audit of isotretinoin prescribing practices n.
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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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  • 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?
acne why treat
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
  • 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

current recommendations
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
prescribing rights
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
the debate
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:

inequalities of access to isotretinoin
Inequalities of access to Isotretinoin

PHARMAC Consultation Letter(30th October, 2008)

  • 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
results 1
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
results 2
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
results 3
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
conclusions and discussion
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
  • 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
further research
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