Poka-Yoke Pharmaceuticals

poka-yoke, mistake proof, fail proof, drugs, embeda, lean, six sigmaKing 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:

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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Comments

blog post: Poka-Yoke Pharmaceuticals http://tinyurl.com/pfnp65

This comment was originally posted on Twitter

@backtype: nice work, but lately it’s not picking-up on wp 2.8.4; post should have a few tweets http://is.gd/2oDXo, but none were picked-up

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Brilliant – error proofing a pharmaceutical against abuse http://bit.ly/W33ez

This comment was originally posted on Twitter

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

RT @leanblog: Brilliant – error proofing a pharmaceutical against abuse http://bit.ly/W33ez

This comment was originally posted on Twitter

Great example – should become the standard RT @leanblog Brilliant error proofing a pharmaceutical against abuse http://bit.ly/W33ez

This comment was originally posted on Twitter

RT @leanblog: Brilliant – error proofing a pharmaceutical against abuse http://bit.ly/W33ez

This comment was originally posted on Twitter

RT @GrahamHill @leanblog: Brilliant – error proofing a pharmaceutical against abuse http://bit.ly/W33ez

This comment was originally posted on Twitter

RT @leanblog: Brilliant – error proofing a pharmaceutical against abuse http://bit.ly/W33ez [via @GrahamHill ]

This comment was originally posted on Twitter

RT @ethicsblogger RT @leanblog: Brilliant – error proofing a pharmaceutical against abuse http://bit.ly/W33ez [via @GrahamHill ]

This comment was originally posted on Twitter

Poka Yoke rts @ethicsblogger @leanblog: Brilliant – error proofing a pharmaceutical against abuse http://bit.ly/W33ez [via @GrahamHill ]

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Poka-Yoke Pharmaceuticals http://bit.ly/7k4vA (via feedly) #lean

This comment was originally posted on Twitter

Poka-Yoke Pharmaceuticals http://bit.ly/7k4vA (via feedly) #lean

This comment was originally posted on Twitter

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.

[...] Peter Abilla offers a great new example of design that accommodates human frailty: Embeda, a newly FDA-approved pain-killer with …an interesting property: If you take the medication as prescribed, it works fine; if you abuse the medication, it ceases to work. …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. [...]

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