Tag Archives: opioid

Principles of opioid maintenance analgesia for chronic pain

  1. Successful management of chronic pain usually does not require the use of opioids; however, some patients with chronic pain can benefit from long-term opioid maintenance analgesia (OMA). These patients function better, maintain improved pain control with acceptable side effects, and continue to use their medications in a responsible, reliable manner.
  2. In some patients, pain cannot be managed with long-term use of opioids. Pain control is marginal, function does not improve, side effects may prohibit ongoing therapy, or the patient’s abilityto keep medication use under control is poor or erratic.
  3. Opioids are rarely adequate as the sole treatment for complex chronic pain, which usually requires a multimodal and often a multidisciplinary approach.
  4. OMA for chronic pain is neither a patient’s right nor a privilege. It is one treatment approach that may be chosen by mutual agreement between patient and physician.
  5. Candidates for OMA should:
    • Have an established diagnosis that is concordant with moderate to severe pain
    • Be reliable patients who are known to the physician and are expected to be compliant with the treatment protocol
    • Have exhausted reasonable alternative treatments and be open to new ments in the future
    • Not be using illegal drugs
    • Not be pregnant or likely to become pregnant during the course of treatment
  6. Patients with a history of addiction or poor impulse control are at increased risk for failing to comply with an OMA regimen.
  7. For daily pain, long-acting opioids taken on a fixed schedule are generally preferred for OMA. Limited quantities of nonopioids or shorter-acting opioids are acceptable for breakthrough pain in some cases.
  8. For episodic pain, limited quantities of opioid analgesics may be prescribed as needed.
  9. Meperidine hydrochloride is a poor choice for OMA because of metabolite toxicity with repeated dosing.
  10. For patients initiating OMA, a signed agreement outlining expectations and responsibilities is recommended (see box below). Failure to comply with the agreement should result in discontinuation of OMA or actions to ensure compliance in the future.
  11. Continuation of OMA depends on the following five factors:
    • The medication is safe with acceptable side effects.
    • The medication is effective; that is, pain is reduced and function and quality of life are improved.
    • The patient is a reliable and responsible participant in the treatment program.
    • The condition causing pain persists.
    • No specific or better alternative treatments are available.
  12. The physician’s responsibilities for OMA include:
    • Initial assessment of the pain problem, including relevant medical, psychological, and social factors
    • Scheduling regular office visits for reassessing pain and related conditions; monitoring safety, efficacy, and compliance; and managing side effects
    • Being prepared to continue OMA when it is working
    • Being prepared to taper and discontinue OMAwhen it is not working
    • Thorough documentation of the responsibilities listed
  13. Techniques for monitoring compliance include:
    • Conducting patient interviews
    • Checking patient’s compliance with appoint-ments
    • Obtaining collateral information from family members, other physicians, nurses, and pharmacists
    • Obtaining pharmacy profiles
    • Scheduling drug screens
  14. When discontinuing OMA, the weaning schedule depends on daily dosage and duration of treatment. No weaning is needed when opioids havebeen used occasionally; daily opioid use may re-quire weaning that ranges from 10 days to a few months.
  15. Referral to a pain specialist for consideration of OMA is warranted when:
    • The cause of pain is unclear
    • Behavioral, psychological, and social factors complicate the pain problem
    • The physician is unsure what additional treatment may be effective, or how to administer such treatment

Adapted, with permission, from Fairview Pain Management Center, Minneapolis.

Medical Use of Opioids does not Promote Drug Diversion

A recent article in the Journal of the American Medical Association (Joranson DE, Ryan KM, Gilson AM, Dahl JL: Trends in medical use and abuse of opioid analgesics. JAMA 2000 Apr 5;283(13):1710_4) sheds some light on the use versus abuse issue. These investigators reviewed multiple databases between about 1990-1996. They found that the prescribing of strong opioids increased by 59%, 1168%, 23%, and 19% for morphine, fentanyl, oxycodone and hydromorphone, respectively. Only the medical use of meperidine (Demerol fell (by 35%), which is a good thing, since of all the opioids, Demerol is probably the least safe for chronic use because it occasionally produces seizures. Despite this massive increase in prescribing (that has probably increased exponentially in the last four years), ìdrug abuse mentionsî for these opioids rose by only drug (6.6%), and even more impressively, the proportion of mentions for opioid abuse relative to total drug abuse mentions decreased from 5.1% to 3.8%. This article supports the view that, like almost anything, opioids are abusable, but that with expert medical help, this is a very rare occurrence, and for years weíve probably let a few rotten apples ruin things for the whole bushel.

