FDA Draft Guidelines for Pharmaceutical Social Media

Samantha Reba

Junior Writer

Last week, the US Food and Drug Administration (FDA) released draft guidelines addressing responsibilities of pharmaceutical manufacturers and distributors related to real-time online communications and interactions. The proposal outlines various levels of responsibility related to content posted by or about a company. The guidelines cover but are not limited to corporate blogs, microblogs, online communities, podcasts, Facebook, and Twitter.

The guidelines limit pharmaceutical companies’ responsibility for content posted via social media where they have no control over or ownership of the platform or content. Firms would be held increasingly responsible in situations where they have powers of editorial review or otherwise influence posted content. The FDA draft calls for companies to send monthly reports of all covered online activity to the agency. If companies have any input into posted material, it would need to be reported to the FDA. 

The pharmaceutical industry has until April to submit comments and suggestions to the FDA concerning the guidelines. Until then, firms are being asked to file monthly reports while the debate over user-generated content continues. The new rules should allow more flexibility regarding interactions with patients via social media channels without requiring an audit of every comment submitted. Many questions remain to be answered but for now the discussion appears to be moving in the right direction.

The Association of Medical Illustrators Annual Meeting

 

          
Samantha Reba
Junior Writer

The 68th Annual Meeting of the Association of Medical Illustrators (AMI) took place July 17-21 in Salt Lake City, Utah. As the premier conference on medical and scientific visualization, the annual AMI meeting brings together a diverse array of professionals engaged in promoting the power of visual media to advance understanding of the life sciences. Two of our esteemed medical illustrators, Mike Boasso and Satyen Tripathi, were able to travel out to the city to attend 4 days of the conference.

Among other things, this year’s conference, entitled “FUSION: Connecting Minds, Visualizing Science & Medicine,” consisted of daily workshops led by a host of highly regarded professionals. Satyen had the opportunity to sit in on a workshop led by Chris Converse, a multimedia designer and developer from the Philadelphia area.  Chris has been a featured speaker at HOW Design, AIGA, and Adobe MAX conferences, and has written and hosted a variety of training videos. The subject of the workshop that Satyen attended was Adobe Edge Animate, which is the newest addition to the Adobe family. The program combines Adobe and web standards with rich features that allow the user to design and animate every interactive experience.

Mike, who’s been attending AMI Annual Meetings for a decade, was able to grab a seat in the ZBrush® for Beginners workshop led by Wes Price, an associate professor of media arts and animation at the Art Institute of Colorado. Mr. Price’s workshop discussed the importance of ZBrush®, the prominent program that’s become a very powerful and useful tool in the field of biomedical visualization.

In addition to the workshops, a salon was created to showcase medical illustrations from across the country. The artwork remained on display for the entirety of the conference.

More than 300 professionals turned out for the meeting. Speakers included: Roberta Ness, MD, MPH, Dean of The University of Texas School of Public Health; Jens Krüger, PhD , Chair of the High Performance Computing Graphics & Visualization group at the University of Duisburg-Essen; Frederic Hellman, MD, Delaware County Medical Examiner; Peleg Top, Marketing Strategist; Carlos Machado, MD, Physician/Illustrator at Ciba-Geigy/Novartis; and Carl Zimmer, Author.

The 69th Annual Meeting of the Association of Medical Illustrators will take place July 23-26, 2014 in Rochester, MN. Mike and Satyen are already looking forward to attending.

Helping Family Caregivers

Many years ago, long before the Internet, I suddenly became a caregiver for my father when the final stages of his cancer were too much for my mother to handle alone. Without any training or advice, I found myself getting deeper and deeper into the role reversal of child caring for parent.

At first, the tasks were easy, comprising little more than helping Dad by running errands or driving him to appointments. As his disease progressed, so did my involvement with his care. I figured out how to help him with bathing and changing his colostomy bag while trying to maintain a sense of dignity for both of us. The dignity didn’t last long, as his needs grew and his abilities diminished. By the time his life ended, I was intimately involved in every aspect of his daily life. Although his final months had drained me physically and emotionally, I wouldn’t trade that time for anything. We both, finally, came to understand how much we meant to each other.

Today, things have changed for the better. Training and advice are readily available online. Want to know how to change a colostomy bag? There’s a video on the Internet that shows the process in detail. Need information about financial assistance with lifesaving medication? It’s on the Net. Looking for help with the emotional roller coaster that caregivers often experience? A wealth of resources are available online.

It’s a good thing that caregiver education is available because the number of people who become family caregivers is growing, and growing fast. In 2010, 30% of adults were family caregivers, with almost two-thirds of them supporting a parent or in-law. By 2012, the number had jumped to 39%, and this trend is expected to continue. Fueling the trend is an aging population, the recent economic downturn that has reduced the use of paid, professional caregivers, and improved healthcare that extends lifespans.

