Code of Conduct - Question & Answers

11. Service Oriented Items - October 2005
 
Question 1:
We are concerned about a new dose form for two of our products. Physicians need to specifically write XX on the prescription in order to get XX. Otherwise what happens is the patient will get the older formulation of X. In another case at our company, there has been confusion with other products with similar sounding names.

We as an industry are not permitted to provide prescription pads for physicians. In light of this, some companies (not sure which ones) have provided a product stamp for prescription pads which is not subject to misinterpretation due to hand writing. Could you ask what the ruling is on creating these ink 'stampers' to provide for physicians to reduce any risk of misinterpretation of hand-writing.

Response:
The Code of Conduct stipulates “member companies must not distribute service-oriented items (…) which cannot be justified if subjected to scrutiny by members of the health professions and the public.” The definition of an “acceptable service-oriented items are those whose primary goal is to enhance the health care practitioner's or patient's understanding of a condition or its treatment.” If an item helps to ensure that the patient gets the treatment his/her health care professional intended to prescribe, then it falls into the “acceptable service-oriented items” category.

Question 2:
Company X is proposing to initiate a Smart-Sample program with the firm Sampling Technologies Inc (STI). This program involves the use of sampling cards for Rx drugs which patients receive from physicians instead of regular samples.

According to Sampling Technologies, the Smart-Samples have been used by over 20 brand name pharmaceutical and diagnostic manufacturers in Canada for over 30 brands in the Canadian market.

One of the elements of this program is a printed card with two detachable sections:

Part 1 (the SmartSample) is a pre-printed prescription sample card which the physician fills in (for a limited quantity of medication to evaluate patient response) and gives to the patient instead of the regular samples; the patient in turn uses this card to obtain the samples from the pharmacy.

Part 2 (Physician Convenience Prescription) is a pre-printed prescription for the same product which the physician fills in and gives to the patient at the same time as the sample card. If the patient is satisfied with the response to treatment and has no adverse effects, he/she can then return to the pharmacy to have the prescription filled.

According to the supplier, SmartSample®,has been fully endorsed and approved by Health Canada's Therapeutic Product Directorate on August 19, 2002. Provincial pharmacy regulatory bodies have approved STI's offerings before their launch into the market. SmartSample® and the SmartSample / Physician Convenience Prescription format have had their development lead by advisory Boards (Physician and Pharmacy) who have expertise in medicine and pharmacy, aligning their recommendations with Canada's Food and Drug Act, the Provincial Pharmacy Act and a special interest in optimal patient care and patient safety.

STI's sampling process also adheres to Canada Research-Based Pharmaceutical Companies Code of Conduct with respect to Clinical Evaluation Packages (“Samples”), by following the rules of Canada's Food and Drug Act and adhering to a format that has the interests of HCP's and patients at heart.

STI presented to the Rx&D Operations Support Group, September 24, 2003 on the SmartSample® sampling process. However, at the time the Physician Convenience Prescription (Part 2) had not been implemented.

Our question pertains to the Physician Convenience Prescription (Part 2 of the program):

Specific to chronic therapies and optimal patient care, physicians and regulatory bodies provided STI with SmartSample® improvement recommendations post launch. A new SmartSample® format for chronic therapy use was developed to include a continued therapy section (Physician Convenience Prescription – part 2) which would be monitored (logged) at pharmacy with the sample, and whose use is determined solely by the physician after a decision has been made to prescribe the sample. We believe this product is aligned with Section 3 and 11 (3.1.2 and 11.2) of the Rx&D Code of Conduct “They (CEP's) can also be used, when appropriate, to determine a patient's clinical response to drug therapy before a full course of therapy is prescribed” by involving the pharmacist on continuation of therapy after a CEP has been tolerated for a chronic illness.

The rationale for the prohibition of pre-printed prescription pads is that their use was deemed inappropriate because it influenced the prescribing decisions of the physician prior to making the choice on a medication being prescribed and offered no added educational value for Healthcare Professionals. In contrast, the physician decides whether or not to fill out the Physician Convenience Prescription after they have already decided to provide a free sample of the SmartSampled brand. The physician has the added comfort of involving another HCP, the pharmacist, in monitoring a patient's progress post sample, which actually builds on the recommendations in the Rx&D Code of Conduct, Section 3.2.2, on clinical evaluation packages.

Could you please confirm if the Physician Convenience Prescription (part 2 of the program) is in compliance with the Rx & D Code?

Response:
Please refer to Section 11 of the Code of Conduct. It is upon the member company to gauge compliance with General Principles set out in Section 11, specifically, member companies must consider how such services-oriented items may be perceived by health care professionals and the public.

Question 3:
X is considering a sample/prescription technology offered by companies such as STI (sampling technologies incorporated) and Formedic PTM, whereby physicians are offered coded and branded leave behinds (no product claims, all according to Health Canada Regulations), which, once completed by the physician, become a prescription for the indicated product. The completed prescription entitles the patient to receive a sample quantity of medication at no charge from their pharmacy of choice (pharmacy is reimbursed the dispensing fee + cost of goods from the pharmaceutical company). Additionally, the option exists to provide the physician with the follow up prescription (tear off or sticker to affix to MD prescription pad), which they would also give to the patient, to fill subsequent to the “trial prescription”. It is our understanding that several Rx & D member companies are currently utilizing this technology. We would like to ensure that both components of these programs are within the spirit and code of Rx&D.

Response:
It is our understanding that Health Canada and other regulatory bodies have endorsed a sample technology. It is up to the member company to: 1. Ensure that this endorsement is still valid, and 2. To respect the criteria of Section11.