Tackling the Opioid Problem - Analgesic Prescribing in the Emergency Department


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Tackling the Opioid Problem - Analgesic Prescribing in the Emergency Department

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  • A significant number of prescriptions for opioids were for conditions classed as non-chronic
  • Tackling the Opioid Problem - Analgesic Prescribing in the Emergency Department

    1. 1. Tackling the opioid problem and analgesic prescribing... Brad Lawther Acute Pain Service Department of Anaesthesia SCGH
    2. 2. Relevance to the ED… “just go to the ED and say your back hurts and walk away with some oxy & benzos, and a note for a week off work too. Sweet!” •bluelight.org •drugs-forum.com •opiophile.com
    3. 3. Outline • Oxycontin story – Commercial triumph, public health tragedy • Address the opioid problem • Industry’s response: Abuse deterrent formulations • Clinician’s response: Approach to pain management
    4. 4. Oxycontin… • Purdue Pharma introduced oxycontin in 1996 • Sales grew from $48 million in 1996 to $1.1 billion in 2001 • Commercial success = merits of the drug? • No advantage over appropriate doses of other potent opioids • “Aggressive marketing campaign”
    5. 5. Marketing… • Pain management and speaker training conferences in Californian resorts – all expenses paid symposia • Prescriber profiles on individual physicians – target the highest opioid prescribing physicians by zip code • Lucrative bonus system – Purdue paid $40 million in sales incentive bonuses in one year • Introduced ‘Patient starter coupons’ over 30000 coupons redeemed nationally • Branded promotional items (GET IN THE SWING WITH OXYCONTIN)
    6. 6. Marketing… • Targeted the chronic non- cancer related pain, despite the evidence • Oxycontin prescriptions for CNCP increased from 670000 in 1997 to 6.2 million in 2002 • Partners Against Pain website – claimed < 1% risk of addiction • Purdue distributed 15000 copies of an Oxycontin video to physicians without FDA review • Making unsubstantiated claims regarding its benefits to patients
    7. 7. Misrepresentation • Most frequently prescribed brand name opioid for treating moderate to severe pain by mid 2000’s • Commercial success stained by escalating abuse / misuse / and diversion • On 10 May 2007 an affiliate of Purdue Pharma pled guilty to criminal charges of misbranding Oxycontin by claiming less addictive, less abuse, less diversion • PAID out $634 million in fines
    8. 8. Our contribution… • “ In contemporary medical culture, self-reports of pain are above question and the treatment of pain is held up as the holy grail of compassionate medical care.” 2 • The prioritization of the subjective experience of pain has been reinforced by the modern practice of regularly assessing patient satisfaction – which may affect physician reimbursement or job security. • A cultural change contributing to our dilemma is the “all suffering is avoidable” ethos that pervades many aspects of modern life. Patients may believe that any kind of pain, physical or mental, is indicative of pathology and therefore amenable to treatment 2. Lembke A. Why doctors prescribe opioids to known opioid abusers. NEJM 2012; 367:1580-1
    9. 9. Opioid Prescribing Lembke A. Why Doctors Prescribe Opioids to Known Opioid Abusers. N Engl J Med. 2012 Oct 25;367(17):1580-1 •In 2010, there were reportedly as many as 2.4 million opioid abusers in this US, and the number of new abusers had increased by 225% between 1992 and 2000. •Sixty percent of the opioids that are abused are obtained directly or indirectly through a physician’s prescription.
    10. 10. Sources of prescription opioids5
    11. 11. Perspective from a pain patient: “I know I’m addicted to (opioids), and it’s the doctors’ fault because they prescribed them. But I’ll sue them if they leave me in pain.”
    13. 13. • Prescription painkillers became the second most prevalent type of abused drug after marijuana • Deaths from unintentional drug overdoses in the United States rose steeply since the early 1990s and were the second leading cause of accidental death, with 27,658 such deaths recorded in 2007. • That increase has been propelled by a rising number of overdoses of opioids, which caused 11,499 of the deaths in 2007 — more than heroin and cocaine combined. • Visits to emergency departments for opioid abuse more than doubled between 2004 and 2008, and admissions to substance- abuse treatment programs increased by 400% between 1998 and 2008.
    14. 14. New users of illicit drugs5 5. Substance Abuse and Mental Health Services Administration, Results from the 2012 National Survey on Drug Use and Health: Summary of National Findings, NSDUH Series H-46, HHS Publication No. (SMA) 13-4795. Rockville, MD: Substance Abuse and Mental Health Services Administration, 2013.
