Second Tweet on Competence in Medical Writing, Editing, and Social Media

A guide from the World Health Organization for presenting your message logically and coherently. Tweets will be aggregated at #cmwesm

First Tweet on Competence in Medical Writing, Editing, and Social Media

Here's a resource from AAAS to help medical writers to communicate scientific content appropriately.  These tweets will be aggregated on Twitter under the following hashtag: #cmwesm

Competence Tweet Series Begins Monday, July 1

Our 30-day tweet series on competence in medical writing and editing will begin July 1 and continue throughout the month at the leisurely pace of a tweet per day.

Each tweet will relate in some way to one of the key competencies of a medical writer identified in a 2012 survey by the American Medical Writers Association (AMWA). A total of 1,177 individuals completed the survey, which produced 68 competencies, but we will just tweet about the top 30. AMWA members may view the list by visiting http://goo.gl/dUpkg.

Tweets will originate from the account of the Board of Editors in the Life Sciences, @BELS_Editors. Tweets will also originate from my personal Twitter account, @Grantsmeister, and as updates from my LinkedIn page, http://goo.gl/ZIdDS.

If needed, background information on the series may also be posted here on my blog, Delaware Valley Medical Writer. 

Tweets will be aggregated under the symbol #cmwesm. The letters stand for “competence in medical writing, editing, and social media.” This means you can catch up on what you’ve missed by visiting your Twitter account and searching on #cmwesm. This hashtag has been registered with the Healthcare Hashtags Project.

If you're still coming up to speed on Twitter, here's a great guide to the basics, published by the London School of Economics. http://goo.gl/Sg6ST

At the end of the series, we'll meet for a one-hour tweet chat. Time and date of the chat will be announced later. (Coordinating time zones may require some discussion.)

Before the chat, I will send around a list of discussion questions. This list is still forming, but is sure to include the following:

1) How can editors help ensure competence in medical and science writing?

2) Why do you think "maintain confidentiality of information" ranks 3rd in importance on the list of 68 basic medical writing competencies?

Hope to meet you soon, in the Twitterverse!

Don

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.

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.

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!

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.

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

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! 

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.

New Certificate in Science Fundamentals

Summary of a meeting held Oct. 11 during the annual conference of the American Medical Writers Association (AMWA)

AMWA President Sue Hudson (pictured above) started the meeting by asking for a show of hands to indicate how many people in the room had earned science degrees. Sue then asked how many had earned English or humanities degrees. She discovered the proportion ran about two-thirds humanities and one-third science, out of 40–50 people in the room.

Sue then explained how the new certificate is primarily for people with English and humanities degrees. Sue explained her degree is in journalism. She started her career as a technical writer for a company that made photographic equipment. In 1995 she began editing medical manuscripts with her husband. She described the certificate as being designed for people like her: writers with a non-science background who want to improve their knowledge of science without pursuing an advanced degree.

Sue said the certificate is also for people who have an advanced degree in one area of science who would like to get an orientation to another area. As an example, Sue mentioned a biochemist who wants to learn a bit more about a clinical specialty, or a clinician who wants an orientation to molecular biology. Finally, Sue added, the certificate is for those individuals who simply enjoy the rigor of working toward an educational goal.

The idea for the new certificate came out of a 2005 membership survey, in which members said they would like to see AMWA offer more science instruction. Each workshop is designed to give no more than an introduction to a topic. Sue assured her listeners that AMWA leaders have no illusions that completing one three-hour workshop will make anyone a scientist. Instead, each science workshop is supposed to give attendees an overview of the topic, an introduction to key concepts and methods, and suggest good resources to learn more.

Sue said staff members have made a conscious effort to make the science fundamentals certificate similar in many respects to the core certificate. So, for example, the two certificates both require completion of eight workshops, four from a general list and four from a specialty list. Enrollment costs the same for the two certificates: $125 for members and $235 for nonmembers. Workshops can be taken in any order, but all eight must be completed within 6 years.

Apparently many AMWA members have taken credit-bearing workshops in excess of the number required for the core certificate. Dane Russo, AMWA education manager, explained that these workshops may be applied toward the science fundamentals certificate, under three conditions: 1) the person’s certificate enrollment was paid-up at the time he or she took the workshop, 2) the topic of the workshop is on the list of topics for the science fundamentals certificate, and 3) the workshop has not yet been applied toward another certificate. Dane encouraged AMWA members who are uncertain of their educational history to check their personal records using the members-only section of the association’s Web site.

