CHESTERFIELD, United Kingdom, Dec.
7, 2016 /PRNewswire/ -- Mallinckrodt Pharmaceuticals
(NYSE: MNK), a leading global specialty pharmaceutical company,
announced results from a retrospective, claims-based health
economic analysis on use of intravenous (IV)
acetaminophen versus oral acetaminophen for managing
post-operative pain in patients undergoing total knee arthroplasty.
The results were presented Tuesday, Dec. 6,
2016, at the 28th Annual National Forum on
Quality Improvement in Health Care of the Institute for Healthcare
Improvement (IHI) in Orlando,
Fla.
"Triple Aim as a Conceptual Framework for Conducting Comparative
Effectiveness Research in Postoperative Pain" [Pham A, Hansen R,
Böing EA, Wan GJ, Lovelace B, Miller TE] utilized IHI's Triple Aim
framework[1] to assess certain outcomes resulting from different
treatment strategies for postoperative pain management. Triple Aim
requires simultaneous pursuit of reducing health care expenditures,
improving patient experience and advancing population health.
(Access the data abstract and/or poster online. Please note you
will need to register on the website and then type "Mallinckrodt" into the organization search field on
the right.)
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 Premier Inc. inpatient
hospital database from January 2012
to September 2015 included 190,691
total knee arthroplasty surgical patients from U.S. hospitals, with
56,475 patients (30%) receiving IV acetaminophen. Subjects were
included regardless of additional pain management modalities
administered.
Results
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 University of Washington
School of Pharmacy and Duke University
School of Medicine.
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 the United
States. The U.S. Food and Drug Administration approved
OFIRMEV in November 2010. OFIRMEV is
available to hospitals and outpatient and ambulatory surgical
centers across the U.S.
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:
|
- the dose in milligrams (mg) and
milliliters (mL) is not confused;
|
- the dosing is based on weight for patients
under 50 kg;
|
- infusion pumps are properly programmed;
and
|
- the total daily dose of acetaminophen from
all sources does not exceed maximum daily limits.
|
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.
|
CONTRAINDICATIONS
- 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.
ADVERSE REACTIONS
- 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.
ABOUT MALLINCKRODT
Mallinckrodt is a global business that develops,
manufactures, markets and distributes specialty pharmaceutical
products and therapies, as well as nuclear imaging products. Areas
of focus include autoimmune and rare diseases in specialty areas
like neurology, rheumatology, nephrology, pulmonology and
ophthalmology; immunotherapy and neonatal respiratory critical care
therapies; analgesics and hemostasis products; and central nervous
system drugs. The company's core strengths include the acquisition
and management of highly regulated raw materials and specialized
chemistry, formulation and manufacturing capabilities. The
company's Specialty Brands segment includes branded medicines and
its Specialty Generics segment includes specialty generic drugs,
active pharmaceutical ingredients and external manufacturing. To
learn more about Mallinckrodt, visit
www.mallinckrodt.com.
Mallinckrodt uses its website as a
channel of distribution of important company information, such as
press releases, investor presentations and other financial
information. It also uses its website to expedite public access to
time-critical information regarding the company in advance of or in
lieu of distributing a press release or a filing with the U.S.
Securities and Exchange Commission disclosing the same information.
Therefore, investors should look to the Investor Relations page of
the website for important and time-critical information. Visitors
to the website can also register to receive automatic e-mail and
other notifications alerting them when new information is made
available on the Investor Relations page of the website.
CONTACTS
Investor Relations
Coleman N.
Lannum, CFA
Senior Vice President, Investor Strategy and IRO
314-654-6649
cole.lannum@mallinckrodt.com
Daniel J. Speciale, CPA
Director, Investor Relations
314-654-3638
daniel.speciale@mallinckrodt.com
Media
Rhonda
Sciarra
Senior Communications Manager
908-238-6765
rhonda.sciarra@mallinckrodt.com
Meredith Fischer
Chief Public Affairs Officer
314-654-3318
meredith.fischer@mallinckrodt.com
[1] The IHI Triple Aim is a framework developed by the Institute
for Healthcare Improvement that describes an approach to optimizing
health system performance. It is IHI's belief that new designs must
be developed to simultaneously pursue three dimensions, which the
IHI calls the "Triple Aim":
- 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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SOURCE Mallinckrodt Pharmaceuticals