Frequently Asked Questions

 

General Topics

 



What is the definition of “medical device” for purposes of this policy?

For purposes of this policy, the term “medical device” refers to any device that is tracked pursuant to the federal Safe Medical Device Act, which generally includes devices that are implantable or life-sustaining.


How is this policy being enforced?

With respect to violations by Industry representatives, enforcement shall be the responsibility of the UPMC Supply Chain Management and the University’s Purchasing Department. With respect to UPMC employees, violations of the policy shall be handled first by the individual’s immediate supervisor and the UPMC Ethics and Compliance Office; in the case of SOHS personnel, violations of the policy shall be handled first by the individual’s dean and department chair; or both (for dual status personnel). Existing policies of UPMC and the University related to employment actions shall apply to any action taken, including any provisions in those policies for appeal of decisions.


What is the guidance surrounding authorship and ghostwriting?

The Industry Relationship Policy prohibits SOHS and UPMC personnel from lending their name to articles or presentations ghostwritten by industry. The Uniform Requirements for Manuscripts Submitted to Biomedical Journals provides detailed guidance about the accepted standards for being listed as an author on a submitted manuscript. Individuals shall have made specific and substantial contributions in the design, conduct, analysis, and writing of a manuscript in order to be listed as an author. Acquisition of funding, collection of data, or general supervision of the research group, alone, does not justify authorship. Many journals now require the corresponding author to describe the roles of each author. In addition, each author is expected to take public responsibility for the integrity and accuracy of the publication.

Access to litigation documents has revealed an unsavory apparent disregard for authorship requirements by members of the academy in collaboration with for-profit sponsors of clinical trials. Academics who have had little or no participation in the clinical trial have been asked to add their and their institutions’ good names to a manuscript that is in essentially final form, having been writing by the sponsor. In addition to being the ethical antithesis of the precepts of scientific reporting, such actions may also result in very public embarrassment.

A series of articles in the Journal of the American Medical Association provides both data and discussion on this topic:

Editorial: Impugning the Integrity of Medical Science: The Adverse Effects of Industry Influence

Guest Authorship and Ghostwriting in Publications Related to Rofecoxib: A Case Study of Industry Documents From Rofecoxib Litigation

Reporting Mortality Findings in Trials of Rofecoxib for Alzheimer Disease or Cognitive Impairment: A Case Study Based on Documents From Rofecoxib Litigation


Where/how are medication samples allowed to be dispensed?

In 2008 UPMC surveyed all of its outpatient facilities to determine which sites would continue to maintain and dispense medication samples provided by Industry. For those sites that opted to provide samples to their patients, training was undertaken to assist them in complying with regulatory requirements for inventory management and proper dispensing.

A working group composed of physicians, pharmacists, and administrators from across the Health System developed a plan to centralize the receipt of samples from manufacturers. Under this plan, offices are able to select a supply of the medications they need from the inventory. Samples are delivered to sites through couriers or overnight express service.

These sites are permitted to invite Industry representatives who have completed required educational modules to deliver samples to their offices. Representatives must comply with all aspects of the IR Policy, including prohibitions on gifts and meals.

For more information:
Contact the Information Center at 412-647-2406 or email IndustryRelation@upmc.edu. The Policy and other supporting materials can be found at: http://www.coi.pitt.edu/IndustryRelationships.

For the October 27, 2008 announcement of the eSample Center launch, click here:
http://www.coi.pitt.edu/IndustryRelationships/PolicyTools/eSampleLaunchMemo.pdf

For a Step-by-Step Guide and a Tutorial about the eSample Center, visit: http://industryrelations.infonet.upmc.com/training.htm

For FAQs about the eSample Center: http://industryrelations.infonet.upmc.com/faqs.htm


Can Industry support continuing education and community education programs?

Under the Industry Relationship Policy, Industry can provide funds to the University or UPMC for accredited or non-accredited activities (including training programs on new devices) through guidelines established in the Accreditation Council for Continuing Medical Education Standards for Commercial Support. According to these standards, the University and/or UPMC must retain control over the content and faculty selection, and presentations must allow for balanced discussion of alternative approaches, as appropriate. Industry can provide financial support through an educational grant but cannot directly pay for food, social events, faculty honoraria, or any other costs associated with the activity. Industry-sponsored exhibits are permitted in off-campus and certain on-campus locations for the purpose of disseminating information about products and services. However, the distribution of gifts is not permitted.

Further guidance on more specific types of activities can be found at the following FAQs:


What are the appropriate procedures for establishing SOHS/UPMC/Vendor relationships?

The following guidance relates to acceptable procedures for inviting Industry Representatives to meetings at the Schools of the Health Sciences (“SOHS”) and/or UPMC premises.

All Industry Representatives seeking a vendor relationship with the SOHS or UPMC must first complete a mandatory training course, which is available online at: http://cme.hs.pitt.edu and after login select Vendor Training. New users must first create an account.

Registered representatives may then be invited by SOHS or UPMC, via the appropriate Purchasing Department, to schedule a meeting to discuss a new drug, device, or hospital supply item.

This training and registration process is NOT required for 1) visits from Industry auditors reviewing Industry-sponsored clinical trials; or 2) visits to initiate or review research projects.