Pain Management Risk Mitigation

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2 Pain Management Risk Mitigation Thomas B. Gregory, Pharm.D., BCPS, CPE FASPE Pain Management Pharmacy Specialist CoxHealth Springfield, MO

3 Disclosure and Conflict of Interest Thomas B. Gregory, Pharm.D. serves as an Clinical advisory board member for Diachii Sankyo

4 Pharmacist Objectives At the conclusion of this program, the pharmacist will be able to: 1. List medications commonly used in the management of pain 2. Recognize the medico-legal considerations regarding the management of pain 3. Identify appropriate practices regarding documentation as they relate to pain management

5 Technician Objectives At the conclusion of this program, the pharmacy technician will be able to: 1. Name common medication families that are used to treat patients in pain 2. Report red flags in processing patient prescription orders to the pharmacist on duty for evaluation 3. Select available electronic prescription databases to retrieve and report information about a patients prescription history to the pharmacist

6 Definitions Pain 1 : An unpleasant sensory and emotional experience associated with actual or potential tissue damage, or described in terms of such damage Risk mitigation 2 : A systematic reduction in the extent of exposure to a risk or the likelihood of its occurrence 1. accessed accessed

7 Medications Used in Pain Management Acetaminophen NSAIDs Glucocorticoids Antidepressants Anticonvulsants Local anesthetics Skeletal muscle relaxants Opioids and their antagonists

8 Hitting the Target(s) Stimulation of nociceptors causes signal transduction to the dorsal horn Transduction The spinothalamic tract transmits the signals to the brain where pain is first experienced Transmission and perception Descending pathways from the brain attempt to block the signal from the periphery Modulation accessed June 21, 2018

9 Acetaminophen Mechanism of action is still not entirely known Thought to be a partial COX inhibitor March 2014 FDA mandates all prescription drug combination products containing acetaminophen cap the dose at 325 mg Maximum daily dose limits vary based on comorbidities and who you ask FDA vs Johnson and Johnson COX: Cyclooxygenase FDA: Food and Drug Administration accessed June 21, accessed June 21, 2018

10 Acetaminophen, cont. Largest concern is unintentional overdoses Metabolism of acetaminophen by the liver is a saturable process Over the counter products and cumulative acetaminophen dosing accessed June 21, 2018

11 Nonsteroidal Anti-Inflammatory Agents (NSAIDs) COX 1 more specific to the GI tract and renal homeostasis COX 2 more specific to inflammation and platelet aggregation Certain comorbidities limit the use of most NSAIDs Patients on anticoagulants Patients with renal dysfunction Pregnancy

12 NSAIDs and COX Selectivity accessed June 21, 2018

13 Glucocorticoids Mechanism of action leads to a decrease in production of heat shock proteins intracellularly leading to decreased inflammation Multiple routes of administration May be used for short courses (bursts) or longer +/- taper?

14 Glucocorticoids, cont. Caution should be exercised in patients with the following conditions Diabetes Psychiatric history Heart failure Adrenal suppression Taper needed when therapy exceeds 10 to 14 days Immunocompromised

15 Tricyclic Antidepressants (TCA) Mechanism of action is through inhibition of norepinephrine and serotonin reuptake and inhibition of sodium channel action potentials The antidepressant effects and the neuropathic pain analgesia (non-labeled indication) are independent Higher dosing and longer treatment duration needed for antidepressant effects Caution should be exercised in patients With cardiac arrhythmias Over the age of 65

16 Serotonin Norepinephrine Reuptake Inhibitors (SNRI) Mechanism of action is through inhibition of norepinephrine and serotonin reuptake Dosing is generally higher for treating neuropathic pain compared to treating depression Withdrawal syndromes can occur if patients are taken off SNRI therapy abruptly Anxiety, irritability, headache, paresthesia, nervousness Caution should be exercised in patients with liver dysfunction, uncontrolled hypertension, or moderate cardiovascular disease

17 Antiepileptics The primary antiepileptics used in pain management work on calcium channels (gabapentinoids) Gabapentin Pregabalin Other antiepileptics have had mixed results regarding neuropathic pain (non-labeled indications) Topiramate Oxcarbazepine Carbamazepine for trigeminal neuralgia

18 Local Anesthetics Mechanism of action is through membrane stabilization of sodium channels preventing depolarization and signal transduction Acute uses for local anesthesia (procedures, etc.) Multiple routes of administration Parenteral and non-parenteral Patches are indicated for the management of postherpetic neuralgia

