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Wisconsin Informed Consent for Medication

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INFORMED CONSENT FOR MEDICATION

Dosage and / or Side Effect information last revised on 04/28/2017

Completion of this form is voluntary. If not completed, the medication cannot be administered without a court order unless in an emergency.

This consent is maintained in the client’s record and is accessible to authorized users.

MEDICATION CATEGORY
MEDICATION
RECOMMENDED DAILY TOTAL DOSAGE RANGE
ANTICIPATED DOSAGE RANGE

The anticipated dosage range is to be individualized, may be above or below the recommended range but no medication will be administered without your informed and written consent.

Recommended daily total dosage range of manufacturer, as stated in Physician’s Desk Reference (PDR) or another standard reference.

This medication will be administered

1. Reason for Use of Psychotropic Medication and Benefits Expected (note if this is ‘Off-Label’ Use)

2. Alternative mode(s) of treatment other than OR in addition to medications include

Note: Some of these would be applicable only in an inpatient environment.

Other Alternatives:

3. Probable consequences of NOT receiving the proposed medication are

Impairment of

Possible increase in symptoms leading to potential

Other Consequences:

Note: These consequences may vary depending upon whether or not the individual is in an inpatient setting. It is also possible that in unusual situations, little or no adverse consequences may occur if the medications are not administered.

Client Initial

Date

4. Possible side effects, warnings, and cautions associated with this medication are listed below. This is not an all-inclusive list but is representative of items of potential clinical significance to you. For more information on this medication, you may consult further with your physician or refer to a standard text, such as the PDR. As part of monitoring some of these potential side effects, your physician may order laboratory or other tests. The treatment team will closely monitor individuals who are unable to readily communicate side effects in order to enhance care and treatment.

Continued – Possible side effects, warnings, and cautions associated with this medication.

Most Common Side Effects

In females: Common side effects may be changes in vaginal bleeding... symptoms of blood sugar problems.

In males: Common side effects include weight gain, fatigue, hypertension, headaches, mental depression, hyperglycemia, impotence, hypogonadism, leg cramps and diminished spermatogenesis.

In both males and females: Abdominal pain or cramping; bloating or swelling of ankles or feet; blood pressure increase; dizziness; drowsiness; headache; mood changes; nervousness; pain or irritation at place of injection site; swelling of face, ankles, or feet; unusual or rapid weight gain.

Less Common Side Effects

Mental depression; skin rash; unexpected or increased flow of breast milk; acne; breast pain or tenderness; brown spots on exposed skin; hot flashes; loss or gain of body, facial, or scalp hair; loss of sexual desire; trouble in sleeping.

Warning

Black Box Warning:

Women who use injectable medroxyprogesterone acetate may lose significant bone mineral density. Bone loss is greater with increasing duration of use and may not be completely reversible.

INFORMED CONSENT FOR MEDICATION

Medication: Depo-Provera - (Medroxyprogesterone acetate)

By my signature below, I GIVE consent for the named medication on Page 1 and anticipated dosage range. My signature also indicates that I understand the following:

  1. I can refuse to give consent or can withdraw my consent at any time with written notification to the institution director or designee.
  2. Questions regarding this medication can be discussed with the Interdisciplinary Team, including the physician.
  3. Questions regarding any behavior support plan or behavior intervention plan can be directed to the client’s social worker, case manager, or psychologist.
  4. I have the right to request a review at any time of my record.
  5. I have a legal right to file a complaint if I feel that client rights have been inappropriately restricted.
  6. My consent permits the dose to be changed within the anticipated dosage range without signing another consent.
  7. I understand the reasons for the use of the medication, its potential risks and benefits, other alternative treatment(s), and the probable consequences if the proposed medication is not given.
  8. This medication consent is for a period effective immediately and not to exceed fifteen (15) months from the date of my signature.

SIGNATURES

As parent/guardian (POA-HC) was not available for signature, he/she was verbally informed of the information in this consent.

