Dear Friends and Colleagues:
Attached an interesting article from a recent edition of BusinessWeek reporting the emergence of cognition enhancers as the next financial goldmine for pharmaceutical companies seeking new applications for existing drugs.
I am categorically opposed to permit the expansion of the clinical application for these medications and look forward to your comments and response.
Happy Holidays, Merry Christmas, Happy Hanukkah.
Yours
Bernd
Bernd Wollschlaeger,MD,FAAFP,FASAM
President, Florida Society of Addiction Medicine
DRUGS December 18, 2008, 5:00PM EST
A Boom in Memory-Enhancing Drugs?
Some scientists predict boomers and college grads alike will fuel a boom in so-called cognition drugs. But at what risk?
By Ellen Gibson
Facing an important job interview, the college graduate searches her closet for the perfect outfit, then rifles through her medicine cabinet for just the right cognitive-enhancement pill. Adderall, perhaps, to help her concentrate. Or Provigil, for alertness...or maybe a beta blocker to combat jitters?
Doctors in the U.S. who track drug trends say scenarios like this could play out in a thousand variations as college students who grew up using prescription drugs as study aids enter the workforce. Many high-powered professionals are already popping such pills in secret. Within a few years they could be joined by millions of older adults, including baby boomers who decide there's nothing wrong with using "smart drugs" to ward off senior moments. The drug industry will benefit mightily if public opinion swings this way.
Many healthy people have trepidations about tinkering with the brain using addictive or otherwise risky pharmaceuticals. But those reservations are eroding for several reasons. A whole generation has come of age using attention-deficit drugs such as Adderall and Ritalin, a category valued at nearly $4.7 billion in 2007. A lot of teenagers have used them casually as study aids, often buying them on the Internet. And now, overworked professionals are seeing the appeal. "From assembly-line workers to surgeons, many different kinds of employee may benefit from enhancement and want access to it," wrote Martha J. Farah, director of the Center for Cognitive Neuroscience at the University of Pennsylvania, in a recent commentary in the science journal Nature. In the controversial essay, she and her co-authors, including Stanford Law School Professor Henry T. Greely, declared it's time for people to overcome their squeamishness: "Mentally competent adults should be able to engage in cognitive enhancement using drugs."
Cognition drugs are already a big market. Adderall XR, the extended-release version of the ADHD drug, brings Shire Pharmaceuticals (SHPGY) $1 billion a year. Pfizer's (PFE) Alzheimer's drug Aricept had U.S. sales of $1.6 billion in 2007—and it may give a boost to healthy people as well. In a small study, airline pilots on the drug showed some improvement in short-term memory. Then there's Provigil, a narcolepsy treatment that pulls in $840 million for Cephalon CEPH). Analysts say a fair portion of that comes from healthy people who use it to stay awake.
A half-dozen companies now have memory drugs in their research pipelines that the U.S. Food & Drug Administration will review initially as treatments for Alzheimer's or age-related dementia. But Steven Ferris, a neurologist and former committee member at the FDA, says there is huge potential for a memory treatment aimed at still-healthy baby boomers—and predicts that the FDA will ultimately condone such uses. "The first evidence-based memory treatment could be a $20 billion drug," predicts Ferris, who now runs an aging and dementia research center at New York University School of Medicine.
At the FDA, cognitive enhancement is barely on the radar right now. The majority of medicines the agency oversees are designed to treat diseases. Drug companies believe this could present a problem for smart drugs—a worry that may be inhibiting research spending in this area. "Regulators would have a hard time approving [cognition drugs] if they're not intended for a medical condition," in part because they have known health risks, says Shire spokesperson Matthew Cabrey.
Indeed, ADHD medications carry so-called black box warnings on their labels. Potential side effects of Adderall range from insomnia to cardiac events. Medical ethicists have a separate set of concerns. They worry poor people don't have the same access to these drugs as the wealthy.
What's more, if social concerns about smart drugs were to vanish, pressure to use them in the workplace might become irresistible. Under certain circumstances, "it is totally understandable for a manager to encourage people to change their work performance through drugs," Martha Farah said in an interview.
Her colleague Dr. Anjan Chatterjee, a neurologist at the University of Pennsylvania Hospital, raises another red flag. Creative insights often arise when the mind is allowed to wander, he says. If drugs that sharpen concentration become widespread in the workplace, they may nurture "a bunch of automatons that are very good at implementing things but have nothing to implement."
Chatterjee has thought deeply about this new class of drugs. In a famous 2004 research paper, he coined the term "cosmetic neurology," and he compares the current state of cognitive enhancement to the advent of cosmetic surgery. That specialty evolved as doctors struggled to help disfigured soldiers returning from World War I. It then morphed into a form of "elective self-improvement," he says. The same could happen with smart drugs. After all, the FDA currently regulates treatments for wrinkles, hair loss, and sexual dysfunction, which are not strictly medical in nature. Cognition drugs are the next obvious frontier. Says Chatterjee: "This is inevitable."
Gibson is an editorial assistant with BusinessWeek.
Monday, December 22, 2008
Saturday, December 6, 2008
Baclofen for the Treatment of Alcoholism?
Dear Friends and Colleagues:
A recent BBC news report highlighted a book written by a French cardiologist describing his " cure from alcoholism" utilizing Baclofen.
Attached you find the news report and a reference to a SMALL double-blind randomized trial suggesting a beneficial effect of Baclofen for the treatment of alcoholism.
Looking forward to your comments.
Yours
Bernd
Bernd Wollschlaeger,MD,FAAFP,FASAM
President, Florida Society of Addiction Medicine
======================================================================================
BBC NEWS
France abuzz over alcoholic 'cure'
By Hugh Schofield
Paris
An eminent French cardiologist has triggered an impassioned debate in the medical world over his claim to have discovered a cure for alcoholism.
Dr Olivier Ameisen, 55, one of France's top heart specialists, says he overcame his own addiction to alcohol by self-administering doses of a muscle-relaxant called baclofen.
He has now written a book about his experience - Le Dernier Verre (The Last Glass) - in which he calls for clinical trials to test his theory that baclofen suppresses the craving for drink.
Widespread media coverage of his book in France has led to a rush of demands from alcoholics for similar treatment, and some doctors have reported unexpected successes after prescribing it.
But many other specialists are sceptical, warning of the dangers of so-called miracle cures.
'Needed alcohol'
Dr Ameisen was associate professor of cardiology at New York's Cornell University, and in 1994 he opened a profitable private practice in Manhattan.
But, stricken by an overwhelming feeling of inadequacy - he says he felt like "an impostor waiting to be unmasked" - he found relief in large quantities of whisky and gin.
"I detested the taste of alcohol. But I needed its effects to exist in society," he says in Le Dernier Verre, which comes out in English next month.
Dr Ameisen says he tried every known remedy to end his dependence. Between 1997 and 1999 he spent a total of nine months confined in clinics - but nothing worked.
Fearing for his own patients, he gave up his practice and returned to Paris. Then, in 2000, he read an article about an American man who was treated with baclofen for muscle spasms and found that it eased his addiction to cocaine.
Further investigation uncovered research showing that the drug worked on rats to cut addiction to alcohol or cocaine.
But, strangely, Dr Ameisen found that baclofen was unknown to specialists on dependence.
In March 2002 he began treating himself with daily doses of five milligrams.
"The first effects were a magical muscular relaxation and baby-like sleep," he says. Almost immediately he also detected a lessening in his desire for drink.
Gradually, he increased the daily dosage to a maximum of 270mg, and found that he was "cured". Today he continues to take 30 to 50mg a day.
"Mine is the first case in which a course of medicine has completely suppressed alcohol addiction," he says.
"Now I can have a glass and it has no effect. Above all, I no longer have that irrepressible need to drink."
Not licensed
With its eye-catching message, Le Dernier Verre has been an autumn best-seller - prompting thousands of recovering alcoholics to ask to be prescribed with baclofen.
Some doctors have decided to ignore the fact that the drug is not authorised for treating alcoholism, and report exciting results.
"I prescribed it to two alcoholics who were really at the end of the road. To be honest, it was pretty miraculous," says Dr Renaud de Beaurepaire of the Paul-Guiraud hospital at Villejuif near Paris.
In Geneva, Dr Pascal Garche put 12 patients on baclofen, of whom seven came through reporting marked improvements.
"I have never had reactions like this before. We cannot ignore findings such as this - the book is going to set the cat among the pigeons," he said.
However, many specialists fear that media excitement over Dr Ameisen's theory is obscuring the complex nature of alcoholism.
"Encouraging people to think that there is a miracle molecule is to completely misunderstand the nature of alcoholism, and is extremely irresponsible, " says Dr Michel Reynaud of Paul-Brousse hospital in Paris.
"We need comprehensive tests to determine how this drug acts, if it is effective and at what dosage, and if it is genuinely harmless in the longer term, " says Alain Rigaud, president of the National Association for the Prevention of Alcoholism and Addiction.
"But even if it turns out to work, that does not mean a drug alone is the solution."
Story from BBC NEWS:
http://news.bbc.co.uk/go/pr/fr/-/2/hi/europe/7768141.stm
Published: 2008/12/06 16:44:46 GMT
======================================================================================
PROCEEDINGS OF A SYMPOSIUM ENTITLED: 'GABAB RECEPTORS: A TARGET OF NEW TREATMENTS FOR ALCOHOLISM AND DRUG ABUSE'
BACLOFEN EFFICACY IN REDUCING ALCOHOL CRAVING AND INTAKE: A PRELIMINARY DOUBLE-BLIND RANDOMIZED CONTROLLED STUDY
Giovanni Addolorato*, Fabio Caputo2, Esmeralda Capristo, Marco Domenicali2, Mauro Bernardi2, Luigi Janiri1, Roberta Agabio3, Giancarlo Colombo4, Gian Luigi Gessa3,4,5 and Giovanni Gasbarrini
Institute of Internal Medicine and
1 Institute of Psychiatry, Catholic University of Rome, Rome,
2 ‘G. Fontana’ Centre for the Study and Treatment of the Alcohol Addiction, University of Bologna, Bologna,
3 ‘Bernard B. Brodie’ Department of Neuroscience, University of Cagliari,
4 C.N.R. Institute of Neurogenetics and Neuropharmacology, Cagliari and
5 Neuroscienze S.c.a r.l., Cagliari, Italy
Received 15 March 2002; first review notified 19 April 2002; accepted 22 April 2002
ABSTRACT
— Aims: The {gamma}-aminobutyric acid (GABAB) receptor agonist, baclofen, has recently been shown to reduce alcohol intake in alcohol-preferring rats and alcohol consumption and craving for alcohol in an open study in humans. The present study was aimed at providing a first evaluation of the efficacy of baclofen in inducing and maintaining abstinence and reducing craving for alcohol in alcohol-dependent patients in a double-blind placebo-controlled design. Methods: A total of 39 alcohol-dependent patients were consecutively enrolled in the study. After 12–24 h of abstinence from alcohol, patients were randomly divided into two groups. Twenty patients were treated with baclofen and 19 with placebo. Drug and placebo were orally administered for 30 consecutive days. Baclofen was administered at the dose of 15 mg/day for the first 3 days and 30 mg/day for the subsequent 27 days, divided into three daily doses. Patients were monitored as out-patients on a weekly basis. At each visit alcohol intake, abstinence from alcohol, alcohol craving and changes in affective disorders were evaluated.
Results: A higher percentage of subjects totally abstinent from alcohol and a higher number of cumulative abstinence days throughout the study period were found in the baclofen, compared to the placebo, group. A decrease in the obsessive and compulsive components of craving was found in the baclofen compared to the placebo group; likewise, alcohol intake was reduced in the baclofen group. A decrease in state anxiety was found in the baclofen compared to the placebo group. No significant difference was found between the two groups in terms of current depressive symptoms. Baclofen proved to be easily manageable and no patient discontinued treatment due to the presence of side-effects. No patient was affected by craving for the drug and/or drug abuse.
Conclusions: Baclofen proved to be effective in inducing abstinence from alcohol and reducing alcohol craving and consumption in alcoholics. With the limits posed by the small number of subjects involved, the results of this preliminary double-blind study suggest that baclofen may represent a potentially useful drug in the treatment of alcohol-dependent patients and thus merits further investigations.
=======================================================================================
Baclofen Use in the Treatment of Alcohol Delirium Tremens
We read with great interest the recent meta-analysis by Mayo-Smith et al1 about the management of alcohol withdrawal delirium (AWD). The authors included new clinical data on the management of AWD, ranging from a single case report to a prospective randomized trial from 1966 to 2001. Since the time considered, among the possible new drugs useful in the management of AWD, the authors did not mention the possible utility of the {gamma}-aminobutyric acid {beta}(GABA receptor agonist baclofen. Baclofen is able to suppress alcohol withdrawal symptoms both in animals2 and in humans3 and may be effective in reducing voluntary alcohol intake in alcohol-preferring rats2 and alcohol craving and intake in alcoholic individuals.4 We recently described a patient in whom AWD was rapidly and completely suppressed by baclofen administration.5 We believe that prior clinical data suggest that baclofen could be a useful new drug in the treatment of AWD, although future controlled clinical trials are needed to confirm its safety and effectiveness.
AUTHOR INFORMATION
Correspondence: Dr Addolorato, Institute of Internal Medicine, Catholic University, Gemelli Hospital, L.go A. Gemelli 8, 00168-Rome, Italy (g.addolorato@rm.unicatt.it).
Lorenzo Leggio, MD; Ludovico Abenavoli, MD; Fabio Caputo, MD; Giovanni Gasbarrini, MD; Giovanni Addolorato, MD
REFERENCES
1. Mayo-Smith MF, Beecher LH, Fisher TL, et al, Working Group on the Management of Alcohol Withdrawal Delirium, Practice Committee, American Society of Addiction Medicine. Management of alcohol withdrawal delirium: an evidence-based practice guideline. Arch Intern Med. 2004;164:1405-1412. FREE FULL TEXT
2. Colombo G, Agabio R, Carai MAM, et al. Ability of baclofen in reducing alcohol intake and withdrawal severity, I: preclinical evidence. Alcohol Clin Exp Res. 2000;24:58-66. FULL TEXT | ISI | PUBMED
3. Addolorato G, Caputo F, Capristo E, et al. Rapid suppression of alcohol withdrawal syndrome by baclofen. Am J Med. 2002;112:226-229. FULL TEXT | ISI | PUBMED
4. Addolorato G, Caputo F, Capristo E, et al. Baclofen efficacy in reducing alcohol craving and intake: a preliminary double-blind randomized controlled study. Alcohol Alcohol. 2002;37:504-508. FREE FULL TEXT
5. Addolorato G, Leggio L, Abenavoli L, et al. Suppression of alcohol delirium tremens by baclofen administration: a case report. Clin Neuropharmacol. 2003;26:258-262. PUBMED
Arch Intern Med. 2005;165:586.
A recent BBC news report highlighted a book written by a French cardiologist describing his " cure from alcoholism" utilizing Baclofen.
Attached you find the news report and a reference to a SMALL double-blind randomized trial suggesting a beneficial effect of Baclofen for the treatment of alcoholism.
Looking forward to your comments.
Yours
Bernd
Bernd Wollschlaeger,MD,FAAFP,FASAM
President, Florida Society of Addiction Medicine
======================================================================================
BBC NEWS
France abuzz over alcoholic 'cure'
By Hugh Schofield
Paris
An eminent French cardiologist has triggered an impassioned debate in the medical world over his claim to have discovered a cure for alcoholism.
Dr Olivier Ameisen, 55, one of France's top heart specialists, says he overcame his own addiction to alcohol by self-administering doses of a muscle-relaxant called baclofen.
