In keeping with Hospira's values, Integrity and Ownership/Accountability,
ethics and compliance are important to how the corporation operates. Some of the
many steps Hospira is taking to comply with applicable laws, regulations and other
requirements are provided below.
CALIFORNIA
Declaration
This Declaration is made by Hospira, Inc. as of July 1, 2011, in accordance with
the provisions of California Health & Safety Code §§ 119400 et seq., also
known as CA S.B. 1765 ("California Law").
Hospira, Inc.'s Vision is "Advancing Wellness™ … through the right people
and the right products." Guided by that vision and values, two of which are Integrity
and Ownership/Accountability, Hospira is committed to the highest standards of ethical
practice. Hospira’s employees and contractors are expected to follow Hospira’s
Code of Business Conduct
(“Code”) which serves as the company’s ethical compass. As a part
of the company's ongoing efforts in the area of ethics and compliance, Hospira has
adopted a comprehensive compliance program ("Compliance Program") designed to ensure
compliance with, and to prevent and detect violations of, applicable laws and other
requirements related to interactions with licensed prescribers of drugs and other
healthcare professionals.
Hospira’s Compliance Program is in accordance with the Compliance Program
Guidance for Pharmaceutical Manufacturers issued in April 2003 by the Office of
Inspector General of the Department of Health and Human Services ("OIG Guidance").
In order to align Hospira's activities with the OIG Guidance as well as applicable
laws and industry codes, the company has tailored its Compliance Program to address
the wide variety of interactions that Hospira, as a manufacturer and supplier of
specialty injectable pharmaceutical drugs and medication delivery technology, has
with healthcare professionals.
The California Law states that pharmaceutical companies shall include in their compliance
programs policies for compliance with the PhRMA Code of Ethics (PhRMA Code). Because Hospira has both pharmaceutical products
and medical devices within its product portfolio, Hospira has implemented a set
of policies and procedures that conform with the 2009 versions of the PhRMA Code
and the
AdvaMed Code of Ethics. The AdvaMed Code is substantially similar to the
PhRMA Code. The limited distinctions between the two codes have been recognized
in Hospira's policies and procedures, where relevant, based on the distinction between
interactions with healthcare professionals regarding pharmaceutical products on
the one hand and medical devices on the other
Hospira recognizes that it is in the best interests of patients, the end users of
Hospira's products, for Hospira to educate and train healthcare professionals in
the use of its medical technology. Consequently, for interactions with healthcare
professionals related solely to Hospira's medical devices, Hospira requires its
employees to adhere to provisions that are based on the AdvaMed Code. Hospira is
a member of AdvaMed and in December 2009, Hospira certified to its having adopted
the AdvaMed Code. Hospira is listed on the AdvaMed website http://www.advamed.org/memberportal/about/code as one of the
companies that have certified to adoption of the AdvaMed Code.
The California Law requires that each "company shall establish explicitly …a specific
annual dollar limit on gifts, promotional materials or items or activities that
the company may give or otherwise provide to an individual medical or healthcare
professional," with certain exclusions specified in the California Law. Hospira
has established $3,000 as its annual maximum limit for individual medical or healthcare
professionals in California.
The Overview of Hospira's Comprehensive Compliance Program, set forth below, reflects
the program that Hospira uses to comply with the applicable laws, including the
California Law, as well as the OIG Guidance and applicable industry codes of ethics.
Recognizing that compliance is a dynamic process and that changes may occur from
time to time in the applicable laws, OIG Guidance and industry codes, Hospira continuously
reassesses its Compliance Program to assure compliance with applicable laws, OIG
Compliance Program Guidance, industry codes of ethics and other relevant requirements.
When significant changes are made to Hospira’s Compliance Program, Hospira
trains and certifies its employees on the revised compliance program requirements.
To the best of Hospira's knowledge and belief and based on a good faith understanding
of the applicable statutory requirements, Hospira is in substantial compliance with
its Compliance Program and with the requirements of the California Law.
