The Australian Pharmaceutical Manufacturers Association Code of Conduct: guiding the promotion of prescription medicines

Promotional messages are designed to be persuasive. Pharmaceutical promotion can influence not only the use of a product, but also our beliefs about medicines. For this reason, it is essential that promotional information is accurate, balanced and not misleading. In Australia, the promotion of prescription medicines is regulated by legislation and guided by the Australian Pharmaceutical Manufacturers Association Code of Conduct. The Code sets standards for promotional activities, including the information content. The system is dependent upon a complaints mechanism for ensuring that promotion complies with the Code, as most promotional material is not monitored by an independent body before publication. Health professionals should lodge complaints against misleading or inappropriate promotion to enhance the effectiveness of the system.

Advertising and promotion are part of everyday life. In the U.S.A., people may be exposed to as many as 5000 advertisements each day. Health professionals are particularly exposed to the promotion of medicines. This appears in our journals, on the pens and notepads on our desks, on displays at the conferences and symposia we attend and it is brought to our attention during the visits of pharmaceutical representatives. It is so pervasive that it is easy to think that it plays no part in our lives nor has any influence on the way we use medicines. Unfortunately, studies tell us otherwise. Promotional practices are influential on our beliefs about medicines and also on prescribing.¹

Pharmaceutical promotion is a persuasive communication. It involves the conscious attempt to move health professionals from being unaware of a drug product's existence to a stage of repeated prescription. As promotion has the potential to change behaviour and because it is a major source of drug information for health professionals, the messages promoting prescribing should be factual, evidence-based, unambiguous and balanced.

Unfortunately, in many countries, promotion is not factual nor evidence-based. Inaccurate and inappropriate promotional claims abound and this has the potential to contribute to irrational drug use. For example, aspirin is commonly promoted in third world countries as suitable for use in children, while antihistamines are promoted as appetite stimulants and other medicines as brain tonics. Consequently, many countries around the world have regulated the promotion of medicines. The World Health Organization (WHO) advocates the regulation of promotion, urging all its member states to develop guidelines for promotional practice, which are consistent with national health policy and which support rational drug use. The WHO has published 'Ethical criteria for medicinal drug promotion' as a model for such guidelines.²

In Australia, promotion of medicinal drugs is regulated by government legislation including the Therapeutic Goods Act. The Australian Pharmaceutical Manufacturers Association (APMA) Code of Conduct is a guide for industry on how to advertise and promote prescription medicines. Acceptance and observance of the Code is a condition of membership of the APMA. The current membership covers 95% of the prescription medicines industry

The APMA Code contains standards for all types of promotional material including all printed and audiovisual promotional material. It also sets standards for pharmaceutical representatives, sample supply, hospitality, industry-sponsored market research and postmarketing surveillance studies, trade displays and communications aimed at the general public.

All promotional claims should be current, accurate, balanced and not misleading either directly, by implication or by omission. The Code also states that promotional material should be in good taste and that comparative information, if provided, should be factual, fair and capable of substantiation. Claims must conform to approved product information or to the scientific literature, but only if the latter does not conflict with the product information.

The Code restricts many activities including those proscribed by legislation. For example, prescription medicines cannot be promoted to the general public and companies cannot promote their products for indications which are not listed in approved product information. Starter packs cannot be left with receptionists unless there is a request form signed by the doctor. In addition, pharmaceutical representatives cannot promote products over the telephone unless you first agree, promotional material must not be marked for urgent attention, unsolicited reprints of journal articles must be consistent with product information and the word 'safe' cannot be used unless it is substantiated.

The majority of promotional material is not screened by an independent body before publication. Responsible companies, however, usually screen material in-house. The APMA has established a monitoring subcommittee that monitors promotional material retrospectively. In August 1996, this committee monitored 31 advertisements concerning central nervous system drugs which had been published between February and April that same year. Monitoring revealed that 26 (84%) were in accord with the Code, one (3%) was considered a technical breach of the Code and 4 (13%) were considered potential breaches of the Code.

The main means for ensuring that promotional claims are in accord with the Code's standards is through a complaints mechanism. Health professionals, pharmaceutical companies and other interested parties are encouraged to lodge complaints with the APMA when they perceive promotional practice to be inappropriate.

