Published Feb 29, 2004
Dave ARNP
629 Posts
drawing the line between pain management and addiction
from psychopharmacology update
when congress returns this month from its august break, lawmakers are sure to take up the issue of oxycontin (oxycodone) abuse. and one of the questions likely to be asked is: should pain management physicians, or those with related expertise, be the only ones allowed to prescribe the painkiller?
the debate will follow a summer's worth of headlines from across the nation that have screamed the consequences of abusing the prescription medication:
two drug company employees in new jersey, and physicians in kentucky, west virginia and connecticut caught allegedly diverting it. vermont stops paying for it for certain welfare beneficiaries. west virginia's attorney general sues the drug maker, alleging aggressive and irresponsible marketing tactics. and in many locations, people dead after overdoses.
oxycontin, manufactured by perdue pharma l.p. of stamford, conn., is a schedule ii controlled substance that has been available by prescription since 1995. doctors prescribe the semisynthetic opioid analgesic for patients with chronic or long-lasting pain, such as for cancer patients and those with musculoskeletal problems.
the narcotic's active ingredient is oxycodone, which also is found in painkillers such as tylox. but while tylox typically contains 5 milligrams of oxycodone and requires dosing every three or four hours, oxycontin tablets contain amounts ranging from 10 to 160 milligrams in a time-release form that can last up to 12 hours.
oxycontin goes by a variety of street names: "poor man's heroin," "hillbilly heroin," "oxy," "o.c.," "killer," and "oxycotton," among them. by prescription, the drug costs $1 per 10 milligrams, or $4 per 40-milligram tablet. street prices vary, but the drug generally sells for 50 cents to $1 per milligram. abusers of oxycontin crush the pill, destroying the time-release mechanism, and snort it or dilute it in water and inject it. abusers feel the "rush" in a short time, rather than over 12 hours.
in july, the food and drug administration (fda) upgraded its warnings about the drug's dangers and required its labeling to include a "black box warning," the strongest type of warning for an fda-approved drug.
with oxycontin addicts starting to show up this year in significant numbers on the doorsteps of methadone clinics and other treatment centers in maine, appalachia and other regions, mark w. parrino, president of the american methadone treatment association, inc., argues that physicians need more education about addiction medicine. they also need to re-examine their philosophy of care.
"at some point, pain management ends and something other than pain management begins," parrino told psychopharmacology update.
indeed, the line between pain relief and addiction can be hazy. pain management vs. addiction
gerald m. aronoff, m.d., dabpm, faadep, the medical director of the north american pain and disability group in charlotte,n.c., offered perhaps one of the more basic distinctions. a person's functioning improves with successful pain relief, he told psychopharmacology update. when the line is crossed to addiction, functioning is not enhanced; it suffers, he said.
an april advisory on oxycontin from the center for substance abuse treatment(csat) -- the government's first breaking-news advisory for treatment professionals -- also weighs in on the distinction.
"addiction is characterized by the repeated, compulsive use of a sub-stance despite adverse social, psychologic and/or physical consequences. addiction is often (but not always) accompanied by physical dependence, withdrawal syndrome and tolerance."
since opioid analgesics often cause sleepiness, calmness and constipation, withdrawal often involves insomnia, anxiety and diarrhea.
research sponsored by the national institute on drug abuse has found that most patients on prescribed opioids will not become addicted. but they may become dependent on the narcotic, and will require a qualified physician for withdrawal.
for these patients, gradually decreasing the medication dose over time "brings the former pain patient to a drug-free state without any craving for repeated doses, "according to csat. the addict, though, "continues to have a severe and uncontrollable craving that almost always leads to eventual relapse in the absence of adequate treatment," the advisory states. responsible pain management
in managing chronic pain, aronoff stresses this fundamental concept for physicians: "that we don't ask people to live with pain until we have adequately evaluated it." this means not only understanding the pain, but the person in pain, and his or her expression of that pain.
lots of time may be needed for this -- "with chronic pain, often there are no shortcuts," aronoff observed. yet managed care's emphasis on cost efficiencies don't encourage doctors to spend the necessary time on pain patients, which aronoff regards as "one of the major problems plaguing the pain management field today."
he has spent 23 years in the fulltime management of chronic pain, including as director of the boston pain center and medical director of the presbyterian center for pain medicine at the presbyterian orthopedic hospital in charlotte.
board-certified in pain medicine and in psychiatry and neurology, among other specialties, aronoff has written several books and articles about chronic pain. one study looking at the risk of addiction in opioid use, published in the current review of pain, 2000, 4: 112-121, was supported by a research grant from perdue pharmaceuticals.
once a thorough history of the pain patient has been taken, aronoff said, the goal then becomes threefold:
opioids for pain
while short-acting opioids such as tylenol iii and percocet have been used for decades for acute, often post-operative pain, doctors pretty much eschewed the use of narcotics for chronic pain. this was partly out of concerns about addiction and partly based on what aronoff said was the erroneous conclusion that they weren't effective in reducing pain.
but experience and research with long-term cancer pain treatment suggests that for certain patients, opioids have a low morbidity, and can help reduce suffering, enhance functional activity level and improve the quality of life without risk of addictive behaviors, aronoff writes in his study, "opioids in chronic pain management: is there a significant risk of addiction?"
as a sustained-action opioid, oxycontin is an excellent analgesic, aronoff said. it has few side effects and the drug's half-life is relatively short. other sustained-action opioids are methadone, mscontin or morphine and a transdermal preparation called the duragesic patch.
