Life Science Compliance Update

December 21, 2017

PhRMA Releases New Policy Proposals

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On December 11, 2017, the Pharmaceutical Research and Manufacturers of America (PhRMA) issued statements of support for several policy proposals focused on resolving the opioid crisis. The proposals included: limits on prescribing, a ban on prescribing of Schedule II opioids in an office setting, ongoing prescriber training, and expanded access to addiction treatment options.

Along with the policy proposals came an announcement that PhRMA and the Addiction Policy Forum have entered into a multi-year, multi-million dollar initiative to combat the opioid crisis and implement the Forum's plan to help solve the opioid crisis.

PhRMA and Addiction Policy Forum Partnership

The plan identified eight strategic focus areas to address addiction and the recommendations included analysis of key states to identify gaps in existing programs, increased education efforts for patients and families and the development of an online portal to connect individuals with addiction treatment options and information.

“We are deeply committed to addressing the opioid crisis and advancing solutions that will make a meaningful difference for families and communities,” said PhRMA President and CEO Stephen J. Ubl. “This is only possible if we make a point to listen, partner with organizations and experts on the ground, and ensure that our top priority is saving lives. The Addiction Policy Forum is actively working to provide resources to reduce the stigma surrounding addiction and treatment, and we are proud to support their efforts through this new partnership.”

“The challenge in front of us requires that everyone be at the table, working together to implement comprehensive, long-lasting solutions that will save lives,” said Jessica Hulsey Nickel, President and CEO of the Addiction Policy Forum. “We look forward to partnering with leaders in the biopharmaceutical community to help states, cities, towns and families change the trajectory of this crisis.”

Policy Proposals

Prescriber Requirements and Limitations

PhRMA recommends seven-day prescription limits on opioids for acute pain except for “certain conditions or patients, such as chronic pain, pain associated with cancer diagnosis or treatment, palliative care, hospice or end-of-life care, residents of long-term care or nursing facilities and individuals receiving medication assisted treatments for addiction” or when a medical professional determines that the condition causing the acute pain warrants more than the initial supply.

PhRMA also supports a 30-day supply limit for opioids for chronic pain so long as they are coupled with efforts to encourage appropriate use. PhRMA suggests regular checking of prescription drug monitoring programs (PDMPs), regular reassessments of the patient's treatment plan, development of guidelines to inform appropriate treatment of pain, and use of patient treatment agreements to ensure communication between patients and providers.

PhRMA also wants to prohibit dispensing Schedule II medications in an office setting. This would include prescriptions such as methadone, oxycodone, fentanyl, and hydrocodone.

Ongoing Prescriber Education

PhRMA echoes recommendations by experts and regulators, including FDA, that more training and educational tools are needed to help physicians and prescribers responsibly prescribe opioids. The group says mandatory training should be provided for pain management, risks and benefits of prescription opioids, screening for mental health, new pain treatment alternatives and PDMPs.

But PhRMA takes the calls one step further, by arguing licensure should be contingent on ongoing opioid training. “Ongoing training should be a requirement for prescribers seeking either a Drug Enforcement Administration (DEA) license or license renewal to prescribe controlled substances or a state license from an entity such as a Board of Pharmacy.”

Expand Coverage and Access to Addiction Treatments

PhRMA supports expediting review and encouraging development of non-opioid pain medications; ADFs; and medications to treat opioid use disorder, addiction and overdose. The recommendation falls in line with FDA's push for development of new, non-opioid pain medications as well as ADFs and medication-assisted treatment (MAT).

In October, Gottlieb told lawmakers at a House Energy & Commerce Committee hearing that FDA is looking at research that could support a label indication for MAT and provide direction for potential long-term use by patients suffering from addiction.

The agency has also discussed efforts to encourage development of generic ADFs, including by publishing final guidance in November outlining how the agency will evaluate generic ADF oral opioids.

December 19, 2017

Report Issued on Third Annual Joint Accreditation Leadership Summit

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On June 9, 2017, the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC) participated in the third annual Joint Accreditation Leadership Summit. During this Summit, interprofessional continuing education (IPCE) professionals discussed various challenges and opportunities related to IPCE. 

The Summit was conducted in three parts and included discussion about publishing research and disseminating success stories about IPCE; case examples of research in action; and “hot topics” in IPCE, with attendees participating in breakout sessions to share and learn from each other’s experiences in managing IPCE programs.

