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Direct-to-consumer advertising of pharmaceuticals

July 2016

Position statement 88


Summary

Direct-to-consumer advertising runs counter to the principles of best possible care for mental health consumers. Accordingly, the RANZCP advocates for a revision of the current legislation allowing direct-to-consumer advertising in all countries where it is currently operating.

Introduction

The Royal Australian and New Zealand College of Psychiatrists (RANZCP) encourages its members to implement best practice principles and make clinical decisions based on the best available evidence. A key role of the RANZCP is promoting the best possible care for mental health consumers. In the view of the RANZCP, direct-to-consumer advertising runs counter to these principles. Accordingly, the RANZCP advocates for a revision of the current legislation allowing direct-to-consumer advertising in all countries where it is currently operating.

Definition of DTCA

Direct-to-consumer advertising (DTCA) is a form of promotion that aims to market prescription pharmaceutical products to the end patient rather than health care professionals. DTCA for pharmaceutical products can appear in a variety of media, including magazines, newspapers, social media, TV and radio. DTCA can have a variety of purposes – for instance, to convince customers that a company’s pharmaceutical products are the best, inform consumers about uses for established products or announce new products (FDA, 2015; Ventola, 2011).

Background

Only a few countries currently permit DTCA, including the United States and New Zealand. In Australia, DTCA is prohibited under the Therapeutic Goods Act 1989 and the Competition and Consumer Act 2010. In New Zealand, the Medicines Act 1981 outlines the regulations relating to the advertising of medicines and medical devices. When the legislation was enacted in 1981, prescription medicines were not widely advertised and it was not until 1997 when the United States relaxed regulations around advertising pharmaceuticals that New Zealand experienced an increase in DTCA.

Impacts of DTCA

The RANZCP has carefully considered both the negative and positive impacts DTCA may have on the provision of healthcare:
  • Providing information to consumers - The pharmaceutical industry argues that the benefits of DTCA include disseminating health information about illnesses and treatment, reducing stigma and empowering consumers by providing information and encouraging choice. However, research suggests that information provided to consumers by the pharmaceutical industry is likely to be biased in favour of benefits over potential harms. A recent study found that only 13% of pharmaceutical advertisements provided any evidence to support their claims about efficacy (Schwartz and Woloshin, 2013). Where evidence is made available, the data tends to exaggerate the magnitude of the benefits (Every-Palmer, Duggal & Menkes, 2014).
  • Issues relating to prescribing and potential harm - Studies conducted in the United States found that consumers exposed to DTCA were more likely to believe that they needed medication, to request products advertised on television, and to receive prescriptions for these products (Gilbody et al., 2005). There are also examples where significant harm has arisen from under-reporting of safety risks. For example in 2012, Glaxo Smith Kline promoted the safe use of an antidepressant in a paediatric setting despite established concerns about the risk profile in this population (Bond, 2013). DTCA also encourages health professionals to engage in prescribing off-label uses of pharmaceutical products where the potential to cause consumer harm may increase further (Humphreys, 2009).
  • Impact on the doctor-patient relationship - DTCA may affect the doctor-patient relationship inseveral ways. Most commonly, DTCA prompts consumers to request advertised drugs. Whilesometimes useful, many doctors (especially general practitioners) find themselves being asked to prescribe medications that they do not consider are clinically indicated (Robinson et al., 2004; Humphreys, 2009). Resisting consumers’ requests may place the therapeutic relationship under stress and may lengthen the duration of consultations (Robinson et al., 2004).
  • Potential cost implications for the consumer and tax-payer - The pharmaceutical industry invests significantly in marketing and promoting branded products, which often have no efficacy advantage over generic alternatives. Higher costs are passed on to the consumer and tax-payer. In 2011, GSK phased out the asthma inhaler Becotide and replaced it with the more expensive but generally equivalent Flixotide. GSK developed a million dollar promotional campaign targeted at consumers that generated sales of $3 million (McMillian, 2011) demonstrating how DTCA can increase pharmaceutical costs.
The NZ national drug purchaser PHARMAC has been successful in containing pharmaceutical costs by sourcing generic pharmaceuticals, making the New Zealand health sector one of the most costeffective
in the OECD (Commonwealth Fund, 2014). A British study found that potential savings of £1 billion (out of a total pharmaceutical budget of £9 billion) could be made by doctors prescribing generic alternatives (Moon et al., 2011).

