Narcotic contracts: informed consent?

Both of those sample contracts are for post-surgical pain. Would someone being given narcotics long-term for chronic pain be asked to sign a similar contract? I'm guessing there would be some modifications because in that case the patient and doctor might not be looking at being able to stop the medication.

I happened to snatch these off the web, but they are pretty representative.

I would think things might differ for terminal patients, where addiction has no down side, if the drugs make their last days more comfortable then thats all that matters. In the terminal case the issue would be are the side effects worse than the situation without the drugs if the answer is no go for it.

These contracts are not appropriate for end of life care where the goals, risks, and benefits are different.

Lemme revise that: these specific contracts would not be appropriate in this scenario, but some type of contract may in fact be appropriate.

I agree that some kind of contract/informed consent is appropriate, both to protect the patient and provider, for the usual reasons. But as with most treatment, and especially treatment of pain, the patient's decision-making process may not be the most rational as they are focused on STOPPING THE PAIN (or obtaining what they may well perceive as essential health care), and may feel differently about the risks or treatment once they are in a different state of mind. This does not obviate the need for informed consent, though; I only mention that it is not only patients who are already on or have a significant history of narcotics that may decrease the effectiveness of contracts/informed consent. In the end it comes down to the provider's ability to communicate as well as understand the patient and his/her situation.

I think that having a contract like this just for narcotics is not appropriate. I think it does put to much specific pressure on those who need narcotics and singles them out for stigmatization. I think a better approach would be to write it such that it would apply to all treatments, and all prescriptions. The only reason narcotics is being singled out is because of legal restrictions on their use, and the legal jeopardy that a physician might be exposed to because of prescribing narcotics. I think that legal jeopardy is a poor reason for a physician to adopt practices.

I think the prohibition of âstreet drugsâ is too broad. The prescribing of narcotics needed for pain should not be held hostage to compliance with the legal system, or with the physicians personal preferences, for example nicotine addiction. I think this prohibition should be no different than for a patient not receiving a prescription of narcotics. More important is that the patient bring up such things with their physician, so that the physician has the opportunity to practice harm reduction.

I think there should be a requirement for the patient to discuss all drugs and all psychoactive substances including street drugs, alcohol, antihistamines, and other OTC medications before using them. I think an explicit call-out of drug interactions is warranted. If there is a prohibition, it should be about things that interact adversely with the narcotics, for example alcohol and solvent huffing, even though alcohol is legal.

I think there should also be discussion of how opiates slow reflexes and cloud judgment and cautions about driving, using heavy machinery, those sorts of things.

I would add a statement that in the event this contract is broken, that continuity of care requires that this contract and how it was broken will be relayed to the pharmacist and to future primary care physicians.

I would mention the reasons for requiring such a contract, the legal trouble that the physician could get into, and that in the event that the breaking of the contract involves illegal behavior by the patient, that the patient waves all patient-physician confidentiality regarding that illegal behavior. This illegal behavior might be limited to diversion of physician supplied drugs, changing prescriptions, stealing drugs from the practice.

I think the contract should be a little more explicit that the goal is to provide the patient with enough narcotics to be used safely and effectively. That it would be easy to just say no, and have them take aspirin.

Can the patient give informed consent under such circumstances? That is a more difficult question. Whether they can or not, you have to make it something that the hypothetical âreasonable manâ would be able to agree to. I think you have to make the consequences if they break the contract not so dire that it causes the patient a worse problem. I think a potential adverse problem is that if the patient does break the contract, that the patient's self-image as someone who can follow through on a contract is so damaged that there are long term consequences. This is the type of contract that you never want to be broken, like never asking a question you don't want an honest answer to.

When I have been depressed and suicidal, and clinicians have wanted me to make a âcontractâ that I wouldn't harm myself, that has always been very troubling to me. That is a level of self-autonomy that I am just unwilling to give up to anyone. I simply don't trust anyone enough to do that.

