The pill implicated in blood clot death
A woman who died of a blood clot was not adequately informed of the risks of taking the combined oral contraceptive pill, the Health and Disability Commissioner has found.
In a decision released today, commissioner Anthony Hill said a GP at an unnamed medical centre breached the health code by prescribing the combined oral contraceptive pill Estelle without a proper assessment of the woman's suitability or recording of her blood pressure.
The doctor's documentation was poor and she had failed to tell the woman of her risk factors and alternatives.
Other GPs at the centre who provided repeat prescriptions of the pill for the woman without discussions of its risks and alternatives were found to have fallen below an appropriate standard of care.
The medical centre also breached the code by failing to ensure the woman's ongoing use of Estelle was adequately monitored, the commissioner found.
According to Medsafe, there are several risks associated with taking a combined oral contraceptive such as Estelle. Users have a fivefold increased risk of developing thromboembolism. There is also an increased risk of stroke and cardiovascular risks in some women.
The deceased woman was overweight, a smoker, over 35-years-old, and had a family history of thromboembolism. She was therefore at significant risk of developing deep vein thrombosis, and not a good candidate for the pill, the comissioner said.
However, she also suffered from polycystic ovary syndrome, which Estelle is used to treat.
The woman had been prescribed Estelle until 2005, when her GP deemed it to be unsuitable because of the risk factors. She was instead prescribed the mini pill, which does not carry the same risks.
In November 2007, she transferred to a different medical centre, and asked to change back to Estelle. This was prescribed by a new GP, who did not document the prescription or any discussion of the risks associated with it or alternative options.
The GP told the commission she thought the woman was "was aware of her risk factors" because she had taken Estelle before.
Between 2008 and 2011, three different doctors provided repeat prescriptions of Estelle, but there were no medical reviews undertaken and little documented evidence of a discussion about risk factors, the commission found.
High blood pressure can indicate an increased risk of stroke while on the pill, but the woman's blood pressure was not recorded until October 2009.
Each GP assumed the previous doctor had discussed the risks and alternatives.
In early 2011, the woman went to a different GP with a swollen and painful leg, which was confirmed to be superficial vein thrombosis - much less serious than deep vein thrombosis - and treated.
Later that year, she underwent surgery to remove her gallbladder.
The woman was discharged the day after her surgery. Two weeks later, she died suddenly at home of a pulmonary embolism, thought to have been caused by deep vein thrombosis in her calf.
It was not the commissioner's job to determine cause of death or whether the care provided by the GPs or hospital contributed to the woman's death.
The woman had a right to make a choice about her treatment, and there was evidence to suggest she chose to use Estelle, the commissioner said.
But she also had the right to be fully informed before making that choice.
"Instead of taking responsibility for discussing risks and alternatives with [the woman], her GPs assumed that other providers had done so, in the absence of any documentation to support such an assumption," he said.
"In my view, basing treatment decisions and the provision of information on assumptions alone is a dangerous practice."
The commissioner recommended both the GP who prescribed Estelle and the medical centre apologise to the woman's family.
The medical centre underwent an audit, and was found to have instigated remedial actions as a result of the incident.
The woman is survived by her husband and two young children.