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Audit of Isotretinoin prescribing practices

Audit of Isotretinoin prescribing practices. By Philippa Ho. Aim. To analyse the counselling, prescribing and monitoring practices of Isotretinoin by doctors in my practice. Are we adhering to guidelines?

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Audit of Isotretinoin prescribing practices

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  1. Audit of Isotretinoin prescribing practices By Philippa Ho

  2. Aim • 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 – why treat? • 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. Isotretinoin • 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. Current Recommendations • 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. Prescribing Rights • 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. The Debate Arguments for: • 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 Arguments against:

  8. Inequalities of access to Isotretinoin PHARMAC Consultation Letter(30th October, 2008)

  9. Method • 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. Results 1 • 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. Results 2 • 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. Results 3 • 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. Conclusions and Discussion • 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. Recommendations • 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. Further research • 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

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