Poka-Yoke Pharmaceuticals

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King 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.

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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