He has now written a book about his experience - Le Dernier Verre (The Last Glass) - in which he calls for clinical trials to test his theory that baclofen suppresses the craving for drink.
Widespread media coverage of his book in France has led to a rush of demands from alcoholics for similar treatment, and some doctors have reported unexpected successes after prescribing it.
But many other specialists are sceptical, warning of the dangers of so-called miracle cures.
'Needed alcohol'
Dr Ameisen was associate professor of cardiology at New York's Cornell University, and in 1994 he opened a profitable private practice in Manhattan.
But, stricken by an overwhelming feeling of inadequacy - he says he felt like "an impostor waiting to be unmasked" - he found relief in large quantities of whisky and gin.
"I detested the taste of alcohol. But I needed its effects to exist in society," he says in Le Dernier Verre, which comes out in English next month.
Dr Ameisen says he tried every known remedy to end his dependence. Between 1997 and 1999 he spent a total of nine months confined in clinics - but nothing worked.
Fearing for his own patients, he gave up his practice and returned to Paris. Then, in 2000, he read an article about an American man who was treated with baclofen for muscle spasms and found that it eased his addiction to cocaine.
Further investigation uncovered research showing that the drug worked on rats to cut addiction to alcohol or cocaine.
But, strangely, Dr Ameisen found that baclofen was unknown to specialists on dependence.
In March 2002 he began treating himself with daily doses of five milligrams.
"The first effects were a magical muscular relaxation and baby-like sleep," he says. Almost immediately he also detected a lessening in his desire for drink.
Gradually, he increased the daily dosage to a maximum of 270mg, and found that he was "cured". Today he continues to take 30 to 50mg a day.
"Mine is the first case in which a course of medicine has completely suppressed alcohol addiction," he says.
"Now I can have a glass and it has no effect. Above all, I no longer have that irrepressible need to drink."
Not licensed
With its eye-catching message, Le Dernier Verre has been an autumn best-seller - prompting thousands of recovering alcoholics to ask to be prescribed with baclofen.
Some doctors have decided to ignore the fact that the drug is not authorised for treating alcoholism, and report exciting results.
"I prescribed it to two alcoholics who were really at the end of the road. To be honest, it was pretty miraculous," says Dr Renaud de Beaurepaire of the Paul-Guiraud hospital at Villejuif near Paris.
In Geneva, Dr Pascal Garche put 12 patients on baclofen, of whom seven came through reporting marked improvements.
"I have never had reactions like this before. We cannot ignore findings such as this - the book is going to set the cat among the pigeons," he said.
However, many specialists fear that media excitement over Dr Ameisen's theory is obscuring the complex nature of alcoholism.
"Encouraging people to think that there is a miracle molecule is to completely misunderstand the nature of alcoholism, and is extremely irresponsible, " says Dr Michel Reynaud of Paul-Brousse hospital in Paris.
"We need comprehensive tests to determine how this drug acts, if it is effective and at what dosage, and if it is genuinely harmless in the longer term, " says Alain Rigaud, president of the National Association for the Prevention of Alcoholism and Addiction.
"But even if it turns out to work, that does not mean a drug alone is the solution."
Story from BBC NEWS:
http://news.bbc.co.uk/go/pr/fr/-/2/hi/europe/7768141.stm
Published: 2008/12/06 16:44:46 GMT
======================================================================================
PROCEEDINGS OF A SYMPOSIUM ENTITLED: 'GABAB RECEPTORS: A TARGET OF NEW TREATMENTS FOR ALCOHOLISM AND DRUG ABUSE'
BACLOFEN EFFICACY IN REDUCING ALCOHOL CRAVING AND INTAKE: A PRELIMINARY DOUBLE-BLIND RANDOMIZED CONTROLLED STUDY
Giovanni Addolorato*, Fabio Caputo2, Esmeralda Capristo, Marco Domenicali2, Mauro Bernardi2, Luigi Janiri1, Roberta Agabio3, Giancarlo Colombo4, Gian Luigi Gessa3,4,5 and Giovanni Gasbarrini
Institute of Internal Medicine and
1 Institute of Psychiatry, Catholic University of Rome, Rome,
2 ‘G. Fontana’ Centre for the Study and Treatment of the Alcohol Addiction, University of Bologna, Bologna,
3 ‘Bernard B. Brodie’ Department of Neuroscience, University of Cagliari,
4 C.N.R. Institute of Neurogenetics and Neuropharmacology, Cagliari and
5 Neuroscienze S.c.a r.l., Cagliari, Italy
Received 15 March 2002; first review notified 19 April 2002; accepted 22 April 2002
ABSTRACT
— Aims: The {gamma}-aminobutyric acid (GABAB) receptor agonist, baclofen, has recently been shown to reduce alcohol intake in alcohol-preferring rats and alcohol consumption and craving for alcohol in an open study in humans. The present study was aimed at providing a first evaluation of the efficacy of baclofen in inducing and maintaining abstinence and reducing craving for alcohol in alcohol-dependent patients in a double-blind placebo-controlled design. Methods: A total of 39 alcohol-dependent patients were consecutively enrolled in the study. After 12–24 h of abstinence from alcohol, patients were randomly divided into two groups. Twenty patients were treated with baclofen and 19 with placebo. Drug and placebo were orally administered for 30 consecutive days. Baclofen was administered at the dose of 15 mg/day for the first 3 days and 30 mg/day for the subsequent 27 days, divided into three daily doses. Patients were monitored as out-patients on a weekly basis. At each visit alcohol intake, abstinence from alcohol, alcohol craving and changes in affective disorders were evaluated.
Results: A higher percentage of subjects totally abstinent from alcohol and a higher number of cumulative abstinence days throughout the study period were found in the baclofen, compared to the placebo, group. A decrease in the obsessive and compulsive components of craving was found in the baclofen compared to the placebo group; likewise, alcohol intake was reduced in the baclofen group. A decrease in state anxiety was found in the baclofen compared to the placebo group. No significant difference was found between the two groups in terms of current depressive symptoms. Baclofen proved to be easily manageable and no patient discontinued treatment due to the presence of side-effects. No patient was affected by craving for the drug and/or drug abuse.
Conclusions: Baclofen proved to be effective in inducing abstinence from alcohol and reducing alcohol craving and consumption in alcoholics. With the limits posed by the small number of subjects involved, the results of this preliminary double-blind study suggest that baclofen may represent a potentially useful drug in the treatment of alcohol-dependent patients and thus merits further investigations.
=======================================================================================
Baclofen Use in the Treatment of Alcohol Delirium Tremens
We read with great interest the recent meta-analysis by Mayo-Smith et al1 about the management of alcohol withdrawal delirium (AWD). The authors included new clinical data on the management of AWD, ranging from a single case report to a prospective randomized trial from 1966 to 2001. Since the time considered, among the possible new drugs useful in the management of AWD, the authors did not mention the possible utility of the {gamma}-aminobutyric acid {beta}(GABA receptor agonist baclofen. Baclofen is able to suppress alcohol withdrawal symptoms both in animals2 and in humans3 and may be effective in reducing voluntary alcohol intake in alcohol-preferring rats2 and alcohol craving and intake in alcoholic individuals.4 We recently described a patient in whom AWD was rapidly and completely suppressed by baclofen administration.5 We believe that prior clinical data suggest that baclofen could be a useful new drug in the treatment of AWD, although future controlled clinical trials are needed to confirm its safety and effectiveness.
AUTHOR INFORMATION
Correspondence: Dr Addolorato, Institute of Internal Medicine, Catholic University, Gemelli Hospital, L.go A. Gemelli 8, 00168-Rome, Italy (g.addolorato@rm.unicatt.it).
Lorenzo Leggio, MD; Ludovico Abenavoli, MD; Fabio Caputo, MD; Giovanni Gasbarrini, MD; Giovanni Addolorato, MD
REFERENCES
1. Mayo-Smith MF, Beecher LH, Fisher TL, et al, Working Group on the Management of Alcohol Withdrawal Delirium, Practice Committee, American Society of Addiction Medicine. Management of alcohol withdrawal delirium: an evidence-based practice guideline. Arch Intern Med. 2004;164:1405-1412. FREE FULL TEXT
2. Colombo G, Agabio R, Carai MAM, et al. Ability of baclofen in reducing alcohol intake and withdrawal severity, I: preclinical evidence. Alcohol Clin Exp Res. 2000;24:58-66. FULL TEXT | ISI | PUBMED
3. Addolorato G, Caputo F, Capristo E, et al. Rapid suppression of alcohol withdrawal syndrome by baclofen. Am J Med. 2002;112:226-229. FULL TEXT | ISI | PUBMED
4. Addolorato G, Caputo F, Capristo E, et al. Baclofen efficacy in reducing alcohol craving and intake: a preliminary double-blind randomized controlled study. Alcohol Alcohol. 2002;37:504-508. FREE FULL TEXT
5. Addolorato G, Leggio L, Abenavoli L, et al. Suppression of alcohol delirium tremens by baclofen administration: a case report. Clin Neuropharmacol. 2003;26:258-262. PUBMED
Arch Intern Med. 2005;165:586.
Thursday, November 6, 2008
Buprenorphine in the News
Dear Friends and Colleagues:
Attached the results of a recently published study to evaluate the efficacy of continuing buprenorphine-naloxone for 12 weeks vs detoxification for opioid-addicted youth.
Not surprisingly the results indicate that opioid-positive urine test results, retention in the trial, self-reported opioid use, injecting behavior, enrollment in nonstudy treatment, and use of cocaine and marijuana strongly favored patients in the 12-week buprenorphine-naloxone group during weeks 1 through 12. They had much less use of opioids, cocaine, and marijuana; much better treatment retention; and much less injecting and need for additional treatment while on medication.
In a commentary ( see http://jama.ama-assn.org/cgi/content/full/300/17/2057) David A Fiellin,MD points out that
" The results of this trial should prompt clinicians to use caution when tapering buprenorphine-naloxone in adolescent patients who receive this medication. Supportive counseling; close monitoring for relapse; and, in some cases, naltrexone should be offered following buprenorphine tapers. From a research perspective, additional efforts are needed to provide a stronger evidence base from which to make recommendations for adolescents who use opioids. There is limited research on prevention of opioid experimentation and effective strategies to identify experimentation and intercede to disrupt the transition from opioid use to abuse and dependence. No information is available regarding the efficacy of treatment with medications such as methadone or buprenorphine-naloxone compared with nonagonist approaches (eg, naltrexone) or nonpharmacologic approaches such as short-term rehabilitation or partial hospitalization programs."
"The high rate of relapse seen with both medication taper protocols in the current trial involving opioid-dependent adolescents, combined with the adverse social, legal, and infectious consequences of opioid dependence—and the risk for overdose with relapse—makes the need for rigorous evidence in this area urgent. These findings are another important reminder that there are no quick fixes for opioid dependence."
In his commentary Fiellin also remarks that
" There is appropriate concern about providing these medications to young individuals despite the substantial risks of opioid dependence. This concern stems from the fact that these medications prolong a state of opioid physical dependence and therefore may limit an adolescent's chance for obtaining abstinence without an opioid-based medication. "
I do not agree with his judgment because in my opinion we are using methadone and buprenorphine to provide a withdrawal free condition which then can be used to apply all the other non-pharmacological approaches to adjust and improve their overall functional state ( personal, professional, social, financial, family etc.). There is no room for any ideological or orthodox thinking in treating patients suffering from the brain disease of addiction. Do we also detox patients from antidepressants or antipsychotics when they are suffering from mental diseases?
Looking forward to your comments.
Yours
Bernd
Bernd Wolllschlaeger,MD,FAAFP,FASAM
President,Florida Society of Addiction Medicine
JAMA November 5th,2008
Extended vs Short-term Buprenorphine-Naloxone for Treatment of Opioid-Addicted Youth
A Randomized Trial
George E. Woody, MD; Sabrina A. Poole, MS; Geetha Subramaniam, MD; Karen Dugosh, PhD; Michael Bogenschutz, MD; Patrick Abbott, MD; Ashwin Patkar, MD; Mark Publicker, MD; Karen McCain, MSN, FNP; Jennifer Sharpe Potter, PhD, MPH; Robert Forman, PhD; Victoria Vetter, MD; Laura McNicholas, MD, PhD; Jack Blaine, MD; Kevin G. Lynch, PhD; Paul Fudala, PhD
JAMA. 2008;300(17):2003-2011.
ABSTRACT
Context The usual treatment for opioid-addicted youth is detoxification and counseling. Extended medication-assisted therapy may be more helpful.
Objective To evaluate the efficacy of continuing buprenorphine-naloxone for 12 weeks vs detoxification for opioid-addicted youth.
Design, Setting, and Patients Clinical trial at 6 community programs from July 2003 to December 2006 including 152 patients aged 15 to 21 years who were randomized to 12 weeks of buprenorphine-naloxone or a 14-day taper (detox).
Interventions Patients in the 12-week buprenorphine-naloxone group were prescribed up to 24 mg per day for 9 weeks and then tapered to week 12; patients in the detox group were prescribed up to 14 mg per day and then tapered to day 14. All were offered weekly individual and group counseling.
Main Outcome Measure Opioid-positive urine test result at weeks 4, 8, and 12.
Results: The number of patients younger than 18 years was too small to analyze separately, but overall, patients in the detox group had higher proportions of opioid-positive urine test results at weeks 4 and 8 but not at week 12 (22 = 4.93, P = .09). At week 4, 59 detox patients had positive results (61%; 95% confidence interval [CI] = 47%-75%) vs 58 12-week buprenorphine-naloxone patients (26%; 95% CI = 14%-38%). At week 8, 53 detox patients had positive results (54%; 95% CI = 38%-70%) vs 52 12-week buprenorphine-naloxone patients (23%; 95% CI = 11%-35%). At week 12, 53 detox patients had positive results (51%; 95% CI = 35%-67%) vs 49 12-week buprenorphine-naloxone patients (43%; 95% CI = 29%-57%). By week 12, 16 of 78 detox patients (20.5%) remained in treatment vs 52 of 74 12-week buprenorphine-naloxone patients (70%; 21 = 32.90, P < .001). During weeks 1 through 12, patients in the 12-week buprenorphine-naloxone group reported less opioid use (21 = 18.45, P < .001), less injecting (21 = 6.00, P = .01), and less nonstudy addiction treatment (21 = 25.82, P < .001). High levels of opioid use occurred in both groups at follow-up. Four of 83 patients who tested negative for hepatitis C at baseline were positive for hepatitis C at week 12.
Conclusions: Continuing treatment with buprenorphine-naloxone improved outcome compared with short-term detoxification. Further research is necessary to assess the efficacy and safety of longer-term treatment with buprenorphine for young individuals with opioid dependence.
Trial Registration clinicaltrials.gov Identifier: NCT00078130
See http://jama.ama-assn.org/cgi/content/full/300/17/2003 for the full text of the article.
Attached the results of a recently published study to evaluate the efficacy of continuing buprenorphine-naloxone for 12 weeks vs detoxification for opioid-addicted youth.
Not surprisingly the results indicate that opioid-positive urine test results, retention in the trial, self-reported opioid use, injecting behavior, enrollment in nonstudy treatment, and use of cocaine and marijuana strongly favored patients in the 12-week buprenorphine-naloxone group during weeks 1 through 12. They had much less use of opioids, cocaine, and marijuana; much better treatment retention; and much less injecting and need for additional treatment while on medication.