"we're in a mode where everyone's picking on opioids," said aronoff. "they are not terrible drugs...they have a wider margin of safety than the nonsteroidal anti-inflammatory drugs" because they carry fewer or little risk to the gastrointestinal tract and to the liver.
making them off-limits would mean a "major step backward in our ability to manage pain," he said. physician training needed
aronoff cites the agency for health care policy and research as having found in its clinical practice guidelines for both acute and cancer pain management that "most clinicians have inadequate training in evaluation and management of pain."
clinical guidelines for the appropriate use of opioid medications in treating pain have been developed by the federation of state medical boards (fsmb) and the american academy of pain medicine. the aapm also is developing an educational program for health care professionals to assess pain, determine opioid use, detect addiction and prevent diversion.
aronoff said he strongly supports educating health care providers at all levels as well as the public about pain management, drug use and addiction.
he also believes that the ability to prescribe oxycontin should not be limited to pain management physicians.
"it can be done very adequately by primary care doctors with both the interest and the experience and who are willing to spend the time" needed to understand the patient and his or her pain, said aronoff. prescribing oxycontin
in prescribing oxycontin, or any other opioid, aronoff has this advice: "know what you're treating."
doctors prescribe oxycontin for people in moderate to severe chronic pain, such as cancer patients and people with chronic back pain. in general, pain stemming from trauma to the body, such as damaged tissue and bones, is most opioid-responsive. neuropathic and central pain is less responsive, but can be effective. psychogenic pain is generally nonresponsive and is inappropriate for chronic opioid treatment.
doctors generally start noncancer patients at 10- to 20-milligram tablets of oxycontin. the patient gradually is titrated up. for break-through pain, aronoff also may prescribe a short-acting analgesic, such as actiq, a transmucosal form of fentanyl.
for cancer patients and others who have been on opioids, it's necessary to total the amount of narcotic the patient has been getting and make a dose conversion. note that a 160-milligram tablet could push those who are opioid-naïve into overdose. death occurs through respiratory depression.
common opioid side effects are constipation, nausea, sedation, dizziness, vomiting, pruritus, headache, dry mouth, sweating, and weakness. except for constipation, they may diminish over time with oxycontin.
from a pain management perspective, the beauty of oxycontin is its 12-hour analgesic effect, enabling people to sleep through the night and avoid the continuous lurch from pain to side effects.
stomach fluids dissolve the tablet surface, exposing a hydrophobic/ acrylic matrix. pain relief starts to occur within an hour as some of the only active ingredient, oxycodone, is released and absorbed. pain control continues as the tablet matrix slowly releases the rest of the oxycodone. crushing the tablet disarms the time-release mechanism.
earlier this month, the drug maker, perdue pharma l.p., told the new york times that it had decided against using a chemical safeguard to reduce misuse of oxycontin because it had not expected the drug to be abused. more than 100 overdose deaths from oxycontin's abuse have been reported nationwide.
the manufacturer said it was working to develop a sustained-action narcotic that also contained an antagonist to combat abuse. antagonists block receptors in the brain that opiates also use, but don't affect a drug if it is taken as prescribed. a reformulated drug would take three to five years to develop, the company has said.
but some drug-abuse experts have lambasted perdue pharma for failing to develop such a drug earlier, and have pointed to other manufacturers that took such precautions. they cite winthrop laboratories, which added an antagonist to its painkiller talwin, and reckitt benckiser pharmaceuticals, which added naloxone to buprenorphine.
for the csat advisory, go to: http://www.health.org/govpubs/ms726/.
for the fsmb's model guidelines for the use of controlled substances for the treatment of pain, go to: http://www.fsmb.org and click on policy documents.
for more information:
http://www.fda.gov/cder/drug/infopage/oxycontin/default.htm
http://www.usdoj.gov/ndic/pubs/651/abuse.htm
http://www.purduepharma.com
http://www.pain.com/painexpo/exhibits/purdue/oxycontin.cfm tips on prescribing for addicts
gerald m. aronoff, m.d., has seen more than 12,000 patients in his 23 years as a fulltime pain management specialist. there are some groups of pain patients for whom he will avoid prescribing sustained-action opioids, such as oxycontin, or take special precautions when prescribing them.
current and former drug addicts are enormously complicated to treat, he says. aronoff believes they deserve a chance at good pain control, but he changes his treatment criteria when prescribing narcotics for this population.
he requires the handful of active addicts he sees in his private practice to come to the office at shorter intervals than other patients, and he cuts them off at the first signs of drug-seeking behavior, such as altering a prescription or seeking additional treatment for the same problem from other doctors.
but not all drug-seeking behaviors signal an abuse problem, he cautioned. some pain patients who are receiving inadequate pain management also may engage in such behaviors to find relief; this is called pseudoaddiction.
current and former drug abusers, aronoff says, are best managed by pain medicine physicians with expertise in managing substance abuse problems, or by addiction medicine specialists.
other groups of people for whom he generally stays away from prescribing sustained-action opioids include those with:
how widespread is oxycontin addiction?
the scope of oxycontin addiction is impossible to gauge accurately. tests that pick up oxycodone do not specifically screen for one brand of the medication. nationwide, emergency room mentions of prescription drugs containing oxycodone jumped 68 percent from 1999 to 2000, according to an annual report released in july by the substance abuse and mental health services administration (samhsa). such mentions jumped 108 percent in the two years since 1998, the drug abuse warning network (dawn) report shows.
http://www.medscape.com/viewarticle/407878