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Form 8-K

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the

Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): December 6, 2012

Cadence Pharmaceuticals, Inc.

(Exact name of registrant as specified in its charter)

Delaware

001-33103

41-2142317

(State or other jurisdiction

of incorporation)

(Commission

File Number)

(IRS Employer

Identification No.)

12481 High Bluff Drive, Suite 200

San Diego, California 92130

(Address of principal executive offices, including zip code)

(858) 436-1400

(Registrant’s telephone number, including area code)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

¨	Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

¨	Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

¨	Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

¨	Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Item 7.01.

Regulation FD Disclosure.

Cadence Pharmaceuticals, Inc. (“Cadence”) hosted an Analyst and Investor Day on December 6, 2012. A copy of the slides used during the event is attached as Exhibit 99.1 to this Current Report on Form 8-K, and Theodore R. Schroeder, President and Chief Executive Officer of Cadence, and other executive officers expect to use selections from these slides at various upcoming meetings.

In accordance with General Instruction B.2. of Form 8-K, the information under Items 7.01 and 9.01 of this Current Report on Form 8-K, including Exhibit 99.1, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liability of that section, nor shall it be deemed incorporated by reference in any filing under the Exchange Act or the Securities Act of 1933, as amended, whether made before or after the date hereof, except as expressly set forth by specific reference to Items 7.01 and 9.01 to this Current Report on Form 8-K in such filing.

By filing this information, Cadence makes no admission as to the materiality of any information in this report. The information contained in this report and the exhibit hereto is intended to be considered in the context of Cadence’s filings with the Securities and Exchange Commission and other public announcements that Cadence makes, by press release or otherwise, from time to time. Cadence undertakes no duty or obligation to publicly update or revise the information contained in this report or the exhibit hereto, although it may do so from time to time as its management believes is appropriate. Any such updating may be made through the filing of other reports or documents with the Securities and Exchange Commission, through press releases, through its website or through other public disclosure.

Item 9.01.

Financial Statements and Exhibits.

(d) Exhibits.


Exhibit Number		Description of Exhibit
99.1		Analyst and Investor Day Presentation, dated December 6, 2012

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.


CADENCE PHARMACEUTICALS, INC.

By:		/s/ William R. LaRue
		William R. LaRue
		Senior Vice President, Chief Financial Officer, Treasurer and Assistant Secretary

Date: December 6, 2012

EXHIBIT INDEX


Exhibit Number		Description of Exhibit
99.1		Analyst and Investor Day Presentation, dated December 6, 2012

Analyst and Investor Day Presentation

Improving the lives of hospitalized patients

Cadence Pharmaceuticals

Analyst and Investor Day

Millennium Broadway Hotel

New York City

December 6, 2012

Exhibit

99.1

This presentation includes forward-looking statements, which are based on our current beliefs and expectations. Such statements include,

without limitation, statements regarding: the anticipated U.S. market opportunity for OFIRMEV; our financial estimates and projections; our

expectations regarding growth in customer base, market base, order rates and market penetration, and their ability to drive revenue growth

for

OFIRMEV;

physician

projections

regarding

OFIRMEV

utilization

surgical

inpatients

and

the

average

number

doses

administered

patients;

statements

regarding

the

prospects

for

approval

the

FTC

and

DOJ

our

settlement

with

Perrigo

Company,

and for ultimately receiving any payments under that settlement from Perrigo; our confidence in the strength of the patents covering

OFIRMEV and ability to prevail in the ongoing intellectual property litigation against Exela PharmaSci and its affiliates; the sustainability of

our core business; the sufficiency of our capital resources to fund our operations; and our ability to execute our strategies for acquiring, in-

licensing, developing and commercializing proprietary products principally for use in the hospital setting.

