What information is required for informed consent for Winrho (Rho(D) immune globulin) administration?

Informed Consent Requirements for WinRho Administration

Informed consent for WinRho (Rho(D) immune globulin) administration must include disclosure of potential serious adverse events including hemolytic anemia, intravascular hemolysis, disseminated intravascular coagulation, renal failure, and rare risk of death. 1

Essential Information for Informed Consent

Medication Information

• Full medication name: Rho(D) immune globulin (WinRho)
• Purpose of administration (prevention of RhD alloimmunization or treatment of ITP)
• Route of administration (IV preferred, especially in thrombocytopenic patients; IM as alternative) 2
• Dosage calculation (25 mg/125 IU per 1 mL of RhD-positive RBC exposure) 2

Risk Disclosure

• Common adverse effects:

  • Hemolytic anemia (dose-limiting toxicity)
  • Fever and chills 1
  • Headaches
  • Flushing
  • Blood pressure changes and tachycardia

• Rare but serious adverse effects:

  • Intravascular hemolysis
  • Disseminated intravascular coagulation (DIC)
  • Renal failure
  • Rare risk of death 1
  • Hypersensitivity reactions in patients with IgA deficiency 3

Special Warnings

• WinRho is derived from human plasma and carries theoretical risk of transmitting infectious agents despite screening measures 3
• Bleeding complications may occur in patients with thrombocytopenia or bleeding disorders 3
• NEVER administer intravenously for certain formulations (e.g., HyperRHO S/D Full Dose) 3
• NEVER administer to neonates 3

Documentation Requirements

Healthcare providers must document in the patient's permanent medical record:

• Date of WinRho administration
• Manufacturer of the product
• Lot number
• Name, address, and title of person administering the product 1
• Edition date of vaccine information materials provided to patient
• Date these materials were provided 1

Consent Process

While the National Childhood Vaccine Injury Act does not explicitly require a signature for consent, documentation of informed consent is recommended and may be required by certain state or local authorities 1. The consent process should include:

1. Discussion of benefits and risks
2. Alternative treatments if applicable
3. Opportunity for questions
4. Documentation of the consent discussion

Special Considerations

• For patients with bleeding disorders: Use a fine needle (23 gauge or smaller) and apply firm pressure to the site without rubbing for at least 2 minutes if administering intramuscularly 1
• For patients with IgA deficiency: Weigh benefits against potential hypersensitivity reaction risks 3
• For patients receiving WinRho for ITP: Be aware of transient cytokine/chemokine production that may cause initial side effects 4

Practical Approach to Consent

1. Provide written information about WinRho
2. Discuss all potential risks and benefits verbally
3. Document the discussion in the medical record
4. Obtain written consent when possible
5. Ensure emergency equipment is available during administration

Following these guidelines ensures proper informed consent that prioritizes patient safety while meeting regulatory requirements for WinRho administration.