In a commentary ( see http://jama.ama-assn.org/cgi/content/full/300/17/2057) David A Fiellin,MD points out that
" The results of this trial should prompt clinicians to use caution when tapering buprenorphine-naloxone in adolescent patients who receive this medication. Supportive counseling; close monitoring for relapse; and, in some cases, naltrexone should be offered following buprenorphine tapers. From a research perspective, additional efforts are needed to provide a stronger evidence base from which to make recommendations for adolescents who use opioids. There is limited research on prevention of opioid experimentation and effective strategies to identify experimentation and intercede to disrupt the transition from opioid use to abuse and dependence. No information is available regarding the efficacy of treatment with medications such as methadone or buprenorphine-naloxone compared with nonagonist approaches (eg, naltrexone) or nonpharmacologic approaches such as short-term rehabilitation or partial hospitalization programs."
"The high rate of relapse seen with both medication taper protocols in the current trial involving opioid-dependent adolescents, combined with the adverse social, legal, and infectious consequences of opioid dependence—and the risk for overdose with relapse—makes the need for rigorous evidence in this area urgent. These findings are another important reminder that there are no quick fixes for opioid dependence."
In his commentary Fiellin also remarks that
" There is appropriate concern about providing these medications to young individuals despite the substantial risks of opioid dependence. This concern stems from the fact that these medications prolong a state of opioid physical dependence and therefore may limit an adolescent's chance for obtaining abstinence without an opioid-based medication. "
I do not agree with his judgment because in my opinion we are using methadone and buprenorphine to provide a withdrawal free condition which then can be used to apply all the other non-pharmacological approaches to adjust and improve their overall functional state ( personal, professional, social, financial, family etc.). There is no room for any ideological or orthodox thinking in treating patients suffering from the brain disease of addiction. Do we also detox patients from antidepressants or antipsychotics when they are suffering from mental diseases?
Looking forward to your comments.
Yours
Bernd
Bernd Wolllschlaeger,MD,FAAFP,FASAM
President,Florida Society of Addiction Medicine
JAMA November 5th,2008
Extended vs Short-term Buprenorphine-Naloxone for Treatment of Opioid-Addicted Youth
A Randomized Trial
George E. Woody, MD; Sabrina A. Poole, MS; Geetha Subramaniam, MD; Karen Dugosh, PhD; Michael Bogenschutz, MD; Patrick Abbott, MD; Ashwin Patkar, MD; Mark Publicker, MD; Karen McCain, MSN, FNP; Jennifer Sharpe Potter, PhD, MPH; Robert Forman, PhD; Victoria Vetter, MD; Laura McNicholas, MD, PhD; Jack Blaine, MD; Kevin G. Lynch, PhD; Paul Fudala, PhD
JAMA. 2008;300(17):2003-2011.
ABSTRACT
Context The usual treatment for opioid-addicted youth is detoxification and counseling. Extended medication-assisted therapy may be more helpful.
Objective To evaluate the efficacy of continuing buprenorphine-naloxone for 12 weeks vs detoxification for opioid-addicted youth.
Design, Setting, and Patients Clinical trial at 6 community programs from July 2003 to December 2006 including 152 patients aged 15 to 21 years who were randomized to 12 weeks of buprenorphine-naloxone or a 14-day taper (detox).
Interventions Patients in the 12-week buprenorphine-naloxone group were prescribed up to 24 mg per day for 9 weeks and then tapered to week 12; patients in the detox group were prescribed up to 14 mg per day and then tapered to day 14. All were offered weekly individual and group counseling.
Main Outcome Measure Opioid-positive urine test result at weeks 4, 8, and 12.
Results: The number of patients younger than 18 years was too small to analyze separately, but overall, patients in the detox group had higher proportions of opioid-positive urine test results at weeks 4 and 8 but not at week 12 (22 = 4.93, P = .09). At week 4, 59 detox patients had positive results (61%; 95% confidence interval [CI] = 47%-75%) vs 58 12-week buprenorphine-naloxone patients (26%; 95% CI = 14%-38%). At week 8, 53 detox patients had positive results (54%; 95% CI = 38%-70%) vs 52 12-week buprenorphine-naloxone patients (23%; 95% CI = 11%-35%). At week 12, 53 detox patients had positive results (51%; 95% CI = 35%-67%) vs 49 12-week buprenorphine-naloxone patients (43%; 95% CI = 29%-57%). By week 12, 16 of 78 detox patients (20.5%) remained in treatment vs 52 of 74 12-week buprenorphine-naloxone patients (70%; 21 = 32.90, P < .001). During weeks 1 through 12, patients in the 12-week buprenorphine-naloxone group reported less opioid use (21 = 18.45, P < .001), less injecting (21 = 6.00, P = .01), and less nonstudy addiction treatment (21 = 25.82, P < .001). High levels of opioid use occurred in both groups at follow-up. Four of 83 patients who tested negative for hepatitis C at baseline were positive for hepatitis C at week 12.
Conclusions: Continuing treatment with buprenorphine-naloxone improved outcome compared with short-term detoxification. Further research is necessary to assess the efficacy and safety of longer-term treatment with buprenorphine for young individuals with opioid dependence.
Trial Registration clinicaltrials.gov Identifier: NCT00078130
See http://jama.ama-assn.org/cgi/content/full/300/17/2003 for the full text of the article.
Tuesday, November 4, 2008
Independent Practice of Addiction Medicne
Thank you for the comment.
The independent practice of addiction medicine implies that we want to provide the physicians the tools (practice management, risk management etc.) to provide practice-based addiction medicine care modalities in their practices. The availability of Suboxone, Revia, etc. and the desire of patients to be treated in an outpatient settings provides a unique opportunity to solidify and expand our practices. Lets dare to think out-of-the box. Looking forward to your comments.
Bernd
The independent practice of addiction medicine implies that we want to provide the physicians the tools (practice management, risk management etc.) to provide practice-based addiction medicine care modalities in their practices. The availability of Suboxone, Revia, etc. and the desire of patients to be treated in an outpatient settings provides a unique opportunity to solidify and expand our practices. Lets dare to think out-of-the box. Looking forward to your comments.
Bernd
Sunday, November 2, 2008
FSAM NEWS
Dear Friends and Colleagues:
As your President I have set myself two simple but, nevertheless, challenging goals:
1. to improve the communication with our members.
2. to assist and support the independent practice of addiction medicine.
COMMUNICATION:
• I can be reached 24/7 via cell phone (305) 940-8717, or via e-mail at info@miamihealth.com, or via http://twitter.com/dadedoc.
• I am willing to travel to your local hospital to talk about ASAM, FSAM and the practice of addiction medicine.
• I am available for CME programs or can support you in developing educational outreach programs.
PRACTICE SUPPORT:
• As a member of the Medical Specialty Action Group(MSAG) I participated in the formation of the American Board of Addiction Medicine. The Board is now an independent entity and held is first meeting in April 2008. The formation of ABAM is an important milestone in the recognition of Addiction Medicine as a medical specialty. For more information see http://www.asam.org/CMS/images/PDF/AboutASAM/2008_Number-2_ABAM%20Issue.pdf .
• Parity Legislation: On October 3, 2008, President Bush signed HR 1424 into law. This bill, commonly known as the Wall Street "bailout bill" included a previously approved tax extenders bill as well as the compromise parity legislation. The Parity provisions contained is also known as Section 511:Paul Wellstone and Pete Domenici Mental Health Parity and Addiction Equity Act of 2008. It amends the Employee Retirement Income Security Act of 1974 (ERISA), the Public Health Service Act, and the Internal Revenue Code to require a group health plan that provides both medical and surgical benefits and mental health or substance use disorder benefits to ensure that: (1) the financial requirements, such as deductibles and copayments, applicable to such mental health or substance use disorder benefits are no more restrictive than the predominant financial requirements applied to substantially all medical and surgical benefits covered by the plan; (2) there are no separate cost sharing requirements that are applicable only with respect to mental health or substance use disorder benefits; (3) the treatment limitations applicable to such mental health or substance use disorder benefits are no more restrictive than the predominant treatment limitations applied to substantially all medical and surgical benefits covered by the plan; and (4) there are no separate treatment limitations that are applicable only with respect to mental health or substance use disorder benefits.
• Requires the criteria for medical necessity determinations and the reason for any denial of reimbursement or payment for services made under the plan with respect to mental health or substance use disorder benefits to be made available by the plan administrator.
• Requires the plan to provide out-of network coverage for mental health or substance use disorder benefits if the plan provides coverage for medical or surgical benefits provided by out-of network providers.
• Exempts from the requirements of this Act a group health plan if the application of this Act results in an increase for the plan year of the actual total costs of coverage with respect to medical and surgical benefits and mental health and substance use disorder benefits by an amount that exceeds 2% for the first plan year and 1% for each subsequent plan year. Requires determinations as to increases in actual costs under a plan to be made and certified by a qualified and licensed actuary.
• Requires determinations for such an exemption to be made after such plan has complied with this Act for the first six months of the plan year.
• Sets forth requirements for notifications of exemptions under this Act, including notification of the Secretary of Health and Human Services, the appropriate state agencies, and participants and beneficiaries in the plan.
• Authorizes the Secretary and the appropriate state agency to audit the books and records of a group health plan relating to an exemption.
• Directs the Secretary to: (1) report to the appropriate congressional committees on compliance of group health plans with the requirements of this Act; and (2) publish guidance and information concerning the requirements of this Act and provide assistance concerning such requirements and the continued operation of applicable state law.
• Requires the Comptroller General to report to Congress on the specific rates, patterns, and trends in coverage and exclusion of specific mental health and substance use disorder diagnoses by health plans and health insurance.Most plans will begin implementing the new requirements in January 2010. This act represents a milestone in our struggle for parity and we need to closely monitor its implementation.
Please be advised that ASAM allocated significant financial resources to accomplish these two important goals: ABAM formation, Parity Bill.
Therefore, the ASAM Board decided to increase the membership dues to $390 for regular membership. This increase may be met with criticism but please rest assured that each and every dollar will be used to expand and strengthen our organization.
I look forward to your comments and please join our organization or renew your membership.
I also hope that I can count on your support for my candidacy as Region X Regional Director. You should have received your ballot already and please vote either via paper ballot or online.
Looking forward speaking with you soon.
Yours truly,
Bernd Wollschlaeger,MD,FAAFP,FASAM
President,Florida Society of Addiction Medicine
President, Dade County Medical Association
As your President I have set myself two simple but, nevertheless, challenging goals:
1. to improve the communication with our members.
2. to assist and support the independent practice of addiction medicine.
COMMUNICATION:
• I can be reached 24/7 via cell phone (305) 940-8717, or via e-mail at info@miamihealth.com, or via http://twitter.com/dadedoc.
• I am willing to travel to your local hospital to talk about ASAM, FSAM and the practice of addiction medicine.
• I am available for CME programs or can support you in developing educational outreach programs.
PRACTICE SUPPORT:
• As a member of the Medical Specialty Action Group(MSAG) I participated in the formation of the American Board of Addiction Medicine. The Board is now an independent entity and held is first meeting in April 2008. The formation of ABAM is an important milestone in the recognition of Addiction Medicine as a medical specialty. For more information see http://www.asam.org/CMS/images/PDF/AboutASAM/2008_Number-2_ABAM%20Issue.pdf .
• Parity Legislation: On October 3, 2008, President Bush signed HR 1424 into law. This bill, commonly known as the Wall Street "bailout bill" included a previously approved tax extenders bill as well as the compromise parity legislation. The Parity provisions contained is also known as Section 511:Paul Wellstone and Pete Domenici Mental Health Parity and Addiction Equity Act of 2008. It amends the Employee Retirement Income Security Act of 1974 (ERISA), the Public Health Service Act, and the Internal Revenue Code to require a group health plan that provides both medical and surgical benefits and mental health or substance use disorder benefits to ensure that: (1) the financial requirements, such as deductibles and copayments, applicable to such mental health or substance use disorder benefits are no more restrictive than the predominant financial requirements applied to substantially all medical and surgical benefits covered by the plan; (2) there are no separate cost sharing requirements that are applicable only with respect to mental health or substance use disorder benefits; (3) the treatment limitations applicable to such mental health or substance use disorder benefits are no more restrictive than the predominant treatment limitations applied to substantially all medical and surgical benefits covered by the plan; and (4) there are no separate treatment limitations that are applicable only with respect to mental health or substance use disorder benefits.
• Requires the criteria for medical necessity determinations and the reason for any denial of reimbursement or payment for services made under the plan with respect to mental health or substance use disorder benefits to be made available by the plan administrator.
• Requires the plan to provide out-of network coverage for mental health or substance use disorder benefits if the plan provides coverage for medical or surgical benefits provided by out-of network providers.
• Exempts from the requirements of this Act a group health plan if the application of this Act results in an increase for the plan year of the actual total costs of coverage with respect to medical and surgical benefits and mental health and substance use disorder benefits by an amount that exceeds 2% for the first plan year and 1% for each subsequent plan year. Requires determinations as to increases in actual costs under a plan to be made and certified by a qualified and licensed actuary.
• Requires determinations for such an exemption to be made after such plan has complied with this Act for the first six months of the plan year.
• Sets forth requirements for notifications of exemptions under this Act, including notification of the Secretary of Health and Human Services, the appropriate state agencies, and participants and beneficiaries in the plan.
• Authorizes the Secretary and the appropriate state agency to audit the books and records of a group health plan relating to an exemption.
• Directs the Secretary to: (1) report to the appropriate congressional committees on compliance of group health plans with the requirements of this Act; and (2) publish guidance and information concerning the requirements of this Act and provide assistance concerning such requirements and the continued operation of applicable state law.
• Requires the Comptroller General to report to Congress on the specific rates, patterns, and trends in coverage and exclusion of specific mental health and substance use disorder diagnoses by health plans and health insurance.Most plans will begin implementing the new requirements in January 2010. This act represents a milestone in our struggle for parity and we need to closely monitor its implementation.
Please be advised that ASAM allocated significant financial resources to accomplish these two important goals: ABAM formation, Parity Bill.
Therefore, the ASAM Board decided to increase the membership dues to $390 for regular membership. This increase may be met with criticism but please rest assured that each and every dollar will be used to expand and strengthen our organization.
I look forward to your comments and please join our organization or renew your membership.
I also hope that I can count on your support for my candidacy as Region X Regional Director. You should have received your ballot already and please vote either via paper ballot or online.
Looking forward speaking with you soon.
Yours truly,
Bernd Wollschlaeger,MD,FAAFP,FASAM
President,Florida Society of Addiction Medicine
President, Dade County Medical Association
ASAM Elections
Dear Friends and Colleagues:
I hope that I can count on your support for my candidacy as Region X Regional Director. You should have received your ballot already and please vote either via paper ballot or online.
Yours truly,
Bernd Wollschlaeger,MD,FAAFP.FASAM
I hope that I can count on your support for my candidacy as Region X Regional Director. You should have received your ballot already and please vote either via paper ballot or online.
Yours truly,
Bernd Wollschlaeger,MD,FAAFP.FASAM
Tuesday, April 8, 2008
Mental Health Parity
Dear Friends and Colleagues:
Representative Ed Homan (R-Tampa) has been tirelessly working on a Mental Health Parity Bill.
Today, it passed with 18-Yeas and )-Nays the Healthcare Council.
House Bill 19 amends s. 627.6688, F.S., to add substance-related disorders to the mandated offering required
by that section. The bill repeals s. 627.669, F.S., which imposes a mandated offering for substance abuse
services. The bill further amends s. 627.6688, F.S., to specifically define those mental health conditions that
must be covered within the mandated offering, generally including all diagnostic categories of mental health
conditions listed in the most recent edition of the Diagnostic and Statistical Manual of Mental Disorders and as
listed in the mental and behavioral disorders section of the current International Classification of Diseases.