Michele Vivirito, annual conference administrator, explained the standard workshop template that instructors will use as they prepare instruction. Again, Michele emphasized the goal is not to train future scientists, but rather to train writers and editors to read and understand scientific material, thereby enhancing their credibility with doctors and scientists.

According to Michele, the basic workshop template encourages instructors to provide an introduction, a glossary, an overview of basic concepts, a description of common techniques, a review of the homework, and a list of resources for further study. The homework template suggests that instructors ask their students to learn about key resources in the specialty area, read a current scientific article about the topic, and use one or more resources to prepare a passage of text for discussion at the workshop.

Susan Aiello, workshop coordinator for the certificate, encouraged scientists in attendance to consider offering workshops within their medical specialty areas, such as eyes, bone, skin, heart, etc. Prospective leaders should submit a CV, and indicate whether they want to lead the workshop alone or with a co-leader. Susan said new workshops are usually offered on a non-credit basis at first. Then they are modified, based on student input, before being offered for credit.

In response to a question from the floor, Dominic De Bellis, past president of the Empire State-Metro NY chapter and past president of AMWA, tried to explain the level of instruction to be delivered. De Bellis stated it will be possible to have an English major with no formal science training enroll in a workshop alongside someone who has earned a doctorate in cell biology. This is a common instructional challenge in AMWA workshops, De Bellis said. Instructors must be able to simultaneously answer questions from someone who is totally lost, while also answering high-end questions from someone with extensive background in a related topic. This is one reason why precourse assignments are so useful, De Bellis said. Homework helps instructors get a feel for the level of instruction that will be most helpful for the largest number of students, as they try to find a middle ground.

Barbara Snyder, outgoing education administrator for AMWA, said she has asked workshop leaders to tone down the level of their instruction in the past, because some of them get carried away with technical and scientific details.

“I’m extremely happy that a program like this exists,” said Alisa Gayle Mayor, a member of AMWA’s Delaware Valley Chapter. Mayor has begun work toward earning the certificate because she came to the medical writing field with a humanities background. Mayor encouraged AMWA leaders to publicize the new certificate program widely, so more people can take advantage of it.

For a list of science fundamental workshops, see column in the upper right corner.

News from Atlanta

This week the medical writing action moves to Atlanta, Georgia, site of the 67th annual conference of the American Medical Writers Association. At least three medical writers from upstate New York are attending: Lois Baker from Buffalo and Danielle Masursky and Don Harting from Syracuse.

Tomorrow night, Thursday, about 30 members of the Empire State-Metro NY chapter for AMWA are scheduled to go out to dinner together at an Indian restaurant near the conference hotel. The outing is being spearheaded by Anjani Shah, the chapter treasurer. Anjani's from Scarsdale, outside New York City.

Tonight Don, Lois Baker, and several other AMWA members met over cocktails and snacks at the reception hosted by ReSearch Pharmaceutical Services.

Thank You, All

Thanks to everyone who came to our networking lunch, esp. Elaine Wackerow, Denny Harrigan, Julie Bonney, Darryl Geddes, Maria Hosmer-Briggs, Danielle Masursky, Bharati Hegde, Sarah Peirce-Sandner, Anne Nafziger, Lois Baker, Peter Ensminger, Fred Wilson, Mary Royer, and Mary Kay Winchell.

Mary Kay and Sarah are working on a program evaluation so people who attended can tell us what they liked best, and make suggestions for future programs.

Once again, thank you to Upstate Medical University for hosting this event, esp. Darryl who arranged the room and free parking and George Paul who arranged the laptop, projector, and pull-down screen. We really appreciate your hospitality!

Thanks, too, to AMWA HQ staff, esp. Ronnie Streff for helping with publicity and Bonnie Green for sending literature. And many thanks to state chapter officers, including Anjani Shah, our treasurer, Bob Kirsch, our past president, and Renee Cohen, PR director, for their help making this program a reality.

We couldn't have done it without you!

Fourth Podcast

This five-minute talk was given by Peter Ensminger, an expert in photobiology, during our networking lunch. Thank you, Peter!

Third Podcast

This recording lasts about 7 minutes and features Lois Baker, senior health science writer at the University of Buffalo. Thank you, Lois, for sharing your perspective!

Follow this link to learn more:

Our Panelists

DISTINGUISHED PANEL: Four successful medical writers shared their perspectives on getting started in this exciting profession during a recent networking lunch in Syracuse, New York. Pictured, from left to right, are Peter Ensminger, PhD; Lois Baker, MS; Mary Royer, MS; and Fred Wilson, MS. Digital recordings of their presentations, each about six minutes long, are available by clicking links on this blog. (Photo by Don Harting.)

