Health Economic Data on OFIRMEV® (Acetaminophen) Injection Presented at 28th Annual National Forum of the Institute for Healthcare Improvement
CHESTERFIELD, United Kingdom,
"Triple Aim as a Conceptual Framework for
The analysis included patients undergoing total knee arthroplasty starting on the day of surgery and continuing up to the third postoperative day, and examined the impact of IV acetaminophen (OFIRMEV) versus oral acetaminophen – administered as components of a multimodal analgesia (MMA) pain management strategy – on:
- Health care expenditures measured in terms of hospital length of stay (LOS) and total hospitalization costs,
- Patient experience related to potential opioid-related complications and opioid consumption, and
- Population health measures reflecting post-hospital discharge outcomes including 30-day readmissions and discharge status to home or skilled nursing facility.
The retrospective cohort analysis of the
The retrospective analysis showed that, compared to oral acetaminophen, use of IV acetaminophen as a component of MMA pain management was associated with:
- Health care expenditures: Shorter LOS and decreased hospitalization costs;
- Patient experience: Reduced opioid-use and opioid-related complications;
- Population health: Lower likelihood of 30-day readmissions or discharge to skilled nursing facility, and greater likelihood of home discharge.
The analysis was conducted in collaboration with researchers from the
Health Economic Research Limitations
- The differences observed between IV and oral acetaminophen patients on outcomes (e.g., LOS, hospitalization costs, morphine equivalent dose, hospital discharge status or readmissions, bowel obstruction, nausea/vomiting, respiratory depression) could be explained by unmeasured confounders. Investigators attempted to statistically adjust for these differences in accounting for potentially confounding variables, but unmeasured factors might still play a role in the associations reported.
- The medication use data in the Premier database reflects the amount and dose charged rather than what was administered. However, systematic differences in billing of other pain medications between patients who did or did not receive IV acetaminophen is not suspected.
- The population of patients seen in Premier hospitals is not randomly sampled although the database represents 20 percent of all hospitalizations in the U.S. Therefore, these results may not be generalizable outside of Premier hospitals.
ABOUT OFIRMEV (Acetaminophen) Injection
OFIRMEV is the first and only IV formulation of acetaminophen to be approved and currently marketed in
INDICATIONS AND USAGE
OFIRMEV (acetaminophen) Injection is indicated for the management of mild to moderate pain, management of moderate to severe pain with adjunctive opioid analgesics, and reduction of fever.
IMPORTANT RISK INFORMATION
WARNING: RISK OF MEDICATION ERRORS AND HEPATOTOXICITY
Take care when prescribing, preparing, and administering OFIRMEV Injection to avoid dosing errors which could result in accidental overdose and death. In particular, be careful to ensure that:
OFIRMEV contains acetaminophen. Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant and death. Most of the cases of liver injury are associated with the use of acetaminophen at doses that exceed the recommended maximum daily limits, and often involve more than one acetaminophen-containing product.
- Acetaminophen is contraindicated in patients with:
- known hypersensitivity to acetaminophen or to any of the excipients in the IV formulation.
- severe hepatic impairment or severe active liver disease.
WARNINGS AND PRECAUTIONS
- Administration of acetaminophen in doses higher than recommended may result in hepatic injury, including the risk of liver failure and death. Do not exceed the maximum recommended daily dose of acetaminophen. The maximum recommended daily dose of acetaminophen includes all routes of acetaminophen administration and all acetaminophen-containing products administered, including combination products. Dosing errors could result in accidental overdose and death.
- Use caution when administering acetaminophen in patients with the following conditions: hepatic impairment or active hepatic disease, alcoholism, chronic malnutrition, severe hypovolemia (e.g., due to dehydration or blood loss), or severe renal impairment (creatinine clearance = 30 mL/min).
- Rarely, acetaminophen may cause serious skin reactions such as acute generalized exanthematous pustulosis, Stevens-Johnson Syndrome, and toxic epidermal necrolysis, which can be fatal.
- Hypersensitivity and anaphylaxis associated with the use of acetaminophen have been reported. Clinical signs included swelling of the face, mouth, and throat, respiratory distress, urticaria, rash, and pruritus.
- The antipyretic effects of OFIRMEV may mask fever.
- Serious adverse reactions may include hepatic injury, serious skin reactions, hypersensitivity, and anaphylaxis.
- Common adverse reactions in adults include nausea, vomiting, headache, and insomnia. Common adverse reactions in pediatric patients include nausea, vomiting, constipation, pruritus, agitation, and atelectasis.
USE IN SPECIFIC POPULATIONS
- Pregnancy Category C. OFIRMEV should be given to a pregnant woman only if clearly needed.
- Breastfeeding: While studies with OFIRMEV have not been conducted, acetaminophen is secreted in human milk in small quantities after oral administration.
- Pediatric Use: The effectiveness of OFIRMEV for the treatment of acute pain and fever has not been studied in pediatric patients < 2 years of age.
For additional Important Risk Information, including complete boxed warning, see Full Prescribing Information.
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 The IHI Triple Aim is a framework developed by the
- Improving the patient experience of care (including quality and satisfaction);
- Improving the health of populations; and
- Reducing the per capita cost of health care.
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