EU ROACCUTANE/ISOTRETINOIN PREGNANCY REPORTING FORM
FOR ROCHE USE ONLY / Initial / Follow-upRoche Received Date: / Local No: / MCN:
Report Type: / Prospective / Retrospective
1. / REPORTER INFORMATION
Reporter Name:
Type: / Physician (speciality) / Pharmacist / Consumer / o Other (Specify)
Contact Address: / Telephone Number:
Fax Number:
Postal/zip Code: / E-mail:
2. / EXPOSED PARENT'S DETAILS
Who was exposed: / Father / Mother / Initials / Date of Birth:
d / d / m / m / m / yyyy
Height: / inch / cm / Age at Conception:
Weight: / Ibs / Kg / Postal Code (France only)
Ethnic origin: / Black / Caucasian/white / Asian / Other / (Specify)
3. CURRENT MEDICATION (Enter all relevant medications taken before and during pregnancy, including contraceptive medication, or if father
exposed enter medication taken prior to conception only)
Drug Name
(Generic/trade) / Suspect / Lot/
Batch# / Manufacturer / Route / Strength and Formulation
(25mg, cap, tab)
1.
2.
3.
4.
5.
Dosage Regimen / Start Date
dd/mmm/yyyy / Stop Date
dd/mmm/yyyy / Ongoing / Indication for Use
1.
2.
3.
4.
5.
4. PREVIOUS ACNE TREATMENT
Drug Name
(Generic/trade) / Lot/
Batch# / Manufacturer / Start
(mmm,yyyy) / Stop
(mmm,yyyy) / Route / Strength, Form
& Dose
(25mg, cap, tab)
1.
2.
3.
4.
EU ROACCUTANE/ISOTRETINOIN PREGNANCY REPORTING FORM (Cont'd)
Roche Received Date: / Local No: / MCN:
Report Type: / Prospective / Retrospective
5. PREGNANCY INFORMATION
LMP Date: / Est. / Estimated Date of Delivery:
d / d / m / m / m / yyyy / d / d / m / mm / m / yyyy
Conception
Date: / Est. / Date of positive pregnancy test:
d / d / m / m / m / yyyy / d / d / m / m / m / yyyy
Reason for pregnancy:
6. MEDICAL HISTORY
Contraception (may choose more than one) / Number of Previous / Risk Factors/
Medical History
None / Condom / Pregnancies / Unknown
Contraceptive Medication / Surgical Sterilisation (Male) / Therapeutic
Abortions / Alcohol
(please specify in Section 3) / (Female)
Allergies*
Diaphragm / Withdrawal / Spontaneous
Abortions / Diabetes*
IUD / Rhythm / Infection*
Infertility (Male) / Unknown / Stillbirth / Smoking
(Female) / Reason for chosen methods: / Deliveries / Drug abuse
Spermicide / Babies born
with defects / Epilepsy*
Asthma*
If none – why? / Hypertension*
(*specify below)
Other/Relevant History (further information on any of the above including medical conditions that may be associated with
congenital anomalies - include dates and outcome)
7. PREGNANCY STATUS
Pregnancy ongoing / Premature delivery / Spontaneous abortion / Ectopic pregnancy
Normal delivery / Stillbirth / Threatened abortion / Unknown
C-section / Therapeutic abortion / Missed abortion / False positive pregnancy
(Provide date of test below)
Provide Date if applicable:
d / d / m / m / m / yyyy
8. RELEVANT LABORATORY TESTS/PROCEDURES PRE AND POST OUTCOME (e.g. Amniocentesis, ultrasound)
Tests
/ Results
units and normal values if applicable /
Pending
/ Pre/Post Outcome? / Datedd/mmm/yyyy
1. / Pre
Post
2. / Pre
Post
3. / Pre
Post
Further Details:
EU ROACCUTANE/ISOTRETINOIN PREGNANCY REPORTING FORM (Cont'd)
Roche Received Date: / Local No: / MCN:
Report Type: / Prospective / Retrospective
9. INFANT/FOETAL OUTCOME
Unknown
Lost to follow up
Number of infants/fetuses / (In the event of more than 1 infant/fetus complete Infant Information section 9 – 11 on a separate form)
Normal baby
Normal fetus
Birth defect (structural/chromosomal) / specify
Other disorder (non structural,premature birth) / specify
Death / Date / Cause of death:
d / d / m / m / m / yyyy
Autopsy results:
10. / INFANT INFORMATION
Initials:
Gender: / Weight: / Length: / Head Circumference:
Male / Ibs / inch / inch
Female / kgs / cm / cm
Gestational Age at Delivery/Abortion / (weeks)
Apgar Scores / 1 Minute / 5 Minutes / 10 Minutes
Were there any unusual features about the pregnancy or its outcome?
Yes / No
If Yes, specify
Follow-up Examination of the Child:
Date:
d / d / m / m / m / yyyy
Findings:
Paediatrician (in case of referral); Name:
Address: / Telephone No:
Fax No:
E-mail:
11. RELEVANT LABORATORY TESTS/PROCEDURES FOR BABY/FOETUS
Tests / Results
(unit and normal values if applicable) / Pending / Date
dd/mmm/yyyy
1.
2.
3.
4.
EU ROACCUTANE/ISOTRETINOIN PREGNANCY REPORTING FORM (Cont'd)
Roche Received Date: / Local No: / MCN:
Report Type: / Prospective / Retrospective
12. PREGNANCY PREVENTION CHECKLIST
PLEASE COMPLETE FOR PATIENTS PRESCRIBED ROACCUTANE
1. Counselling regarding the risks of pregnancy during Roaccutane therapy and contraceptive methods was done prior to
Rocaccutane by: / Not done
2. Baseline Pregnancy Test to qualify for Roaccutane therapy? / Yes / No
Type: / Date:
d / d / m / m / m / yyyy
3. Was monthly follow-up done? / Yes / No / N/A
4. Was monthly follow-up pregnancy testing done? / Yes / No / N/A
Most recent test / Type: / Date: / Result:
d / d / m / m / m / yyyy
5. Was a pregnancy test done 5 weeks after stopping Roaccutane? / Yes / No / N/A
Type: / Date: / Result:
d / d / m / m / m / yyyy
6. Was the patient verbally warned about pregnancy risks? / Yes / No
7. Did the patient sign an acknowledgement form? / Yes / No / Not applicable
Date:
d / d / m / m / m / yyyy
8. Was the patient given a Patient Brochure on Contraception? / Yes / No
9. Was the patient given a Patient Information Brochure? / Yes / No
10. Were other written materials given to the patient? / Yes / No
Please specify:
11. Was the prescription for Roaccutane handled as per dispensing limitations? / Yes / No
30 Day Supply? / Yes / No
7 Day prescription validity? / Yes / No
12. Were the patient’s chosen contraceptive methods discussed with the prescriber? / Yes / No
13. Did the patient verbalise an understanding of pregnancy risks and contraceptive
methods presented to her? / Yes / No
Reporter Signature: / Date:
If completed by Roche delegate, ensure the data completed reflects the reporter's opinion
FOR ROCHE USE ONLY / Signature: / Date:PRINT NAME:
OPTIONAL SUPPLEMENTARY INFORMATION FORM FOR EU ROACCUTANE/ISOTRETINOIN PREGNANCY REPORTING
FOR ROCHE USE ONLYRoche Received Date: / Local No: / MCN:
ADDITIONAL INFORMATION (Optional):
Signature:
Date:
Version 1, July 2003