The bill deletes current law limiting mental health benefits by specific service areas, such as inpatient benefits,
and inserts a general statement that the mental health benefits may not be more restrictive than the treatment
limitations and cost-sharing requirements that are applicable to other diseases, illnesses, and medical
conditions.
The bill mandates that the parity requirements be separately applied to each benefit package offered by an
employer.
The bill would have an indeterminate negative fiscal impact on the State Employees’ Group Health Self-
Insurance Trust Fund.
The effective date of the bill is January 1, 2009.
For more detailed information please visit http://edhoman.com/public/parity.html
Bill Number: 0019
Bill Name: HB 19
Action: Favorable With Council Substitute
Committee: Healthcare Council
Location: Morris Hall (17 HOB)
Duration: 3.50
Date: 4/8/2008 8:30:00 AM
Sponsor: Homan (CO-SPONSORS) Anderson; Brandenburg; Brisé; ...
Subject: Coverage for Mental, Nervous, and Substance-relate...
Y Anderson Y Galvano Y Harrell Y Patronis Y Schwartz
Y Ausley Y Garcia, R. Y Hays Y Porth Y Skidmore
Y Bean Y Gibson, H. Y Hooper Y Roberson Y Zapata
Y Cusack Y Grimsley Y Hudson
Total Yeas: 18 Total Nays: 0 Total Missed: 0 Total Votes: 18
Please contact your legislator to thank them for their support and encourage them to move this bill forward for final passage.
Also contact Rep. Ed Homan to express your support for his efforts and contribute to his campaign.
Yours
Bernd
Representative Ed Homan (R-Tampa) has been tirelessly working on a Mental Health Parity Bill.
Today, it passed with 18-Yeas and )-Nays the Healthcare Council.
House Bill 19 amends s. 627.6688, F.S., to add substance-related disorders to the mandated offering required
by that section. The bill repeals s. 627.669, F.S., which imposes a mandated offering for substance abuse
services. The bill further amends s. 627.6688, F.S., to specifically define those mental health conditions that
must be covered within the mandated offering, generally including all diagnostic categories of mental health
conditions listed in the most recent edition of the Diagnostic and Statistical Manual of Mental Disorders and as
listed in the mental and behavioral disorders section of the current International Classification of Diseases.
The bill deletes current law limiting mental health benefits by specific service areas, such as inpatient benefits,
and inserts a general statement that the mental health benefits may not be more restrictive than the treatment
limitations and cost-sharing requirements that are applicable to other diseases, illnesses, and medical
conditions.
The bill mandates that the parity requirements be separately applied to each benefit package offered by an
employer.
The bill would have an indeterminate negative fiscal impact on the State Employees’ Group Health Self-
Insurance Trust Fund.
The effective date of the bill is January 1, 2009.
For more detailed information please visit http://edhoman.com/public/parity.html
Bill Number: 0019
Bill Name: HB 19
Action: Favorable With Council Substitute
Committee: Healthcare Council
Location: Morris Hall (17 HOB)
Duration: 3.50
Date: 4/8/2008 8:30:00 AM
Sponsor: Homan (CO-SPONSORS) Anderson; Brandenburg; Brisé; ...
Subject: Coverage for Mental, Nervous, and Substance-relate...
Y Anderson Y Galvano Y Harrell Y Patronis Y Schwartz
Y Ausley Y Garcia, R. Y Hays Y Porth Y Skidmore
Y Bean Y Gibson, H. Y Hooper Y Roberson Y Zapata
Y Cusack Y Grimsley Y Hudson
Total Yeas: 18 Total Nays: 0 Total Missed: 0 Total Votes: 18
Please contact your legislator to thank them for their support and encourage them to move this bill forward for final passage.
Also contact Rep. Ed Homan to express your support for his efforts and contribute to his campaign.
Yours
Bernd
Monday, March 24, 2008
AMA NEWS Article
"Because so many patient problems have fallen at the feet of primary care, we need to look at ways primary care can be part of the solution and not part of the problem," said Michael M. Miller, MD, president of the American Society of Addiction Medicine.
Dear Friends and Colleagues:
Attached a very informative article from a recent AMA NEWS edition.
Some great quotes including Mark Gold and Michael Miller,MDs.
Bernd
AMA NEWS 03/17/08
HEALTH & SCIENCE
Dangerous diversions: Specter of prescription drug abuse creates tough balancing act for doctors
Questioning patients about past addictive disorders can alert physicians to the need for care when prescribing medication with the potential for misuse.
By Susan J. Landers, AMNews staff. March 17, 2008.
Walking the line between appropriately prescribing controlled substances and unwittingly contributing to the increase in prescription drug abuse becomes less precarious when certain precautions are taken, say those familiar with the balancing act.
Prescription drug abuse is widespread and on the rise. Nearly 7 million Americans abused prescription drugs in 2005, compared with 3.8 million in 2000 -- an 80% jump, says the Justice Dept.
While research has shown that most medications are prescribed responsibly and that the Internet and street sales feed the illegal drug trade, physicians could play a larger role in fighting this problem, several experts said.
Prescribing of controlled substances has increased dramatically, said Robert DuPont, MD, president of the Institute for Behavior and Health, a nonprofit drug abuse policy organization in Rockville, Md., a block from the National Institute on Drug Abuse, where he served as the first director.
"Before the last decade, doctors were very reluctant to prescribe these medications to outpatients. But because of concern about the undertreatment of pain, their prescription has become ubiquitous," Dr. DuPont said.
If physicians think their practices are immune from prescription abuse, they should think again, said Mark Gold, MD, distinguished professor and chief of addiction medicine at the University of Florida's McKnight Brain Institute in Gainesville.
10% of adults will have some kind of addictive disorder in their lifetimes.
Properly prescribed medications can be diverted by teens pilfering drugs from their parents' medicine cabinet before heading out to a party. Or patients may sell their medications to supplement their incomes. And then there are the "doctor shoppers" who hit a different physician's office every day, seeking controlled substances.
Regardless of how it happens, the outcome of this abuse can be deadly. Actor Heath Ledger, who died Jan. 22 after taking a variety of prescribed medications, can be counted among its victims, as can musicians Elvis Presley, Judy Garland, Dinah Washington and Jimi Hendrix.
For as long as there have been medicines, the danger of overuse, experimentation and abuse has existed. The rise of patent medicines -- based largely on morphine and cocaine -- in the middle and late 1800s resulted in one in 200 Americans becoming addicted. These widely used substances were embraced by doctors and patients alike before harm was detected and the first drug control laws were passed.
That was then. The drugs of choice now, according to the National Institute on Drug Abuse, are opioids commonly prescribed to treat pain; central nervous system depressants used to treat anxiety and sleep disorders; and stimulants used to treat narcolepsy and attention-deficit hyperactivity disorder.
Pain reliever or drug of abuse?
But there is a flip side. The same medications subject to abuse provide much-needed relief to patients. A larger problem comes when pain is not treated adequately or when patients are afraid to ask for pain relief because they fear they might become addicted, said A. Thomas McLellan, PhD, CEO and founder of the Treatment Research Institute, a nonprofit group in Philadelphia that studies addiction.
American Medical Association policy also cautions that undertreating pain is a concern that must be balanced against the risk of abuse.
70 million Americans experience pain every day.
Undertreatment of chronic pain is an important public health concern, said B. Todd Sitzman, MD, MPH, president of the American Academy of Pain Medicine. An aging population means that arthritis, cancer, degenerative disc disease and other disorders will become more common, leading to an increase rather than a decrease in pain scripts, he said.
The need for both pain treatment and addiction treatment is clear. "We know there are 70 million Americans who experience pain every day. Along with that, we know 10% of the adult population will have some kind of addictive disorder in their lifetime, although most will be addicted to some legal substance, like alcohol."
Primary care physicians can address these problems before even picking up a pen and prescription pad, several physicians said. "Because so many patient problems have fallen at the feet of primary care, we need to look at ways primary care can be part of the solution and not part of the problem," said Michael M. Miller, MD, president of the American Society of Addiction Medicine.
A report about prescription drug abuse will be presented at the AMA Annual Meeting in June. Current AMA policy supports physician education, research activities and the development of state-based programs.
As a first step, physicians need to ask questions about a patient's history of addiction or previous difficulties in controlling their prescription drug use, Dr. Miller said. While addiction to opioids and psychostimulants is relatively rare when the medications are properly prescribed, these screening questions can alert physicians to the need to exercise particular caution, he said.
Doctors can incorporate such queries into a busy practice, Dr. Gold said. Questions about tobacco use, once a rarity, are commonplace today.
Doctors may think that national statistics don't apply to their practices, he said, but that's not the case. "Tobacco, alcohol and drug problems are so important in our society and health system, it is imperative for physicians to acquire the skill to ask and intervene."
Physicians also should consider what might happen to the medication that isn't used right away, said Kyle Kampman, MD, medical director of the Charles O'Brien Center for Addiction Treatment at the University of Pennsylvania. Physicians often provide too many pills, he said. "We hate to see somebody in pain run out of medicine, so sometimes we may be a little too generous."
Pharmaceutical leftovers are kept in case patients need them again. And where are they stored? In medicine cabinets and kitchens, where they can be found by children and others, Dr. Kampman said.
Physicians need to warn patients to lock up unused medications, he added. "Patients tell me they worked as a maid at the height of their addiction and they would go through people's medicine cabinets. I had a patient who was a roofer tell me, 'If you ever let a roofer in your house and in the bathroom, chances are they are looking through your medicine cabinet.' "
Physicians also need to look for signs of abuse, such as patients who return early for a refill. "It's a joke among addiction providers that sinks and toilets seem to be magnets for people's medications. That's an excuse you often hear: 'I dumped my medicine down the sink or down the toilet.' So that should ring alarm bells," Dr. Kampman said.
If this occurs, it's best to confront a patient directly, he said. Sometimes patients will acknowledge a problem, and the physician needs to stop prescribing and insist the patient be evaluated for substance abuse, Dr. Kampman said.
Other times, patients' pain is undertreated, leading them to take increasing amounts of a medicine. In these cases, referral to a pain specialist is necessary, he added.
Every physician prescribing controlled substances has clear responsibilities set forth by the Federation of State Medical Boards, Dr. Sitzman said. These duties -- which include obtaining a physical exam before prescribing, having a written treatment plan and stressing the responsibilities of both patient and physician -- aren't always followed closely, he said.
Physicians should tell patients that it is illegal to share medications with other people, and that unused or expired drugs should be destroyed, Dr. DuPont said. Destroying them means rendering them unusable by mixing them with cat litter or coffee grounds. Flushing them down the toilet is permissible only if the label says so, according to the Office of National Drug Control Policy.
Detecting doctor shoppers
Turning to a prescription drug monitoring program, a searchable database for tracking users of controlled substances, is another option for physicians on the trail of doctor shoppers. For instance, the Indiana Scheduled Prescription Electronic Collection & Tracking program is gaining popularity in that state.
"It takes about 30 seconds to check to see if patients are filling other prescriptions," said family physician Terry Haffner, MD, of Kokomo. Previously available only to law enforcement agencies, the INSPECT program opened to doctors last July.
Congress enacted the National All Schedules Prescription Electronic Reporting Act in 2005 with strong doctor support. But the law, which authorizes a system of federally supported, state-based drug monitoring programs, has yet to be funded.
NASPER investment is critical, said Andrea Trescot, MD, president of the American Society of Interventional Pain Physicians. If it were funded, the law would provide an important preventive tool, she said.
Talk-show host Rush Limbaugh might not have gotten into trouble with prescription abuse if NASPER had been operational, she noted. He was charged in 2006 with doctor shopping to get extra pain killers. "When he saw a second doctor, [that] doctor would have said, wait a second, maybe there is a problem here. Let's see if we can intervene before you crash, burn and die."
Discuss on SermoBack to top.
ADDITIONAL INFORMATION:
Getting pain pills
Friends and relatives were the primary source of prescription pain relievers abused by those 12 and older, a new survey finds. But physicians were also sources.
56% of respondents said they had received pain relievers free from a friend or relative.
19% received them from a doctor.
9% bought them from a friend or relative.
7% identified another source.
5% took them from a friend or relative.
4% bought them from a drug dealer.
Source: "2006 National Survey on Drug Use and Health: national findings," Substance Abuse and Mental Health Services Administration, September 2007
Back to top.
Controlling controlled substances
Specialists in pain medicine and addiction medicine suggest ways to prevent drug diversion:
Ask patients about a history of addiction or any previous difficulties in controlling prescription drug use.
Don't prescribe too many pills. Those that aren't used are often kept where they can be found by teens and visitors.
Warn patients to lock up their medications.
Encourage patients to dispose of unused medicine by mixing it with coffee grounds or cat litter, wrapping it in a plastic bag, and then a paper bag, before throwing it in the trash.
Be aware of signs of misuse or of inadequate pain relief, such as "losing" prescriptions and medications or running out early.
Back to top.
Abusing Rx drugs, and more
More than 2.1 million teens reported abusing prescribed substances in 2006, according to a national survey on drug use and health released last September. People 12 and older who reported using an illicit drug for the first time in the past year (numbers are in thousands):
2,150,000 used pain relievers
2,063,000 used marijuana
1,112,000 used tranquilizers
997,000 used cocaine
860,000 used ecstasy
783,000 used inhalants
267,000 used sedatives
264,000 used LSD
258,000 used meth
91,000 used heroin
69,000 used PCP
Source: "2006 National Survey on Drug Use and Health: National Findings," Substance Abuse and Mental Health Services Administration, September 2007
Back to top.
Weblink
American Society of Addiction Medicine (www.asam.org)
American Academy of Pain Medicine (www.painmed.org)
American Society of Interventional Pain Physicians (www.asipp.org)
Dear Friends and Colleagues:
Attached a very informative article from a recent AMA NEWS edition.
Some great quotes including Mark Gold and Michael Miller,MDs.
Bernd
AMA NEWS 03/17/08
HEALTH & SCIENCE
Dangerous diversions: Specter of prescription drug abuse creates tough balancing act for doctors
Questioning patients about past addictive disorders can alert physicians to the need for care when prescribing medication with the potential for misuse.
By Susan J. Landers, AMNews staff. March 17, 2008.
Walking the line between appropriately prescribing controlled substances and unwittingly contributing to the increase in prescription drug abuse becomes less precarious when certain precautions are taken, say those familiar with the balancing act.
Prescription drug abuse is widespread and on the rise. Nearly 7 million Americans abused prescription drugs in 2005, compared with 3.8 million in 2000 -- an 80% jump, says the Justice Dept.
While research has shown that most medications are prescribed responsibly and that the Internet and street sales feed the illegal drug trade, physicians could play a larger role in fighting this problem, several experts said.
Prescribing of controlled substances has increased dramatically, said Robert DuPont, MD, president of the Institute for Behavior and Health, a nonprofit drug abuse policy organization in Rockville, Md., a block from the National Institute on Drug Abuse, where he served as the first director.
"Before the last decade, doctors were very reluctant to prescribe these medications to outpatients. But because of concern about the undertreatment of pain, their prescription has become ubiquitous," Dr. DuPont said.
If physicians think their practices are immune from prescription abuse, they should think again, said Mark Gold, MD, distinguished professor and chief of addiction medicine at the University of Florida's McKnight Brain Institute in Gainesville.
10% of adults will have some kind of addictive disorder in their lifetimes.
Properly prescribed medications can be diverted by teens pilfering drugs from their parents' medicine cabinet before heading out to a party. Or patients may sell their medications to supplement their incomes. And then there are the "doctor shoppers" who hit a different physician's office every day, seeking controlled substances.