Addiction

In considering the contemporary role of opioids it must be borne in mind that, although these substances are subject to abuse, the intention for which opioids exist is the treatment of pain. Far too often, the potential for abuse interferes with the appropriate use of pain medications for those in need. Although drug abuse is a compelling public health problem, allowing abuse potential to limit access to opioids for those with medical illnesses is an unjust response. A useful analogy is our system of using checks to pay for purchases which is circumvented when ìbadî checks are ìbounced,î —- but we donít respond by banning checks as legal tender, a policy decision that would punish everyone. If you believe in a higher power, especially one that did not put us here to suffer unnecessarily, then we can reason that God gave us the opioids and their derivatives to better cope with pain and suffering. Unfortunately, as a culture we have been tragically ineffective in distinguishing between drug abuse and the treatment of pain, and thus when it comes to pain medications, it has been a classic case of a few bad apples ruining things for the whole bunch: todayís patients with pain have become the innocent victims of a war on drugs that should have nothing to do with them.

Research consistently demonstrates that exposure to pain medications does not foster addiction. In fact, under-prescribing is more likely to fuel addictive behavior, because pain is never relieved, and patients are left feeling abandoned, left to continually seek help that becomes increasingly elusive. With chronic treatment, patients may become tolerant or accustomed to the effects of opioids (thus requiring higher doses over time), and physical dependence (the onset of withdrawal or an abstinence syndrome when treatment is abruptly stopped) may arise, but addiction, a reversible complication, is extremely rare, occurring in no more than a few per cent of patients exposed to analgesics in the course of treatment. Tolerance and physical dependence are inevitable biologic consequences of chronic opioid use, that are independent of the patientís background, values and circumstances. The onset of tolerance and physical dependence are expected, are unrelated to addiction and are not problematic since they can be overcome by simply adjusting doses pf medications gradually. Addiction, which is the same as psychological dependence, is an infrequent outcome that is highly dependent on the patientís prior history, experiences and values. Addiction involves compulsive, nonmedical use of drugs that persists despite the presence or threat of physiologic or psychological harm, and indeed is a highly disruptive phenomena. Rare in otherwise well-adjusted individuals, exaggerated perceptions of its dangers causes a great many patients with legitimate pain to be mistrusted and undertreated. Unfortunately, when pain is ignored, most other aspects of healing (rest, mood, nutrition, energy and rehabilitation) also falter. Too often, we operate from the mistaken belief that simple exposure to painkillers produces addiction, while in fact addiction appears to be much more person- and style-specific than substance-specific. Predisposition to addiction has much more to do with an individualís style of coping with adversity, stress and illness. Addicts are less functional as a result of their drug use and become more isolated from the mainstream of life, family and work, while patients using drugs appropriately are consequently more functional, less isolated, and more prone to resuming activities they once avoided because of pain.

In the course of twenty years of educating physicians and nurses, patients and their families, administrators and policymakers and other interested parties about pain management, the topic of addiction never fails to elicit great interest. As a means to convey my thinking about this complex issue and especially the thorny distinction between addiction and the treatment of painful medical disorders with drugs. I created and have come to rely on a vignette that, by employing an analogy focuses our attention in a way that may help us think more clearly about issues that appear bewilderingly complex but are perhaps more simple than they appear to be.

So….heaven forbid, your teenage child or grandchild ìborrowsî the key to the family car, say a Ford Taurus, goes on to drink a six pack of beer and then wraps said car around a tree. Fortunate enough to walk away from the event, employing another example of adolescent logic, he/she draws the following conclusion: ìFord Taurusí are bad cars.î

The obvious corollary is that drugs, in and of themselves are neither ìgoodî nor ìbad,î although their use can produce dramatically opposed good or bad outcomes depending on how they are prescribed, dispensed and taken (ìdriven,î if you will). Our culture strives to ascribe pat answers to complex phenomenon, and thus arises the oversimplistic temptation to denounce a substance as being responsible for a behavioral problem, because it is often easier than looking honestly at our own maladaptive behaviors. As we have come to recognize the dangers of alcohol and tobacco, it becomes clear that the problem of addiction transcends the domain of illicit drugs, and viewed from an even broader perspective we have come to recognize the hazards of addictions to activities as diverse as gambling, risk-taking and sex.

