Do doctors need to advise patients of every possible side effect?
Short answer: no.
I. Now what?
The saga continues. A doctor wrote in to the Straits Times Forum (I’m sure he was just one of many doctors who wrote in). His main point was that it is not practical for doctors to flag every possible side effect. He gave an example of Panadol having more than 20 potential side effects and the difficulty of informing patients of all potential adverse effects. [Link]
Based on my conversations, it seems like most folks are concerned that it is unreasonable to expect doctors to list every possible side effect when prescribing medication, especially in the GP / Polyclinic setting.
II. And your take?
I agree! It is not practical to list all possible side effects when prescribing medication. But the forum letter reflects a key misunderstanding.
There is no obligation for doctors to flag out every possible side effect when prescribing medication.
III. But Dr Lim got fined $100,000 for precisely that!
Hold on. Let’s take it step by step.
First of all, let’s take a closer look at actual case involving Dr Lim. Go on, read it. [Link]
…
Actually, who am I kidding? You’re not going to read it. You’re just going to rely on me to summarise it right? Fine.
The key points to note are :-
(a) Dr Lim pleaded guilty to a charge of “professional misconduct” under section 53(1)(d) of the Medical Registration Act (“MRA”).
(b) The MRA does not define what is “professional misconduct”. But Dr Lim pleaded guilty to the charge that :-
- he had acted in breach of the SMC Ethical Code and Ethical Guidelines (“ECEG”);
- in that he failed to obtain informed consent from the patient, as would be expected from a reasonable and competent doctor in his position;
- in that he failed to advise the patient of the risks and possible complications arising from the treatment;
- which amounts to such serious negligence that it objectively portrays an abuse of the privileges which accompany registration as a medical practitioner.
Woah that’s a pretty big mouthful. But the heart of the matter is that SMC considered his breach of the ECEG to amount to “professional misconduct”.
So let’s see what the ECEG says about prescribing medication. [Link]
“B5. Prescription of medicine…
(3) You must ensure that patients are informed of the purpose of the medicine
prescribed and the expected results. You must ensure that patients know
the more common and important drug interactions and side effects, or
those likely to be significant to specific patients.
(4) You must always elicit a history of drug allergy. If this history is unclear, you must justify the material risks of prescribing the drug or class of drug and the patients must understand and consent to the risks.”
So the SMC expects doctors to flag the more common and important side effects. SMC does not expect doctors to list all side effects.
My view is further reinforced when we look at the 2002 edition of the ECEG (which has been replaced by the current edition). [Link] Let’s see what it says about prescribing medication.
“4.1.3 A doctor shall prescribe, dispense or supply medicines only on clear medical grounds and in reasonable quantities as appropriate to the patient’s needs. This includes prescription by a doctor for his own use. Patients shall be appropriately informed about the purpose of the prescribed medicines, contraindications and possible side effects.”
In other words :-
(a) in the past, the SMC required doctors to ensure that patients are “appropriately informed” about “possible side effects”; but
(b) now, the SMC requires doctors to ensure that patients know the “more common and important” side effects, including side effects “likely to be significant to specific patients”.
You see the difference? There is no longer an obligation to inform patients of all side effects. It looks like the SMC eased up slightly (for once?)
For completeness, I should highlight that Dr Lim admitted to a breach of the obligation to provide informed consent [Guideline 4.2.2], and not a breach of obligations in relation to the prescription of medication. But again, my focus here is on the more typical GP / Polyclinic situation where there is more time pressure on doctors.
IV. Ok, so can you give me a simple summary?
Sure. When prescribing medication, there is no need to list every single possible side effect. But you should flag the more common and important side effects. And if you have reason to believe that certain side effects are likely to be significant to specific patients (e.g. drowsiness is significant to a heavy machinery operator!), flag out those side effects to those patients.
V. Dude this is still very complicated.
But it’s not as bad as having to list out every single side effect right. And for the record, please don’t have a habit of spamming patients with possible side effects — this hinders effective communication which is also an obligation under the ECEG [Guideline C2]. And your patients will develop a headache for which they will need yet another prescription.
VI. Hold on, but what does this have to do with the Hii Chii Kok test?
Good question! This post focuses on SMC disciplinary proceedings (which Dr Lim was fined under). In an upcoming post, I will discuss what doctors should do to avoid being sued by patients (which is a different risk altogether).
In the meantime, get in touch if you have a burning query that just can’t wait!
As usual, this is not legal advice, for general information only, etc etc. You know the drill.