Verbal Consent

Client Initial

Date

Enter text✕

What the Wisconsin Informed Consent for Medication Is

The Wisconsin Informed Consent for Medication is a written record documenting a patient's voluntary agreement to receive a prescribed medication after being informed about the drug's purpose, expected benefits, common and serious risks, alternatives, and instructions for use. It records the patient's identity, the prescribing clinician, medication name and dosage, the date of consent, and signatures or authorized electronic authentication. The form supports clinical decision-making, regulatory compliance, and continuity of care by creating a durable record of the patient's informed choice.

Why a Proper Informed Consent Matters

A clear, complete consent form protects patient autonomy, documents clinical disclosures, and reduces legal and clinical risk. It ensures patients understand treatment trade-offs and provides a reproducible record for audits, billing, and care transitions.

Why a Proper Informed Consent Matters

Who Completes and Signs This Consent

Common users include prescribing clinicians, nurses, pharmacists, and authorized staff who document clinical counseling and obtain patient agreement.

  • Patients or legal guardians who are competent to consent to medication therapy.
  • Prescribing clinician responsible for explaining risks, benefits, and alternatives.
  • Authorized clinical staff who witness or facilitate the consent process.

Primary Signatories and Roles

Prescriber

A licensed clinician (physician, APRN, PA) who explains indications, alternatives, expected outcomes, and material risks; documents counseling and signs to attest to the discussion and medical necessity.

Patient/Guardian

The individual receiving medication or their legally authorized representative who confirms understanding and gives voluntary authorization; signs or electronically authenticates and may withdraw consent per stated procedure.

Essential Elements of a Professional Consent Form

A well-designed Wisconsin Informed Consent for Medication collects identity and context, explains medication specifics in plain language, documents alternatives and risks, records authorization, and captures clinician attestation and retention instructions.

Patient Identity

Full legal name, date of birth, and medical record number when available; prevents misidentification and ensures the consent attaches to the correct chart.

Medication Details

Drug name, dose, route, frequency, and intended duration so the patient understands exactly what therapy is being authorized.

Risks and Benefits

Plain-language summary of common side effects, serious risks, and expected benefits to enable informed decision-making.

Alternatives

Reasonable nonpharmacologic or alternative pharmacologic options, including risks of declining treatment when clinically applicable.

Signature and Date

Signed by patient or guardian and prescriber; includes date and time. Electronic signatures acceptable when legal requirements are met.

Clinician Attestation

Provider statement confirming the discussion occurred, any questions were answered, and documented counseling was provided.

Step-by-Step: Completing the Consent with the Patient

Follow this sequence to obtain and document informed consent efficiently and consistently.

  • 01
    Prepare the form: Populate patient and medication fields before discussion.
  • 02
    Explain clearly: Discuss purpose, benefits, risks, and alternatives verbally.
  • 03
    Ask for questions: Confirm comprehension and answer any patient concerns.
  • 04
    Document signature: Collect signature or e-authentication and record the date.

Configuring an Electronic Consent Workflow

Standardize settings to capture consent, audit details, and secure storage when configuring e-consent workflows.

Field Configuration
Authentication Level Email + SMS code or healthcare-specific ID verification
Consumer Disclosure Provide ESIGN disclosure for consumer-facing records
Attachments Include patient education handouts as PDFs
Audit Trail Enable IP, timestamp, and user action logging

Typical Electronic Consent Flow

Electronic consent follows predictable stages from creation to storage; each stage produces audit evidence.

  • Create form: Provider or clinic prepares the consent document.
  • Authenticate signer: Signer confirms identity via chosen method.
  • Sign and timestamp: Signature captured with date and audit metadata.
  • Store securely: Signed copy saved to EHR and secure archive.

Technical Considerations for eConsent Platforms

Choose a platform that supports required authentication, audit trails, secure storage, and regulatory controls.