The recent media feeding frenzy condemning a newer opioid compound, Oxycontin is a prototypic example of how unless such hysteria can be curbed many of the advances that have been made on the behalf of patients with chronic pain can be summarily annihilated. Oxycontin is simply a preparation of an opioid drug that is slowly released over twelve hours to promote even relief without the roller coaster effects and the clock-watching associated with short-acting painkillers. The recognition by abusers that this when crushed, chewed, sniffed or injected, the safety of this miraculous ìtiny time pillî could be bypassed led major news organs to irresponsibly capitalize on the sensationalist aspects of this criminal misuse of a product that used properly has helped countless sufferers. This irresponsible journalism has not only disseminsated an otherwise obscure strategy of abuse in the minds of susceptible addicts, but has terrified patients who have been benefitting from an otherwise appropriate treatment for years, and has frightened prescribing physicians and pharmacist who are now reluctant to dispense an otherwise very helpful drug. Just like a truly resourceful burglar will find a way to circumvent even the most stringent security system, an addict who is truly intent on abusing drugs will find a mechanism to abuse almost anything. The bottom line message is not to throw out the baby with the bathwater: the answer to curbing addiction to prescription drugs is not to limit their availability, but to teach doctors, patients and pharmacists to communicate more effectively about a problem that is distressing to all of us.

Patients should be aware that while the risk of addiction is exaggerated by even (well meaning) experts, it still exists. Addiction may arise in between 0.1-10% of patients, but it is a treatable disorder, and shouldnít interfere with the consideration of trials of opioids in patients with lower risk profiles. Individuals who have had difficulties with drugs, alcohol and tobacco in the past are at high risk for addiction and are generally considered poor candidates for treatment. Patients in denial who expect a ìquick fixî and wish to eliminate rather than manage pain are also likely to encounter difficulties with treatment.

Can narcotics be used effectively to treat chronic pain?

Iíve already indicated that the use of opioids is controversial in essentially all settings. Debate still persists about medicating terminal patients, so you can imagine how heated the discussion becomes for treating chronic pain, a setting in which there is no end in sight and where complaints often appear to be out of proportion to accompanying physical signs or x-ray findings. Regrettably, most of todayís cure-oriented physicians still do not understand chronic pain. Since it has only been recently that, stimulated by hordes of frustrated patients, a few physicians have even developed the courage to ask questions about chronic pain and opioids, it is not surprising that answers are still elusive.

This question is actually probably best regarded as two related questions: (1) are opioids effective in relieving chronic pain, and (2) if so, when (if ever) is their use appropriate? The bad news is that the ultimate answer to whether opioids are effective in the long term will only be answered with certainty with controlled clinical trials which have not even yet been proposed. Since it would be unethical to allow patients to suffer while awaiting this data, we need to be asking what is known that will help guide todayís treatment safely?

The good news is that there has been increasing experience with using opioids to treat chronic pain due to a variety of causes. While still not as reliable as a controlled trial, data from this experience can be cautiously applied to many of todayís patients with chronic pain. It appears that opioids effectively reduce pain over long intervals in a proportion of patients with chronic pain without intolerable side effects or problems with addiction. One key point here is that as long as the source of pain persists, pain can often be reduced but rarely if ever is it eliminated. Thus, if treatment is to even have a chance at success, patients must maintain realistic expectations, such as a 50% reduction in pain severity. Another key point relates to side effects: in fact, most patients will experience side effects when opioids are first started or their dose is changed, but when medications are started in low doses, are only gradually increased, and with reliance on long-acting formulations side effects can usually be resolved or minimized. Most patients will continue to experience low level side effects as long as opioid therapy is ongoing, but this may represent a reasonable tradeoff if pain is severe. While opioids may produce dangerous respiratory depression when used erratically, this almost never occurs with carefully supervised use. Nausea, sedation and itch are common at first, but usually resolve over time. Constipation is an ongoing difficulty that can and must be prevented with activity, diet and regular gentle laxative use. Because fatigue so commonly accompanies chronic pain, most patients cannot tolerate high doses of opioids, and thus must be satisfied with partial relief. In other words, while opioids are helpful in some cases, they donít eliminate chronic pain: patients continue to have ongoing, but lower grade symptoms, with some good and some bad days. These drugs are not a panacea, but simply represent one of the many tools at our disposal to help make chronic pain more bearable. Moreover, opioids are usually not a first line treatment, and work best when integrated with other drug treatments like antidepressants, anti-inflammatories, muscle relaxants and anticonvulsants, as well as with non-drug therapies like physical therapy, distraction and relaxation training.

