Saturday, July 16, 2011

A rainbow of potions and pills (by Skylanda)

The New York Times this week reports on a phenomenon that you’ve likely experienced if you take more than a couple of prescription drugs, or especially if you care for an elderly parent who juggles a rainbow of blood pressure meds, statins, prostate shrinkers, memory enhancers, and other sundry pills and potions: all that confusion that happens when one generic pharmaceutical is substituted for another, and suddenly a little oval pink pill they’ve been taking for years is substituted with an oblong white pill and the patient no longer has any idea what they are taking for what purpose anymore.

The article suggests that the problem lies in the transition that occurs when expensive branded drugs go generic: you knew that your Viagra was a little blue diamond because Pfizer masterminded a decade-long PR program to ensure that you knew this. But when the little blue pill or the big purple pill turns into a bland little yellow thing, the patient loses the differentiation between those and the six other bland little tablets they are taking. Lipitor is next on the block to go generic this year – and about time: as one of the highest-potency anti-cholesterol drugs, a generic Lipitor could stop the hair-splitting between those who can take the old low-potency statins and those who need the expensive blockbuster cholesterol medications like Crestor and Lipitor. But still: those generics will be variable, produced by dozens of generics makers, likely in a rainbow of neutral colors - instead of the old oval white that Lipitor users have been taking since the drug came onto the market 14 years ago.

Marketing people argue that the look of a pill is part of a company’s right to set their product aside from all other products – including generic equivalents; generics should not carry the same look of branded Viagra or Prilosec (the famed first Purple Pill) because that was part of the propriety marketing of the patented drug. Proponents of drug safety argue the opposite: that changing the drug’s look when it goes off-patent to a variety of appearances that change every time a pharmacy stocks a different supplier contributes to confusion, non-compliance, and even harmful drug errors. (This would also save me at least half a dozen conversations a week in which a patient tries to explain which medication they are taking by saying, “You know, it’s a that little yellow one with the oval shape, you must know what it is…” I try to cut these conversations short as fast as possible: I do not know what pill that is, and there is no utility to my committing these thousands of variations to memory. I prescribe between 20-50 medications on a daily basis, and some hundreds more as a matter of course, most of which have dozens of generic variations. You want your doctor to spend their free brain space reading up on the latest data, engaging in lively discussions with colleagues about the evidence on controversial cases, maybe reviewing ways to make their office practice more efficient. You do not want them wasting space limited brain space brain memorizing the size and shape of infinite varieties of generic pills.)

To a certain extent, I agree with the latter: confusion would drop precipitously if one drug always came in the same form, no variation between size, shape, or color. But there is a fundamental flaw in that thinking, a deeper problem with pharmaceutical labeling, and a systematic fix parallel to the color and size issue that strikes deeper at the heart of medical error:

Currently, all medications on the market are required to carry a unique identifier code; to figure out what a drug is from the code on any pill, you essentially have to run it through a program that is designed to suss out this information. This code identifies the drug and maker, but often with letter and number combinations that have nothing to do with what is in the pill – they just have to use a unique code (AN 627, for example is – inexplicably – one formulation of tramadol). What would work better? Regulators could require that the unique identifier be almost microscopically small, but that every pill actually have the generic name and dose imprinted or inscribed on it. Like this.

This may not solve the issue of the elderly patient whose sight is beginning to fail but who is still juggling their own medications – certainly the big-pink-pill versus small-yellow-pill is going to be a lot easier to distinguish than the tiny writing it will take to fit words like “atorvastatin 20mg” on a standard Lipitor tablet. But it will help caretakers keep the jumble of meds apart – and it can help give hospital and care facility nurses a layer of final checks on medications that are completely lacking now: when you know you are supposed to be handing out the combination blood pressure drug Zestoretic but the only marker on the pill is an “A” on one side and a “26” on the other, you have no final verification that you chose the right medication from the supply, that the Pyxis machine spat out the right drug, that you did not mix up the drugs between the first patient’s room, the emergency call back to the desk, the stop by a third patient’s room who has been frantically delirious all night, and finally back to the room of the second patient who is receiving the medication: all part of the normal chaos that nurses cope with on a shift-wide basis.

Forcing the use of generic names from the day a drug is marketed would also encourage an early familiarity and reliance on generic names, which separates providers and patients from the attachment to well-branded and well-marketed drugs later on. In training I had faculty who refused to let trainees use brand names of drugs – even those which had no off-patent equivalent – because they were so passionate about the effect of branded drug pricing on health care costs; it was atorvastatin or no name at all.

In medicine – as in most disciplines – some errors are fundamentally due to individual incompetence and cannot be fixed by systemic solutions; these are few and far between. Most errors have systemic solutions that could drastically reduce harm, and this is a core example of them. Maintaining the same shape, size, and color to medications across the generics would be ideal, but labeling clear identifiers on pills at all is such a fundamentally much more important issue that has largely not even hit the radar: a issue of convenience, an issue of efficiency, and moreover, an issue of safety for you and your family as the patients who rely on these products to maintain their health.

Cross-posted from my recently relocated and re-launched blog at America, Love it or Heal It.