The Challenges of Opioid Dispensing

Transcription

1 The Challenges of Opioid Dispensing William R. Kirchain, PharmD, CDE XULA Instructor, Pharmacy Law President, Louisiana Pharmacists Association CDC Guideline for Prescribing Opioids for Chronic Pain United States, 2016 Recommendations and Reports / March 18, 2016 / 65(1);1 49 Centers for Disease Control and Prevention CDC 24/7: Saving Lives, Protecting People tm 1

2 The Clinical Issue Inadequate treatment of Pain = Suffering vs. Opiate Use Disorder The Criminal Issue CSA: opiate use disorder (OUD) is crimal CSA: treatment of OUD is limited Medicaid: funding & access is limited Private Insurance: also limits access leads to accelerated criminality 2

3 CDC Guidelines 1. Non pharmacologic & nonopioid therapy are preferred for chronic pain. Physical therapy & Exercise Therapy Cognitive Behavioral Therapy Weight loss (for osteoarthritis) Non opioid Therapy Acetaminophen NSAIDS (low dose, limited time) Duloxetine (other SNRI) Pregabalin, Gabapentin Carbamazepine Amitriptyline 3

4 CDC Guidelines 2. Before Tx for chronic pain; establish realistic goals for pain relief & function, while planning how Tx will be D/c d. Continue Tx only clinically meaningful improvement. CDC Guidelines 3. Before & during Tx, discuss risks/benefits of Tx along with PT duties for managing Tx. start Tx for chronic pain, use immediate release NOT extended release opioids. 4

5 CDC Guidelines 5. Use dose. Reassess before 50 morphine milligram equivalents (MME/d); Carefully justify 90 MME/d. 6. For acute pain; 3 days is best; >7 days rarely needed. 7. Assess benefits/harms within 1 4 wks for chronic pain & before dose. Then Q 3 months. Work to taper opioids. CDC Guidelines start & Q 3 months; evaluate risk factors. Consider naloxone when; Hx of OD, Hx of SUD, 50 MME/d, Concurrent Benzo. 9. Review the PMP to determine if PT is receiving dosages or combinations risk for OD. 5

6 CDC Guidelines 10.For chronic pain; urine drug start TX & at least annually. 11. Avoid opioids & benzodiazepines. 12.Offer/arrange TX with buprenorphine or methadone combined with behavioral Tx for PT who develop OUD. Changes in the Law U.S.C. C.A.R.A LA. H.B. 192 LA. S.B. 55 LA. Emergency Rule: Naloxone 6

7 CARA 2016 C-II Opioids (not amphetamines) 1 st Rx 7 day supply Except for Documented Hospice Patients: Any quantity Documented Palliative Care Patients: Any quantity Documented Chronic Cancer Pain Patients: Any quantity Documented Need for More: Any quantity Must discuss risks CARA 2016 Partial fills ofc-ii (2)(a) Unless prohibited by State Law; A pharmacist may dispense the C-II opioid in an amount < the quantity indicated if requested in accordance with 21 USC 829 (CARA 2016; Sec. 702)... for up to 30 days. 7

8 Other Documentation Note in the PMP the amount filled Note in the Electronic Record the amount filled HR 192 Limits 1 st Time Rx for opiates to 7 day supply Requires counseling; risks of opioid use & necessity of the Rx Requires (promotes) notice the patient may opt for a lesser quantity Preempts the 72 hour Rule on partial fills Requires a notation in EHR within 7 days Exempts Rx needed to tx the acute condition Exempts Rx for cancer pain; palliative care 8

9 S.B. 55 Must Check PMP: Prior to 1 st Rx & Q90days Except hospitalized patients, hospice patients, terminally ill patients, cancer patients, PMP is unavailable & Rx 7 day supply Assessing the C-II Opioid Rx Florida Rule: 1 st & Q3M Rx Check the PMP Assess the patient OR Discuss Rx with Prescriber 9

10 Check the PMP Frequency & Diversity of Opioids (other) Good faith medical exam? (Telemedicine Eval. is considered acceptable by LSBME) Rxer s Usual Course of Practice? Excessive quantity? Same Drug, Dose, Sig, #pills?!! Calculate the MME/d ( 50) C-II Quantity: Federal Rules 1. No refills C II, no expiration date 2. C-II, C-III, C-IV, C-V no quantity limit 10