You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Our actual

future results may differ materially from our current expectations due to the risks and uncertainties inherent in our business. In addition, past

results and trends may not be indicative or a guarantee of future results or trends. These risks include, but are not limited to: our

dependence

the

successful

commercialization

OFIRMEV,

which

our

only

product;

our

ability

achieve

broad

market

acceptance

and generate revenues from sales of OFIRMEV; our dependence on our contract manufacturers and our ability to ensure an adequate and

continued supply of OFIRMEV to meet market demand; our ability to successfully enforce our marketing exclusivities and intellectual

property rights, and to defend the patents covering OFIRMEV, including our current patent litigation; the potential that we may be required

to continue patent litigation for substantial lengths of time, file additional lawsuits to defend our patent rights from challenges by Exela or

other companies that may submit ANDAs for generic versions of OFIRMEV, and the substantial costs associated with such lawsuits;

potential product liability exposure; the risk that we may not be able to raise sufficient capital when needed, or at all; and other risks detailed

under “Risk Factors”

and elsewhere in our Annual Report on Form 10-K for the period ended December 31, 2011, and our other filings

made with the Securities and Exchange Commission from time to time.

All forward-looking statements are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of

Section 21E of the Private Securities Litigation Reform Act of 1995 and we undertake no obligation to revise or update this presentation to

reflect events or circumstances after the date hereof.

Caution on forward-looking statements

CADENCE

, OFIRMEV

and the Cadence and OFIRMEV logos are trademarks of Cadence Pharmaceuticals, Inc.

Agenda

Introductory Remarks

Theodore R. Schroeder, President & CEO

Cadence Pharmaceuticals

OFIRMEV: Driving Sustainable Growth

Scott A. Byrd, Senior Vice President, Chief Commercial Officer

Cadence Pharmaceuticals

Clinical Experience with OFIRMEV

David Cziperle, M.D.

Clinical Assistant Professor of Thoracic and Cardiovascular Surgery at Loyola University

Q&A

Multi-modal

Pain

Management:

Potential

Improve

the

Cost

and

Quality

Care

Robert Ang, M.D., Vice President, Medical Affairs

Cadence Pharmaceuticals

Pain Management; A Hospital Pharmacist’s Perspective

John Marshall, PharmD, BCPS

Clinical Pharmacy Coordinator-Critical Care, Beth Israel Deaconess Medical Center

Q&A Panel

Closing Remarks

Theodore R. Schroeder, President & CEO

OFIRMEV

product overview

OFIRMEV

(acetaminophen) injection

A non-NSAID, non-opioid IV antipyretic / analgesic agent

Approved by FDA on November 2, 2010

Approved for:

–

Mild to moderate pain

–

Moderate to severe pain with adjunctive opioid

analgesics

–

Fever

–

Approved for use in adults and children 2 years of

age and older

OFIRMEV is contraindicated in patients with severe hepatic impairment, severe active liver

disease or with known hypersensitivity to acetaminophen or to any of the excipients in the

formulation.

Acetaminophen should be used with caution in patients with the following conditions:

hepatic impairment or active hepatic disease, alcoholism, chronic malnutrition, severe

hypovolemia, or severe renal impairment.

Do not exceed the maximum recommended daily dose of acetaminophen. Administration of

acetaminophen by any route in doses higher than recommended may result in hepatic

injury, including the risk of severe hepatotoxicity and death.

OFIRMEV should only be administered as a 15 minute intravenous infusion.

Discontinue OFIRMEV immediately if symptoms associated with allergy or hypersensitivity

occur. Do not use in patients with acetaminophen allergy.

The most common adverse reactions in patients treated with OFIRMEV were nausea,

vomiting, headache, and insomnia in adult patients and nausea, vomiting, constipation,

pruritus, agitation, and atelectasis in pediatric patients.

The antipyretic effects of OFIRMEV may mask fever in patients treated for post-surgical

pain.

To report SUSPECTED ADVERSE REACTIONS, contact Cadence Pharmaceuticals Inc. at 1-

877-MIS-CADX (1-877-647-2239) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

OFIRMEV

important safety information

OFIRMEV:

Driving Sustainable Growth

Scott A. Byrd

Senior Vice President,

Chief Commercial Officer

Cadence Pharmaceuticals

Launch,

Growth,

Expansion:

building

blocks

Stage III

Increase Doses Per

Patient

Stage II

Broaden Physician

Utilization

Stage I

Create Access

Launch,

Growth,

Expansion:

promotional

effort

Onco

(Acute

Pain)

Quality/

Administration

Burn/

Trauma

ICUs

RPh

ASA

Surg

Gen

Card

Neuro

Ortho

Ob/

Gyn

Other

Hospitals continue to add OFIRMEV to formulary

–

Formulary adoption exceeded company projections

–

Over 400 hospitals added OFIRMEV in 2012, for a total of over 2,000 formulary approvals

through Sep 2012

Launch

Performance:

rapid

formulary

penetration

Source: Cadence Internal Data

Significant and continuous growth in new customers

Launch Performance:

significant growth in new customers

Source: Source Healthcare Analytics, Source®

PHAST Institution, Oct 23, 2012.