19 Skeletal Muscle Relaxants Multiple medications are included in this general taxonomy Certain agents approved for spasticity Baclofen and tizanidine Others stand out for reasons other than their indication Cyclobenzaprine and orphenadrine regarding their anticholinergic effects Chlorzoxazone and its potential for hepatotoxicity Carisopradol and meprobamate with known potential for abuse

20 Opioids Opioids work on multiple receptors within the central nervous system Analgesia and adverse effects are derived from mostly Mu receptors There is no ceiling dose for analgesia however as doses increase the incidence of adverse effects increases CDC (2016) and VA/DoD (2017) guidelines outlining the use of opioids in chronic pain have been published

21 Opioid Metabolism Metabolic pathways can become saturated leading to metabolism by other pathways Codeine à à à à à Oxycodone 2D6 à noroxycodone 3A à oxymorphone accessed June 21, 2018

22 Immediate Release (IR) vs Extended Release (ER) Initial therapy should include the use of IR formulations ER preparations are appropriate for patients 1. That routinely use the IR preparation with relief of pain 2. That are not experiencing adverse effects which decrease quality of life 3. That are on stable doses of IR preparations and have been for an appropriate time frame IR and ER preparation use should be re-evaluated for safety and efficacy periodically

23 Opioid adverse and side effects Accounted for 8.45% of medication related fatalities in ,000+ opioid over doses in 2017 Populations at greater risk for experiencing adverse effects Patients with sleep apnea and sleep disordered breathing Pregnancy Hepatic or renal dysfunction Age greater than 65 Mental health or substance use disorders Nonfatal overdose history 2015 Annual Report of the American Association of Poison Control Centers National Poison Data System (NPDS): 33rd Annual Report. Clinical Toxicology 2016; 54 (10): CDC Guideline for Prescribing Opioids for Chronic Pain United States, MMWR 2016; 65(1): 1-49

24 Current events surrounding opioids Centers for Medicaid and Medicare Services * 1, Missouri 2 and some pharmacies 3 are limiting opioid prescribing Opioid naive patients * Slated for 2019 Shortages of opioids DEA mandated 4 Manufacturers Plans/MedicareAdvtgSpecRateStats/Downloads/Advance2019Part2.pdf accessed 7/5/ accessed 7/11/ accessed 7/5/ accessed 7/5/ accessed 7/5/20018

25 Naloxone Available as intra-nasal and intramuscular injections for ambulatory care / outpatient use Intra-nasal 2 mg or 4 mg individual spray dosage forms Intramuscular available in 0.4 and 2 mg single dose injectors and vials To be administered to anyone with suspected opioid overdose. Someone needs to call emergency services (911) after naloxone has been used!

26 Medication counseling Asking open ended questions Express empathy Use active listening techniques Use every day language and terms Proper use of medication Common side effects, emphasizing the patient reporting any of those side effects to a health care provider accessed 6/28/2018

27 Pain medication counseling Patient reported response to medications Patient goals associated with use of pain medications Medication refills and policies on early refills Safe storage and disposal of medications Appropriate candidate for naloxone per protocol or standing order? accessed 6/28/2018

28 Section summary Multiple medication families are indicated for the management of pain The use of opioids as well as their scrutiny have increased in past years to epidemic proportions Patient education regarding safe and effective medication use is a key part of pain management

29 Medico-legal implications in pain management Corresponding responsibility, prescription drug monitoring programs and red flags, oh my!

30 Corresponding responsibility The responsibility for the proper prescribing and dispensing of controlled substances is upon the prescribing practitioner, but a corresponding responsibility rests with the pharmacist who fills the prescription. accessed 6/25/2018

31 Corresponding responsibility, cont. Pharmacy technicians Patient profile review and updating Gather 3 rd party medication history for pharmacist review Pharmacists Counseling on opioid or pain adjunct medication side effects Naloxone education Verification of technician / intern work

32 Medico-legal responsibilities Patient prescriber relationship Legitimate medical need for prescribed medication Prescribed in the usual course of professional practice Reasonable steps taken to prevent patient harm Appropriate documentation of the above

33 Chronic pain litigation, a history Medical management represented 17 % of 51 selected and reviewed chronic pain malpractice claims in Death was the result in 57% of those claims Medical management represented 24 of 37 selected cases (64.8%) for medical malpractice in Death was the outcome in 75% of those cases 1. Anesthesiology 112; 4: Anesthesia and Analgesia 125;5:

