Informed consent is the process by which the treating health care provider discloses appropriate information to a competent patient so that the patient may make a voluntary choice to accept or refuse treatment.
It originates from the legal and ethical right the patient has to direct what happens to his or her body and from the ethical duty of the physician to involve the patient in his or her health care.
The essential elements of informed consent include:
- Reasonable alternatives to the proposed intervention
- The relevant risks, benefits, and uncertainties related to each alternative
- The nature of the decision/procedure
- Assessment of patient understanding
- The acceptance of the intervention by the patient
- Reasonable physician standard: what would a typical physician say about this intervention? This standard allows the physician to determine what information is appropriate to disclose. However, this standard is often inadequate, since most research shows that the typical physician tells the patient very little. This standard is also generally considered inconsistent with the goals of informed consent, as the focus is on the physician rather than on what the patient needs to know.
- Reasonable patient standard: what would the average patient need to know in order to be an informed participant in the decision? This standard focuses on considering what a typical patient would need to know in order to understand the decision at hand.
- Subjective standard: what would this particular patient need to know and understand in order to make an informed decision? This standard is the most challenging to incorporate into practice, since it requires tailoring information to each patient.
Our informed consent is free to use in medical practice provided the authors are credited and the content is not altered.
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Benzodiazepine Informed Consent
[box] Authored by Benzodiazepine Information Coalition benzoinfo.com and the Alliance for Benzodiazepine Best Practices benzoreform.org. Revised 06/19/2021. Please visit our websites for more information and resources.[/box]
Please review the information listed here and initial each item when you have reviewed it with your provider and understand each statement. This document provides important but not all concerns related to benzodiazepine use.
______I understand that I am being prescribed __________________ (provider to complete), which is in the class of medications known as benzodiazepines (BZs).
______My provider is prescribing a BZ for the following condition(s):
__________________________________________________________________________(provider to complete)
______My provider has discussed available alternatives to BZs. (provider to list, including non-medication options)
______BZs are meant for short-term (<2-4 weeks) or intermittent use due to their long term-risks, including physical dependence. There are no studies showing convincing evidence of long-term benefit.
______FDA-approved indications for BZs include short-term relief of anxiety, insomnia, certain seizure conditions, acute alcohol withdrawal, procedural anesthesia, and muscle spasms (which is questioned). All other indications are considered “off-label” use.
_____BZs have a ”boxed” warning (the FDA’s strongest warning) for risks when combined with opioids, and the risks of abuse, addiction, physical dependence, and withdrawal.
______Common side effects of BZ use include drowsiness, dizziness, balance problems, confusion,muscle weakness, and depression. Serious risks include injuries/falls/broken bones, car accidents, breathing problems (especially in those with underlying lung problems), suicidal/violent thoughts, overdose / overdose death (especially when combined with opioids or alcohol), and death unrelated to overdose. Long term risks (>2-4 weeks use) of BZ include memory loss, osteoporosis, tolerance, physical dependence, withdrawal symptoms, addiction, increased healthcare costs, reduced quality of life, and worsening of the original symptoms that were being treated. For an extended list of adverse effects, see the FDA medication guide at https://www.fda.gov/drugs/drug-safety-and-availability/medication-guides and other sources.
______When I take these medications regularly, I may develop tolerance (needing a higher dose to have the same effect). I may also develop tolerance withdrawal (withdrawal symptoms that happen even though the dose has not been lowered). Symptoms of tolerance or tolerance withdrawal may be mistaken for worsening of my original problem or a new medical condition.
______When I take BZs regularly, physical dependence can develop in a matter of days, even when taken exactly as prescribed. This means my body needs the drug to function, and I will have withdrawal symptoms if the medication is stopped or the dose is reduced.
______Interdose withdrawal (withdrawal symptoms between doses) may occur, especially with short-acting BZs (e.g. Xanax, Ativan). This may be corrected by switching to a longer-acting BZ (e.g. Valium).
______I understand that BZs should never be stopped abruptly, as this can result in severe withdrawal symptoms (e.g., psychosis, seizures, and death). It can also increase the risk of BZ injury syndrome.
______I understand that to stop using BZs, I will have to slowly reduce the dose of the medication, called “tapering.” A BZ taper can last anywhere from months to years, and should be tailored to the individual. BZs are not available in doses that are convenient to taper and may need to be compounded or divided in order to make small reductions. Benzodiazepine withdrawal can be extremely severe and disabling, with symptoms lasting years in some cases, even with a slow taper plan (<5% a month).
______Symptoms of BZ withdrawal include (but are not limited to) extreme fear/anxiety, tremor, fast heart rate, high blood pressure, agitation, perceptual disturbances, blurry vision and floaters, severe muscle spasm and pain, involuntary twitching/movements, nerve pain, memory problems, loss of thinking ability, loss of ability to do everyday tasks, extreme fatigue, muscle atrophy and weakness, weight gain or loss, hypersensitivity to light and sound, suicidal thoughts, gastrointestinal problems (delayed emptying of the stomach, food sensitivities, diarrhea, constipation, and abdominal pain), tinnitus (ringing in the ears), head pressure/pain, blood sugar disturbances, disrupted menstrual cycle and other hormone problems. For an extended list of symptoms see: https://www.benzoinfo.com/benzodiazepine-withdrawal-post-withdrawal-symptoms/
______BZ use can cause changes in the nervous system, resulting in BZ injury syndrome (also called protracted withdrawal). This occurs in 10-15% or more of patients who discontinue long-term BZ use. Symptoms may last years, and in some cases damage may be permanent.
______I understand the above listed BZ adverse effects can occur at “low doses,” even when taken exactly as prescribed by my provider, and can develop in the absence of addiction or an “addictive personality.”
______For Women: Taking BZs while pregnant carries a risk of miscarriage and can cause risk to the newborn–including breathing and breastfeeding problems, flaccid muscles, and withdrawal syndrome.
______For Elderly: Patients over age 65 have an especially high risk of side effects like falls, fractures, and problems with thinking and memory, partly due to slower metabolism of the drug from aging.
______I understand I should not combine this medication with alcohol, Z-drugs (such as Ambien or Lunesta), other BZs, opioids, or any other drug that causes sedation. Doing so can put me at risk of overdose and death due to combined effects on breathing. I agree to tell my provider if new medications are added to my regimen.
Patient Name: ________________________________ Patient DOB: ___/___/___
Patient Signature: _____________________________ Date: ___/___/___
Provider Signature: ____________________________ Date: ___/___/___