Extended lifespans are a wondrous development, but they place a larger demand on family caregivers. As modern medicine develops new therapies, family caregivers may need more education about disease states and therapy options to help their loved ones make the best possible choices. Once the best option has been selected, the regimen can require a large number of medications and dosing schedules to keep track of. Even the ideal regimen is of little value if medicines aren’t taken as directed. The help of a caregiver can make a dramatic difference.

For example, COPD patients with spousal caregivers had 19% higher adherence to antihypertensive medication and 33% higher adherence to long-acting beta agonist medication, compared to a group without caregivers.
 
COPD is not an isolated example. Among cardiac patients, 39% reported being prescribed 7 or more medications, and one in four reported being non-adherent to their medications. Patients with a caregiver were 40% more likely to be adherent to their medications, compared to a group without caregivers.

So, caregivers can make a significant difference. But, they are unlikely to do so unless they are educated about their loved ones’ disease states, treatment options, and the best ways to ensure adherence. The problem is that there is little treatment-specific information available online. The reams of general information that is available may be of little use in our age of increasingly targeted therapies.

Fortunately, Artcraft Health Education can provide caregivers with most everything they need. Our service offering includes:

• Disease-state education 
• Education for caregivers on how to assist loved ones in choosing therapy options
• A wide variety of adherence aids, including:

• Education detailing the rationale behind and value of strict adherence 
• Appointment and medication reminders
• Usage instructions
• Injection kits
• Mobile and tablet tracker apps
• Demo injection pens with sound chips and scrolling instructions
• Infusion mats
• Pill organizers, dispensers, and vials
• Measured dosage dispensers

Over the years, being a caregiver has changed for the better. A wealth of great general health information can be found online. But, caregivers still need specialized education if they are to fulfill the promise of the latest medical advances. Contact Artcraft Health Education today and learn how our caregiver materials can help you improve health outcomes and achieve your marketing objectives.

Tom Savonick - Medical Writer

Happy 4th of July from Artcraft Health Education!

Adherence By The Numbers

Some people call it medication compliance, others call it adherence. Whatever you call it, not doing it is a huge problem for payors, providers, and patients. Here’s why:

 

A Practitioner Says: 

“As a family physician, I see the negative impact nonadherence has on patients each day. I also see the positive impact that adherence to treatment protocols has and the improved quality of life many individuals experience as a result.” Rebecca Jaffe, MD

An Industry Spokesperson Says: 

“Improving adherence for diabetes alone could result in more than one million avoided emergency room visits and hospitalizations every year, saving over $8 billion a year.” John Castellani, president and chief executive officer of the Pharmaceutical Research and Manufacturers of America (PhRMA)

An Academic Researcher Says: 

“Increasing the effectiveness of adherence interventions may have a far greater impact on the health of the population than any improvement in specific medical treatments.” R. Bryan Haynes, MD, PhD

A Global Health Proponent Says: 

“There is no single intervention strategy, or package of strategies that has been shown to be effective across all patients, conditions and settings. Consequently, interventions that target adherence must be tailored to the particular illness-related demands experienced by the patient.” World Health Organization

The Leading Patient Education Provider Says: 

“We offer a complete range of educational materials and adherence aids, all custom tailored to the specific needs of a patient cohort. We provide patients with clear information and healthcare professionals with tools to facilitate one-on-one communication with patients.” Artcraft Health Education

Tom Savonick - Medical Writer

Transition of Care to the Pharmacy

Lynn Altmaier, BS, BSN, RN, MSc Senior Medical Writer

As of January 1, 2013, the Affordable Care Act (ACA) requires health systems, including pharmacists and physician groups, to form accountable care organizations (ACOs) that work together to provide coordinated care for eligible Medicare Part D recipients. Pharmacists will be responsible for consulting with patients and their healthcare providers and conducting comprehensive medication reviews to optimize appropriate medication use. They have the education and experience to reduce medication-related problems and improve health outcomes through medication therapy management (MTM), health promotion, and education. They are also in a position to ensure the success of ACOs by mediating the use of medications, reducing medication-related adverse events, preventing hospital readmissions, and helping patients manage chronic conditions.

