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Formulary_Proposal_Presentation (4)

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Formulary_Proposal_Presentation (4)

  1. 1. Acetaminophen (APAP)/Opioid Combination Oral Product Safety Initiative Carrie Recker, PharmD Candidate Sue Skledar, RPh, MPH, FASHP, UPMC System On behalf of the System Pain Management Physician Advisory and Pharmacy Work Groups
  2. 2. •  Acetaminophen metabolized in the liver •  Glucuronide conjugation and sulfation process with renal excretion à Inactive (nontoxic) metabolites •  Small component: metabolized by CYP450 system to N-acetyl-p-benzoquinoneimine (NAPQI) •  Liver-toxic metabolite quickly detoxified by glutathione •  Large APAP dosesà saturated conjugation processà glutathione depletedà NAPQI buildupà liver injury •  In acute overdose, signs may not be apparent until 3-5 days after initial ingestion Mechanism of APAP-Induced Liver Toxicity
  3. 3. Acetaminophen Hazards •  2007: Analgesics were the most commonly occurring drug category contributing to ED visits •  2011: In patients aged >40 years, the rate of ED visits related to use of opioid-containing acetaminophen products was four times higher than the rate of visits from non-opioid-containing products •  2013: Acetaminophen poisoning is the most common medication poisoning reported to U.S. poison centers and accounts for more than 30,000 hospital admissions every year in the U.S. alone. National Hospital Ambulatory Medical Care Survey: 2007 Emergency Department Summary. http://www.cdc.gov/nchs/data/nhsr/nhsr026.pdf. (Accessed August 20, 2014). Am J Prev Med. 2011;40:585-592. West J Emerg Med. 2013; 14:218-226.
  4. 4. Jun 2009" Action Timeline Jan 2011" •  FDA asks manufacturers to limit strength of APAP in combination products to 325 mg per dosage unit" July 2012" •  UPMC removes APAP/opioid combination products >325 mg from formulary " •  Auto- substitution of lower APAP- containing combination product" January 2014" •  Manufacturer limits become mandatory and products containing >325 mg APAP per dosage unit are removed from market" UPMC Cerner 4g/day dosing rule active since May 2007 Drug Safety and Risk Management Advisory Committee, Nonprescription Drugs Advisory Committee, and the Anesthetic and Life Support Drugs Advisory Committee of the FDA Center for Drug Evaluation and Research Meeting. (2009). http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/DrugSafetyandRiskManagementAdvisoryCommittee/ UCM179888.pdf. (Accessed 2014 Aug 21). •  McNeil changes OTC product labeling 3000 mg daily limit." •  Adult dose maximum remains 4000 mg per day" •  Infant Tylenol labeling and concentration change" •  FDA Advisory Panel votes (20 to 17) to ban all APAP- containing narcotic combination products" Aug 2011"
  5. 5. Current Dosing per Product Labeling APAP 325 mg oral! APAP 500 mg oral! APAP IV! 10 mg/ml ! Adult Dosing Directions! 2 tablets by mouth every 4-6 hours" 2 tablets by mouth every 6 hours" 1000 mg every 6 hours OR 650 mg every 4 hours" Maximum Daily Dose! Not to exceed 10 tablets in 24 hours" Not to exceed 6 tablets in 24 hours" Minimum dosing interval of 4 hours" (4000 mg)" APAP total in 24 hours! 3.25 grams" (3250 mg)" 3 grams" (3000 mg)" 4 grams" (4000 mg)" Tylenol prescribing information. Fort Washington, PA: McNeil Consumer Healthcare; 2010. Ofirmev prescribing information. San Diego,CA: Cadence Pharmaceuticals; 2010 Nov.
  6. 6. What is our next UPMC action step for Safety? 6
  7. 7. Commonly Prescribed APAP/Opioid Products 7 Medication Components Can both separate ingredients be dispensed?" Percocet® " 5/325 mg tablet" Oxycodone/APAP" Oxycodone 5 mg plus APAP 325 mg" Ultracet® " 37.5/325 mg tablet" Tramadol/APAP" Tramadol 50 mg plus APAP 325 mg" Tylenol® #3 tablet" 30 mg Codeine/ 300 mg APAP" Codeine 30 mg plus APAP 325 mg" Tylenol® #4 tablet" 60 mg Codeine/ 300 mg APAP" Codeine 60 mg plus APAP 325 mg" Vicodin®" 5/300 mg tablet" Hydrocodone/APAP" N/A; no immediate-release hydrocodone product available" Norco® " 5/325 mg tablet" Hydrocodone/APAP" N/A; no immediate-release hydrocodone product available"
  8. 8. 2014 Survey of Hospital Practices Site Eliminated combination products? Which agents? Do pharmacists interchange? Northwestern  Memorial  Hospital  (IL)   Par7al   Percocet,  Percodan  off   formulary   No;  use  Norco  products   Rush  University  Medical  Center  (IL)   Yes   Ultracet,  Vicodin  5/500   Yes;  Percocet.  Ultram  and  APAP   ordered  separate.  Use  Norco   products   Albany  Medical  Center  Hospital  (NY)   Yes   Percocet     Yes  (implementa7on  through   CPOE  order  sets)   Staten  Island  University  Hospital  (NY)   Yes     All  except  Percocet   Yes   Froedtert  &  The  Medical  College  of   Wisconsin  (WI)   Yes   Percocet,  Ultracet   Yes   Santa  Clara  Valley  Hospital  and   Health  System  (CA)   Par7al   Tylenol  w/codeine  liquid   (peds)   Yes.  Norco,  Percocet,  Tylenol  #3   s7ll  on  formulary   University  of  Virginia  Health  System   Yes   Percocet   Tylenol  w/codeine     (all  products)   Yes   UPMC  Hamot   Par7al   All  except  Vicodin   Yes   UPMC  Bedford   Par7al   Ultracet   Yes   Data Source: UHC Consortium. August 2014
  9. 9. Recommendations •  The following oral APAP/opioid combination products be designated non-formulary: •  Percocet®, Ultracet®, Tylenol® No. 3 and No. 4 with Codeine •  No new starts of these combination products in-house •  Pharmacists will automatically interchange to separate components at appropriate dosing frequency •  Example: Percocet 5/325 1 tablet Q6H PRN = one oxycodone 5 mg Q6H PRN plus one APAP 325 mg Q6H prn •  Pharmacist will not interchange to APAP separate component order if patient already has an active APAP order •  Pharmacist will automatically discontinue duplicate APAP orders if they are active on the patient’s profile. •  Acetaminophen/codeine oral solution, if ordered, will be automatically interchanged to hydrocodone oral solution (5 mg/5mL with homatropine 1.5 mg/5 mL [Hydromet®]) •  If patient continuing these products as a home medication: •  Pharmacist will interchange to individual components •  Norco® [or Vicodin®] products (hydrocodone/APAP): •  Pharmacist will dispense the combination product as prescribed for new or home continuation orders due to lack of availability of immediate-release hydrocodone product at this time

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