Benzodiazepine Informed Consent
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.
Benzodiazepine Informed Consent
Some examples of important information that should be disclosed in the process of providing informed consent for new patients being offered a benzodiazepine and/or Z-drug prescription:
- The patient should be informed that they are being prescribed a benzodiazepine, which is a minor tranquilizer, which is a drug in the same class as Valium (diazepam).
- These drugs are recommended by the manufacturer (and numerous other professional and regulatory bodies) to be taken intermittently (not regular or daily use) or, when taken regularly, for no longer than a successive 2-4 week time period (including the tapering off period).
- Long-term use may worsen anxiety and panic (due to tolerance) and hinder recovery from these conditions in the long run.
- Taken any longer than 2-4 weeks, even as directed without abuse, these drugs can cause tolerance, interdose withdrawal, physical dependence and subsequent withdrawal syndromes, including the protracted withdrawal syndrome from benzodiazepines, which can last years.
- The withdrawal syndromes can be debilitating, severe, and are said to sometimes be worse than heroin withdrawal. Sudden cessation after long-term can cause seizures, suicide, and even death.
- Cessation of the benzodiazepine after long-term use requires a slow and controlled taper that can take many months or years to complete because that’s how long it takes the down-regulated GABA receptors to heal in withdrawal-susceptible individuals.
- Additive effects may occur with patients taking other depressant drugs such as alcohol or sedative antidepressants. A combination of opiates and benzodiazepines can prove deadly. W-BAD Note: antidepressants such as SSRIs or SNRIs may be stimulating to the fragile CNS in benzo withdrawal and recovery. Use caution when considering other medications.
- Elderly individuals should be warned that, due to decreased metabolism, they may be at risk for an increased susceptibility to the sedative effects of benzodiazepines which may cause mental confusion, cognitive impairment suggesting dementia and ataxia leading to falls and fractures.
- In pregnancy, there is a risk of adverse effects on the fetus, neonatal depression (floppy infant syndrome) and neonatal withdrawal effects.
- There are genetic differences from person to person in drug metabolism. Neuropsychiatric pharmacogenomic testing is available to determine how you metabolize benzodiazepines prior to being prescribed them.
- The patient should be warned about the risks of ingesting a fluoroquinolone antibiotic while taking benzodiazepines.
- Benzodiazepines may be implicated in an increased risk of dementia and other health issues, illness, and morbidity.
Sample Benzodiazepine Informed Consent
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Please review the information listed here and put your initials next to each item when you have reviewed it with your provider and feel you understand each statement.
______I understand that I am being prescribed ________________ which is in the class of drugs known as benzodiazepines.
______My provider is prescribing a benzodiazepine for the following condition(s):
______My provider has discussed with me all available alternatives to benzodiazepines. (Provider please list below, including nonpharmacologic options)
______Benzodiazepines are meant for short-term (<2-4 weeks) or intermittent use according to most guidelines. Clinical trials showing their benefit studied patients over a time period of a few months. There are no studies showing convincing evidence of long term benefits.
______The risks of benzodiazepines include (but are not limited to) slowed thinking and reaction times, poor focus, confusion, memory loss, less control of emotions and actions, dementia, depression, weakness, falls and broken bones, car accidents, breathing problems (especially in those with an underlying lung condition such as COPD or sleep apnea), sleepiness/sedation, osteoporosis, suicidal and violent thoughts, tolerance, withdrawal symptoms, physical dependence, addiction, worsening of the original symptoms that were being treated, and increased healthcare costs. For a comprehensive list of adverse effects, please see the pharmacy and/or FDA drug sheet.
______Tolerance to the medication can develop over time, necessitating an increase in dose to achieve the same effect. Patients may also develop symptoms of tolerance withdrawal (withdrawal symptoms that occur even though the dose has not been reduced). Symptoms of tolerance and tolerance withdrawal are often difficult to diagnose, and may be attributed to worsening of the patient’s underlying disease or a new medical condition.
______Physical dependence can develop in a matter of days. This means your body becomes reliant on the drug to function. Withdrawal symptoms will develop if the drug is stopped or the dosage is reduced.
______Interdose withdrawal (withdrawal symptoms between doses) may occur, especially with shorter acting benzodiazepines such as Xanax and Ativan. This issue may be corrected by switching to a benzodiazepine with a longer half life.
______A benzodiazepine should never be stopped abruptly after daily use, as this can result in severe withdrawal symptoms including psychosis, seizures, and death. It can also increase the risk of post-acute withdrawal syndrome (PAWS) and protracted withdrawal.
______A benzodiazepine taper can last anywhere from months to years, depending on the needs of the individual. Benzodiazepines 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 syndrome (BWS) can be extremely severe and disabling, with symptoms lasting years in some cases, even with a slow taper plan (5-10% reductions every 2-4 weeks).
______Symptoms of BWS 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, malabsorption, 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 a comprehensive list of symptoms please see: https://www.benzoinfo.com/2017/10/09/common-benzodiazepine-withdrawal-post-withdrawal-symptoms/
______BWS can result in protracted withdrawal and neurologic injury lasting years, and in some cases the damage may be permanent.
______I understand the above listed benzodiazepine adverse effects–including tolerance, withdrawal, and dependence–can occur at any dose of the medication (even “low doses”), and even when taken exactly as prescribed by my provider.
______I understand physical dependence and withdrawal syndrome can develop in the absence of addiction or an “addictive personality.”
______Taking benzodiazepines while pregnant carries a risk of fetal abnormalities and can cause risk to the newborn–including breathing problems, flaccid muscles, and withdrawal syndrome.
______Patients over age 65 have an especially high risk of side effects like falls, fractures, and dementia 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 benzodiazepines, 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 notify my provider of any new medications that are added to my regimen.
Patient Name: ________________________________ Patient DOB: ___/___/___
Patient Signature: _____________________________ Date: ___/___/___
Provider Signature: ____________________________ Date: ___/___/___