What are opioids?

There are at least two important ways to answer this question. Unfortunately, the most scientific definition, while straightforward, is so disarmingly simple, that it doesnít tell us nearly all of what we need to know about these medications, because it ignores the important cultural forces that influence our use of these medications: the opioids comprise a class of medications that have been employed to relieve pain for well over one hundred years. Their use is so routine in certain settings (after surgery, in the Emergency Room, for labor and delivery, for cancer and in the laboratory) that they are regarded as the standard against which all other pain-killing drugs (analgesics) are compared. These drugs, previously referred to as ìnarcoticsî are derived from or are chemically related to opium, the main constituent of the poppy plant (papaver somniferum), which has been used as a pain killer since biblical times. Science has only recently demonstrated that the human body makes substances that possess a similar structure and function. These endorphins, enkephalins and other molecules, referred to as ìendogenous opioids,î are thought to be responsible for the so-called ìrunnerís high.î

While the above explanation is accurate, it does not even begin to portray the raging controversy that exists surrounding the contemporary use of opioids. While the term ìopioidî is awkward at first, it is preferred to the term ìnarcotic.î Contemporary authorities including the authors of our most important pharmacology textbook, Goodman and Gillmanís The Pharmacologic Basis of Therapeutics have advised that we abandon the term narcotic. It is so culturally and socially laden with references to drug abuse that its has use a chilling effect on prescribers and patients alike, interfering with appropriate treatment of pain. The lurid images of back alley abuse conjured by the term narcotic eclipse its scientific meaning, and as a result, the term opioid is strongly preferred.

In the midst of the tremendous progress that has been made generally in medicine and specifically in our understanding of pain and its treatment it is practically unthinkable that the individual who has done the most to advance our thinking about this issue is Jack Kevorkian. It has taken, arguably a fanatic, if not a lunatic (this authorís thoughts) to bring to our attention that despite the most sophisticated health care delivery system in the world, many Americans inappropriately are led to seek an early death because their pain is not adequately addressed. Since medical science is by no means perfect, those who suffer are not necessarily entitled to relief of their pain, but they are certainly at least entitled to our best efforts to achieve improvement, and by no means should they be subjected to humiliation or derision for seeking the relief of suffering. Although when ignored, unrelieved pain like any other chronic illness leads to depression, pain is almost always fundamentally a medical problem, so we should no more coerce the sufferer to ìtough it outî than we would encourage a diabetic to withhold taking their insulin as a means to ìbuild their character.î While we donít readily admit it, modern medicine actually cures very little of todayís maladies: diabetes and hypertension are not eradicated, but are managed, and thus the mandate to manage chronic pain over a patientís lifetime should not be a surprise or a dilemma that we, as a culture, should shrink away from. These unfortunate individuals should certainly not be discarded as having ìfailedî our current treatments, rather we should acknowledge the shortcomings of current therapies. It is only recently that pain in patients with life threatening cancer has been treated more effectively, and although legislation exists to protect the rights of those with chronic pain (and the prescribing physician), in reality, one practically needs to be dying in this country in order to be assured of getting adequate pain relief.