I think it's impossible to take the self-protection out of the physician's mind. Every professional code of ethics that I can remember, besides noting the importance of patient autonomy, also notes the provider's responsibility to his/herself. Patients will and have threatened to sue over non-issues simply to get a refund. (Often without realizing that in certain situations, the practitioner would have given a refund without qualms if simply asked nicely.) My malpractice insurer will discount my rate if I take an approved risk-management course every year. Fortunately, covering one's ass often coincides quite well with providing high quality patient care.

@ Daedalus2u: I don't know what was in the contracts you were asked to sign when you were depressed and suicidal, but having a patient give written agreement rather than solely verbal agreement significantly increases patient compliance with treatment recommendations.

"Does being a chronic narcotic user, and the physical changes this entails, make adhering to this contract prima facie implausible?"

What room is there for a "no" answer to this question? Even before everything we know about the behavior of addicts, it is self-evident they already cannot adhere to such a contract before they've ever encountered one.

What reason would anyone have to believe they care about a contract or take it seriously? How many non-addict patients really even take the contract seriously?

This is a totally different argument from "do you still give narcotics to them?" which I'm guessing is probably "yes" but on a case by case basis.

Here's something I don't understand: A lot of the self-preservation fear you discuss above is due to government enforcement and skepticism of narcotic administration even for valid purposes as evidenced by numerous misguided prosecutions in the last decade.

Doctors have a very loud political voice in this country, why isn't there a movement to collectively stand up for your rights as professionals to administer any medication you see fit appropriately, in your best judgment, and for the dogs to be called off and perhaps some protective federal legislation passed?

Obviously every system of any type in any industry is & will be abused eternally, but selective enforcement by those not in the business of practicing medicine to the point of inserting paranoia into aspects of care which are complex enough in the first place is pretty outrageous. I think this is something the public can deeply sympathize with, after all, they're the ones who could some day need such care.

I will need time to digest all of the erroneous assumptions in your comment, Shirley.

Darren, I don't disagree that such things might be helpful in increasing patient compliance. It caused me much distress, and no I never signed any such contract. I couldn't even agree to a verbal one.

I think I understand my psychology behind my refusal. The senior clinicians I worked with, never asked that of me. I think a "contract-style" method of suicide prevention is unfortunate. I think it is more ethically problematic than the contract for narcotics that PalMD is talking about.

The thing that angers me is that honest doctors with their patients' best interests at heart AND honest patients in pain are the ones being punished for the actions of a few.

Irrational fear of addiction coupled with gung-ho law and order advocates has led to a sorry lot of laws and silliness.

pain is a powerful motivator in and of itself. i think we could turn around and replace the "known effects of narcotics" with "known effects of pain" and probably have another fairly complicated question on our hands.

Narcotics contracts for acute post-op pain? How can you have trusting patient-surgeon relationship built on the implication that the patient can't be trusted to appropriately use narcotic analgesics as prescribed? In six years and several thousand cases, I've discharged nearly every post-op patient from the hospital with a small but ample supply of percocet/vicodin/dilaudid and no narcotics contract, and I'm not aware of any that have developed long-term dependence (maybe I'm just ignorant.) It's rare that a patient even requests ongoing narcotics beyond the second or third post-op week; indeed it's far more common for patients to be reluctant to take them at all (despite significant pain) for fear of dependence. Maybe I've been lucky/naive, but to me a narcotics contract sends the wrong message to your patient *in the acute setting.*

Philosophically every clinician needs to decide whether they are going to inherently trust or mistrust their patients. For me, I would rather base my practice on an inherent (hopefully mutual) trust that my patient will try to get well and that I will do what I am able to help them. Including treating their pain. I'm sure I've been burned for a handful of vicodin here and there over the years, but I would rather have put a few (probably less than 100 tabs total) vicodin in the wrong hands than fail to treat patients' pain because I inherently mistrust the veracity of their complaint.

