Doctors 'need not list all possible side effects' of drugs or treatment

SINGAPORE — Doctors do not have to lay out “every possible side effect and potential complications” of a drug or treatment, Senior Minister of State for Health Lam Pin Min clarified in Parliament on Monday (Feb 11).

He was responding to questions from Members of Parliament about a recent case in which orthopaedic surgeon Lim Lian Arn was fined S$100,000 for failing to inform his patient of possible complications that could arise from a steroid injection which he was giving her.

The severity of the fine triggered an outcry among the medical community. Dr Lam said there could be a review of disciplinary processes and the sentencing framework for errant doctors.

The Ministry of Health (MOH) will discuss the issue with medical professionals and associations, "in the context of a broader review of the current rules, processes and legal position", he said.

“We will continue to look at some of the concerns of the medical profession... and at the same time, if necessary, review disciplinary process(es) and even amend the law moving forward.”

He also clarified that the outcome of this case did not mean that a doctor must lay out every possible side effect and potential complications of a drug or treatment.

“Dr Lim admitted that he was guilty of failing to inform the patient of any risks and complications; he was not found guilty for failing to inform the patient of all possible complications that could arise from the H&L Injection.”

The Singapore Medical Council, the watchdog that had taken Dr Lim to task, said the same about two weeks ago, when it reassured doctors here that they need only to convey “relevant and material” information to their patients and not all possible complications of a treatment or procedure.

BACKGROUND

Dr Lim was brought in front of a disciplinary tribunal after his patient complained that he had failed to advise her on the possible complications arising from an injection of a steroid and local anaesthetic treatment known as an H&L injection.

He pleaded guilty to a charge of professional misconduct and asked for the maximum fine of S$100,000 in lieu of suspension, or a three-month suspension if warranted. The SMC was initially seeking a five-month suspension.

After considering sentencing precedents and the facts and circumstances of the case, the tribunal agreed with Dr Lim’s lawyers that the maximum fine of S$100,000 would be an appropriate sentence.

The case caused an uproar in the medical community, with doctors arguing that it is not standard practice to tell patients of all minor side effects arising from procedures or medicine, especially if the treatment is common and the risk is generally low, as in the case of the H&L injection.

In the weeks following the sentence, more than 6,000 people — including doctors — signed an online petition asking MOH to clarify its stand on the need for doctors to obtain “informed consent” from patients for minor procedures. 

QUESTIONS RAISED

Members of Parliament noted that the case could have possible implications on the practice of medicine, with regard to what constitutes “informed consent” and what is material information that is required to be disclosed to patients.

Non-Constituency MP Daniel Goh asked exactly how many side effects a doctor should list, and cited the possible scenario in which a doctor does not inform a patient about one potential side effect that ends up afflicting the patient.

Nominated MP Irene Quay asked if the S$100,000 penalty was commensurate with similar cases in the past, while Mr Desmond Choo (Tampines GRC) asked how MOH would reassure doctors that only egregious cases will attract heavy penalties.

Dr Lim Wee Kiak (Sembawang GRC) asked whether the case could be reopened, and if the current maximum fine of S$100,000 for disciplinary cases would be reviewed.

MOH’S RESPONSE

Dr Lam clarified that “it is wrong to infer” that the SMC’s ruling in Dr Lim’s case “makes it mandatory for a doctor to lay out and get the consent of a patient for every possible side effect and potential complications of a drug or treatment”.

The SMC had also said in January that “remote risks with minor consequences” will generally be deemed immaterial and do not need to be disclosed.

What information a doctor needs to give a patient, before a treatment or procedure, will depend on the “specific facts of the case, including the (patient’s) particular circumstances”, Dr Lam said.

He also noted that there has been considerable concern in the medical profession about the maximum fine having been imposed on Dr Lim.

“The concerns are understandable, when considering the facts and circumstances of this case. Many fair-minded doctors would think that the penalty imposed was harsh,” Dr Lam said. However, he pointed out that Dr Lim had asked for the fine in lieu of suspension.

He added that the case would not be reopened, as the sentence had been decided by the disciplinary tribunal and accepted by both Dr Lim and the SMC.

The appointment of a Sentencing Guidelines Committee at the beginning of this year will help in ensuring consistency and fairness in sentencing, and improve transparency and rigour in the disciplinary process, he said.

The Health Ministry “will carefully consider what steps are necessary to maintain the trust between patients, doctors, SMC and MOH”, Dr Lam said.