Tag Archives: pain management

Another Side to Guidelines

What makes for quality guidelines? This remains an open question, based on the packed room for a discussion on the importance of quality guidelines at the annual meeting of the American Academy of Pain Medicine.

courtesy of flickr user Steve Kay (creative commons)

Two speakers at the meeting  shared their views on the development of guidelines in general and the American Pain Society guidelines for low back pain in particular.

Dr. Richard Rosenquist of the University of Iowa in Iowa City, acknowledged that reviewing the literature in pursuit of quality guidelines can be challenging at best. “You can’t find the data to support what you believe,” he said. But he added that guidelines have a role to play in quality care, and that as a specialty, pain medicine physicians need to develop widely accepted outcome measures.

Dr. Laxmaiah Manchikanti of the Pain Management Center in Paducah, Ky., took a more provocative stance, suggesting that clinical guidelines lack accountability. And they are expensive. Dr. Manchikanti said that, based on his research into the subject, a systematic review of guidelines costs hundreds of thousands of dollars, and “the actual impact on quality of care is impossible to determine,” he said.

Disclosing funding for guidelines is an important part of accountability, Dr. Manchikanti emphasized. He noted that most clinicians never know what organizations paid their guideline-writing peers for their work, and that information should be available.

What do you think? Should authors of guidelines disclose when they have been compensated by the organizations that are promoting the guidelines?

–Heidi Splete (on twitter @hsplete)

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Drug Makers Go High-Tech to Prevent Opioid Abuse

Daytona 500 practice run (U.S. Air Force photo by Larry McTighe via Wikimedia Commons)

In the heart of Appalachia, there have long been doughty renegades who prefer not to pay taxes on their whiskey (also known as moonshine or a potential substance of abuse). These ingenious individuals have continually come up with imaginative ways to distill and distribute their products, while evading law enforcement (also known as revenuers). In fact, one of America’s favorite pastime — NASCAR — was born of the need of moonshiners to outrun the revenuers.

These days though, the game is being played the other way around.  Drugmakers, with encouragement from the government, are coming up with some pretty cool ways to prevent the abuse and misuse of opioids and other prescription drugs, which have become another of American’s favorite pastimes. In 2009, 16 million Americans age 12 and older had taken a prescription pain reliever, tranquilizer, stimulant, or sedative for nonmedical purposes at least once in the year prior to being surveyed, according to the National Survey on Drug Use and Health.

Dr. Lynn Webster discussed some innovative technologies to prevent opioid misuse at the annual meeting of the American Academy of Pain Medicine. So what’s on the horizon?

Approved in 2010, Exalgo is an extended-release formulation of hydromorphone that is indicated for once-daily administration for the management of moderate-to-severe pain in opioid-tolerant patients requiring continuous, around-the-clock opioid analgesia for an extended period of time. The drug uses a new technology – osmotic-controlled release oral delivery system (OROS) — which uses osmosis to attract water in the body to the inside of the capsule to trigger release of hydromorphone. It takes about 6 hours for the drug to release effective levels of hydromorphone and 4-5 days of use to reach a steady state of the drug in the body, said Dr. Webster.

Oxycontin abuse (courtesy of 51fifty via Wikimedia Commons)

Acurox is an oral immediate-release oxycodone tablet with a proposed indication for the relief of moderate to severe pain. Acurox uses another new technology, this one designed to deter misuse and abuse by intentional swallowing of excess quantities of tablets, intravenous injection of dissolved tablets, and nasal snorting of crushed tablets.

Collegium Pharmaceutical is developing an extended-release opioid formulation using DETERx technology to thwart abuse. Crushing or chewing prior to ingestion is a commonly used method of abusing oxycodone. Company studies have demonstrated that the plasma profile for the new DETERx formulation pill, when chewed, was bioequivalent to the taking the pill whole and as intended. This suggests that attempting to breakdown the sustained-release microspheres by chewing would not result in a meaningful increase in plasma level.
“It’s an abuse-resistant formulation, in that [potential abusers]can’t extract more than is intended for drug delivery,” said Dr. Webster.

Perhaps the most interesting and impressive technology is being developed by PharmacoFore. According to the company, the delivery system’s developer, the novel Bio-Activated Molecular Delivery (Bio-MD) technology effectively deters prescription drug abuse at a molecular level. “This technology does not involve the reformulation of existing opioid drugs in physical matrices that are easily circumvented by simple extraction methods. Our opioid Bio-MD systems are “activated” to release clinically effective opioid drugs only when exposed to the correct physiologic conditions (i.e., ingested).”

The system uses a mechanism “that locks in the amount of release of an opioid from a moiety, which is attached to a molecule … it can be any opioid … it’s an inert compound until it’s activated to be released,” said Dr. Webster. Essentially, the opioid molecule is attached to this delivery compound, which is “kind of like a clock. The intrinsic trypsin in our GI tract will activate that clock, which will cause a process to begin … and it will allow that drug to be released.” The “clock” compound determines how much time it will take for the active compound to be released and can be attached to any opioid. “It’s very early on though,” cautioned Dr. Webster. This molecular delivery system is in phase I trials.

