Prescription drug abuse is a large and growing problem. In the decade between 1992 and 2002, prescriptions for controlled substances increased roughly three times faster than prescriptions for noncontrolled substances and 12 times faster than the general population. With drug/formulation
tampering now a prevalent problem, regulators and manufacturers have turned to the manufacturing process for ways to decrease the likelihood that a specific formulation is abuse-ready. Abuse-deterrent formulations are one aspect of a comprehensive approach to prescription drug risk management.
Several approaches seem most likely to deter misuse and abuse: adding agonists or excipients that foil tampering efforts, using physical barriers, and designing prodrugs. Abbreviations: ADF = Abuse-deterrent formulation, CSA = Controlled Substances Act, DEA = Drug Enforcement Agency,
FDA = Food and Drug Administration, NDA = New Drug Application.
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