A key recommendation of the previous year’s Joint Accreditation Leadership Summit was to build a body of research that demonstrates the effectiveness of IPCE in improving team performance and patient care. This year, the Summit focused on strategies for conducting and disseminating such research.

“We need to develop better models for sharing what works,” said Graham McMahon, MD, MMSc, President and CEO, ACCME. “We do that by looking at ourselves, looking at our programs, counting our wins, understanding the challenges we have, measuring that change, and sharing it with each other. That is research, and that is how we learn from each other.”

In the first session, participants explored how to design IPCE activities in a way that also produces data that can be published or otherwise shared with colleagues. Scott Reeves, PhD, MSc, PGCE, BSc, Professor in Interprofessional Research at Kingston University and St. George’s, University of London, and Editor in Chief of the Journal of Interprofessional Care, led the session. He offered insight to IPCE professionals about how to broaden their objectives to reach beyond their own institution and learners, including research and dissemination of outcomes that offer insight to the wider IPCE community. The purpose of gathering and publishing data, Reeves said, is two-fold: to understand the impact of activities on participants, and to disseminate those findings for the benefit of others.

The evaluation of IPCE activities is strengthened by the use of a theoretical perspective and evaluation model. Choosing a theoretical and/or evaluation framework can help to focus the work, as well as create more generalizable knowledge that contributes to scholarly work about IPCE. An evaluation model helps to capture a wider range of data and produce more comprehensive studies.

At the end of the day, Summit participants separated into four topic-based breakout sessions, led by their peers and Joint Accreditation staff. During this session, attendees had the opportunity to discuss a topic in-depth, to learn from each other’s experiences, and report back to the larger group. Topics included identifying educational gaps and needs for interprofessional teams; innovative strategies to evaluate change in interprofessional teams; identifying ways to recognize exemplary practices through accreditation with commendation; and further discussion on planning, conducting, and publishing IPCE research.

The Summit was designed to build a community of practice to sustain, stimulate, and nurture IPCE professionals. Through sharing stories and best practices, the growing community of practice advances the field, paves the way for future IPCE professionals, and generates collaboration with colleagues in undergraduate and graduate interprofessional education. With the support of their community, IPCE professionals will improve the care delivered to patients and communities across the country.

The report concluded with three key lessons for conducting research: creating a plan, developing partnerships, and sharing your results.

December 12, 2017

Alliance for Continuing Education in the Health Professions Annual Conference

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January 20, 2018 through January 23, 2018, the Alliance for Continuing Education in the Health Professions (the Alliance) will hold their 2018 Annual Conference in Orlando, Florida at the Grande Lakes hotel.

The Annual Conference boasts four days of education and networking events, starting off on Saturday, January 20, 2018, with several early morning workshops followed by afternoon member section meetings. Closing out the first day are the Opening Night Awards Dinner and the President’s Dessert Reception.

On Sunday, January 21, 2018, attendees will hear the Annual State of the Alliance, followed by a keynote speech on understanding the new era of empowered, engaged e-patients. The day then breaks out into groups where topics like “Physician and Patient Beliefs About Patient Satisfaction: Aligned or Discordant,” “FAQs (and Answers!) Regarding the New CHCP Exam,” “Nurturing Effective Teams: Creating an Educational Home Where Together is Better,” and “Applying Facebook and Other Social Network Approaches into Interprofessional Continuing Education,” among many others, will be discussed. Closing out Sunday’s events is the Alliance Got Talent competition, where your peers will be performing a variety of acts.

The third day, Monday, January 22, 2018, begins with a keynote speech entitled, “Will You Be the Disruptor or the Disrupted? The Battlegrounds Over Health Care for the Next 10 Years,” before breaking off into various breakout groups throughout the day.

Our editor, Thomas Sullivan, will be part of the breakout panel discussion, “Understanding MACRA’s New QI-CME Improvement Activity: What You Need to Know to Maximize this Opportunity for Your Organization.” The program is an informal panel with three participants discussing MACRA’s physician incentives for quality care under Medicare, the Quality Payment Program and CE Opportunities. Ways to design an QI CME activity to meet the CMS MACRA definition will also be discussed.

Tuesday, January 23, 2018, the morning begins with breakout sessions discussing topics such as: integrating the patient perspective into the PM&R education process; ensuring patient voices are heard through video narratives; and how to break the silo mentality to address real world needs. The conference closes with a plenary session around noon.

If you are interested in attending this conference, you can register here.

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