11 C-II Opioids Quantity in Louisiana Rx r NOT Licensed in LA Limited to 10 day supply; prohibits dispensing the same C-II to same PT when prescribed by ANY non LA Rx r for 60 days. (10/60 Rule) Exceptions If assess PMP on Rx r, 10/60 rule does NOT apply. OR If Rx r indicates a Dx of cancer; terminal illness; limit does NOT apply. LA Rule on In State Rx rs & C-II Rx: No limits Morphine Milligrams Equivalent (MME/d) Drug (doses in mg/day except where noted) CONVERSION FACTOR Morphine 1 Codeine 0.15 Fentanyl transdermal (in mcg/hr) 2.4 Hydrocodone 1 Hydromorphone 4 Methadone 1 20 mg/day mg/day mg/day mg/day 12 Oxycodone 1.5 Oxymorphone 3 a.pdf 11

12 Opioid MME Calculators PainKiller Calculator Jason Hartley OPIOD CALC NYC: www1.nyc.gov/site/doh/providers/health topics/opioid prescribing.page PainKiller Calculator: play.google.com/store/apps/details?id=us.jasonh.mme&hl=en OPIOD FPM: fpm.anzca.edu.au/front page news/free opioid calculator app Assess the Patient I. What did the prescriber tell you this was for? II. How did they tell you to take it? III. What did they tell you to expect? Opiate Specific IV. Have you every had a problem with opioids or alcohol? V. What are your Tx goals? VI. Are you taking a Benzo, or Anticholinergics, Kava kava? 12

13 Chronic Pain Patient Opioid use NOT controlling ADL Opioid use Improves QoL Opioid use Improves Function ADR: Wants dose or D/c drug Complains of Constipation Expresses concern about underlying Dx Follows Prescriber PT Agreement Wants to Dispose of Meds Opioid Use Disorder Patient Opioid use is CONTROLLING ADL Opioid use Impairs QoL Opioid use has no impact on Function ADR: Wants NO Change or dose Constipation? Unconcerned or unaware of Dx Often Noncompliant with Agreement Never has Meds to Dispose Regularly loses Prescription ADL = Activities of Daily Living QoL = Quality of Life Dx = Diagnosis Webster LR, Dove B. Avoiding opiate abuse while managing pain. Sunrise Press, MN, Other Issues Driving and Work Safety ETOH, Benzo, Anticholinergics Employment Impact Constipation (paralytic ileus) Hyperalgesia Tolerance (drug rotation) Hypogonadism 13

14 Prescriber Patient Agreements Pharmacist may request a copy Patient Responsibilities a. Adherence & Compliance b. Avoidance of Self Adjustment of Tx c. Actively Participate in Non drug TX d. Locked in for Pain Rx e. Agree to reveal other Meds Payer Patient Agreements Lock In Programs 42 CFR (d) may place appropriate limits on a service based on such criteria as medical necessity or on utilization control... 14

15 Naloxone Naloxone MME/d 50 or Opioid Rotation Risk for OD Hx OUD, SUD, Previous OD Hx Depression, Respiratory Infection MHx Benzo, Anticholinergics Requested by patient 15

16 Instructions to Patient (Caregiver) Signs & Symptoms of OD Call 911 Injection technique How to access OUD Tx OD Signs & Symptoms Confusion, Ataxia, Dyphonia Feeling dizzy or faint Stertor, Apnea, Sonorous Rhonchus Cyanosis Dysania, Hypersomnia 16

17 Patient Information.pdf Patient Information.pdf 17

18 prevention/tools best practices/od kit materials/ call

19 OUD & SUD Treatment Suicide Safe 19

20 Health Resources & Services Agency Federal Office of Rural Health Policy: Rural Health Opioid Program (HRSA ) / ruralhealth / programopportunities / fundingopportunities / default.aspx FDA News Release: FDA requests removal of Opana ER for risks related to abuse. June 8, 2017 Today, the FDA requested Endo Pharmaceuticals remove Opana ER (oxymorphone hydrochloride), from the market. the agency is seeking removal based on its concern that the benefits no longer outweigh its risks. The decision is based on a review of postmarketing data, which demonstrated a shift in the route of abuse from nasal to injection. Injection abuse of reformulated Opana ER has been associated with outbreaks of HIV, hepatitis C, and thrombotic microangiopathy. 20

21 Ancillary Issue: Needle Exchange STD Transmission HIV, Hep C, DR Syphillus LLR Title Prescription Devices. A A legitimate medical need includes the prevention of the transmission of communicable diseases. HB 250 Allows local governments to establish needle exchange programs. 21

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