Regardless of how it happens, the outcome of this abuse can be deadly. Actor Heath Ledger, who died Jan. 22 after taking a variety of prescribed medications, can be counted among its victims, as can musicians Elvis Presley, Judy Garland, Dinah Washington and Jimi Hendrix.
For as long as there have been medicines, the danger of overuse, experimentation and abuse has existed. The rise of patent medicines -- based largely on morphine and cocaine -- in the middle and late 1800s resulted in one in 200 Americans becoming addicted. These widely used substances were embraced by doctors and patients alike before harm was detected and the first drug control laws were passed.
That was then. The drugs of choice now, according to the National Institute on Drug Abuse, are opioids commonly prescribed to treat pain; central nervous system depressants used to treat anxiety and sleep disorders; and stimulants used to treat narcolepsy and attention-deficit hyperactivity disorder.
Pain reliever or drug of abuse?
But there is a flip side. The same medications subject to abuse provide much-needed relief to patients. A larger problem comes when pain is not treated adequately or when patients are afraid to ask for pain relief because they fear they might become addicted, said A. Thomas McLellan, PhD, CEO and founder of the Treatment Research Institute, a nonprofit group in Philadelphia that studies addiction.
American Medical Association policy also cautions that undertreating pain is a concern that must be balanced against the risk of abuse.
70 million Americans experience pain every day.
Undertreatment of chronic pain is an important public health concern, said B. Todd Sitzman, MD, MPH, president of the American Academy of Pain Medicine. An aging population means that arthritis, cancer, degenerative disc disease and other disorders will become more common, leading to an increase rather than a decrease in pain scripts, he said.
The need for both pain treatment and addiction treatment is clear. "We know there are 70 million Americans who experience pain every day. Along with that, we know 10% of the adult population will have some kind of addictive disorder in their lifetime, although most will be addicted to some legal substance, like alcohol."
Primary care physicians can address these problems before even picking up a pen and prescription pad, several physicians said. "Because so many patient problems have fallen at the feet of primary care, we need to look at ways primary care can be part of the solution and not part of the problem," said Michael M. Miller, MD, president of the American Society of Addiction Medicine.
A report about prescription drug abuse will be presented at the AMA Annual Meeting in June. Current AMA policy supports physician education, research activities and the development of state-based programs.
As a first step, physicians need to ask questions about a patient's history of addiction or previous difficulties in controlling their prescription drug use, Dr. Miller said. While addiction to opioids and psychostimulants is relatively rare when the medications are properly prescribed, these screening questions can alert physicians to the need to exercise particular caution, he said.
Doctors can incorporate such queries into a busy practice, Dr. Gold said. Questions about tobacco use, once a rarity, are commonplace today.
Doctors may think that national statistics don't apply to their practices, he said, but that's not the case. "Tobacco, alcohol and drug problems are so important in our society and health system, it is imperative for physicians to acquire the skill to ask and intervene."
Physicians also should consider what might happen to the medication that isn't used right away, said Kyle Kampman, MD, medical director of the Charles O'Brien Center for Addiction Treatment at the University of Pennsylvania. Physicians often provide too many pills, he said. "We hate to see somebody in pain run out of medicine, so sometimes we may be a little too generous."
Pharmaceutical leftovers are kept in case patients need them again. And where are they stored? In medicine cabinets and kitchens, where they can be found by children and others, Dr. Kampman said.
Physicians need to warn patients to lock up unused medications, he added. "Patients tell me they worked as a maid at the height of their addiction and they would go through people's medicine cabinets. I had a patient who was a roofer tell me, 'If you ever let a roofer in your house and in the bathroom, chances are they are looking through your medicine cabinet.' "
Physicians also need to look for signs of abuse, such as patients who return early for a refill. "It's a joke among addiction providers that sinks and toilets seem to be magnets for people's medications. That's an excuse you often hear: 'I dumped my medicine down the sink or down the toilet.' So that should ring alarm bells," Dr. Kampman said.
If this occurs, it's best to confront a patient directly, he said. Sometimes patients will acknowledge a problem, and the physician needs to stop prescribing and insist the patient be evaluated for substance abuse, Dr. Kampman said.
Other times, patients' pain is undertreated, leading them to take increasing amounts of a medicine. In these cases, referral to a pain specialist is necessary, he added.
Every physician prescribing controlled substances has clear responsibilities set forth by the Federation of State Medical Boards, Dr. Sitzman said. These duties -- which include obtaining a physical exam before prescribing, having a written treatment plan and stressing the responsibilities of both patient and physician -- aren't always followed closely, he said.
Physicians should tell patients that it is illegal to share medications with other people, and that unused or expired drugs should be destroyed, Dr. DuPont said. Destroying them means rendering them unusable by mixing them with cat litter or coffee grounds. Flushing them down the toilet is permissible only if the label says so, according to the Office of National Drug Control Policy.
Detecting doctor shoppers
Turning to a prescription drug monitoring program, a searchable database for tracking users of controlled substances, is another option for physicians on the trail of doctor shoppers. For instance, the Indiana Scheduled Prescription Electronic Collection & Tracking program is gaining popularity in that state.
"It takes about 30 seconds to check to see if patients are filling other prescriptions," said family physician Terry Haffner, MD, of Kokomo. Previously available only to law enforcement agencies, the INSPECT program opened to doctors last July.
Congress enacted the National All Schedules Prescription Electronic Reporting Act in 2005 with strong doctor support. But the law, which authorizes a system of federally supported, state-based drug monitoring programs, has yet to be funded.
NASPER investment is critical, said Andrea Trescot, MD, president of the American Society of Interventional Pain Physicians. If it were funded, the law would provide an important preventive tool, she said.
Talk-show host Rush Limbaugh might not have gotten into trouble with prescription abuse if NASPER had been operational, she noted. He was charged in 2006 with doctor shopping to get extra pain killers. "When he saw a second doctor, [that] doctor would have said, wait a second, maybe there is a problem here. Let's see if we can intervene before you crash, burn and die."
Discuss on SermoBack to top.
ADDITIONAL INFORMATION:
Getting pain pills
Friends and relatives were the primary source of prescription pain relievers abused by those 12 and older, a new survey finds. But physicians were also sources.
56% of respondents said they had received pain relievers free from a friend or relative.
19% received them from a doctor.
9% bought them from a friend or relative.
7% identified another source.
5% took them from a friend or relative.
4% bought them from a drug dealer.
Source: "2006 National Survey on Drug Use and Health: national findings," Substance Abuse and Mental Health Services Administration, September 2007
Back to top.
Controlling controlled substances
Specialists in pain medicine and addiction medicine suggest ways to prevent drug diversion:
Ask patients about a history of addiction or any previous difficulties in controlling prescription drug use.
Don't prescribe too many pills. Those that aren't used are often kept where they can be found by teens and visitors.
Warn patients to lock up their medications.
Encourage patients to dispose of unused medicine by mixing it with coffee grounds or cat litter, wrapping it in a plastic bag, and then a paper bag, before throwing it in the trash.
Be aware of signs of misuse or of inadequate pain relief, such as "losing" prescriptions and medications or running out early.
Back to top.
Abusing Rx drugs, and more
More than 2.1 million teens reported abusing prescribed substances in 2006, according to a national survey on drug use and health released last September. People 12 and older who reported using an illicit drug for the first time in the past year (numbers are in thousands):
2,150,000 used pain relievers
2,063,000 used marijuana
1,112,000 used tranquilizers
997,000 used cocaine
860,000 used ecstasy
783,000 used inhalants
267,000 used sedatives
264,000 used LSD
258,000 used meth
91,000 used heroin
69,000 used PCP
Source: "2006 National Survey on Drug Use and Health: National Findings," Substance Abuse and Mental Health Services Administration, September 2007
Back to top.
Weblink
American Society of Addiction Medicine (www.asam.org)
American Academy of Pain Medicine (www.painmed.org)
American Society of Interventional Pain Physicians (www.asipp.org)
Monday, March 17, 2008
Impaired Healthcare Professionals in the news
Dear Friends and Colleagues:
Attached you find an article from the Sunday edition of the Miami Herald regarding the issue of impaired healthcare professionals.
Despite the apparent criticism of an opaque system that appears (for the public at least) to protect impaired practitioners Dr.Pomm points out the obvious success rate of the monitoring system.
I think that we need to proactively monitor our own profession and report those who truly need assistance and support.
We should not leave it up to the public or the lawyers to judge us but be proactive in the pursuit of protecting our patients and our profession.
I am looking forward to your comments.
Yours
Bernd
==============================================================================
Posted on Sun, Mar. 16, 2008
Healthcare practitioners with drug problems hidden by the system
BY JOHN DORSCHNER AND PATRICK DANNER
In August 2006, the former wife of a Broward psychologist sent a letter to state authorities saying she had visited his home 'and saw cocaine paraphernalia, an empty bottle of Oxycontin and a small Ziploc bag . . . with `whitish-beigy' colored small rocks,'' according to a court document.
That event started an investigation and later a lawsuit against ''John Doe, Ph.D.'' The psychologist's name has not been revealed. The Department of Health won't say if he's still practicing. ''Everything about this case is confidential,'' says spokeswoman Eulinda Jackson.
The case is another example of how far state regulators will go to protect healthcare professionals.
''Doctors like to protect other doctors,'' says Sidney M. Wolfe, a physician with the Washington-based Public Citizen consumer group which has published a series of studies on how lax regulatory groups are in disciplining healthcare professionals.
In the case of the unknown psychologist confidentiality is key in order to get professionals to seek help, says Raymond Pomm, head of the group that handles the impaired physicians' program. ``If we don't protect them, they won't come knocking on the door.''
But court records reveal John Doe, Ph.D. refused to participate. Pomm's program, Professional Resource Network, asked him to respond to his ex-wife's allegations. He didn't. In October 2006, PRN sent him a certified letter. He didn't respond. Over the next year, PRN kept repeating the request.
Finally, in November, the Department of Health sued ''John Doe Ph.D'' in Broward Circuit Court to compel him to submit to a mental and physical test. Wherever his real name appeared in court documents, it was blacked out. The psychologist has yet to respond.
''It's always been troubling to me that the profession protects itself to the detriment of the public,'' says Ervin Gonzalez, a Coral Gables lawyer who has represented patients in malpractice lawsuits. ``The profession closes in and has star chamber-type proceedings that no one knows about or hears about. I think it should be in the sunshine. I think it should be transparent.''
Gonzalez says doctors generally are allowed to continue to practice while the Department of Health brings such actions. That due process is a fundamental right, but ''after there is a probable cause finding and evidence of a legitimate risk to the public, then I think the public should know,'' he says.
That means making the physician's name public at that point so patients can decide for themselves. ''It's a matter of great public importance, I believe,'' Gonzalez says.
According to the state's Medical Quality Assurance Division, 127 complaints were received in fiscal 2007 concerning Florida's 3,571 licensed psychologists. In 12 cases, investigators found there was probable cause that state rules had been violated. Final outcome: No licenses revoked, one suspended and 11 psychologists were fined.
State officials have asked that the John Doe Ph.D. file be sealed completely, but the judge has yet to make a decision and a hearing last month was postponed. The state statute governing such cases requires that the psychologist's name be kept confidential in court documents and proceedings be closed to the public. But nothing in the statute says that the entire file must be sealed.
The attorney for the Health Department in the case, Cynthia L. Jakeman, did not respond to a request for comment.
Pomm says PRN has a ''very strict'' program of testing and compliance, and the doctors are highly motivated because they don't want to lose their licenses. He says 87.2 percent of medical doctors and osteopathic physicians successfully complete the program and never relapse -- a far better success rate than most rehab programs.
''We see 9.3 percent relapse one time, 1.7 percent relapse two times only and 1.8 percent three times or more. These are very good rates,'' says Pomm.
However, ''before July 1, 2005, there was a loophole,'' in which practitioners who had successfully completed the program and were thought to have relapsed could not be forced to take a urine test. ''We fixed that with legislation,'' says Pomm. Under the present PRN program, if a practitioner misses a urine test or a group counseling session, ``we basically pull them out of practice.''
In the case of John Doe Ph.D., court filings hint at multiple problems. One document indicates he successfully completed a PRN program in January 2006. In a filing in a custody battle for his children, he said he had been ''clean'' of ''hard-core'' drugs from August 2000 to April 2006, ``when he began taking a prescription of oxycodone for chronic neck, back and right knee pain.''
On Aug. 5, 2006, he said he was in an opiate detox program. Less than three weeks later, his ex-wife notified PRN of seeing drug paraphernalia in his home.
When the Health Department sued John Doe Ph.D., it stated ''probable cause existed to believe that respondent was unable to practice psychology with reasonable skill and safety,'' which appears to indicate that the department was asking the psychology board to suspend his license. However, in the minutes of that board's regular meetings, available on the Internet, there is no indication of any Broward psychologist being suspended for drug allegations.
Arthur Levin of the Center for Medical Consumers in New York says ''it's just crazy'' for regulators to protect the identity of a healthcare practitioner who refuses to cooperate. Levin appreciates the need for confidentiality. ``I live with somebody who is in recovery. But it's a little different in the case of a professional.''
Some believe impairment problems are not as critical with a psychologist as they would be with, say, a heart surgeon, but Michael Herkov, a clinical psychologist and a professor at the University of North Florida, says psychology also involves life-and-death decisions.
''Psychologists don't just listen,'' says Herkov. ``Bartenders listen. Psychologists are involved in the diagnosis and treatment of mental disorders. . . . More people die each year from suicide than do from homicide. Decisions have to be made. Do you have to be hospitalized immediately? . . . These are situations with serious consequences.''
Court records show it's unusual for the Department of Health to sue a John Doe to demand the taking of mental and physical exams. There are only four such cases in Miami-Dade and Broward counties over the past five years. The other two cases in Broward involve John Doe, MD and Jane Doe, LPN (licensed practical nurse).
In Miami-Dade, the lone such case involves a Jane Doe, RN (registered nurse). There is no indication of what the case was about or how it was resolved.
When a consumer hears rumors about a practitioner and drug use, such allegations are virtually impossible to check out.
Some months ago, a person called a Miami Herald reporter and named a Miami-Dade cosmetic surgeon who continued to practice while having drug problems. The caller gave detailed information, such as saying the surgeon relapsed six times in rehab programs.
On the Department of Health website, the surgeon is indicated as having a ''clear/active license.'' No disciplinary actions are listed.
When a reporter asked Pomm about the surgeon, he said he couldn't say anything about specific doctors.
Attached you find an article from the Sunday edition of the Miami Herald regarding the issue of impaired healthcare professionals.
Despite the apparent criticism of an opaque system that appears (for the public at least) to protect impaired practitioners Dr.Pomm points out the obvious success rate of the monitoring system.
I think that we need to proactively monitor our own profession and report those who truly need assistance and support.
We should not leave it up to the public or the lawyers to judge us but be proactive in the pursuit of protecting our patients and our profession.
I am looking forward to your comments.
Yours
Bernd
==============================================================================
Posted on Sun, Mar. 16, 2008
Healthcare practitioners with drug problems hidden by the system
BY JOHN DORSCHNER AND PATRICK DANNER
In August 2006, the former wife of a Broward psychologist sent a letter to state authorities saying she had visited his home 'and saw cocaine paraphernalia, an empty bottle of Oxycontin and a small Ziploc bag . . . with `whitish-beigy' colored small rocks,'' according to a court document.
That event started an investigation and later a lawsuit against ''John Doe, Ph.D.'' The psychologist's name has not been revealed. The Department of Health won't say if he's still practicing. ''Everything about this case is confidential,'' says spokeswoman Eulinda Jackson.
