My Favorite MedDRA Story – the “Mobile MedDRA Unit”

Patty Mozzicato
Chief Medical Officer, MSSO

While at Bristol-Myers Squibb as a drug safety physician, I was deeply involved with our company’s roll out of MedDRA back in late 1998 and early 1999. In fact, I trained all the early users of MedDRA at BMS – which was quite a challenge since all I had for resources at that time was the MedDRA Introductory Guide and the MSSO browser.

BMS rolled out MedDRA on 25 May 1999; on the very same day, we also implemented our brand new state-of-the-art Web-based safety database. Needless to say, it was quite a tense day as everyone was waiting to see if the new system would perform as well in real time as it had in testing. Furthermore, we had this new fangled dictionary to deal with! I needed to provide my drug safety colleagues with some much-needed support to get them through their first day using MedDRA, but I wanted to do it in a light-hearted way.

That morning, I put on my long white lab coat, my bicycle helmet (with a red cross that said “Mobile MedDRA Unit” on it), and my in-line skates (rollerblades).As the new system, including MedDRA Version 2.1, came on line, I whizzed around the floor of the safety department on my skates, going from office to office and asking if anyone had any MedDRA questions as they worked on safety reports.

I’m thrilled to say that the implementation of the new safety system and MedDRA went very well that day, and everyone enjoyed a laugh (at my expense, but that’s OK!). To this day, my former BMS colleagues love to remind me of that day I skated about as the “Mobile MedDRA Unit.”

My favorite MedDRA Story “Speak your Mind or else…”

Philippe Thouvay

Back in 1999, as a Drug Safety Physician, I was in charge of implementing MedDRA in Global Drug Safety at Roche and designing MedDRA training for a global audience trying to be as clear as possible but just at the time we went live with MedDRA I received from one of our Affiliate a report mentioning “the patient fell between the two beds”. Wishing to know more of the circumstances of the fall thinking of making good use of MedDRA granularity (was it due to dizziness or syncope etc…) I requested follow-up information without clarifying what I meant by follow-up.

This is what I received as follow-up information:

And my colleagues thinking they had better be perfectly clear added:

I realized then what cultural differences meant and that I should never leave room for interpretation! As a consequence, I asked colleagues worldwide to review my training slides to make sure I would deliver clear messages in the future.

My Favorite MedDRA Story – the “Can I have a copy?”

Heather Ford-Chatterton RN BSN

While at Frontier Science and Technology Research Foundation as a MedDRA Coding Supervisor, I created many resource documents for our clinical sites to help them submit accurate and quality information to be MedDRA coded.  However, on a number of occasions I would still need to send out QA emails asking clinical sites to clarify the medical information they submitted so that an accurate MedDRA code could be applied.

On one occasion I asked if the clinician could clarify a body site association with a report of candidiasis.My rationale for this was the need to apply a MedDRA code and that a body site would ensure the clinical event was classified into the correct System Organ Classes (primary and secondary). The clinician did provide the body site, but requested: “please send me a copy of this MedDRA thing so I can avoid QA emails in the future!”

Unfortunately, I had to decline the request as sending a ‘copy’ wasn’t feasible or advisable. Instead I referred the clinician to the help documents I created and all ended well.The clinician learned more about MedDRA and the Quality of source data than he would have with a simple ‘copy’!

My Favorite MedDRA Story – “Felt like a zombie”

Eva Rump
International Medical Officer, MSSO

Back in 2000 in one of the ”Coding with MedDRA” classes, I wanted to demonstrate how one can cope from a coder perspective with vague and imprecise verbatims reported from investigators. Aside from discussing several other broad concepts such as “disorder,” I opened in the Browser the PT Feeling abnormal with all the subordinate LLTs to show a variety of strange feeling expressions which can occur in real life and certainly are hard to be interpreted into something better than “Feeling abnormal.”

Suddenly one of the attendees exclaimed, “Oh, I know this term ‘Felt like a zombie.’ It came from us [the trainee’s company].” He told the whole story from a subject in a phase one study reporting that he “feels like a zombie;” this was exactly how the term had been entered as a synonym into their database. The question on how such a term found its way into MedDRA was not hard to figure out either. One of the original experts in the Working Group that developed for MedDRA was the director of the safety department in this company, and obviously not only MCA’s synonyms had been taken into MedDRA. This original German company vanished years ago but one of its verbatims will stay forever as an LLT in MedDRA.

My Favorite MedDRA Story – the “Mystery Note”

Hilary Vass
AstraZeneca Pharmaceuticals

When we first introduced MedDRA we thought it essential to get as many folk to attend training as possible. We thought the sessions had gone really well until we found the following note on the floor when tidying up. (The pictures cover the front and reverse of the note.)

Anyway I did use it afterwards as an alternative to an "Any questions slide" and then asked the audience what was on the reverse. No one ever guessed.

My Favorite MedDRA Story – the “Halo Effect”

Scott Vitiello
MedDRA MSSO

I was setting up the MedDRA MSSO booth for the Boston DIA conference. I saw at another booth attendant struggling with unpacking a piece of equipment. I went over to assist this person. We began to talk, and this person mentioned to me that he was glad that the MedDRA MSSO booth was next to their booth. I asked “Why?” and he said because of the “Halo Effect.” I asked “What does he mean by that?” The gentlemen explained to me that since the MedDRA MSSO booth was close to their booth, it provided their company with instant credibility.

My Favorite MedDRA Story – “A Model MedDRA Mix-up”

Judy Harrison
Medical Officer, MedDRA MSSO

Some of the MSSO’s MedDRA training courses are conducted at commercial computer and business training facilities where various classes on computer applications are typically being held at the same time as our course. On occasion, people arrive late for the course, hurriedly apologize, and seat themselves at an empty desk. A few minutes pass before a confused look comes over their faces as they realize that they have no idea what I’m talking about and that this is not the “Introduction to Excel” class they were expecting. They then excuse themselves and head for the correct classroom.

To avoid such disruptions, I sometimes post a sign saying “MedDRA” outside our classroom. At one training center in Southern California, I noticed that the people arriving for the course were uniformly young and attractive, and were somewhat more skimpily attired than our typical attendees. Assuming that this was simply just a normal Californian characteristic, I welcomed them to the course. Again, I noticed confused looks and it became apparent that these people had mixed up the MedDRA class with a casting call for a modeling agency being held next door. They must have thought that the “MedDRA” sign was some sort of acronym for Modeling Recruitment Agency.

What we will never know is if someone who was signed up for the MedDRA training also mixed up the classrooms and was diverted into a modeling career instead.