    15. 15. 9. Paulozzi LJ, Budnitz DS, Yongli X. Increasing deaths from opioid analgeiscs in the United States. Pharmacoepidem Dr S 2006; 15:618-27.
    16. 16. What about Australia… • Between 1991 and 2007, oxycodone use in Australia increased ten-fold4 • Australia had the third-highest oxycodone use per head population in 20094 • Much of the supply of prescription opioids is in the context of treatment for CNCP • CNCP in Australia is common, with estimates ranging as high as 20 per cent of the population 3. United Nations Office on Drugs and Crimes. World Drug Report 2010. From http://www.unodc.org/unodc/en/data-and-analysis/WDR-2010.html 4. International Narcotics Control Board. Narcotic drugs – technical reports. Estimated world requirements for 2011 – Statistics for 2009. From http://www.incb.org/incb/narcotic_drugs_reports .html
    17. 17. • According to PBS statistics for 2011: • Oxycodone > 3,000,000 scripts • Buprenorphine > 1,600,000 scripts • Hydromorphone ~89,000 scripts
    18. 18. Increasing supply of opioids
    19. 19. Community program for opioid pharmacotherapy • The National Opioid Pharmacotherapy Statistics Annual Data (NOPSAD) Collection: 2012 report provides information on clients receiving opioid pharmacotherapy treatment on a snapshot day in June. • Almost 47,000 (0.2%) Australians were on a course of pharmacotherapy treatment for their opioid dependence on a snapshot day in June 2012 (double the number since 1998 -from around 25, 000 people) • 2 in 3 clients were male, Median age of clients was 39
    20. 20. • Australian illicit drug-reporting system6 • 2012 sample of 924 “people who inject drugs” (PWID) • 48% of WA sample admitted to illicit oxycodone use in preceding 6/12, 35% nationally • Most purchased from a friend or dealer • Reported reasons for using oxycodone: • 48% to self-treat dependence • 36% to seek intoxication • 26% as substitute for heroin or opiates 6. Stafford, J. and Burns, L. (2013). Australian Drug Trends 2012. Findings from the Illicit Drug Reporting System (IDRS). Australian Drug Trend Series No. 91. Sydney, National Drug and Alcohol Research Centre, University of New South Wales.
    21. 21. • Harrison C, Charles J et al. Opioid prescribing in Australian general practice. Med J Aust 2012; 196 (6): 380-381. • Analysed data from the Bettering the Evaluation and Care of Health (BEACH) program for the period April 2010 to March 2011, examining encounters at which opioids were either prescribed or supplied directly to patients. • In the 2010–11 BEACH data year, at least one opioid was prescribed or supplied at 4666 of the 95 839 encounters (4.9%) recorded from 892 GPs (93.1% of the 958 GPs who participated in that year).
    22. 22. Industry’s Response • In response to a 4-fold increase in opioid related overdose deaths and increasing availability of prescription opioids the FDA specifically targeted the abuse of extended-release and long-acting opioid formulas • Intentional abusers use the drug to stimulate an associated high, euphoric or other psychotropic effect.
    23. 23. Abuse Deterrent Formulations • Opioid analgesics can be abused in a number of ways, for example; they can be swallowed whole, crushed and swallowed, crushed and snorted, crushed and smoked, or crushed, dissolved and injected. • Overall, the oral route is the most common route of abuse of prescription opioids, followed by snorting and injection • Abuse-deterrent formulations should target known or expected routes of abuse for the opioid drug substance for that formulation.
    24. 24. Abuse deterrent opioids • The pharmaceutical industry has attempted to formulate drugs which are tamper resistant and abuse deterrent. • They are NOT tamper proof or abuse proof. • These efforts include: • Physical/chemical barriers • Formulations with an antagonist • Combination with an aversive agent • Delivery systems such as depot • Use of pro-drugs • A combination of the above
    25. 25. Extended release opioids as targets for ADF • ER opioids are a target for abusers than immediate-release (IR) formulations because of their per-dose level of drug. • By altering the prescribed formulation, many abusers seek to create what is known as the “dump” effect, or an acceleration associated with a rapid “high.” The effect results in a much higher peak serum concentration (Cmax) over a shorter duration of time (Tmax). This pharmacokinetic change results in a pharmacodynamic response or in the abuser’s desired “reward” of euphoria. Therefore, each opioid should be examined for its potential abuse quotient (AQ = Cmax/Tmax).
