In a bid to tighten its voluntary code of practice, the Association of the British Pharmaceutical Industry has proposed various amendments that address a familiar array of issues, such as prescribing information, disclosure of clinical trial data and relationships with patient organizations. Most amendments refine existing language. One notable change, though, would be a stricter stance toward giving away samples, or starter packs as they are more commonly called, for use in emergency situations.
An amendment acknowledges that packs really are promotional in nature and states that distribution to primary care prescribers under such circumstances would not be permitted. By contrast, the existing code insists packs are not samples. "Starter packs are small packs designed to provide sufficient medicine for a primary care prescriber to initiate treatment in such circumstances as a 'call out' in the night or in other instances where there might be some undesirable or unavoidable delay in have a prescription dispensed," according to the current language.
This definition would be removed. Why? The proposed amendments result from changes to the Code of Practice of the International Federation of Pharmaceutical Manufacturers and Associations, another trade group, and to UK law. Specifically, the sample amendment cites government policy that "there is no role for short-term supplies provided by pharmaceutical companies to medical practitioners for use in emergency situations" and that the use of starter packs are not appropriate. The amendment also notes that the UK's Medicines and Healthcare products Regulatory Agency considers packs to be samples for promotional or advertising purposes (read the amendment here).
In the US, you may recall, drugmakers regularly distribute samples. The Code of Practice adopted by the Pharmaceutical Research and Manufacturers of America trade group, known as PhRMA, states that "it is appropriate to provide product samples for patient use in accordance with the Prescription Drug Marketing Act," which was passed in 1987 and guides how samples may be distributed (read here and here is the PhRMA code).
However, the proposed amendment to the ABPI code leaves intact the notion that titration packs, free good and bonus stock provided to pharmacists and others are not samples.
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