Abuse Deterrent Formulations

Drugs of choice among recreational abusers are changing. Spurned by calls from congress, the FDA and state Attourney Generals, drug makers have started to combat the abuse if their prescription medicines.

The prescription drug abuse epidemic now claims more American lives than car crashes, prompting state and federal leaders, including the Congressional Caucus on Prescription Drug Abuse and 48 state Attorneys General to urge FDA action

The NIH lists the most commonly abused drugs and drug catagories, as well as how these drugs are abused. Click here to see the list. The graph below is from a University of Michigan survey of 12th graders, note the number of abused prescription drugs.

The National Survey on Drug Use and Health data for 2009 found that among Americans 12 years or older who used analgesics nonmedically in the previous 12 months:

  • 55.3% said they obtained pain relievers from a friend or relative for free
  • 17.6% had fraudulently obtained prescriptions
  • 9.9% purchased drugs from a friend or family member
  • 5% stole them from a friend or family member

Only 5% purchased their supply from a dealer. Forget the “dealer” stereotype that you think of—“pill ladies” is now street slang for elderly women who augment their income by selling their prescription medication to others.

Abuse Deterrent Products

Now Abuse-deterrent formulations target the known or expected routes of abuse, such as crushing in order to snort or dissolving in order to inject, for the specific opioid drug substance in that formulation. The science of abuse deterrence is relatively new, and both the formulation technologies and the analytical, clinical, and statistical methods for evaluating those technologies are rapidly evolving. FDA considers the development of abuse-deterrent formulations to be a public health priority and is encouraging their development.

There are a few drugs on the market that use abuse deterrent formulations. Most of these fall into one of three Approaches Known to Deter

Combination Products

Abusers tend to find combination products that include certain other drugs (eg, acetaminophen, aspirin, ibuprofen, and caffeine) with the main drug (usually an opioid) less abusable for the same reasons pharmacists dislike combination products—the nonopioid product can add toxicity risks to the product.

Physical Barriers

Abusers sometimes go to great lengths to extract a drug. If crushing is ineffective, they proceed to simple chemical manipulations, multistep extraction, or laboratory-level processes. ADFs using physical barriers circumvent common tampering methods. Extended-, sustained-, or controlled-release formulations deter abuse to differing degrees. Video of Congressman Hal Rogers (KY-05) demonstrating a crush resistant pill.

Prodrugs

The newest concept is using prodrugs—agents that are inactive or significantly less active until metabolized. This deters intravenous or intranasal use. Once administered, prodrugs are metabolized into active metabolites.

Prescription drugs will always run the risk of being abused. But I like the idea of providing incentives to drug companies to develop products that make that abuse harder.

This is a conversation, not an editorial. Did I forget something, get it wrong or do you agree? Please Comment, Like, Re-Tweet and Share

 

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