Life Science Compliance Update

December 02, 2016

New Report Demonstrates Effectiveness of IPCE

Report-writing

On April 20, 2016, the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC) convened a Leadership Summit for Jointly Accredited Providers at the ACCME’s offices in Chicago.  

The goal of the summit was to provide an opportunity for jointly accredited providers – as leaders in the continuing healthcare education community – to work collaboratively to identify organizational models that are effective in promoting and improving interprofessional collaborative practice (IPCP) through interprofessional continuing education (IPCE) and to share success stories that demonstrate the impact of their educational efforts.

A new report, crafted based on the 2016 Joint Accreditation Leadership Summit, shows how IPCE contributes to improving healthcare team collaboration and patient care. The report includes best practices, challenges, case examples, key recommendations, and data about the value and impact of IPCE.

Report Highlights

Inclusive Team

IPCE builds team collaboration across multiple professions, from chaplains to community health workers – from physicians to psychologists – from safety experts to social workers. Additionally, teamwork takes a fundamental, on-going commitment to the principles of IPCE – the secret to collaboration is to actually collaborate.

Patient-Centered Teams

IPCE also creates a safe space where all learners, including patients, have a voice. Education that includes patients as planners, teachers, and learners, motivates powerful and lasting change. The report encouraged participants to ask: how is the structure helping patients? What professions affect patient outcomes? It is important to remember that the purpose and value of the program is to support the patient.

Cultural Care, Compassionate Value

By bringing together teams, IPCE effectively builds skills that are essential for improving care for patients and communities, such as cultural competency, compassionate values, and communications. The report notes that IPCE is a philosophy and that you “have to be a true believer, keep on living it, preaching it,” encouraging leaders to “infuse your enthusiasm into the program.”

Public Health Priorities

IPCE programs partner with institutions and communities to address quality, safety, and public health concerns such as sepsis, obesity, end-of-life care, heart disease, and cancer.

Recommendations

The report also included eight recommendations for creating and sustaining a successful ICPE program: develop buy-in from leadership; support your organization’s strategic mission; build your IPCE team and model best practices; involve patients; implement a phased-in approach; focus on quality; measure outcomes; and communicate the value of IPCE.

Videos

Along with the report a series of videos was released, which feature educators describing their goals and accomplishments, what brings them joy and pride in their work, and advice for creating IPCE programs.

Comments from Leadership

All three jointly accredited provider groups support the report, with each having a representative offer comments on the report.

“This report illustrates how jointly accredited providers are working every day to make a difference. These efforts have made, and will continue to make, a substantial difference to healthcare teams and the patients they serve. Interprofessional continuing education creates empowered teams that think courageously together, solve complex problems, and see the value of their own and their colleagues’ contributions. I encourage health system leaders and other stakeholders to recognize that an investment in education is an investment in people and to think about how they can leverage the power of education to support their community of clinicians and patients.”— Graham McMahon, MD, MMSc, President and CEO, ACCME

“We are not going to change the healthcare system unless professionals in practice learn from, about, and with each other and foster that learning in the students coming up behind them. This report shows the important work being done by jointly accredited providers and documents the benefits and outcomes of their work. As accreditors, it shows us what we need to do better to support that work going forward.”—Peter H. Vlasses, PharmD, DSc (Hon), BCPS, FCCP, Executive Director, ACPE

“As evidenced by this report, our community of continuing education providers has demonstrably improved collaborative care among healthcare professionals and patient outcomes. ANCC is so proud of the enthusiasm, commitment, and dedication that shines through in their examples. We hope that the stories and strategies provide both inspiration and practical tips for educators across the healthcare professions who are striving to benefit patients by building stronger teams.” — Kathy Chappell, PhD, RN, FNAP, FAAN, Senior Vice President, Certification/Measurement, Accreditation and Research, ANCC

September 29, 2016

Prescriber Education Campaign on Opioids Launched

Search-and-Rescue-Homepage-1-302x227

We have been hearing for years about the opioid crisis our country is facing, a crisis that was partially brought about by abuse of prescription pain relievers. From Congressional investigations, to Executive branch actions, to a letter from the Surgeon General, many of our country’s leaders are concerned about the epidemic and are constantly trying to craft solutions.

