Compliance

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 and Overview of Hospira’s Comprehensive Compliance Program

  • MAINE

Clinical Trial Disclosure

 

CALIFORNIA


Declaration and Overview of Hospira’s Comprehensive Compliance Program

Declaration

This Declaration is made by Hospira, Inc. as of July 1, 2014, in accordance with the provisions of California Health & Safety Code §§ 119400 et seq., also known as CA S.B. 1765 ("California S.B. 1765").

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 S.B. 1765 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 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 Hospira has 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 S.B. 1765 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 S.B. 1765. 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 S.B. 1765, 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 S.B. 1765.

For information related to Hospira's Compliance Program, please contact Hospira's Office of Ethics & Compliance by any of the following means:

  • Hospira’s Global Ethics & Compliance Helpline (available 24-7) via toll-free phone (+1-866-311-4632) or via a web-based reporting tool (www.Hospira.EthicsPoint.com). 

Note: Hospira uses the services of a third party, to administer the toll-free phone Helpline and web-based reporting tool. 

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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 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, all other direct reports to the Chief Executive Officer, Vice President, Internal Audit, Vice President and Associate General Counsel, and Director, Global Ethics & Compliance. 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 www.Hospira.EthicsPoint.com. 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 on an as needed basis 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 S.B. 1765 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.

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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.

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