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I only want Vicodin, not the Amoxicillin.

"I only want the Vicodin, not the Amoxicillin." "Don't you have the yellow ones? The white ones don't work for me." "What do you mean the refill is five day's early. I'm out!"

Sound familiar? Most pharmacists have dealt with potential abuse issues time and time again. Lately, it seems like the FDA agrees. On October 24, Janet Woodcock, Director of the Center for Drug Evaluation and Research, released a statement announcing it's intent to pursue Schedule II status for all hydrocodone products, instead of the Schedule III classification combination products currently have. While the FDA cannot singlehandedly reclassify a drug's status, it is submitting a recommendation to Health and Human Services and then to the Drug Enforcement Agency regarding it's potential for abuse and misuse.

Prescription pain medications are powerful indeed: in 2007 alone, 28,000 Americans died from unintentional drug overdose. Of those, approximately 12,000 were from opiods. It seems like non-medical use can also be a slippery slope, as 29% of people ages 12 and older who used illicit drugs for the first time chose to do it via prescription painkillers; most obtained the drugs from friends. Additionally, prescription drugs made the list as the #2 abused drug category in the U.S., right behind marijuana.

On a regional level, the Substance Abuse and Mental Health Services Administration estimates that 4.33% of Texans ages 12 and older have used prescription pain relievers for non-medical purposes during 2010-2011, with the highest percentage of users between 18-25 years of age. The State has implemented programs to attempt to decrease non-legitimate use, such as the Texas Prescription Program, which allows practitioners and prescribers to search a database storing information about a patient's controlled substance usage and dates issued or filled. Many other states have similar existing programs or are in the process of implementing such programs, but are these measure enough to deter prescription drug abuse?

Despite the prevalence of opioid abuse and misuse, there are many legitimate patients for whom prescription painkillers are a necessity. The Institute of Medicine's June 2011 report, Relieving Pain in America: A Blueprint for Transforming Prevention, Care, Education and Research, estimates that chronic pain affects about 100 million U.S. adults. Caring for these patients presents its own challenges, and a whole host of associations and subspecialties have sprung up in the past thirty years to address them, including the American Academy of Pain Medicine, the American Academy of Pain Management, and the American Society of Interventional Pain Physicians. These practitioners see an ever increasing number of patients suffering from chronic pain due to a wide variety of diseases ranging from diabetes to cancer.

If hydrocodone products are reclassified as a Schedule II drug, chronic pain patients may suffer due to increased regulatory control. Since Schedule II prescriptions must be written for no more than a 90-day supply, and cannot be faxed or phoned in, this may cause a significant obstacle for chronic pain patients who often find it difficult to visit a physician regularly. Acute pain issues would also be directly affected, potentially causing a drastic increase in visits to emergency rooms and urgent care centers to manage immediate pain needs.

In the past few years, we have seen an increase in both legitimate pain prescription usage and an increase in drug diversion and abuse. States have tightened their restrictions on controlled substance dispensing (see: carisoprodol, a common muscle relaxant, reclassified in Texas as a Schedule IV substance, and many other states moving tramadol to controlled substance status.) Databases have been created to trach controlled substance use, and pharmacists use their best judgement to decide whether a prescription is appropriate. While on the pharmacist's end we are not privy to the patient's entire medical record, we do share a responsibility to ensure the prescription in question is dispensed according to the course of professional practice and for legitimate medical purposes.

The debate: two major pharmacists' associations, the American Pharmacists Association and the American Society of Health-System pharmacists, are in opposition on this matter. APhA wrote a letter to Health and Human Services in Association with many other groups (the Academy of Managed Care Pharmacy, the American Society of Consultant Pharmacists, the National Alliance of State Pharmacy Associations, the National Association of Chain Drug Stores, and the National Community Pharmacists Association) expressing its reservations regarding the proposed change. "Rescheduling will have a profoundly negative impact on patients who legitmately need these medications and a negligible impact on drug abuse." ASHP, on the other hand, released a statement calling "concerns regarding record-keeping and security processes resulting from rescheduling 'valid,'" but countered this by stating that they are "outweighed by the public health benefit arising from increased control of durgs with high abuse potential."

What do you think: In the end, will the legitimate patient suffer due to increased regulatory control, or does the potential decrease in drug abuse outweigh these problems?