•

10%

growth

unique

accounts

ordering

OFIRMEV

vs.

•

Growth driven by hospital adoption

Launch Performance:

rapid penetration of perioperative pain management

Source:

Premier Hospital Database, report provided by Premier Research Services Nov. 9, 2012

Analysis of patient discharge data

Sample includes over 400 hospitals representing approximately 4.5M surgical patient discharges/year

Launch Performance:

increasing utilization per patient

Source:

Premier Hospital Database, report provided by Premier Research Services Nov. 9, 2012

Analysis of patient discharge data

Sample includes over 400 hospitals representing approximately 4.5M surgical patient discharges/year

OFIRMEV sales continue to accelerate

•

Annualized October ‘12 sales $73M

Launch Performance:

significant sales growth through Oct 2012

Source:

Source

Healthcare

Analytics,

Source®

PHAST

Institution,

Nov

21,

2012.

Launch Performance:

top-tier revenue growth during first 2 years of launch

Source:

Source

Healthcare

Analytics,

Source®

PHAST

Institution.

Cubist

Pharmaceuticals,

Inc.

Form

10-Q

reports.

Based

Cadence

comparison

other

selected

product

launches

hospital

market

over

period

Mar

2006

–

Oct

2012.

OPAT utilization from Cubist Corporate Presentation, Cubist.IP.9.06.

** Cubicin monthly sales are averaged within each quarter

OFIRMEV hospital sales growth compares favorably vs. recent hospital

launches despite significantly lower price.

Launch Performance:

top-tier revenue growth during first 2 years of launch

Source:

Source

Healthcare

Analytics,

Source®

PHAST

Institution.

Cubist

Pharmaceuticals,

Inc.

Form

10Q

reports.

Based

Cadence

comparison

other

selected

product

launches

hospital

market

over

period

Mar

2006

–

Oct

2012.

OPAT utilization from Cubist Corporate Presentation, Cubist.IP.9.06.

** Cubicin monthly sales are averaged within each quarter

OFIRMEV hospital sales growth compares favorably vs. recent hospital

launches despite significantly lower price.

Achieving

Sustainable

Growth:

market

dynamics

*Awareness, Trial, Usage (ATU) study conducted by GfK Healthcare, May 2012 (n=180 surgeons and anesthesiologists)

Headwinds

–

Hospital silo management

–

Hospital budget pressures

Tailwinds

–

CMS and Joint Commission focus on quality of pain management

•

Value Based Purchasing Program, HCAHPS

•

Joint Commission Sentinel Event Alert “Safe Use of Opioids”

–

Positive physician and nurse experience with OFIRMEV

•

98% of physicians surveyed reported that OFIRMEV’s efficacy met or

exceeded their expectations*

•

2 of 3 indicate they are very likely to recommend to colleagues*

–

Growing base of positive local data (clinical and economic)

Achieving

Sustainable

Growth:

commercial

strategy

Broaden and deepen post-op pain utilization

–

Increase penetration of surgeon user base

–

Continue to improve ease of use (stocking at point of care, standing orders,

etc.)

–

Increase initiatives with front line caregivers–

nurses and physician

assistants

Expand into non-operative acute pain management

–

Non-operative acute pain management estimated to represent 30-40% of IV

analgesic use

–

Non-operative applications currently account for only about 10% of

OFIRMEV use

Demonstrate that multi-modal pain management may be a key

solution to the economic and quality squeeze being experienced

by hospitals

Long

Term

Growth

Opportunity:

three

key

drivers

Share of

Patients

Doses per

Patient

Price

Significant and

sustainable future

growth

Perioperative Pain

Population

Long

Term

Opportunity:

ketorolac

case

study

Limitations of NSAIDs

Benchmarking potential future use of OFIRMEV against ketorolac utilization

OFIRMEV Eligible

Population

NSAID

Treated

Population

Perioperative Pain Population

Contraindications/ Boxed Warnings:

