The role of abuse-deterrent formulations in countering opioid misuse and abuse

This article focused on abuse-deterrent formulations or ADFs of various drug products. Opioid pain relievers are highly abused, with the highest percent of abuse found in pain clinics (8 to 16%). Abusers are known to tamper with the original drug product through various means that include crushing the tablet, administering rectally, combining with alcohol, smoking, and more. The FDA hopes that by regulating the design or both pre and post-marketing studies they will be able to encourage ADFs. Ways in which to make a drug in an abuse-deterrent form is by rendering the drug inactive when tampered with. The product could also be formulated with physiochemical barriers to abuse. Various post-marketing studies will determine whether the completed product actually results in meaningful abuse reductions. Current ADF products include oxycodone with Intac technology, which requires an excessive amount of force to crush or break the tablet. Also, when this formulation comes into contact with water, it transforms into a consistency that can not be drawn into a syringe.

While these formulations have proven to decrease abuse rates in patients seeking pain management, the cost burden might affect the availability for patients at risk of abuse. Most of these products are only available as brand name products, as generic opioids are not in ADF form. In our Drug Development class we have learned a lot about the drug development process when it comes to brand versus generic formulation. How long will it take for these formulations to become available? What barriers might patients face to obtain these products and what are some possible solutions? The article brings up a good point of offering savings cards or coupons for these products. Would this encourage ADFs over regularly formulated opioid pain relievers?

Nguyen V, Raffa RB, Taylor R. The role of abuse-deterrent formulations in countering opioid misuse and abuse. J Clin Pharm Ther. 2015; 40:629-34.

http://onlinelibrary.wiley.com/enhanced/doi/10.1111/jcpt.12337/

2 thoughts on “The role of abuse-deterrent formulations in countering opioid misuse and abuse”

  1. I found the Intac technology to be quite amazing. I was not even aware of these protective technologies that can be built into tablets. I’m curious in regards to the medication becoming inactive if it comes in contact with water. Does this affect how it is metabolized by the human body as can and surely be in contact with water? I’m also curious as to why they are not available in generic forms. I’m sure the cost of manufacturing comes in to play. Overall, i found this really amazing and shows a new viewpoint for how the drug protects one from inside the body, as well as outside.

  2. I think the use of manufacturer savings cards will be an effective way of making opioids available to those that actually need it. I think the brand medication should be listed as the preferred medication by insurance companies if the brand is available in ADF. I think this would benefit the insurance companies as well has patients using the drug because opioid overdose is a growing issue. I think insurance companies would save money from hospital visits due to overdose in the long term. In addition, insurance companies may request prior authorizations for patients who have high risk of overdose. Patients who may be flagged for high-risk are those that reside in poor communities or experience chronic pain and regularly take opioids as opposed to a one time thing. The use of prior authorizations may make it more difficult for patients who are not using opioids for its intended purpose to obtain the medications.

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