Code of Conduct - Question & Answers

11. Service Oriented Items - August 2005
 
Question 1:
We have been engaged by a client to develop a patient website and patient brochure for a new medication for women. PAAB has nearly completed the process of approving the website and brochure, and has asked us to submit this question to you “as a courtesy” to ensure that the peripheral complies with the Rx & D code of conduct. Included in our design for the patient brochure is a digital peripheral designed to assist patients maintain regimen compliance.

The peripheral included in the patient brochure is a digicard housing an electronic diary. It may be uploaded to any pc-compatible electronic device running Windows XP or 2000 and allows her to do the following in an interactive mode:

• Set the date/time for her daily consumption of her medication so she may be reminded of it;
• Have easy electronic access to monograph instructions on what to do in case she has forgotten to take the medication;
• Have electronic access to information relevant to the medication approved for the website and the brochure and related to its proper use;
• Use the digicard to record other information at the patient's discretion.

Is this peripheral, which is to be included in the patient brochure and thus available to the patient only once she has been prescribed the medication, compliant with the Rx & D code?

Response:
This “digicard” is acceptable, only once the patient has been prescribed the product. At the same time the digicard should meet all of the requirements of PAAB, including the type of information that can be provided to the patient. Please note that at no time may the company provide a patient with an electronic device i.e. a PDA to upload the information.

Question 2:
Requesting your assessment of a project. The project is a Physician Experience Kit, which is requirement project for the launch of X.

The project description is as follows:

8 x 10 paper bag with rope handle with X branding design and company X, PAAB and Rx&D logos (latter two, if applicable), and company X product code for warehousing. The only copy on the bag is, “Please consult Prescribing Information for details on Dosage and Administration, Warnings and Precautions and patient selection criteria.”

The bag, or Physician Experience Kit, as it is named, will be handled by the rep and handed to the physician as a patient treatment trial. The rep will include a few pill bottles, in the dose range he deems the physician will require to adequately assess patient treatment, the X Dose Card, Product Monograph and a non-X branded information patient pamphlet.

We will be printing 700 of these trial bags for delivery to company X reps.

Please provide us with your recommendations or approval. PAAB is requesting some form of assessment before they can provide theirs.

Response:
As the “bag” in question may be used for more than the “Physician Experience Kit” it does not meet the Rx&D Code of Conduct.

Question 3:
We have a product that we consider a Service Oriented Item and removed the name of our product as well as all the information relating to X. We will only display the name of our company.

My question is the following:
Is it possible to write with the name of the company: "Supports the appropriate use of antibiotics"

Response:
Please refer to Section 11, Article 11.2. It is upon to member companies to gauge compliance with the general principle set out in Section 11, Article 11.1.