Patients receiving aspirin or

NSAIDs

Nursing mothers & labor/delivery

Active or history of peptic

ulcers or GI bleeding

Advanced renal impairment

Prophylactic analgesic prior to

major surgery

High Risk of Bleeding

Long

Term

Opportunity:

patients

Physicians project OFIRMEV to be much more broadly utilized than

NSAIDs

Sources:

Premier

Hospital

Database,

report

provided

Premier

Research

Services

Nov

2012

**Awareness, Trial, Usage (ATU) study conducted by GfK Healthcare, May 2012 (n=180 surgeons and anesthesiologists)

Question: Thinking ahead to 3 years from now, what proportion of your surgical procedures do you expect to include the

use of OFIRMEV?

Long

Term

Opportunity:

doses

per

patient

Physicians project significant increases in doses per patient

Source: Awareness, Trial, Usage Study conducted by GfK Healthcare, May 2012

Question 1: When you use OFIRMEV, how many vials are you using per one typical surgical procedure?

Question 2: How many vials of OFIRMEV do you expect to use per one typical surgical procedure 3 years from now?

Long

Term

Growth

Opportunity:

three

key

drivers

Share of

Patients

Doses per

Patient

Price

Significant and

sustainable future

growth

David J. Cziperle, M.D., FACS

American Board of Surgery

American Board of Thoracic Surgery

31 Thoracic and Cardiovascular Surgeons

3 Vascular Surgeons

3500 annual Cardiac Procedures

4000 annual Thoracic/Vascular Procedures

22 Hospitals

21 Community Based Hospitals

1 University Based Hospital

Practice Area Encompasses 3 States and a 250 Mile

Geographic Radius

Multiple Healthcare Systems

Late 2010

I was contacted by a senior pharmaceutical representative

regarding a new product “Intravenous Acetaminophen”

Initial contact was approximately 5 minutes

Subsequent contact was approximately 90 minutes

My Initial Response

What’s the big deal….acetaminophen has been around

since the 1950s?

Why hasn’t an intravenous product been available?

Does it really work?

Is it safe?

Why should I use it instead of the traditional oral and

rectal acetaminophen products?

How much does it cost?

What I Subsequently Learned

OFIRMEV is the only drug of its kind. A new class of Non-Opioid, Non-

NSAID intravenous analgesic. Approved for use in adults and children

greater than 2 years of age. Also utilized to treat fever.

Used in Europe as PERFALGAN since 2002

Over 400 million doses utilized in 60 countries prior to US approval

A well established safety profile

Traditional utilization of oral and rectal acetaminophen has substandard

and unpredictable absorption that translates into an ineffective

patient

treatment response

Cost approximately $10.80 per dose

Early 2011

November 2010 presentation to Cadence Pharmaceutical

management team regarding daily clinical practice of a

Thoracic and Cardiovascular Surgeon

Opened a dialogue about potential OFIRMEV utilization in

patients undergoing Thoracic and Cardiovascular Surgical

Procedures

Traditional Analgesic Experience

Pain ….The Fifth Vital Sign

Patients who experience severe pain have a prolonged

recovery time and an increased risk of complications

Utilize narcotics/opioids for pain treatment

Narcotic related side effects are to be expected

Traditional Pain Treatment

Paradigm

Mild Pain……………Administer Narcotics/Opioids

Moderate Pain…….Administer More Narcotics/Opioids

Severe Pain…………Administer increasing doses of

Narcotics/Opioids.

Consider sustained

release products/Epidural/PCA

2004 ASA Task Force

Recommended a multi-modality pain management

strategy

Slow to gain traction as Traditional Pain Management

Paradigm was well entrenched

Surgeons continued to rely on narcotics/opioids as the

foundation of pain management

Surgeons began to embrace pain pumps/local nerve

blocks/NSAIDs

Surgeons primarily focused on live patient discharges with

little emphasis on patient satisfaction

2012 Pain Treatment Paradigm

Mild Pain……………Administer Non-Narcotic/Non-Opioid

(OFIRMEV)

Moderate Pain…….Administer Non-Narcotic/Non-Opioid

(OFIRMEV) Consider other Non-Narcotic/Non-Opioid

agents and techniques

Severe Pain…………Administer Narcotic/Opioids as an

adjunct to a foundation of Non-Narcotic/Non-Opioids

(OFIRMEV)

OFIRMEV…A New Product

Before Utilizing the First Dose

Physician exposure to the OFIRMEV clinical studies.