Moonshine still in Knox County, Tennessee photographed by TVA in 1936 (courtesy of Wikimedia Commons)

Still, if the drug companies are able to get these technologies approved, we could see a drop in prescription drug abuse. It remains to be seen if there will be a corresponding increase in moonshine.

Kerri Wachter

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Filed under Anesthesia and Analgesia, Family Medicine, IMNG, Internal Medicine, Oncology, Primary care

Cancer Treatment: Problems Come With Success

Image courtesy of Wikimedia Commons user LadyofProcrastination

Thanks to earlier diagnosis and better treatments, we’ve started thinking of some cancers as chronic diseases — similar to asthma and diabetes. Cancer survivorship is definitely on the rise. The CDC recently reported that the number of cancer survivors in the United States rose from 3 million in 1971 and 9.8 million in 2001 to 11.5 million in 2007.

With a growing number of cancer survivors — who can live for years and  decades after diagnosis — there is a corresponding risk for pain medication addiction.  Gone are the days when oncologists can prescribe opioids like candy, according to a session at the annual meeting of the American Academy of Pain Medicine. Opioid misuse — and substance abuse in general — is a growing problem among cancer patients, according to experts at the session.

“We’re starting to see a lot more in the way of substance abuse of every stripe, in people – not necessarily who are developing substance abuse problems after they are exposed to opioids for their cancer pain – but actually the opposite. There are a lot of folks making it to tertiary cancer care centers with a history of addiction.”

Dr. Passik gave an example of a female patient, who lived with metastatic breast cancer for 11 years and who had a pre-existing polysubstance abuse problem as well. “What’s different about this case from before I had gray hair and before I spent 25 years working in psycho-oncology? When I first started in this field, this woman’s life expectancy would have been measured in months and now it’s measured in years to decades.”

Cancer patients need to be screened for abuse potential, said Steven Passik, Ph.D., a professor of psychiatry and anesthesiology at Vanderbilt University. Abuse risk management strategies are regularly used in non-cancer pain management, he said. It’s time for oncologists and other cancer specialists to start using the same strategies.

WHO Pain Ladder (courtesy of WHO)

Currently, in the WHO and NCCN guidelines, opioids are a mainstay for the treatment of cancer pain, said Dr. Dhanalakshmi Koyyalagunta, who is an associate professor of pain medicine at the MD Anderson Cancer Center in Houston. But “cancer is not a terminal disease any more … we have to change our paradigms as to how we approach these patients and how we treat them.” A good place to start is with a familiarity of the Clinical Guidelines for the Use of Chronic Opioid Therapy in Chronic Noncancer Pain.

It’s also important to identify and treat coexisting conditions that are frequently faced by cancer patients, said Diane Novy, Ph.D., who is a professor of pain management at MD Anderson. These include affective disorders, acute stress, problems related to cancer pain or treatment pain, family stress, and problems with work — and there are non-opioid treatment options for these issues.

Of course all this is not to say that opioids should never be used for pain management in cancer patients. Rather, clinicians need to screen for abuse risk factors before they prescribe these drugs and set up a monitoring system (random urine checks, pill counts, etc.).

Still — and not to belittle the suffering associated with substance abuse — having to change the way we look at cancer pain management to consider long-term treatment seems like a welcome challenge.

Kerri Wachter

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Filed under Anesthesia and Analgesia, IMNG, Internal Medicine, Oncology

Complementary, My Dear Doctors

courtesy of flickr user gnomesmam, creative commons

From a workshop celebrating the 10th anniversary of the NIH’s National Center for Complementary and Alternative Medicine, Bethesda, Md.:

Believe it or not, the National Institutes of Health has had a National Center for Complementary and Alternative Medicine for 10 years. To celebrate, they hosted a workshop with several speakers who addressed some big topics in complementary and alternative medicine.

What stuck out for me (pun intended) was Dr. Bruce R. Rosen of Harvard Medical School, who spoke about “Acupuncture, Pain, and Placebo.” Dr. Rosen cited some studies that showed a significant impact of acupuncture vs. no acupuncture for relieving chronic pain and pain associated with carpal tunnel syndrome, to name a few examples.

In one study (I didn’t get the citation) sham acupunture was as effective as the real thing, and both were significantly more effective than no acupuncture.

I’m not suggesting that real acupunture doesn’t have benefits. But this particular study reminded me of a similar study a few years ago in which sham knee surgery was as effective as the real thing. Looks like more evidence for the power of the placebo effect, or in this case, maybe just a more “hands-on” approach to pain management.

-Heidi Splete (@hsplete on twitter)
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Filed under Alternative and Complementary Medicine, Family Medicine, IMNG, Uncategorized