Memo
From: [physician name]
Re: Interferon and Ribavirin Combination Therapy
is being evaluated prior to treatment for chronic Hepatitis C (HCV). Patients with risk factors for retinal
disease (e.g. diabetes and hypertension) should receive a complete ocular and retinal examination prior
to instituting peginterferon and this examination should be repeated if the patient develops changes in
vision during treatment. The information on ophthalmologic side-effects of interferon and ribavirin
combination therapy for HCV is:
Ophthalmologic Disorders
Decrease or loss of vision, retinal artery or vein thrombosis, retinal hemorrhages and cotton wool spots,
optic neuritis, and papilledema are induced or aggravated by treatment with alpha interferons. All patients
should receive an eye examination at baseline. Patients with preexisting ophthalmologic disorders (e.g.
diabetic or hypertensive retinopathy) should receive periodic ophthalmologic exams during interferon
alpha treatment. Any patient who develops ocular symptoms should receive a prompt and complete eye
examination. Interferon treatment should be discontinued in patients who develop new or worsening
ophthalmologic disorders.
Date of evaluation:
Findings:
Patient is:
Cleared for interferon plus ribavirin therapy
Not cleared for interferon plus ribavirin therapy
Physician Signature:
Physician Name (printed):
Address:
Phone Number:
Please fax completed form to [physician fax number].
Memo
From: [physician name]
Re: Interferon and Ribavirin Combination Therapy
is being evaluated prior to treatment for chronic Hepatitis C (HCV). The information on cardiac side
effects of interferon and ribavirin combination therapy for HCV is:
Cardiovascular Events
Cardiovascular events, which include hypotension, arrhythmia, tachycardia, cardiomyopathy, angina
pectoris, and myocardial infarction, have been observed in patients treated with interferon. Interferon
should be used cautiously in patients with cardiovascular disease. Patients with a history of myocardial
infarction and arrhythmic disorders who require interferon therapy are closely monitored. Patients with a
history of significant or unstable cardiac disease should not be treated with interferon plus ribavirin
combination therapy. The primary toxicity of ribavirin is hemolytic anemia. Reductions in hemoglobin
levels occurred in approximately 10% of patients treated with ribavirin/interferon alfa therapy.
The patient has the following cardiac risk factors:
Male gender
Smoker
Diabetes Mellitus
Hypertension
Hyperlipidemia
Family history of premature atherosclerotic cardiovascular disease
Date of evaluation:
Findings:
Patient is:
Cleared for interferon plus ribavirin therapy
Not cleared for interferon plus ribavirin therapy
Physician Signature:
Physician Name (printed):
Address:
Phone Number:
Please fax completed form to [physician fax number].
Memo
From: [physician name]
Re: Interferon and Ribavirin Combination Therapy
is being evaluated prior to treatment for chronic Hepatitis C (HCV). The information on psychiatric side
effects of interferon and ribavirin combination therapy for HCV is:
Neuropsychiatric Events
Life-threatening or fatal neuropsychiatric events, including suicide, suicidal and homicidal ideation,
depression, relapse or drug addiction/overdose, and aggressive behavior have occurred in patients with
and without a previous psychiatric disease during pegylated interferon treatment and follow-up.
Psychosis, hallucinations, bipolar disorders, and mania have been observed in patients with a history of
psychiatric disorders. Patients should be advised to report immediately any symptoms of depression
and/or suicidal ideation to their prescribing physicians. Physicians should monitor all patients for evidence
of depression and other psychiatric symptoms. In severe cases, pegylated interferon should be stopped
immediately and psychiatric intervention instituted.
Date of evaluation:
Findings:
Patient is:
Cleared for interferon plus ribavirin therapy
Not cleared for interferon plus ribavirin therapy
Physician Signature:
Physician Name (printed):
Address:
Phone Number:
Please fax completed form to [physician fax number].
Memo
From: [physician name]
Re: Interferon and Ribavirin Combination Therapy
is being evaluated prior to treatment for chronic Hepatitis C (HCV). The information on endocrine side
effects of interferon and ribavirin combination therapy for HCV is:
Endocrine Events
Peginterferon causes or aggravates hypothyroidism and hyperthyroidism. Hyperglycemia, hypoglycemia,
and diabetes mellitus have been observed to develop in patients treated with peginterferon. Patients with
these conditions at baseline who cannot be effectively treated by medication should not begin therapy
with peginterferon. Patients who develop these conditions during treatment and cannot be controlled with
medication may require discontinuation of peginterferon therapy.
