2.  To analyse the counselling, prescribing and monitoring practices of Isotretinoin by doctors in my practice.  Are we adhering to guidelines?  Where can improvements be made to help mitigate the risks of using Isotretinoin?

3.  Acne is common and is suffered by most teenagers and up to half of adults  0.6-1.4% of young adults have severe acne  Up to half of 12-20 year olds with acne develop psychological or social problems

4.  Teratogenecity - Even a single exposure can cause severe birth defects - Review in NZMJ indicated that the pregnancy rate on Isotretinoin in NZ had been underestimated  Increased depression/suicidality - Studies have failed to demonstrate a clear link

5.  Pre-prescription counselling  Two forms of adequate contraception  Consent form  Baseline LFTs, FBC, fasting lipids, beta HCG (if female), repeated at 1 month and at end of treatment  Monthly pregnancy test and three- monthly LFTs  Regular monitoring of mood

6.  As of 01 March 2009, General Practitioners and Nurse practitioners became eligible to prescribe fully funded Isotretinoin under SA  Previously access to fully funded medication only through dermatologists  Debate in NZ and internationally, strong opposition by dermatologists

7. Arguments for: Arguments against:  GPs have better awareness of overall history  GPs are better placed to address counselling issues and contraception  GPs experienced in prescribing complex medicines  Avoid long travel and wait times to see a specialist dermatologist  GPs lack training and my find it difficult to ascertain dose requirement  Larger number of pregnancy exposures  Larger exposure to potential mental health side effects  Dermatologists see more acne patients  Pressure to prescribe

8. PHARMAC Consultation Letter(30 th October, 2008)

9.  Medtech32 query build searching for prescriptions of Isotretinoin from 01/03/2009 to present day  Difficulties with change in trade name  Classifications for “Acne Vulgaris” and special authority submissions  16 patients identified  Analysed pre-prescription counselling, consent procedures, contraception advice, mood monitoring, blood monitoring and side effects

10.  56% female, 44%male  Age range 14 to 51, mean age 17.8 years  Documented discussion of adverse effects in all but 1 patient  Consent in medtech in 56%  Discussion about need for 2 forms of contraception documented in 57% of applicable

11.  BetaHCG ordered with baseline bloods in 75% of women but measured sporadically after that  Three monthly bloods were ordered in 81% but only 63% were undertaken  Documentation of mood monitoring in 44%, 13% had a known history of depression

12.  79% with dry skin, lips and eyes  Other side effects – muscle aches, ↑cholesterol, and deranged LFTs (all 7% each)  Two patients stopped treatment due to significant side effects, one for hair loss and the other due to suicidality

13.  Isotretinoin is being prescribed appropriately  Pre-prescription counselling – mostly done over one session  Lack of documented consent, selection of appropriate consent form  BetaHCGs not routinely checked prior to prescriptions  Patient compliance with blood tests  Serious risk of harm with 2 out of 16 patients with significant side effects

14.  Two sessions for initial consultation  Best practice consent form  Mandatory beta-HCGs prior to every prescription  Adequate documentation of mood at every consult  Strategies to improve patient compliance  Best Practice Decision Support module is a good tool to use

15.  Comparing results with GP practices from different areas, particularly looking at whether access to Isotretinoin has truly improved  Comparing results with dermatologists to see if there are any differences in how well we monitor our patients