STAINES-UPON-THAMES, United
Kingdom, July 9, 2018
/PRNewswire/ -- Mallinckrodt plc
(NYSE: MNK), a leading global specialty pharmaceutical company,
today announced two retrospective analyses that provide health
economic insights on use of OFIRMEV® (acetaminophen)
injection – intravenous (IV) acetaminophen – in total knee
arthroplasty (TKA) and its impact on length of stay, discharge
status and readmissions. Results from these two studies were
recently published in the Journal of Knee Surgery.
The intended audiences of these studies are population-based
decision makers with knowledge and expertise in the area of health
care economic analysis and its limitations.
"Postoperative pain can be difficult to control after TKA," said
Tunde Otulana, MD, Chief Medical
Officer at Mallinckrodt. "We are
pleased to share these additional studies that provide health
economic insights concerning IV acetaminophen in the management of
acute pain in the surgical setting."
Both retrospective analyses were conducted in the Premier Inc.
inpatient hospital database of patients who underwent TKA, and who
received either IV or oral acetaminophen from the day of surgery up
to day 3 as part of their postoperative pain management, from
January 2012 to September 2015. A total of 134,216 patients
receiving oral acetaminophen and 56,475 patients receiving IV
acetaminophen were included in the two studies.
Impact of Intravenous Acetaminophen on Lengths of Stay and
Discharge Status after Total Knee Arthroplasty1
assessed the postoperative outcomes of TKA patients who received IV
acetaminophen versus oral acetaminophen, evaluating the hospital
lengths of stay and discharge dispositions. Lengths of stay were
calculated as the number of days from the date of hospital
admission to the date of discharge, and the discharge disposition
was categorized as to home or to a skilled nursing facility
(SNF).
Key highlights of the analyses, after adjusting for baseline
characteristics between treatment groups, include:
- Compared with the oral group, the IV acetaminophen group had a
0.14-day shorter length of stay (95% confidence
interval2 [CI], –0.15 to –0.13; p < 0.001).
- Compared with the oral group, the IV group was 22% more likely
to be discharged to home (odds ratio [OR] = 1.22; 95% CI, 1.19 to
1.25; p < 0.001).
- Compared with the oral group, the IV group was 13% less likely
to be discharged to a SNF (OR=0.87; 95% CI, 0.85 to 0.90; p <
0.001).
Intravenous Acetaminophen May Be Associated with Reduced Odds
of 30-Day Readmission after Total Knee Arthroplasty3
evaluated 30-day hospital readmission rates in TKA patients who
received either IV or oral acetaminophen perioperatively and sought
to extrapolate the potential annual cost savings on a national
level. All causes of readmissions that occurred between patient
discharge and 30 days post discharge were recorded.
Key highlights include:
- The readmission rate was 0.04% in the IV and 0.14% in the oral
acetaminophen cohorts.
- After adjusting for baseline characteristics between the
treatment groups, IV acetaminophen was associated with a 71%
decreased likelihood of readmission within 30 days (OR=0.29; 95%
CI, 0.23 to 0.351; p < 0.001) when compared to oral
acetaminophen.
- The reduction in readmissions in the IV acetaminophen group may
potentially result in $160 million
savings per year on a national level, after accounting for the
medication cost.
These two analyses were company-sponsored and conducted in
collaboration with researchers primarily from the University of Washington School of Pharmacy,
Cleveland Clinic and Joint Replacement Center of Texas.
Limitations of these Studies
- Data from these studies were obtained from a large
observational administrative database, which can be subject to
errors in data collection or data entry.
- Dosage and amount of acetaminophen were recorded from hospital
charges instead of what was actually given to the patients.
- Other adjuvant pain control modalities, such as nerve blocks
and wound infiltration, were not assessed or controlled for.
However, potential for bias is minimized since these modalities are
commonly used with both IV and oral acetaminophen.
- Like other healthcare databases, the Premier database can only
capture patient records after readmission to the same network
hospital. Therefore, the true readmission rate might actually be
larger.