The case is another example of how far state regulators will go to protect healthcare professionals.
''Doctors like to protect other doctors,'' says Sidney M. Wolfe, a physician with the Washington-based Public Citizen consumer group which has published a series of studies on how lax regulatory groups are in disciplining healthcare professionals.
In the case of the unknown psychologist confidentiality is key in order to get professionals to seek help, says Raymond Pomm, head of the group that handles the impaired physicians' program. ``If we don't protect them, they won't come knocking on the door.''
But court records reveal John Doe, Ph.D. refused to participate. Pomm's program, Professional Resource Network, asked him to respond to his ex-wife's allegations. He didn't. In October 2006, PRN sent him a certified letter. He didn't respond. Over the next year, PRN kept repeating the request.
Finally, in November, the Department of Health sued ''John Doe Ph.D'' in Broward Circuit Court to compel him to submit to a mental and physical test. Wherever his real name appeared in court documents, it was blacked out. The psychologist has yet to respond.
''It's always been troubling to me that the profession protects itself to the detriment of the public,'' says Ervin Gonzalez, a Coral Gables lawyer who has represented patients in malpractice lawsuits. ``The profession closes in and has star chamber-type proceedings that no one knows about or hears about. I think it should be in the sunshine. I think it should be transparent.''
Gonzalez says doctors generally are allowed to continue to practice while the Department of Health brings such actions. That due process is a fundamental right, but ''after there is a probable cause finding and evidence of a legitimate risk to the public, then I think the public should know,'' he says.
That means making the physician's name public at that point so patients can decide for themselves. ''It's a matter of great public importance, I believe,'' Gonzalez says.
According to the state's Medical Quality Assurance Division, 127 complaints were received in fiscal 2007 concerning Florida's 3,571 licensed psychologists. In 12 cases, investigators found there was probable cause that state rules had been violated. Final outcome: No licenses revoked, one suspended and 11 psychologists were fined.
State officials have asked that the John Doe Ph.D. file be sealed completely, but the judge has yet to make a decision and a hearing last month was postponed. The state statute governing such cases requires that the psychologist's name be kept confidential in court documents and proceedings be closed to the public. But nothing in the statute says that the entire file must be sealed.
The attorney for the Health Department in the case, Cynthia L. Jakeman, did not respond to a request for comment.
Pomm says PRN has a ''very strict'' program of testing and compliance, and the doctors are highly motivated because they don't want to lose their licenses. He says 87.2 percent of medical doctors and osteopathic physicians successfully complete the program and never relapse -- a far better success rate than most rehab programs.
''We see 9.3 percent relapse one time, 1.7 percent relapse two times only and 1.8 percent three times or more. These are very good rates,'' says Pomm.
However, ''before July 1, 2005, there was a loophole,'' in which practitioners who had successfully completed the program and were thought to have relapsed could not be forced to take a urine test. ''We fixed that with legislation,'' says Pomm. Under the present PRN program, if a practitioner misses a urine test or a group counseling session, ``we basically pull them out of practice.''
In the case of John Doe Ph.D., court filings hint at multiple problems. One document indicates he successfully completed a PRN program in January 2006. In a filing in a custody battle for his children, he said he had been ''clean'' of ''hard-core'' drugs from August 2000 to April 2006, ``when he began taking a prescription of oxycodone for chronic neck, back and right knee pain.''
On Aug. 5, 2006, he said he was in an opiate detox program. Less than three weeks later, his ex-wife notified PRN of seeing drug paraphernalia in his home.
When the Health Department sued John Doe Ph.D., it stated ''probable cause existed to believe that respondent was unable to practice psychology with reasonable skill and safety,'' which appears to indicate that the department was asking the psychology board to suspend his license. However, in the minutes of that board's regular meetings, available on the Internet, there is no indication of any Broward psychologist being suspended for drug allegations.
Arthur Levin of the Center for Medical Consumers in New York says ''it's just crazy'' for regulators to protect the identity of a healthcare practitioner who refuses to cooperate. Levin appreciates the need for confidentiality. ``I live with somebody who is in recovery. But it's a little different in the case of a professional.''
Some believe impairment problems are not as critical with a psychologist as they would be with, say, a heart surgeon, but Michael Herkov, a clinical psychologist and a professor at the University of North Florida, says psychology also involves life-and-death decisions.
''Psychologists don't just listen,'' says Herkov. ``Bartenders listen. Psychologists are involved in the diagnosis and treatment of mental disorders. . . . More people die each year from suicide than do from homicide. Decisions have to be made. Do you have to be hospitalized immediately? . . . These are situations with serious consequences.''
Court records show it's unusual for the Department of Health to sue a John Doe to demand the taking of mental and physical exams. There are only four such cases in Miami-Dade and Broward counties over the past five years. The other two cases in Broward involve John Doe, MD and Jane Doe, LPN (licensed practical nurse).
In Miami-Dade, the lone such case involves a Jane Doe, RN (registered nurse). There is no indication of what the case was about or how it was resolved.
When a consumer hears rumors about a practitioner and drug use, such allegations are virtually impossible to check out.
Some months ago, a person called a Miami Herald reporter and named a Miami-Dade cosmetic surgeon who continued to practice while having drug problems. The caller gave detailed information, such as saying the surgeon relapsed six times in rehab programs.
On the Department of Health website, the surgeon is indicated as having a ''clear/active license.'' No disciplinary actions are listed.
When a reporter asked Pomm about the surgeon, he said he couldn't say anything about specific doctors.
Saturday, February 23, 2008
JOURNAL CLUB: Cocaine Abuse - A Case report
Attached a case report published in the current edition of CONSULTANT http://www.consultantlive.com/print.jhtml;jsessionid=ZCJKOW4131PZGQSNDLPSKHSCJUNN2JVN?articleID=206503919&url_prefix=
Looking forward to your comments.
Yours
Bernd
Renal Infarction: An Unusual Complication of Cocaine Abuse
By ASIM ABBASI, MD, ANDY ARWARI, MD, ALI ALIZADEHSOVARI, MD, and SAMER NUHAILY, MD,
February 01, 2008 URL: http://www.consultantlive.com/showArticle.jhtml?articleId=206503919
A 63-year-old African American man presented with severe epigastric pain of 1 day's duration. The pain was sharp and continuous and radiated toward the left flank. There were no aggravating or relieving factors or previous similar episodes. The patient denied fever, chills, urgency, frequent or painful urination, and gross hematuria. Earlier that day, he had taken an antacid for presumed gastritis and had a bout of emesis. The patient had a history of cocaine abuse and admitted that he had smoked one fourth of a bag of cocaine the day before presentation.
Blood pressure was 159/93 mm Hg; heart rate, 73 beats per minute; temperature, 36.9°C (98.4°F); respiration rate, 18 breaths per minute; and oxygen saturation, 98% on room air. The chest was clear. Cardiac findings were within normal limits. The abdomen was scaphoid, without scars, rashes, or lesions. There was severe epigastric tenderness and tenderness to percussion of left costovertebral angle, without guarding, spasm, or rebound; no masses or abnormal pulsations were noted. Genitourinary and rectal findings were normal; stool was guaiac-negative. Other physical findings were noncontributory.
The differential diagnosis included renal colic, pyelonephritis, acute gastritis, mesenteric ischemia, and renal infarction. Intravenous hydration with normal saline was started, pending the results of further investigations.
The white blood cell count was 17,300/µL, with 77.2% neutrophils; the hemoglobin level was 13.6 g/dL. Hematocrit was 40.2%; platelet count, 266,000/µL; blood urea nitrogen, 7 mg/dL; serum creatinine, 1.0 mg/dL; total protein, 6.1 g/dL; and serum albumin, 3.0 g/dL. Total bilirubin was 1.1 mg/dL; aspartate aminotransferase, 63 U/L; alanine aminotransferase, 41 U/L; alkaline phosphatase, 51 U/L; serum sodium, 135 mEq/L; potassium, 3.5 mEq/L; chloride, 104 mEq/L; carbon dioxide, 36.2 mEq/L; and lactate dehydrogenase, 341 U/L. A urinalysis showed trace proteinuria, 1 to 3 red blood cells per high-power field, and no white blood cells or casts. Urine toxicology confirmed the presence of cocaine.
CT scans of the abdomen showed acute infarcts in the medial upper pole and lateral lower pole of the left kidney (Figure). There was no vascular disease in the abdominal aorta, celiac artery, or superior mesenteric arteries. No definite plaque lesions were seen in the right or left renal arteries.
Duplex ultrasonography showed normal blood flow in both renal arteries. Blood and urine cultures were negative. Screening for hypercoagulability (factor V Leiden, prothrombin gene, protein C, protein S, antithrombin III, antiphospholipid antibody, and homocysteine); collagen disease (rheumatoid factor and antinuclear antibody); and lipid disorders was negative for thromboembolic phenomena. A transesophageal echocardiogram showed no evidence of an intracardiac thrombus or valvular vegetations.
Cocaine-induced renal infarction was diagnosed by exclusion. The patient was given supportive therapy for 3 days and was discharged. His renal function was observed during the hospitalization, and renal failure did not occur. His serum creatinine level at the time of discharge was 1.1 mg/dL.
RENAL COMPLICATIONS OF COCAINE ABUSE
Cocaine abuse has reached epidemic proportions in United States.1 Cocaine use has deleterious effects on multiple organ systems. Common toxic effects on the vascular system include myocardial ischemia, mesenteric ischemia, and cerebrovascular accidents. Myocardial ischemia and cerebrovascular accidents are the most common causes of hospitalizations related to cocaine abuse. The annual cost of cocaine-related hospitalizations has exceeded $80 million.2
Renal injury. Renal complications of cocaine abuse are relatively rare. The pathophysiology of renal injury involves changes in renal hemodynamics, glomerular matrix synthesis, degradation, oxidative stress, and induction of renal atherogenesis. These changes may lead to both acute and chronic renal injury. There are several case reports of acute tubular necrosis caused by rhabdomyolysis after cocaine abuse.3 Acute renal failure with accelerated hypertension or malignant hypertension can be precipitated by cocaine use.4
Other renal complications include acid-base and electrolyte imbalance (with both acidemia and alkalemia), increased incidence of urinary tract infection in cocaine-exposed infants, and increased risk of chronic renal failure in patients with hypertension—especially in African Americans.
Renal infarction. Spontaneous renal infarction secondary to cocaine abuse is rare. Patients usually pre- sent with persistent flank or abdominal pain with or without fever, nausea, and vomiting. Of the reported cases of cocaine-induced renal infarction, most involved the right kidney. The predilection for the right kidney may be related to increased resis- tance to blood flow in the right renal artery, compared with the left renal artery, because of its longer course.5
Pathophysiology. The precise mechanism of cocaine-induced renal infarction is unclear. Platelet aggregation and endothelial and vasospastic injury secondary to thromboxane synthesis are possible causes.6 Renal biopsy findings may include arterial and venous thrombosis as well as obliterative arteriopathy. However, our observation in this case and a review of the literature suggest that renal infarction can occur without thrombosis in patients with a history of cocaine abuse.
Laboratory studies. Leukocytosis, hematuria, and elevated levels of lactate dehydrogenase are common but nonspecific findings in patients with renal infarction. These findings can also be seen in patients who have renal venous thrombosis, papillary necrosis, and nephrolithiasis.
Diagnosis. A CT scan of the abdomen is both sensitive and specific for the diagnosis of renal infarction. With the use of intravenous contrast, renal arteries can also be evaluated for plaques or clots. Sagittal reconstruction through the abdominal aorta can adequately demonstrate findings in the aorta, celiac trunk, and superior mesenteric arteries. Coronal reconstruction of the renal arteries is usually best.
The possibility of infarction secondary to an embolic phenomenon should be ruled out with hypercoagulability studies and transesophageal echocardiography.
Treatment and outcome. There is no consensus on the treatment of renal infarction. For this patient, supportive therapy was started early on admission. Because his renal function did not decline, no further treatment was warranted. He was referred to social services for treatment of cocaine abuse but was lost to follow-up.
KEY POINTS FOR YOUR PRACTICE
Consider renal infarction in a patient with a history of cocaine abuse who presents with acute abdominal or flank pain.
A CT scan of the abdomen is both sensitive and specific for the diagnosis of renal infarction.
Further evaluation with transesophageal echocardiography and laboratory studies for thromboembolic phenomena is indicated to rule out embolic infarction.
Looking forward to your comments.
Yours
Bernd
Renal Infarction: An Unusual Complication of Cocaine Abuse
By ASIM ABBASI, MD, ANDY ARWARI, MD, ALI ALIZADEHSOVARI, MD, and SAMER NUHAILY, MD,
February 01, 2008 URL: http://www.consultantlive.com/showArticle.jhtml?articleId=206503919
A 63-year-old African American man presented with severe epigastric pain of 1 day's duration. The pain was sharp and continuous and radiated toward the left flank. There were no aggravating or relieving factors or previous similar episodes. The patient denied fever, chills, urgency, frequent or painful urination, and gross hematuria. Earlier that day, he had taken an antacid for presumed gastritis and had a bout of emesis. The patient had a history of cocaine abuse and admitted that he had smoked one fourth of a bag of cocaine the day before presentation.
Blood pressure was 159/93 mm Hg; heart rate, 73 beats per minute; temperature, 36.9°C (98.4°F); respiration rate, 18 breaths per minute; and oxygen saturation, 98% on room air. The chest was clear. Cardiac findings were within normal limits. The abdomen was scaphoid, without scars, rashes, or lesions. There was severe epigastric tenderness and tenderness to percussion of left costovertebral angle, without guarding, spasm, or rebound; no masses or abnormal pulsations were noted. Genitourinary and rectal findings were normal; stool was guaiac-negative. Other physical findings were noncontributory.
The differential diagnosis included renal colic, pyelonephritis, acute gastritis, mesenteric ischemia, and renal infarction. Intravenous hydration with normal saline was started, pending the results of further investigations.
The white blood cell count was 17,300/µL, with 77.2% neutrophils; the hemoglobin level was 13.6 g/dL. Hematocrit was 40.2%; platelet count, 266,000/µL; blood urea nitrogen, 7 mg/dL; serum creatinine, 1.0 mg/dL; total protein, 6.1 g/dL; and serum albumin, 3.0 g/dL. Total bilirubin was 1.1 mg/dL; aspartate aminotransferase, 63 U/L; alanine aminotransferase, 41 U/L; alkaline phosphatase, 51 U/L; serum sodium, 135 mEq/L; potassium, 3.5 mEq/L; chloride, 104 mEq/L; carbon dioxide, 36.2 mEq/L; and lactate dehydrogenase, 341 U/L. A urinalysis showed trace proteinuria, 1 to 3 red blood cells per high-power field, and no white blood cells or casts. Urine toxicology confirmed the presence of cocaine.
CT scans of the abdomen showed acute infarcts in the medial upper pole and lateral lower pole of the left kidney (Figure). There was no vascular disease in the abdominal aorta, celiac artery, or superior mesenteric arteries. No definite plaque lesions were seen in the right or left renal arteries.
Duplex ultrasonography showed normal blood flow in both renal arteries. Blood and urine cultures were negative. Screening for hypercoagulability (factor V Leiden, prothrombin gene, protein C, protein S, antithrombin III, antiphospholipid antibody, and homocysteine); collagen disease (rheumatoid factor and antinuclear antibody); and lipid disorders was negative for thromboembolic phenomena. A transesophageal echocardiogram showed no evidence of an intracardiac thrombus or valvular vegetations.
