A recent GP case reinforces key lessons for doctors including discussing any new material risks or side effects that emerge when treating patients who have been taking medications for a long time. It also highlights the importance of updating and documenting a patient’s consent to treatment.
As this member case illustrates, consent to treatment is not a simple tick-box exercise. It’s a process involving conversations between doctor and patient where an understanding is gained of the patient’s aims, expectations and concerns. Risks are explored, including those risks which are material to the patient. What is appropriate to discuss from a risk perspective will vary from patient to patient and may change over time.
Complaint based on insufficient risk information
The patient was a heavy smoker and her medical history included type 2 diabetes, hypercholesterolaemia and coronary artery stenting following a myocardial infarction. Given her risk of cardiovascular disease, the doctor had recommended statin therapy, which led to a marked improvement in her cholesterol levels.
Several years after starting statin treatment, the patient reported nocturnal paraesthesia and numbness affecting her right thumb and forefinger, which would resolve quickly after changing bodily position. Later, she complained of soreness and altered sensation in the same hand.
Subsequently, the patient made a complaint to the state’s complaints body alleging that she had not been given sufficient information about the risks and side effects of taking statin medications. The patient, who had been taking statins for two decades, claimed she had developed peripheral neuropathy within six months of commencing statin therapy. However, she did not report this to the doctor at the time.
Response demonstrates good care
In response to the complaint, the doctor was able to demonstrate that she had good medical notes. This included documenting regular cardiovascular risk assessments and counselling regarding the patient’s risk of a cardiovascular event in the absence of statin therapy. Different medications were also trialled.
At the time the patient was commenced on statin therapy, the doctor discussed the known risks of liver damage and muscle inflammation. In more recent years, the risks of diabetes onset and memory loss were also discussed with the patient, as evidence of those risks emerged. The doctor did not discuss the risk of peripheral neuropathy on the basis there is no clear evidence in the medical literature that peripheral neuropathy is a known risk of statin therapy.
The doctor referred the patient to a neurologist whose investigations confirmed C6 radiculopathy and significant spinal cord stenosis at C5-6. The neurologist also expressed concerns that she had undergone chiropractic neck manipulation. The patient underwent cervical spinal decompression and reported her paraesthesia had partially resolved.
Extensive investigations by specialists in the fields of neurology, neurosurgery, cardiology and immunology showed no evidence of muscle disease related to statin use, or that the patient’s symptoms were associated with neuropathy. The patient was diagnosed with psychogenic dystonia and remained convinced her symptoms were caused by the statin therapy.
No action taken
In this case, it helped that our member was a highly experienced GP who was used to dealing with challenging patients. The patient was clearly fixed in her views as to the cause of her symptoms, even in the face of specialist opinions, multiple investigations and alternative diagnoses. The evidence suggested the ongoing symptoms were more likely due to her advancing age, cervical spondylosis and psychogenic dystonia.
The complaints body took no regulatory action against the doctor, finding the care and treatment provided was reasonable, and no clinical issues were identified requiring further investigation. No concerns were raised regarding the patient’s consent to undergo statin therapy.
In this case, the doctor’s consent process held up to scrutiny and her records were a key factor in her defence. However, the case reinforces that patients need to be given sufficient information about the benefits and risks of a treatment to make an informed decision, and that the benefits and risks may change over time.
- Informed consent is a process involving discussions between the doctor and patient to clarify the patient’s aims, expectations and concerns.
- In circumstances where a patient has been taking a treatment for a significant period of time, consider whether you need to update their consent to treatment and discuss any new material risks or side effects which have emerged. Remember, what is material will vary from patient to patient.
- Record your discussions with the patient in the medical records.
- If appropriate, refer the patient for specialist opinion, arrange investigations and liaise/seek support from colleagues.
- If you feel the doctor-patient relationship has broken down to the extent that you can no longer provide care in the patient’s best interests, it may be appropriate to refer the patient to another doctor, as we recommended to the member in this case.
If you receive a complaint, please contact us for medico-legal advice at firstname.lastname@example.org or on 1800 128 268, available 24/7, after hours and on weekends in emergencies.
eLearning course: Consent: informed consent and more
Factsheet: Consent: the essentials
eLearning course: Medical records: Chapter one – documentation
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