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  • Benzodiazepine Informed Consent Form

  • This consent form outlines the agreement between the patient and Aspire Medical Group regarding the use of benzodiazepines as part of the patient’s treatment plan. It is crucial for patients to understand the benefits, risks, and responsibilities associated with benzodiazepine use to ensure safe and effective treatment. The following information aims to educate the patient on the risks associated with benzodiazepine use, facilitating understanding and consent to a treatment contract.

    About Benzodiazepines

    Benzodiazepines are central nervous system (CNS) depressants classified as Schedule IV controlled substances under the Controlled Substances Act. They are prescribed to treat conditions such as:

    • Generalized anxiety disorder
    • Insomnia
    • Seizures
    • Social phobia
    • Alcohol withdrawal
    • Panic disorder
    • Premedication before medical procedures
    • Muscle spasms

    Commonly prescribed benzodiazepines include Diazepam (Valium®), Alprazolam (Xanax®), Lorazepam (Ativan®), Clonazepam (Klonopin®), Temazepam (Restoril®) and Chlordiazepoxide (Librium®). Each of these benzodiazepines has specific indications based on their pharmacokinetic properties and clinical effectiveness. 

    Benzodiazepines primarily work by enhancing the activity of the neurotransmitter gamma-aminobutyric acid (GABA) at the GABA-A receptor in the CNS, reducing neuronal excitability. This results in their sedative and anxiolytic effects, which can alleviate anxiety, induce sleep, and manage symptoms associated with alcohol withdrawal.

    Benefits When Used as Directed

    When used according to medical guidance, benzodiazepines can offer significant therapeutic benefits, such as:

    • Rapid relief of anxiety and panic attacks
    • Induction of sleep in patients with severe insomnia
    • Management of alcohol withdrawal symptoms

    Side Effects and Risks of Benzodiazepines

    Benzodiazepines can cause various side effects, which may include:

    Common Side Effects:

    • Drowsiness
    • Dizziness
    • Low blood pressure
    • Loss of motor coordination
    • Confusion

    Serious Side Effects:

    • Psychiatric symptoms such as emotional blunting, depression, psychosis, and disinhibition
    • Paradoxical reactions such as increased anxiety, agitation, and aggression, especially in older adults or individuals with a history of substance abuse

    FDA "Boxed Warning":

    In 2020, the FDA updated the "Boxed Warning" for benzodiazepines to emphasize the risk of abuse and misuse, which can lead to overdose or death, especially when combined with CNS depressants like opioid pain relievers, alcohol, or illicit drugs. Combining these substances can result in sedation, respiratory depression, coma, and death.

    Discontinuation Risks:
    Abrupt discontinuation of benzodiazepines can lead to severe, life-threatening withdrawal symptoms or a recurrence of the original symptoms. If discontinuation is necessary, you must consult your prescriber to plan a safe tapering schedule.

    Long-Term Use Risks

    • Physiological dependence and tolerance
    • Memory and cognitive decline
    • Increased risk of falls and accidents and drug interactions
    • Patients over 65 years old are particularly vulnerable to these risks.

    For a more extensive list of adverse effects, please refer to the FDA medication guide at FDA Medication Guides 

    https://www.fda.gov/drugs/drug-safety-and-availability/medication-guides

    Safety and Monitoring
    Adherence to the prescribed dosage and regular monitoring by healthcare providers are crucial to minimize side effects and ensure the safe and effective use of benzodiazepine medications.

    Emergency Contact
    If you experience any severe side effects, such as difficulty breathing, chest pain, confusion, or any other unusual symptoms, contact your provider immediately. If the situation is severe, call 911 or go to the nearest emergency room. 

  • Alternative Treatments to Benzodiazepines 

  • Benzodiazepines are often prescribed for anxiety disorders, insomnia, and panic disorders, but long-term use can lead to dependency and other risks. Alternative treatments are available for managing these conditions without the risks associated with benzodiazepines.