The Partnership for Drug-Free Kids, an organization committed to helping families struggling with their son or daughter’s substance abuse, created the “Search and Rescue” campaign, a prescriber education campaign developed with support from the Food and Drug Administration (FDA) that gives healthcare providers the resources they need to prescribe opioids responsibly and prevent the misuse and abuse of medicine in their practices. The campaign was piloted in Maryland and Rhode Island in 2014, and expanded to six states in 2015. On September 15, 2016, the Partnership for Drug-Free Kids announced the national launch of the campaign.

The goal of the “Search and Rescue” campaign is to equip prescribers with skills to be proactive in identifying and helping patients at risk for prescription drug abuse. The campaign will attempt to connect prescribers to training, information, and resources that can help educate them, and the FDA encourages them to share the educational content with their peers.

FDA and Partnership Comments on “Search and Rescue”

Dr. Janet Woodcock, the Director of the FDA’s Center for Drug Evaluation and Research (CDER), is, along with the FDA, “proud to support this campaign to educate and inform providers about the risks of addiction and the misuse and abuse of opioids in their efforts to treat their patients’ pain responsibly and prevent the misuse and abuse of these drugs.” She further noted, “educating the healthcare community on appropriate prescribing of prescription opioid medications is a cornerstone of the FDA’s Opioid Action Plan, and continues to be a top priority for the agency, as well as for the Department of Health and Human Services (HHS) and across the federal government.”

According to Marcia Lee Taylor, President and CEO of the Partnership, “Today’s opioid epidemic has reached alarming and tragic proportions, with 78 opioid overdose deaths occurring daily in the United States. Addressing this dire national problem requires a multi-pronged approach, involving parents, educators, community leaders, treatment professionals and healthcare providers. The Partnership is proud to apply its communications expertise to the challenge of reaching and helping educate prescribers, who can and must be a huge part of the solution.”

The Website

The Search and Rescue website offers many resources for providers, including information on each state’s PDMP, brief educational videos, a database with accredited CME/CE REMS-compliant activities, an opioid risk assessment, links to a SAMHSA treatment locator to help patients find a local opioid treatment program, and a quick fact sheet for prescribers. 

Other Ways Search and Rescue is Helping

The “Search and Rescue” campaign makes innovative use of social media, optimized search, and earned media to reach family physicians, physician assistants and nurse practitioners, focusing on sending them to the website to learn more.

The Partnership is working with other national organizations, including the American Medical Association Task Force to Reduce Prescription Opioid Abuse, the American Academy of Pediatrics, the American Dental Association (ADA), and others, to promote “Search and Rescue” to their members.

March 23, 2016

Senate HELP Committee Continues Work on 21st Century Cures Corollary

Earlier this week, the Senate Health, Education, Labor, and Pensions (HELP) Committee held a hearing on a package of legislative measures that are targeted at facilitating medical innovation. This hearing, the second in a set of three, is the Senate's response to the House-passed 21st Century Cures Act (H.R. 6). We wrote about the first hearing, and a recap can be found here.

While the second meeting featured much partisan debate and fanfare, the Committee advanced all seven medical innovation measures before them, with six passing by voice and one measure passing by roll call vote of 20-2.

In opening statements, Senator Lamar Alexander, Committee Chairman, acknowledged the anticipated contention on the panel over what he referred to as a "surge" of additional mandatory funding requested by Democrats for the Food and Drug Administration (FDA) and the National Institutes of Health (NIH). Even expecting contention, the Chairman expressed optimism about the Committee's capacity for compromise, stating that if the Committee successfully creates an innovation agenda, it may be the "most important legislation passed this year."

As may be expected, Ranking Member Senator Patty Murray and Senator Elizabeth Warren both showed strong support for increasing mandatory funding for the FDA and the NIH, each introducing an amendment to S. 1878: one to create a medical device evaluation system and the other to create a biomedical innovation fund. Senator Murray also expressed concern that some of these bills may increase FDA responsibilities and not compensate the FDA for that. While both senators started out firmly believing that any agreement needed to include increased funding, they both withdrew their amendments, including any requests for additional funding, in order to find other consensus points and come to an agreement.

The measures approved in the Committee are as follows:

The Advancing Hope Act of 2015

This bill amends the Federal Food, Drug, and Cosmetic Act (FDCA) to expand the priority review voucher program for rare pediatric diseases to including treatments for both sickle cell disease and pediatric cancers. The voucher program will be extended by removing the provision that terminates the program one year after the FDA's issuance of three rare pediatric disease vouchers. However, a voucher may not be issued for a rare pediatric disease product, if a voucher was ever issued for the product as a tropical disease product. Additionally, a drug sponsor that intends to request a voucher for a rare pediatric disease drug must notify the FDA of their intent to do so upon submission of their new drug application.