The proponents of DTCA suggest there are benefits in advertising prescription medicines. Some arguments put forward are it ‘meets consumers’ desire for information, that a DTCA-initiated enquiry is positive for health professionals, who can use it to discuss the reason for the request and relevant treatment options’ (Ministry of Health, 2006). DTCA is also argued to prompt consumers to ‘seek more information about their health status and resulting in higher levels of compliance with treatment regimes’ (Hoek, 2001).

The RANZCP considers that the potential adverse impacts of DTCA outweigh the potential benefits. Independent research conducted by Massey University in New Zealand concluded that the benefit information is communicated more effectively than risk information (Hoek, 2001).

The RANZCP supports the prohibition of DTCA in all countries, therefore, we advocate DTCA is discontinued in New Zealand and not introduced in Australia.

Recommendations

The RANZCP recommends the following actions:
  • That the RANZCP works collaboratively with other medical colleges and health organisations to promote prohibition of DTCA.
  • That the RANZCP works with Australian and New Zealand regulatory bodies to improve health literacy to help ensure that consumers / patients are able to make better informed decisions about pharmaceutical products.
  • That dialogue between consumers and health practitioners should be encouraged to ensure that the best treatment options are considered in an environment as free as possible from any commercial influence.

Commonwealth Fund (2014) International Profiles of Health Care Systems. Available at:
www.commonwealthfund.org/~/media/files/publications/fundreport/
2015/jan/1802_mossialos_intl_profiles_2014_v7.pdf.

Every-Palmer S, Duggal, R, Menkes, DB (2014) Direct-to-consumer advertising of prescription
medication in New Zealand.
New Zealand Medical Journal 127: 102-110.

Food and Drug Administration, United States (FDA) (2015) Drug Advertising: A Glossary of Terms.
Available at:
www.fda.gov/Drugs/ResourcesForYou/Consumers/PrescriptionDrugAdvertising/ucm072025.htm#D

Gilbody S, Wilson P, Watt I. Benefits and harms of direct to consumer advertising: a systematic review
(2005) Quality and Safety Health Care 14: 246-50.

Hoek J et al. (2001) Could Less be More? An Analysis of Direct to Consumer Advertising of Prescription
Medicines
. Marketing Bulletin 12, Article 1.

Humphreys G (2009) Direct-to-consumer advertising under fire. Bulletin of the World Health Organization
87(8): 576–577.

Menkes DB (2011) New Zealand doctors and the pharmaceutical industry—time to cut the cord? New
Zealand Medical Journal
1341: 6-8.

Ministry of Health (2006) Direct-to-Consumer Advertising of Prescription Medicines in New Zealand:
Summary of Submissions.


Moon J Fleet AS Godman BB et al. (2011) Getting better value from the NHS drugs budget. British
Medical Journal
342: 30-2.

Robinson AR, Hohmann KB, Rifkin JI, Topp D, Gilroy CM, Pickard JA, Anderson RJ (2004) Direct-to-consumer
pharmaceutical advertising: physician and public opinion and potential effects on the physician-patient relationship. Archive of Internal Medicine 164(4): 427-32.

Schwartz LM and Woloshin S (2013) The Drug Facts Box: Improving the communication of prescription
drug information. National Academy of Science USA 110: 14069-74.

Ventola CL (2011) Direct-to-consumer pharmaceutical advertising: therapeutic or toxic? PT 36(10): 669–
684.


Disclaimer: This information is intended to provide general guidance to practitioners, and should not be relied on as a substitute for proper assessment with respect to the merits of each case and the needs of the patient. The RANZCP endeavours to ensure that information is accurate and current at the time of preparation, but takes no responsibility for matters arising from changed circumstances, information or material that may have become subsequently available.