Second Podcast

A second podcast is now available, recorded Tuesday, Sept. 11 during the networking lunch.

Follow this link

to listen to the recording of Mary Royer's presentation about getting started in medical writing. Thank you, Mary, for sharing your experience!

Can Anyone Help Linda?

Here is a message posted by Linda Favata, of Canandaigua, who wanted to attend the Tuesday lunch but something came up at the last minute. Linda's post appears in double quotation marks below. If anyone can answer her question, please do.

"One of the things I was looking forward to was the networking. My husband and I are originally from Rome, NY. We have moved all over and just moved back to NY from Massachusetts a year ago this past August. We are now living in Canandaigua.

I have been working as a clinical research consultant for the past several (~9) years. My main client, for whom I have worked for 6+ years, is in Massachusetts. Due to a recent reorganization by my client, my hours have been reduced from a max of 40 hours/wk to a max of 10 hours/wk. I am about to sign a contract with another device company, also in Massachusetts, for a project that will take about 60 hours total time, hopefully leading to some additional work. I was hoping to link up with someone with experience in writing abstracts and manuscripts and learn where I might get some experience and background in preparing these types of documents. I also have experience in preparing regulatory documents. It has been several years, however, since I did regulatory work, as most of the device companies have split clinical and regulatory into two separate groups.
At the time I was involved in regulatory, I was managing both regulatory and clinical.

If you know of anyone who may be able to assist me in learning about abstracts, manuscripts, posters, or who just may have some contacts for writing (preferably for medical devices), please feel free to have them contact me. My address, telephone number, and e-mail are as follows:

Linda L. Favata
5237 Sammys Way
Canandaigua, NY 14424

Phone: 585-396-3297
e-mail: llfava@frontiernet.net"

First Podcast

Here is a link to the first podcast produced from our Sept. 11 networking lunch. If you click on this link


you will go to a page describing the podcast in more detail, and you will be able to listen on your computer or download it to your MP3 player. The podcast runs about 6 minutes. In it Fred Wilson of Camillus, a successful medical writer, describes what it's like and how he got started.


Many thanks to Fred for his cooperation in making this podcast possible, and to Upstate Medical University, for hosting the lunch.

Parking Update

CONVENIENT, FREE PARKING is available for people attending the American Medical Writers Association networking lunch at Upstate Medical University in Syracuse on Tuesday, Sept. 11.

Be sure to park in the CNY Medical Center garage, in the 700 block of Irving Avenue. The name is shown above the main entrance. This garage is right across the street from Weiskotten Hall, where the lunch is being held on the ninth floor.

To receive your free parking, YOU MUST BRING YOUR PARKING TICKET TO THE LUNCH. Our hosts at Upstate will validate your ticket, so you won't be required to pay when you leave the garage. This will save you about $6.

If for some reason you cannot park in the CNY Medical Center garage, your second choice would be a meter along Irving Avenue, if you can find one, but you will have to pay for it yourself. Your third choice would be the Upstate Medical University garage on Adams Street. Why? Because our hosts at University can also validate your parking ticket there. HOWEVER, the Upstate garage is two and half VERY LONG BLOCKS away from Weiskotten, and you have to dodge construction vehicles en route because the sidewalks are blocked in places, and it's a steep uphill climb unless you know your way through the bowels of University Hospital. So this option is not recommended!

Handicapped parking with direct access to Weiskotten is available in a small lot on the far south side of the building. Driving south along Irving Ave., take a right at the first light past the building. The lot is on your right, across from the Veterans Administration hospital.

No matter where you park, you will need to find your way to the top floor of the new section of Weiskotten. (The new section has nine stories, while the old section tops out at four.) Best bet: use the building's main entrance on Irving Avenue. You will know you're in the right place when you read this inscription on the foyer wall: "Dedicated to all those who purpose to serve humanity." That's us!

You'll see a stack of complimentary copies of the New York Times on the receptionist's desk. Ask him or her how to get to the cafeteria. There is no security check, and no badge is required, since you are not in the hospital. You will need to zigzag to follow the corridors around behind the auditorium (a left, a right, then another right) until you find the main bank of elevators, just past a bio lab. Take the elevator to the ninth floor, then follow your nose to the cafeteria, and ask anyone for the Doust Board Room, which is right next door.

If you wish to use MapQuest to obtain driving directions, the street address of Weiskotten Hall is 766 Irving Avenue.

We will start meeting at noon, the program starts at 12:25, and we plan to end at 1:30. If you want to learn more about AMWA, you might want to stick around a little longer.

Hope to see you there!