To Prescribe or Not To Prescribe

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1 To Prescribe or Not To Prescribe AzSHRM Quarterly Meeting May 11, 2018 Presented by: Karen Wright, RN BSN ARM CPHRM MICA Senior Risk Management Consultant 1

2 OBJECTIVES List three common classes of medications which tend to be inappropriately prescribed. Identify at least two reasons unnecessary medications may be prescribed for patients. 2

3 ACCORDING TO ISMP Two out of every three patients who visit a doctor leaves with at least one prescription for medication Close to 40% of the U.S. population receive prescriptions for 4 or more medications The rate of adverse drug reactions increases dramatically after a patient is on 4 or more medications At least 20% of all harm to hospitalized patients is associated with medication errors Source: Institute for Safe Medical Practice (ISMP) 3

4 ADVERSE DRUG EVENTS & MEDICATION ERRORS Adverse drug events (ADE) account for more than 3.5 million physician visits and 1 million emergency department visits Preventable medication errors impact more than 7 million patients Cost almost $21 billion annually across all care settings Source: The alarming reality of medication error: a patient case and review of Pennsylvania and national data. Retrieved from: 4

5 PATIENT DEATHS DUE TO MEDICAL ERRORS Diagnostic Errors: 41 percent Medication Errors: 39 percent Treatment Errors: 26 percent Source: British Medical Journal, Quality & Safety April,

6 MEDICATION ERRORS Can occur anywhere in the distribution system Prescribing Repackaging Dispensing Administration Monitoring Common causes include: Poor communication Ambiguities in product names, directions for use, medical abbreviation or legibility Patient misuse due to poor understanding of directions for use Source: FDA. Retrieved from: 6

7 CONTRIBUTING FACTORS IN MEDICAL MALPRACTICE CASES Missed/Delayed Diagnosis Medication errors/adverse drug reactions (12-13 percent) Lack of communication Poor documentation Source: PIAA 7

8 MOST EXPENSIVE ALLEGATIONS Improper performance Missed or misdiagnosis Failure to supervise or monitor care Medication errors Source: PIAA 8

9 LET S LOOK AT THE LOSSES MICA closed 82 medication related claims and suits between 8/1/2012-8/31/ % of these claims resulted in a fatality The three most prevalent drug classes represented in medication related claims were: oanticoagulants 22% oopioids 18% oantibiotics 13% These three drug classes represented 53% of the medication related claims closed during this timeframe 9

10 FIVE MOST EXPENSIVE MISADVENTURES Medication Related Treatment Related Surgical Related Diagnosis Related Obstetrical Related 10

11 Contributing Factors 11

12 CONTRIBUTING FACTORS: ASSOCIATED PERSON Other Physician / Surgeon Nurse (RN or LPN) Non-Licensed Staff Advanced Healthcare Professional Other 19% 10% 9% 30% 32% 12

13 CONTRIBUTING FACTOR: COMMUNICATION Inadequate Communication with Patient/Family Inadequate Hand-Off Failure to Timely Communicate with Team Failure to Instruct Patient Inadequate Communication of an Unexpected Critical Finding 34% 20% 17% 13% 7% 13

14 CONTRIBUTING FACTOR: SYSTEM RELATED Top Three Issues Inadequate follow up or failure to close the loop Inadequate policies and procedures Inadequate supervision of staff 14

15 CONTRIBUTING FACTOR: MEDICAL RECORD ISSUES 78% of the medical record issues contributing to a medication related claim or lawsuit involved incomplete notes 15

16 CONTRIBUTING PARTY Patient Family or Others Associated with Patient 16

17 Anticoagulants 17

18 ANTICOAGULANTS: An All or Nothing Case 51 year-old patient Complex medical history, had been on Coumadin for 6 years Over next 6 years I/M managed Coumadin therapy Patient scheduled for oral surgery instructed to stop Coumadin 7 days prior to surgery Patient called post-op to schedule appointment for INR draw refused to see PA When INR drawn it was 1.1 instructed to take Coumadin 10 mg Next day presented to ED with c/o headache, left-sided weakness and confusion 18

19 ANTICOAGULANT S: Problems with the Case Defense attorney called this the all or nothing case Patient instructions were not consistently documented Experts were critical that INR was not reassessed prior to surgery They also testified 7 day discontinuation was too long 19

20 Recommendations Develop a reliable system to ensure monitoring requirements are followed Educate patient verbally and in writing don t assume the know Anticoagulants added during hospitalization should be clearly indicated Coordination of care: clear understanding among physicians who will be monitoring patient s anticoagulation therapy 20

21 Opioid Therapy 21

22 DATA SHARING PROJECTS (DSP): OPIOID-RELATED CLAIMS ANALYSIS FOR Reprinted with permission from PIAA. Managing Opioids: Prescribing Practices and Claims. Research Notes. September 2017 Edition, Copyright 2017, PIAA. 22

23 PIAA DSP OPIOID CLAIMS TRENDS ACROSS TWO 5-YEAR PERIODS Reprinted with permission from PIAA. Managing Opioids: Prescribing Practices and Claims. Research Notes. September 2017 Edition, Copyright 2017, PIAA. 23

24 MICA s OPIOID RELATED CLOSED CLAIMS Claims closed from 2006 through % resulted in patient fatality Paid/close ratio 29% Thirty-eight percent decrease in average indemnity from 2006 through 2010 to 2011 through

