Tuesday, August 2, 2011

Pharma’s Headache Becomes Writer’s Meal Ticket


Is REMS on your radar? If not, it should be. This growing federal program presents a potential new source of income for both freelance and staff medical writers.

REMS stands for risk evaluation and mitigation strategy. (Technically the acronym is singular, but it sounds plural, so many writers use it that way.) The REMS program was created by the Food and Drug Administration Amendments Act of 2007 as a way to make sure the benefits of new drugs outweigh the risks.

More than 180 risk mitigation strategies have been approved by FDA so far. More are being created every month: 42 were created or updated during the first quarter of 2011. Some are short and simple, others are long and complex.

Approved strategies come in 3 main types. The simplest type requires a medication guide that is distributed inside the drug package (or single dispensing unit, as a pharmacist might say). The medium complex type is called a communication plan, and it adds a “Dear Healthcare Provider” letter explaining the particular risks and benefits of the medication. The communication plan may also involve a small amount of education. The highest level of complexity is called Elements to Assure Safe Use (ETASU). This level is rare; only 21 had been approved by 2011. FDA reserves this step for drugs that are easily misused or abused, such as painkillers. The ETASU for Abstral (fentanyl) sublingual tablets, for example, is 123 pages long, and that just describes the program, it does not include the copy required for the special Web site, the letters to healthcare providers, the certification program for pharmacists, the pharmacy knowledge assessment, and the letters to distributors. As you can see, the REMS program represents a headache for pharma because the money to produce all of these materials comes out of the manufacturer’s pocket. This is why industry spoke out so strongly at an FDA advisory hearing last summer on the future of REMS.

MEAL TICKET

Marilyn Whiteley, PharmD, senior director for global medical writing at PPD Inc. in Morrisville, North Carolina, gave a presentation on REMS at the AMWA national conference in Milwaukee. According to Whiteley, the REMS program presents a valuable work opportunity for medical writers because of the diversity of materials required, the sheer size of some of the programs, the need for consistency and clarity, and the fact that many strategies, once approved, must be updated or renewed on a periodic basis. The best way to position yourself for success in this new market, Whiteley says, is to educate yourself, look for transferable skills, get trained in the areas where you are weak, then market yourself.

In the next year or 2, we can expect to read and hear more about REMS for a class of painkillers called opioid analgesics. Federal public health officials are very concerned by recent statistics showing increased misuse, abuse, and diversion of the extended release and long-lasting forms of these painkillers. These are the types of REMS that often are the most extensive, and therefore offer the greatest employment opportunities. The FDA will determine what must be included, and it will be up to the pharmaceutical companies to decide whether to do the work in-house or outsource to contractors. Pharma won’t just be hiring medical writers: these programs also involve Web design, graphic design, marketing, and continuing education expertise including needs assessment and instructional design.

CME POTENTIAL

The continuing education angle was seized upon by Murray Kopelow, MD, executive director of the Accreditation Council for Continuing Medical Education in Chicago. Dr Kopelow traveled to Washington DC last summer to testify at an FDA advisory hearing, reminding the FDA that accredited CME providers would be delighted to help physicians and pharmacists earn continuing education credit while attending training programs required under future REMS.

A similar approach is being taken by George Mejicano, MD, MS, FACME, president of the Alliance for Continuing Medical Education. This summer, the Alliance issued a joint press release with 5 other organizations expressing strong support of certified CME within the FDA’s REMS program for opioids. Exactly how to fund these activities without violating the ACCME standards for commercial support has not yet been worked out, so stay tuned.









Monday, March 28, 2011

Health Care Journalists Coming to Town in April

The Association of Health Care Journalists will hold its annual meeting in Philadelphia in about 2 weeks. Click here for more information.

Thursday, March 24, 2011

Thank You, Laure Perrier!

Hats off to Laure Perrier at the University of Toronto. Drawing on the university's Research and Development Resource Base, Ms Perrier provided me with a list of 7 recent journal articles and 19 seminal articles on the topic of needs assessment in CME around the world. I'll be tweeting more about these during March and April. Here's a hint of what's to come:

1) Educational needs of off-service residents in emergency medicine in Chicago
2) Faculty development in a Persian Gulf medical school
3) Educational needs of pharmacists in Doha, Qatar
4) Informational needs of NHL survivors and their physicians
5) Educational needs of primary care providers in Dublin, Ireland
6) Needs assessment as a strategic planning tool at a university in India
7) Educational needs of junior GPs in England

This list doesn't even include the seminal articles!

So if needs assessment in CME is your bag, stay tuned for fun!

Monday, March 14, 2011

Annual Princeton Conference -- Don't Miss It!

This year's annual Delaware Valley chapter conference in Princeton is shaping up to be another winner, thanks to veteran conference organizer Brian Bass and his team. 

15th Annual Princeton Conference
Hosted by American Medical Writers Association, Delaware Valley Chapter
Saturday, May 14, 2011
Plainsboro, New Jersey

Morning workshop titles:
1) Organizing the Medical Paper
2) Summarizing  Clinical Efficacy Data
3) Improving Question Writing in CME

Afternoon workshop titles:
1) Writing Abstracts
2) Summarizing Clinical Safety Data
3) Using EndNote to Manage References


Click here for more information and to register.

Wednesday, March 9, 2011

Networking Reception Next Week

March 16 Networking Reception

Come out and network with members of the Delaware Valley Chapter of the American Medical Writers Association at the Doubletree Guest Suites in Plymouth Meeting. 

Hors d'oeuvres and cash bar will be provided. Cash bar prices range from $4.00-$8.00. Bring lots of business cards to exchange!

For details and to register, visit www.amwa-dvc.org

Tuesday, March 8, 2011

Freelance Workshop is Next Month!

If you live in the Delaware Valley and you're interested in medical writing, be sure to attend the freelance workshop on Saturday, April 2 in King of Prussia. The event is hosted by the Delaware Valley chapter of the American Medical Writers Association. I will be moderating a discussion of professional credentials for medical writers. Hope you can join us! 

Thursday, February 24, 2011

Changeover

I am reactivating this blog and changing its title to reflect the fact that I have moved from Syracuse, New York to Downingtown, Pennsylvania.