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Mallinckrodt Recognizes Patient Safety Awareness Week, Endorses Multimodal Analgesia Approach to Minimize Opioid Overuse in Hospital Acute Pain Management

CHESTERFIELD, United Kingdom - March 17, 2016 - Mallinckrodt plc (NYSE: MNK), a leading global specialty biopharmaceutical company, today announced its support of Patient Safety Awareness Week, March 13-19, 2016, and called for greater awareness of potential risks of the overreliance on opioids in the treatment of acute pain in U.S. hospitals.

Patient Safety Awareness Week is designed to increase awareness about patient safety concerns - including safe and responsible use of medications - among healthcare professionals and the public as a program of the National Patient Safety Foundation (NPSF), an independent, non-profit organization that works to advance patient safety and keep patients and healthcare professionals who care for them free from harm.

"At Mallinckrodt, we are committed to efforts that foster a healthcare environment that supports keeping patients safe and free from harm," said Steve Romano, MD, Senior Vice President and Chief Scientific Officer. "Patient Safety Awareness Week provides an important opportunity to raise awareness of how a multimodal analgesia approach - starting with non-opioid medications and minimizing or avoiding, if possible, opioid use - may provide a better way to help manage acute pain in hospitals. We applaud NPSF efforts in creating a platform that helps elevate critical dialogue on such patient safety issues."

Acute pain, which usually begins suddenly and lasts a short time, affects people of all ages.¹ Causes may include surgery, broken bones, dental work, burns or cuts, labor and childbirth.² More than 80% of patients report pain after surgery, and 86% of these patients report moderate, severe or extreme pain.³ Postoperative pain is the primary concern of most patients prior to surgery1 and pain is a major component of the recovery process.⁴

Still, more than 7 out of 10 hospitalized patients treated with intravenous (IV) analgesia receive IV opioids alone, ⁵ and while opioids can play an important role in acute and chronic pain treatment, the overuse of opioids in acute pain management in the hospital setting can present safety risks. Specifically:

• An overreliance on opioids alone or opioid monotherapy in hospitals is associated with serious adverse drug events,^6,7,8 including respiratory depression and death, falls, sedation, delirium and bowel obstructions^2,9,10 for all patients but in particular for certain patient groups, including the elderly, children, critically ill patients, and people who are obese, smoke, who have chronic sleep apnea, who have no recent opioid use and post-surgical patients.¹¹
• Safety risks associated with abuse, addiction and diversion continue to be a significant public safety concern.^12,13
• Unintended consequences of opioid overuse in hospitals is associated with increased costs to the healthcare system, including extended hospital length of stay and readmissions requiring a greater burden of care.^14,15,16

The use of a multimodal analgesia approach to pain treatment - one that uses non-opioid pain medicines in conjunction with lesser amounts of or without opioids - can help reduce potential associated unintended consequences.^{6,17,18,19,20} Safe and effective pain management is important - and should be individualized - for every patient, and Mallinckrodt supports this individualized, multimodal approach to treat acute pain in hospitals.

As part of Patient Safety Awareness Week, Mallinckrodt is hosting an educational webinar for healthcare professionals "The Use of Multimodal Analgesia in Treating Acute Pain: A Focus on Quality of Patient Care." The webinar will address unmet needs in acute pain management including the use of non-opioids as a foundation of multimodal analgesia and the importance of the patient experience in the era of HCAHPS (Hospital Consumer Assessment of Healthcare Providers and Systems).

Learn more about Patient Safety Awareness Week at unitedforpatientsafety.org.

ABOUT MALLINCKRODT
Mallinckrodt is a global business that develops, manufactures, markets and distributes specialty pharmaceutical and biopharmaceutical products and therapies, as well as nuclear imaging products. Areas of focus include autoimmune and rare diseases in specialty areas like neurology, rheumatology, nephrology and pulmonology; 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; its Specialty Generics segment includes specialty generic drugs, active pharmaceutical ingredients and external manufacturing; and the Nuclear Imaging segment includes nuclear imaging agents. 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 (SEC) 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:

Media
Rhonda Sciarra
Senior Communications Manager
314-654-8618
rhonda.sciarra@mallinckrodt.com

Meredith Fischer
Senior Vice President, Communications and Public Affairs
314-654-3318
meredith.fischer@mallinckrodt.com

Investor Relations
Coleman N. Lannum, CFA
Senior Vice President, Investor Strategy and IRO
314-654-6649
cole.lannum@mallinckrodt.com

¹ Savage SR, Kirsh KL, Passik SD. Challenges in Using Opioids to Treat Pain in Persons With Substance Use Disorders. Addiction Science & Clinical Practice. 2008;4(2):4-25.