    1. Non-Benzodiazepine Medications

    • Selective Serotonin Reuptake Inhibitors (SSRIs): Medications such as sertraline (Zoloft), escitalopram (Lexapro), or fluoxetine (Prozac) are commonly used to manage anxiety and panic disorders by balancing serotonin levels in the brain.
    • Serotonin-Norepinephrine Reuptake Inhibitors (SNRIs): Medications such as venlafaxine (Effexor) and duloxetine (Cymbalta) can be effective for treating anxiety and depression.
    • Buspirone (Buspar): A non-benzodiazepine anxiolytic used for generalized anxiety disorder (GAD). It is less sedating and does not have the dependency risks associated with benzodiazepines.
    • Beta-Blockers: Propranolol and other beta-blockers can help manage physical symptoms of anxiety, such as rapid heart rate and trembling, particularly for performance anxiety.

    2. Psychotherapy

    • Cognitive Behavioral Therapy (CBT): CBT is highly effective for treating anxiety disorders, panic disorders, and phobias. It helps patients identify and change negative thought patterns that contribute to anxiety.
    • Exposure Therapy: Often used for phobias and PTSD, this therapy involves gradually exposing individuals to anxiety-inducing situations in a controlled manner to reduce fear over time.
    • Acceptance and Commitment Therapy (ACT): This therapy encourages patients to accept anxious feelings rather than avoid them, while also taking proactive steps toward living a fulfilling life despite those feelings.

    3. Lifestyle and Natural Approaches

    • Relaxation Techniques: Practices like deep breathing exercises, progressive muscle relaxation, and guided imagery can help reduce anxiety symptoms without medication.
    • Meditation and Mindfulness: These practices help manage stress and anxiety by promoting relaxation and focusing on the present moment.
    • Exercise: Regular physical activity can naturally reduce anxiety by releasing endorphins and improving overall mood.
    • Herbal Supplements: Some patients may benefit from natural remedies such as valerian root, passionflower, or chamomile, though they should consult with their healthcare provider before use due to potential interactions with medications.
  • Patient Responsibilities and Guidelines

    During my benzodiazepine treatment, I agree to adhere to the following conditions:
  • 1. Personal use: I understand that my benzodiazepine prescription is intended for my personal use only. I will not share, sell, or trade my medication. Doing so is a violation of clinic policy and against the law. Such actions will result in discontinuation of my prescription and termination of treatment.

    2. Provider notification: I will not seek benzodiazepines from other providers without notifying my prescriber.

    3. Controlled medication disclosure: I will not obtain other controlled medication without first informing my prescriber. Under certain circumstances, if I obtain any additional narcotic from other physicians such as an emergency room physician, I will notify my prescriber immediately by calling the office at (617) 991-9151.

    4. Medication disclosure: I will disclose all prescribed and over-the-counter medications to avoid harmful interactions.

    5. Dosage and frequency: I will not alter the dosage or frequency of my medication without first consulting my prescriber during scheduled appointments (not via phone, at night, on weekends, or holidays). Any changes in dosing must be approved by my prescriber.

    6. Proper use: Benzodiazepines should be taken strictly as prescribed and not altered in form (e.g., injected, crushed, snorted).

    7. Drug and alcohol interaction: I will not combine my medication with other drugs without consulting my prescriber first, nor will I combine my benzodiazepine medication with alcohol. Use of benzodiazepines with other medications that may cause drowsiness, such as opioid pain relievers (including non-prescription codeine), or with alcohol can be serious and life-threatening. Naloxone will not reverse the effects of benzodiazepine overdose. I understand that their use will jeopardize my continued prescription.

    8. Discontinuation and withdrawal: Discontinuing benzodiazepines abruptly after extended use can cause potentially life-threatening withdrawal symptoms. I will consult with my prescriber before stopping my medication to discuss a tapering plan.

    9. Storage and disposal: All medications, including benzodiazepines, should be stored securely out of reach of others, especially children and pets. Unused medication should be returned to the pharmacy for safe disposal.

    10. Appointment and refill policy: Patients are responsible for scheduling regular appointments and contacting the office at least 72 hours before running out of medication for refills. Refills are processed during office visits or regular office hours only.

    11. Renewal conditions: Renewals of my benzodiazepine prescription are contingent upon my adherence to scheduled appointments and compliance with prescription directions. I understand that my prescriber will determine the frequency of my visits, and I will comply with these expectations. If I need to cancel an appointment, I agree to do so at least twenty-four (24) hours before the scheduled time by calling the office at (617) 991-9151.

    12. No early refills: I understand that I may not obtain an early refill or replacement supplies for lost, stolen, or damaged benzodiazepine medication.

