Implanon and Medical Indemnity

Report authors Dr Beres Wenck, Chair of the Royal Australian College of General Practitioners (RACGP) National Committee GP Advocacy and Support, and Penelope Johnston, National Risk Manager at MDA National, say the medical profession is increasingly accepting the need to incorporate risk-management strategies into medical practice.

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 in two stages.

The first stage was to contain potential costs of litigation 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 RACGP was enlisted to develop clinical 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 when such treatments and devices are to be used in general practice," Ms Johnson said.

The Medical Journal of Australia is a publication of the Australian Medical Association.