    26. 26. Targin
    27. 27. Targin • From the experts… • “I am over 40 years old and have had a habit for over half my life...Im not here to be talked out of it...I’m here to find a safe way to get it into me via IV...I know i know i know...Has anyone in the entire f……. world managed to IV theze yet?” (May 2012) • “Don't IV these unless you wanna get f……. up in a bad way dude....” (2012) • “I am on Targin and u will be thrown into withdrawls (bad) if you try any other route than oral administration...” (March 2013)
    28. 28. ‘NEW Oxycontin’ • A new ‘tamper-proof’ formulation of oxycodone was released in Australia on 1 April this year, with the aim of reducing opioid abuse. • At the same time the old formulation was withdrawn, and the lowest dose (5 mg) deleted from the PBS.
    29. 29. Reformulated Oxycontin
    30. 30. Reformulated Oxycontin • From the experts.. • OxyContin® 10 mg, 15 mg, 20 mg, 30 mg, 40 mg, 60 mg and 80 mg tablets have been reformulated, and comprise a matrix formulation with a hydro-gelling property (i.e. particles or whole tablets become highly viscous (gel-like) in water), intended to be crush-deterrent and to reduce the rapid release of oxycodone upon accidental or intentional misuse. • The tablets have been heat-treated to increase the mechanical strength of the tablet.
    31. 31. Reformulated Oxycontin
    32. 32. Oxycontin
    33. 33. Spectrum…
    34. 34. Prescription opioids
    35. 35. What impact can we have? • STOP contributing to overall availability • Ask about drug / substance misuse • Diversion is real problem • Think about risk factors for abuse (warning signs) • Choose ‘less attractive’ opioids • Limit duration of opioid therapy • Involve specialist services
    36. 36. Predicting future abuse • Continuum from aberrance to abuse11 • Screening for aberrant drug-taking behaviour 11. Webster LR, Webster RM. Predicting aberrant behaviors in opioid-treated patients: preliminary validation of the opioid risk tool. Pain Med 2005; 6 :432-442.
    37. 37. Aberrant behaviours11 • Using opioids in addition to those prescribed • Forging or selling prescriptions • Seeking euphoria or relief from anxiety • Injecting opioids intended for oral use • Unauthorised dose escalation • Obtaining opioid prescriptions from multiple sources
    38. 38. What might alert us to risk of aberrance?
    39. 39. Opioid Risk Tool13 • Used to predict aberrance in patients prescribed opioids for chronic pain • Self reported; five categories • Family history substance abuse • Personal history of substance abuse • Age • History of preadolescent sexual abuse • Psychological disease 13. Kahan M et al. Can Fam Physician 2006;52(9):1081-7
    40. 40. Opioid Risk Tool13 13. Kahan M et al. Can Fam Physician 2006;52(9):1081-7
    41. 41. Does aberrance predict abuse? • Primary care sample14 • 801 patients on daily opioids for chronic non-cancer pain • Screened for aberrant drug-related behaviours • Assessed or opioid use disorder based on DSM IV criteria for opioid abuse or dependence • Odds ratio of 48.27 (13.63-171.04) for opioid use disorder in those with 4 or more aberrant behaviours 14. Fleming MF, Balousek SL, Klessig CL, Mundt MP, Brown DD. Substance use disorders in a primary care sample receiving daily opioid therapy. J Pain 2007; 8: 573-82.
    42. 42. Thorough assessment12 Assessment priorities Medication history and verification Current treatment providers Non-prescription and Illicit drug use Post-operative course after previous surgery Drug allergies (e.g. to NSAID, tramadol and gabanoids) Chronic pain diagnosis and prognosis Do current doses seem proportionate? Baseline pain scores and function Medical comorbidities: blood-borne viruses, liver disease Psychiatric comorbidities: personality disorders, anxiety 12. Huxtable CA, Roberts LJ. Acute pain management in opioid-tolerant patients: a growing challenge. Anaesth Intensive Care, 2011; 39:804-23.