Complaints have to be in writing and include 'the nature of the practice being complained about and a simple explanation of the reason(s) for the objection'. Once lodged, complaints are heard by the Code of Conduct Subcommittee. This is chaired by a lawyer with experience in trade practice and includes medical, industry and consumer representatives. In the year 1 July 1997 to 30 June 1998, the APMA Code of Conduct Subcommittee evaluated 39 complaints, of which 32 were found to breach the Code.³

An example of a complaint lodged in 1997 is that concerning a promotional brochure that stated 'New [fluvoxamine]. It's the difference that matters'. The complainant suggested that some claims in this brochure were misleading and implied fluvoxamine was superior to other selective serotonin reuptake inhibitors (SSRIs) with regard to sexual dysfunction, adverse effects and drug interactions. It was found that 'statements inferring [fluvoxamine's] superiority over other SSRIs for drug interactions were incorrect and unsubstantiated', that 'figures quoted in the data implying [fluvoxamine's] superiority over other SSRIs regarding sexual dysfunction were inaccurate' and that 'the clinical relevance of the study used was unknown'.³

Deciding if a piece of promotion is misleading can be difficult, particularly if you are hearing about a new product for the first time. However, there are some common causes of misleading claims. These include claims based on poorly-designed studies, obsolete data, information outside of approved product information and the use of animal or in vitro data to support clinical claims.

To date, most complaints received by the APMA are lodged by pharmaceutical companies, with very few originating from health professionals. Complaints from health professionals are vital to ensure the system is robust, as very often health professionals are in the best position to scrutinise promotional practice. For example, it is very difficult for anyone other than health professionals to monitor the activities of pharmaceutical representatives.

If a promotional claim is in breach of the Code, the APMA Code of Conduct Subcommittee may impose a sanction. Sanctions include the requirement to cease or modify the promotional practice, publishing corrective letters or retraction statements, the imposition of fines of up to $30000 or expulsion from the APMA membership. For example, a complaint was lodged regarding a promotional letter that claimed that fluvastatin was 'the ideal first-line statin'. This claim was found to be unsubstantiated. The letter was also found to imply use for an unapproved indication. As a result, the company was required to withdraw the promotional material, send a corrective letter to all recipients of the original letter and pay a $10 000 fine.³

There has been much debate over whether codes of conduct are an effective mechanism for controlling pharmaceutical promotion.^4,5 A series of studies by clinical pharmacologists, conducted between 1985 and 1992, led to the conclusion that the quality of information in advertisements had improved.⁶ The adherence of many other activities, such as symposia and the activities of pharmaceutical representatives, to the Code has not been well studied. A small study of pharmaceutical representatives' presentations to doctors suggested that the information provided was not always accurate, nor in accordance with the Code.⁷

The current system is limited by the retrospective detection of Code breaches. Complaints against misleading or inaccurate promotional messages can only be lodged after the messages have been published, by which time they have had the potential to influence practice. Monitoring does not overcome this, as it is also retrospective. While promotional messages which are in breach of the Code may be required to be withdrawn and not appear in future, this does not redress their prior dissemination. The only recourse for re-education under the current system is the publication of corrective letters. The success of corrective letters as a method for righting erroneous beliefs that have resulted from misleading promotion is an area that requires more consideration.

Although fines can be imposed for Code breaches, when compared with promotional budgets these may not be significant. The uppermost sanction that can be imposed is expulsion from membership of the APMA, a sanction which has not yet been employed. A further limitation is that non-member companies are not bound by the Code.

These limitations highlight the need for a co-regulatory approach to pharmaceutical promotion. Government must take an active stance in regulating promotional practice where the Code of Conduct is limited. Further, the regulatory system is strengthened if an active, interested third party operates a 'watchdog' role. Support for an organisation of this type is warranted. In Australia, the Medical Lobby for Appropriate Marketing has undertaken this role in recent years, although limited funding has reduced its capacity to continue this activity.

Even if the Code worked optimally, practitioners should be aware that promotional messages can be accurate but may still not support the quality use of medicines. This situation arises because medicines may be promoted for any indication listed in the approved product information. These indications may not reflect the objective recommendations of independent sources of information such as the Therapeutic Guidelines or the Australian Medicines Handbook. For example, dextropropoxyphene is indicated for mild to moderate pain, but the Australian Medicines Handbook recommends its use should be avoided as 'a systematic overview of current trials indicates that the combination of dextropropoxyphene with paracetamol has no greater analgesic effect than paracetamol alone for moderate pain such as that after surgery'.

Enforcement of the APMA Code of Conduct is vital to ensuring that the system is effective. The current self-regulatory system relies on a complaints mechanism for recognising Code breaches. This system can only be effective if complaints are lodged whenever there is concern that promotional practice is inappropriate. It is essential that health professionals become more active participants in this process.

To lodge a complaint or to obtain a copy of the Code of Conduct, please write to:

Australian Pharmaceutical Manufacturers Association
Level 7, 88 Walker Street
North Sydney NSW 2060

Telephone: (02) 9922 2699
Facsimile: (02) 9959 4860

Web site: http://www.apma.com.au

The following statements are either true or false.

1. All advertisements for prescription medicines have to be checked, before publication, by the Australian Pharmaceutical Manufacturers Association.

2. Pharmaceutical samples should not be left with a doctor's receptionist unless the doctor has made a written request for them.

Answers to self-test questions

1. False

2. True