Yevgeniy Lyutov, PharmD Candidate; Mitchelle Rodriguez, PharmD Candidate; Katherine Tromp, PharmD
abuse is the intentional use of a medication without a prescription, in a way other than as
prescribed, or for the experience or feeling it causes.1 Prescription drug misuse can consists of
using a medication in a manner or at a dose that was not recommended by a healthcare
professional.2 The misuse and abuse of prescription drugs
is a growing epidemic in the United States. It is estimated that over 20% of Americans have abused
The National Institute on Drug
Abuse (NIDA) reports the most commonly abused medications are pain relievers, tranquilizers,
stimulants, and sedatives. They also state that among these medications, pain relievers are the
most frequently abused prescription drug. The CDC reported 1 in 20 US individuals have used
painkillers for non-medical use in 2010.4
Among adolescents, prescription
and over-the-counter medications account for most of the commonly abused illicit drugs. The 2011
Monitoring the Future Study (MTF) from NIDA and National Institute of Health (NIH) showed that 1 in
12 high school seniors reported nonmedical use of Vicodin®; 1 in 20 reported abuse of
OxyContin®. They also reported that when high school students were asked how prescription
narcotics were obtained for nonmedical use, 70% of 12th graders said they were given to them by a
friend or relative.6
Prescription opioid analgesics
are an important component of pain management. Abuse and misuse of these products, however, have
created a serious and growing public health problem. As a result of this growing drug problem, the
Food and Drug Administration (FDA) and several drug companies have taken on the task of formulating
abuse deterrent formulations for opioids, the most commonly abused painkillers.
In January 2013, the FDA issued a
draft guidance document that is meant to assist industry in developing new formulations of opioid
drugs with abuse-deterrent properties. Abuse deterrent formulations (ADFs) should mitigate abuse
liability, reduce dependence potential, and decrease public health risk. In the guidance document
from the FDA they have categorized abuse-deterrent formulations based on the mechanism by which
they deter abuse (see Table 1).7 In recent years, several products have
gained, are in the process of achieving or have attempted approval from FDA.
Overall, the development of opioids that are
formulated to deter abuse is a step in the right direction. The use of ADFs in the management of
chronic pain has the potential to curb the growing abuse of opioids but in order to truly make a
difference; these products must be readily available. The recent guidance document released by FDA
is meant to help generic drug companies meet the requirements brand name ADFs do.
There are various obstacles that
ADFs need to overcome, including availability and efficacy. The majority of the ADFs are still in
the approval process, have failed to prove they deter abuse, or have been taken off the market
(voluntarily or mandated) [Table 2]. ADFs have demonstrated abuse deterrent capacity theoretically
but lack clinical evidence supporting their abuse deterring properties. ADFs also face the
availability of less expensive, more bioavailable opioids. Additionally, ADFs have not been able to
deter the most common form of abuse, swallowing a number of intact pills or tablets to achieve a
feeling of euphoria. Due to the pharmacologic nature of opioid analgesics and their need for the
management of pain, the extent to which an abuse-deterrent product is able to reduce abuse will
never be absolute.
- Topics in Brief: Prescription Drug Abuse. National Institute on Drug Abuse.
2011. Accessed March 11, 2013.
- Klein M. Combating Misuse and Abuse of Prescription Drugs. FDA Consumer
Updates. 2010. Accessed March 17, 2013. http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm220112.htm
- Substance Abuse and Mental Health Services Administration, Results from
the 2010 National Survey on Drug Use and Health: Summary of National Findings, NSDUH
Series H-41, HHS Publication No. (SMA) 11-4658. Rockville, MD: Substance Abuse and Mental
Health Services Administration, 2011.
- The Centers for Disease Control and Prevention. http://www.cdc.gov/
- Hahn C, McPherson M, Rubingh C. Pharmacotherapy for pain management: new
treatment approaches. American Pharmacist Association. Sept 2008
- Johnston, L. D., O'Malley, P. M., Bachman, J. G., & Schulenberg, J. E.
(2012). Monitoring the Future national survey results on drug use, 1975-2011. Volume I:
Secondary school students. Ann Arbor: Institute for Social Research, The University of
- Guidance for Industry Abuse-Deterrent Opioids - Evaluation and Labeling;
2013. US Food and Drug Administration. 2013. Accessed March 12, 2013. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM334743.pdf
- Remoxy. DURECT Corporation product information. 2013. Accessed March 13,
- Acurox® Briefing Information for a Joint Meeting of
the Anesthetic and Life Support Drugs Advisory Committee and Drug Safety and Risk Management
Advisory Committee. Food and Drug Administration. 2010. Accessed march 13, 2013. http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/AnestheticAndLifeSupportDrugsAdvisoryCommittee/UCM209143.pdf
- Alpharma Pharmaceuticals LLC: NDA 22-321 ALO-01 (Morphine Sulfate
Extended-Release with Sequestered Naltrexone Hydrochloride) Capsules. 2008. Accessed March 13,
- Probuphine® Titan Pharmaceuticals, Inc. 2013. Accessed March 18,
- NRP290. New River Pharmaceuticals. 2004. Accessed
March 18, 2013. http://www.nrpharma.com/products/NRP290.htm
- Remoxy. Pain Therapeutics. Accessed March 19,
Accessed March 19, 2013
- Oxytrex. Pain Therapeutics. Accessed March 19,
- Embeda. Enforcement Report for May 11, 2011. FDA.
2011. Accessed March 19, 2013. http://www.fda.gov/Safety/Recalls/EnforcementReports/ucm255019.htm
- Talwin Nx in:Perform Rx Drug Information Update.
2010. Accessed March 19, 2013. http://www.performrx.com/drug_updates/Drug_Information_Update_Jan_10.pdf
- Suboxone. FDA Apporved Products. Accessed March