Conflict of Interest in Health Care

GIFTS FROM INDUSTRY negative of these gifts?

"Evidence... that gifts from industry often misdirect physicians from their primary responsibility... to act consistently in the best interest of their patients"

PT Practice and Biomedical Equipment regulations for reps coming to PT practice and info on product 4

1. Scheduled appointment to speak to any provider 2. If contact with patient, permission and consent obtained 3. Industry rep may offer technical advise about their equipment but cannot give advice about patient care 4. Industry rep is prohibited from manipulating equipment while in use on a patient, may not touch the patient or scrub in on any procedure

Conflict of Interest Definition American Heritage Dictionary:

A conflict between a person's private interests and public obligations." A potential conflict of interest occurs when there is a possibility that an individuals private interests, or his or her family's interests, may influence the individual's professional actions, decisions or judgment. A conflict of interest involves the abuse of trust.

DMU Conflict of Interest Policy

Access of Industry Representatives to DMU Must have an appointment with a specific individual Students may attend meeting with direct faculty supervision Meeting in a non-patient care area Limit contact time to receive the necessary information and not impact patient care work flow Immediately after the meeting, the representative will leave

Declarations standards for all lectures given at DMU 4

Agency -Self; these are my opinions COI -None; nothing for sale FDA -No off-label recommendations Rules of engagement -Adult conversation

PT Practice Unintentional Limitations for providers regarding meeting with reps and getting pharm/ equipment 3

Difficult to have collaborative lunches with other healthcare providers Cost to patients to trial different medications or equipment due to no samples Limited educational information about new products or medications that are developed

Direct to Consumer Advertising Questions to ask about research studies or pharmaceuticals? 4

Does this population resemble mine? Are they for real?! Is this a disease v "undiscovered opportunity"? And who is paying for what? -You are (time) and so is your patient ($).

Students Interactions with Industry impact industry has on students? importance of student- industry interactions

Medical student-industry interactions can be common. Students may tend to be permissive regarding the acceptance of gifts. Students underestimate the influence of gifts may have on their behavior. It is important as a student to understand physician-industry relationships and the potential risk for conflict of interest.

Professional Practice important aspects to remember about your practice regarding phar. reps

No gifts of any monetary value No food (unless associated with an approved CME event) No promotional items - even if received at vendor fairs! All reps must have an appointment, confine their activities to a designated area, and abide by the PhARMA code for interactions with health professionals Lectures permitted if speaker discloses financial interests, uses EBM.

Industry and Pharmaceutical Samples -Policy for having samples at DMU -how are samples or products reviewed? -how are samples kept at clinic + monitored?

Policy to have limited pharmaceutical samples available to DMU patients on the financial assistance program Pharmaceutical Review Committee (PRC) will review and approve the sample or product Samples -kept in a designated locked storage cabinet -Industry rep will log in sample and clinic staff must log it out at distribution.

Contributions to Education where does money for research come from? where does money for residencies and fellowships come from?

Approximately 40% of clinical departments receive funding for resident and fellowship training Grants Devices, supplies Training time with industry representatives is necessary when new products or procedures are being introduced to healthcare providers As of 2006, approximately 62% of medical school CME income comes from commercial support As of 2012, 35-40% of CME delivered to healthcare professionals was funded by unrestricted educational grants from the pharmaceutical industry where pharma companies are not permitted to have any influence whatsoever on the content

Contributions to Research

Biomedical research expenditures by industry exceed that of the Federal government. In 2010, JAMA reported that by 2007, industry contributed the most money to biomedical research Industry = 58% NIH = 27% State and local governments = 5% Non Federal sources = 5% Not-for-profit = 4%

Procedure in Family Practice meeting with pharm rep Clinic Manager -role 2 physician -role

Clinic Manager -the 'gate keeper' and meets with the sales representative -accepts the information and shares with the providers Provider follows-up with the sales rep if desired -*Accepts appointments mainly with immunization reps due to providing useful information for the practice with new programs and vaccines being developed

Guidelines on Physician Interaction with Industry reason for increase reg. guidelines for conflict of interest 4

In recent years, there has been an increase in regulatory guidelines in the area of conflict of interest with a focus on physician relationships with the pharmaceutical industry Reasons for this increase include: -Potential influence of pharmaceutical marketing on patient care -Bias in research and results reporting -Rising costs of health care -Fraud and abuse

Direct to Consumer Advertising In what business is the pharmaceutical company? Questions to ask about pharmaceuticals

Know thine (enemy/adversary.) In what business is the pharmaceutical company? -"...the law requires corporate directors and managers to pursue...wealth maximization in preference to the interests of other stakeholders or society at large..." -job= make money for shareholders<-- how they do it is by making drugs Drug to consumer is ALL brand-name<--that's 100%! -its all about the power of advertisement to sell drugs

Professional Practice Provider discussion should include:

Provider discussion should include: 1. How were the studies conducted 2. Patient population outcomes 3. Absolute contraindications of product use

Addressing Conflict of Interest: 3 important elements to adress?

Recognition of the conflict Disclosure of the conflict appropriately Management of conflicts of interest

Current ACOG Committee Opinion, 2012 "Sunshine Act" -what is it? -requires what?

Relationship of Ob/Gyns with industry structured to ENHANCE, rather than detract, from patient obligations requires industry to report any "payment or other transfer of value" to physicians or teaching hospitals: PUBLICLY AVAILABLE and promotes transparency

Medicalization of everyday life

all solutions involve a pill, never lifestyle changes. Howcome-whyfor do that be?

Conflict of Interest in Health Care The term conflict of interest refers to? 2 elements

circumstances in which this commitment to the fiduciary relationship is compromised. Conflict of interest contains two elements: 1) an individual with an obligation, fiduciary or otherwise, and 2) the presence of conflicting interests that may undermine fulfillment of the obligation. ACOG Committee Opinion, #359, reaffirmed, 2015