For information related to Hospira's Compliance Program, please contact Hospira's
Office of Ethics & Compliance by any of the following means:
Back to Top
Overview of Hospira’s Comprehensive Compliance Program
Introduction
Hospira, Inc. is committed to conducting business in a manner that is ethical and
in compliance with applicable law and other requirements. To that end, the company
has established and maintains an effective ethics and compliance program addressing
interactions with healthcare professionals ("Compliance Program"). Hospira is committed
to reviewing the Compliance Program regularly to identify ways to enhance the program
and to address new and emerging risk areas and legal, regulatory and other requirements.
The purpose of the Compliance Program is to provide Hospira's officers, employees,
contractors, and agents with clear ethical and compliance direction for their interactions
with healthcare professionals on behalf of Hospira. In addition, the Compliance
Program is designed to prevent and detect violations of applicable laws, Code of Business Conduct ("Code") and company policies.
While it is expected that officers, employees, contractors and agents will comply
with applicable laws, Hospira's Code and policies, the company understands that
the implementation of the Compliance Program cannot eliminate all risk of improper
conduct. In the event that Hospira becomes aware of possible violations of law,
the Code or policies, the company will investigate the matter and, where appropriate,
take disciplinary action and implement measures to correct and prevent similar violations.
Hospira's Compliance Program related to interactions with healthcare professionals
is in accordance with the "Compliance Program Guidance for Pharmaceutical Manufacturers"
issued in April 2003 by the Office of Inspector General of the Department of Health
and Human Services ("OIG Guidance"). In order to align activities with applicable
laws and industry codes, Hospira has tailored its Compliance Program to address
the wide variety of interactions that Hospira, as a manufacturer and supplier of
specialty pharmaceutical drugs and medication delivery technology, has with healthcare
professionals.
Hospira's Compliance Program provides for compliance with its Procedures for Interactions
with Healthcare Professionals (“PICs”) which are based on the OIG Guidance,
applicable federal and state laws, and on the Codes of Ethics of the Pharmaceutical
Research and Manufacturers Association ("PhRMA Code") and the Advanced Medical Technology
Association ("AdvaMed Code"). While the PhRMA Code and AdvaMed Code are substantially
similar, the limited distinctions between the Codes have been recognized in Hospira's
implementation of its policies and procedures, as appropriate, based on the nature
of the product lines that give rise to particular interactions with healthcare professionals.
Hospira routinely trains and certifies relevant employees on its policies and procedures..
Written Standards
Hospira established and published its Code with the input of senior management and
employees throughout the company. The Code provides Eight Principles of Integrity
for all officers, employees, agents and contractors, which include, but are not
limited to, complying with laws and regulations, promoting a culture of integrity
in the workplace, proper use of assets, maintaining accurate books and records,
avoiding conflicts of interest and acting with integrity in interactions with third
parties (e.g., healthcare professionals).
Policies and procedures for specific compliance areas are in place to reflect Hospira's
culture, processes and requirements. Specifically included are Hospira's comprehensive
procedures relative to interactions with United States healthcare professionals.
Those procedures are known as the Procedures for Interactions with Healthcare Professionals
or "PICs." The PICs are based on legal requirements and guidance from the Department
of Health & Human Services Office of Inspector General as well as applicable industry
and professional codes of ethics. PICs cover procedures related to meals, the provision
of educational items, charitable contributions, medical education grants, and other
guidelines related to interactions with healthcare professionals.
In response to California Health & Safety Code §§119400 et seq., also
known as CA S.B. 1765, Hospira has established an annual spending limit for educational
items or activities directed toward "individual medical and healthcare professionals"
in California. This annual maximum limit is $3,000 per individual medical or healthcare
professional. This annual maximum limit excludes payments made for legitimate professional
services provided by a health care or medical professional such as consulting. This
limit also excludes disposable items given to healthcare professionals intended
for free distribution to patients, printed advertisements about Hospira products
given to healthcare professionals, and financial support for continuing medical
education forums and for health educational scholarships.