Cocaine-induced renal infarction was diagnosed by exclusion. The patient was given supportive therapy for 3 days and was discharged. His renal function was observed during the hospitalization, and renal failure did not occur. His serum creatinine level at the time of discharge was 1.1 mg/dL.
RENAL COMPLICATIONS OF COCAINE ABUSE
Cocaine abuse has reached epidemic proportions in United States.1 Cocaine use has deleterious effects on multiple organ systems. Common toxic effects on the vascular system include myocardial ischemia, mesenteric ischemia, and cerebrovascular accidents. Myocardial ischemia and cerebrovascular accidents are the most common causes of hospitalizations related to cocaine abuse. The annual cost of cocaine-related hospitalizations has exceeded $80 million.2
Renal injury. Renal complications of cocaine abuse are relatively rare. The pathophysiology of renal injury involves changes in renal hemodynamics, glomerular matrix synthesis, degradation, oxidative stress, and induction of renal atherogenesis. These changes may lead to both acute and chronic renal injury. There are several case reports of acute tubular necrosis caused by rhabdomyolysis after cocaine abuse.3 Acute renal failure with accelerated hypertension or malignant hypertension can be precipitated by cocaine use.4
Other renal complications include acid-base and electrolyte imbalance (with both acidemia and alkalemia), increased incidence of urinary tract infection in cocaine-exposed infants, and increased risk of chronic renal failure in patients with hypertension—especially in African Americans.
Renal infarction. Spontaneous renal infarction secondary to cocaine abuse is rare. Patients usually pre- sent with persistent flank or abdominal pain with or without fever, nausea, and vomiting. Of the reported cases of cocaine-induced renal infarction, most involved the right kidney. The predilection for the right kidney may be related to increased resis- tance to blood flow in the right renal artery, compared with the left renal artery, because of its longer course.5
Pathophysiology. The precise mechanism of cocaine-induced renal infarction is unclear. Platelet aggregation and endothelial and vasospastic injury secondary to thromboxane synthesis are possible causes.6 Renal biopsy findings may include arterial and venous thrombosis as well as obliterative arteriopathy. However, our observation in this case and a review of the literature suggest that renal infarction can occur without thrombosis in patients with a history of cocaine abuse.
Laboratory studies. Leukocytosis, hematuria, and elevated levels of lactate dehydrogenase are common but nonspecific findings in patients with renal infarction. These findings can also be seen in patients who have renal venous thrombosis, papillary necrosis, and nephrolithiasis.
Diagnosis. A CT scan of the abdomen is both sensitive and specific for the diagnosis of renal infarction. With the use of intravenous contrast, renal arteries can also be evaluated for plaques or clots. Sagittal reconstruction through the abdominal aorta can adequately demonstrate findings in the aorta, celiac trunk, and superior mesenteric arteries. Coronal reconstruction of the renal arteries is usually best.
The possibility of infarction secondary to an embolic phenomenon should be ruled out with hypercoagulability studies and transesophageal echocardiography.
Treatment and outcome. There is no consensus on the treatment of renal infarction. For this patient, supportive therapy was started early on admission. Because his renal function did not decline, no further treatment was warranted. He was referred to social services for treatment of cocaine abuse but was lost to follow-up.
KEY POINTS FOR YOUR PRACTICE
Consider renal infarction in a patient with a history of cocaine abuse who presents with acute abdominal or flank pain.
A CT scan of the abdomen is both sensitive and specific for the diagnosis of renal infarction.
Further evaluation with transesophageal echocardiography and laboratory studies for thromboembolic phenomena is indicated to rule out embolic infarction.
Sunday, February 10, 2008
Journal Club
Dear Friends and Colleagues;
Attached a series of articles published in Family Medicine Journals and Magazines regarding substance Abuse and Dependence:
1) Baclofen Cuts Alcohol Use in Cirrhosis Patients
2) Warning Reissued for Fentanyl Deaths, Side Effects
3) FDA Warns About Methadone-Related Deaths, Serious Events
4) Research Sought on Physicians' Addiction Recovery
I look forward to your comments.
Bernd
====================================================================================
Family Practice News
Volume 38, Issue 2, Page 23 (15 January 2008)
Baclofen Cuts Alcohol Use in Cirrhosis Patients
JOHN R. BELL (Associate Editor)
Alcohol-dependent persons with cirrhosis of the liver who were treated with baclofen, a ?-aminobutyric acid-B receptor agonist, were more than six times as likely to cease their alcohol use as were patients who took a placebo, according to a study.
The trial is the first “in which effectiveness and safety of an anticraving drug has been investigated in individuals with advanced liver disease,” wrote Dr. Giovanni Addolorato of the Catholic University of Rome, and colleagues. They reported results for 84 alcohol-dependent patients with a diagnosis of cirrhosis who were randomly assigned in equal number to a 12-week regimen of either baclofen or placebo.
The baclofen dosage was 5 mg three times daily for the first 3 days and 10 mg three times daily thereafter. Mean patient age was 49 years in both groups. Patients were seen weekly for the first month, then every 2 weeks until the end of the study (Lancet 2007;370:1915-22).
At 12 weeks, 30 (71%) of the 42 patients in the baclofen group were abstinent from alcohol, compared with 12 (29%) of the 42 patients in the placebo group (odds ratio 6.3).
In addition, those given baclofen showed improvements in measures of liver function, including ALT, bilirubin, international normalized ratio, ?-glutamyltransferase, and albumin. The drug was also associated with a greater number of nondrinking days than was placebo (63 days vs. 31 days), as well as a lower rate of relapse to heavy drinking at 60 days (19% vs. 45%).
Treatment with baclofen also reduced alcohol cravings, as measured with the obsessive-compulsive drinking scale.
Baclofen was not associated with any hepatotoxicity. There were no incidents of encephalopathy or hyperammonemia and no serious events leading to discontinuation of the drug. Tolerability was reported as fair, with headache, tiredness, vertigo, and sleepiness reported in small numbers of patients in both groups.
These results “suggest that baclofen, because of its anticraving action and safety, could have an important role for treatment of alcohol-dependent patients with advanced liver disease,” the researchers wrote. They cautioned that further studies are needed to establish optimal treatment duration and longer-term tolerance.
In a commentary accompanying the report, Dr. James C. Garbutt of the University of North Carolina at Chapel Hill, and Barbara Flannery, Ph.D., of RTI International, Baltimore, called the findings “surprisingly robust” and of potentially great clinical importance, given the routine exclusion of alcoholic patients with cirrhosis from trials of anticraving drugs because of the concern about hepatotoxicity (Lancet 2007;370:1884-5).
They also noted that the higher dropout rate in the placebo group (31%) versus the baclofen group (14%) is of interest, because it may have skewed the results in favor of baclofen, given that these were assumed to be because of relapse, and thus affected the primary end point.
The study authors declared no financial conflict of interest. The study was supported by the Italian Ministry for University, Scientific, and Technological Research, and by the European Research Advisory Board.
====================================================================================
Family Practice News
Volume 38, Issue 2, Page 23 (15 January 2008)
Warning Reissued for Fentanyl Deaths, Side Effects
Recent reports of death and life-threatening side effects associated with the fentanyl patch prompted the Food and Drug Administration to once again issue a warning about improper prescribing and use of the transdermal administration.
The last warning came in 2005 after similar reports.
The warning applies to the name brand Duragesic patch (manufactured by Johnson & Johnson) as well as other, generic versions of the patch, and to all dosages, Dr. Robert Rappaport said during a teleconference with reporters.
This particular warning does not, however, apply to other fentanyl formulations.
A warning about the buccal formulation of fentanyl was issued in September 2007. Fentanyl was approved in 1990 for opioid-tolerant patients who had chronic, moderate to severe pain.
The patch is given most commonly to patients who have cancer.
“The fentanyl patches are to be prescribed only for patients who are already tolerant of opioid drug products,” according to Dr. Rappaport.
“Unfortunately, what we are still seeing is that, in some cases, prescribers are giving these patches to patients who are not opioid tolerant, [either] for treatment post surgery, for mild pain, even for a headache. And in those patients this can cause serious and life-threatening respiratory depression.”
Signs of fentanyl overdose include trouble breathing or slow or shallow breathing, slow heartbeat, severe sleepiness, cold or clammy skin, trouble walking or talking, or feeling faint, dizzy, or confused, according to the agency.
Dr. Rappaport, who is the FDA's director of the division of anesthesia, analgesia, and rheumatology products, also emphasized the importance of patient education.
“The prescribers must inform and educate their patients about how to use these products and the dangers of using them in certain ways.
“For instance, [the patches] cannot be used in a setting where they would be exposed to heat, such as in a hot tub, [with] a heating pad, or a heated water bed,” he emphsized, because the high temperatures may increase the amount of fentanyl that reaches the blood stream.
For a full guide to the proper handling, disposal, and replacement of the patches, see www.fda.gov/cder/drug/infopage/fentanyl/fentanyl_apply.pdf.
“We are working with the … manufacturers to continue to add more warnings and cautions on the label and more instructions on the proper use of these products. And we're adding a medication guide that patients will receive with their product at the pharmacy as well,” said Dr. Rappaport.
Although the Food and Drug Administration has said that it did not have available the exact numbers of serious adverse events that have been reported since the last warning, Dr. Rappaport confirmed that at least one event had occurred when a physician prescribed the patch for headache relief, “and it's likely to be a considerably higher number than that.”
In July 2005, the agency issued a similar warning that the patch should be used only in strict accordance with the directions on the product label and in the package insert.
Dr. Rappaport defended the usefulness of the patch in opioid-resistant patients who suffer from chronic pain. However, although these products “fill an important need, improper use and misuse can be life-threatening,” he added.
Health care professionals who encounter any adverse or serious events associated with fentanyl are urged to contact the MedWatch program atwww.fda.gov/medwatch/report/hcp.htmor by telephone at 800-FDA-1088.
=====================================================================================
Family Practice News
Volume 36, Issue 24, Page 5 (15 December 2006)
FDA Warns About Methadone-Related Deaths, Serious Events
Reports of deaths, cardiac arrhythmias, respiratory depression, and other serious adverse events in people treated with methadone for pain prompted the Food and Drug Administration to issue a public health advisory and revise its prescribing information for methadone hydrochloride.
The advisory, which appeared Nov. 27 on the FDA's Web site, states that deaths and life-threatening side effects have been reported in patients just starting treatment with methadone and in those who have switched from other narcotic analgesics to methadone.
“These adverse events are the possible result of unintentional methadone overdoses, drug interactions, and methadone's cardiac toxicities (QT prolongation and Torsades de Pointes),” according to the information for health care professionals also posted on the site. The FDA emphasizes that physicians who prescribe methadone should be familiar with the drug's toxicities and distinctive pharmacologic properties, and that patients on methadone should be closely monitored, particularly when treatment is started and when the dose is adjusted.
The FDA has not changed any requirements governing methadone administration or dosage, according to officials who participated in a teleconference about the advisory. The new label represents the first revision in decades, however, and contains detailed prescribing information not previously available. For example, an expanded section on drug-drug interactions includes drugs that did not exist when physicians started prescribing methadone for pain control in the 1940s. The revision also contains a new table on converting oral morphine to oral methadone for chronic administration.
Conversion tables for other opioids and time frames for methadone rotation are not provided—primarily because these are difficult issues. “Where we did not see consensus in the literature we remained silent,” said Dr. Celia Jaffe Winchell, a team leader for addiction-treatment drugs in the FDA's Center for Drug Evaluation and Research.
Although methadone-related deaths have been on the rise for some years, Dr. Winchell said the FDA decided to act now because recent reports of adverse events and deaths “suggest a lack of information about methadone on the part of prescribers and patients may have played a role.”
These recent reports followed growing use of methadone for chronic pain, according to Dr. Winchell. Starting in the 1970s, methadone prescribing had been largely confined to tightly regulated addiction treatment programs. Over the last decade, calls for better treatment of chronic pain led to resurgence of analgesic use with a wide spectrum of practitioners, not just pain and addiction specialists, starting to prescribe methadone.
“One of the things we are trying to achieve with this series of patient and physician alerts is to educate people about just how complicated the use of methadone can be,” said Dr. Robert Rappaport, director of the FDA's Division of Anesthesia, Analgesia, and Rheumatology Products.
The FDA cannot stop methadone prescribing by physicians who are not pain specialists, Dr. Rappaport said. And even if it could, there are not enough pain specialists to meet the need. Therefore, the agency is seeking to increase knowledge about special properties of methadone that can put patients at risk.
“What we are trying to do is to get the word out to everybody,” Dr. Rappaport said.
Methadone's analgesic effects last for 4–8 hours, but its elimination half-life is 8–59 hours. Because of that, methadone's peak respiratory depressant effects “typically occur later and persist longer than its peak analgesic effects,” according to the FDA.
The agency recommends that physicians evaluate drugs that will be administered with methadone for potential interactions, that the risks of methadone should be carefully weighed against its potential benefits—and that the 40-mg dispersible methadone tablets should not be prescribed for pain, since this formulation is approved only for detoxification and maintenance treatment of narcotic addiction.
Because cross-tolerance between methadone and other opioids is incomplete, switching patients from other opioids to methadone is complex, so patients with a tolerance for other opioids can experience a methadone overdose.
The FDA also recommends that health care professionals who prescribe methadone carefully read and follow the prescribing information for Dolophine, the marketed methadone product, which was revised and approved on Nov. 17. Methadone is approved for moderate to severe pain that is not responsive to nonnarcotic analgesics, as well as for detoxification and maintenance treatment of opioid addiction.
The public health advisory on methadone, new prescribing information, and information for patients and physicians can be found atwww.fda.gov/cder/drug/infopage/methadone/default.htm. Serious adverse events associated with methadone can be reported to the FDA's MedWatch program atwww.fda.gov/medwatch/report.htm, by fax at 800-FDA-0178, or by calling 800-FDA-1088.
Senior Writer Elizabeth Mechcatie contributed to this report.
=====================================================================================
Family Practice News
Volume 38, Issue 1, Page 47 (1 January 2008)
Research Sought on Physicians' Addiction Recovery
CORONADO, CALIF. — Of 104 physicians in New York state who were admitted to substance abuse treatment programs between 2003 and 2004 and were monitored for a mean of 41 months by the state's Committee for Physicians' Health, only 9 (9%) were discharged because of noncompliance with program expectations.
That might spell success at first glance, but at the annual meeting of the American Academy of Addiction Psychiatry, Dr. Marc Galanter emphasized the need for more research to optimize treatment outcomes for physicians in recovery.
“There are still a number of issues to be considered,” said Dr. Galanter, professor of psychiatry and director of the division of alcoholism and drug abuse in the department of psychiatry at New York University, New York. “One is the need for prospective study—following the treatment contemporaneously—which we have yet to see,” he said. “Another is to better understand the role of medication.
Buprenorphine inevitably will be used more widely; however, the question of whether physicians should be allowed to practice while taking opioid maintenance therapy is likely to become a political issue at the state level. Dr. Galanter advised that a more active role for cognitive-behavioral therapy “be studied because this is a modality that is currently regarded as essential to effective treatment.”
Dr. Galanter based his remarks on results from a study he led that sought to provide an independent evaluation of the oversight and rehabilitation of 104 substance-abusing physicians who had completed their monitoring period by the New York State Committee for Physicians' Health (CPH). About 30% of physicians who enroll in the CPH program receive at least 28 days of inpatient treatment. Components of ambulatory management include workplace monitoring, 12-step program attendance, and random urine toxicologies.
