title: A retrospective cohort study of long-term immediate-release hydrocodone/acetaminophen use and acetaminophen dosing above the Food and Drug Administration recommended maximum daily limit among commercially insured individuals in the United States (2008-2013).
abstract: Immediate-release (IR) hydrocodone/acetaminophen is the most prescribed opioid in the United States; however, patterns of use, including long-term treatment and dose, are not well described. Duration of use, including the percentage of patients on long-term treatment (>90 days of continuous use), was assessed for patients newly prescribed IR hydrocodone/acetaminophen compared to other opioid analgesics in a national commercial insurance database (January 2008-September 2013). Though only a small percentage of IR hydrocodone/acetaminophen patients continued treatment long-term (1.7%), the number was large (104,839) and was nearly 5 times the number receiving extended-release (ER) morphine (n = 22,338) and nearly 4 times the number receiving ER oxycodone (n = 26,946) long-term. Using a less conservative allowable gap in treatment increased the number of patients meeting the criteria for long-term use (approximately 160,000 for IR hydrocodone/acetaminophen vs <30,000 for ER morphine and ER oxycodone). Most patients meeting these criteria received IR hydrocodone doses between >20 and ≤60 mg/d (n = 56,220, 53.6%) in month 4; 5.5% (n = 5,743) received doses >60 mg/d. Moreover, approximately 15% of IR hydrocodone/acetaminophen patients (n > 900,000) were prescribed total daily acetaminophen doses exceeding 4 g (the limit recommended by the U.S. Food and Drug Administration) at their initial IR hydrocodone/acetaminophen prescription or any time during therapy.
  
  
  CONCLUSIONS
  Although most patients were prescribed IR hydrocodone/acetaminophen for acute pain, the number of patients prescribed long-term therapy exceeds the number of patients prescribed ER opioids. It is important to consider the benefits and risks inherent with long-term opioid therapy, whether with IR or ER opioids, to ensure safe use of these products.
authors.affiliation: Purdue Pharma LP, Stamford, Connecticut. Electronic address: angela.deveaugh-geiss@pharma.com.
authors.forename: Angela
authors.initials: A
authors.lastname: DeVeaugh-Geiss
authors.affiliation: Purdue Pharma LP, Stamford, Connecticut.
authors.forename: Aditi
authors.initials: A
authors.lastname: Kadakia
authors.affiliation: Purdue Pharma LP, Stamford, Connecticut.
authors.forename: Howard
authors.initials: H
authors.lastname: Chilcoat
authors.affiliation: Purdue Pharma LP, Stamford, Connecticut.
authors.forename: Louis
authors.initials: L
authors.lastname: Alexander
authors.affiliation: Purdue Pharma LP, Stamford, Connecticut.
authors.forename: Paul
authors.initials: P
authors.lastname: Coplan
mesh_terms: D000082:Acetaminophen / Q000627:therapeutic use*; D000293:Adolescent; D000328:Adult; D000701:Analgesics, Opioid / Q000627:therapeutic use*; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000627:therapeutic use*; D015331:Cohort Studies; D004338:Drug Combinations; D016503:Drug Delivery Systems / Q000379:methods / Q000592:standards; D005260:Female; D006801:Humans; D006853:Hydrocodone / Q000627:therapeutic use*; D007357:Insurance, Physician Services / Q000706:statistics & numerical data; D008297:Male; D008875:Middle Aged; D010146:Pain / Q000188:drug therapy*; D010147:Pain Measurement; D013997:Time Factors; D014481:United States; D014486:United States Food and Drug Administration / Q000592:standards*; D055815:Young Adult
chemical_list: D000701:Analgesics, Opioid; D000894:Anti-Inflammatory Agents, Non-Steroidal; D004338:Drug Combinations; C083640:acetaminophen, hydrocodone drug combination; D000082:Acetaminophen; D006853:Hydrocodone
keywords: Hydrocodone; acetaminophen; immediate-release opioids; long-term opioid therapy; utilization