Leadership and Structure
Hospira has an Office of Ethics & Compliance ("OEC") that serves as the focal point
of the company's ethics and compliance programs. The Vice President, Global Ethics
& Compliance leads the OEC and reports directly to the Chairman and Chief Executive
Officer of Hospira. The OEC organization is responsible for developing and directing
ethics and compliance initiatives including, but not limited to the Code and PICs,
integrating those initiatives into the decision-making processes of all levels of
the organization, and oversight of the company's specific compliance programs. The
OEC provides regular reports to senior management and to the Board of Directors
and various committees thereof on the status of the company's ethics and compliance
programs.
The company's senior management has established an Ethics & Compliance Steering
Committee ("Steering Committee") that consists of the corporate officers of the
company and all other direct reports to the Chief Executive Officer. The charter
of the Steering Committee includes overseeing the Office of Ethics & Compliance
and addressing significant ethics and compliance matters that arise in the company.
The Steering Committee, which meets quarterly, helps establish the appropriate "tone
at the top."
Education and Training
Hospira recognizes that education and training is a key part of an effective compliance
program. All employees and contractors receive training and certification on the
Code as soon as they become employed by Hospira. The Code refresher trainings are
given on a regular basis to all employees and contractors of Hospira. It is emphasized
in the trainings that all employees and contractors must abide by the Code and must
take responsibility by reporting any actual or potential violations of the Code
to a manager, Human Resources, Office of Ethics & Compliance or Legal. A helpline
brochure is also provided to Hospira employees and contractors and serves as a vehicle
of information for reporting violations of the Code.
Additional ethics and compliance education and training programs are provided on
an ongoing basis as required by an individual's job responsibilities and by changes
in the laws and company policies and procedures. Specifically with regard to interactions
with healthcare professionals, Hospira provides training to employees and contractors
focused on the types of interactions that they are likely to have with healthcare
professionals. Hospira employees and contractors who interact with healthcare professionals
are regularly trained and certified on PICs.
Internal Lines of Communication
Hospira fosters open communication and dialogue between employees and management
through a variety of mechanisms. Hospira maintains various policies that have been
designed to provide employees and other stakeholders with a means to communicate
with management. These policies address anonymous reporting, confidentiality, open-door
and non-retaliation.
Several communication channels are available to employees and include the employee's
supervisor, other members of management, Human Resources, Legal, Finance and the
OEC. Communication also includes dialogue between the OEC, senior management and
the Board of Directors regarding significant ethics and compliance initiatives and
issues.
Employees, customers, suppliers, and other stakeholders are able to ask questions
in a confidential manner about ethical or compliance issues or to report possible
violations of the Code, applicable law or company policies or procedures, without
fear of retaliation, and anonymously, if they so desire, by contacting the OEC directly
or through Hospira’s Global Ethics & Compliance Helpline (“Helpline”).
Individuals may contact the Helpline (available 24-7) via toll-free telephone at
1-866-311-4632 or via a web-based reporting tool at
https://secure.ethicspoint.com/domain/media/en/gui/22267/index.html. The
Helpline is administered by a third party, EthicsPoint, on behalf of Hospira. Helpline
reports are submitted to the OEC which then evaluates the information and engages
the appropriate resources to address the question or report in a timely and appropriate
manner.
Screening
Hospira follows strict background screening procedures as reflected in its Background
Screening Policy in order to ensure that it does not employ or do business with
persons or organizations that have been excluded, debarred, suspended or are otherwise
ineligible to participate in Federal healthcare programs. Hospira also partners
with its contract employee supply companies to either allow Hospira to conduct background
checks of the contract employees or have the other companies conduct their own background
screenings based on Hospira's standards. To ensure compliance with all state and
federal laws, Hospira also conducts annual checks of its employees using the U.S.