The researchers, who were not affiliated with CPH, selected the 104 records at random (Am. J. Addict. 2007;16:117–23). The mean age of the study participants was 42 years, most (96) were male, about half (51) were married, and 66 were employed as physicians at the time of admission.
More than half (59) had a history of substance abuse treatment, and 38 had attended 12-step meetings before program admission. In addition, 33 were in psychotherapy of some sort prior to admission, and 27 were taking psychiatric medications, primarily antidepressants.
“This underlines the importance of psychiatric input and oversight in these programs,” said Dr. Galanter, who is also the editor of the journal Substance Abuse.
The most common primary substance of abuse was alcohol (38), followed by prescription opiates (35). The top five medical specialties represented were anesthesia (22 physicians), internal medicine (11), family medicine (10), obstetrics and gynecology (9), and pediatrics (8).
On average, the overall period of treatment and monitoring was 41 months, and 30 participants required inpatient hospitalization at study entry.
Fifteen physicians did not want to attend 12-step meetings but were pressed by counselors to do so. Of those, nine later went. “The outcome of those pressed to go was not significantly different from that of the other patients,” he said. “So apparently the coercive nature of the treatment in that regard was not compromising to the outcome.”
Of the 104 patients, 38 relapsed as confirmed by urine toxicology or by confirmation from an informed source. Even under good circumstances, some relapse is inevitable before the patient is stabilized, Dr. Galanter said.
“The pressure of the needs of public health that they experience puts them in a difficult position,” Dr. Galanter said. “My impression is that it's remarkable how effective they are in balancing the physician needs against the demands of the general public.”
Predictors of relapse included past use of cocaine, unemployment at the time of program admission, a greater mean number of urines tested, and a longer length of program involvement.
Nine patients were discharged for noncompliance with program expectations. “They essentially lost the option of practicing medicine,” he said. “Relatively speaking, this gives you an idea of a very good outcome, considering that full compliance is essential to success in this program.”
Attached a series of articles published in Family Medicine Journals and Magazines regarding substance Abuse and Dependence:
1) Baclofen Cuts Alcohol Use in Cirrhosis Patients
2) Warning Reissued for Fentanyl Deaths, Side Effects
3) FDA Warns About Methadone-Related Deaths, Serious Events
4) Research Sought on Physicians' Addiction Recovery
I look forward to your comments.
Bernd
====================================================================================
Family Practice News
Volume 38, Issue 2, Page 23 (15 January 2008)
Baclofen Cuts Alcohol Use in Cirrhosis Patients
JOHN R. BELL (Associate Editor)
Alcohol-dependent persons with cirrhosis of the liver who were treated with baclofen, a ?-aminobutyric acid-B receptor agonist, were more than six times as likely to cease their alcohol use as were patients who took a placebo, according to a study.
The trial is the first “in which effectiveness and safety of an anticraving drug has been investigated in individuals with advanced liver disease,” wrote Dr. Giovanni Addolorato of the Catholic University of Rome, and colleagues. They reported results for 84 alcohol-dependent patients with a diagnosis of cirrhosis who were randomly assigned in equal number to a 12-week regimen of either baclofen or placebo.
The baclofen dosage was 5 mg three times daily for the first 3 days and 10 mg three times daily thereafter. Mean patient age was 49 years in both groups. Patients were seen weekly for the first month, then every 2 weeks until the end of the study (Lancet 2007;370:1915-22).
At 12 weeks, 30 (71%) of the 42 patients in the baclofen group were abstinent from alcohol, compared with 12 (29%) of the 42 patients in the placebo group (odds ratio 6.3).
In addition, those given baclofen showed improvements in measures of liver function, including ALT, bilirubin, international normalized ratio, ?-glutamyltransferase, and albumin. The drug was also associated with a greater number of nondrinking days than was placebo (63 days vs. 31 days), as well as a lower rate of relapse to heavy drinking at 60 days (19% vs. 45%).
Treatment with baclofen also reduced alcohol cravings, as measured with the obsessive-compulsive drinking scale.
Baclofen was not associated with any hepatotoxicity. There were no incidents of encephalopathy or hyperammonemia and no serious events leading to discontinuation of the drug. Tolerability was reported as fair, with headache, tiredness, vertigo, and sleepiness reported in small numbers of patients in both groups.
These results “suggest that baclofen, because of its anticraving action and safety, could have an important role for treatment of alcohol-dependent patients with advanced liver disease,” the researchers wrote. They cautioned that further studies are needed to establish optimal treatment duration and longer-term tolerance.
In a commentary accompanying the report, Dr. James C. Garbutt of the University of North Carolina at Chapel Hill, and Barbara Flannery, Ph.D., of RTI International, Baltimore, called the findings “surprisingly robust” and of potentially great clinical importance, given the routine exclusion of alcoholic patients with cirrhosis from trials of anticraving drugs because of the concern about hepatotoxicity (Lancet 2007;370:1884-5).
They also noted that the higher dropout rate in the placebo group (31%) versus the baclofen group (14%) is of interest, because it may have skewed the results in favor of baclofen, given that these were assumed to be because of relapse, and thus affected the primary end point.
The study authors declared no financial conflict of interest. The study was supported by the Italian Ministry for University, Scientific, and Technological Research, and by the European Research Advisory Board.
====================================================================================
Family Practice News
Volume 38, Issue 2, Page 23 (15 January 2008)
Warning Reissued for Fentanyl Deaths, Side Effects
Recent reports of death and life-threatening side effects associated with the fentanyl patch prompted the Food and Drug Administration to once again issue a warning about improper prescribing and use of the transdermal administration.
The last warning came in 2005 after similar reports.
The warning applies to the name brand Duragesic patch (manufactured by Johnson & Johnson) as well as other, generic versions of the patch, and to all dosages, Dr. Robert Rappaport said during a teleconference with reporters.
This particular warning does not, however, apply to other fentanyl formulations.
A warning about the buccal formulation of fentanyl was issued in September 2007. Fentanyl was approved in 1990 for opioid-tolerant patients who had chronic, moderate to severe pain.
The patch is given most commonly to patients who have cancer.
“The fentanyl patches are to be prescribed only for patients who are already tolerant of opioid drug products,” according to Dr. Rappaport.
“Unfortunately, what we are still seeing is that, in some cases, prescribers are giving these patches to patients who are not opioid tolerant, [either] for treatment post surgery, for mild pain, even for a headache. And in those patients this can cause serious and life-threatening respiratory depression.”
Signs of fentanyl overdose include trouble breathing or slow or shallow breathing, slow heartbeat, severe sleepiness, cold or clammy skin, trouble walking or talking, or feeling faint, dizzy, or confused, according to the agency.
Dr. Rappaport, who is the FDA's director of the division of anesthesia, analgesia, and rheumatology products, also emphasized the importance of patient education.
“The prescribers must inform and educate their patients about how to use these products and the dangers of using them in certain ways.
“For instance, [the patches] cannot be used in a setting where they would be exposed to heat, such as in a hot tub, [with] a heating pad, or a heated water bed,” he emphsized, because the high temperatures may increase the amount of fentanyl that reaches the blood stream.
For a full guide to the proper handling, disposal, and replacement of the patches, see www.fda.gov/cder/drug/infopage/fentanyl/fentanyl_apply.pdf.
“We are working with the … manufacturers to continue to add more warnings and cautions on the label and more instructions on the proper use of these products. And we're adding a medication guide that patients will receive with their product at the pharmacy as well,” said Dr. Rappaport.
Although the Food and Drug Administration has said that it did not have available the exact numbers of serious adverse events that have been reported since the last warning, Dr. Rappaport confirmed that at least one event had occurred when a physician prescribed the patch for headache relief, “and it's likely to be a considerably higher number than that.”
In July 2005, the agency issued a similar warning that the patch should be used only in strict accordance with the directions on the product label and in the package insert.
Dr. Rappaport defended the usefulness of the patch in opioid-resistant patients who suffer from chronic pain. However, although these products “fill an important need, improper use and misuse can be life-threatening,” he added.
Health care professionals who encounter any adverse or serious events associated with fentanyl are urged to contact the MedWatch program atwww.fda.gov/medwatch/report/hcp.htmor by telephone at 800-FDA-1088.
=====================================================================================
Family Practice News
Volume 36, Issue 24, Page 5 (15 December 2006)
FDA Warns About Methadone-Related Deaths, Serious Events
Reports of deaths, cardiac arrhythmias, respiratory depression, and other serious adverse events in people treated with methadone for pain prompted the Food and Drug Administration to issue a public health advisory and revise its prescribing information for methadone hydrochloride.
The advisory, which appeared Nov. 27 on the FDA's Web site, states that deaths and life-threatening side effects have been reported in patients just starting treatment with methadone and in those who have switched from other narcotic analgesics to methadone.
“These adverse events are the possible result of unintentional methadone overdoses, drug interactions, and methadone's cardiac toxicities (QT prolongation and Torsades de Pointes),” according to the information for health care professionals also posted on the site. The FDA emphasizes that physicians who prescribe methadone should be familiar with the drug's toxicities and distinctive pharmacologic properties, and that patients on methadone should be closely monitored, particularly when treatment is started and when the dose is adjusted.
The FDA has not changed any requirements governing methadone administration or dosage, according to officials who participated in a teleconference about the advisory. The new label represents the first revision in decades, however, and contains detailed prescribing information not previously available. For example, an expanded section on drug-drug interactions includes drugs that did not exist when physicians started prescribing methadone for pain control in the 1940s. The revision also contains a new table on converting oral morphine to oral methadone for chronic administration.
Conversion tables for other opioids and time frames for methadone rotation are not provided—primarily because these are difficult issues. “Where we did not see consensus in the literature we remained silent,” said Dr. Celia Jaffe Winchell, a team leader for addiction-treatment drugs in the FDA's Center for Drug Evaluation and Research.
Although methadone-related deaths have been on the rise for some years, Dr. Winchell said the FDA decided to act now because recent reports of adverse events and deaths “suggest a lack of information about methadone on the part of prescribers and patients may have played a role.”
These recent reports followed growing use of methadone for chronic pain, according to Dr. Winchell. Starting in the 1970s, methadone prescribing had been largely confined to tightly regulated addiction treatment programs. Over the last decade, calls for better treatment of chronic pain led to resurgence of analgesic use with a wide spectrum of practitioners, not just pain and addiction specialists, starting to prescribe methadone.
“One of the things we are trying to achieve with this series of patient and physician alerts is to educate people about just how complicated the use of methadone can be,” said Dr. Robert Rappaport, director of the FDA's Division of Anesthesia, Analgesia, and Rheumatology Products.
The FDA cannot stop methadone prescribing by physicians who are not pain specialists, Dr. Rappaport said. And even if it could, there are not enough pain specialists to meet the need. Therefore, the agency is seeking to increase knowledge about special properties of methadone that can put patients at risk.
“What we are trying to do is to get the word out to everybody,” Dr. Rappaport said.
Methadone's analgesic effects last for 4–8 hours, but its elimination half-life is 8–59 hours. Because of that, methadone's peak respiratory depressant effects “typically occur later and persist longer than its peak analgesic effects,” according to the FDA.
The agency recommends that physicians evaluate drugs that will be administered with methadone for potential interactions, that the risks of methadone should be carefully weighed against its potential benefits—and that the 40-mg dispersible methadone tablets should not be prescribed for pain, since this formulation is approved only for detoxification and maintenance treatment of narcotic addiction.
Because cross-tolerance between methadone and other opioids is incomplete, switching patients from other opioids to methadone is complex, so patients with a tolerance for other opioids can experience a methadone overdose.
The FDA also recommends that health care professionals who prescribe methadone carefully read and follow the prescribing information for Dolophine, the marketed methadone product, which was revised and approved on Nov. 17. Methadone is approved for moderate to severe pain that is not responsive to nonnarcotic analgesics, as well as for detoxification and maintenance treatment of opioid addiction.
The public health advisory on methadone, new prescribing information, and information for patients and physicians can be found atwww.fda.gov/cder/drug/infopage/methadone/default.htm. Serious adverse events associated with methadone can be reported to the FDA's MedWatch program atwww.fda.gov/medwatch/report.htm, by fax at 800-FDA-0178, or by calling 800-FDA-1088.
Senior Writer Elizabeth Mechcatie contributed to this report.
=====================================================================================
Family Practice News
Volume 38, Issue 1, Page 47 (1 January 2008)
Research Sought on Physicians' Addiction Recovery
CORONADO, CALIF. — Of 104 physicians in New York state who were admitted to substance abuse treatment programs between 2003 and 2004 and were monitored for a mean of 41 months by the state's Committee for Physicians' Health, only 9 (9%) were discharged because of noncompliance with program expectations.
That might spell success at first glance, but at the annual meeting of the American Academy of Addiction Psychiatry, Dr. Marc Galanter emphasized the need for more research to optimize treatment outcomes for physicians in recovery.
“There are still a number of issues to be considered,” said Dr. Galanter, professor of psychiatry and director of the division of alcoholism and drug abuse in the department of psychiatry at New York University, New York. “One is the need for prospective study—following the treatment contemporaneously—which we have yet to see,” he said. “Another is to better understand the role of medication.
Buprenorphine inevitably will be used more widely; however, the question of whether physicians should be allowed to practice while taking opioid maintenance therapy is likely to become a political issue at the state level. Dr. Galanter advised that a more active role for cognitive-behavioral therapy “be studied because this is a modality that is currently regarded as essential to effective treatment.”
Dr. Galanter based his remarks on results from a study he led that sought to provide an independent evaluation of the oversight and rehabilitation of 104 substance-abusing physicians who had completed their monitoring period by the New York State Committee for Physicians' Health (CPH). About 30% of physicians who enroll in the CPH program receive at least 28 days of inpatient treatment. Components of ambulatory management include workplace monitoring, 12-step program attendance, and random urine toxicologies.
The researchers, who were not affiliated with CPH, selected the 104 records at random (Am. J. Addict. 2007;16:117–23). The mean age of the study participants was 42 years, most (96) were male, about half (51) were married, and 66 were employed as physicians at the time of admission.
More than half (59) had a history of substance abuse treatment, and 38 had attended 12-step meetings before program admission. In addition, 33 were in psychotherapy of some sort prior to admission, and 27 were taking psychiatric medications, primarily antidepressants.
“This underlines the importance of psychiatric input and oversight in these programs,” said Dr. Galanter, who is also the editor of the journal Substance Abuse.
The most common primary substance of abuse was alcohol (38), followed by prescription opiates (35). The top five medical specialties represented were anesthesia (22 physicians), internal medicine (11), family medicine (10), obstetrics and gynecology (9), and pediatrics (8).
On average, the overall period of treatment and monitoring was 41 months, and 30 participants required inpatient hospitalization at study entry.
Fifteen physicians did not want to attend 12-step meetings but were pressed by counselors to do so. Of those, nine later went. “The outcome of those pressed to go was not significantly different from that of the other patients,” he said. “So apparently the coercive nature of the treatment in that regard was not compromising to the outcome.”
Of the 104 patients, 38 relapsed as confirmed by urine toxicology or by confirmation from an informed source. Even under good circumstances, some relapse is inevitable before the patient is stabilized, Dr. Galanter said.
“The pressure of the needs of public health that they experience puts them in a difficult position,” Dr. Galanter said. “My impression is that it's remarkable how effective they are in balancing the physician needs against the demands of the general public.”
Predictors of relapse included past use of cocaine, unemployment at the time of program admission, a greater mean number of urines tested, and a longer length of program involvement.
Nine patients were discharged for noncompliance with program expectations. “They essentially lost the option of practicing medicine,” he said. “Relatively speaking, this gives you an idea of a very good outcome, considering that full compliance is essential to success in this program.”
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