers Patient provided information is considered insufficient

40 Appropriate Pain Management Development of individualized treatment plan and goals Reasonably attainable improvement in pain and function Improvement in pain-associated symptoms Should be established EARLY and revisited regularly Should include any further diagnostic evaluations, consultations or referrals, or additional therapies Informed Consent Written informed consent and treatment agreement is recommended Risks and benefits Side effects Tolerance and dependence Addiction and misuse Overdose Prescribing policies and expectations Number and frequency of refills Early refill or replacement policy Reasons treatment may be adjusted or discontinued

41 Appropriate Pain Management Informed Consent Patient -specific treatment goals Pain management Restoration of function Safety Patient responsibility for safe medication use Provider and/or pharmacy lock-in Periodic drug testing Provider policy for continuity of care in unforeseen circumstances Covering provider policy True emergencies Opioid trial Generally no more than 90 days Specific evaluation points Careful monitoring for both benefits and harm Lowest possible dose Titration Short-acting Rotate to long-acting if indicated Thorough review of trial period prior to decision to continue

42 Appropriate Pain Management Ongoing monitoring, adaptive treatment plan Review progress New information about etiology, if available Include patient overall health and level of function Obtain collateral information from family or close contacts re: function and pain response The Five A s Analgesia is patient experiencing reduction in pain Activity demonstrated improvement in function Adverse effects Aberrant substance-related behaviors Affect mood of patient

43 Appropriate Pain Management Medical records Copies of signed consent form and treatment agreement Medical history Results of physical exam, lab tests Results of risk assessment Include screening instruments, if used Description of treatments provided Medical records Instructions to patient and any significant others Results of ongoing monitoring of patient progress Notes on evaluations by and consultations with experts Any other supporting information Authorization for release of information to other treatment providers

44 Treatment Discontinuation Continually weigh risks and benefits of continued treatment Reasons to discontinue Resolution of underlying painful condition Emergence of intolerable side effects Inadequate analgesic effect Failure to improve patient quality of life Deteriorating function Significant aberrant medication use Patient should be provided safely structured tapering regimen Can be managed by provider OR can refer to addiction specialist Should NOT mark the end of treatment if patient is still experiencing pain

45 Model Policy Deviation The Board will not take disciplinary action against a physician for deviating from this Model Policy when contemporaneous medical records show reasonable cause for such a deviation. Validity of treatment plan will be judged on: Available documentation Effective management of pain while addressing patient function Quality of life and productivity factors Mitigation of risk of misuse, abuse, diversion and overdose

46 1 Buprenorphine waiver providers in Wyoming 6 1 Riverton Evansville Rock Springs Buprenorphine Treatment Practitioner Locator. Substance Abuse and Mental Health Services Administration. Updated Daily: Accessed 5/3/2018

47 Questions?

48 Contact Stevi Sy, PharmD Regional Medication Safety Lead Developed by Mountain-Pacific Quality Health, the Medicare Quality Innovation Network-Quality Improvement Organization (QIN-QIO) for Montana, Wyoming, Alaska, Hawaii and the U.S. Pacific Territories of Guam and American Samoa and the Commonwealth of the Northern Mariana Islands, under contract with the Centers for Medicare & Medicaid Services (CMS), an agency of the U.S. Department of Health and Human Services. The contents presented do not necessarily reflect CMS policy. 11SOW-MPQHF-WY-C