Florida Pain Patient Faces Decades in Prison for Pain Medication

Richard Paey, 45, of Hudson, Florida, is disabled. Injured in a traffic accident in 1985 while attending law school at the University of Pennsylvania, Paey suffered a severely herniated disk in his lower back. A first surgery failed, and a second operation, an experimental procedure involving screw inserted into his spine, only aggravated matters. It left his backbone splintered and the mass of nerves surrounding it mangled. Paey, who relies on a wheelchair for mobility, was left in excruciating chronic pain, which he treated with prescribed opioid pain relievers.

But Paey’s odyssey from being just another of America’s tens of millions of chronic pain sufferers to a Florida jail cell was about to get underway. Paey and his family had been living in New Jersey, where a physician prescribed large amounts of opioid pain relievers for Paey, but when they moved to Florida, they could not find doctors willing to provide the high-dosage prescriptions needed to fend off the pain that tormented him.

Paey, who has also been diagnosed with advanced multiple sclerosis, resorted to filling out prescription forms obtained from his New Jersey doctor and eventually came to the attention of the Drug Enforcement Administration and the Pasco County Sheriff’s Office. Investigators reported watching Paey and his wheelchair roll into one pharmacy after another to pick up fraudulent prescriptions, adding up to more than 200 prescriptions and 18,000 pain pills in a year’s time.

No one could take so many pills, investigators suspected. Paey must be a drug dealer. And they charged him as one, even though no one has ever presented any evidence that Paey did anything with the pain pills except ease his own pain. Now, after two mistrials, plea bargain offers made and withdrawn, and plea bargain offers rejected by Paey, prosecutors have managed to win a conviction. A week from today, a Florida judge will decide Paey’s fate, although if the judge follows state law, there is not much to decide. As a convicted Florida “drug trafficker,” Paey faces a mandatory minimum sentence of 25 years in prison.

In a last minute bid to win freedom for Paey, who is currently imprisoned in the hospital wing of the Pasco County Jail and is being treated with a morphine pump while in jail, his attorneys will use the occasion of next Friday’s hearing to ask that the verdict be dismissed on the grounds that Paey’s New Jersey physician, Dr. Steven Nurkiewicz, lied on the stand when he testified that he did not give Paey permission to fill out undated prescription forms.

“The state knew Dr. Nurkiewicz was lying when he said he did not provide the prescription forms and that he only prescribed small numbers of pain pills, but they said he wasn’t on trial, and they won’t charge him with perjury,” said Paey’s wife Linda. “We tried to get a mistrial, but they were still able to put Nurkiewicz on the stand knowing that he had lied,” she told DRCNet. “They feel like the end justifies the means, that my husband is a bad person, and that they’ve invested too much money in prosecuting him to let him get away. Now they will lose face if they drop the charges,” she said.

“We were so naÔve when this began,” she said. “They accused him of selling the medicine and we said no, he’s a pain patient. I thought that once they saw that was true, they would understand. But no. They not only charged him as a drug trafficker, but they harassed his doctors to stop him from getting more pain medication.”

Paey’s family and a growing number of supporters are not merely relying on the courts for justice, but taking his case to the court of public opinion. A letter writing campaign to local newspapers is underway, and the St. Petersburg Times has editorialized on Paey’s behalf. Paey has also drawn support from national organizations including the Pain Relief Network (http://www.painreliefnetwork.org) and the November Coalition (http://www.november.org), a group working to end the drug war and free its prisoners. This evening, supporters will hold a vigil outside the Pasco County Courthouse in Port Richey.

“Richard Paey is a hero, not a criminal,” said Siobhan Reynolds, founder and executive director of the Pain Relief Network, as she prepared to board a flight for Tampa Wednesday. “The more people hear about this case, the more disturbed they are. He refused plea bargains because he would not be complicit in criminalizing his own efforts to save his own life,” she told DRCNet. “This is about medicine and medical care, not about illegal drugs or drug trafficking, and it is startlingly clear that local prosecutors and the DEA have totally lost track of that distinction.”

The Pain Relief Network and other Paey supporters will ask the prosecutors to not stand in the way of the acquittal motion, Reynolds said. “We are calling on them to join the motion to acquit. This was not a real crime, only a statutory one,” she said. “We want them to do the right thing for this suffering individual.”