Date of evaluation:
Findings:
Patient is:
Cleared for interferon plus ribavirin therapy
Not cleared for interferon plus ribavirin therapy
Physician Signature:
Physician Name (printed):
Address:
Phone Number:
Please fax completed form to [physician fax number].
Disclosure and Consent to Take Interferon and Ribavirin
I understand that I will be taking the medications Interferon (Pegasys®, Peg-Intron®, or Infergen®), and
Ribavirin, very potent and potentially toxic drugs. After discussion of the nature, alternatives, risks, and
benefits of these medications with my physician, I agree to take them. I understand that Interferon and
Ribavirin are being used to manage my Hepatitis C. This combination has shown the highest efficacy in
treating Hepatitis C. I understand that there are risks to not treating chronic hepatitis C, including disease
progression, developing cirrhosis, liver cancer, and liver failure. I also understand there are risks and
hazards related to the use of these drugs.
The potential adverse effects of Interferon and Ribavirin include, but are not limited to:
1. Lack of response, with Hepatitis C still present after treatment.
2. Injection reactions, including pain, rash, and severe flu-like symptoms.
3. Neuropsychiatric symptoms, including sleep disorders, difficulty with memory and concentration,
psychosis, mood disorders, severe depression, and even suicide.
4. Increased risk of infections, including sepsis (blood poisoning), fungal and other infections,
pneumonia – all of which can be fatal.
5. Birth defects in children conceived while on the medication, or within 6 months of stopping the
medication.
6. Development of low blood counts, which can be fatal.
7. Development of eye problems including retinal hemorrhages.
8. Thyroid problems, which may persist after treatment.
9. Hair loss or thinning, which is usually reversible.
10. Autoimmune disorders, including arthritis, lupus, and psoriasis.
11. Increased risk of development of cancers, including lymphomas.
12. I understand that there may be other potential side effects not listed here.
I have been given an opportunity to ask questions about my condition, alternative treatment options, and
risks of treatment and I believe that I have sufficient information to give this informed consent.
I have had all of my questions and concerns answered to my satisfaction. I understand that I can refuse
to take Interferon and Ribavirin – in which case my disease will likely progress, possibly to cirrhosis and
liver cancer, and I may need a liver transplant. I understand that no warranty or guarantee has been
made to me as a result of using this drug or the possibility of curing my condition. I acknowledge that I
have been given a copy of this consent form with all blank spaces filled in and I can review it with others,
including legal counsel. I willingly give my consent to take Interferon and Ribavirin.
Signature:
Date:
Printed Name:
Patient’s Printed Name (if signed by Legal Representative):
Patient/Legal Representative
Side Effects of Interferon and Ribavirin in the Treatment of Hepatitis C
Interferon
Fatigue, malaise
Muscle aches
Headaches
Nausea, vomiting, loss of appetite
Injection site tenderness
Diarrhea
Fever, chills
Weight loss
Insomnia
Depression
Personality changes, forgetfulness, irritability, anxiety, emotional lability
Mild bone marrow suppression – decreased platelets, white blood cells
Dry, itchy skin
Hair loss (reversible)
Worsening of diabetes control
Ribavirin
Anemia
Dizziness
Fatigue
Itching/dry skin
Respiratory problems: mild shortness of breath, nasal or sinus congestion, cough
Nausea
Uncommon/Serious Side Effects
Bacterial infections (pneumonia, abscess)
Autoimmune disease flare (rheumatoid arthritis, lupus, psoriasis, etc.)
Severe depression, psychosis, disorientation, suicidal ideation
Substance abuse relapse
Seizures
Vision loss (retinal artery or vein thrombosis or ischemia)
Damage to the back of the eye (retinopathy)
Renal failure (interstitial nephritis)
Heart attack, weakened heart muscle
Birth defects (female patient or female partner of male patient)
Thyroid abnormalities (usually not reversible, but treatable)
Severe reduction in blood cell counts (white cells, red cells, and platelets)
Isolated loss of nerve function, “nerve palsy” (facial, oculomotor)
Pancreatitis (inflammation of pancreas)
I have reviewed and understand the above. My questions have been answered.
Patient Signature:
Date:
Patient Teaching Documentation Tool
Patient Name:
Date:
Present: Patient Spouse Family Significant Other Friend
Topic (check off when complete)
Pre-medication regimen
Treatment regimen
Medication Storage
Needed equipment provided (circle all that apply)
Needle/syringes vial alcohol pads sharp containers pillbox
Pharmaceutical provided kit: Schering Roche
Determining and preparing the correct dose
Inspecting the content inside the syringe
Selecting and rotating injection site
Site preparation
Needle Insertion/Injection
Sharps disposal
Follow-up labs and appointments; schedule and importance
Side effect management (Side Effects Module for the patient)
Patient education material and support information provided as desired
Pregnancy and contraception guidelines reviewed and reinforced
Need to avoid alcohol use reviewed
Consent form signed
I understand the instructions regarding the storage, preparation, and administration of my medication,
side effects and management, the importance of ongoing blood testing, and contact with staff during
treatment, and when to call.