Government's debarment lists.
Auditing and Monitoring
Hospira's ethics and compliance program includes monitoring, auditing, and evaluation
of employees’ compliance with the company's Code, PICs and other ethics and compliance
policies and procedures. These efforts are conducted by the Office of Ethics & Compliance
on its own or in cooperation with Internal Audit, Legal and/or other functions of
Hospira. In accordance with the OIG Guidance, the nature of reviews as well as the
extent and frequency of Hospira's compliance monitoring and auditing vary according
to a number of factors. Based upon legal and regulatory requirements, changes in
business practices, and other considerations, the company utilizes ongoing assessments
of its compliance programs to identify and address new and emerging risk areas.
Corrective and Preventative Action
Hospira's ethics and compliance program clearly establishes the fact that inappropriate
conduct will be investigated and addressed. In matters where violations of law or
Hospira's Code or PICs are identified, disciplinary, corrective and preventative
action will be taken in order to address the violation and deter future violations.
Hospira uses a cross-functional committee known as the Exception Review Committee
("Committee") to evaluate and address in a consistent manner potential ethics and
compliance issues involving interactions with healthcare professionals. This committee
is comprised of representatives from the OEC, Legal, Commercial, Human Resources,
Medical Affairs, Finance and other functions as appropriate, and is chaired by the
Director, Global Ethics & Compliance. The Committee meets regularly to review "exceptions"
or items that have been identified as compliance concerns or potential violations.
Such reviews are performed on a case-by-case basis. In instances where a violation
of Hospira Code or policy is determined to have occurred, the Committee will ensure
that an appropriate response occurs, including disciplinary action when necessary.
In instances where a violation of law would be determined to have occurred, the
OEC would work with Hospira’s Legal Department, HR and others to develop the
appropriate corrective action plan. That plan could include reporting of the matter
to law enforcement authorities in appropriate circumstances.
Hospira's Compliance Program is reasonably designed to prevent and detect conduct
that may be inconsistent with the requirements of the California Law and other applicable
laws and requirements. Notwithstanding the comprehensive nature of Hospira's Compliance
Program, the company recognizes that no program can completely eliminate the possibility
that an individual will engage in improper conduct. When any such improper conduct
is reported or detected, Hospira will investigate the matter and address it promptly
and responsibly with corrective action including, but not limited to, appropriate
disciplinary measures.
Conclusion
Hospira is committed to conducting its business in a manner that is ethical and
in compliance with applicable laws, Hospira’s Code, PICs and other company
policies and procedures. The company recognizes that compliance can best be achieved
by ongoing efforts to communicate Hospira's values, the Code and policies and procedures
to company officers, employees, contractors and agents. Hospira is engaged in that
continuous effort and will from time to time update this overview to reflect changes
that are made in the Compliance Program.
Back to Top
MAINE
Clinical Trial Disclosure
For information about clinical trials conducted by Hospira, Inc., visit
http://www.clinicaltrials.gov. This information is being provided in part
to ensure compliance with the State of Maine's Clinical Trial Disclosure Law
(LD 1618). The information contained on these sites is not intended to replace the
advice of a healthcare professional. Only a physician can determine if a specific
medicine is the correct treatment for a particular patient. Nothing on this Web
site or the links contained herein should be construed as the giving of advice or
the making of a recommendation, and this information should not be relied on as
the basis for any decision or action. The information contained on this site and
the site to which this site links is not intended to promote or otherwise commercialize
(directly or indirectly) any off-label or unapproved uses of Hospira products.
The information on this Web site is not intended to be used by physicians for making
prescribing decisions. When making prescribing decisions, physicians should always
refer to the specific labeling information approved for the patient's country
or region.
Links to third party Web sites are provided for convenience only. Hospira, Inc.
does not express any opinion on the content of any third party Web sites and expressly
disclaims any liability for all third party information and the use of it.
Back to Top