Journals advertisements

Finally, at launch and beyond, plans need to be in place for journal advertising and detailing of the product to doctors by sales representatives. As noted above, the customer base of pharmaceuticals is complex and the needs of individual customers differ. For GPs and specialists, information about the product will be via advertising, representative detailing and mailings. For NHS staff such as those working in Health Authorities or within PCOs, the information will need to be more focused on cost effectiveness and service provision. For practice nurses, the emphasis will be on educational materials and practical aspects of the product s use. Disease awareness programmes for patients will be developed where appropriate. 

Numerous other detailed provisions exist in the Code, for example, dealing with the use of the word safe, the provision of prescribing information on audio-visual material, the number of pages permitted in a journal advertisement and, most recently, the internet (see Section 12.3.1.4). 

Complaints about pharmaceutical advertising made under the ABPl Code of Practice are taken up by the PMCPA. The PMCPA was established by the ABPl as from 1 January 1993 to administer the ABPl Code of Practice and consists of a director, secretary and deputy secretary. The authority is responsible for the provision of advice, guidance, conciliation and training on the Code of Practice, as well as for the operation of the complaints procedure. It is also responsible for scrutinising journal advertising on a regular basis. 

The PMCPA also carries out a routine scrutiny of journal advertising under which advertisements are checked for compliance with the code on straightforward matters. Where potential breaches of the code are identified, these are taken up with the company concerned. Only where the matter raised under scrutiny cannot be settled between the Authority and the company is it then referred through to the Panel and the Appeal Board for a formal ruling. 

Sponsors are required to submit copies of promotional materials, for example, journal advertisements, detail pieces such as file cards, etc. to FDA at the time of initial dissemination. This means that the sponsor is to submit them to FDA simultaneously with the use of that piece or program. It is also possible for companies to engage FDA in review of proposed programs or advertisements, in order to gain feedback on acceptability. This is particularly important for broadcast advertisements aimed at consumers, such as those viewed on television. If promotional materials are deemed to be violative by FDA, for example, if they are false and misleading, a sponsor must withdraw the advertisements and in some cases undertake new campaigns to correct the objectionable statements. 

In the case of a journal advertisement where the prescribing information appears overleaf, at either the beginning or the end of the advertisement, a reference to where it can be found must appear on the outer edge of the other page or double page spread of the advertisement in a type size such that a lower case x is no less than 2 mm in height. 

See Clause 4 and in particular Clause 4.7 regarding the requirements for prescribing information in journal advertisements. 

With these caveats in mind, 1 now briefly examine various ratios (Table 9.2). Rosenthal et al. (2002) report that while DTCA increased from 1.2% of total revenues in 1996 to 2.2% in 2000, over this same time period, hospital-based promotion and medical journal advertising decreased from 1.6% to 1.1 % of total revenues. Although the DTCA-to-sales ratio fell slightly in 2001 and 2002, by 2003, at 2.2%, its value is the same as in 2000. These numbers. 

The physician s involvement in clinical research does not end with the completion of the clinical study. Medical reports, clinical study reports, and sections of NDAs must be written. Interactions with regulatory agencies that require the physician s input may occur frequently. Physicians in clinical research may also be called upon to promote new drugs in a scientific environment by organizing symposia and workshops and by reviewing journal advertisements and promotional material for medical validity and accuracy. 

Abbreviated journal advertisements (with only the indication being given in the advertisement, bound into a publication and no larger than 420cm2) must contain the asterisked peirticu-lars and a statement that further information is available on request to the licence holder or in the Summary of Product Characteristics or data sheet. 

Promotional material such as mailings and journal advertisements must not be designed to disguise their real nature. Where a pharmaceutical company pays for, or otherwise secures or arranges, the publication of promotional material in journals, such promotional material must not resemble editorial matter. 

Printed promotional materials include journal advertisements, stand panels, etc. 

Journal advertising must comply with the following ... 

All promotional materials, including journal advertisements, must be accompanied by either full or abridged PI. 

Skill 4.3 Evaluating the credibility of scientific claims made in various forums (e.g., mass media, professional journals, advertising). 

---