Vicodin Set for Stricter FDA Controls – Addiction Issues Cited

The Federal Drug Administration (FDA) (www.fda.gov
) convened a panel recently to consider whether or not to place stricter controls on hydrocodone combination drugs. The panel voted to move hydrocodone combination drugs such as Vicodin, Lortab and others from its current Schedule III classification into the more restrictive Schedule II classification.

In a 19 to 10 decision, the advisory committee voted to reclassify the opioid drug after hearing testimony at its two-day hearing from a wide range of sources including government agencies, physicians, scientists, addiction counselors and the families of opioid overdose victims.

What This Means for Physicians and Patients

With hydrocodone currently being classified as a Schedule III drug, physicians are able to write prescriptions for patients that would give them a 6-month supply of the drug. Under Schedule II classification, the maximum supply would be capped at a 3-month supply. In addition, clinicians will no longer be able to phone prescriptions into pharmacies but will have to provide an actual written prescription instead.

Addiction specialists argue that restricting the amount of hydrocodone and the ease of obtaining the pills will have a downstream positive effect on abusers, especially young people who may find the drug in their parents’ medicine cabinet and are trying the drug in record numbers.

Hydrocodone AbuseHydrocodone Abuse in the United States

Pills containing hydrocodone are the most-often prescribed drugs in the United States. Over 131 million prescriptions for hydrocodone were written in 2012 to over 47 million patients.

With millions of pills readily available, and legal, the opiate abuse problem in the United States has hit epidemic proportions. Joseph Rannazzisi, Deputy Assistant Administrator of the Office of Diversion Control at the Drug Enforcement Agency (DEA), pointed out at the hearing that hydrocodone is often a gateway drug used by innocents, not knowing the path they have started to using other even more addictive, opioids.

“This drug has got a hold of this society and it’s just killing us,” Rannazzisi said.

The DEA is on the front lines of abuse and addiction in this country and had strong words for the advisory committee: “The diversion, trafficking and abuse of hydrocodone and oxycodone are mainly associated with pharmaceutical products manufactured, distributed and prescribed within the U.S. There is no clandestine production of these substances. The production and prescription of these products have increased dramatically in recent years.”

Prescribing Physicians Should Take Notice

Prescribing physicians in the United States may need to take notice and review their prescribing habits and practices. With opioid addiction in this country at record levels, some responsibility must fall clearly on the shoulders of physicians and pharmaceutical manufacturers for allowing so many millions of pills to become so readily available to all.

Recommended Resources
www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/DrugSafetyandRiskManagementAdvisoryCommittee/UCM337148.pdf
http://www.pressherald.com/news/nationworld/fda-to-consider-bid-to-tighten-narcotic-rules_2013-01-24.html

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