34 Pharmacy litigation California BOP v. Pacifica Pharmacy and pharmacist 1 Failure to address controlled substance red flags BOP = Board of Pharmacy accessed 7/6/2018

35 Pharmacy litigation, cont. Nebraska v. Safeway Inc. Failure to screen drug interactions resulting in patient death accessed 7/6/2018

36 Pharmacy litigation, cont. Roberts v. Rite Aid Corp. Failure to report suspected drug abuse resulting in death accessed 7/6/2018

37 Prescription drug monitoring program

38 St. Louis PDMP Pharmacists and supervising prescribers have access to the data in participating counties Pharmacy technicians and mid level providers may be delegates as well and have access to the same information Information should be accessed in the usual course of dispensing controlled substances and aid the pharmacist in determining patient safety prior to dispensing PDMP = prescription drug monitoring program

39 St. Louis PDMP county participation accessed 6/25/2018. Map accurate as of 5/14/2018

40 Other PDMPs Other states participate in PDMPs as well Pharmacists practicing in close proximity to other states with PDMP capabilities Patients living in adjoining states but filling in Missouri pharmacies Many states also participate in PMP Interconnect Should be accessed only for legitimate purposes, HIPAA compliance PDMP = Prescription drug monitoring program accessed 6/25/2018

41 PMP InterConnect map PMP = prescription monitoring program accessed 6/25/2018

42 CyberAccess MO HealthNet participants have their medication information accessible to prescribers and pharmacists Medication history and prior authorizations Diagnostics, procedure history, precertification and other prescriber information Pharmacists and technicians (as delegates) have access to this information in real time

43 Risk factors for opioid misuse and abuse Demographic factors Pain severity and interference with activities of daily living Comorbid psychopathology Morphine equivalent daily dose Pain Physician 20 Suppl

44 Red flags with controlled substances 1. Patients traveling in groups with similar controlled substance prescriptions presenting to the pharmacy at the same time 2. Hand written prescriptions that appear to be too flawless 3. Prescriber is know to be under review or suspended from prescribing controlled substances accessed 6/26/2018

45 Red flags with controlled substances, cont. 4. Patient implies or directly threatens pharmacy staff 5. Patient appears under the influence or exhibiting withdrawal symptoms 6. Patient has prescriptions for controlled and noncontrolled substances but only wants the controlled substances filled 7. Patient does not disclose other or previous pharmacies filling controlled substances or a history of not being truthful with staff accessed 6/26/2018

46 Red flags with controlled substances, cont. 8. Therapeutic duplication with multiple extended release or immediate release opioids 9. Cocktails of controlled substances Benzodiazepine, muscle relaxer and opioid 10. Prescription appears altered 11. Prescription is from a prescriber acting outside of the scope of their licensure 12. Patient indicates the controlled substance will be diverted accessed 6/26/2018

47 Risk evaluation and mitigation strategies (REMS) Extended release (ER) opioid REMS in place for 1 Prescriber education Prescriber counseling on ER opioids Pharmacist dispensed medication guide Opioid analgesic education 2 Focuses on all health care providers Patient counseling regarding safe use of opioids and use of naloxone for suspected opioid overdose 1. EXTENDED-RELEASE (ER) AND LONG-ACTING (LA) OPIOID ANALGESICS RISK EVALUATION AND MITIGATION STRATEGY (REMS) version FDA s Opioid Analgesic REMS Education Blueprint for Health Care Providers Involved in the Treatment and Monitoring of Patients with Pain version

48 Missouri BNDD Prescriptions You Never Want to Fill A controlled substance prescription that a practitioner has written for themselves A prescription that is not for a specific patient, but for stock in another practice A prescription for methadone or other Schedule II drug, when it is for addiction detox or maintenance, for an adult A prescription that does not have a prescriber s signature accessed 6/29/2018

49 Naloxone dispensing Done under physician protocol -or- standing order Protocol with a physician including duration of the protocol, review timeline, signatures, education to be provided, and other elements 1 Standing order involves any Missouri practicing pharmacist and pre-specifies the education to be provided 2 Protocol order does NOT need to be turned into a prescription, does need an invoice/ bill of sale Qualified first responder agency distribution 1. accessed accessed

50 Naloxone dispensing, cont. Education MUST be provided to the person receiving the naloxone Risk factors for opioid overdose Signs of opioid overdose Appropriate use of naloxone for opioid overdose The specifics of the education must be included in the protocol 1 The standing order indicates the education to be provided at a minimum accessed 7/4/ accessed 7/4/2018