Having said that, I worked as a primary care PA for 4 years and did use narcotics contracts when embarking on anticipated long-term narcotic use. In addition to the stipulations placed on the patient (similar to those in the contracts you linked), our contract stipulated that I acknowledge the patient's legitimate pain and agreed to treat the pain to make them as comfortable and functional as I could with the treatments available. I think the contract is not simply coercive and does offer legitimate benefit to the patient that can be easily explained. It creates a safe space for me to treat their pain (ok, that mostly benefits me), but it also validates the patient's pain and need for treatment. It creates the security for the patient that I will continue to treat their pain, will not abruptly change the rules or cut them off from treatment. I hope (and believe from anecdote) that it also removes the stigma of the recurrent call for refills. The contract lets the office staff know this is expected and neither a cause for concern nor ill-judgement. Most patients are aware of the stigma and legal atmosphere surrounding narcotics, and I always felt that clearing the air at the outset let us get to the heart of treatment without the unmentioned elephant in the corner.

Or maybe I'm just rationalizing.

As a recovering alcoholic, I am very interested in the responses this post receives. I contracted meningitis shortly after I got sober and was not in a state of mind to refuse the morphine given to me. Lucky for my, my primary care doc did rounds every day and reassured me that even though I had been given narcotics, he would make sure I did not leave the hospital addicted to pain medication. It was a sincere and real fear that I battled. Am I sober? Am I not sober? Is this wrong? But a little calm bedside manner in which he reassured me that there was no other recourse for the kind of pain I was experiencing helped me to accept it. I did NOT leave the hospital addicted to morphine, but the fear was real and tangible.

I was not in a state in which informed consent or contract signing was a possibility. And because my medical history was not known in the ER, I was subject to re-addiction. Frightening indeed.

This contract idea is a typical looney-tunes solution from CYA doctors. Signing a contract with a drug addict? Yeah, that makes almost as much sense as signing a contract with someone in debilitating pain. Such nonsense from supposedly intelligent people....I guess doing your job properly and carefully when dealing with narcotics just doesn't enter the equation. I put this silly idea alongside the confidence inspiring idea where doctors make their patients sign a contract promising not to sue for malpractice. Why don't you just make the patient sign a contract where they promise to get better on their own?

"I will need time to digest all of the erroneous assumptions in your comment, Shirley."

please elaborate? I'd rather not pre-emptively defend myself by recounting every possible implied assumption and explain why they were made without knowing what you're thinking.

My group has never used these for acute post-op pain (?!?), but the group does have a controlled substances use agreement (note the wording) for the use of controlled substances for chronic conditions. It's a standard in our area. We have an incredibly high prevalence of addiction in our population. And, yes, we are aware of the concept of pseudoaddiction.
Our chronic controlled substances use agreement is there for patient protection too. Knowing that there may be a random pill count means that someone's spouse/kids/whomever may not be taking the meds from them. Sounds like a weak defense til you hear someone say, "Yeah, my [whatever] was pretty pissed when s/he saw that, but it was a relief for me."
I'm happy to send it to you for reference, if you'd like, PalMD, but would rather not post it and 'out' myself.
The main one is opioid/pain-related. However, it's adaptable for the benzodiazepines and the stimulants.

These postop ones are a distraction. I was speaking more of what Silver is talking about. We spent a very, very long time developing the contract we use, which is for people being treated with narcotics chronically.

Slightly tangential, since I know you don't control the institutional framework you work within, but I think it's a very dangerous precedent that doctors can get into "very serious trouble" over this.
I mean, I suppose it's one thing if a doctor is prescribing dozens or hundreds of narcotic scripts a year for people who obviously don't need them. But the whole "you should know your patients well enough to know if they are going to do something illegal, and you are responsible if you help them do so" just gives me the squeamies. What if they applied that to doctors administering, oh, say a morning after pill in accordance with the law in their state to a patient in a neighboring state where it would not be legal?
SQUEAMIES I SAY.

@ Daedalus2u, I am disturbed on your behalf that you were asked to sign a contract that you wouldn't try to harm yourself when you were depressed and suicidal, by definition not in sound mind. This seems to me like an abuse by the clinician. I've been depressed and full of suicidal thoughts, myself, though in no danger of actually carrying them out; nonetheless, I'd have refused to sign, too.

Pal â

Congrats on another thought-provoking post.

