Tuesday, August 16, 2011

CASE 2: Discussion with the Examiner Station (8 mins)

A Medical Representative visited your practice to discuss with you a relatively new medication Drug A.  It is a new antidepressant and has shown to be as effective as the traditional SSRI but with a better tolerance profile.

Discuss with the Examiner on what do you need to know before prescibing this new medication for your patients.

(What is your approach to this case?)


  1. Before prescibing this new medication to my patients, I need to know some details about the study/studies from which the conclusions have been drawn that this new antidepressant has shown to be effective as the traditional SSRI but with a better tolerance profile.

    1. The topic is relevant to general practice, could possibly influence treatment choice, and is applicable.

    2. However, need to appraise the quality and hierarchy of the study.

    ---hierarchy of evidence (from high to low)

    systematic r/v and meta-nanlysis > randomised controlled trial with definite results > randomised controlled trial with no definitive results > cohort studies > Case control study > cross - sectional survey > case reports

    ---- quality of the study
    > how the study was designed/conducted?
    > sample: size, randomised?
    > BIAS: sponsor for the study? double blind?
    > measurement: end point of the study
    > time and period of the study?
    > statistical analysis, P value
    > results/conclusion relevant and conclusive?

    3. I don't think it's proper to be paid for the visit to discuss this new medication. I would like to have information and read the article, then make my decision whether I am going to prescribe the medication to my patient without bias.

    4. other points?

    Dr Tricia

  2. Tricia

    The trial is a double blind study comparing with one of the traditional SSRI. What else "specifically" do you want to know about the study?

    Dr Vinh Tran MBBS FRACGP

  3. I particularly want to know whether the study was a randomised controlled study, and comparison of the baseline characteristics between the two groups in the following aspects-
    1. sample size,
    2. duration of the study,
    5. concomitant medications in the 3 months before and during the study
    6. pre -existing comorbidities,
    7. medical encounters before and during the study, such as clinic visit, hospitalisation, diagnosis and treatment


  4. Tricia,

    Can you clarify the points further???

    For example...in 1) you mentioned sample size...I presume that you mean the larger the study the better.....etc etc...

    Dr Vinh Tran

  5. Thanks for pointing out this. Yes, I mean the larger the study the better and also compare the size between the two groups.


  6. Tricia,

    Can you clarify further? eg...
    Is the study group representative of my patient?
    Is the results biased ??is it sponsored by drug company
    etc etc.....

    Dr Vinh Tran

  7. Before presentation of the new drug, vested or potentially conflict of interest should be brought out first. like this drug is from company A where i work, compared to company B..etc
    FDA approval..medicare schedule..etc
    of course you have to ask about the type of study done, samples, stats, adverse reactions, short/long term follow up..etc tricia mostly covered it above

    but if your patient is getting better with the ssri you are using then why change?

    1. Your last comment is quite valid. Often we need to remind ourselves that in medicine, "new" is not necessarily better and "new" often means that it has been less "trialled and provened" and may not be as safe as the "old and tested". Hence, when one wants to use a new drug, we must have a good reason for it and not just to "try it" for the sake of "trying it".

  8. I Would Like to know about the side effects of the Medication.
    know the available long term benifit
    I would Like to check if ther eis any human control trial proving benifit to patient.
    is there ant study or trial comparing other commonly used anitdepressant