² Acute vs. Chronic Pain, The Cleveland Clinic Website, Available at: http://my.clevelandclinic.org/services/anesthesiology/pain-management/diseases-conditions/hic-acute-vs-chronic-pain. Accessed Oct. 29, 2015.

³ Gan TJ, Habib AS, Miller TE, White W, Apfelbaum JL. Incidence, patient satisfaction, and perceptions of post-surgical pain: results from a US national survey. Curr Med Res Opin. 2014; 30 (1): 5149-160.

⁴ Pavlin DJ, Chen C, Penaloza DA, Buckley FP. A survey of pain and other symptoms that affect the recovery process after discharge from an ambulatory surgery unit. J Clin Anesthesia. 2004; 16(3): 200-206.

⁵ Premier Healthcare Alliance [paid-access hospital research database: data from January 2011-March 2015]. Charlotte, NC: Premier, Inc. Updated June 2015.

⁶ Remy C, Marret E, Bonnet F. Effects of acetaminophen on morphine side-effects and consumption after major surgery: meta-analysis of randomized controlled trials. Br J Anaesth. 2005;94(4):505-513.

⁷ Apfel CC, Korttila K, Abdalla M, et al. A factorial trial of six interventions for the prevention of postoperative nausea and vomiting. N Engl J Med. 2004;350(24):2441-2451.

⁸ Wheeler M, Oderda GM, Ashburn MA, Lipman AG. Adverse events associated with postoperative opioid analgesia: a systematic review. J Pain. 2002;3(3):159-180.

⁹ Morphine sulfate [package insert]. Lake Forest, IL: Hospira, Inc.; 2011.

¹⁰ Kane-Gill SL, Rubin EC, Smithburger PL, Buckley MS, Dasta JF. The cost of opioid-related adverse drug events. J Pain Palliat Care Pharmacother. 2014;28(3):282-293.

¹¹ The Joint Commission. Safe use of opioids in hospitals. Sentinel Event Alert. 2012;49:1-5.

¹² Hooten WM, St Sauver JL, McGree ME, Jacobson DJ, Warner DO. Incidence and risk factors for progression from short-term to episodic or long-term opioid prescribing: a population-based study. Mayo Clin Proc. 2015;90(7):850-856.

¹³ American College of Preventive Medicine (ACPM). Use, abuse, misuse, and disposal of prescription pain medication time tool: a resource from the American College of Preventive Medicine: a clinical reference. www.acpm.org/?UseAbuseRxClinRef. Published 2011. Accessed August 13, 2015.

¹⁴ The Advisory Board Company. Cost and quality impact of multi-modal pain regimens: an observational study of over 2.5 million cases from 400 acute care hospitals. Washington, DC; 2014.

¹⁵ Oderda GM, Gan TJ, Johnson BH, Robinson SB. Effect of opioid-related adverse events on outcomes in selected surgical patients. J Pain Palliat Care Pharmacother. 2013;27(1):62-70.

¹⁶ Pizzi LT, Toner R, Foley K, et al. Relationship between potential opioid-related adverse effects and hospital length of stay in patients receiving opioids after orthopedic surgery. Pharmacotherapy. 2012;32(6):502-514.

¹⁷ American Society of Anesthesiologists Task Force on Acute Pain Management. Practice guidelines for acute pain management in the perioperative setting: an updated report by the American Society of Anesthesiologists Task Force on Acute Pain Management. Anesthesiology. 2012;116(2):248-273.

¹⁸ Kehlet H, Dahl JB. The value of "multimodal" or "balanced analgesia" in postoperative pain treatment. Anesth Analg. 1993;77(5):1048-1056.

¹⁹ White PF. Multimodal analgesia: its role in preventing postoperative pain. Curr Opin Investig Drugs. 2008;9(1):76-82.

²⁰ Garcia RM, Cassinelli EH, Messerschmitt PJ, Furey CG, Bohlman HH.