From the POV of a patient with chronic pain, I don't think that being a chronic narcotic user makes adhering to the contract implausible. I have three pain-causing DXs, and have used narcotics on a daily schedule, every day, for about six years. It allows me to function as a "normal" person. My docs (at a pain clinic) and I have a contract very similar to the ones linked in the blog entry, but including monthly drug tests and that I keep the meds locked up. I adhere to the contract, no sweat, probably in large part for two reasons: first, positive reinforcement is a powerful motivator; second, my docs have a very open line of communication with me, so I can talk to them at any time about problems I'm having.

That's not to say that if my pain level is high enough, I don't consider other methods to handle pain. Seriously, if my pain is at a seven or eight, I'd consider sleeping with Rush Limbaugh to get something stronger (how's that for a disturbing thought?). But I don't, for a number of reasons. I get a massage instead, or try to divert myself with TV, reading, a good political argument, or blogs. ;-)

It sounds to me as if you wonder if an opiate-dependent patient's ability to agree to a narcotics contract is somehow impaired by their opiate use, or am I reading that wrongly? I have a job in IT, and can think as well as ever. My mental status is the same as "normal" when on my meds (with the exception of being considerably less bitchy). As far as I know, people on long-term opiates don't generally get a "high" from the drugs if they are taken as prescribed. So is your thought more along the lines that if someone needs opiates enough, they might sign anything to get their meds?

I'm not so sure that judgment is necessarily impaired by chronic opiate use, but it may be by various addictive behaviors etc that are not present in all opiate users.

shirley, you seem to be confusing "dependent" and "addicted". They are not the same.

Thanks for opening up this discussion, Pal. It's a fascinating topic.

Opioid contracts are part of the guidelines for chronic pain management, issued in 2009 by the American Pain Society (J.Pain, 2009 Volume 10, Issue 2, Pages 113-130). The sorry state of evidence supporting the use of these contracts is reviewed on page 84 of this document:
http://www.ampainsoc.org/pub/pdf/Opioid_Final_Evidence_Report.pdf

Despite a lack of evidence that use of contracts has a positive impact on patient outcomes, they have become standard of care.

The FDA is considering a new Risk Evaluation and Management Strategy to be applied to certain schedule-II long-acting opioids. While the content of the plan hasn't been formalized, all public communications from the Agency have contained requirements for signed prescriber-patient agreements.

The flip side of this issue is that deaths from opioid misadventure are a substantial problem in the US. Most of these result from overdose, inappropriate use in non-indicated situations and non-medical use (e.g. sharing of prescription medicines, and diversion to non-patients). There are hundreds of deaths of teens who steal pain medicines from relatives and share them at parties.

This is a challenging case of the needs of patients (in terms of access to effective pain treatment) being in direct conflict with the needs of society at large (in terms of deaths of non-patients and risk to physicians).

As a disclaimer, I work for a pharma company and have a direct conflict-of-interest in this area.

I'm a little amped up on this topic because I was just reading about it a few days ago after seeing a 60 minutes piece about this guy in florida. He was crippled by a car accident and in a wheelchair, then got MS. His need for narcotics for pain management had become immense.

He moved from new jersey to florida and was unable to find a doctor in florida who would work with him, so he asked his old doctor to write his prescriptions. The pharmacy became suspicious of an out of state doctor writing narcotics prescriptions and called the sheriff. He was charged with possession over the legal amount of narcotics (which was equiv to 60 pills) and was given a 25 year mandatory sentence, where he got a 24/7 morphine pump in prison anyway.

He ended up getting pardoned by the governor (charlie crist) after 3 years in prison, but wow. There seems to be a general consensus that doctors are either under treating pain or refuse to treat it with narcotics at all due to the atmosphere of suspicion surrounding them now with all of the "hillbilly heroin" stories being tossed around. I just generally find the topic disturbing/disheartening.

#25 - "There are hundreds of deaths of teens who steal pain medicines from relatives and share them at parties."

This article: http://www.slate.com/id/2214444/ would seem to refute that statement, but maybe you are talking about something else? Got any cites or more info? If not, the statement encourages paranoia of the type that lands innocent people in jail -- see shirley's example of the Florida case.