INDICATIONS AND USAGE
OFIRMEV (acetaminophen)
injection is indicated for the management of mild to moderate pain
in adult and pediatric patients 2 years and older, the management
of moderate to severe pain with adjunctive opioid analgesics in
adult and pediatric patients 2 years and older, and the reduction
of fever in adult and pediatric patients.
IMPORTANT SAFETY INFORMATION
WARNING: RISK OF
MEDICATION ERRORS AND HEPATOTOXICITY See
full prescribing information for complete boxed
warning
|
|
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.
- In patients with severe hepatic impairment or severe active
liver disease.
WARNINGS AND PRECAUTIONS
- Administration of acetaminophen in doses higher than
recommended (by all routes of administration and from all
acetaminophen-containing products including combination products)
may result in hepatic injury, including the risk of liver failure
and death.
- Use caution when administering acetaminophen in patients with
the following conditions: hepatic impairment or active hepatic
disease, in cases of alcoholism, chronic malnutrition, severe
hypovolemia, or severe renal impairment (creatinine clearance ≤ 30
mL/min).
- Discontinue OFIRMEV immediately at the first appearance of skin
rash and if symptoms associated with allergy or hypersensitivity
occur. Do not use in patients with acetaminophen allergy.
- Take care when prescribing, preparing, and administering
OFIRMEV injection to avoid dosing errors which could result in
accidental overdose and death. (5.3)
ADVERSE REACTIONS
- The most common adverse reactions in patients treated with
OFIRMEV were nausea, vomiting, headache, and insomnia in adult
patients; nausea, vomiting, constipation, and pruritus in pediatric
patients.
For additional Important Safety Information, including complete
Boxed Warning, please click here for Full Prescribing
Information, which can also be found at OFIRMEV.com.
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.
CAUTIONARY STATEMENTS RELATED TO FORWARD-LOOKING
STATEMENTS
This release includes forward-looking statements
concerning OFIRMEV® (acetaminophen) injection, including
anticipated benefits associated with its use. The statements are
based on assumptions about many important factors, including the
following, which could cause actual results to differ materially
from those in the forward-looking statements: satisfaction of
regulatory and other requirements; actions of regulatory bodies and
other governmental authorities; changes in laws and regulations;
issues with product quality, manufacturing or supply, or patient
safety issues; and other risks identified and described in more
detail in the "Risk Factors" section of Mallinckrodt's most recent Annual Report on Form
10-K and other filings with the SEC, all of which are available on
its website. The forward-looking statements made herein speak only
as of the date hereof and Mallinckrodt
does not assume any obligation to update or revise any
forward-looking statement, whether as a result of new information,
future events and developments or otherwise, except as required by
law.
ABOUT MALLINCKRODT
Mallinckrodt is a global business that develops,
manufactures, markets and distributes specialty pharmaceutical
products and therapies. 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
gastrointestinal products. 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
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time-critical information regarding the company in advance of or in
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Securities and Exchange Commission (SEC) disclosing the same
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Relations page of the website for important and time-critical
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information is made available on the Investor Relations page of the
website.
CONTACTS
Media
Rhonda Sciarra
Senior Communications Manager
908-238-6765
rhonda.sciarra@mnk.com
Meredith Fischer
Chief Public Affairs Officer
314-654-3318
meredith.fischer@mnk.com
Investor Relations
Daniel J. Speciale, CPA
Investor Relations and Strategy Officer
314-654-3638
daniel.speciale@mnk.com
Mallinckrodt, the "M" brandmark and
the Mallinckrodt Pharmaceuticals logo are trademarks of a
Mallinckrodt company. Other brands are
trademarks of a Mallinckrodt company or
their respective owners. © 2018 07/18
1 Barrington JW, Hansen RN, Lovelace B et al. Impact
of Intravenous Acetaminophen on Lengths of Stay and Discharge
Status after Total Knee Arthroplasty. Journal of Knee
Surgery. 2018 Mar 7.
2 A range of values so defined that there is a specified
probability that the value of a parameter lies within it.
3 Mont MA, Lovelace B, Pham A et al. Intravenous
Acetaminophen May Be Associated with Reduced Odds of 30-Day
Readmission after Total Knee Arthroplasty. Journal of Knee
Surgery. 2018 May 7.
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SOURCE Mallinckrodt plc