Outstanding improvement in patient satisfaction scores

coupled with decreased narcotic consumption in multiple

studies across multiple surgical specialties

Well Established Safety Profile

World-Wide Experience

Low Cost Per Dose

Obtaining Hospital Formulary Approval

Hospital Formulary Process

A Formal Process

Can be complicated with many potential pitfalls

Potential Restrictions to

Utilization….Surgeons/Anesthesiologists/NPO status/Not

Automatic Renewal

Committee

Members…...Physicians/Pharmacists/Administrators

IF YOU CANNOT PASS THE FORMULARY

PROCESS…..THE PRODUCT IS DOOMED!!!!!

Post-Formulary Approval

The Initial Physician Experience

Is OFIRMEV Effective?

Ease of Administration

Positive Patient Feedback

Positive Nursing Feedback

Any Adverse Effects?

Post-Formulary Approval

Initial Pharmacy Experience

Is there Physician interest in OFIRMEV?

Is OFIRMEV being utilized responsibly?

Impact of OFIRMEV on Pharmacy budget

Ordering/Storage/Distribution Issues

Is OFIRMEV placed at point of use or is it hidden in the

basement?

Institution Trial Impact Studies….Does OFIRMEV meet

expectations?

Navigating Through Pharmacy

Issues

Physician-Patient care relationship is paramount

Physicians must use OFIRMEV responsibly

Physician as educator of

Pharmacists/Administrators/Nursing Staff/Medical Staff

Persistence

December 2012

OFIRMEV Personal Experience

Approaching 18-24 months of clinical experience

Utilized in every patient unless contraindicated

Initial dose administered in the operating room

Duration of Use 24-48 hours (4-8 doses per patient)

Part of Standing Orders

No adverse effects noted to date

Good Patient Satisfaction Scores

December 2012

OFIRMEV Personal Experience

Many patients no longer receive narcotics/opioids

Selected patients bypass the PACU

Generally, Decreased Length of Stay

Overall Decreased use of Pain Pumps/Epidurals/PCAs

EMR/CPOE Best Practice Guidelines

OFIRMEV has been added to Orthopedic/Bariatric/General

Surgery/Plastic Surgery/Neurosurgery/Thoracic and

Cardiovascular standing order sets. Exceptional outcome

across 250 mile practice radius across multi-specialties

The Future…Beyond 2012

Impact of August 2012 Joint Commission Sentinel Event

Alert Regarding Safe Use of Opioids in Hospitals

HCAHPS……….Hospital Consumer Assessment of

Healthcare Providers and Systems

Affordable Care Act of 2010……..Hospital Reimbursements

Based on HCAHPS Scores

Physician Reimbursement Based on “Report Cards”

NEXT STEPS

Physician Education regarding multimodal pain

management strategy and utilization of OFIRMEV to

decrease narcotic/opioid consumption

Hospital CEO/CFO/administration education regarding

Budget Impact Model utilizing multimodal pain

management

to achieve narcotic/opioid reduction and

reduce adverse effects

The Joint Commission/HCAHPS/Affordable Care Act are

here to stay

NEXT STEPS

Hospital CEO/CFO acceptance of increased Pharmacy

costs due to OFIRMEV utilization in order to achieve

potential cost reduction benefit to the institution from

better patient satisfaction scores and decreased

narcotic/opioid utilization

Incorporation of OFIRMEV in best practice pattern subset

standing physician orders in EMR/CPOE systems

Achieving any of the above “Next Steps”

should lead to an

increase in OFIRMEV utilization

Multimodal Pain Management:

Potential to Improve the Cost and

Quality of Care

Dr. Robert Ang, MD MBA

Vice President, Medical Affairs

Cadence Pharmaceuticals

Opioids:

frequent

adverse

events

Type of Opioid-

Related Adverse

Event

Incidence Following:

PCA

Opioids

IM or IV Bolus

Opioids

Gastrointestinal

37.1%

28.2%

Central nervous

system

33.9%

75.9%

Pruritus

14.7%

13.9%

Urinary retention

16.4%

4.1%

Respiratory

depression

1.8%

2.4%

Source: Oderda G. Pharmacotherapy 2012;32(9 Suppl):6-11

Opioids:

considerable

costs

adverse

events

Estimated Per-Patient Cost Increase by

Opioid-Related Adverse Event Type

Ileus data from Simons R, et al. Reg Anesth Pain Med 2009; PS3:17; all other data from Oderda GM, et al. J Pain Symptom

Manage 2003 Mar;25(3):276-83. Inflation adjustment uses cost increases for inpatient hospital services.