Also, "Dr. Benedikt Fischer of Simon Fraser University and coauthor write "the pre-eminent risk in most deaths was from the use of multiple drugs involving prescription opioids and other substances that are widely and legally dispensed."
http://www.sciencedaily.com/releases/2009/12/091207123105.htm

I'm thinking chronic pain patients would benefit from a short film documenting the dangers of mixing drugs. There should be a quiz afterwards too!

And I'm in total agreement with becca @20.

A couple of things:

One, I find it ironic that you include "informed consent" in the title of your article since item 8 of both of the "contracts" you link to basically require the patient to give up his right to informed consent or any type of consent at all. You have to agree to do anything the provider says or you're back to constant pain.

Two, I would like to point out that these "contracts" are signed under duress. "Agree" to this or I'll leave you in pain. This does not seem to be the most ethical or compassionate behaviour. You don't want to give up your rights to say no to any treatment, you don't want to be treated like a criminal, you don't want to give up your rights to confidentiality? Well, good luck controlling that pain with aspirin and hot packs. And stop that whimpering, it's more than most people had through out a lot of history.

I wonder if providers who use these "contracts" would think about using a similar contract for another drug that can be abused and diverted: insulin. You don't want to give up your rights to say no to any treatment, you don't want to be treated like a criminal, you don't want to give up your rights to confidentiality? Well, good luck controlling that blood sugar with diet and exercise. And stop that whining, it's all the options people had through out a lot of history.

Your points are well taken, jk, but...

item 8 of both of the "contracts" you link to basically require the patient to give up his right to informed consent or any type of consent at all.

No. I think you may misunderstand what "informed consent" means. IC doesn't mean you get complete privacy to everything or complete autonomy in everything. It simply means you are informed as to your choices and you consent to a particular thing. In this case, you are informed that if you wish to receive narcotics in this situation (which is not analogous to diabetes/insulin at all) you will consent to certain responsibilities and certain limitations on your privacy.

I like the idea of such a contract - if nothing else it shows the patient how serious these medicines are.

However, I have endometriosis and before I started menstrual suppression (via constant birth control pills) I took Darvocet for the pain each month (even after laparascopic surgery.) I am sure that if I were in unrelenting pain alleviated only by narcotics, I'd sign anything put in front of me. So the argument that the patient is under duress seems valid.

However, I don't know of anything better that can be done by a doctor to try to reduce some of the risk of prescribing narcotics.

@24, OleanderTea

What is the difference between "dependent" and "addicted"? Is it that one becomes dependent on something they need, but addicted to something they don't need?

Here's a great description of the difference between addiction and dependence. A quick summary: addicts take drugs to get high and escape life; people who depend on pain medication take it to control pain and be able to participate in life again.

I think the difference is more nuanced than hydropsyche suggests. Dependence is an adaptive change wherein repeated exposure to a substance results in physiologic changes such that abrupt cessation leads to withdrawal symptoms. Addiction is less precise, but generally involves continued compulsive use of a substance despite ongoing adverse consequences of that use. Addiction often involves physical dependence, but a person can be physically dependent without being addicted. So a person can be dependent on even high levels of a narcotic without being classified as addicted.

I think the addicted/dependent distinction isn't entirely medical or physiological. In a sense, it's a combination of "are you taking these to get high?" and "is the person, on balance, better off with or without the drug?" If someone is taking a drug long-term, they are likely to be physically dependent, whether it's insulin, a narcotic, or an SSRI.

Withdrawal symptoms are a physical thing. The person's body doesn't check in first and intercept them if the person is a chronic pain patient whose pharmacy was unexpectedly out of the medicine they need, rather than a junkie who has decided to quit using heroin.

@7: daedalus2u,

It sounds like you were asked to "contract for safety," which is/was an often-used tool in the management of the suicidal patient. A quick search suggests it no longer is felt to be effective, but when I was a student, it was considered standard, both as a deterrent and as a means of assessing the risk of successful attempt ("Do you have a plan/how would you do it? Can you promise/contract that you won't go through with it?") Your refusal/inability to sign simply put you in a higher risk pool - or so it was thought.

