Starter packs: a good start to therapy?

Samples of drugs are often given to doctors by pharmaceutical representatives as part of a marketing strategy. Despite the well described advantages of drug samples, little has been published on the potential adverse outcomes. A series of consumer calls to the Adverse Medicine Events Line has highlighted concerns regarding the quality use of medicines associated with drug samples. The most commonly reported problems were drug samples being supplied to patients with inadequate information regarding dosage, administration, storage and possible adverse effects. In addition, some patients were given excessive quantities of a drug. To reduce such adverse outcomes, the drug industry, health professionals and consumers should be aware of the potential problems associated with starter packs.

Starter packs are samples of drugs given to doctors by pharmaceutical representatives, often as part of a marketing strategy. Medicines Australia's Code of Conduct states that starter packs are '… a quantity of a product supplied without cost to medical practitioners, dentists and hospital pharmacists'.¹

There are both advantages and disadvantages in the provision of starter packs. From a manufacturer's perspective, starter packs provide an avenue to introduce new or unique products to the marketplace. Evidence suggests that drug samples influence prescribing behaviour and increase prescribing of a particular product.^2,3,4,5 Advantages for doctors include being able to assess the efficacy or tolerability of new treatments and to provide immediate treatment such as antibiotics after hours. This is especially beneficial in remote or rural populations. Likewise, patients can try a new drug before having to pay for a prescription and may be able to access drugs that are not yet available on the Pharmaceutical Benefits Scheme (PBS).

These advantages must be weighed against significant, but less well described, disadvantages. These include unregulated supply and the potential for:

• use of expensive medicines when effective and less expensive alternatives are available^4,6
• increased demand for drugs not listed on the PBS
• issue of expired or poorly stored stock⁷
• inability to track or recall the product⁷
• medicine issued without a label or accompanying consumer medicines information.⁸

Samples are big business. Marketing expenditure on drug samples by American pharmaceutical companies has increased annually since 1996, with a total estimated allocation of US$10.5 billion in 2001.⁹ Yet a recent literature review identified only 23 papers that had studied the impact of sampling in any capacity. The primary focus of these studies was the influence of drug samples on prescribing behaviour. Very little has been published on the potential adverse outcomes associated with samples.¹⁰

The Adverse Medicine Events Line is a national consumer hotline for reporting 'when things go wrong with medicines'. This two-year project, funded by the Australian Council for Safety and Quality in Health Care and operated by Mater Pharmacy Services, identified a series of calls from consumers where provision of starter packs by doctors resulted in either poor quality use of medicines or an adverse outcome. The motivation for these consumer calls was primarily inadequate drug information. None of the samples had been labelled, none was accompanied by consumer medicines information or simple written instructions regarding dosage, administration, indication, storage, possible interactions or adverse effects. The nature of these events and the related quality use of medicine problems are described in Table 1.

This series of cases shows that lack of information accompanying starter packs can cause medicine misadventure, specifically:

• increased patient anxiety
• treatment delay
• unintended doubling-up of similar medicines
• inadvertent use of two strengths of the same medicine
• inappropriate use due to patient confusion.

In addition, this case series highlighted the fact that some patients were being given excessive quantities of a drug. With starter packs, there is also an increased potential for medication error when the same health professional prescribes, dispenses and possibly administers the drug without any checks on the process.

The provision of starter packs by primary health carers requires that medicines be appropriately labelled and accompanied by consumer medicines information or equivalent. Failure to label starter packs contravenes some state and territory legislation. A legislative review¹¹led to agreement that labelling of prescription starter packs will be regulated.¹The feasibility of this remains to be determined.

To minimise medicinal misadventure, the drug industry, health professionals and consumers need to be aware of the potential consequences for the quality use of medicines when starter packs are provided.