    43. 43. Opiate Attractiveness Scale15 15. Butler SF, Benoit C, Budman SH, Fernandez KC, McCormick C, Venuti SW. Development and validation of an Opioid Attractiveness Scale: a novel measure of the attractiveness of opioid products to potential abusers. Harm Reduct J 2006; 3:5
    44. 44. Drug factors and misuse: opioid attractiveness • Abuse liability15 • Availability • Cost • Peer preferences • Drug features: speed of onset, routes, psychomimetic properties 15. Butler SF, Benoit C, Budman SH, Fernandez KC, McCormick C, Venuti SW. Development and validation of an Opioid Attractiveness Scale: a novel measure of the attractiveness of opioid products to potential abusers. Harm Reduct J 2006; 3:5
    45. 45. OAS rankings15 Hydrocodone Oxycodone SR Pentazocine and naloxone Morphine (MS Contin) Methadone Hydromorphone Fentanyl lozenges (Actiq) Morphine SR (Avinza) Morphine extended release (Kadian) Oxycodone and paracetamol Buprenorphine and naloxone Fentanyl matrix patch Butorphanol nasal spray Fentanyl reservoir patch (Duragesic) Decreasing ‘attractiven ess’
    46. 46. Relevance to the ED… “just go to the ED and say your back hurts and walk away with some oxy & benzos, and a note for a week off work too. Sweet!” •bluelight.org •drugs-forum.com •opiophile.com
    47. 47. Common scenario • Axial mechanical lumbo-sacral pain • Non-specific +/- radiating pain • NOT life-threatening • Majority spontaneously recover in 2/52 • Recurrences are common
    48. 48. SERIOUS is RARE RED FLAGS excluded •Trauma # •Neoplasm •Infxn •Neuro sequelae ‘Help me Doc I’m in pain…’
    49. 49. 1. Paracetamol • Well absorbed orally with peak levels approx 45 mins (slower if taken with food) • Duration of effect 1 – 4 hours • Hepatotoxic in overdose • Superadditive analgesic effect with opioids when levels are maintained.
    50. 50. 2. NSAID • Celecoxib 100-200mg BD • Naproxen 500mg BD • Meloxican 15mg OD For 2 days and then PRN CAUTION : Elderly, renal failure, vol. deplete
    51. 51. 3. Tramadol • Centrally acting, atypical, opioid analgesic • Serotonin and NA reuptake inhibition • Active metabolites with opioid like effects • Nociceptive & neuropathic components • Orally or IV 50 – 100 mg 4/24 PRN • Active metabolites renally excreted • Can have drug interactions with antidepressants • In those with previous mild adverse effects consider SR
    52. 52. 3. Opioids • Are not all created equal • Most cause hyperalgesia in a dose dependent fashion • Buprenorphine 200 – 400 mcg SL 2/24 PRN Explain need to dissolve under the tongue & will not work if swallowed • Reserve oxycodone for use in those > 70 years old • AVOID IV opioids if possible
    53. 53. Buprenorphine • Full mu opioid agonist • High receptor affinity – consider in naloxone reversal • Ceiling effect for resp. depression • SL route – onset 15-45 mins, peak @ 1 hr • Transdermal – onset 12-24 hours • Minimal gut effect • NOT dialysable, but minimal renal excretion • Primary site of action spinally NOT brain – less abuse potential
    54. 54. Gabapentinoids? • They bind to pre-synaptic voltage gated Calcium channels in the CNS and prevent release of excitatory neurotransmitters • They bind to and inhibit NMDA receptors in the CNS to also reduce Calcium influx into neurons (like Ketamine) • Modulate pain transmission & inhibit central sensitization
    55. 55. What are their clinical effects? • Antihyperalgesic • Stop the induction of pain by opioids and pain transmission itself • Reduce pain • NNT 3.6 for a 50% reduction in pain • Reduce opioid requirements • Reduce opioid side effects • Somnolence, pruritis, urinary retention, nausea and vomiting • Reduce incidence of chronic post operative pain by 50% to 90%.
    56. 56. What are their issues? • Only available orally • Pregabalin is PBS listed, but gabapentin can be $$ for patients • Gabapentin absorption is saturable • 600mg doesn’t give twice the concentrations as 300mg • Renally excreted unchanged • Time to peak plasma level for pregabalin 1 hour, peak CSF level 8 hours • Common side effects – sedation, dizziness/headache, visual disturbances
    57. 57. More benefits… • Because affect neurotransmitters, need to start at low doses and work up, and need to wean off if taken chronically • No pharmacokinetic drug interactions • Not a drug of dependence • Not lethal in overdose • Easily Dialysable • Excellent side-effect profile in comparison to alternative analgesics
    58. 58. Starting gabapentinoids • If starting with a plan to continue for 2 weeks, may need a brief Observation ward stay • Advise on drowsiness, if daytime somnolence problematic consider nocte only dose • Inform GP if able • Gabapentin 100mg TDS • Pregabalin 75 -150mg BD • Avoid in over 70’s – concern over falls…
    59. 59. 4. Other • Clonidine – Analgesic / anxiolytic • Clonazepam • Amitriptyline or Nortriptyline
    60. 60. Management after discharge • Follow-up • e.g. chronic pain review, GP review • Limiting durations of opioid therapy – consider time to resolution of acute episode • Avoiding potent opioids or choosing less ‘attractive’ opioids • Activity-based opioid regimen • Limit quantity of opioid on discharge • Reverse step ladder – wean • Advise on driving etc.