Reference: The No Harm Contract in the emergency assessment of suicidal risk. AU Stanford EJ; Goetz RR; Bloom JD SO J Clin Psychiatry 1994 Aug;55(8):344-8.)

As someone who does deal with chronic pain, I can safely say that I'd sign it, if it meant sweet relief.

@Dan, who said:

@24, OleanderTea

What is the difference between "dependent" and "addicted"? Is it that one becomes dependent on something they need, but addicted to something they don't need?

Well...sort of. The short answer is you can become dependent (not addicted) without it being a problem in your life. It's like the diabetic-and-insulin analogy. And what people don't realize is that lot of medications cause your body to become physically dependent -- antidepressants and corticosteroids (like prednisone) spring to mind as examples. So dependence shouldn't have any judgmental overtones to it.

Addiction is when a patient uses medication in a way other than how it was prescribed. If I were to take an extra percocet after a hard day at work (when I have no increased pain), that could demonstrate addictive behavior. If I start taking my meds more frequently, or at a higher dose than normal, that could demonstrate addictive behavior. If I craved the drug, that could demonstrate addictive behavior.

There can be considerable overlap between dependence and abuse, and when you throw in medication tolerance (which happens with long-term opiate use) it can really become a mess. And that is where I bet the docs have problems. Most physicians don't want their patients to suffer pain needlessly, but they also want to make sure they are treating a need, and not assisting an addiction.

I have to disagree. Section 8 means you get no choice at all. No autonomy at all. Period. You have to agree to anything that provider wants with out even knowing what it is. What ever he wants, even if it makes your condition worse, or is degrading, or is more dangerous than you would want to risk, or harms you. It's do it or go back to the pain.

Sure, you can walk away any time you want to go back to the pain. If that is a choice, then last year I chose to let burglars have my TV because I did not stay in my house 24 hours a day, seven days a week.

And I would also disagree strongly about the the diabetes/insulin analogy. In both cases, you would have a provider who controls access to something that a given person needs to live a normal life. If you wish to be able to buy insulin, you will give up the right to make any choices about your treatment and give up your right to privacy. If the "contract" is valid in one situation, then it is valid in both. It is just that our society has demonized people in pain as part of war on drug users and are sympathetic to people with diabetes.

I very much appreciate all the comments here. This is a tough topic, and I'm planning a follow up post to address some the issues you folks have raised.

I agree with people, that like me, have severe chronic pain issues. I'd sign anything. Heck. I'll happily show up on the occasion ( for me fortunately not often) so they can dole out the dose themselves.

Instead I get less effective pain management. It's a big dent in my life.

I don't usually comment on things like this, but my experience lately brings me to. I agree that some medications are necessary, for a patient to enjoy a quality of life that would otherwise be denied to them in human history, from opiates, to insulin. We have established that taken properly and as instructed these drugs usually do not produce a "high" that addicts are looking for. Why are people in this medical position stigmatized and criminalized by a permanent record that indicates they need legal documentation to be in compliance? This is an abhorrent use of CYA in my opinion. Many of these patients are already stigmatized by their conditions. Now let's make them feel like criminals, good work.

It is a CYA tool if there ever was one. These so-called contracts are nothing more or nothing less. A person in chronic pain asked to sign one of these is not in a position to say "No" in fact, the legality of a contract or testimony of a patient taking morphine would not be recognized in most courts. For a patient, this is intimidation and shame on the doctors or practices that demand this, shame on the American Pain Society for their irrational paranoia.
What if the contracts were worded more to the consequences to the Doctor rather than the patient? "I, Doctor X, agree to treat Patient Y for chronic pain and agree that any abuse of narcotics or illegal substances by Y is a result of my, Dr. X, incompetence in treating Y's pain. That incompetence will result in Dr X being investigated by the authorities, imprisonment and/or loss of my medical license."
Does that sound any more rational than these contracts? SurgPA, hats off to you!

Nothing a good malpractice lawyer can tear apart. If you have a patient for 1 to 10 years and then give them this, they are going to do something about it right away. One you will lose this patient and everyone he can tell on the internet Two you can expect serious trouble from the lawyer.

Um...I don't think you have any clue what you're talking about.