    13. No pharmacy refill requests: I understand that pharmacy refill requests for controlled medications, including benzodiazepines, are not accepted.

    14. Substance use disclosure: I will inform my prescriber of alcohol or drug use, past or present, as well as any history of alcoholism or addiction.

    15. Toxicology screenings: I consent to random urine or serum toxicology screenings as may be requested by my prescriber. Further refills or prescriptions will be contingent upon completion of the requested screening. I understand that all out-of-pocket expenses associated with drug screenings are my responsibility.

    16. Pill counts: I consent to random pill counts as may be requested by my prescriber. If requested, I will bring my medication in the original container to my next in-office appointment within the requested timeframe, so that a staff member may verify the number of pills in my possession. Further refills or prescriptions will be contingent upon completion of the requested screening.

    17. Substance use screening and consequences: I understand that the presence of unauthorized and/or illegal substances, or the absence of prescribed medications, in the screenings described in this agreement may prompt referral for assessment for a substance abuse disorder or discharge from the practice. An unexpected result on the urine drug screen may lead to the discontinuation of my benzodiazepine prescription.

    18. Pregnancy: If I intend to become pregnant or become pregnant during treatment, I understand that it is crucial to inform my prescriber promptly. This notification is necessary to discuss the potential risks of benzodiazepines to the fetus and to consider appropriate tapering options. I acknowledge that failure to notify my prescriber may result in harm to my unborn child. I absolve my prescriber and Aspire Medical Group from any liability for harm that may occur to myself and/or my unborn child.

    19. Adjunctive management programs: I agree to participate in adjunctive management programs as recommended by my prescriber, such as psychotherapy, meditation, exercise, use of non-controlled medications, and/or other complementary therapies.

    20. Information sharing: I consent to sharing my medical information with other healthcare professionals involved in my care if it is deemed medically necessary. I acknowledge that my prescriber has the authority to disclose relevant information to facilitate comprehensive and coordinated healthcare services.

    21. Prescription monitoring program: I understand that my prescriber will verify that I am receiving only the controlled substances that I have reported previously and only from prescribers that have been previously reported by checking the Massachusetts Prescription Drug Monitoring Program, as required by law.

    22. No exceptions requests: I understand and agree that I will not place calls to the office staff with demands for variations or exceptions to this agreement. I acknowledge that adherence to the terms outlined in this agreement is essential for safe and effective treatment. Any concerns or questions regarding my treatment plan should be discussed during scheduled appointments or as otherwise instructed by my healthcare provider.

  • Patient Acknowledgment and Consent

    By signing this form, I certify that:
    • I certify that I have read and understand all the conditions on Benzodiazepine Consent Form. I have been given the opportunity to ask questions, and all my questions have been answered to my satisfaction.
    • I have informed my healthcare provider of all my medical conditions, known allergies to drugs or other substances, and any past adverse reactions I have experienced. I have also informed my provider of all medications and supplements I am currently taking.
    • I understand and accept the risks, conditions, and terms of the proposed treatment as presented. I acknowledge that my prescriber reserves the right to discontinue treatment or adjust the treatment plan as needed. I understand that failure to comply with the terms of this agreement may result in the discontinuation of my benzodiazepine prescription and/or termination from the practice.
    • I acknowledge that no guarantees have been made to me regarding the outcome of this treatment.
    • I consent to the use of benzodiazepines as part of my treatment plan. I understand that my treatment with these medications will be governed by the terms of this agreement.
    • By signing this form, I voluntarily consent to treatment and agree to the use of electronic records and signatures.
    • I am signing this form voluntarily, and I confirm that I have the full legal authority to be bound by this agreement. By signing, I voluntarily give my consent for treatment and accept the risks, conditions, and terms outlined in this document.
  • Electronic Signatures

  • By providing my electronic signature below, I agree to the terms and conditions outlined in this agreement. I agree to the use of electronic records and signatures. I acknowledge that I have read the related consumer disclosure.

    The parties acknowledge and agree that this financial agreement form may be executed by electronic signature, which shall be considered as an original signature for all purposes and shall have the same force and effect as an original signature. Without limitation, “electronic signature” shall include faxed versions of an original signature or electronically scanned and transmitted versions (e.g., via PDF) of an original signature.

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  • If the patient is a minor or is not legally competent to provide consent, the signature of a parent, guardian, or legal representative is required

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