25 OPIOID THERAPY: Drug Seeking Behavior? 42 year-old seen as new patient History included HTN and multiple carpal tunnel surgeries in last 2 years Also seeing a psychiatrist and taking Cymbalta and Xanax Seeking Oxycodone for chronic pain from carpal tunnel Ten days later physician received warning fax from re: benzodiazepines & Oxycodone Three weeks later patient called wanting an early prescription for Oxycodone death in the family required travel When flight landed, patient was unconscious in seat Autopsy: Acute intoxication due to combined effects of Oxycodone, Xanax and Estazolam 25

26 OPIOIDS: Problems with the Case 1. Response to pharmacy warning not documented 2. Conversation regarding discontinuation of benzodiazepine was not documented 3. Records from previous treating physician never requested 4. No documentation of informed consent / pain management agreement 5. Possible HIPAA violation 26

27 27

28 Recommendations Establish realistic treatment goals for pain management and functional improvements. Include the known risks, realistic benefits and alternatives of opioid therapy in the informed consent discussion and document it in the patient s record. A written agreement between physician and patient outlining patient responsibilities is recommended for safe and responsible opioid prescribing. The agreement should be signed by the patient and include, but not be limited to: baseline screening for urine/serum medication levels and at least annually; number and frequency of all prescription refills; reasons for which drug therapy may be discontinued; requirement that the patient obtain all controlled substance prescriptions from one physician and one pharmacy. Consider alternative pain management therapies such as physical therapy, exercise, biofeedback, acupuncture and others, especially for patients vulnerable to addiction. 28

29 When Prescribing Only consider opioid therapy if nonpharmacologic therapy and nonopioid pharmacologic therapy have not been beneficial for pain and function. Review the patient s profile on the state s Board of Pharmacy controlled substances monitoring database before prescribing Schedule II, III or IV drugs. Prescribe the lowest effective dosage of immediate-release opioids Avoid extended-release/long-acting opioids when initiating opioid therapy for chronic pain. Start with low dosages and slowly advance the dosage. If at all possible, avoid concurrently prescribing benzodiazepines and opioids. 29

30 Antibiotics 30

31 ANTIBIOTICS 13% of MICA s medication related closed claims and suits related to antibiotics CDC estimates that 47 million excess prescriptions for antibiotics 1 Additional risks for patients include o Allergic reactions o Clostridium difficile o Interactions with other medications 1. CDC: 1 in 3 antibiotic prescriptions unnecessary. Press Release. May 3, Retrieved from 31

32 SURVEY: U.S. DOCTORS PRESCRIBING UNNECESSARY DRUGS 5000 American College of Physician members were asked to identify two treatments frequently used by internists that are unlikely to provide high value care to patients Antibiotics o 27% respondents said antibiotics administered when they have no benefit o Most commonly prescribed to treat upper respiratory infections even though most are caused by viruses o Expense versus value Value is a function of benefits, risks and cost of intervention Thompson, D. U.S. doctors still over-prescribing drugs: survey. Dec. 5,2016. Retrieved from 32

33 ANTIBIOTIC: Drug Interaction 54 year-old male with history of HTN, mild cardiomegaly referral to cardiology Five years later, testing revealed non-ischemic cardiomyopathy secondary to viral cardiomyopathy, plus possible alcohol contributing Medications: Digoxin, Coumadin, Lopressor and Diovan One year later, failed cardioversion for a-fib hospitalized and started on Tikosyn (dofetilide) patient told not to take Bactrim while taking Tikosyn Patient seen in PCP s office for laceration on left leg Bactrim ordered Seen 3 days later, instructed to continue Bactrim for 2 weeks Ten days later patient collapsed while walking into post office EMS responded, extended resuscitation successful but severe neurologic damage 33

34 ANTIBIOTICS: Problems with the Case Lawsuit named pharmacy, PA and PCP Physician - failed to appropriately supervise PA Physician signed both PA s encounter notes when Bactrim ordered PA failed to recognize the significant risk of interaction between Bactrim and Tikosyn Experts said PA should have known about the interaction Pharmacy Bactrim inappropriately dispensed Pharmacist failed to follow protocol to check for interactions 34

35 TO PRESCRIBE OR NOT TO PRESCRIBE PRESSURE NOT TO PRESCRIBE Pressure From regulatory agencies and other organizations Opioids Watchful waiting encouraged with antibiotics From formularies PRESSURE TO PRESCRIBE From patients or family members Negative survey results From advertising Sincere desire to provide relief From patients who cannot afford medication 35

36 Take Away Points Counsel patient / family on medication risks, benefits, side effects and alternatives Provide written medication instructions and verbally review them with patient/family Explain risks before pt experiences an adverse outcome Stay up-to-date on drug risk and side effects If medication carries significant risks, get a consent form signed o Use pain management contract when prescribing opioids Use drug information aids such as phone apps or websites Pay attention to pop-up alerts on EMR Address patient noncompliance with medication regimen 36

37 ADDITIONALLY Disclosure - honest communication following an adverse event Patients and families tend to be more forgiving when the feel the clinician genuinely care and have their best interest in mind Develop policies and procedure regarding medication management and monitor that they are consistently followed o For opioid therapy this will include drug screens Document staff competencies Document objective rationale for prescribing Seek to coordinate care between primary and specialist care to ensure responsibility for medication management is clearly delineated Finally, document, document, document 37

38 Questions 38

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