2011年4月26日 星期二

Yes, you need to explain to your patients whenever you prescribe steroids (though I do not agree).


Important message 
The important message here is that unless you are ready to go to the Court of Final Appeal, it is highly likely that you will be found professional misconduct if you get complaint by your patient for giving steroids without voluntary notification and explanation to the extent that he can make an informed choice. 

The judgment from the Court of Appeal 
A paediatrician was found guilty of professional misconduct in 2008 for three charges:
  1. without proper justifications, he prescribed to the patient Celestamine which contained steroid for treating the patient’s upper respiratory tract infection on about 26 occasions;
  2. he prescribed to the patient Celestamine which contained steroid without advising the patient’s parent about the nature and side effects of Celestamine;
  3. upon enquiry of the patient’s father on whether Celestamine contained steroid, he did not reply him in the positive and instead, he told him that Celestamine was not regarded as a steroid.

He appealed to the Court of Appeal against all three charges.  The judgment was handed down on March 8, 2011 (CACV 374/2008).  The appeal against all charges was dismissed and the doctor remained guilty of professional misconduct.  What concerned me most is the second charge.  The charge was constructed in a way that a doctor was strictly liable to advise about the nature and side effects of steroids when prescribed.  In fact I have written on this subject several times before.  The sad news is that the Court of Appeal seemed to agree to this strict liability.  Let us have a look at the judgment.

Hon Tang Ag CJHC agreed that the Appellant could not be blamed for not informing the parents of any side-effect because none was expected from the dosage and duration of steroid given.  However, he also agreed to the judgment of the Medical Council that the Appellant failed to inform the parents of the nature of Celestamine that it contained steroid.  He quoted the judgment from the Medical Council:

Judgment of Medical Council: Para 14 and 15
For a medicine which has known potential side effects, patients should be advised of its nature so that they can make an informed choice as to whether to accept the medicine.  Steroid is such a medicine, as it has been shown to have some significant side effects.  There is general concern about the use of steroid, and patients should be given the proper advice before it is prescribed.  This is so even if the dosage prescribed does not have any side effect.  It must be borne in mind that patients are not medically trained and so are unlikely to understand technical medical terms.  While it is neither necessary nor helpful to advise patients of the chemical composition of the medicine, patients should be informed in laymen terms what the medicines are.

We bear in mind that Celestamine in the dosage prescribed has no significant side effects.  However, there was a danger that the patient might see other doctors and if the other doctors also prescribed steroid this might result in a dosage which would increase the risk of side effects…

Hon Tang Ag CJHC ruled that the above “is a finding which the Medical Council was entitled to make, and I can see no reason to disagree.” 

My observations
  • No one seems to care anymore about the basic principle of innocent until proved otherwise.  Was the doctor below expected standard in the first place?  Had he breached the Code?
  • The Code at 9.6: Where a drug is commonly known to have serious side effects, the doctor has the responsibility to properly explain the side effects to the patient before prescribing the drug.  Note that only “side effects” are mentioned here.  And in fact it should be “serious side effects”.
  • However, in the charge, the doctor is expected to explain the nature and side effects of Celestamine.  Note that “the nature” was added and this became the crucial point for upholding the second charge in the appeal.  There was also another twist in the judgment: “For a medicine which has known potential side effects, patients should be advised of its nature…”  There was a change from the logical “explanation of side effects if there are serious side effects” in the Code to “advise of nature when there are known potential side effects”.  Can anyone think of any medication that does not have known potential side effects?
  • I do not buy the reasons given in the Medical Council judgment.  I consider them reversal of the burden of proof.  Speculation that a patient would like to know doesn’t mean that failure to do so by the doctor equates professional misconduct.
  • The long-shot argument that there might be prolonged use by other doctors if the nature of steroid was not explained was in fact adequately addressed by the strict requirement of drug labeling.
  • An awkward situation is expected.  Now imagine that you are a patient.  Your doctor explains to you in a serious manner that he is going to give you a drug that contains steroid.  However, there is absolutely no side effect expected from the dosage and duration given.  My natural response is why he wastes time to tell me this nonsense?  Then I would suspect that he must be hiding something and he is luring me to give consent to something serious.  And then if I were a guy who follows the Medical Council logic, I would try to take all the other medications that the doctor gives me in excess dosage and prolonged duration than that prescribed, thinking that they should be safe as they are not specifically warned against like the case of steroids. 
  • Finally, note the comment by the judge.  He just quoted the Medical Council judgment and said that the Medical Council was “entitled” to make such judgment.  He was right not to step too much into professional judgment.  If the medical professional wants to require the doctor to explain to patients each and every nature and side effect of each and every drug, just let it be. 

My advice 
No matter you find the above argument and observation absurd or logical, they should be for interest only.  They should not be given more weight than the article of food and romance by Dr. Eve LAI.  What you should remember absolutely is the fact that it is now established firmly that doctors need to explain to patients the nature and side effects of steroids or steroid containing medications when they are prescribed.  It is highly likely that consent from patient is needed for steroids.  Regarding how the side effects be explained when there is no side effect, I can give no advice.


(Source: HKMA News April 2011)