# Draft Questions for Lotronex Advisory Committee

April 16, 2002

2:45 p.m.

Questions:

1.  Should Lotronex be made available to patients with irritable bowel
    syndrome (IBS) through restricted marketing?

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a.  If yes, describe the patient population for which the benefits of
    the drug outweigh the risks. For example: Should the degree of
    disability, severity of symptoms, chronicity of IBS, failure of
    conventional IBS therapies, or sex be taken into account? If so,
    how?

b.  If no, clarify whether Lotronex should be withheld completely from
    the market or if marketing of Lotronex without restrictions is
    acceptable. Explain your rationale.

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2.  Process controls for **patients** prescribed Lotronex

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a.  Should patient registration be a part of a risk-management program?
    Why or why not?

b.  GlaxoSmithKline (GSK) has proposed a utilization study of the
    UnitedHealthcare Research Database (UHC) as a mechanism to audit
    whether appropriate patients are being prescribed Lotronex. Is this
    auditing mechanism adequate to achieve this goal? If not, please
    describe an appropriate auditing mechanism.

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a.  GSK has proposed a pharmacy-based study using the Slone Epidemiology
    Unit and Eckerd Corporation to audit patients' knowledge and
    awareness of the risks and benefits of Lotronex. Is this auditing
    mechanism adequate to achieve this goal? If not, describe an
    appropriate auditing mechanism.

b.  Define adequate performance on the knowledge survey.

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3.  Process controls for **physicians** prescribing Lotronex:

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a.  Should the risk-management plan limit prescribing to certain
    physicians? If so, what types of physicians and what qualifications
    are needed?

b.  Should physician registration be a component of a risk-management
    plan? Why or why not?

c.  GSK has proposed a plan in which physicians self-attest to their
    qualifications by signing the "Section for the Physician" on the
    Patient-Physician Agreement. This agreement is then filed in the
    patient's medical record. The agreement is not filed at a central
    location. Is this proposal adequate to evaluate physician adherence
    to the program (e.g., the extent of Lotronex prescribing outside of
    the program)? Why or why not? In not, describe an appropriate
    auditing mechanism.

d.  Define an adequate level of adherence to the program by physicians.

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4.  Process controls for **pharmacists** dispensing Lotronex:

> GSK has proposed that pharmacists accept only written prescriptions
> with an affixed sticker and that the pharmacists dispense a Medication
> Guide when the prescription is filled or refilled. Is this proposal
> adequate to evaluate pharmacist adherence to the program? Why or why
> not? If not, describe an appropriate auditing mechanism.

5.  Evaluation of safety outcomes:

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a.  Should clinical outcomes (e.g., ischemic colitis, severe
    constipation, and death) be used to assess the success of the
    risk-management program? For example, should the rates and/or degree
    of severity of ischemic colitis and constipation be monitored with
    the specific goal of evaluating the effectiveness of the program?
    Why or why not?

b.  If so, specify the adverse events that should be assessed. Describe
    acceptable rates for these adverse events and/or acceptable degrees
    of severity.

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6.  Please provide any additional comments that you may have about a
    Lotronex risk-management program, such as the need for additional
    studies.