Avoidance of Opioid-Related Adverse

Events May Reduce Hospital Costs

Retrospective

analysis

>180,000

surgical

inpatients

utilizing

the

Premier

Research

Database,

patients

undergoing

open/lap

colectomy,

lap

cholecystectomy,

hysterectomy

and

total

hip

replacement

Case matching used +/-

3 years of age, gender and APR severity of illness

Oderda GM, et al. Poster presented at 2011 Midyear Clinical Meeting of ASHP, New Orleans

The Joint Commission Sentinel Event Alert

Source: The Joint Commission Sentinel Event Alert. Safe use of opioids in hospitals. Issue 49; August 8, 2012.

•

What

Sentinel

Event?

–

Definition: an unexpected occurrence

involving death or serious physical or

psychological injury, or the risk thereof

–

Sentinel Event Alerts issued to compel

immediate investigation and response

•

New

Alert:

“Safe

use

opioids

hospitals”

–

Recommendations

for

pain

management

order

to avoid

opioid

overdose

–

Provide

numerous

actions

that

can

taken

avoid opioid-related

adverse

events

–

Endorses

the

use

non-opioids

first

line

approach

minimize

opioid

consumption

Inpatient Budget Impact Model

Use:

Proprietary, unbranded disease-state

awareness tool for population-based

decision makers only

Data Inputs:

•

Prepopulated (though customizable):

o

surgical procedure volume;

o

opioid-related adverse event

incidence rates (e.g. PONV,

ileus, respiratory depression);

and

o

adverse event incidence costs.

•

Facility’s goal for % opioid reduction

•

Relationship between opioid

reduction and adverse event

incidence reduction

Inpatient Budget Impact Model: Outputs

Model Outputs:

The model illustrates the

estimated budget impact

in several ways, providing

users with both high-level

and department-specific

summaries.

Potential overall savings

are displayed as:

annual cost savings,

cost savings per stay, or

cost savings per

procedure.

Note: Opioid consumption reduction is highly dependent on clinical trial design, and the clinical consequence of any

amount of opioid consumption reduction may not have been evaluated or demonstrated in a given trial.

IV Acetaminophen and Opioid Consumption

Sources: 1. Sinatra et al., Anesthesiology 2005; 102(4): 822-831; 2. Memis et al., J Critical Care 2010;25(3):458-462;

Data

file,

Cadence

Pharmaceuticals,

Inc.

;

Atef

al.,

Eur

Arch

Otorhinolaryngol

2008;

265(3):

351-3555.

JOHN MARSHALL, PHARMD, BCPS

CLINICAL COORDINATOR –

CRITICAL CARE

BETH ISRAEL DEACONESS MEDICAL CENTER

ADJUNCT ASSOCIATE PROFESSOR OF CLINICAL

PHARMACY

MASSACHUSETTS COLLEGE OF PHARMACY AND

HEALTH SCIENCES

BOSTON MA

IV Acetaminophen –

A Hospital

Pharmacy Perspective

Improve the Health & Well-Being

Of Patients, Families, Employees & Physicians

Through Innovative Clinical Care, Education, & Research

System

Advance as a system of care

Clinical

Care

Education

Research

People

Engage and develop

our people every day

Fiscal Year 2013

BIDMC

Operating Plan

True

North

Grow and enhance a market-leading system of care…

…that delivers the highest value…

…by creating and sustaining a culture of continuous improvement…

…through engagement, development, and support of our

employees, physicians, patients & families

•

Develop,

standardize, improve

transitions among

sites of care

•

Respond effectively

to the needs of our

network and

affiliates

•

Achieve optimal

alignment between

physicians &

hospitals

•

Enhance wellness

and safety

•

Promote & support a

culture of service

excellence and

continuous

improvement

•

Optimize & support

learning &

development

For new drugs, it can be easy for pharmacy

decision makers to think like this…

BIDMC Pharmacy

Silo Mentality

Thinks: “Am I

improving patient

care?”