  • Authentication: Email, SMS, KBA, or SSO
  • Security: TLS in transit; AES-256 at rest
  • Integrations: EHR and cloud storage

eSignature Vendor Pricing and Feature Comparison

Basic pricing and feature availability for common eSignature vendors. signNow appears first per comparison format; verify vendor plans before purchasing.

signNow DocuSign Adobe Sign PandaDoc HelloSign
Starting Price $8/user/mo $15/user/mo $14/user/mo $19/user/mo $15/user/mo
Free Trial 7-day free trial Varies by plan Varies by plan Varies by plan Varies by plan
Bulk Send Yes Yes Yes Yes No
Audit Trail Yes Yes Yes Yes Yes
HIPAA Compliant Yes Yes Yes No No

Security and Compliance Controls to Include

Encryption: TLS 1.2/1.3; AES-256 at rest
Audit Trail: Comprehensive IP and timestamp logs
BAA Availability: Business Associate Agreement required
Access Controls: Role-based permissions and SSO
21 CFR Part 11: Supported for regulated records
Certifications: SOC 2 Type II and ISO 27001

Consequences of Incomplete or Invalid Consent

Civil Liability: Malpractice or tort claims possible
Regulatory Sanction: State licensing board actions
Invalid Consent: Treatment authority may be void
Billing Denials: Payer claims may be refused
HIPAA Fines: Breach penalties and corrective actions
Reputational Harm: Loss of patient trust

Practical Tips for Reliable Consent Documentation

Adopt consistent practices that reduce errors, support legal defensibility, and integrate with clinical workflows.

Verify patient identity before signing
Confirm full legal name and date of birth against medical record or government ID. Identity mismatches can invalidate the consent or create adverse safety events; document the method used for verification.
Use plain language for explanations
Avoid medical jargon. Describe benefits and risks in terms the patient can understand and check comprehension verbally; document the patient's questions and clinician responses on the form.
Record exact medication instructions
Include dose, route, schedule, and storage instructions. Precise directions reduce medication errors and support accurate dispensing and nursing administration.
Ensure secure storage and exportability
Store signed consents in the EHR and a secure archive with export options; maintain audit trails and ensure records are retrievable for audits and transfers of care.

Time-Sensitive Dates and Review Intervals

Track key dates on the consent form to ensure validity, timely review, and compliance with clinical and legal requirements.

Signature Date:

Date the form at the time of signing; establishes the effective consent date.

Effective Date:

Specify when medication administration begins if different from signature date.

Periodic Review:

Schedule reassessment for high-risk medications or long-term therapies.

Revocation Notice:

Document how and when a patient may withdraw consent.

Retention Trigger:

Record retention timelines begin at signature or last effective date.

Real-World Examples of Consent Use

Two representative scenarios illustrate how the form is used across care settings.

Outpatient Clinic Example

A primary care clinic documents counseling for a new antihypertensive medication, including risks and alternatives, answered patient questions.

  • The clinician signs the attestation.
  • The signed consent is stored in the EHR, printed for the patient, and remains available for future medication reconciliation and audits.

Long-Term Care Example

A nursing facility obtains guardian consent for psychotropic medication after documenting capacity assessment and alternatives.

  • Staff witness the signature.
  • The consent accompanies the resident's chart, triggers pharmacy verification, and is reviewed at monthly care plan meetings to monitor efficacy and side effects.

Common Pitfalls to Avoid

  • Incomplete medication details, such as missing dose or route, can lead to administration errors and liability exposure.
  • Using medical jargon without plain-language explanation reduces patient comprehension and undermines informed choice.
  • Failing to document questions asked and answers given can weaken legal defensibility of the consent.
  • Relying on undocumented verbal consent or unsigned forms risks invalidation and payer or regulatory disputes.

Frequently Asked Questions About Medication Consent

Answers to common operational and legal questions when preparing or digitizing an informed consent for medication.


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