The Centers for Medicare and Medicaid Services recently approved Walgreens as the first pharmacy chain to be part of an ACO. Walgreens is partnering with physicians and hospitals to form ACOs in Florida, New Jersey, and Texas to help improve health outcomes, access, and convenience while lowering health care costs. Walgreens announced April 4, 2013 that it will be expanding services at its 360 Take Care Clinic locations to include diagnostic and treatment services for chronic conditions such as diabetes, hypertension, and high cholesterol. CVS, the nation's largest retail clinic chain with 620 MinuteClinic locations, also has plans to expand its primary care services to include chronic disease management. MinuteClinics are partnering with several large health systems, including Cleveland Clinic, UCLA Medical Center, and Indiana University Health to collaborate on disease management and patient education.

In addition to retail clinics, self-service kiosks that check vital signs and give advice about health and disease risk are being integrated into the market. Rite Aid has partnered with OptumHealth to deliver more cost-effective, "personalized" healthcare at the touch of a button. A person visiting a Rite Aid NowClinic can walk into a private room near the pharmacy counter, register online, answer a few questions about their health problem, and access free education or talk with a nurse via video chat at no charge. If a person wants to speak to a physician, he or she can pay with a credit card for a 10-minute visit and add additional time if necessary. Vitals such as blood pressure may be taken on an automatic cuff and communicated directly to the physician who might write a prescription, if appropriate, or refer the person to a local provider. The NowClinic, which initially started as an online system accessed from home, has expanded its in-store "virtual visit" kiosks to 22 states.

According to a RAND Health study, use of retail clinics increased 10-fold between 2007 and 2009.(1) And the number is expected to climb even higher after January 2014, when an estimated 30 million people who are currently uninsured get healthcare coverage under the ACA. With care initiated at retail clinics being 30% to 40% less expensive than similar care provided at a physician's office, and 80% less than care provided in an emergency room, retail clinics and self-directed care may not only be a means of convenient care, but an answer to our healthcare crisis.(2) A recent study found that the use of retail clinics was associated with a lower total cost of care, primarily due to lower medical expenses at physicians' offices and hospital inpatient care, and fewer emergency department visits.(3)

The U.S. Food and Drug Administration (FDA) is taking "self-service" to a new level with a recent proposal that would allow patients to use technology to evaluate their own health needs and obtain prescription medications over the counter at the pharmacy without ever seeing a physician. The FDA argues that many patients do not seek medical care or prescriptions for certain conditions because of the time and cost associated with seeing a physician and getting a prescription.(4) This new delivery model would allow some medications for chronic conditions, such as asthma and allergies, to be sold under "conditions for safe use." Criteria for conditions for safe use would be assessed using technology such as patient kiosks, remote diagnostic tools, and online questionnaires that determine a patients' needs and appropriate medications.

Janet Woodcock, MD, director of the FDA's Center for Drug Evaluation and Research, supports the proposal, stating "It is clear that there are now many interactive mechanisms that can step the consumer through the process of self-diagnosing and medication selection in a much more comprehensive manner than by them reading the drug fact box." Pharmacists would assist patients in determining their need for medications and help them verify their self-diagnosis. Diseases and conditions that require a confirmation of diagnosis or routine monitoring with diagnostic testing (eg, blood test for cholesterol levels or liver function tests) could be available in the pharmacy. Eric Juhl, director of federal public policy for the National Association of Chain Drug Stores, states "Pharmacists are not only qualified to help educate patients, they also are more accessible than any other health care professional due to the number of drugstores in the U.S. and their extended hours. They are experts in appropriate use of medications and are uniquely qualified to take on this new role."

Although the verdict is still out on how this transition of care to the pharmacy will impact the healthcare system, it is clear that there is an increased need for patient education at the point of care and tools to support continuity of care among providers. Pharmacists and retail clinics will need to be armed with educational resources to reinforce treatment plans, support adherence initiatives, and help consumers make decisions about their health care. Artcraft Health Education (AHE) has long been on the forefront of identifying the best solutions for patient education at multiple touch points. AHE understands the value of patient comprehension and retention in improving adherence and health outcomes. Whether it be a digital animation available at the touch of a kiosk button, take-home resources that simplify a medication regimen, or information about participating in a clinical trial, AHE can help.

References

1. Ashwood JS, Reid RO, Setodji CM, et al. Trends in retail clinic use among the commercially insured. Am J Manag Care. 2011;17(11):e443-e448. http://www.ajmc.com/articles/Trends-in-Retail-Clinic-Use-Among-the-Commercially-Insured. Accessed May 15, 2013.

2. Use of retail clinics rises 10-fold over two-year period. RAND Corporation. http://www.rand.org/news/press/2011/11/22.html. Published November 22, 2011. Accessed May 15, 2013.

3. Sussman A, Dunham L, Snower K, et al. Retail clinic utilization associated with lower total cost of care. Am J Manag Care. 2013;19(4):e148-e157. http://www.ajmc.com/articles/Retail-Clinic-Utilization-Associated-With-Lower-Total-Cost-of-Care. Accessed May 15, 2013.