Patient Signature and date
Staff signature and date
Pegylated Interferon/Ribavirin Treatment
Patient Name:
Genotype:
Liver Biopsy:
Viral Load:
Pegylated Interferon Injection
Dose: injected in fat under skin once weekly
Usually at bedtime
Choose the same day each week
Ribavirin Pills
Daily Dose: mg (pills/day)
Take pills every morning and pills every evening
Treatment Process
Call the office after your first injection
We will send you a schedule for office visits and monitoring lab tests for the next 24 weeks
Medication Refills
Order medication refills from your specialty pharmacy at least one week in advance of when you need
them
[Physician Name] • [physician phone number].
Gastroenterology Laboratory Request Form
Hepatitis C Treatment Labs
Date:
Patient’s Name:
Date of Birth:
Diagnosis: Chronic Hepatitis C ICD-9 Code: 070.54, 790.4, 573.3
Physician:
Please perform the following tests:
CBC and differential
Prothrombin time
Hepatic Function Panel
Basic Metabolic Panel
TSH
Iron
TIBC
Ferritin
HCV-RNA quantitation by PCR
Urine Pregnancy Test
Alpha fetroprotein level
(Last Name) (First Name) (M.I.)
CES-D Scale
(Department of Health and Human Services, National Institute of Mental Health)
Circle the number for each statement that best describes how often you felt or behaved this way during
the past week.
During the Past Week
0: Rarely or none of the time (Less than 1 Day)
1: Some or a little of the time (1–2 days)
2: Occasionally or a moderate amount of time (3–4 days)
3: Most or all of the time (5–7 days)
1. I was bothered by things that usually don’t bother me. 0, 1, 2, 3
2. I did not feel like eating; my appetite was poor. 0, 1, 2, 3
3. I felt that I could not shake off the blues even with help from my family or friends. 0, 1, 2, 3
4. I felt that I was just as good as other people. 0, 1, 2, 3
5. I had trouble keeping my mind on what I was doing. 0, 1, 2, 3
6. I felt depressed. 0, 1, 2, 3
7. I felt that everything I did was an effort. 0, 1, 2, 3
8. I felt hopeful about the future. 0, 1, 2, 3
9. I thought my life had been a failure. 0, 1, 2, 3
10. I felt fearful. 0, 1, 2, 3
11. My sleep was restless. 0, 1, 2, 3
12. I was happy. 0, 1, 2, 3
13. I talked less than usual. 0, 1, 2, 3
14. I felt lonely. 0, 1, 2, 3
15. People were unfriendly. 0, 1, 2, 3
16. I enjoyed life. 0, 1, 2, 3
17. I had crying spells. 0, 1, 2, 3
18. I felt sad. 0, 1, 2, 3
19. I felt that people disliked me. 0, 1, 2, 3
20. I could not get “going”. 0, 1, 2, 3
Center for Epidemiologic Studies Depression Scale (CES-D)/Monitoring Flow Sheet
Patient Name
Phone
Patient ID
Currently on antidepressant? Yes/No
Antidepressant/Dose:
Prior History of Depression? Yes/No
Prior antidepressant use? Yes/No
Antidepressant/Dose:
Month of Treatment
Date of Test
Your Initials
CES-D Score
Score >16? Yes/No
Intervention or Antidepressant/Dose
Baseline
Month 1
Month 2
Month 3
Month 4
Month 5
Month 6
Month 7
Month 8
Month 9
Month 10
Month 11
Month 12
Center for Epidemiologic Studies Depression Scale (CES-D) Scoring
The CES-D consists of 20 questions. Patients are instructed to circle the number for each statement that
best describes how often they felt or behaved this way during the past week. The score is the sum of the
weights for the 20 items. The weight for each item corresponds to the number
chosen for each (0–3), except for items 4, 8, 12, and 16, which are reversed (3–0). The possible range of
scores for the scale is 0–60. The following cut-off scores best approximate the severity stages of
depression: 0–9=none or minimal, 10–16 mild, 17–24 moderate, and >24 moderate to severe. Scores
greater than 16 have been considered to reflect the need for further assessment and evaluation of the
patient for depression.
Initials
Signature
Initials
Signature
Initials
Signature