51 Standing order education Every person dispensed or sold naloxone under this standing order shall receive education regarding the risk factors of overdose, signs of an overdose, overdose response steps, and the use of naloxone. accessed 7/5/2018

52 Naloxone protocol/ standing order accessed 6/25/2018

53 Section summary Pharmacists have a corresponding responsibility for appropriate prescribing of controlled substances When in doubt, contact the prescribers office regarding the prescription Electronic databases are available to review medication dispensing and assess for compliance Reviewing all controlled substance prescriptions for potential red flags involves all levels of pharmacy staff

54 Documentation If it s not documented, it NEVER happened.

55 Pharmacy records Patient counseling per federal laws, state laws and the pharmacy s policies Opioid agreements with prescribers Discrepancies between the PDMP and patient medication fill history Red flags after reviewing the PDMP PDMP = prescription drug monitoring program

56 Naloxone record keeping Prescription requirements, if filled as prescription under protocol Five year minimum retention Distribution with transaction date, product dispensed with strength, dose and quantity Two year minimum retention It is a good practice to document the education provided

57 Case #1 24 year old male from Kansas presents with a prescription for #120 oxycodone 5 mg tablets with a sig of Take one tablet every 4 hours PRN from his Arkansas dentist. Patient is new to your practice and appears to be fidgeting in the chair waiting for his prescription. During his intake he denies previous narcotic use. He also says his insurance has lapsed and will pay cash. What would you do?

58 Case #1, cont. What goes into your prescription documentation? Contact the prescriber and clarify the order Review of PDMP and other 3 rd party medication databases and note any discrepancies Patient behaviors and any verbal discussion in quotes if from the patient

59 Case #1, cont. You find out he has commercial insurance and the oxycodone is too soon. The PDMP in Kansas reveals he has filled oxycodone, alprazolam and fentanyl patches in the past two weeks from multiple providers. The patient keeps approaching the counter and states to one of the technician staff this is easy, just put the pills in the bottle and give them to me. The pharmacist now has the dentist on the phone, what would you do?

60 Case #1, cont. After your interaction with the dentist, the prescription in verbally cancelled. What do you document from or about the patient? Be detailed (including explicative language) in this interaction and note it on the patient s pharmacy records and use quotes Patient leaves after realizing he will not receive the medication

61 Learning Assessment: Question 1 Which of the following medications below could be considered part of a pain management medication regimen? A. Morphine B. Gabapentin C. Naproxen D. All the above

62 Learning Assessment: Question 2 All of the following medication families are used commonly to manage pain EXCEPT? A. Non-steroidal anti-inflammatory drugs (NSAIDS) B. Opioids C. Local anesthetics D. HMG Co-A reductase inhibitors

63 Learning Assessment: Question 3 Pharmacists have a corresponding responsibility to ensure that controlled substances are being written for legitimate medical conditions and should contact the prescriber for any red flag regarding the prescription. A. True B. False

64 Learning Assessment: Question 4 Which of the following would be a red flag that should be reported to the pharmacist on duty regarding a patient attempting to fill a prescription for controlled substances? A. Patients traveling in groups with similar controlled substance prescriptions presenting to the pharmacy at the same time B. Patient implies or directly threatens pharmacy staff C. Patient appears under the influence or exhibiting withdrawal symptoms D. Patient does not disclose other or previous pharmacies filling controlled substances or a history of not being truthful with staff E. All of the above

65 Learning Assessment: Question 5 All of the following are appropriate risk mitigating strategies that pharmacists should employ in their practice with regards to controlled substances EXCEPT: A. Verify the prescription with the provider s office if any inconsistencies or questions regarding validity arise B. Review any applicable electronic or other sources of medication refill history available C. Tell the patient the pharmacy will only dispense the prescription if they fill all of their medications with that pharmacy only and demand a transfer of all other prescriptions to that pharmacy D. Document pertinent information regarding the patient and the legitimacy of their prescription in the electronic prescription processing system or on the back of the prescription (or its electronic equivalent) and keep those records with the prescription as per Missouri Board of Pharmacy regulations or pharmacy policies.

66 Learning Assessment: Question 6 Which of the following sources could be used to obtain information about a patient s medication fill history? A. St. Louis County Prescription drug monitoring program B. Missouri Healthnet C. Contacting the patients other pharmacy providers D. All the above

67 Questions or comments? Thank you for your attention and have a good day.

68 Additional Resources St. Louis County PDMP: MO HealthNet CyberAccess: Missouri BNDD: DEA take back day updates:

69 Speaker Contract Information