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Misdirection Can Be Fatal 

by Laurie Gelb, March 17, 2009

ETHEX has initiated a retail-level recall of tablets found after the fact to have been manufactured in non-cGMP conditions. A Blues plan finally sent out a one-page masterpiece of misdirection, one that I'm confident was replicated similarly nationwide, to patients for whom one of the affected scripts was reimbursed. Unfortunately, in this case, misdirection could potentially be fatal, so a communication like this is worth delving into.

First, the letter is dated February 2009, though received in March. ETHEX PR is dated Jan. 28, so there's been a communication delay.

The salutation, despite the fact that these letters are obviously databased from PBM records, is the time-honored "Dear Valued Member." So what would cue a member that this letter, unlike several others received this quarter, should actually be read? The outer envelope holds no clue, either.

The sentence announcing the recall is in bold. That seems scary and necessitating action, doesn't it? But no.

We read that these prescriptions were no longer processed by the PBM as of January 30. If I were comparing this with recalls for cars or food, that would mean that I should take it back and get something fixed or refunded, yes?

Not here. Of course, use of the word "recall" isn't the plan's doing, but there remains the responsibility to explain it.

About halfway down the page, we read " is recommended that you continue to take them [the medications] in accordance with your prescriptions, as the risk of suddenly stopping needed medications may increase your risk for side effects."

Side effects -- not quite the term that most clinicians would characterize as the risk of suddenly d/c'ing nitrates or beta blockers. So this letter is presuming that the patient knows why s/he is on each medication (and remember, each of these is listed only under its full generic name). Alas, if the good ship Argo...and since the letter lists each of the recalled tabs, without specifying which one(s) were filled for the patient, it would be easy to skim this long, complex list and not see the connection. Another form letter gone astray, one might think.

But let's say the patient does recognize one of these meds. She should be thinking that she should do nothing, right? Side effects and all that. But the very next sentence advises: "Your physician is in the best position to help you slowly discontinue use of the medication..."

Wait a second. So the member is supposed to "discontinue?" That sounds like "stop?" But that logic fails when there's no mention of getting a replacement supply, because, of course, the letter is not really recommending that anyone d/c her meds. It's just saying that if you wanted to, you should let your doc in. In fact, it's not saying anything at all, but merely palming patients off on the Ethex customer service number or the MedWatch URL.

The closing: "Thank you for your attention to this matter," once again suggests that you should do something, but by this time, we're immune to confusion (and conclusions). Time to cue up the David Bowie song, "Changes."

This letter mentions five different organizations by name: the plan, its PBM, its pharmacy "consultant," ETHEX and the FDA. However, nowhere does the letter explain any of their responsibilities, roles, accountability or possible usefulness in sorting out any of the letter's contents.

Some of the recalled tabs may be over-generous with the active ingredients. Nowhere in this letter does this fact appear. What to do about refills when shortages for some of the compounds in question have been news for months is nowhere addressed (some patients have been switched over to immediate release vs. extended release metoprolol, for example). Even if the PBM is fully stocked, that reassurance is not made. Nor are terms like cGMP explained. Nor is it identified which drug(s) on the list may apply to the patient (we call it a mail merge with a form field). A single-spaced missive that fills a page, this letter raises more questions than it answers, yet it hints delicately at clinical implications.

When you read polls about distrust, mistrust and misunderstanding of the health insurance industry, remember this letter. A patient who is on a recalled med, based on the PBM's data, is sent a letter in a 8.5 x 11" envelope, signed by a PharmD. There's bold face type and mention of the FDA. It seems serious and worth reading, (well, if you get past the first sentence regarding "changes to prescription drugs in the marketplace"). But, in the end, it's not only unhelpful, it's anxiety-producing or a sedative, depending on which sentences one reads. The tone is cold, formal, impenetrable and replete with jargon. Health plan as robot? We are here.

What would the LA Times think and write about a physician who sent this letter? A hospital? What would you think? Need a plan somehow avoid any visible role in medication management beyond formulary access? The plan will certainly assume a broader role when it comes to hospitalization, surgery, medical devices, etc. and patients know this very well.

So to the Blues plan and your sisters and brothers: After the next recall, if you can't acknowledge the facts for whatever reason (and remember, there's more than one general counsel in the sea), please send your members somewhere that offers actual answers. For example, see the simple language about this recall at the Facts & Comparisons Web site: Ironically, this para is written for HCPs, but is simpler than many of your letters to members.

And next time, don't delay. Spring for a mail merge that produces a personalized salutation and short name rx info. A member with a condition serious enough to justify a drug that you're paying for deserves personhood, not to mention the fact that you might want to converse with that person in the future. Names of drugs and people are a good start. Run your next effort by some real patients, please, and if you can't come to grips with the fact that these are sick people, you might want to think about finding a vertical with lower stakes.

Thank you for your attention to this matter.

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