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Everyday Poka-Yoke: Pharmaceuticals

by Pete Abilla on August 17, 2009

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poka yoke pharmaceuticalsKing Pharmaceutical (NYSE: KG) recently had a drug approved by the Food and Drug Administration (FDA).  Their drug, Embeda, has an interesting property: If you take the medication as prescribed, it works fine; if you abuse the medication, it ceases to work.  This is Poka-Yoke (ポカヨケ) for Pharmaceutical drugs.

Poka-Yoke (ポカヨケ), translated, means mistake-proof, or fail-proof.  In it’s simplest form, it is a method that prevents failures.  Poka-Yoke is a critical piece in Lean Thinking, pioneered by Shigeo Shingo.  Examples of Poka-Yoke might include:

  • Clocky, a clock that prevents you from sleeping-in
  • A Key can enter a keyhole in only one way
  • Needle cap, to prevent needle pin pricks
  • A Microwave stops working, when the door is opened
  • Aza Raskin explains Poka-Yoke for Humane Interfaces (Aza is a friend of shmula & his dad invented the Macintosh – Jef Raskin)

In their FDA approval press release:

We are focused on developing medicines that use novel technologies designed to reduce drug liking and make it more difficult to extract the active ingredient.  We anticipate a September 2009 launch for EMBEDA (TM).

Utilizing King’s proprietary technology, EMBEDA(TM) contains extended-release morphine pellets, each with an inner core of naltrexone hydrochloride, an opioid receptor antagonist. If taken as directed, the morphine relieves pain while the sequestered naltrexone hydrochloride passes through the body with no intended clinical effect. If EMBEDA(TM) is crushed or chewed, the naltrexone is released and absorbed with the morphine, reversing the morphine’s subjective and analgesic effects.

poka yoke, prevent defects

At the heart of Poka-Yoke is Prevention and an awareness of Human Frailty: we want to stop problems before they occur.  Indeed, preventing abuse, addiction, medication dependence, tragedy to the individual and families, or death, is a novel and innovative use for Poka-Yoke.

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{ 2 comments… read them below or add one }

Mark Graban August 20, 2009 at 11:43 am

That is absolutely brilliant. Thanks for finding and sharing that!

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Karen Wilhelm August 28, 2009 at 1:15 pm

Regarding addiction as a brain disorder, medical in nature, this is treatment within treatment. I wonder if the naltrexone would also inhibit the patient from using any other opiates while being treated for pain.

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