The conviction of Richard Paey comes as Florida is in the midst of its own version of drug czar John Walters’ war on prescription drug abuse. Alongside such high profile actions as the investigation of Rush Limbaugh and the nearly monthly arrests of pain management physicians, the Florida legislature has been at work crafting a prescription monitoring bill that would allow doctors and law enforcement to access a database showing prescriptions to all potentially addictive drugs statewide.

As part of the White House’s National Drug Control Strategy, Walters is pushing for more states to join the 15 that already have such programs. They would help reduce abuse by allowing physicians and law enforcement to spot patients seeking multiple prescriptions, Walters said. Paey’s representative, state Sen. Mike Fasano, is sponsoring the bill in the state Senate. The bill would protect patient privacy by making it a felony to unlawfully divulge patient information, Fasano told the Orlando Sentinel in February.

But Paey’s case shows the danger of such a database, said Reynolds. “Richard Paey was prosecuted three times in the very same district that is represented by Senator Mike Fasano, the sponsor of Florida’s prescription monitoring bill. Fasano’s claim that prosecutors won’t use private medical information gathered in government computers against patients in pain, is exposed for the hollow assurance it is,” Reynolds said. “Law enforcement already looms over medicine to such an extent that patients with the highest dose requirements, those with the most severe pain, can’t find medical help. Prescription Drug Monitoring Programs only ensure that the under-treatment of pain will continue to plague our most vulnerable citizens and their families.”

Still, the Senate bill and its companion bill in the Florida House are moving.

Meanwhile, Paey’s supporters are gathering for a last minute effort to bring him home.

“John Chase of the November Coalition and Siobhan Reynolds have really been working hard to get the word out,” said Linda Paey. “I couldn’t do all this myself. But we are encouraged by all the support we are finding out there. The Times editorial certainly helped. And my coworkers and neighbors have been very supportive. There are people I don’t know who pull up in my driveway and offer their support,” she said. “It’s a little shocking.” She has also had nibbles from the CBS news program 60 Minutes, Paey said.

Linda Paey is not pleased with local law enforcement and prosecutors. “They have done nothing but try to prosecute my husband, and they used the most disgusting tactics. They’re used to threatening everyone with long mandatory minimum sentences, then getting them to cop a plea and get probation,” she said. “If these people are so dangerous they need mandatory minimum sentences, why do they turn around and give them probation?” she asked.

“This case should not even be in the courts,” Paey added. “Cases like this should be given to the medical board to see if there was any wrongdoing to begin with. Instead, they assume the doctor is over-prescribing or the patient is abusing the drugs, but they don’t know that. It’s an easy way for cops and prosecutors to look tough on drugs.”

“My husband refused to plea bargain because he believes this prosecution is wrong, that this should not be happening. I haven’t been able to convince him otherwise. Now he is collateral damage in the war on drugs.”

And now Richard Paey and his supporters have only a week in which to act to prevent him from being sent to prison for 25 years. Paey’s case is not only an object lesson in the way a dogmatic war on drugs creates new victims, but also a sad commentary on the state of our nation’s judicial systems. When someone is punished for actually trying to defend himself against criminal charges, as opposed to accepting a plea bargain of guilt, something is very much amiss in the halls of justice.

To read the House prescription monitoring bill online, go to:
http://www.flsenate.gov/session/…BillNum=0397

To read the Senate version, go to:
http://www.flsenate.gov/session/…&billnum=580

Ziconotide

Ziconotide is a novel non-opioid, non local anesthetic, developed for the treatment of severe chronic pain.

The analysis, which included 105 patients, revealed that the difference in pain reduction between the two groups was substantial with a reduction in pain scores of approximately 40% in one group compared to no change in the placebo griup.

Ziconotide also seems to improve the sleep pattern in some patients with chronic severe pain. Patients experienced positive effects on nocturnal sleep duration and believed that remaining pain symptoms interfered less with their daily life.

Compared with placebo, ziconotide was associated with significantly more adverse effects, including somnolence, confusion, urinary incontinence, and fever, but these were reversible with dose reduction. Seven cases of meningitis occurred in patients with external drug delivery systems.

Ziconotide (formerly SNX-111) selectively blocks N-type voltage-sensitive calcium channels and may be effective in patients with pain that is refractory to opioid therapy or those with intolerable opioid-related adverse effects.

more information can be found here http://docmd.com/ziconotide/