The bill's sponsor, Senator Robert Casey explained that this program is integral to fostering innovation and incentivizing private companies to invest in rare children's diseases. Such an incentive is necessary because private companies tend to not see a return on research investment in this area.

This is the one measure passed via a roll call, following adoption of the following amendments: (1) specify the criteria for "rare pediatric disease," (2) insert a section related to rare pediatric disease product applications, (3) require the comptroller to conduct a study on the GAO report on the effectiveness of awarding priority review vouchers for the sponsorship of rare pediatric disease product application, and (4) require the results of the study to be reported to congress.

The Advancing Breakthrough Medical Devices for Patients Act of 2015

This bill amends the FDCA to expand the FDA's priority review of breakthrough medical devise to include all classes of devices. Currently, only new or highest risk (Class III) devices are eligible. However, this bill would make it so that upon a sponsor's request, the FDA would be forced to determine whether a device meets the criteria for priority review as a breakthrough device.

To expedite the development and review of designated medical devices, the FDA must: "assign a team of staff for each device, adopt an efficient process for dispute resolution, provide for interactive and timely communication with the device sponsor, expedite review of manufacturing and quality systems compliance, disclose to the sponsor in advance the topics of any consultation between the FDA and external experts or an advisory committee and provide the sponsor the opportunity to recommend external experts, [and] assign staff to address questions by institutional review committees concerning investigational use of the device."

Senator Richard Burr emphasized the idea that this measure would not change the standards that devices are required to meet in order to reach the market, but instead simply changes the approach by which device approvals can be accelerated.

The Medical Countermeasures Innovation Act of 2015

This bill encourages the development of medical countermeasures in case of biological attacks and naturally occurring outbreaks. This bill is intended to build upon the Pandemic and All-Hazards Preparedness Act, by leveraging the innovation of the private sector through priority review vouchers. The urgency of this problem has been exemplified with the Ebola and Zika outbreaks over the past year.

The Medical Electronic Data Technology Enhancement for Consumers Health Act

This bill amends the FCPA to exclude several classes of devices from FDA-regulation as a medical device. Some of the included classes are: administrative, operational, or financial records software used in health care settings; software for maintaining or encouraging a healthy lifestyle unrelated to medical treatment; electronic patient records, excluding software for interpreting or analyzing medical image data; software for clinical laboratory testing, excluding software for interpreting or analyzing test data; and software that provides medical recommendations and the basis for those recommendations to health care professionals, excluding software for acquiring, processing, or analyzing medical images or signals.

The bill also states that the FDA must classify a medical device accessory according to its intended function, not the classification of the medical device with which it is used.

This measure was adopted without any discussion.

The Combination Product Regulatory Fairness Act of 2015

This bill attempts to address regulations on combination drug and device products. There was little discussion accompanying this bill, but Senator Casey did briefly speak out in favor of the measure, noting that it will allow for improved communication with the FDA and manufacturers.

The Patient-Focused Impact Assessment Act of 2015

This bill amends the FDCA to require the package of information published by the FDA upon approval of a new drug to include documentation of efforts to assess patient engagement. The required documentation must include identification of patient-focused drug development tools and an explanation of whether certain information was reviewed or examined, including any patient preferences and patient-reported or caregiver-reported outcomes. The FDA is also required to annually summarize, and publish, the data that is collected in this documentation.

Senator Susan Collins, a cosponsor of the bill, believes that patient input is a valuable resource and should play a larger role in FDA decision-making.

The Adding Zika Virus to the FDA Priority Review Voucher Program Act

This bill also amends the FDCA, to add the Zika virus to the list of tropical diseases under the priority review voucher program. The priority review voucher program awards a voucher to the sponsor of a new drug or a new biological product that is approved to prevent or treat a tropical disease, which allows the holder of the voucher to have a future new drug or biological product application acted upon by the FDA within six months.

Chairman Alexander mentioned at the outset of this meeting that the Zika virus is a top concern and priority for the HELP panel.

The final HELP Committee on medical innovation is slated for April 6, 2016, at which time Chairman Alexander hopes to have a final package ready for floor consideration.

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