Life Science Compliance Update

December 07, 2017

HCEA To Host Webinar on New International Ethics Rules

Download

On Wednesday, December 13, 2017, the Healthcare Convention & Exhibitors Association (HCEA) will present a webinar entitled: “Preparing for the 2018 Ethical MeDTECH, APACMed and China Codes Impact on International Attendee Participation at US Meetings.”

As we have previously written about, beginning January 1, 2018, medical device companies in various regions of the world will no longer be able to directly sponsor participant’s travel to educational meetings. The Accreditation Council for Continuing Medical Education (ACCME) and other organizations have applauded this effort, as it furthers the independence of education and helps to align international codes with current United States standards.

However, because of financial constraints in many markets around the world, healthcare providers depend on outside support to attend US-based meetings. Therefore, it is possible that your annual meeting may see some changes in 2018 and beyond. This webinar will review the codes and explore some of the concerns expressed by medical meeting planners.

The webinar will be moderated by Policy & Medicine’s editor, Thomas Sullivan, and includes panelists: Aline Lautenberg, General Counsel and Director of Legal and Compliance at Eucomed, EDMA, and MedTech Europe; Matthew E. Wetzel, Vice President and Assistant General Counsel at AdvaMed; and Christine Wooster, Chief Revenue Officer at the Heart Rhythm Society.

Registration for the webinar is free for HCEA members and $50 for non-HCEA members. For additional information, contact Kristen Leikwold at kleikwold@hcea.org or call (703) 935-1961.

To register for the webinar, click here.

July 25, 2017

New Report Releases Strategies to Reduce Opioid Epidemic

NationalAcademiesLogo1

The National Academies of Sciences, Engineering, and Medicine recently released a report, requested by the United States Food and Drug Administration, that highlights what can be done to stop the opioid use disorder and other opioid-related harms without closing access to opioids for patients who need them.

The committee that conducted the study and wrote the report recommended actions the FDA, other federal agencies, state and local governments, and health-related organizations should take – which include promoting more cautious prescribing of opioids, expanding access to treatment for opioid use disorder, preventing more overdose deaths, weighing societal impacts in opioid-related regulatory decisions, and investing in research to better understand the nature of pain and develop non-addictive alternatives.

In more recent years, national initiatives to reduce opioid prescribing have modestly decreased the number of prescription opioids dispensed. Unfortunately, many people who otherwise would have been using prescription opioids have transitioned to heroin use. According to the report, the declining price of heroin, together with regulatory efforts designed to reduce harms associated with the use of prescription opioids – including the availability of abuse-deterrent formulations – may be contributing to increased heroin use.

One approach to addressing the opioid epidemic is to have a fundamental shift in the nation’s approach to prescribing practices and improve awareness of the risks and benefits of opioids. Therefore, the committee recommended education for both health professionals and the public. Such education should involve mandating pain-related education for all health professionals who provide care to people with pain, requiring and providing basic training in the treatment of opioid use disorder for health care providers, and training prescribers and pharmacists to recognize and counsel patients who are at risk for opioid use disorder or overdose.  In addition, the lack of attention paid to educating the public about the risks and benefits of prescription opioids needs to be addressed. The report called for an evaluation of the impact and cost of an education program that raises awareness among patients with pain and the public.

The committee stressed that restrictions on lawful access to prescription opioids could have other unintended effects, and any policy designed to curtail legal access to them will inevitably drive some people toward the illegal market. Therefore, a strategy for reducing lawful access to opioids should be coupled with an investment in treatment for the millions who have opioid use disorder. 

The committee recommended that states – with assistance from relevant federal agencies, particularly the Substance Abuse and Mental Health Services Administration – provide universal access to evidence-based treatment for opioid use disorder in a variety of settings, including hospitals, criminal justice settings, and substance-use treatment programs. The U.S. Department of Health and Human Services (HHS) and state health financing agencies should also remove impediments to full coverage of medications approved by the FDA for treatment of opioid use disorder.

Several other strategies that the committee recommended include:

  • the FDA should complete a review of the safety and effectiveness of all approved opioids;
  • states should convene a public-private partnership to implement drug take-back programs that allow drugs to be returned to any pharmacy on any day, rather than relying on occasional take-back events;
  • public and private payers, including insurance companies, should develop reimbursement models that support evidence-based and cost-effective comprehensive pain management, including both drug and non-drug treatments for pain;
  • HHS, in concert with state organizations, should conduct or sponsor research on how data from prescription drug monitoring programs can be better leveraged to track opioid prescribing and dispensing information; and
  • the National Institutes of Health, the Substance Abuse and Mental Health Services Administration, the U.S. Department of Veterans Affairs, and industry should invest in research that examines the nature of pain and opioid use disorder, as well as develop new non-addictive treatments for pain.

