Healthy Skepticism Library item: 13661

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Publication type: news

Taylor L.
New ABPI Code targets relationships, ADRs
Pharma Times 2008 May 12
http://www.pharmatimes.com/uknews/article.aspx?id=13458&src=EWorldNews

Full text:

The new version of the Association of the British Pharmaceutical Industry (ABPI) Code of Practice, which takes effect on July 1, requires drugmakers to provide more details about their relationships with health care professionals and patient associations, and includes specific requirements for companies on informing patients about how and where to report adverse drug reactions (ADRs).

Also, and for the first time, it requires firms to make public the details of all ongoing clinical trials.

Clause 4.10 of the amended Code states that all promotional material (other than promotional aids) must include “prominent” information about ADR reporting mechanisms. This can be done by including a statement such as “Information about adverse event reporting can be found at www.yellowcard.govt.uk” followed by: “adverse events should also be reported to [the relevant pharmaceutical company].” A phone number for the relevant department at the drug firm may be included here, says the Code, which goes on to advise companies that: “text is more likely to be deemed to be prominent if it is presented in a larger type size than used for the prescribing information.”

The Code’s new requirements also include the need for companies to make publicly available a short description of their support for patient groups, whether this is financial or “significant indirect” support, and for sponsorship declarations to “accurately reflect” the nature of the company’s involvement.

Companies will need to have a contract for health professionals and others employed as consultants, and they are “strongly encouraged” by the Code to require consultations to declare this as an interest. It also encourages firms to make publicly available information about donations and grants to institutions and other bodies that support health care and research.

Other changes to the Code include: – more guidance on meetings and hospitality, with further curbs on “extravagant” entertaining; – more limitations on the supply of samples which, the Code stresses, must never be used to promote a product’s usage; – publication of interim reports of Code case proceedings when the need to audit the company’s procedures will delay publication of the final report; – and advertisements giving details of the outcome of certain cases investigated under the Code are now to be published in the nursing media as well as in medical and pharmaceutical journals.

The 50-year-old Code is operated, at arm’s length from the ABPI, by the Prescription Medicines Code of Practice Authority (PMCPA). The new revisions to the current Code, which dates from January 2006, are based in part on the European Federation of Pharmaceutical Industries and Associations’ (EFPIA) revised Code on the Promotion of Prescription-only Medicines to and Interactions with Healthcare Professionals, which was adopted by the EFPIA Board on September 28 2007, and the Federation’s new Code of Practice on Relationships between the Pharmaceutical Industry and Patient Organisations. Both codes are required to be adopted by all EFPIA member associations no later than July 1. In addition, the new ABPI Code includes amendments which reflect “experience, comments and suggestions received since the introduction of the 2006 Code,” comments ABPI president Chris Brinsmead.

- The Yellow Card (YC) side effects reporting scheme was set up in 1964 in the wake of the thalidomide tragedy. In February, the Medicines and Healthcare products Regulatory Agency (MHRA) launched a scheme to encourage consumers to use the scheme by getting pharmacists to discuss it when they talk to customers about their medicines. The MHRA says it receives around 20,000 YC reports of suspected side effects annually.