“The best care is always

the cheapest care”

Thinks: “Am I

improving drug use?”

“I need to keep my

drug budget as small

as possible”

What makes BIDMC different?

The anatomy of a drug’s approval and subsequent

use at a hospital

Pharmacokinetics

Reaches 70% higher concentration (Cmax) than oral acetaminophen in

first 15 minutes, but overall AUC after 1 dose was the same.

Product information Cadence Pharmaceuticals, ofirmev.com

Better pain control

Better pain relief with

IV acetaminophen

compared to placebo

(under standard of

care)

Sinatra et al. Anesthesiology. 2005;102:822-831.

Opioid Reduction Effect

Less opioids

required when IV

acetaminophen is

used compared to

placebo (under

standard of care)

Sinatra et al. Anesthesiology. 2005;102:822-831.

Opioid reduction

This is an extremely attractive possibility with IV

acetaminophen

Sentinel Event Alert (Joint Commission)

Goal to reduce opioid side effects

Post operative nausea/vomiting

Postoperative ileus

Delirium/Over-sedation

Why did BIDMC add OFIRMEV to formulary?

IV acetaminophen was brought forth by critical care

physicians

There remains an unmet need in optimizing pain control

in the hospital setting

The American Society of Anesthesiologists recommends a

multi-modal approach to pain management

It was thought that being able to utilize IV

acetaminophen would also reinvigorate the use of PO

acetaminophen as an analgesic

IV acetaminophen approval

IV acetaminophen was approved for use in patients who

are unable to tolerate oral routes of acetaminophen

No formal (IT) restrictions were placed on the ordering or

duration of therapy

FY 2012 purchases

Overall use –

PACU vs. Inpatient

48% of utilization is for patients admitted to the general

ward/ICU

52% of utilization is in the Post Anesthesia Care Unit

(PACU)

Inpatient use

Inpatient use -

analgesia

Average age of patients: 60

Average number of doses per patient: 6

84% also receiving opioids

Utilization as a multi-modal agent

24% also receiving NSAIDs (ibuprofen, ketorolac)

Most common settings for inpatient use

Most common indications for inpatient use

Inpatient use

PACU Utilization

PACU

PACU practice is highly nurse-driven

Many orders for pain medications are written, and it

is left to the nurse to determine which agents are

utilized, and in what order.

PACU pain control and IV acetaminophen

First line for PACU pain control

Where IV acetaminophen fits especially well

Patients who are at-risk for opioid-induced side effects

Elderly

Obese

Dementia

Concomitant administration of other sedatives

Patients who have a history of experiencing opioid

adverse effects

Post-operative nausea and vomiting

Opioid-induced delirium

Additional considerations potentially affecting IV

acetaminophen utilization

Improving patient satisfaction

Reimbursement

Competition

Patient safety

Reducing preventable harm = Cost savings

What’s next?

Reducing needless variability in care for patients

experiencing pain across the medical center

Using evidence-based data to create better pain

control algorithms

Measuring clinical benefit from reduced opioid

utilization

Side effects

Patient satisfaction

Closing Remarks

Theodore R. Schroeder

President and Chief Executive Officer

Cadence Pharmaceuticals

Par IV litigation update:

settlement with Perrigo announced Nov. 28, 2012

Lawsuit against Perrigo / Paddock to be dismissed with prejudice

Exclusive right of first refusal granted to Perrigo to negotiate

authorized generic agreement with Cadence for the U.S.

Non-exclusive right granted to Perrigo to market generic IV

acetaminophen product under Perrigo’s ANDA, after Dec. 6, 2020, or

earlier under certain circumstances.

–

Perrigo would purchase the product exclusively from Cadence.

–

Cadence would receive product costs plus administrative fee, and

a royalty

payment based on net profits from sales of the AG product

Other details are confidential, and the agreements are subject to FTC /

DOJ review

Litigation remains ongoing against Exela Pharma Sciences, LLC, Exela

PharmaSci, Inc. and Exela Holdings, Inc.