HYDROCODONE BITARTRATE

HYDROCODONE IN THE NEWS

NEW YORK -- Despite continuing gains in the treatment of other conditions like depression and lipidemia, narcotic analgesics remain the most prescribed class of medicines in the United States, according to new research from IMS Health.

Opioid-based pain medications continue to eclipse both antidepressants and statins, IMS reported, with a total of 154 million prescriptions dispensed over the 12 months ended in June. That equates to a prescription growth rate of 5 percent for that period and compares with 146.4 million prescriptions filled for antidepressants and 132.2 million for statins.

The rise in prescriptions for narcotic analgesics has come despite recent trends that could prompt even higher utilization of statin-based medications. Among them: recent moves by federal health watchdogs to lower recommendations for cholesterol levels among Americans. The change in recommended lipid levels could boost doctors' reliance on statins, including the most prescribed medicine and blockbuster best seller Lipitor.

In addition, statins were supported with $1.9 billion in direct-to-consumer advertising over the 12-month period ended in June, according to IMS.

Conversely, there are no DTC ad budgets for narcotics and other drugs that are regulated by both the Drug Enforcement Administration and the Food and Drug Administration. And any press reports on that class of medicines typically focus on the negative aspects of narcotic analgesics, namely the serious potential for addiction among users and the rise in robberies and other crimes at pharmacies stocking the drugs.

Despite their drawbacks, narcotic analgesics remain a key element of any pain management regimen when used as directed and monitored by a health care practitioner. The reason is obvious to both patients and their physicians: They provide relief to those who suffer from either chronic or acute pain.

In fact, the category is growing, even though most narcotic analgesics have moved heavily into generic competition--a trend oftentimes responsible for the dampening of a category. According to Express Scripts' 2003 drug trend report, the percent change in the brand/generic mix of narcotic analgesics fell 6.8 percent, indicating greater generic use, even though total utilization within the drug class was up 74 percent.

And given the inclination for managed care organizations to mitigate prescription drug costs as much as possible, the move of so many pain management medications into generic competition is expected to boost prescribing further among physicians. "Physicians are going to be more likely to then learn how to use [pain management medications] more skillfully in conjunction with [other medications]," suggested Rollin Gallagher, president of the American Board of Pain Medicine.

The number of pills prescribed with each prescription is on the rise, as well. According to Express Scripts' drug trend report, narcotic analgesics had the greatest shift upward in units per prescription, climbing 6.2 percent, compared with an overall decline of 0.1 percent across all categories. And that trend is on the rise, Express Scripts reported, from a 4.7 percent gain in 2002 and a 2.7 percent gain in 2001. "This pattern suggests that more members are taking narcotics on a maintenance basis, rather than on an acute basis," the report noted.

The move toward generic competition continues, especially with generic alternatives for Janssen's blockbuster Duragesic pain patch and Purdue Pharma's OxyContin extended release on the cusp of reaching the marketplace. The generic conversion of those medicines, which together accounted for $3.5 billion in 2003 pharmaceutical branded sales, is expected to happen by the end of next year.

That bodes well for the 50 million to 75 million Americans who live with chronic pain daily. According to the Joint Commission on the Accreditation of Healthcare Organizations, nearly one-third of Americans will experience chronic pain at some point in their lives.

And chronic pain does not discriminate by age, noted the American Chronic Pain Association. In its Americans Living with Pain Survey, released earlier this year, the ACPA found that people are experiencing pain at a younger age than what may be commonly perceived or assumed. Proportionally, just as many younger people surveyed experience back pain as do middle-aged and older adults.

Perhaps because of the stigma of abuse associated with the use of opioid treatments, the survey found that 72 percent of chronic pain sufferers have lived with their pain for more than three years, and 34 percent have lived with undertreated pain for more than a decade.

The survey also found that more than half of pain management patients are concerned about the potential side effects of narcotic remedies--50 percent reported being concerned about addiction or the need for higher dosage over time, and 49 percent were worried about having to take narcotics for the rest of their lives. Overall, 44 percent of respondents expressed hesitancy in taking prescription narcotics.

Educating both consumers and health care professionals on the proper use of pare medications could spell opportunity in this category.

"[Pain medicines] are abusable if someone has an addiction problem," Gallagher noted. "But that's only a small percentage of the patients. You have 90 percent of the population who have no problems with addiction, and then you have the 10 percent who have problems with addiction disorders who may have problems with the use of these drugs."

Unfortunately, those 10 percent with addiction problems make for more compelling news stories, which skews public perception on the use of pain management therapies and makes the remaining 90 percent victims of societal attitudes, Gallagher said.

"What you end up having is a person with a serious disease ... and yet they are reluctant to go seek treatment, they don t know how to get to good treatment, and they don't even know what good treatment is," he said.