Implanon and medical indemnity: a case study of risk management using the Australian standard.

The contraceptive implant Implanon (Organon) was introduced in Australia in May 2001, and in the next 18 months was associated with an unprecedented number of adverse incident reports to medical indemnity insurers, including almost 100 unintended pregnancies. The medical indemnity insurer, MDA National, responded to this by applying the Australian and New Zealand Standard for Risk Management (AS/NZS 4360: 1999) in two stages. The first stage was to contain potential costs by moving the treatment into the general practice procedural category, resulting in a one-year moratorium on its use for most general practitioner members (prudential risk management). The second stage was to manage the clinical risk by developing strategies to reduce identified risks associated with the procedure. The Royal Australian College of General Practitioners (RACGP) was enlisted to develop guidelines for use of Implanon, with a consent form and checklists for doctors and patients, enabling MDA National to reinstate the treatment to the general practice non-procedural category. This case demonstrates the need for early risk assessment and development of risk-management tools for new treatments and devices, a role that is appropriate for the RACGP.