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. 2012 Nov 26;98(1):31–42. doi: 10.1210/jc.2012-2909

Table 3.

Standards for oral TKI use in thyroid cancer patients

General practice standards

  1. Standardized treatment regimens (medication, dosage, and route of administration)

  2. Standardized written protocol for drug-specific laboratory and diagnostic testing

  3. Protocol for frequency of office visits and monitoring

  4. Group policy for obtaining informed consent and templates for each drug

  5. Specialty prescriptions and supportive resources (including financial) for each medication

  6. Easily accessible referral list for specialty consultants

  7. Policies and procedures for practitioners on call and emergency response team

Patient information/education

  1. Informed consent (obtained before initiation of therapy) to include:

    1. Information regarding diagnosis and extent of disease

    2. Goals and duration of therapy

    3. Adverse events and treatment of common adverse events

    4. Symptoms that require notification

    5. Contact information (daytime, on-call, and emergency contact information)

    6. Medication-specific informed consent reviewed with patient, signed by patient, and placed in permanent medical record

  2. Education/monitoring

    1. Patient education materials reviewed and provided to patient

    2. Review with patient frequency of office visits, laboratory and diagnostic imaging planned

Documentation

  1. Patient chart (documented when therapy initiated)

    1. Pathological confirmation of diagnosis

    2. Initial cancer stage and cancer status

    3. Medical history and physical exam (including vital signs and pain level) as well as assessment of performance status and organ function-specific TKI to be used

    4. Allergies/hypersensitivity reactions

    5. Patient comprehension of disease, treatment options, and current treatment regimen

    6. Receipt of patient informed consent

    7. Assessment of psychosocial concerns and support available

    8. Plan for follow-up, frequency of office visits, and monitoring

  2. Orders/prescribing

    1. Standardized order set that includes medication name, dosage, and route of administration

    2. Orders for initial and subsequent laboratory and diagnostic testing (per established evidence-based guidelines)

    3. Incorporate into patient's medical record either a written prescription, a standardized preprinted/electronic prescription, or specialty pharmacy prescription

Monitoring

  1. Patient documentation at each clinic visit

    1. Interim history changes

    2. Changes in clinical status, weight, performance status, and/or vital signs (including pain)

    3. Evaluation of adverse events related and unrelated to TKI using standardized definitions (example NCI CTCAE)

    4. Patient's psychosocial concerns and support

    5. Current medications (including possible interactions)

    6. Documentation of dose modification

    7. Documentation of disease status (if applicable)

  2. General practice standards (to be regularly assessed)

    1. Medication-specific protocols regarding: frequency of office visits, laboratory, and diagnostic studies to be performed

    2. Policies and updated group guidelines

      1. Daytime, on-call, and emergency contact information

      2. General order sets

      3. Quality of care