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Consent Form Isotretinoin

All patients

Read the following statements carefully and ask questions if anything is not clear. Do not sign the consent form unless you agree with these statements:-

  • I have been informed of common risks of treatment including dryness of the skin, eyes and lips; nosebleeds; sun-sensitivity; muscle and joint aches; impaired night vision and increased fats in the blood (hyperlipidamia).
  • I have been informed of rarer risks of treatment including inflammation of the liver (hepatitis) or pancreas (pancreatitis); raised pressure within the brain; sexual side effects (which rarely can persist after stopping treatment) and inflammatory bowel disease.
  • I understand that this is not a complete list of all possible side effects and that additional side effects that are not widely recognised at the present time may become apparent in the future.
  • I have been informed that isotretinoin can cause mood disturbance and depression and has rarely been associated with suicide. I will immediately stop taking isotretinoin and contact my doctor if I notice changes in my mood or depression.
  • I understand that I must not donate blood during treatment with isotretinoin and for at least one month afterwards.
  • I understand that I will require regular follow up appointments (after one month and then at a minimum every three months) and blood tests (a minimum of one blood prior to treatment and one blood tests whilst taking isotretinoin). I understand that if I take isotretinoin without completing the advised blood tests I am risk of serious or life-threatening side effects.
  • I have been provided with a patient information leaflet produced by the British Association of Dermatologists on isotretinoin. I understand that this contains critical safety information and I will read this in detail prior to starting treatment.
  • I am aware that acne may worsen once Isotretinoin has been started. Rarely this can lead to a severe flare of the acne resulting in scarring.

Female only

Read the following statements carefully and ask questions if anything is not clear. Do not sign the consent form unless you agree with these statements:-

  • I understand that isotretinoin can cause serious birth defects and that I must not take isotretinoin if I am pregnant or breast feeding.
  • I understand that if I am sexually active I must use two methods of contraception for at least one month prior to treatment, for the duration of treatment and for a minumum of one month after completing the course of treatment.
  • I have been informed that I must tell my doctor immediately and stop taking isotretion if I become pregnant or believe that I may be pregnant.
  • I have been informed that the Medicines and Healthcare products Regulatory Agency advises that all women with child-bearing potential are enrolled in a pregnancy prevention programme (full details are available in the British Association of Dermatologists patient information leaflet). This includes the requirement to attend the clinic monthly for a pregnancy test. I am aware that should I opt out of the pregnancy prevention programme I am responsible for not becoming pregnant during the course of treatment.

I would like to participate in the pregnancy prevention programme:

OR

I would like to opt out of the pregnancy prevention programme:

By signing the form I have confirmed that I have read the above information and have had adequate time to make a decision about my care. I have confirmed the site(s) and procedure(s) and I have had the opportunity to ask questions about the treatment and alternatives. I have been provided with aftercare instructions. I consent to the above procedure(s) and to photographs being taken for my confidential medical record.
You must sign the consent form.
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