June 11, 2015

AMSA Scorecard Provides Useful Conflicts of Interest Tool For Industry Compliance Professionals

 

AMSA Scorecard

Periodically since 2007, the American Medical Student Association (AMSA) has released a “Scorecard,” ranking medical schools on how strict their policies are regarding interactions between their students and faculty and the pharmaceutical and device industries. The AMSA Scorecard is decidedly anti-industry, but by consolidating all of the conflict of interest documents for schools around the country, the list is actually a very useful tool for compliance professionals who must be attentive to a wide range of university policies. 

This initial AMSA Scorecard graded medical schools simply on whether they had a policy regulating the interactions between their students and faculty and the pharmaceutical and device industries. In 2008, AMSA worked with the Pew Prescription Project, an initiative of the Pew Charitable Trusts, to develop an updated Scorecard, “which used a more rigorous and transparent methodology to assess the content of policies at medical schools throughout the country,” states AMSA. In 2014, the AMSA instituted “further changes to the scoring methodology that better assess the nuances of medical center and industry relationships.”  

Leading up to 2014, the "AMSA scorecard methodology working group reviewed the literature on conflicts of interest, including the recent recommendations published by the Pew Task Force on Medical Conflicts of Interest." As a result, AMSA changed the number of domains from 11 to 14 for medical schools, and 16 for teaching hospitals. AMSA focuses on conflict-of-interest policies directly related to industry marketing and education. While not addressed in the scorecard, "academic medical centers should also have robust policies to ensure the integrity of basic and clinical research," AMSA advises.

AMSA Scores

The domains AMSA rates are:

  1. Gifts from industry
  2. Meals from industry
  3. Industry-sponsored promotional speaking relationships
  4. Industry support of ACCME-accredited CME
  5. Attendance of industry-sponsored promotional events
  6. Industry-funded scholarships and awards
  7. Ghostwriting and honorary authorship
  8. Consulting and advising relationships
  9. Access of pharmaceutical sales representatives
  10. Access of medical device representatives
  11. Conflict of interest disclosure
  12. Existence of an adequate conflict-of-interest medical school curriculum
  13. Extension of COI policies to adjunct/courtesy faculty and affiliated hospitals/clinics
  14. Enforcement and sanctions of policies

For teaching hospitals, AMSA also scores on pharmaceutical samples and P&T committees. 


How Does AMSA score these domains?

Some of AMSA's decisions about "model" policies are worth noting (click on the image for a clearer view). 

AMSA Examples

 

On the topic of continuing medical education, hospitals get a “1” if they follow standards laid out by the Accreditation Council for Continuing Medical Education (ACCME). AMSA states: “Studies (of course they don't state what those studies are) have shown that industry funding of continuing medical education programs tends to bias topic choices and content in favor of the sponsors’ products and therapeutic areas.” Thus, to achieve a “model” policy ranking according to the AMSA scorecard, the policy would have to state “that industry funding is not accepted for the support of accredited CME courses except in certain clearly defined circumstances.”  Whatever AMSA defines them.

Other domains are similarly strict. For example, on the subject of pharmaceutical sales representatives, a “3” score would mean sales reps are not allowed any access to any faculty or trainees in academic medical centers or affiliated clinical entities. 

View AMSA's criteria for their various scores here

----

Leading institutions such as the Mayo Clinic, Cleveland Clinic, and Ohio State University’s Wexner Medical Center, just to name a few, are given B ratings by the AMSA. While the score itself is not of much help to compliance professionals, AMSA  has put together a comprehensive and helpful resource for anyone who has to monitor and keep track of a potentially long list of COI policies at various medical centers and teaching hospitals. As pharmaceutical and device manufacturers must track and report virtually all of their interactions with physicians and teaching hospitals in a public database under the Sunshine Act, the industry must remain mindful of academic policies and various issues related to their collaborations with the entities. 

 

Newsletter


Preview | Powered by FeedBlitz

Search


 
Sponsors
December 2017
Sun Mon Tue Wed Thu Fri Sat
1 2
3 4 5 6 7 8 9
10 11 12 13 14 15 16
17 18 19 20 21 22 23
24 25 26 27 28 29 30
31