The impact of restrictions on pain relief

Late last year, the Food and Drug Administration published an official online statement, proposing new restrictions that will make regulations on some of the most commonly prescribed pain medicines, such as Vicodin, stricter. According to the official statement, the “FDA has become increasingly concerned about the abuse and misuse of opioid products, which have sadly reached epidemic proportions in certain parts of the United States1.”

The classification of “epidemic” is not an exaggeration. Centers for Disease Control and Prevention (CDC) reported that there were more than 36,000 deaths from drug overdoses in 2008, and most of these deaths were the result of prescription drug overdose2. Among prescription drug overdoses, prescription painkillers, also known as opioid pain relievers, caused nearly three quarters of deaths. In 2010, more than 12 million people reported using prescription painkillers for nonmedical purposes. Setting aside the shocking number of drug overdoses and their rapid increase in recent years, the overall consumption rate of pain relievers in the United States is quite astonishing compared to that of other nations: approximately 80% of the world’s pain pills are consumed in the United States, according to 2011 congressional testimony from the American Society of Interventional Pain Physicians3.

Thus, it seems reasonable that the FDA is proposing this “upgrade” of opioids to a Schedule II drug. The Drug Enforcement Administration classifies all drugs into five schedules, based on “whether they have a currently accepted medical use in treatment in the United States, their relative abuse potential and their likelihood of causing dependence when abused4.”  Schedule II drugs are defined as drugs with a high potential for abuse and are considered dangerous. A Schedule II classification of opioids would mean that drug addicts, as well as pain patients in need of relief, would have a more difficult time obtaining them. A written prescription from a doctor would be required, and refills would be prohibited without consulting the doctor for another written prescription.

This new policy would bring considerably large difficulties to chronic pain patients, especially since most chronic pain sufferers are relatively immobile elderly people. In addition, some predict that pain specialists would turn to other pain relievers, such as methadone5. What about its impact on addicts? Would it effectively decrease the number of deaths by drug overdoses? Some argue that a stricter regulation of opioids would simply turn addicts to heroin and other street drugs, thus having little or no tangible impact on drug overdose in the United States.

Opioids, a family of hydrocodone products, are most often prescribed for severe toothaches and injury-related pain6. Princeton University, an NCAA Division I school, has 38 varsity sports and nearly 35 club teams. With more than half of all undergraduates participating in intercollegiate varsity or club competitions, the number of sport-related injuries is certainly not low. However, when the proposed stricter regulation of opioids goes into effect in the near future, doctors at McCosh will likely be less willing to prescribe these pain relievers, as they are now in Schedule II. For those students who are prescribed pain relievers, they might be less willing to visit McCosh again to obtain another written prescription for a refill. Instead, they might choose to take extra doses of over-the-counter pain relievers. The possibility of overdose of acetaminophen and nonsteroidal anti-inflammatory drugs (NSAIDs) among college students is concerning.

Lastly, the FDA proposed a requirement for the labels on opioids to be changed. Currently, the labels say they are for “the relief of moderate to severe pain in patients requiring continuous, around-the-clock opioid treatment for an extended period time.” The new labels will say the drugs should be used only when “alternative treatment options are inadequate.” Several past required labeling changes have unleashed a series of unintended negative consequences. For example, the FDA’s requirement of a black box warning of increased risk of “suicidality” in children and adolescents taking antidepressant medications in 2007 not only failed to significantly decrease the suicide rates, but in turn unintentionally led to a decreased willingness of parents to seek professional help for their depressed children7. The question of what consequences this upcoming change will bring still lingers.

 

ENDNOTES

(1) U.S. Food the Drug Administration http://www.fda.gov/drugs/drugsafety/ucm372089.htm

(2) Centers of Disease Control and Prevention http://www.cdc.gov/homeandrecreationalsafety/rxbrief/

(3) CNN, http://www.cnn.com/2013/10/25/us/fda-painkiller-controls/

(4) Drug Enforcement Administration, http://www.justice.gov/dea/druginfo/ds.shtml

(5) “FDA” proposal to curb pain killer overdose deaths would add burden to pain patients.  http://www.huffingtonpost.com/radley-balko/fda-overdose-pain_b_4165417.html

(6) National Institute on Drug Abuse http://www.drugabuse.gov/publications/research-reports/prescription-drugs/opioids/what-are-opioids

(7) “Antidepressant use in Children, Adolescents, and Adults” http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/UCM096273

REFERENCES

Balko, Radley. “FDA Proposal To Curb Painkiller Overdose Deaths Would Add Burdens For Pain Patients.” The Huffington Post. TheHuffingtonPost.com, 26 Oct. 2013. Web. 03 Nov. 2013. <http://www.huffingtonpost.com/radley-balko/fda-overdose-pain_b_4165417.html>.

Bentz, Leslie, Jacque Wilson, Nadia Kounang, and Stephanie Smith. “FDA Aims to Tighten Control of Hydrocodone.” CNN.com. Cable News Network, 25 Oct. 2013. Web. 3 Nov. 2013.

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FDA. “Drugs.” Statement on Proposed Hydrocodone Reclassification from Janet Woodcock, M.D., Director, Center for Drug Evaluation and Research. Food and Drug Administration, 24 Oct. 2013. Web. 03 Nov. 2013. <http://www.fda.gov/drugs/drugsafety/ucm372089.htm>.

Green TC, Graub LE, Carver HW, Kinzly M, Heimer R. Epidemiologic trends and geographic patterns of fatal opioid intoxications in Connecticut, USA: 1997–2007. Drug and Alcohol Dependence 2011;115:221-8.

Hall AJ, Logan JE, Toblin RL, Kaplan JA, Kraner JC, Bixler D, et al. Patterns of abuse among unintentional pharmaceutical overdose fatalities. JAMA 2008;300(22):2613-20.

NIH. “Prescription Drugs: Abuse and Addiction.” What Are Opioids? National Institute of Drug Abuse, Oct. 2011. Web. 03 Nov. 2013. <http://www.drugabuse.gov/publications/research-reports/prescription-drugs/opioids/what-are-opioids>.

Paulozzi LJ, Logan JE, Hall AJ, McKinstry E, Kaplan JA, Crosby AE. A comparison of drug overdose deaths involving methadone and other opioid analgesics in West Virginia. Addiction 2009;104(9):1541-8.

White AG, Birnbaum HG, Schiller M, Tang J, Katz NP. Analytic models to identify patients at risk for prescription opioid abuse. Am J of Managed Care 2009;15(12):897-906.

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