4. Using innovative technologies and other conditions of safe use to expand which drug products can be considered nonprescription; public hearing. Department of Health and Human Services Food and Drug Administration. http://www.gpo.gov/fdsys/pkg/FR-2012-02-28/pdf/2012-4597.pdf. Published February 28, 2012. Accessed May 15, 2013.

Gamification

Gene S Lysko, Medical Writer

Gamification is the application of select elements of game theory and game mechanics to solve non-game problems, such as negative behavior.

We’re not playing games here. A patient’s adherence to a treatment plan and a subject’s compliance with research protocols are stubborn and common problems in medicine and clinical research, respectively. The reasons for poor treatment adherence or compliance may be simple, or dizzyingly complex—and sometimes both. “I forgot” can be the result of simple and complex behavioral processes. Grounded in an understanding of certain aspects of human nature, gamification may provide an opportunity to help establish healthy habits and overcome treatment obstacles.

Why it works

People like to compete. They have a natural desire to achieve and to be recognized or rewarded for their success. Gamification takes advantage of these and other traits, engaging people to help them “do better,” eg, following their doctor’s instructions, keeping their appointments, completing their diaries, honoring prohibitions and restrictions specified in research protocols.

Complex gamification systems are built around peoples’ desire to be part of a community, and to occupy a certain position within that community. This position, which we can call status, can be an important source of motivation for many people, as can the opportunity to increase one’s rank in the community. Through the lens of gamification, status is gained and advanced by winning points and unlocking higher and higher levels, in effect defining one’s rank in the community. Points might also be earned with the goal of redeeming them for rewards such as gift cards. Encouragement within a game can be given with simple measures of success such as a progress bar or the awarding of stars or badges.

Examples

Status – Congratulations, you’ve taken all of your medicine today! You are now in the top 20%!

Encouragement - You can do it. You’re halfway there already!

 

Implementation

Because of its very nature, gamification is commonly and effectively built into software. Digital trackers, for example, may take the form of a mobile application, or they may operate within a website. Such trackers are designed to positively influence behaviors such as medication compliance, appointment keeping, and diary completion. Through intuitive functionality and creative design, gamification is often employed as a behavior-modification tool, not as a game.

Conclusion

Gamification can help solve stubborn problems in disease management and clinical research. Simple tools that appeal to common human desires can help establish positive habits and improve treatment adherence and compliance with clinical trial protocols. Artcraft Health Education can help you apply these tactics to your unique challenge. Ask us how.

Shedding Light on the Sunshine Act

On February 1, 2013, the Centers for Medicare and Medicaid Services (CMS) unveiled the final version of the Physician Payments Sunshine ACT (PPSA). The Act was created by Congress to ensure transparency in the interactions between physicians and the manufacturers of pharmaceutical, biotechnology, and medical device products.
An unintended side effect of PPSA is that it created a great deal of confusion concerning educational materials given to physicians by manufacturers. When PPSA was passed by Congress in 2010 it clearly exempted patient education materials. Regardless of the monetary value of educational materials covered by the act, they are exempt from reporting requirements. Examples of materials that are excluded from reporting include:

• Any material that benefits patients or is intended for use by patients
• Patient kits, even those containing samples
• Patient kits, even those containing samples
• Anatomical models that help physicians educate their patients
• A flash drive that contains patient education materials to be distributed to patients
• Overhead expenses, such as printing and time, are excluded as long as they’re directly related to developing materials that benefit patients or are intended for patient use

Confusion arose when CMS announced that it would be narrowly interpreting the exclusion requirements for educational materials. But after the initial confusion, CMS clarified what it meant by “narrowly interpreting,” explaining that “education materials, such as medical textbooks or journal reprints, that are educational to covered recipients but are not intended for patient use or directly beneficial to patients are not included in the exclusion.”
According to CMS, the litmus test for whether an educational material is excluded from reporting requirements is that it must directly benefit patients. The good news in that requirement is that Artcraft Health Education creates an amazing array of educational materials that meet that test. Our custom materials in digital and traditional media help manufacturers reach their key audiences while strictly complying with the PPSA. Call us today to learn more.
Key Upcoming Dates regarding the Physician Payments Sunshine Act

• August 1, 2013: Manufacturers begin collecting information on included payments to physicians
• December 31, 2013: First reporting period ends
• January 1, 2014: Second reporting period begins
• March 31, 2014: Manufacturers report all 2013 information to CMS
• September 30, 2014: CMS releases reports on a public website

Tom Savonick - Medical Writer